For the purposes of this subchapter, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The singular form shall also signify the plural and the masculine form shall also signify the feminine. Words undefined in the following paragraphs shall have the meaning attributed to them in general usage as reflected by definitions in a standard dictionary.
Act means the Act of August 24, 1966 (Pub. L. 89-544), (commonly known as the Laboratory Animal Welfare Act), as amended by the Act of December 24, 1970 (Pub. L. 91-579), (the Animal Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279), (the Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L. 99-198), (the Food Security Act of 1985), and as it may be subsequently amended.
Activity means, for purposes of part 2, subpart C of this subchapter, those elements of research, testing, or teaching procedures that involve the care and use of animals.
Administrative unit means the organizational or management unit at the departmental level of a research facility.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Ambient temperature means the air temperature surrounding the animal.
Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. This term also excludes falconry. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes.
Animal act means any performance of animals where such animals are trained to perform some behavior or action or are part of a show, performance, or exhibition.
APHIS official means any person employed by the Department who is authorized to perform a function under the Act and the regulations in 9 CFR parts 1, 2, and 3.
Attending veterinarian means a person who has graduated from a veterinary school accredited by the American Veterinary Medical Association's Council on Education, or has a certificate issued by the American Veterinary Medical Association's Education Commission for Foreign Veterinary Graduates, or has received equivalent formal education as determined by the Administrator; has received training and/or experience in the care and management of the species being attended; and who has direct or delegated authority for activities involving animals at a facility subject to the jurisdiction of the Secretary.
Bird means any member of the class Aves, excluding eggs, but including birds once the hatching process commences.
Bred for use in research means an animal that is bred in captivity and used for research, teaching, testing, or experimentation purposes.
Buffer area means that area in a primary enclosure for a swim-with-the-dolphin program that is off-limits to members of the public and that directly abuts the interactive area.
Business hours means a reasonable number of hours between 7 a.m. and 7 p.m. each week of the year, during which inspections by APHIS may be made.
Business year means the 12-month period during which business is conducted, and may be either on a calendar or fiscal-year basis.
Carrier means the operator of any airline, railroad, motor carrier, shipping line, or other enterprise which is engaged in the business of transporting any animals for hire. Except anyone transporting a migratory bird covered under the Migratory Bird Treaty Act from the wild to a facility for rehabilitation and eventual release in the wild, or between rehabilitation facilities, and has obtained authorization from the U.S. Fish and Wildlife Service for that purpose, is not a “carrier”.
Cat means any live or dead cat (Felis catus) or any cat-hybrid cross.
Class “A” licensee (breeder) means a person subject to the licensing requirements under part 2 and meeting the definition of a “dealer” (§ 1.1), and whose business involving animals consists only of animals that are bred and raised on the premises in a closed or stable colony and those animals acquired for the sole purpose of maintaining or enhancing the breeding colony.
Class “B” licensee means a person subject to the licensing requirements under part 2 and meeting the definition of a “dealer” (§ 1.1), and whose business includes the purchase and/or resale of any animal. This term includes brokers, and operators of an auction sale, as such individuals negotiate or arrange for the purchase, sale, or transport of animals in commerce. Such individuals do not usually take actual physical possession or control of the animals, and do not usually hold animals in any facilities. A class “B” licensee may also exhibit animals as a minor part of the business.
Class “C” licensee (exhibitor) means a person subject to the licensing requirements under part 2 and meeting the definition of an “exhibitor” (§ 1.1), and whose business involves the showing or displaying of animals to the public. A class “C” licensee may buy and sell animals as a minor part of the business in order to maintain or add to his animal collection.
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State, including any foreign country, or between points within the same State but through any place outside thereof, or within any territory, possession, or the District of Columbia; or
(2) Which affects the commerce described in this part.
Committee means the Institutional Animal Care and Use Committee (IACUC) established under section 13(b) of the Act. It shall consist of at least three (3) members, one of whom is the attending veterinarian of the research facility and one of whom is not affiliated in any way with the facility other than as a member of the committee, however, if the research facility has more than one Doctor of Veterinary Medicine (DVM), another DVM with delegated program responsibility may serve. The research facility shall establish the Committee for the purpose of evaluating the care, treatment, housing, and use of animals, and for certifying compliance with the Act by the research facility.
Dealer means any person who, in commerce, for compensation or profit, delivers for transportation, or transports, except as a carrier, buys, or sells, or negotiates the purchase or sale of: Any dog or other animal whether alive or dead (including unborn animals, organs, limbs, blood, serum, or other parts) for research, teaching, testing, experimentation, exhibition, or use as a pet; or any dog at the wholesale level for hunting, security, or breeding purposes. This term does not include: A retail pet store, as defined in this section; and any retail outlet where dogs are sold for hunting, breeding, or security purposes.
Department means the U.S. Department of Agriculture.
Deputy Administrator means the Deputy Administrator for Animal Care (AC) or any other official of AC to whom authority has been delegated to act in his stead.
Dog means any live or dead dog (Canis familiaris) or any dog-hybrid cross.
Dwarf hamster means any species of hamster such as the Chinese and Armenian species whose adult body size is substantially less than that attained by the Syrian or Golden species of hamsters.
Endangered species means those species defined in the Endangered Species Act (16 U.S.C. 1531 et seq.) and as it may be subsequently amended.
Euthanasia means the humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death
Exhibitor means any person (public or private) exhibiting any animals, which were purchased in commerce or the intended distribution of which affects commerce, or will affect commerce, to the public for compensation, as determined by the Secretary. This term includes carnivals, circuses, animal acts (including free-flighted bird shows), zoos, and educational exhibits, exhibiting such animals whether operated for profit or not. This term excludes retail pet stores, horse, dog, and pigeon races, an owner of a common, domesticated household pet who derives less than a substantial portion of income from a nonprimary source (as determined by the Secretary) for exhibiting an animal that exclusively resides at the residence of the pet owner, organizations sponsoring and all persons participating in State and country fairs, livestock shows, rodeos, field trials, coursing events, falconry, purebred dog and cat shows, bird fancier shows, and any other fairs or exhibitions intended to advance agricultural arts and sciences, as may be determined by the Secretary.
Exotic animal means any animal not identified in the definition of “animal” provided in this part that is native to a foreign country or of foreign origin or character, is not native to the United States, or was introduced from abroad. This term specifically includes animals such as, but not limited to, lions, tigers, leopards, elephants, camels, antelope, anteaters, kangaroos, and water buffalo, and species of foreign domestic cattle, such as Ankole, Gayal, and Yak.
Farm animal means any domestic species of cattle, sheep, swine, goats, llamas, horses, or poultry, which are normally and have historically been kept and raised on farms in the United States and used or intended for use as food or fiber, or for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. This term also includes animals such as rabbits, mink, chinchilla, and ratites when they are used solely for purposes of meat, fur, feathers, or skin, and animals such as horses and llamas when used solely as work and pack animals.
Federal agency means an Executive agency as such term is defined in section 105 of title 5, United States Code, and with respect to any research facility means the agency from which the research facility receives a Federal award for the conduct of research, experimentation, or testing involving the use of animals.
Federal award means any mechanism (including a grant, award, loan, contract, or cooperative agreement) under which Federal funds are used to support the conduct of research, experimentation, or testing, involving the use of animals. The permit system established under the authorities of the Endangered Species Act, the Marine Mammal Protection Act, and the Migratory Bird Treaty Act, are not considered to be Federal awards under the Animal Welfare Act.
Federal research facility means each department, agency, or instrumentality of the United States which uses live animals for research or experimentation.
Field study means a study conducted on free-living wild animals in their natural habitat. However, this term excludes any study that involves an invasive procedure, harms, or materially alters the behavior of an animal under study.
Handling means petting, feeding, watering, cleaning, manipulating, loading, crating, shifting, transferring, immobilizing, restraining, treating, training, working and moving, or any similar activity with respect to any animal.
Housing facility means any land, premises, shed, barn, building, trailer, or other structure or area housing or intended to house animals.
Hybrid cross means an animal resulting from the crossbreeding between two different species or types of animals. Crosses between wild animal species, such as lions and tigers, are considered to be wild animals. Crosses between wild animal species and domestic animals, such as dogs and wolves or buffalo and domestic cattle, are considered to be domestic animals.
Impervious surface means a surface that does not permit the absorption of fluids. Such surfaces are those that can be thoroughly and repeatedly cleaned and disinfected, will not retain odors, and from which fluids bead up and run off or can be removed without their being absorbed into the surface material.
Indoor housing facility means any structure or building with environmental controls housing or intended to house animals and meeting the following three requirements:
(1) It must be capable of controlling the temperature within the building or structure within the limits set forth for that species of animal, of maintaining humidity levels of 30 to 70 percent and of rapidly eliminating odors from within the building; and
(2) It must be an enclosure created by the continuous connection of a roof, floor, and walls (a shed or barn set on top of the ground does not have a continuous connection between the walls and the ground unless a foundation and floor are provided); and
(3) It must have at least one door for entry and exit that can be opened and closed (any windows or openings which provide natural light must be covered with a transparent material such as glass or hard plastic).
Interactive area means that area in a primary enclosure for a swim-with-the-dolphin program where an interactive session takes place.
Interactive session means a swim-with-the-dolphin program session where members of the public enter a primary enclosure to interact with cetaceans.
Intermediate handler means any person, including a department, agency, or instrumentality of the United States or of any State or local government (other than a dealer, research facility, exhibitor, any person excluded from the definition of a dealer, research facility, or exhibitor, an operator of an auction sale, or a carrier), who is engaged in any business in which he receives custody of animals in connection with their transportation in commerce. Except anyone transporting a migratory bird covered under the Migratory Bird Treaty Act from the wild to a facility for rehabilitation and eventual release in the wild, or between rehabilitation facilities, and has obtained authorization from the U.S. Fish and Wildlife Service for that purpose, is not an “intermediate handler”.
Inspector means any person employed by the Department who is authorized to perform a function under the Act and the regulations in 9 CFR parts 1, 2, and 3.
Institutional official means the individual at a research facility who is authorized to legally commit on behalf of the research facility that the requirements of 9 CFR parts 1, 2, and 3 will be met.
Isolation in regard to marine mammals means the physical separation of animals to prevent contact and a separate, noncommon, water circulation and filtration system for the isolated animals.
Licensed veterinarian means a person who has graduated from an accredited school of veterinary medicine or has received equivalent formal education as determined by the Administrator, and who has a valid license to practice veterinary medicine in some State.
Licensee means any person licensed according to the provisions of the Act and the regulations in part 2 of this subchapter.
Major operative procedure means any surgical intervention that penetrates and exposes a body cavity or any procedure which produces permanent impairment of physical or physiological functions.
Minimum horizontal dimension (MHD) means the diameter of a circular pool of water, or in the case of a square, rectangle, oblong, or other shape pool, the diameter of the largest circle that can be inserted within the confines of such a pool of water.
Mobile or traveling housing facility means a transporting vehicle such as a truck, trailer, or railway car, used to house animals while traveling for exhibition or public education purposes.
Nonconditioned animals means animals which have not been subjected to special care and treatment for sufficient time to stabilize, and where necessary, to improve their health.
Nonhuman primate means any nonhuman member of the highest order of mammals including prosimians, monkeys, and apes.
Operator of an auction sale means any person who is engaged in operating an auction at which animals are purchased or sold in commerce.
Outdoor housing facility means any structure, building, land, or premise, housing or intended to house animals, which does not meet the definition of any other type of housing facility provided in the regulations, and in which temperatures cannot be controlled within set limits.
Painful procedure as applied to any animal means any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied, that is, pain in excess of that caused by injections or other minor procedures.
Paralytic drug means a drug which causes partial or complete loss of muscle contraction and which has no anesthetic or analgesic properties, so that the animal cannot move, but is completely aware of its surroundings and can feel pain.
Person means any individual, partnership, firm, joint stock company, corporation, association, trust, estate, or other legal entity.
Pet animal means any animal that has commonly been kept as a pet in family households in the United States, such as dogs, cats, guinea pigs, rabbits, hamsters, and birds. This term also includes but is not limited to such birds as canaries, cockatiels, lovebirds, and budgerigar parakeets. This term excludes exotic animals and wild animals.
Positive physical contact means petting, stroking, or other touching, which is beneficial to the well-being of the animal.
Poultry means any species of chickens, turkeys, swans, partridges, guinea fowl, and pea fowl; ducks, geese, pigeons, and doves; grouse, pheasants, and quail.
Pound or shelter means a facility that accepts and/or seizes animals for the purpose of caring for them, placing them through adoption, or carrying out law enforcement, whether or not the facility is operated for profit.
Primary conveyance means the main method of transportation used to convey an animal from origin to destination, such as a motor vehicle, plane, ship, or train.
Primary enclosure means any structure or device used to restrict an animal or animals to a limited amount of space, such as a room, pen, run, cage, compartment, pool, or hutch.
Principal investigator means an employee of a research facility, or other person associated with a research facility, responsible for a proposal to conduct research and for the design and implementation of research involving animals.
Quorum means a majority of the Committee members.
Random source means dogs and cats obtained from animal pounds or shelters, auction sales, or from any person who did not breed and raise them on his or her premises.
Registrant means any research facility, carrier, intermediate handler, or exhibitor not required to be licensed under section 3 of the Act, registered pursuant to the provisions of the Act and the regulations in part 2 of this subchapter.
Research facility means any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that (1) purchases or transports live animals in commerce, or (2) receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments: Provided, That the Administrator may exempt, by regulation, any such school, institution, organization, or person that does not use or intend to use live dogs or cats, except those schools, institutions, organizations, or persons, which use substantial numbers (as determined by the Administrator) of live animals the principal function of which schools, institutions, organizations, or persons, is biomedical research or testing, when in the judgment of the Administrator, any such exemption does not vitiate the purpose of the Act.
Retail pet store means a place of business or residence at which the seller, buyer, and the animal available for sale are physically present so that every buyer may personally observe the animal prior to purchasing and/or taking custody of that animal after purchase, and where only the following animals are sold or offered for sale, at retail, for use as pets: Dogs, cats, rabbits, guinea pigs, hamsters, gerbils, rats, mice, gophers, chinchillas, domesticated ferrets, domesticated farm-type animals, birds, and coldblooded species. Such definition excludes -
(1) Establishments or persons who deal in dogs used for hunting, security, or breeding purposes;
(2) Establishments or persons exhibiting, selling, or offering to exhibit or sell any wild or exotic or other nonpet species of warmblooded animals such as skunks, raccoons, nonhuman primates, squirrels, ocelots, foxes, coyotes, etc.;
(3) Any establishment or person selling warmblooded animals (except laboratory rats and mice) for research or exhibition purposes;
(4) Any establishment wholesaling any animals (except rats and mice); and
(5) Any establishment exhibiting pet animals in a room that is separate from or adjacent to the retail pet store, or in an outside area, or anywhere off the retail pet store premises.
Sanctuary area means that area in a primary enclosure for a swim-with-the-dolphin program that is off-limits to the public and that directly abuts the buffer area.
Sanitize means to make physically clean and to remove and destroy, to the maximum degree that is practical, agents injurious to health.
Secretary means the Secretary of Agriculture of the United States or his representative who shall be an employee of the Department.
Sheltered housing facility means a housing facility which provides the animals with shelter; protection from the elements; and protection from temperature extremes at all times. A sheltered housing facility may consist of runs or pens totally enclosed in a barn or building, or of connecting inside/outside runs or pens with the inside pens in a totally enclosed building.
Standards means the requirements with respect to the humane housing, exhibition, handling, care, treatment, temperature, and transportation of animals by dealers, exhibitors research facilities, carriers, intermediate handlers, and operators of auction sales as set forth in part 3 of this subchapter.
State means a State of the United States, the District of Columbia, Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, or any other territory or possession of the United States.
Study area means any building room, area, enclosure, or other containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 12 hours.
Swim-with-the-dolphin (SWTD) program means any human-cetacean interactive program in which a member of the public enters the primary enclosure in which an SWTD designated cetacean is housed to interact with the animal. This interaction includes, but such inclusions are not limited to, wading, swimming, snorkeling, or scuba diving in the enclosure. This interaction excludes, but such exclusions are not limited to, feeding and petting pools, and the participation of any member(s) of the public audience as a minor segment of an educational presentation or performance of a show.
Transporting device means an interim vehicle or device, other than man, used to transport an animal between the primary conveyance and the terminal facility or in and around the terminal facility of a carrier or intermediate handler.
Transporting vehicle means any truck, car, trailer, airplane, ship, or railroad car used for transporting animals.
Weaned means that a mammal has become accustomed to take solid food and has so done, without nursing, for a period of at least 5 consecutive days; or that a bird has become accustomed to take food and has so done, without supplemental feeding from a parent or human caretaker, for a period of at least 5 consecutive days.
Wild animal means any animal which is now or historically has been found in the wild, or in the wild state, within the boundaries of the United States, its territories, or possessions. This term includes, but is not limited to, animals such as: Deer, skunk, opossum, raccoon, mink, armadillo, coyote, squirrel, fox, wolf.
Wild state means living in its original, natural condition; not domesticated.
Zoo means any park, building, cage, enclosure, or other structure or premise in which a live animal or animals are kept for public exhibition or viewing, regardless of compensation.
(a)(1) No person shall operate as a dealer, exhibitor, or operator of an auction sale, without a valid license, except persons who are exempt from the licensing requirements under paragraph (a)(3) of this section. A person must be 18 years of age or older to obtain a license. A person seeking a license shall apply on a form which will be furnished by the Deputy Administrator. The applicant shall provide the information requested on the application form, including, but not limited to:
(i) The name of the person applying for the license;
(ii) A valid mailing address through which the applicant can be reached at all times;
(iii) Valid addresses for all locations, facilities, premises, or sites where animals, animal facilities, equipment, and records are held, kept, or maintained;
(iv) The anticipated maximum number of animals on hand at any one time during the period of licensure;
(v) The anticipated type of animals described in paragraph (b)(2)(ii) of this section to be owned, held, maintained, sold, or exhibited, including those animals leased, during the period of licensure;
(vi) If the person is seeking a license as an exhibitor, whether the person intends to exhibit any animal at any location other than the person's location(s) listed pursuant to paragraph (a)(1)(iii) of this section; and
(vii) Disclosure of any plea of nolo contendere (no contest) or finding of violation of Federal, State, or local laws or regulations pertaining to animal cruelty or the transportation, ownership, neglect, or welfare of animals.
(2) The completed application form, along with a $120 license fee, shall be submitted to the appropriate Animal Care office.
(3) The following persons are exempt from the licensing requirements under section 2 or section 3 of the Act:
(i) Retail pet stores as defined in part 1 of this subchapter;
(ii) Any person who sells or negotiates the sale or purchase of any animal except wild or exotic animals, dogs, or cats, and who derives no more than $500 gross income from the sale of such animals during any calendar year and is not otherwise required to obtain a license;
(iii) Any person who maintains a total of four or fewer breeding female pet animals as defined in part 1 of this subchapter, small exotic or wild mammals (such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, jerboas, domesticated ferrets, chinchillas, and gerbils), and/or domesticated farm-type animals (such as cows, goats, pigs, sheep, llamas, and alpacas) and sells only the offspring of these animals, which were born and raised on his or her premises, for pets or exhibition, and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively maintains a total of more than four of these breeding female animals, regardless of ownership, or to any person maintaining such breeding female animals on premises on which more than four of these breeding female animals are maintained, or to any person acting in concert with others where they collectively maintain a total of more than four of these breeding female animals, regardless of ownership. Also exempt from licensing is any person who sells 200 or fewer pet birds 250 grams or less annually, and/or sells 8 or fewer pet birds more than 250 grams annually, determined by average adult weight of the species, which were born and raised on his or her premises, for pets or exhibition, and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively sells more than 200 pet birds 250 grams or less annually, and/or sells more than 8 pet birds more than 250 grams annually, regardless of ownership;
(iv) Any person who sells fewer than 25 dogs and/or cats per year, which were born and raised on his or her premises, for research, teaching, or testing purposes or to any research facility and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively sells 25 or more dogs and/or cats, regardless of ownership, nor to any person acting in concert with others where they collectively sell 25 or more dogs and/or cats, regardless of ownership. The sale of any dog or cat not born and raised on the premises for research purposes requires a license;
(v) Any person who arranges for transportation or transports animals solely for the purpose of breeding, exhibiting in purebred shows, boarding (not in association with commercial transportation), grooming, or medical treatment, and is not otherwise required to obtain a license;
(vi) Any person who buys, sells, transports, or negotiates the sale, purchase, or transportation of any animals used only for the purposes of food, feathers, skin, or fiber (including fur);
(vii) Any person who maintains a total of eight or fewer pet animals as defined in part 1 of this subchapter, small exotic or wild mammals (such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, jerboas, domesticated ferrets, chinchillas, and gerbils), and/or domesticated farm-type animals (such as cows, goats, pigs, sheep, llamas, and alpacas) for exhibition, and is not otherwise required to obtain a license. This exemption does not extend to any person acting in concert with others where they collectively maintain a total of more than eight of these animals for exhibition, regardless of possession and/or ownership;
(viii) Any person who maintains a total of four or fewer raptors for exhibition, holds a valid permit from the U.S. Fish and Wildlife Service, and is not otherwise required to obtain a license. This exemption does not extend to any person acting in concert with others where they collectively maintain a total of more than four raptors for exhibition, regardless of possession and/or ownership;
(ix) Any person who buys animals solely for his or her own use or enjoyment and does not sell or exhibit animals, or is not otherwise required to obtain a license;
(b)(1) No person shall have more than one license. Licenses are issued to specific persons, and are issued for specific activities, types and numbers of animals, and approved sites. A new license must be obtained upon change of ownership, location, activities, or animals. A licensee shall notify Animal Care no fewer than 90 days and obtain a new license before any change in the name, address, substantial control or ownership of his business or operation, locations, activities, and number or type of animals described in paragraph (b)(2) of this section. Any person who is subject to the regulations in this subchapter and who intends to exhibit any animal at any location other than the person's approved site must provide that information on their application form in accordance with paragraph (a) of this section and submit written itineraries in accordance with § 2.126.
(2) Licenses authorize a specific number and specific type(s) of animals, as follows:
(i) Licenses authorize increments of 50 animals on hand at any single point in time during the period of licensure. A licensee must obtain a new license before any change resulting in more than the authorized number of animals on hand at any single point in time during the period of licensure.
(ii) Licenses authorize the use of animals subject to subparts A through G in part 3 of this subchapter, except that, for animals subject to subparts D and F, licenses must specifically authorize the use of each of the following groups of animals: Group 5 (baboons and nonbrachiating species larger than 33 pounds) and Group 6 (great apes over 55 pounds and brachiating species) nonhuman primates; exotic and wild felids (including but not limited to lions, tigers, leopards, cheetahs, jaguars, cougars, lynx, servals, bobcats, and caracals, and any hybrid cross thereof); hyenas and/or exotic and wild canids (including but not limited to wolves, coyotes, foxes, and jackals); bears; and mega-herbivores (including but not limited to elephants, rhinoceroses, hippopotamuses, and giraffes). A licensee must obtain a new license before using any animal beyond those types or numbers of animals authorized under the existing license. Notwithstanding these provisions, a licensee in possession of birds on March 23, 2023, may continue to operate under that license until its scheduled expiration date. APHIS encourages such persons to apply for a new license at least 90 days before expiration of the current one.
(c) A license will be issued to any applicant, except as provided in §§ 2.9 through 2.11, when:
(1) The applicant has met the requirements of this section and §§ 2.2 and 2.3; and
(2) The applicant has paid a $120 license fee to the appropriate Animal Care office. The applicant may pay the fee by certified check, cashier's check, personal check, money order, or credit card. An applicant whose check is returned by a bank will be charged a fee of $20 for each returned check. If an applicant's check is returned, subsequent fees must be paid by certified check, cashier's check, money order, or credit card.
(d) The failure of any person to comply with any provision of the Act, or any of the provisions of the regulations or standards in this subchapter, shall constitute grounds for denial of a license or for its suspension or revocation by the Secretary, as provided in the Act.
Animal Care will supply a copy of the Act and the regulations and standards in this subchapter to an applicant upon request. Signing the application form is an acknowledgement that the applicant has reviewed the Act and the regulations and standards and agrees to comply with them.
(a) Each applicant for a license must demonstrate that his or her location(s) and any animals, facilities, vehicles, equipment, or other locations used or intended for use in the business comply with the Act and the regulations and standards set forth in parts 2 and 3 of this subchapter. Each applicant must make his or her animals, locations, facilities, vehicles, equipment, and records available for inspection during business hours and at other times mutually agreeable to the applicant and APHIS, to ascertain the applicant's compliance with the Act and the regulations and standards.
(b) Each applicant for a license must be inspected by APHIS and demonstrate compliance with the Act and the regulations and standards, as required in paragraph (a) of this section, before APHIS will issue a license. If the first inspection reveals that the applicant's animals, premises, facilities, vehicles, equipment, locations, or records do not meet the applicable requirements of this subchapter, APHIS will advise the applicant of existing deficiencies and the corrective measures that must be completed to come into compliance with the regulations and standards. An applicant who fails the first inspection may request up to two more inspections by APHIS to demonstrate his or her compliance with the Act and the regulations and standards. The applicant must request the second inspection, and if applicable, the third inspection, within 60 days following the first inspection.
(c) Any applicant who fails the third and final prelicense inspection may appeal all or part of the inspection findings to the Deputy Administrator. To appeal, the applicant must send a written statement contesting the inspection finding(s) and include any documentation or other information in support of the appeal. To receive consideration, the appeal must be received by the Deputy Administrator within 7 days of the date the applicant received the third prelicense inspection report. Within 7 days of receiving a timely appeal, the Deputy Administrator will issue a written response to notify the applicant whether APHIS will issue a license or deny the application.
(d) If an applicant fails inspection or fails to request reinspections within the 60-day period, or fails to submit a timely appeal of the third prelicense inspection report as described in paragraph (c) of this section, the applicant cannot reapply for a license for a period of 6 months from the date of the failed third inspection or the expiration of the time to request a third inspection. No license will be issued until the applicant pays the license fee and demonstrates upon inspection that the animals, premises, facilities, vehicles, equipment, locations, and records are in compliance with all applicable requirements in the Act and the regulations and standards in this subchapter.
A licensee or applicant for an initial license shall not interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official in the course of carrying out his or her duties.
(a) A license issued under this part shall be valid and effective for 3 years unless:
(1) The license has been revoked or suspended pursuant to section 19 of the Act or terminated pursuant to § 2.12.
(2) The license is voluntarily terminated upon request of the licensee, in writing, to the Deputy Administrator.
(3) The license has expired, except that:
(i) The Deputy Administrator may issue a temporary license, which automatically expires after 120 days, to an applicant whose immediately preceding 3-year license has expired, if:
(A) The applicant submits the appropriate application form before the expiration date of a preceding license; and
(B) The applicant had no noncompliances with the Act and the regulations and standards in parts 2 and 3 of this subchapter documented in any inspection report during the preceding period of licensure.
(ii) For expedited hearings occurring under § 2.11(b)(2), a license will remain valid and effective until the administrative law judge issues his or her initial decision. Should the administrative law judge's initial decision affirm the denial of the license application, the applicant's license shall terminate immediately.
(4) There will not be a refund of the license fee if a license is denied, or terminated, suspended, or revoked prior to its expiration date.
(b) Any person who seeks the reinstatement of a license that has expired or been terminated must follow the procedure applicable to new applicants for a license set forth in § 2.1.
(c) A license which is invalid under this part shall be surrendered to the Deputy Administrator. If the license cannot be found, the licensee shall provide a written statement so stating to the Deputy Administrator.
Any person who has been or is an officer, agent, or employee of a licensee whose license has been suspended or revoked and who was responsible for or participated in the activity upon which the order of suspension or revocation was based will not be licensed, or registered as a carrier, intermediate handler, dealer, exhibitor, or research facility, within the period during which the order of suspension or revocation is in effect.
(a) Any person whose license or registration has been suspended for any reason shall not be licensed, or registered, in his or her own name or in any other manner, within the period during which the order of suspension is in effect. No partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, will be licensed or registered during that period. Any person whose license has been suspended for any reason may apply to the Deputy Administrator, in writing, for reinstatement of his or her license or registration.
(b) Any person whose license has been revoked shall not be licensed or registered, in his or her own name or in any other manner, and no partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, will be licensed or registered.
(c) Any person whose license has been suspended or revoked shall not buy, sell, transport, exhibit, or deliver for transportation, any animal during the period of suspension or revocation, under any circumstances, whether on his or her behalf or on the behalf of another licensee or registrant.
(a) A license will not be issued to any applicant who:
(1) Has not complied with the requirements of §§ 2.1 through 2.4 and has not paid the fees indicated in § 2.1;
(2) Is not in compliance with the Act or any of the regulations or standards in this subchapter;
(3) Has had a license revoked or whose license is suspended, as set forth in § 2.1(d);
(4) Was an officer, agent, or employee of a licensee whose license has been suspended or revoked and who was responsible for or participated in the activity upon which the order of suspension or revocation was based, as set forth in § 2.9;
(5) Has pled nolo contendere (no contest) or has been found to have violated any Federal, State, or local laws or regulations pertaining to animal cruelty within 3 years of application, or after 3 years if the Administrator determines that the circumstances render the applicant unfit to be licensed;
(6) Is or would be operating in violation or circumvention of any Federal, State, or local laws; or
(7) Has made any false or fraudulent statements or provided any false or fraudulent records to the Department or other government agencies, or has pled nolo contendere (no contest) or has been found to have violated any Federal, State, or local laws or regulations pertaining to the transportation, ownership, neglect, or welfare of animals, or is otherwise unfit to be licensed and the Administrator determines that the issuance of a license would be contrary to the purposes of the Act.
(b)(1) An applicant whose initial license application has been denied may request a hearing in accordance with the applicable rules of practice in 7 CFR part 1 for the purpose of showing why the application for license should not be denied. The denial of an initial license application shall remain in effect until the final decision has been rendered. Should the license denial be upheld, the applicant may again apply for a license 1 year from the date of the final order denying the application, unless the order provides otherwise.
(2) An applicant who submitted a timely appeal of a third prelicense inspection as described in § 2.3(c), and whose appeal results in the denial of the license application, may request an expedited hearing if the applicant held a valid license when he or she submitted the license application that has been denied and the Deputy Administrator received such license application no fewer than 90 days prior to the expiration of the valid license. If the applicant meets the criteria in this paragraph (b)(2), and notwithstanding the timeframes of the proceedings set forth in the applicable rules of practice (7 CFR 1.130 through 1.151):
(i) The applicant must submit the request for an expedited hearing within 30 days of receiving notice from the Deputy Administrator that the license application has been denied;
(ii) The administrative law judge shall set the expedited hearing so that it occurs within 30 days of receiving a timely request for expedited hearing as described in paragraph (b)(2)(i) of this section; and
(iii) The administrative law judge must issue an initial decision no later than 30 days after the expedited hearing.
(iv) The applicant's license will remain valid until the administrative law judge issues his or her initial decision. Should the administrative law judge's initial decision affirm the denial of the license application, the applicant's license shall terminate immediately.
(c) No partnership, firm, corporation, or other legal entity in which a person whose license application has been denied has a substantial interest, financial or otherwise, will be licensed within 1 year of the license denial.
(d) No license will be issued under circumstances that the Administrator determines would circumvent any order, stipulation, or settlement agreement suspending, revoking, terminating, or denying a license or disqualifying a person from engaging in activities under the Act.
A license may be terminated at any time for any reason that a license application may be denied pursuant to § 2.11 after a hearing in accordance with the applicable rules of practice in 7 CFR part 1.
Except as otherwise provided in § 2.3(c), any licensee or registrant may appeal all or part of the inspection findings in an inspection report to the Deputy Administrator. To appeal, the licensee or registrant must send a written statement contesting the inspection finding(s) and include any documentation or other information in support of the appeal. To receive consideration, the appeal must be received by the Deputy Administrator within 21 days of the date the licensee or registrant received the inspection report that is the subject of the appeal.
(a) Each carrier and intermediate handler, and each exhibitor not required to be licensed under section 3 of the Act and the regulations of this subchapter, shall register with the Secretary by completing and filing a properly executed form which will be furnished, upon request, by the Deputy Administrator. The registration form shall be filed with the Deputy Administrator for the State in which the registrant has his or her principal place of business, and shall be updated every 3 years by the completion and filing of a new registration form which will be provided by the Deputy Administrator.
(b) A subsidiary of a business corporation, rather than the parent corporation, will be registered as an exhibitor unless the subsidiary is under such direct control of the parent corporation that the Secretary determines that it is necessary that the parent corporation be registered to effectuate the purposes of the Act.
(c) No registrant or person required to be registered shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
APHIS will supply a copy of the regulations and standards in this subchapter with each registration form. The registrant shall acknowledge receipt of and shall agree to comply with the regulations and standards by signing a form provided for this purpose by APHIS, and by filing it with the Deputy Administrator.
(a) A registrant shall notify the Deputy Administrator by certified mail of any change in the name, address, or ownership, or other change in operations affecting its status as an exhibitor, carrier, or intermediate handler, within 10 days after making such change.
(b)(1) A registrant which has not used, handled, or transported animals for a period of at least 2 years may be placed in an inactive status by making a written request to the Deputy Administrator a registrant shall notify the Deputy Administrator in writing at least 10 days before using, handling, or transporting animals again after being in an inactive status.
(2) A registrant which goes out of business or which ceases to function as a carrier, intermediate handler, or exhibitor, or which changes its method of operation so that it no longer uses, handles, or transports animals, and which does not plan to use, handle, or transport animals again at any time in the future, may have its registration canceled by making a written request to the Deputy Administrator. The former registrant is responsible for reregistering and demonstrating its compliance with the Act and regulations should it start using, handling, or transporting animals at any time after its registration is canceled.
(a) Requirements and procedures. (1) Each research facility, other than a Federal research facility, shall register with the Secretary by completing and filing a properly executed form which will be furnished, upon request, by the Deputy Administrator. The registration form shall be filed with the Deputy Administrator. Except as provided in paragraph (a)(2) of this section, where a school or department of a university or college uses or intends to use live animals for research, tests, experiments, or teaching, the university or college rather than the school or department will be considered the research facility and will be required to register with the Secretary. An official who has the legal authority to bind the parent organization shall sign the registration form.
(2) In any situation in which a school or department of a university or college demonstrates to the Secretary that it is a separate legal entity and its operations and administration are independent of those of the university or college, the school or department will be registered rather than the university or college.
(3) A subsidiary of a business corporation, rather than the parent corporation, will be registered as a research facility unless the subsidiary is under such direct control of the parent corporation that the Secretary determines that it is necessary that the parent corporation be registered to effectuate the purposes of the Act.
(b) Acknowledgment of regulations and standards. APHIS will supply a copy of the regulations and standards in this subchapter with each registration form. The research facility shall acknowledge receipt of and shall agree to comply with the regulations and standards by signing a form provided for this purpose by APHIS, and by filing it with the Deputy Administrator.
(c) Notification of change of operation. A research facility shall notify the Deputy Administrator in writing of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change. The Notification of Change form (APHIS Form 7033) may be used to provide the information.
(d) Duration of a registration and conditions for cancellation of a registration. (1) A research facility that goes out of business or ceases to function as a research facility, or that changes its method of operation so that it no longer uses, handles, or transports animals, and does not plan to use, handle, or transport animals at any time in the future, may have its registration canceled by making a written request to the Deputy Administrator.
(2) If the Deputy Administrator has sufficient evidence showing that a research facility has ceased to function as a research facility, then the Deputy Administrator may cancel the registration on its own, without a written request from the research facility.
(3) If a research facility plans to resume regulated activity, the facility is responsible for submitting a form (APHIS Form 7011A) to reregister at least 10 days prior to it using, handling, or transporting animals. There are no fees associated with such reregistration.
(e) Non-interference with APHIS officials. No research facility shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
(a) The Chief Executive Officer of the research facility shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to assess the research facility's animal program, facilities, and procedures. Except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility.
(b) IACUC membership. (1) The members of each Committee shall be appointed by the Chief Executive Officer of the research facility;
(2) The Committee shall be composed of a Chairman and at least two additional members;
(3) Of the members of the Committee:
(i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility;
(ii) At least one shall not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility. The Secretary intends that such person will provide representation for general community interests in the proper care and treatment of animals;
(4) If the Committee consists of more than three members, not more than three members shall be from the same administrative unit of the facility.
(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall:
(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A—Animal Welfare, as a basis for evaluation;
(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; Provided, however, That animal areas containing free-living wild animals in their natural habitat need not be included in such inspection;
(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility; Provided, however, That the IACUC may determine the best means of conducting evaluations of the research facility's programs and facilities; and Provided, further, That no Committee member wishing to participate in any evaluation conducted under this subpart may be excluded. The IACUC may use subcommittees composed of at least two Committee members and may invite ad hoc consultants to assist in conducting the evaluations, however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations. The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to APHIS and to officials of funding Federal agencies for inspection and copying upon request. The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I, subchapter A—Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity;
(4) Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees;
(5) Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities, or personnel training;
(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section;
(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and
(8) Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section.
(d) IACUC review of activities involving animals. (1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements:
(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals;
(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available;
(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments;
(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will:
(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time;
(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee;
(C) Not include the use of paralytics without anesthesia;
(v) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure;
(vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied;
(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian;
(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
(ix) Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on animals, other than rodents and birds, will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents and birds do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures;
(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless:
(A) Justified for scientific reasons by the principal investigator, in writing;
(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or
(C) In other special circumstances as determined by the Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234;
(xi) Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR part 1, § 1.1 of this subchapter, unless a deviation is justified for scientific reasons, in writing, by the investigator.
(2) Prior to IACUC review, each member of the Committee shall be provided with a list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full Committee review of those activities. If full Committee review is not requested, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities, and shall have the authority to approve, require modifications in (to secure approval), or request full Committee review of any of those activities. If full Committee review is requested for a proposed activity, approval of that activity may be granted only after review, at a convened meeting of a quorum of the IACUC, and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum;
(3) The IACUC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the IACUC unless they are also members of the IACUC;
(4) The IACUC shall notify principal investigators and the research facility in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the principal investigator an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator;
(5) The IACUC shall conduct complete reviews of activities covered by this subchapter at appropriate intervals as determined by the IACUC, but not less than every 3 years. The complete review shall address all requirements related to the care and use of animals under paragraphs (d) and (e) of this section. The IACUC shall be provided a written description of all activities that involve the care and use of animals for review and approval at the end of the term.
(6) The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present;
(7) If the IACUC suspends an activity involving animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any Federal agency funding that activity; and
(8) Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.
(e) A proposal to conduct an activity involving animals, or to make a significant change in an ongoing activity involving animals, must contain the following:
(1) Identification of the species and the approximate number of animals to be used;
(2) A rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used;
(3) A complete description of the proposed use of the animals;
(4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; and
(5) A description of any euthanasia method to be used.
(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel.
(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31.
(c) Training and instruction of personnel must include guidance in at least the following areas:
(1) Humane methods of animal maintenance and experimentation, including:
(i) The basic needs of each species of animal;
(ii) Proper handling and care for the various species of animals used by the facility;
(iii) Proper pre-procedural and post-procedural care of animals; and
(iv) Aseptic surgical methods and procedures;
(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress;
(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility;
(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act;
(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information:
(i) On appropriate methods of animal care and use;
(ii) On alternatives to the use of live animals in research;
(iii) That could prevent unintended and unnecessary duplication of research involving animals; and
(iv) Regarding the intent and requirements of the Act.
(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section:
(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the research facility;
(2) Each research facility shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use; and
(3) The attending veterinarian shall be a voting member of the IACUC; Provided, however, That a research facility with more than one Doctor of Veterinary Medicine (DVM) may appoint to the IACUC another DVM with delegated program responsibility for activities involving animals at the research facility.
(b) Each research facility shall establish and maintain programs of adequate veterinary care that include:
(1) The availability of appropriate facilities, personnel, equipment, and services to comply with the provisions of this subchapter;
(2) The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care;
(3) Daily observation of all animals to assess their health and well-being; Provided, however, That daily observation of animals may be accomplished by someone other than the attending veterinarian; and Provided, further, That a mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian;
(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and
(5) Adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures.
(a) The research facility shall maintain the following IACUC records:
(1) Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations;
(2) Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and
(3) Records of semiannual IACUC reports and recommendations (including minority views), prepared in accordance with the requirements of § 2.31(c)(3) of this subpart, and forwarded to the Institutional Official.
(b) Every research facility shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each live dog or cat purchased or otherwise acquired, owned, held, or otherwise in their possession or under their control, transported, euthanized, sold, or otherwise disposed of by the research facility. The records shall include any offspring born of any animal while in the research facility's possession or under its control:
(1) The name and address of the person from whom a dog or cat was purchased or otherwise acquired, whether or not the person is required to be licensed or registered under the Act;
(2) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(3) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(4) The date of acquisition of each dog or cat;
(5) The official USDA tag number or tattoo assigned to each dog or cat under § 2.38(g) of this subpart;
(6) A description of each dog or cat which shall include:
(i) The species and breed or type of animal;
(ii) The sex;
(iii) The date of birth or approximate age; and
(iv) The color and any distinctive markings;
(7) Any identification number or mark assigned to each dog or cat by the research facility;
(8) If dogs or cats are acquired from any person not licensed or registered under the Act and not a pound or shelter, the research facility must obtain a certification that the animals were born and raised on the person's premises and that the person has sold fewer than 25 dogs and/or cats that year.
(c) In addition to the information required to be kept and maintained by every research facility concerning each live dog or cat under paragraph (a) of this section, every research facility transporting, selling, or otherwise disposing of any live dog or cat to another person, shall make and maintain records or forms which fully and correctly disclose the following information:
(1) The name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of;
(2) The date of transportation, sale, euthanasia, or other disposition of the animal; and
(3) The method of transportation, including the name of the initial carrier or intermediate handler, or if a privately owned vehicle is used to transport the dog or cat, the name of the owner of the privately owned vehicle.
(d)(1) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Acquisition and Dogs and Cats on Hand (APHIS Form 7005) are forms which may be used by research facilities to keep and maintain the information required by paragraph (b) of this section.
(2) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Disposition of Dogs and Cats (APHIS Form 7006) are forms which may be used by research facilities to keep and maintain the information required by paragraph (c) of this section.
(e) One copy of the record containing the information required by paragraphs (b) and (c) of this section shall accompany each shipment of any live dog or cat sold or otherwise disposed of by a research facility; Provided, however, That, except as provided in § 2.133 of this part, information that indicates the source and date of acquisition of any dog or cat need not appear on the copy of the record accompanying the shipment. One copy of the record containing the information required by paragraphs (b) and (c) of this section shall be retained by the research facility.
(f) All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities' premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes. Release of any such materials, including reports, summaries, and photographs that contain trade secrets or commercial or financial information that is privileged or confidential will be governed by applicable sections of the Freedom of Information Act. Whenever the Administrator notifies a research facility in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the research facility shall hold those records until their disposition is authorized in writing by the Administrator.
(a) The reporting facility shall be that segment of the research facility, or that department, agency, or instrumentality of the United States that uses or intends to use live animals in research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report to the Deputy Administrator on or before December 1 of each calendar year. The report shall cover the previous Federal fiscal year. The Annual Report of Research Facility (APHIS Form 7023), Continuation Sheet for Annual Report of Research Facility (APHIS Form 7023A), and Annual Report of Research Facility Column E Explanation (APHIS Form 7023B) are forms which may be used to submit the information required by paragraph (b) of this section.
(b) The annual report shall:
(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility;
(2) Assure that each principal investigator has considered alternatives to painful procedures;
(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected;
(4) State the location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes;
(5) State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group;
(6) State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used;
(7) State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report;
(8) State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.
Each Federal research facility shall establish an Institutional Animal Care and Use Committee which shall have the same composition, duties, and responsibilities required of nonfederal research facilities by § 2.31 with the following exceptions:
(a) The Committee shall report deficiencies to the head of the Federal agency conducting the research rather than to APHIS; and
(b) The head of the Federal agency conducting the research shall be responsible for all corrective action to be taken at the facility and for the granting of all exceptions to inspection protocol.
(a) Information as to business: furnishing of same by research facilities. Each research facility shall furnish to any APHIS official any information concerning the business of the research facility which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations, and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information.
(b) Access and inspection of records and property. (1) Each research facility shall, during business hours, allow APHIS officials:
(i) To enter its place of business;
(ii) To examine records required to be kept by the Act and the regulations in this part;
(iii) To make copies of the records;
(iv) To inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations, and the standards in this subchapter; and
(v) To document, by the taking of photographs and other means, conditions and areas of noncompliance.
(2) The use of a room, table or other facilities necessary for the proper examination of the records and for inspection of the property or animals shall be extended to APHIS officials by the research facility.
(c) Publication of lists of research facilities subject to the provisions of this part. APHIS will publish on its website lists of research facilities registered in accordance with the provisions of this subpart. The lists may also be obtained upon request from the Deputy Administrator.
(d) Inspection for missing animals. Each research facility shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter its place of business to inspect animals and records for the purpose of seeking animals that are missing, under the following conditions:
(1) The police or other law officer shall furnish to the research facility a written description of the missing animal and the name and address of its owner before making a search;
(2) The police or other law officer shall abide by all security measures required by the research facility to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal.
(e) Confiscation and destruction of animals. (1) If an animal being held by a research facility is not being used to carry out research, testing, or experimentation, and is found by an APHIS official to be suffering as a result of the failure of the research facility to comply with any provision of the regulations or the standards set forth in this subchapter, the APHIS official shall make a reasonable effort to notify the research facility of the condition of the animal(s) and request that the condition be corrected and that adequate care be given to alleviate the animal's suffering or distress, or that the animal(s) be destroyed by euthanasia. In the event that the research facility refuses to comply with this request, the APHIS official may confiscate the animal(s) for care, treatment, or disposal as indicated in paragraph (e)(2) of this section, if, in the opinion of the Administrator, the circumstances indicate the animal's health is in danger.
(2) In the event that the APHIS official is unable to locate or notify the research facility as required in this section, the APHIS official shall contact a local police or other law officer to accompany him or her to the premises and shall provide for adequate care when necessary to alleviate the animal's suffering. If, in the opinion of the Administrator, the condition of the animal(s) cannot be corrected by this temporary care, the APHIS official shall confiscate the animal(s).
(3) Confiscated animals may be placed, by sale or donation, with other registrants or licensees that comply with the standards and regulations and can provide proper care, or they may be euthanized. The research facility from which the animals were confiscated shall bear all costs incurred in performing the placement or euthanasia activities authorized by this section.
(f) Handling. (1) Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.
(2)(i) Physical abuse shall not be used to train, work, or otherwise handle animals.
(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals; Provided, however: That the short-term withholding of food or water from animals, when specified in an IACUC-approved activity that includes a description of monitoring procedures, is allowed by these regulations.
(g) Identification of dogs and cats. (1) All live dogs or cats, including those from any exempt source, delivered for transportation, transported, purchased or otherwise acquired, sold, or disposed of by a research facility, shall be identified at the time of such delivery for transportation, purchase, sale, disposal, or acquisition in one of the following ways:
(i) By the official tag or tattoo which was affixed to the animal at the time it was acquired by the research facility, as required by this section; or
(ii) By a tag, tattoo, or collar, applied to the live dog or cat by the research facility and which individually identifies the dog or cat by number.
(2) All official tag or tattoo numbers shall be correctly listed in the records of purchase, acquisition, disposal, or sale which shall be maintained in accordance with § 2.35.
(3) Unweaned puppies or kittens need not be individually identified while they are maintained as a litter with their dam in the same primary enclosure, provided the dam has been individually identified.
(4) The official tag shall be made of a durable alloy such as brass, bronze, or steel, or of a durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may also be used. The tag may be circular in shape and not less than 1
(5) Each tag shall have the following information embossed or stamped on so that it is easily readable:
(i) The letters “USDA”;
(ii) Numbers identifying the State and dealer, exhibitor, or research facility (e.g., 39-AB); and
(iii) Numbers identifying the animal (e.g., 82488).
(6) Official tags shall be serially numbered and shall be applied to dogs or cats in the manner set forth in this section in as close to consecutive numerical order as possible. No tag number shall be used to identify more than one animal or shall be reused within a 5-year period.
(7) Research facilities may obtain, at their own expense, official tags from commercial tag manufacturers.
(8) Each research facility shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a research facility, the facility shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the research facility shall affix another official tag to the animal in the manner prescribed in this section and record the tag number on the official records.
(9) When a dog or cat wearing or identified by an official tag arrives at a research facility, the facility may continue to use that tag to identify the dog or cat or the tag may be replaced as indicated in paragraph (g)(1) of this section. All tags removed by a research facility shall be retained and disposed of as indicated in this section.
(10) Where a dog or cat to which is affixed or which is identified by an official tag is euthanized, or dies from other causes, the research facility shall remove and retain the tag for the required period, as set forth in paragraph (g)(11) of this section.
(11) All official tags removed and retained by a research facility shall be held until called for by an APHIS official or for a period of 1 year.
(12) When official tags are removed from animals for disposal, the tags must be disposed of so as to preclude their reuse for animal identification. No animal identification number shall be used within any 5-year period following its previous use.
(h) Health certification. (1) No research facility, including a Federal research facility, shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state that:
(i) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and
(ii) When so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health.
(2) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234.
(3) The U.S. Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used for health certification by a licensed veterinarian as required by this section.
(i) Holding of animals. If any research facility obtains prior approval of the Deputy Administrator, it may arrange to have another person hold animals: Provided, That:
(1) The other person agrees, in writing, to comply with the regulations in this part and the standards in part 3 of this subchapter, and to allow inspection of the premises by an APHIS official during business hours;
(2) The animals remain under the total control and responsibility of the research facility; and
(3) The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration. APHIS Form 7009 shall be used for approval.
(4) The other person or premises must either be directly included in the research facility's contingency plan required under paragraph (l) of this section or must develop its own contingency plan in accordance with paragraph (l) of this section.
(j) Holding period. Research facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons shall hold the animals for 5 full days, not including the day of acquisition, after acquiring the animal, excluding time in transit, before they may be used by the facility. Research facilities shall comply with the identification of animals requirements set forth in § 2.38(g) during this period.
(k) Compliance with standards and prohibitions. (1) Each research facility shall comply in all respects with the regulations set forth in subpart C of this part and the standards set forth in part 3 of this subchapter for the humane handling, care, treatment, housing, and transportation of animals; Provided, however, That exceptions to the standards in part 3 and the provisions of subpart C of this part may be made only when such exceptions are specified and justified in the proposal to conduct the activity and are approved by the IACUC.
(2) No person shall obtain live dogs or cats by use of false pretenses, misrepresentation, or deception.
(3) No person shall acquire, buy, sell, exhibit, use for research, transport, or offer for transportation, any stolen animal.
(4) Each research facility shall comply with the regulations set forth in § 2.133 of subpart I of this part.
(l) Contingency planning. (1) Research facilities must develop, document, and follow an appropriate plan to provide for the humane handling, treatment, transportation, housing, and care of their animals in the event of an emergency or disaster (one which could reasonably be anticipated and expected to be detrimental to the good health and well-being of the animals in their possession). Such contingency plans must:
(i) Identify situations the facility might experience that would trigger the need for the measures identified in a contingency plan to be put into action including, but not limited to, emergencies such as electrical outages, faulty HVAC systems, fires, and animal escapes, as well as natural disasters the facility is most likely to experience.
(ii) Outline specific tasks required to be carried out in response to the identified emergencies or disasters including, but not limited to, detailed animal evacuation instructions or shelter-in-place instructions and provisions for providing backup sources of food and water as well as sanitation, ventilation, bedding, veterinary care, etc.;
(iii) Identify a chain of command and who (by name or by position title) will be responsible for fulfilling these tasks; and
(iv) Address how response and recovery will be handled in terms of materials, resources, and training needed.
(2) For current registrants, the contingency plan must be in place by July 5, 2022. For research facilities registered after this date, the contingency plan must be in place prior to conducting regulated activities. The plan must be reviewed by the research facility on at least an annual basis to ensure that it adequately addresses the criteria listed in paragraph (l)(1) of this section. Each registrant must maintain documentation of their annual reviews, including documenting any amendments or changes made to their plan since the previous year's review, such as changes made as a result of recently predicted, but historically unforeseen, circumstances (e.g., weather extremes). Contingency plans, as well as all annual review documentation, must be made available to APHIS and any funding Federal agency representatives upon request. The APHIS Contingency Plan form may be used to keep and maintain the information required by paragraph (l)(1) and (2) of this section.
(3) The facility must provide training for its personnel regarding their roles and responsibilities as outlined in the plan. For current registrants, training of facility personnel must be completed within 60 days of the research facility putting their plan in place; for research facilities registered after July 5, 2022, training of facility personnel must be completed within 60 days of the facility putting its contingency plan in place. This deadline applies to employees hired before and up to 30 days after the facility puts its contingency plan in place. For employees hired more than 30 days after the facility puts its contingency plan in place, training must be conducted within 30 days of their start date. Any substantive changes to the plan as a result of the annual review must be communicated to employees through training which must be conducted within 30 days of making the changes.
(a) Each dealer or exhibitor shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section.
(1) Each dealer and exhibitor shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the premises of the dealer or exhibitor; and
(2) Each dealer and exhibitor shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.
(b) Each dealer or exhibitor shall establish and maintain programs of adequate veterinary care that include:
(1) The availability of appropriate facilities, personnel, equipment, and services to comply with the provisions of this subchapter;
(2) The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care;
(3) Daily observation of all animals to assess their health and well-being; Provided, however, That daily observation of animals may be accomplished by someone other than the attending veterinarian; and Provided, further, That a mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian;
(4) Adequate guidance to personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and
(5) Adequate pre-procedural and post-procedural care in accordance with established veterinary medical and nursing procedures.
(a) A class “A” dealer (breeder) shall identify all live dogs and cats on the premises as follows:
(1) All live dogs and cats held on the premises, purchased, or otherwise acquired, sold or otherwise disposed of, or removed from the premises for delivery to a research facility or exhibitor or to another dealer, or for sale, through an auction sale or to any person for use as a pet, shall be identified by an official tag of the type described in § 2.51 affixed to the animal's neck by means of a collar made of material generally considered acceptable to pet owners as a means of identifying their pet dogs or cats
(2) Live puppies or kittens, less than 16 weeks of age, shall be identified by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator; or
(iii) A plastic-type collar acceptable to the Administrator which has legibly placed thereon the information required for an official tag pursuant to § 2.51.
(b) A class “B” dealer shall identify all live dogs and cats under his or her control or on his or her premises as follows:
(1) When live dogs or cats are held, purchased, or otherwise acquired, they shall be immediately identified:
(i) By affixing to the animal's neck an official tag as set forth in § 2.51 by means of a collar made of material generally acceptable to pet owners as a means of identifying their pet dogs or cats
(ii) By a distinctive and legible tattoo marking approved by the Administrator.
(2) If any live dog or cat is already identified by an official tag or tattoo which has been applied by another dealer or exhibitor, the dealer or exhibitor who purchases or otherwise acquires the animal may continue identifying the dog or cat by the previous identification number, or may replace the previous tag with his own official tag or approved tattoo. In either case, the class B dealer or class C exhibitor shall correctly list all old and new official tag numbers or tattoos in his or her records of purchase which shall be maintained in accordance with §§ 2.75 and 2.77. Any new official tag or tattoo number shall be used on all records of any subsequent sales by the dealer or exhibitor, of any dog or cat.
(3) Live puppies or kittens less than 16 weeks of age, shall be identified by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator; or
(iii) A plastic-type collar acceptable to the Administrator which has legibly placed thereon the information required for an official tag pursuant to § 2.51.
(4) When any dealer has made a reasonable effort to affix an official tag to a cat, as set forth in paragraphs (a) and (b) of this section, and has been unable to do so, or when the cat exhibits serious distress from the attachment of a collar and tag, the dealer shall attach the collar and tag to the door of the primary enclosure containing the cat and take measures adequate to maintain the identity of the cat in relation to the tag. Each primary enclosure shall contain no more than one weaned cat without an affixed collar and official tag, unless the cats are identified by a distinctive and legible tattoo or plastic-type collar approved by the Administrator.
(c) A class “C” exhibitor shall identify all live dogs and cats under his or her control or on his or her premises, whether held, purchased, or otherwise acquired:
(1) As set forth in paragraph (b)(1) or (b)(3) of this section, or
(2) By identifying each dog or cat with:
(i) An official USDA sequentially numbered tag that is kept on the door of the animal's cage or run;
(ii) A record book containing each animal's tag number, a written description of each animal, the data required by § 2.75(a), and a clear photograph of each animal; and
(iii) A duplicate tag that accompanies each dog or cat whenever it leaves the compound or premises.
(d) Unweaned puppies or kittens need not be individually identified as required by paragraphs (a) and (b) of this section while they are maintained as a litter with their dam in the same primary enclosure, provided the dam has been individually identified.
(e)(1) All animals, except dogs and cats, delivered for transportation, transported, purchased, sold, or otherwise acquired or disposed of by any dealer or exhibitor shall be identified by the dealer or exhibitor at the time of delivery for transportation, purchase, sale, acquisition or disposal, as provided for in this paragraph and in records maintained as required in §§ 2.75 and 2.77.
(2) When one or more birds are confined in a primary enclosure, the bird shall be identified by:
(i) A label attached to the primary enclosure which shall bear a description of the birds in the primary enclosure, including:
(A) The number of birds;
(B) The species of the birds;
(C) Any distinctive physical features of the birds; and
(D) Any identifying marks on the birds; or
(ii) A leg or wing band applied to each bird in the primary enclosure by the dealer or exhibitor that individually identifies each bird by description or number; or
(iii) A transponder (microchip) placed in a standard anatomical location for the species in accordance with professionally accepted standards, provided that the receiving facility has a compatible transponder (microchip) reader that is capable of reading the transponder (microchip) and that the reader is readily available for use by an APHIS official and/or facility employee accompanying the APHIS official.
(3) When one or more animals, other than dogs, cats, or birds, are confined in a primary enclosure, the animal(s) shall be identified by:
(i) A label attached to the primary enclosure which shall bear a description of the animals in the primary enclosure, including:
(A) The number of animals;
(B) The species of the animals;
(C) Any distinctive physical features of the animals; and
(D) Any identifying marks, tattoos, or tags attached to the animals;
(ii) Marking the primary enclosure with a painted or stenciled number which shall be recorded in the records of the dealer or exhibitor together with:
(A) A description of the animal(s);
(B) The species of the animal(s); and
(C) Any distinctive physical features of the animal(s); or
(iii) A tag or tattoo applied to each animal in the primary enclosure by the dealer or exhibitor which individually identifies each animal by description or number.
(4) When any animal, other than a dog or cat, is not confined in a primary enclosure, it shall be identified on a record, as required by § 2.75, which shall accompany the animal at the time it is delivered for transportation, transported, purchased, or sold, and shall be kept and maintained by the dealer or exhibitor as part of his or her records.
(a) The official tag shall be made of a durable alloy such as brass, bronze, or steel, or of a durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may also be used. The tag shall be one of the following shapes:
(1) Circular in shape and not less than 1
(2) Oblong and flat in shape, not less than 2 inches by
(b) Each tag shall have the following information embossed or stamped on so that it is easily readable:
(1) The letters “USDA”;
(2) Numbers identifying the State and dealer, exhibitor, or research facility (e.g., 39-AB); and
(3) Numbers identifying the animal (e.g., 82488).
(c) Official tags shall be serially numbered. No individual dealer or exhibitor shall use any identification tag number more than once within a 5-year period.
Dealers or exhibitors may obtain, at their own expense, official tags from commercial tag manufacturers.
Official tags obtained by a dealer, exhibitor, or research facility, shall be applied to dogs or cats in the manner set forth in § 2.50 and in as close to consecutive numerical order as possible. No tag number shall be used to identify more than one animal. No number shall be repeated within a 5-year period.
Each dealer or exhibitor shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a dealer or exhibitor, the dealer or exhibitor shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the dealer or exhibitor shall affix another official tag to the animal in the manner prescribed in § 2.50, and record the tag number on the official records.
(a) Where a dog or cat to which is affixed or which is identified by an official tag is euthanized, or dies from other causes, the dealer or exhibitor shall remove and retain the tag for the required period, as set forth in paragraph (b) of this section.
(b) All official tags removed and retained by a dealer or exhibitor shall be held until called for by an APHIS official or for a period of 1 year.
(c) When official tags are removed from animals for disposal, the tags must be disposed of so as to preclude their reuse for animal identification. No animal identification number shall be used within any 5-year period following its previous use.
No person shall buy, sell, exhibit, use for research, transport, or offer for transportation, any stolen animal.
(a)(1) Each dealer, other than operators of auction sales and brokers to whom animals are consigned, and each exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each dog or cat purchased or otherwise acquired, owned, held, or otherwise in his or her possession or under his or her control, or which is transported, euthanized, sold, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born of any animal while in his or her possession or under his or her control.
(i) The name and address of the person from whom a dog or cat was purchased or otherwise acquired whether or not the person is required to be licensed or registered under the Act;
(ii) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(iii) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(iv) The name and address of the person to whom a dog or cat was sold or given and that person's license or registration number if he or she is licensed or registered under the Act;
(v) The date a dog or cat was acquired or disposed of, including by euthanasia;
(vi) The official USDA tag number or tattoo assigned to a dog or cat under §§ 2.50 and 2.54;
(vii) A description of each dog or cat which shall include:
(A) The species and breed or type;
(B) The sex;
(C) The date of birth or approximate age; and
(D) The color and any distinctive markings;
(viii) The method of transportation including the name of the initial carrier or intermediate handler or, if a privately owned vehicle is used to transport a dog or cat, the name of the owner of the privately owned vehicle;
(ix) The date and method of disposition of a dog or cat, e.g., sale, death, euthanasia, or donation.
(2) Each dealer and exhibitor shall use Record of Acquisition and Dogs and Cats on Hand (APHIS Form 7005) and Record of Disposition of Dogs and Cats (APHIS Form 7006) to make, keep, and maintain the information required by paragraph (a)(1) of this section: Provided, that if a dealer or exhibitor who uses a computerized recordkeeping system believes that APHIS Form 7005 and APHIS Form 7006 are unsuitable for him or her to make, keep, and maintain the information required by paragraph (a)(1) of this section, the dealer or exhibitor may request a variance from the requirement to use APHIS Form 7005 and APHIS Form 7006.
(i) The request for a variance must consist of a written statement describing why APHIS Form 7005 and APHIS Form 7006 are unsuitable for the dealer or exhibitor to make, keep, and maintain the information required by paragraph (a)(1) of this section, and a description of the computerized recordkeeping system the person would use in lieu of APHIS Form 7005 and APHIS Form 7006 to make, keep, and maintain the information required by paragraph (a)(1) of this section. APHIS will advise the person as to the disposition of his or her request for a variance from the requirement to use APHIS Form 7005 and APHIS Form 7006.
(ii) A dealer or exhibitor whose request for a variance has been denied may request a hearing in accordance with the applicable rules of practice for the purpose of showing why the request for a variance should not be denied. The denial of the variance shall remain in effect until the final legal decision has been rendered.
(3) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used by dealers and exhibitors to make, keep, and maintain the information required by § 2.78.
(4) One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat sold or otherwise disposed of by a dealer or exhibitor: Provided, however, that, except as provided in § 2.133(b) of this part for dealers, information that indicates the source and date of acquisition of a dog or cat need not appear on the copy of the record accompanying the shipment. One copy of the record containing the information required by paragraph (a)(1) of this section shall be retained by the dealer or exhibitor.
(b)(1) Every dealer other than operators of auction sales and brokers to whom animals are consigned, and exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning animals other than dogs and cats, purchased or otherwise acquired, owned, held, leased, or otherwise in his or her possession or under his or her control, or which is transported, sold, euthanized, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born or hatched of any animal while in his or her possession or under his or her control, to the extent that any identification or counting of offspring can be carried out without unduly disturbing nesting or rearing activities.
(i) The name and address of the person from whom the animals were purchased or otherwise acquired;
(ii) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(iii) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(iv) The name and address of the person to whom an animal was sold or given;
(v) The date of purchase, acquisition, sale, or disposal of the animal(s);
(vi) The species of the animal(s); and
(vii) The number of animals in the shipment.
(2) Record of Animals on Hand (other than dogs and cats) (APHIS Form 7019) and Record of Acquisition, Disposition, or Transport of Animals (other than dogs and cats) (APHIS Form 7020) are forms which may be used by dealers and exhibitors to keep and maintain the information required by paragraph (b)(1) of this section concerning animals other than dogs and cats except as provided in § 2.78.
(3) One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal(s) other than a dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal other than a dog or cat sold or otherwise disposed of by a dealer or exhibitor; Provided, however, That information which indicates the source and date of acquisition of any animal other than a dog or cat need not appear on the copy of the record accompanying the shipment. The dealer or exhibitor shall retain one copy of the record containing the information required by paragraph (b)(1) of this section.
(a) Every operator of an auction sale or broker shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each animal consigned for auction or sold, whether or not a fee or commission is charged:
(1) The name and address of the person who owned or consigned the animal(s) for sale;
(2) The name and address of the buyer or consignee who received the animal;
(3) The USDA license or registration number of the person(s) selling, consigning, buying, or receiving the animals if he or she is licensed or registered under the Act;
(4) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(5) The date of the consignment;
(6) The official USDA tag number or tattoo assigned to the animal under §§ 2.50 and 2.54;
(7) A description of the animal which shall include:
(i) The species and the breed or type of animal;
(ii) The sex of the animal; or if the animal is a bird, only if the sex is readily determinable;
(iii) The date of birth or hatch date; or, if unknown, the approximate age or developmental stage; and
(iv) The color and any distinctive markings; and
(8) The auction sales number or records number assigned to the animal.
(b) One copy of the record containing the information required by paragraph (a) of this section shall be given to the consignor of each animal, one copy of the record shall be given to the purchaser of each animal: Provided, however, That information which indicates the source and date of consignment of any animal need not appear on the copy of the record given the purchaser of any animal. One copy of the record containing the information required by paragraph (a) of this section shall be retained by the operator of such auction sale, or broker, for each animal sold by the auction sale or broker.
(a) In connection with all live animals accepted for shipment on a C.O.D. basis or other arrangement or practice under which the cost of an animal or the transportation of an animal is to be paid and collected upon delivery of the animal to the consignee, the accepting carrier or intermediate handler, if any, shall keep and maintain a copy of the consignor's written guarantee for the payment of transportation charged for any animal not claimed as provided in § 2.80, including, where necessary, both the return transportation charges and an amount sufficient to reimburse the carrier for out-of-pocket expenses incurred for the care, feeding, and storage of the animal. The carrier or intermediate handler at destination shall also keep and maintain a copy of the shipping document containing the time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee, as provided in § 2.80.
(b) In connection with all live dogs, cats, or nonhuman primates delivered for transportation, in commerce, to any carrier or intermediate handler, by any dealer, research facility, exhibitor, operator of an auction sale, broker, or department, agency or instrumentality of the United States or of any state or local government, the accepting carrier or intermediate handler shall keep and maintain a copy of the health certification completed as required by § 2.78, tendered with each live dog, cat, or nonhuman primate.
(a) No dealer, exhibitor, operator of an auction sale, broker, or department, agency, or instrumentality of the United States or of any State or local government shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state that:
(1) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and
(2) when so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health.
(b) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234.
(c) No intermediate handler or carrier to whom any live dog, cat, or nonhuman primate is delivered for transportation by any dealer, research facility, exhibitor, broker, operator of an auction sale, or department, agency, or instrumentality of the United States or any State or local government shall receive a live dog, cat, or nonhuman primate for transportation, in commerce, unless and until it is accompanied by a health certificate issued by a licensed veterinarian in accordance with paragraph (a) of this section, or an exemption issued by the Secretary in accordance with paragraph (b) of this section.
(d) The U.S. Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used for health certification by a licensed veterinarian as required by this section.
(a) No carrier or intermediate handler shall accept any animal for transportation, in commerce, upon any C.O.D. or other basis where any money is to be paid and collected upon delivery of the animal to the consignee, unless the consignor guarantees in writing the payment of all transportation, including any return transportation, if the shipment is unclaimed or the consignee cannot be notified in accordance with paragraphs (b) and (c) of this section, including reimbursing the carrier or intermediate handler for all out-of-pocket expenses incurred for the care, feeding, and storage or housing of the animal.
(b) Any carrier or intermediate handler receiving an animal at a destination on a C.O.D. or other basis any money is to be paid and collected upon delivery of the animal to the consignee shall attempt to notify the consignee at least once every 6 hours for a period of 24 hours after arrival of the animal at the animal holding area of the terminal cargo facility. The carrier or intermediate handler shall record the time, date, and method of each attempted notification and the final notification to the consignee, and the name of the person notifying the consignee, on the shipping document and on the copy of the shipping document accompanying the C.O.D. shipment. If the consignee cannot be notified of the C.O.D. shipment within 24 hours after its arrival, the carrier or intermediate handler shall return the animal to the consignor, or to whomever the consignor has designated, on the next practical available transportation, in accordance with the written agreement required in paragraph (a) of this section and shall notify the consignor. Any carrier or intermediate handler which has notified a consignee of the arrival of a C.O.D. or other shipment of an animal, where any money is to be paid and collected upon delivery of the animal to the consignee, which is not claimed by the consignee within 48 hours from the time of notification, shall return the animal to the consignor, or to whomever the consignor has designated, on the next practical available transportation, in accordance with the written agreement required in paragraph (a) of this section and shall notify the consignor.
(c) It is the responsibility of any carrier or intermediate handler to hold, feed, and care for any animal accepted for transportation, in commerce, under a C.O.D. or other arrangement where any money is to be paid and collected upon delivery of the animal until the consignee accepts shipment at destination or until returned to the consignor or his or her designee should the consignee fail to accept delivery of the animal or if the consignee could not be notified as prescribed in paragraph (b) of this section.
(d) Nothing in this section shall be construed as prohibiting any carrier or intermediate handler from requiring any guarantee in addition to that required in paragraph (a) of this section for the payment of the cost of any transportation or out-of-pocket or other incidental expenses incurred in the transportation of any animal.
(a) No dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall, for a period of 1 year, destroy or dispose of, without the consent in writing of the Administrator, any books, records, documents, or other papers required to be kept and maintained under this part.
(b) Unless otherwise specified, the records required to be kept and maintained under this part shall be held for 1 year after an animal is euthanized or disposed of and for any period in excess of one year as necessary to comply with any applicable Federal, State, or local law. Whenever the Administrator notifies a dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall hold those records until their disposition is authorized by the Administrator.
(a) Each dealer, exhibitor, operator of an auction sale, and intermediate handler shall comply in all respects with the regulations set forth in part 2 and the standards set forth in part 3 of this subchapter for the humane handling, care, treatment, housing, and transportation of animals.
(b) Each carrier shall comply in all respects with the regulations in part 2 and the standards in part 3 of this subchapter setting forth the conditions and requirements for the humane transportation of animals in commerce and their handling, care, and treatment in connection therewith.
(a) Any live dog or cat acquired by a dealer
(1) That any live dog or cat acquired by a dealer or exhibitor from any private or contract animal pound or shelter shall be held by that dealer or exhibitor under his or her supervision and control for a period of not less than 10 full days, not including the day of acquisition, after acquiring the animal, excluding time in transit;
(2) Live dogs or cats which have completed a 5-day holding period with another dealer or exhibitor, or a 10-day holding period with another dealer or exhibitor if obtained from a private or contract shelter or pound, may be sold or otherwise disposed of by subsequent dealers or exhibitors after a minimum holding period of 24 hours by each subsequent dealer or exhibitor excluding time in transit;
(3) Any dog or cat suffering from disease, emaciation, or injury may be destroyed by euthanasia prior to the completion of the holding period required by this section; and
(4) Any live dog or cat, 120 days of age or less, that was obtained from the person that bred and raised such dog or cat, may be exempted from the 5-day holding requirement and may be disposed of by dealers or exhibitors after a minimum holding period of 24 hours, excluding time in transit. Each subsequent dealer or exhibitor must also hold each such dog or cat for a 24-hour period excluding time in transit.
(b) During the period in which any dog or cat is being held as required by this section, the dog or cat shall be unloaded from any means of conveyance in which it was received, for food, water, and rest, and shall be handled, cared for, and treated in accordance with the standards set forth in part 3, subpart A, of this subchapter and § 2.131.
(a) If any dealer or exhibitor obtains the prior approval of the Deputy Administrator, he may arrange to have another person hold animals for the required period provided for in paragraph (a) of § 2.101: Provided, That:
(1) The other person agrees in writing to comply with the regulations in part 2 and the standards in part 3 of this subchapter and to allow inspection of his premises by an APHIS official during business hours; and
(2) The animals remain under the total control and responsibility of the dealer or exhibitor.
(3) Approval will not be given for a dealer or exhibitor holding a license as set forth in § 2.1 to have animals held for purposes of this section by another licensed dealer or exhibitor. APHIS Form 7009 shall be used for approval.
(4) The other person or premises must either be directly included in the dealer's or exhibitor's contingency plan required under § 2.134 or must develop its own contingency plan in accordance with § 2.134.
(b) If any intermediate handler obtains prior approval of the Deputy Administrator, it may arrange to have another person hold animals: Provided, That:
(1) The other person agrees in writing to comply with the regulations in part 2 and the standards in part 3 of this subchapter and to allow inspection of the premises by an APHIS official during business hours; and
(2) The animals remain under the total control and responsibility of the research facility or intermediate handler.
(3) The other person or premises must either be directly included in the intermediate handler's contingency plan required under § 2.134 or must develop its own contingency plan in accordance with § 2.134.
Each dealer, exhibitor, operator of an auction sale, intermediate handler, and carrier shall furnish to any APHIS official any information concerning the business of the dealer, exhibitor, operator of an auction sale, intermediate handler or carrier which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information.
(a) Each dealer, exhibitor, intermediate handler, or carrier, shall, during business hours, allow APHIS officials:
(1) To enter its place of business;
(2) To examine records required to be kept by the Act and the regulations in this part;
(3) To make copies of the records;
(4) To inspect and photograph the facilities, property and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations and the standards in this subchapter; and
(5) To document, by the taking of photographs and other means, conditions and areas of noncompliance.
(b) The use of a room, table, or other facilities necessary for the proper examination of the records and inspection of the property or animals must be extended to APHIS officials by the dealer, exhibitor, intermediate handler or carrier, and a responsible adult shall be made available to accompany APHIS officials during the inspection process.
(c) Any person who is subject to the Animal Welfare regulations and who intends to exhibit any animal at any location other than the person's approved site (including, but not limited to, circuses, traveling educational exhibits, animal acts, and petting zoos), except for travel that does not extend overnight, shall submit a written itinerary to the Deputy Administrator. The itinerary shall be received by the Deputy Administrator no fewer than 2 days in advance of any travel and shall contain complete and accurate information concerning the whereabouts of any animal intended for exhibition at any location other than the person's approved site. If the exhibitor accepts an engagement for which travel will begin with less than 48 hours' notice, the exhibitor shall immediately contact the Deputy Administrator in writing with the required information. APHIS expects such situations to occur infrequently, and exhibitors who repeatedly provide less than 48 hours' notice will, after notice by APHIS, be subject to increased scrutiny under the Act.
(1) The itinerary shall include the following:
(i) The name of the person who intends to exhibit the animal and transport the animal for exhibition purposes, including any business name and current Act license or registration number and, in the event that any animal is leased, borrowed, loaned, or under some similar arrangement, the name of the person who owns such animal;
(ii) The name, identification number or identifying characteristics, species (common or scientific name), sex and age of each animal; and
(iii) The names, dates, and locations (with addresses) where the animals will travel, be housed, and be exhibited, including all anticipated dates and locations (with addresses) for any stops and layovers that allow or require removal of the animals from the transport enclosures. Unanticipated delays of such length shall be reported to the Deputy Administrator the next APHIS business day. APHIS Regional offices are available each weekday, except on Federal holidays, from 8 a.m. to 5 p.m.
(2) The itinerary shall be revised as necessary, and the Deputy Administrator shall be notified of any changes. If initial notification of a change due to an emergency is made by a means other than email or facsimile, it shall be followed by written documentation at the earliest possible time. For changes that occur after normal APHIS business hours, the change shall be conveyed to the Deputy Administrator no later than the following APHIS business day. APHIS Regional offices are available each weekday, except on Federal holidays, from 8 a.m. to 5 p.m.
APHIS will publish on its website lists of persons licensed or registered in accordance with the provisions of this part. The lists may also be obtained upon request from the Deputy Administrator.
Each dealer, exhibitor, intermediate handler and carrier shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter his or her place of business to inspect animals and records for the purpose of seeking animals that are missing, under the following conditions:
(a) The police or other law officer shall furnish to the dealer, exhibitor, intermediate handler or carrier a written description of the missing animal and the name and address of its owner before making a search.
(b) The police or other law officer shall abide by all security measures required by the dealer, exhibitor, intermediate handler or carrier to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal.
(a) If an animal being held by a dealer, exhibitor, intermediate handler, or by a carrier is found by an APHIS official to be suffering as a result of the failure of the dealer, exhibitor, intermediate handler, or carrier to comply with any provision of the regulations or the standards set forth in this subchapter, the APHIS official shall make a reasonable effort to notify the dealer, exhibitor, intermediate handler, or carrier of the condition of the animal(s) and request that the condition be corrected and that adequate care be given to alleviate the animal's suffering or distress, or that the animal(s) be destroyed by euthanasia. In the event that the dealer, exhibitor, intermediate handler, or carrier refuses to comply with this request, the APHIS official may confiscate the animal(s) for care, treatment, or disposal as indicated in paragraph (b) of this section, if, in the opinion of the Administrator, the circumstances indicate the animal's health is in danger.
(b) In the event that the APHIS official is unable to locate or notify the dealer, exhibitor, intermediate handler, or carrier as required in this section, the APHIS official shall contact a local police or other law officer to accompany him to the premises and shall provide for adequate care when necessary to alleviate the animal's suffering. If in the opinion of the Administrator, the condition of the animal(s) cannot be corrected by this temporary care, the APHIS official shall confiscate the animals.
(c) Confiscated animals may be:
(1) Placed, by sale or donation, with other licensees or registrants that comply with the standards and regulations and can provide proper care; or
(2) Placed with persons or facilities that can offer a level of care equal to or exceeding the standards and regulations, as determined by APHIS, even if the persons or facilities are not licensed by or registered with APHIS; or
(3) Euthanized.
(d) The dealer, exhibitor, intermediate handler, or carrier from whom the animals were confiscated must bear all costs incurred in performing the placement or euthanasia activities authorized by this section.
No dog or cat shall be delivered by any person to any carrier or intermediate handler for transportation, in commerce, or shall be transported in commerce by any person, except to a registered research facility, unless such dog or cat is at least eight (8) weeks of age and has been weaned.
(a) All licensees who maintain wild or exotic animals must demonstrate adequate experience and knowledge of the species they maintain.
(b)(1) Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.
(2)(i) Physical abuse shall not be used to train, work, or otherwise handle animals.
(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals; Provided, however, That the short-term withholding of food or water from animals by exhibitors is allowed by these regulations as long as each of the animals affected receives its full dietary and nutrition requirements each day.
(c)(1) During public exhibition, any animal must be handled so there is minimal risk of harm to the animal and to the public, with sufficient distance and/or barriers between the animal and the general viewing public so as to assure the safety of animals and the public.
(2) Performing animals shall be allowed a rest period between performances at least equal to the time for one performance.
(3) Young or immature animals shall not be exposed to rough or excessive public handling or exhibited for periods of time which would be detrimental to their health or well-being.
(4) Drugs, such as tranquilizers, shall not be used to facilitate, allow, or provide for public handling of the animals.
(d)(1) Animals shall be exhibited only for periods of time and under conditions consistent with their good health and well-being.
(2) A responsible, knowledgeable, and readily identifiable employee or attendant must be present at all times during periods of public contact.
(3) During public exhibition, dangerous animals such as lions, tigers, wolves, bears, or elephants must be under the direct control and supervision of a knowledgeable and experienced animal handler.
(4) If public feeding of animals is allowed, the food must be provided by the animal facility and shall be appropriate to the type of animal and its nutritional needs and diet.
(e) When climatic conditions present a threat to an animal's health or well-being, appropriate measures must be taken to alleviate the impact of those conditions. An animal may never be subjected to any combination of temperature, humidity, and time that is detrimental to the animal's health or well-being, taking into consideration such factors as the animal's age, species, breed, overall health status, and acclimation.
(a) A class “B” dealer may obtain live random source dogs and cats only from:
(1) Other dealers who are licensed under the Act and in accordance with the regulations in part 2;
(2) State, county, or city owned and operated animal pounds or shelters; and
(3) A legal entity organized and operated under the laws of the State in which it is located as an animal pound or shelter, such as a humane shelter or contract pound.
(b) No person shall obtain live dogs, cats, or other animals by use of false pretenses, misrepresentation, or deception.
(c) Any dealer, exhibitor, research facility, carrier, or intermediate handler who also operates a private or contract animal pound or shelter shall comply with the following:
(1) The animal pound or shelter shall be located on premises that are physically separated from the licensed or registered facility. The animal housing facility of the pound or shelter shall not be adjacent to the licensed or registered facility.
(2) Accurate and complete records shall be separately maintained by the licensee or registrant and by the pound or shelter. The records shall be in accordance with §§ 2.75 and 2.76, unless the animals are lost or stray. If the animals are lost or stray, the pound or shelter records shall provide:
(i) An accurate description of the animal;
(ii) How, where, from whom, and when the dog or cat was obtained;
(iii) How long the dog or cat was held by the pound or shelter before being transferred to the dealer; and
(iv) The date the dog or cat was transferred to the dealer.
(3) Any dealer who obtains or acquires a live dog or cat from a private or contract pound or shelter, including a pound or shelter he or she operates, shall hold the dog or cat for a period of at least 10 full days, not including the day of acquisition, excluding time in transit, after acquiring the animal, and otherwise in accordance with § 2.101.
(d) No dealer or exhibitor shall knowingly obtain any dog, cat, or other animal from any person who is required to be licensed but who does not hold a current, valid, and unsuspended license. No dealer or exhibitor shall knowingly obtain any dog or cat from any person who is not licensed, other than a pound or shelter, without obtaining a certification that the animals were born and raised on that person's premises and, if the animals are for research purposes, that the person has sold fewer than 25 dogs and/or cats that year, or, if the animals are for use as pets, that the person does not maintain more than four breeding female dogs and/or cats.
(a) Each of the entities listed in paragraphs (a)(1) through (a)(3) of this section that acquire any live dog or cat shall, before selling or providing the live dog or cat to a dealer, hold and care for the dog or cat for a period of not less than 5 full days after acquiring the animal, not including the date of acquisition and excluding time in transit. This holding period shall include at least one Saturday. The provisions of this paragraph apply to:
(1) Each pound or shelter owned and operated by a State, county, or city;
(2) Each private pound or shelter established for the purpose of caring for animals, such as a humane society, or other organization that is under contract with a State, county, or city, that operates as a pound or shelter, and that releases animals on a voluntary basis; and
(3) Each research facility licensed by USDA as a dealer.
(b) A dealer shall not sell, provide, or make available to any person a live random source dog or cat unless the dealer provides the recipient of the dog or cat with certification that contains the following information:
(1) The name, address, USDA license number, and signature of the dealer;
(2) The name, address, USDA license or registration number, if such number exists, and signature of the recipient of the dog or cat;
(3) A description of each dog or cat being sold, provided, or made available that shall include:
(i) The species and breed or type (for mixed breeds, estimate the two dominant breeds or types);
(ii) The sex;
(iii) The date of birth or, if unknown, then the approximate age;
(iv) The color and any distinctive markings; and
(v) The Official USDA-approved identification number of the animal. However, if the certification is attached to a certificate provided by a prior dealer which contains the required description, then only the official identification numbers are required;
(4) The name and address of the person, pound, or shelter from which the dog or cat was acquired by the dealer, and an assurance that the person, pound, or shelter was notified that the cat or dog might be used for research or educational purposes;
(5) The date the dealer acquired the dog or cat from the person, pound, or shelter referred to in paragraph (b)(4) of this section; and
(6) If the dealer acquired the dog or cat from a pound or shelter, a signed statement by the pound or shelter that it met the requirements of paragraph (a) of this section. This statement must at least describe the animals by their official USDA identification numbers. It may be incorporated within the certification if the dealer makes the certification at the time that the animals are acquired from the pound or shelter or it may be made separately and attached to the certification later. If made separately, it must include the same information describing each animal as is required in the certification. A photocopy of the statement will be regarded as a duplicate original.
(c) The original certification required under paragraph (b) of this section shall accompany the shipment of a live dog or cat to be sold, provided, or otherwise made available by the dealer.
(d) A dealer who acquires a live dog or cat from another dealer must obtain from that dealer the certification required by paragraph (b) of this section and must attach that certification (including any previously attached certification) to the certification which he or she provides pursuant to paragraph (b) of this section (a photocopy of the original certification will be deemed a duplicate original if the dealer does not dispose of all of the dogs or cats in a single transaction).
(e) A dealer who completes, provides, or receives a certification required under paragraph (b) of this section shall keep, maintain, and make available for APHIS inspection a copy of the certification for at least 1 year following disposition.
(f) A research facility which acquires any live random source dog or cat from a dealer must obtain the certification required under paragraph (b) of this section and shall keep, maintain, and make available for APHIS inspection the original for at least 3 years following disposition.
(g) In instances where a research facility transfers ownership of a live random source dog or cat acquired from a dealer to another research facility, a copy of the certification required by paragraph (b) of this section must accompany the dog or cat transferred. The research facility to which the dog or cat is transferred shall keep, maintain, and make available for APHIS inspection the copy of the certification for at least 3 years following disposition.
(a) Dealers, exhibitors, intermediate handlers, and carriers must develop, document, and follow an appropriate plan to provide for the humane handling, treatment, transportation, housing, and care of their animals in the event of an emergency or disaster (one which could reasonably be anticipated and expected to be detrimental to the good health and well-being of the animals in their possession). Such contingency plans must:
(1) Identify situations the licensee or registrant might experience that would trigger the need for the measures identified in a contingency plan to be put into action including, but not limited to, emergencies such as electrical outages, faulty HVAC systems, fires, mechanical breakdowns, and animal escapes, as well as natural disasters most likely to be experienced;
(2) Outline specific tasks required to be carried out in response to the identified emergencies or disasters including, but not limited to, detailed animal evacuation instructions or shelter-in-place instructions and provisions for providing backup sources of food and water as well as sanitation, ventilation, bedding, veterinary care, etc.;
(3) Identify a chain of command and who (by name or by position title) will be responsible for fulfilling these tasks; and
(4) Address how response and recovery will be handled in terms of materials, resources, and training needed.
(b) For current licensees and registrants, the contingency plan must be in place by July 5, 2022. For new dealers, exhibitors, intermediate handlers, and carriers licensed or registered after this date, the contingency plan must be in place prior to conducting regulated activities. The plan must be reviewed by the dealer, exhibitor, intermediate handler, or carrier on at least an annual basis to ensure that it adequately addresses the criteria listed in paragraph (a) of this section. Each licensee and registrant must maintain documentation of their annual reviews, including documenting any amendments or changes made to their plan since the previous year's review, such as changes made as a result of recently predicted, but historically unforeseen, circumstances (e.g., weather extremes). Contingency plans, as well as all annual review documentation, must be made available to APHIS upon request. Traveling entities must carry a copy of their contingency plan with them at all times and make it available for APHIS inspection while in travel status. The APHIS Contingency Plan form may be used to keep and maintain the information required by § 2.38(l)(1) and (2).
(c) Dealers, exhibitors, intermediate handlers, and carriers must provide training for their personnel regarding their roles and responsibilities as outlined in the plan. For current licensees and registrants, training of dealer, exhibitor, intermediate handler, and carrier personnel must be completed within 60 days of the licensee and registrant putting their contingency plan in place; for new dealers, exhibitors, intermediate handlers, or carriers licensed or registered after July 5, 2022, training of personnel must be completed within 60 days of the dealer, exhibitor, intermediate handler, or carrier putting their contingency plan in place. This deadline applies to employees hired before and up to 30 days after the date the licensee or registrant puts its contingency plan in place. For employees hired more than 30 days after the date the licensee or registrant puts its contingency plan in place, training must be conducted within 30 days of their start date. Any substantive changes to the plan as a result of the annual review must be communicated to employees through training which must be conducted within 30 days of making the changes.
(a) No person shall import a live dog from any part of the world into the States for purposes of resale unless the dog is accompanied by an import permit issued by APHIS and is imported into the States within 30 days after the proposed date of arrival stated in the import permit.
(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road Unit 84, Riverdale, MD 20737-1234 or though Animal Care's Web site (http://www.aphis.usda.gov/animal_welfare/). Application forms for import permits may be obtained from Animal Care at the address listed above.
(c) The completed application must include the following information:
(1) The name and address of the person intending to export the dog(s) to the States;
(2) The name and address of the person intending to import the dog(s) into the States;
(3) The number of dogs to be imported and the breed, sex, age, color, markings, and other identifying information of each dog;
(4) The purpose of the importation;
(5) The port of embarkation and the mode of transportation;
(6) The port of entry in the United States;
(7) The proposed date of arrival in the States; and
(8) The name and address of the person to whom the dog(s) will be delivered in the States and, if the dog(s) is or are imported for resale for research purposes, the USDA registration number of the research facility where the dog will be used for research, tests, or experiments.
(d) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions for importation under this subpart may be issued for the importation of the dog(s) described in the application if such dog(s) appears to be eligible to be imported. Even though an import permit has been issued for the importation of a dog, the dog may only be imported if all applicable requirements of this subpart and any other applicable regulations of this subchapter and any other statute or regulation of any State or of the United States are met.
(a) Required certificates. Except as provided in paragraph (b) of this section, no person shall import a live dog from any part of the world into the States for purposes of resale unless the following conditions are met:
(1) Health certificate. Each dog is accompanied by an original health certificate issued in English by a licensed veterinarian with a valid license to practice veterinary medicine in the country of export that:
(i) Specifies the name and address of the person intending to import the dog into the States;
(ii) Identifies the dog on the basis of breed, sex, age, color, markings, and other identifying information;
(iii) States that the dog is at least 6 months of age;
(iv) States that the dog was vaccinated, not more than 12 months before the date of arrival at the U.S. port, for distemper, hepatitis, leptospirosis, parvovirus, and parainfluenza virus (DHLPP) at a frequency that provides continuous protection of the dog from those diseases and is in accordance with currently accepted practices as cited in veterinary medicine reference guides;
(v) States that the dog is in good health (i.e., free of any infectious disease or physical abnormality which would endanger the dog or other animals or endanger public health, including, but not limited to, parasitic infection, emaciation, lesions of the skin, nervous system disturbances, jaundice, or diarrhea); and
(vi) Bears the signature and the license number of the veterinarian issuing the certificate.
(2) Rabies vaccination certificate. Each dog is accompanied by a valid rabies vaccination certificate
(i) Specifies the name and address of the person intending to import the dog into the States;
(ii) Identifies the dog on the basis of breed, sex, age, color, markings, and other identifying information;
(iii) Specifies a date of rabies vaccination at least 30 days before the date of arrival of the dog at a U.S. port;
(iv) Specifies a date of expiration of the vaccination which is after the date of arrival of the dog at a U.S. port. If no date of expiration is specified, then the date of vaccination shall be no more than 12 months before the date of arrival at a U.S. port; and
(v) Bears the signature and the license number of the veterinarian issuing the certificate.
(b) Exceptions—(1) Research. The provisions of paragraphs (a)(1)(iii), (a)(1)(iv), (a)(1)(v), and/or (a)(2) of this section do not apply to any person who imports a live dog from any part of the world into the States for resale for use in research, tests, or experiments at a research facility, provided that: Such person submits satisfactory evidence to Animal Care at the time of his or her application for an import permit that the specific provision(s) would interfere with the dog's use in such research, tests, or experiments in accordance with a research proposal and the proposal has been approved by the research facility IACUC.
(2) Veterinary care. The provisions of paragraphs (a)(1)(iii) through (a)(1)(v) and (a)(2) of this section do not apply to any person who imports a live dog from any part of the world into the States for veterinary treatment by a licensed veterinarian and subsequent resale, provided that:
(i) The original health certificate required in paragraph (a)(1) of this section states that the dog is in need of veterinary treatment that cannot be obtained in the country of export and states the name and address of the licensed veterinarian in the United States who intends to provide the dog such veterinary treatment; and
(ii) The person who imports the dog completes a veterinary treatment agreement with Animal Care at the time of application for an import permit and confines the animal until the conditions specified in the agreement are met. Such conditions may include determinations by the licensed veterinarian in the United States that the dog is in good health, has been adequately vaccinated against DHLPP and rabies, and is at least 6 months of age. The person importing the dog shall bear the expense of veterinary treatment and confinement.
(3) Dogs imported into Hawaii from the British Isles, Australia, Guam, or New Zealand. The provisions of paragraph (a)(1)(iii) of this section do not apply to any person who lawfully imports a live dog into the State of Hawaii from the British Isles, Australia, Guam, or New Zealand in compliance with the applicable regulations of the State of Hawaii, provided that the dog is not transported out of the State of Hawaii for purposes of resale at less than 6 months of age.
Upon the arrival of a dog at the port of first arrival in the States, the person intending to import the dog, or his or her agent, must present the import permit and any applicable certifications and veterinary treatment agreement required by this subpart to the collector of customs for use at that port.
Any dog refused entry into the States for noncompliance with the requirements of this subpart or the Act may be removed from the States or may be seized and the person intending to import the dog shall provide for the care (including appropriate veterinary care), forfeiture, and adoption of the dog, at his or her expense.
(a) Structure;
(b) Condition and site. Housing facilities and areas used for storing animal food or bedding must be free of any accumulation of trash, waste material, junk, weeds, and other discarded materials. Animal areas inside of housing facilities must be kept neat and free of clutter, including equipment, furniture, and stored material, but may contain materials actually used and necessary for cleaning the area, and fixtures or equipment necessary for proper husbandry practices and research needs. Housing facilities other than those maintained by research facilities and Federal research facilities must be physically separated from any other business. If a housing facility is located on the same premises as another business, it must be physically separated from the other business so that animals the size of dogs, skunks, and raccoons are prevented from entering it.
(c) Surfaces—(1) General requirements. The surfaces of housing facilities—including houses, dens, and other furniture-type fixtures and objects within the facility—must be constructed in a manner and made of materials that allow them to be readily cleaned and sanitized, or removed or replaced when worn or soiled. Interior surfaces and any surfaces that come in contact with dogs or cats must:
(i) Be free of excessive rust that prevents the required cleaning and sanitization, or that affects the structural strength of the surface; and
(ii) Be free of jagged edges or sharp points that might injure the animals.
(2) Maintenance and replacement of surfaces. All surfaces must be maintained on a regular basis. Surfaces of housing facilities—including houses, dens, and other furniture-type fixtures and objects within the facility—that cannot be readily cleaned and sanitized, must be replaced when worn or soiled.
(3) Cleaning. Hard surfaces with which the dogs or cats come in contact must be spot-cleaned daily and sanitized in accordance with § 3.11(b) of this subpart to prevent accumulation of excreta and reduce disease hazards. Floors made of dirt, absorbent bedding, sand, gravel, grass, or other similar material must be raked or spot-cleaned with sufficient frequency to ensure all animals the freedom to avoid contact with excreta. Contaminated material must be replaced whenever this raking and spot-cleaning is not sufficient to prevent or eliminate odors, insects, pests, or vermin infestation. All other surfaces of housing facilities must be cleaned and sanitized when necessary to satisfy generally accepted husbandry standards and practices. Sanitization may be done using any of the methods provided in § 3.11(b)(3) for primary enclosures.
(d) Water and electric power. The housing facility must have reliable electric power adequate for heating, cooling, ventilation, and lighting, and for carrying out other husbandry requirements in accordance with the regulations in this subpart. The housing facility must provide adequate running potable water for the dogs' and cats' drinking needs, for cleaning, and for carrying out other husbandry requirements.
(e) Storage. Supplies of food and bedding must be stored in a manner that protects the supplies from spoilage, contamination, and vermin infestation. The supplies must be stored off the floor and away from the walls, to allow cleaning underneath and around the supplies. Foods requiring refrigeration must be stored accordingly, and all food must be stored in a manner that prevents contamination and deterioration of its nutritive value. All open supplies of food and bedding must be kept in leakproof containers with tightly fitting lids to prevent contamination and spoilage. Only food and bedding that is currently being used may be kept in the animal areas. Substances that are toxic to the dogs or cats but are required for normal husbandry practices must not be stored in food storage and preparation areas, but may be stored in cabinets in the animal areas.
(f) Drainage and waste disposal. Housing facility operators must provide for regular and frequent collection, removal, and disposal of animal and food wastes, bedding, debris, garbage, water, other fluids and wastes, and dead animals, in a manner that minimizes contamination and disease risks. Housing facilities must be equipped with disposal facilities and drainage systems that are constructed and operated so that animal waste and water are rapidly eliminated and animals stay dry. Disposal and drainage systems must minimize vermin and pest infestation, insects, odors, and disease hazards. All drains must be properly constructed, installed, and maintained. If closed drainage systems are used, they must be equipped with traps and prevent the backflow of gases and the backup of sewage onto the floor. If the facility uses sump or settlement ponds, or other similar systems for drainage and animal waste disposal, the system must be located far enough away from the animal area of the housing facility to prevent odors, diseases, pests, and vermin infestation. Standing puddles of water in animal enclosures must be drained or mopped up so that the animals stay dry. Trash containers in housing facilities and in food storage and food preparation areas must be leakproof and must have tightly fitted lids on them at all times. Dead animals, animal parts, and animal waste must not be kept in food storage or food preparation areas, food freezers, food refrigerators, or animal areas.
(g) Washrooms and sinks. Washing facilities such as washrooms, basins, sinks, or showers must be provided for animal caretakers and must be readily accessible.
(a) Heating, cooling, and temperature. Indoor housing facilities for dogs and cats must be sufficiently heated and cooled when necessary to protect the dogs and cats from temperature or humidity extremes and to provide for their health and well-being. When dogs or cats are present, the ambient temperature in the facility must not fall below 50 °F (10 °C) for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress or discomfort (such as short-haired breeds), and for sick, aged, young, or infirm dogs and cats, except as approved by the attending veterinarian. Dry bedding, solid resting boards, or other methods of conserving body heat must be provided when temperatures are below 50 °F (10 °C). The ambient temperature must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when dogs or cats are present, and must not rise above 85 °F (29.5 °C) for more than 4 consecutive hours when dogs or cats are present. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(b) Ventilation. Indoor housing facilities for dogs and cats must be sufficiently ventilated at all times when dogs or cats are present to provide for their health and well-being, and to minimize odors, drafts, ammonia levels, and moisture condensation. Ventilation must be provided by windows, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air conditioning must be provided when the ambient temperature is 85 °F (29.5 °C) or higher. The relative humidity must be maintained at a level that ensures the health and well-being of the dogs or cats housed therein, in accordance with the directions of the attending veterinarian and generally accepted professional and husbandry practices.
(c) Lighting. Indoor housing facilities for dogs and cats must be lighted well enough to permit routine inspection and cleaning of the facility, and observation of the dogs and cats. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Primary enclosures must be placed so as to protect the dogs and cats from excessive light.
(d) Interior surfaces. The floors and walls of indoor housing facilities, and any other surfaces in contact with the animals, must be impervious to moisture. The ceilings of indoor housing facilities must be impervious to moisture or be replaceable (e.g., a suspended ceiling with replaceable panels).
(a) Heating, cooling, and temperature. The sheltered part of sheltered housing facilities for dogs and cats must be sufficiently heated and cooled when necessary to protect the dogs and cats from temperature or humidity extremes and to provide for their health and well-being. The ambient temperature in the sheltered part of the facility must not fall below 50 °F (10 °C) for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress and discomfort (such as short-haired breeds), and for sick, aged, young, or infirm dogs or cats, except as approved by the attending veterinarian. Dry bedding, solid resting boards, or other methods of conserving body heat must be provided when temperatures are below 50 °F (10 °C). The ambient temperature must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when dogs or cats are present, and must not rise above 85 °F (29.5 °C) for more than 4 consecutive hours when dogs or cats are present. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(b) Ventilation. The enclosed or sheltered part of sheltered housing facilities for dogs and cats must be sufficiently ventilated when dogs or cats are present to provide for their health and well-being, and to minimize odors, drafts, ammonia levels, and moisture condensation. Ventilation must be provided by windows, doors, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air-conditioning, must be provided when the ambient temperature is 85 °F (29.5 °C) or higher.
(c) Lighting. Sheltered housing facilities for dogs and cats must be lighted well enough to permit routine inspection and cleaning of the facility, and observation of the dogs and cats. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Primary enclosures must be placed so as to protect the dogs and cats from excessive light.
(d) Shelter from the elements. Dogs and cats must be provided with adequate shelter from the elements at all times to protect their health and well-being. The shelter structures must be large enough to allow each animal to sit, stand, and lie in a normal manner and to turn about freely.
(e) Surfaces. (1) The following areas in sheltered housing facilities must be impervious to moisture:
(i) Indoor floor areas in contact with the animals;
(ii) Outdoor floor areas in contact with the animals, when the floor areas are not exposed to the direct sun, or are made of a hard material such as wire, wood, metal, or concrete; and
(iii) All walls, boxes, houses, dens, and other surfaces in contact with the animals.
(2) Outside floor areas in contact with the animals and exposed to the direct sun may consist of compacted earth, absorbent bedding, sand, gravel, or grass.
(a) Restrictions. (1) The following categories of dogs or cats must not be kept in outdoor facilities, unless that practice is specifically approved by the attending veterinarian:
(i) Dogs or cats that are not acclimated to the temperatures prevalent in the area or region where they are maintained;
(ii) Breeds of dogs or cats that cannot tolerate the prevalent temperatures of the area without stress or discomfort (such as short-haired breeds in cold climates); and
(iii) Sick, infirm, aged or young dogs or cats.
(2) When their acclimation status is unknown, dogs and cats must not be kept in outdoor facilities when the ambient temperature is less than 50 °F (10 °C).
(b) Shelter from the elements. Outdoor facilities for dogs or cats must include one or more shelter structures that are accessible to each animal in each outdoor facility, and that are large enough to allow each animal in the shelter structure to sit, stand, and lie in a normal manner, and to turn about freely. In addition to the shelter structures, one or more separate outside areas of shade must be provided, large enough to contain all the animals at one time and protect them from the direct rays of the sun. Shelters in outdoor facilities for dogs or cats must contain a roof, four sides, and a floor, and must:
(1) Provide the dogs and cats with adequate protection and shelter from the cold and heat;
(2) Provide the dogs and cats with protection from the direct rays of the sun and the direct effect of wind, rain, or snow;
(3) Be provided with a wind break and rain break at the entrance; and
(4) Contain clean, dry, bedding material if the ambient temperature is below 50 °F (10 °C). Additional clean, dry bedding is required when the temperature is 35 °F (1.7 °C) or lower.
(c) Construction. Building surfaces in contact with animals in outdoor housing facilities must be impervious to moisture. Metal barrels, cars, refrigerators or freezers, and the like must not be used as shelter structures. The floors of outdoor housing facilities may be of compacted earth, absorbent bedding, sand, gravel, or grass, and must be replaced if there are any prevalent odors, diseases, insects, pests, or vermin. All surfaces must be maintained on a regular basis. Surfaces of outdoor housing facilities—including houses, dens, etc.—that cannot be readily cleaned and sanitized, must be replaced when worn or soiled.
(a) Heating, cooling, and temperature. Mobile or traveling housing facilities for dogs and cats must be sufficiently heated and cooled when necessary to protect the dogs and cats from temperature or humidity extremes and to provide for their health and well-being. The ambient temperature in the mobile or traveling housing facility must not fall below 50 °F (10 °C) for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress or discomfort (such as short-haired breeds), and for sick, aged, young, or infirm dogs and cats. Dry bedding, solid resting boards, or other methods of conserving body heat must be provided when temperatures are below 50 °F (10 °C). The ambient temperature must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when dogs or cats are present, and must not exceed 85 °F (29.5 °C) for more than 4 consecutive hours when dogs or cats are present. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(b) Ventilation. Mobile or traveling housing facilities for dogs and cats must be sufficiently ventilated at all times when dogs or cats are present to provide for the health and well-being of the animals, and to minimize odors, drafts, ammonia levels, moisture condensation, and exhaust fumes. Ventilation must be provided by means of windows, doors, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air conditioning, must be provided when the ambient temperature within the animal housing area is 85 °F (29.5 °C) or higher.
(c) Lighting. Mobile or traveling housing facilities for dogs and cats must be lighted well enough to permit proper cleaning and inspection of the facility, and observation of the dogs and cats. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals.
Primary enclosures for dogs and cats must meet the following minimum requirements:
(a) General requirements. (1) Primary enclosures must be designed and constructed of suitable materials so that they are structurally sound. The primary enclosures must be kept in good repair.
(2) Primary enclosures must be constructed and maintained so that they:
(i) Have no sharp points or edges that could injure the dogs and cats;
(ii) Protect the dogs and cats from injury;
(iii) Contain the dogs and cats securely;
(iv) Keep other animals from entering the enclosure;
(v) Enable the dogs and cats to remain dry and clean;
(vi) Provide shelter and protection from extreme temperatures and weather conditions that may be uncomfortable or hazardous to all the dogs and cats;
(vii) Provide sufficient shade to shelter all the dogs and cats housed in the primary enclosure at one time;
(viii) Provide all the dogs and cats with easy and convenient access to clean food and water;
(ix) Enable all surfaces in contact with the dogs and cats to be readily cleaned and sanitized in accordance with § 3.11(b) of this subpart, or be replaceable when worn or soiled;
(x) Have floors that are constructed in a manner that protects the dogs' and cats' feet and legs from injury, and that, if of mesh or slatted construction, do not allow the dogs' and cats' feet to pass through any openings in the floor;
(xi) Provide sufficient space to allow each dog and cat to turn about freely, to stand, sit, and lie in a comfortable, normal position, and to walk in a normal manner; and
(xii) If the suspended floor of a primary enclosure is constructed of metal strands, the strands must either be greater than
(b) Additional requirements for cats—(1) Space. Each cat, including weaned kittens, that is housed in any primary enclosure must be provided minimum vertical space and floor space as follows:
(i) Each primary enclosure housing cats must be at least 24 in. high (60.96 cm);
(ii) Cats up to and including 8.8 lbs (4 kg) must be provided with at least 3.0 ft
(iii) Cats over 8.8 lbs (4 kg) must be provided with at least 4.0 ft
(iv) Each queen with nursing kittens must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices. If the additional amount of floor space for each nursing kitten is equivalent to less than 5 percent of the minimum requirement for the queen, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator; and
(v) The minimum floor space required by this section is exclusive of any food or water pans. The litter pan may be considered part of the floor space if properly cleaned and sanitized.
(2) Compatibility. All cats housed in the same primary enclosure must be compatible, as determined by observation. Not more than 12 adult nonconditioned cats may be housed in the same primary enclosure. Queens in heat may not be housed in the same primary enclosure with sexually mature males, except for breeding. Except when maintained in breeding colonies, queens with litters may not be housed in the same primary enclosure with other adult cats, and kittens under 4 months of age may not be housed in the same primary enclosure with adult cats, other than the dam or foster dam. Cats with a vicious or aggressive disposition must be housed separately.
(3) Litter. In all primary enclosures, a receptacle containing sufficient clean litter must be provided to contain excreta and body wastes.
(4) Resting surfaces. Each primary enclosure housing cats must contain a resting surface or surfaces that, in the aggregate, are large enough to hold all the occupants of the primary enclosure at the same time comfortably. The resting surfaces must be elevated, impervious to moisture, and be able to be easily cleaned and sanitized, or easily replaced when soiled or worn. Low resting surfaces that do not allow the space under them to be comfortably occupied by the animal will be counted as part of the floor space.
(5) Cats in mobile or traveling shows or acts. Cats that are part of a mobile or traveling show or act may be kept, while the show or act is traveling from one temporary location to another, in transport containers that comply with all requirements of § 3.15 other than the marking requirements in § 3.15(a)(6). When the show or act is not traveling, the cats must be placed in primary enclosures that meet the minimum requirements of this section.
(c) Additional requirements for dogs—(1) Space. (i) Each dog housed in a primary enclosure (including weaned puppies) must be provided a minimum amount of floor space, calculated as follows: Find the mathematical square of the sum of the length of the dog in inches (measured from the tip of its nose to the base of its tail) plus 6 inches; then divide the product by 144. The calculation is: (length of dog in inches + 6) × (length of dog in inches + 6) = required floor space in square inches. Required floor space in inches/144 = required floor space in square feet.
(ii) Each bitch with nursing puppies must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices as determined by the attending veterinarian. If the additional amount of floor space for each nursing puppy is less than 5 percent of the minimum requirement for the bitch, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator.
(iii) The interior height of a primary enclosure must be at least 6 inches higher than the head of the tallest dog in the enclosure when it is in a normal standing position: Provided That, prior to February 15, 1994, each dog must be able to stand in a comfortable normal position.
(2) Compatibility. All dogs housed in the same primary enclosure must be compatible, as determined by observation. Not more than 12 adult nonconditioned dogs may be housed in the same primary enclosure. Bitches in heat may not be housed in the same primary enclosure with sexually mature males, except for breeding. Except when maintained in breeding colonies, bitches with litters may not be housed in the same primary enclosure with other adult dogs, and puppies under 4 months of age may not be housed in the same primary enclosure with adult dogs, other than the dam or foster dam. Dogs with a vicious or aggressive disposition must be housed separately.
(3) Dogs in mobile or traveling shows or acts. Dogs that are part of a mobile or traveling show or act may be kept, while the show or act is traveling from one temporary location to another, in transport containers that comply with all requirements of § 3.15 other than the marking requirements in § 3.15(a)(6). When the show or act is not traveling, the dogs must be placed in primary enclosures that meet the minimum requirements of this section.
(4) Prohibited means of primary enclosure. Permanent tethering of dogs is prohibited for use as primary enclosure. Temporary tethering of dogs is prohibited for use as primary enclosure unless approval is obtained from APHIS.
(d) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraphs (b)(1) and (c)(1) of this section, but that provide the dogs or cats with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator.
Dogs and cats that are housed in the same primary enclosure must be compatible, with the following restrictions:
(a) Females in heat (estrus) may not be housed in the same primary enclosure with males, except for breeding purposes;
(b) Any dog or cat exhibiting a vicious or overly aggressive disposition must be housed separately;
(c) Puppies or kittens 4 months of age or less may not be housed in the same primary enclosure with adult dogs or cats other than their dams or foster dams, except when permanently maintained in breeding colonies;
(d) Dogs or cats may not be housed in the same primary enclosure with any other species of animals, unless they are compatible; and
(e) Dogs and cats that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony, as directed by the attending veterinarian. When an entire group or room of dogs and cats is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control.
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan, at a minimum, must comply with each of the following:
(a) Dogs housed individually. Dogs over 12 weeks of age, except bitches with litters, housed, held, or maintained by any dealer, exhibitor, or research facility, including Federal research facilities, must be provided the opportunity for exercise regularly if they are kept individually in cages, pens, or runs that provide less than two times the required floor space for that dog, as indicated by § 3.6(c)(1) of this subpart.
(b) Dogs housed in groups. Dogs over 12 weeks of age housed, held, or maintained in groups by any dealer, exhibitor, or research facility, including Federal research facilities, do not require additional opportunity for exercise regularly if they are maintained in cages, pens, or runs that provide in total at least 100 percent of the required space for each dog if maintained separately. Such animals may be maintained in compatible groups, unless:
(1) Housing in compatible groups is not in accordance with a research proposal and the proposal has been approved by the research facility Committee;
(2) In the opinion of the attending veterinarian, such housing would adversely affect the health or well-being of the dog(s); or
(3) Any dog exhibits aggressive or vicious behavior.
(c) Methods and period of providing exercise opportunity. (1) The frequency, method, and duration of the opportunity for exercise shall be determined by the attending veterinarian and, at research facilities, in consultation with and approval by the Committee.
(2) Dealers, exhibitors, and research facilities, in developing their plan, should consider providing positive physical contact with humans that encourages exercise through play or other similar activities. If a dog is housed, held, or maintained at a facility without sensory contact with another dog, it must be provided with positive physical contact with humans at least daily.
(3) The opportunity for exercise may be provided in a number of ways, such as:
(i) Group housing in cages, pens or runs that provide at least 100 percent of the required space for each dog if maintained separately under the minimum floor space requirements of § 3.6(c)(1) of this subpart;
(ii) Maintaining individually housed dogs in cages, pens, or runs that provide at least twice the minimum floor space required by § 3.6(c)(1) of this subpart;
(iii) Providing access to a run or open area at the frequency and duration prescribed by the attending veterinarian; or
(iv) Other similar activities.
(4) Forced exercise methods or devices such as swimming, treadmills, or carousel-type devices are unacceptable for meeting the exercise requirements of this section.
(d) Exemptions. (1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian.
(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually.
(3) Records of any exemptions must be maintained and made available to USDA officials or any pertinent funding Federal agency upon request.
(a) Dogs and cats must be fed at least once each day, except as otherwise might be required to provide adequate veterinary care. The food must be uncontaminated, wholesome, palatable, and of sufficient quantity and nutritive value to maintain the normal condition and weight of the animal. The diet must be appropriate for the individual animal's age and condition.
(b) Food receptacles must be used for dogs and cats, must be readily accessible to all dogs and cats, and must be located so as to minimize contamination by excreta and pests, and be protected from rain and snow. Feeding pans must either be made of a durable material that can be easily cleaned and sanitized or be disposable. If the food receptacles are not disposable, they must be kept clean and must be sanitized in accordance with § 3.11(b) of this subpart. Sanitization is achieved by using one of the methods described in § 3.11(b)(3) of this subpart. If the food receptacles are disposable, they must be discarded after one use. Self-feeders may be used for the feeding of dry food. If self-feeders are used, they must be kept clean and must be sanitized in accordance with § 3.11(b) of this subpart. Measures must be taken to ensure that there is no molding, deterioration, and caking of feed.
(a) Potable water must be continuously available to the dogs, unless restricted by the attending veterinarian or except as provided in § 3.17(a).
(b) If potable water is not continuously available to the cats, it must be offered to the cats as often as necessary to ensure their health and well-being, but not less than twice daily for at least 1 hour each time, unless restricted by the attending veterinarian.
(c) Water receptacles must be kept clean and sanitized in accordance with § 3.11(b) and before being used to water a different dog or cat or a different social grouping of dogs or cats.
(a) Cleaning of primary enclosures. Excreta and food waste must be removed from primary enclosures daily, and from under primary enclosures as often as necessary to prevent an excessive accumulation of feces and food waste, to prevent soiling of the dogs or cats contained in the primary enclosures, and to reduce disease hazards, insects, pests and odors. When steam or water is used to clean the primary enclosure, whether by hosing, flushing, or other methods, dogs and cats must be removed, unless the enclosure is large enough to ensure the animals would not be harmed, wetted, or distressed in the process. Standing water must be removed from the primary enclosure and animals in other primary enclosures must be protected from being contaminated with water and other wastes during the cleaning. The pans under primary enclosures with grill-type floors and the ground areas under raised runs with mesh or slatted floors must be cleaned as often as necessary to prevent accumulation of feces and food waste and to reduce disease hazards pests, insects and odors.
(b) Sanitization of primary enclosures and food and water receptacles. (1) Used primary enclosures and food and water receptacles must be cleaned and sanitized in accordance with this section before they can be used to house, feed, or water another dog or cat, or social grouping of dogs or cats.
(2) Used primary enclosures and food and water receptacles for dogs and cats must be sanitized at least once every 2 weeks using one of the methods prescribed in paragraph (b)(3) of this section, and more often if necessary to prevent an accumulation of dirt, debris, food waste, excreta, and other disease hazards.
(3) Hard surfaces of primary enclosures and food and water receptacles must be sanitized using one of the following methods:
(i) Live steam under pressure;
(ii) Washing with hot water (at least 180 °F (82.2 °C)) and soap or detergent, as with a mechanical cage washer; or
(iii) Washing all soiled surfaces with appropriate detergent solutions and disinfectants, or by using a combination detergent/disinfectant product that accomplishes the same purpose, with a thorough cleaning of the surfaces to remove organic material, so as to remove all organic material and mineral buildup, and to provide sanitization followed by a clean water rinse.
(4) Pens, runs, and outdoor housing areas using material that cannot be sanitized using the methods provided in paragraph (b)(3) of this section, such as gravel, sand, grass, earth, or absorbent bedding, must be sanitized by removing the contaminated material as necessary to prevent odors, diseases, pests, insects, and vermin infestation.
(c) Housekeeping for premises. Premises where housing facilities are located, including buildings and surrounding grounds, must be kept clean and in good repair to protect the animals from injury, to facilitate the husbandry practices required in this subpart, and to reduce or eliminate breeding and living areas for rodents and other pests and vermin. Premises must be kept free of accumulations of trash, junk, waste products, and discarded matter. Weeds, grasses, and bushes must be controlled so as to facilitate cleaning of the premises and pest control, and to protect the health and well-being of the animals.
(d) Pest control. An effective program for the control of insects, external parasites affecting dogs and cats, and birds and mammals that are pests, must be established and maintained so as to promote the health and well-being of the animals and reduce contamination by pests in animal areas.
Each person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) maintaining dogs and cats must have enough employees to carry out the level of husbandry practices and care required in this subpart. The employees who provide for husbandry and care, or handle animals, must be supervised by an individual who has the knowledge, background, and experience in proper husbandry and care of dogs and cats to supervise others. The employer must be certain that the supervisor and other employees can perform to these standards.
(a) Each dealer, exhibitor, and research facility must follow an appropriate program of veterinary care for dogs that is developed, documented in writing, and signed by the attending veterinarian. Dealers, exhibitors, and research facilities must keep and maintain the written program and make it available for APHIS inspection. The written program of veterinary care must address the requirements for adequate veterinary care for every dealer and exhibitor in § 2.40 of this subchapter and every research facility in § 2.33 of this subchapter, and must also include:
(1) Regularly scheduled visits, not less than once every 12 months, by the attending veterinarian to all premises where animals are kept, to assess and ensure the adequacy of veterinary care and other aspects of animal care and use;
(2) A complete physical examination from head to tail of each dog by the attending veterinarian not less than once every 12 months;
(3) Vaccinations for contagious and/or deadly diseases of dogs (including rabies, parvovirus and distemper) and sampling and treatment of parasites and other pests (including fleas, worms, coccidia, giardia, and heartworm) in accordance with a schedule approved by the attending veterinarian, unless otherwise required by a research protocol approved by the Committee at research facilities; and
(4) Preventative care and treatment to ensure healthy and unmatted hair coats, properly trimmed nails, and clean and healthy eyes, ears, skin, and teeth, unless otherwise required by a research protocol approved by the Committee at research facilities.
(b) Dealers, exhibitors, and research facilities must keep copies of medical records for dogs and make the records available for APHIS inspection. These records must include:
(1) The identity of the animal, including identifying marks, tattoos, or tags on the animal and the animal's breed, sex, and age; Provided, however, that routine husbandry, such as vaccinations, preventive medical procedures, or treatments, performed on all animals in a group (or herd), may be kept on a single record;
(2) If a problem is identified (such as a disease, injury, or illness), the date and a description of the problem, examination findings, test results, plan for treatment and care, and treatment procedures performed, when appropriate;
(3) The names of all vaccines and treatments administered and the dates of administration; and
(4) The dates and findings/results of all screening, routine, or other required or recommended test or examination.
(c) Medical records for dogs shall be kept for the following periods:
(1) The medical records for dogs shall be kept and maintained by the research facility for the duration of the research activity and for an additional 3 years after the dog is euthanized or disposed of, and for any period in excess of 3 years as necessary to comply with any applicable Federal, State, or local law.
(2) The medical records for dogs shall be kept and maintained by the dealer or exhibitor for at least 1 year after the dog is euthanized or disposed of and for any period in excess of 1 year as necessary to comply with any applicable Federal, State, or local law.
(3) Whenever the Administrator notifies a research facility, dealer, or exhibitor in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the research facility, dealer, or exhibitor shall hold those records until their disposition is authorized by the Administrator.
(a) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce more than 4 hours before the scheduled departure time of the primary conveyance on which the animal is to be transported. However, a carrier or intermediate handler may agree with anyone consigning a dog or cat to extend this time by up to 2 hours.
(b) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless they are provided with the name, address, and telephone number of the consignee.
(c) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the dog or cat was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.17. The certification must include the following information for each dog and cat:
(1) The consignor's name and address;
(2) The tag number or tattoo assigned to each dog or cat under §§ 2.38 and 2.50 of this chapter;
(3) The time and date the animal was last fed and watered and the specific instructions for the next feeding(s) and watering(s) for a 24-hour period; and
(4) The consignor's signature and the date and time the certification was signed.
(d) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce in a primary enclosure unless the primary enclosure meets the requirements of § 3.15. A carrier or intermediate handler must not accept a dog or cat for transport if the primary enclosure is obviously defective or damaged and cannot reasonably be expected to safely and comfortably contain the dog or cat without causing suffering or injury.
(e) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless their animal holding area meets the minimum temperature requirements provided in §§ 3.19 and 3.20, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those required in §§ 3.19 and 3.20. Even if the carrier or intermediate handler receives this certification, the temperatures the dog or cat is exposed to while in a terminal facility must not be lower than 45 °F (2.2 °C) for more than 4 consecutive hours when dogs or cats are present, as set forth in § 3.19, nor lower than 45 °F (2.2 °C) for more than 45 minutes, as set forth in § 3.20, when moving dogs or cats to or from terminal facilities or primary conveyances. A copy of the certification must accompany the dog or cat to its destination and must include the following information:
(1) The consignor's name and address;
(2) The tag number or tattoo assigned to each dog or cat under §§ 2.38 and 2.50 of this chapter;
(3) A statement by a veterinarian, dated no more than 10 days before delivery, that to the best of his or her knowledge, each of the dogs or cats contained in the primary enclosure is acclimated to air temperatures lower than 50 °F (10 °C); but not lower than a minimum temperature, specified on a certificate, that the attending veterinarian has determined is based on generally accepted temperature standards for the age, condition, and breed of the dog or cat; and
(4) The signature of the veterinarian and the date the certification was signed.
(f) When a primary enclosure containing a dog or cat has arrived at the animal holding area at a terminal facility after transport, the carrier or intermediate handler must attempt to notify the consignee upon arrival and at least once in every 6-hour period thereafter. The time, date, and method of all attempted notifications and the actual notification of the consignee, and the name of the person who notifies or attempts to notify the consignee must be written either on the carrier's or intermediate handler's copy of the shipping document or on the copy that accompanies the primary enclosure. If the consignee cannot be notified within 24 hours after the dog or cat has arrived at the terminal facility, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. If the consignee is notified of the arrival and does not accept delivery of the dog or cat within 48 hours after arrival of the dog or cat, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. The carrier or intermediate handler must continue to provide proper care, feeding, and housing to the dog or cat, and maintain the dog or cat in accordance with generally accepted professional and husbandry practices until the consignee accepts delivery of the dog or cat or until it is returned to the consignor or to whomever the consignor designates. The carrier or intermediate handler must obligate the consignor to reimburse the carrier or intermediate handler for the cost of return transportation and care.
Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a dog or cat unless the following requirements are met:
(a) Construction of primary enclosures. The dog or cat must be contained in a primary enclosure such as a compartment, transport cage, carton, or crate. Primary enclosures used to transport dogs and cats must be constructed so that:
(1) The primary enclosure is strong enough to contain the dogs and cats securely and comfortably and to withstand the normal rigors of transportation;
(2) The interior of the primary enclosure has no sharp points or edges and no protrusions that could injure the animal contained in it;
(3) The dog or cat is at all times securely contained within the enclosure and cannot put any part of its body outside the enclosure in a way that could result in injury to itself, to handlers, or to persons or animals nearby;
(4) The dog or cat can be easily and quickly removed from the enclosure in an emergency;
(5) Unless the enclosure is permanently affixed to the conveyance, adequate devices such as handles or handholds are provided on its exterior, and enable the enclosure to be lifted without tilting it, and ensure that anyone handling the enclosure will not come into physical contact with the animal contained inside;
(6) Unless the enclosure is permanently affixed to the conveyance, it is clearly marked on top and on one or more sides with the words “Live Animals,” in letters at least 1 inch (2.5 cm.) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure;
(7) Any material, treatment, paint, preservative, or other chemical used in or on the enclosure is nontoxic to the animal and not harmful to the health or well-being of the animal;
(8) Proper ventilation is provided to the animal in accordance with paragraph (c) of this section; and
(9) The primary enclosure has a solid, leak-proof bottom or a removable, leak-proof collection tray under a slatted or mesh floor that prevents seepage of waste products, such as excreta and body fluids, outside of the enclosure. If a slatted or mesh floor is used in the enclosure, it must be designed and constructed so that the animal cannot put any part of its body between the slats or through the holes in the mesh. Unless the dogs and cats are on raised slatted floors or raised floors made of mesh, the primary enclosure must contain enough previously unused litter to absorb and cover excreta. The litter must be of a suitably absorbent material that is safe and nontoxic to the dogs and cats.
(b) Cleaning of primary enclosures. A primary enclosure used to hold or transport dogs or cats in commerce must be cleaned and sanitized before each use in accordance with the methods provided in § 3.11(b)(3) of this subpart. If the dogs or cats are in transit for more than 24 hours, the enclosures must be cleaned and any litter replaced, or other methods, such as moving the animals to another enclosure, must be utilized to prevent the soiling of the dogs or cats by body wastes. If it becomes necessary to remove the dog or cat from the enclosure in order to clean, or to move the dog or cat to another enclosure, this procedure must be completed in a way that safeguards the dog or cat from injury and prevents escape.
(c) Ventilation. (1) Unless the primary enclosure is permanently affixed to the conveyance, there must be:
(i) Ventilation openings located on two opposing walls of the primary enclosure and the openings must be at least 16 percent of the surface area of each such wall, and the total combined surface area of the ventilation openings must be at least 14 percent of the total combined surface area of all the walls of the primary enclosure; or
(ii) Ventilation openings on three walls of the primary enclosure, and the openings on each of the two opposing walls must be at least 8 percent of the total surface area of the two walls, and the ventilation openings on the third wall of the primary enclosure must be at least 50 percent of the total surface area of that wall, and the total combined surface area of the ventilation openings must be at least 14 percent of the total combined surface area of all the walls of the primary enclosure; or
(iii) Ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each of the four walls must be at least 8 percent of the total surface area of each such wall, and the total combined surface area of the openings must be at least 14 percent of total combined surface area of all the walls of the primary enclosure; and
(iv) At least one-third of the ventilation area must be located on the upper half of the primary enclosure.
(2) Unless the primary enclosure is permanently affixed to the conveyance, projecting rims or similar devices must be located on the exterior of each enclosure wall having a ventilation opening, in order to prevent obstruction of the openings. The projecting rims or similar devices must be large enough to provide a minimum air circulation space of 0.75 in. (1.9 cm) between the primary enclosure and anything the enclosure is placed against.
(3) If a primary enclosure is permanently affixed to the primary conveyance so that there is only a front ventilation opening for the enclosure, the primary enclosure must be affixed to the primary conveyance in such a way that the front ventilation opening cannot be blocked, and the front ventilation opening must open directly to an unobstructed aisle or passageway inside the conveyance. The ventilation opening must be at least 90 percent of the total area of the front wall of the enclosure, and must be covered with bars, wire mesh, or smooth expanded metal having air spaces.
(d) Compatibility. (1) Live dogs or cats transported in the same primary enclosure must be of the same species and be maintained in compatible groups, except that dogs and cats that are private pets, are of comparable size, and are compatible, may be transported in the same primary enclosure.
(2) Puppies or kittens 4 months of age or less may not be transported in the same primary enclosure with adult dogs or cats other than their dams.
(3) Dogs or cats that are overly aggressive or exhibit a vicious disposition must be transported individually in a primary enclosure.
(4) Any female dog or cat in heat (estrus) may not be transported in the same primary enclosure with any male dog or cat.
(e) Space and placement. (1) Primary enclosures used to transport live dogs and cats must be large enough to ensure that each animal contained in the primary enclosure has enough space to turn about normally while standing, to stand and sit erect, and to lie in a natural position.
(2) Primary enclosures used to transport dogs and cats must be positioned in the primary conveyance so as to provide protection from the elements.
(f) Transportation by air. (1) No more than one live dog or cat, 6 months of age or older, may be transported in the same primary enclosure when shipped via air carrier.
(2) No more than one live puppy, 8 weeks to 6 months of age, and weighing over 20 lbs (9 kg), may be transported in a primary enclosure when shipped via air carrier.
(3) No more than two live puppies or kittens, 8 weeks to 6 months of age, that are of comparable size, and weighing 20 lbs (9 kg) or less each, may be transported in the same primary enclosure when shipped via air carrier.
(4) Weaned live puppies or kittens less than 8 weeks of age and of comparable size, or puppies or kittens that are less than 8 weeks of age that are littermates and are accompanied by their dam, may be transported in the same primary enclosure when shipped to research facilities, including Federal research facilities.
(g) Transportation by surface vehicle or privately owned aircraft. (1) No more than four live dogs or cats, 8 weeks of age or older, that are of comparable size, may be transported in the same primary enclosure when shipped by surface vehicle (including ground and water transportation) or privately owned aircraft, and only if all other requirements of this section are met.
(2) Weaned live puppies or kittens less than 8 weeks of age and of comparable size, or puppies or kittens that are less than 8 weeks of age that are littermates and are accompanied by their dam, may be transported in the same primary enclosure when shipped to research facilities, including Federal research facilities, and only if all other requirements in this section are met.
(h) Accompanying documents and records. Shipping documents that must accompany shipments of dogs and cats may be held by the operator of the primary conveyance, for surface transportation only, or must be securely attached in a readily accessible manner to the outside of any primary enclosure that is part of the shipment, in a manner that allows them to be detached for examination and securely reattached, such as in a pocket or sleeve. Instructions for administration of drugs, medication, and other special care must be attached to each primary enclosure in a manner that makes them easy to notice, to detach for examination, and to reattach securely. Food and water instructions must be attached in accordance with § 3.14(c).
(a) The animal cargo space of primary conveyances used to transport dogs and cats must be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the animals transported in them, ensures their safety and comfort, and prevents the entry of engine exhaust from the primary conveyance during transportation.
(b) The animal cargo space must have a supply of air that is sufficient for the normal breathing of all the animals being transported in it.
(c) Each primary enclosure containing dogs or cats must be positioned in the animal cargo space in a manner that provides protection from the elements and that allows each dog or cat enough air for normal breathing.
(d) During air transportation, dogs and cats must be held in cargo areas that are heated or cooled as necessary to maintain an ambient temperature and humidity that ensures the health and well-being of the dogs or cats. The cargo areas must be pressurized when the primary conveyance used for air transportation is not on the ground, unless flying under 8,000 ft. Dogs and cats must have adequate air for breathing at all times when being transported.
(e) During surface transportation, auxiliary ventilation, such as fans, blowers or air conditioning, must be used in any animal cargo space containing live dogs or cats when the ambient temperature within the animal cargo space reaches 85 °F (29.5 °C). Moreover, the ambient temperature may not exceed 85 °F (29.5 °C) for a period of more than 4 hours; nor fall below 45 °F (7.2 °C) for a period of more than 4 hours. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(f) Primary enclosures must be positioned in the primary conveyance in a manner that allows the dogs and cats to be quickly and easily removed from the primary conveyance in an emergency.
(g) The interior of the animal cargo space must be kept clean.
(h) Live dogs and cats may not be transported with any material, substance (e.g., dry ice) or device in a manner that may reasonably be expected to harm the dogs and cats or cause inhumane conditions.
(a) Each dog and cat that is 16 weeks of age or more must be offered food at least once every 24 hours. Puppies and kittens less than 16 weeks of age must be offered food at least once every 12 hours. Each dog and cat must be offered potable water at least once every 12 hours. These time periods apply to dealers, exhibitors, research facilities. including Federal research facilities, who transport dogs and cats in their own primary conveyance, starting from the time the dog or cat was last offered food and potable water before transportation was begun. These time periods apply to carriers and intermediate handlers starting from the date and time stated on the certificate provided under § 3.14(c). Each dog and cat must be offered food and potable water within 4 hours before being transported in commerce. Consignors who are subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must certify that each dog and cat was offered food and potable water within the 4 hours preceding delivery of the dog or cat to a carrier or intermediate handler for transportation in commerce, and must certify the date and time the food and potable water was offered, in accordance with § 3.14(c).
(b) Any dealer, research facility, including a Federal research facility, or exhibitor offering any dog or cat to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the dog or cat, written instructions for the in-transit food and water requirements for a 24-hour period for the dogs and cats contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read.
(c) Food and water receptacles must be securely attached inside the primary enclosure and placed so that the receptacles can be filled from outside the enclosure without opening the door. Food and water containers must be designed, constructed, and installed so that a dog or cat cannot leave the primary enclosure through the food or water opening.
(a) Surface transportation (ground and water). Any person subject to the Animal Welfare regulations transporting dogs or cats in commerce must ensure that the operator of the conveyance, or a person accompanying the operator, observes the dogs or cats as often as circumstances allow, but not less than once every 4 hours, to make sure they have sufficient air for normal breathing, that the ambient temperature is within the limits provided in § 3.16(e), and that all applicable standards of this subpart are being complied with. The regulated person must ensure that the operator or person accompanying the operator determines whether any of the dogs or cats are in obvious physical distress and obtains any veterinary care needed for the dogs or cats at the closest available veterinary facility.
(b) Air transportation. During air transportation of dogs or cats, it is the responsibility of the carrier to observe the dogs or cats as frequently as circumstances allow, but not less than once every 4 hours if the animal cargo area is accessible during flight. If the animal cargo area is not accessible during flight, the carrier must observe the dogs or cats whenever they are loaded and unloaded and whenever the animal cargo space is otherwise accessible to make sure they have sufficient air for normal breathing, that the animal cargo area meets the heating and cooling requirements of § 3.16(d), and that all other applicable standards of this subpart are being complied with. The carrier must determine whether any of the dogs or cats are in obvious physical distress, and arrange for any needed veterinary care as soon as possible.
(c) If a dog or cat is obviously ill, injured, or in physical distress, it must not be transported in commerce, except to receive veterinary care for the condition.
(d) Removal during transportation in commerce prohibited. Except during the cleaning of primary enclosures, as required in § 3.15(b), during transportation in commerce a dog or cat must not be removed from its primary enclosure, unless it is placed in another primary enclosure or facility that meets the requirements of § 3.6 or § 3.15.
(e) The transportation regulations contained in this subpart must be complied with until a consignee takes physical delivery of the dog or cat if the animal is consigned for transportation, or until the animal is returned to the consignor.
(a) Placement. Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not commingle shipments of dogs or cats with inanimate cargo in animal holding areas of terminal facilities.
(b) Cleaning, sanitization, and pest control. All animal holding areas of terminal facilities must be cleaned and sanitized in a manner prescribed in § 3.11(b)(3) of this subpart, as often as necessary to prevent an accumulation of debris or excreta and to minimize vermin infestation and disease hazards. Terminal facilities must follow an effective program in all animal holding areas for the control of insects, ectoparasites, and birds and mammals that are pests to dogs and cats.
(c) Ventilation. Ventilation must be provided in any animal holding area in a terminal facility containing dogs or cats, by means of windows, doors, vents, or air conditioning. The air must be circulated by fans, blowers, or air conditioning so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans, vents, fans, blowers, or air conditioning must be used in any animal holding area containing dogs and cats, when the ambient temperature is 85 °F (29.5 °C) or higher
(d) Temperature. The ambient temperature in an animal holding area containing dogs or cats must not fall below 45 °F (7.2 °C) or rise above 85 °F (29.5 °C) for more than four consecutive hours at any time dogs or cats are present. The ambient temperature must be measured in the animal holding area by the carrier, intermediate handler, or a person transporting dogs or cats who is subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3), outside any primary enclosure containing a dog or cat at a point not more than 3 feet (0.91 m) away from an outside wall of the primary enclosure, and approximately midway up the side of the enclosure. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(e) Shelter. Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) holding a live dog or cat in an animal holding area of a terminal facility must provide the following:
(1) Shelter from sunlight and extreme heat. Shade must be provided that is sufficient to protect the dog or cat from the direct rays of the sun.
(2) Shelter from rain or snow. Sufficient protection must be provided to allow the dogs and cats to remain dry during rain, snow, and other precipitation.
(f) Duration. The length of time any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) can hold dogs and cats in animal holding areas of terminal facilities upon arrival is the same as that provided in § 3.14(f).
(a) Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) who moves (including loading and unloading) dogs or cats within, to, or from the animal holding area of a terminal facility or a primary conveyance must do so as quickly and efficiently as possible and must provide the following during movement of the dog or cat:
(1) Shelter from sunlight and extreme heat. Sufficient shade must be provided to protect the dog or cat from the direct rays of the sun. The dog or cat must not be exposed to an ambient air temperature above 85 °F (29.5 °C) for a period of more than 45 minutes while being moved to or from a primary conveyance or a terminal facility. The temperature must be measured in the manner provided in § 3.19(d). The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(2) Shelter from rain and snow. Sufficient protection must be provided to allow the dogs and cats to remain dry during rain, snow, and other precipitation.
(3) Shelter from cold temperatures. Transporting devices on which live dogs or cats are placed to move them must be covered to protect the animals when the outdoor temperature falls below 50 °F (10 °C). The dogs or cats must not be exposed to an ambient temperature below 45 °F (7.2 °C) for a period of more than 45 minutes, unless they are accompanied by a certificate of acclimation to lower temperatures as provided in § 3.14(e). The temperature must be measured in the manner provided in § 3.19(d). The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(b) Any person handling a primary enclosure containing a dog or cat must use care and must avoid causing physical harm or distress to the dog or cat.
(1) A primary enclosure containing a live dog or cat must not be placed on unattended conveyor belts, or on elevated conveyor belts, such as baggage claim conveyor belts and inclined conveyor ramps that lead to baggage claim areas, at any time; except that a primary enclosure may be placed on inclined conveyor ramps used to load and unload aircraft if an attendant is present at each end of the conveyor belt.
(2) A primary enclosure containing a dog or cat must not be tossed, dropped, or needlessly tilted, and must not be stacked in a manner that may reasonably be expected to result in its falling. It must be handled and positioned in the manner that written instructions and arrows on the outside of the primary enclosure indicate.
(c) This section applies to movement of a dog or cat from primary conveyance to primary conveyance, within a primary conveyance or terminal facility, and to or from a terminal facility or a primary conveyance.
(a) Structural strength. Indoor and outdoor housing facilities for guinea pigs or hamsters shall be structurally sound and shall be maintained in good repair, to protect the animals from injury, to contain the animals, and to restrict the entrance of other animals.
(b) Water and electric power. Reliable and adequate electric power, if required to comply with other provisions of this subpart, and adequate potable water shall be available.
(c) Storage. Supplies of food and bedding shall be stored in facilities which adequately protect such supplies against spoilage or deterioration and infestation or contamination by vermin. Food supplies shall be stored in containers with tightly fitting lids or covers or in the original containers as received from the commercial sources of supply. Refrigeration shall be provided for supplies of perishable food.
(d) Waste disposal. Provisions shall be made for the removal and disposal of animal and food wastes, bedding, dead animals, and debris. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, and disease hazards.
(e) Washroom and sinks. Facilities, such as washrooms, basins, or sinks, shall be provided to maintain cleanliness among animal caretakers.
(a) Heating. Indoor housing facilities for guinea pigs or hamsters shall be sufficiently heated when necessary to protect the animals from the cold, and to provide for their health and comfort. The ambient temperature shall not be allowed to fall below 60 °F. nor to exceed 85 °F.
(b) Ventilation. Indoor housing facilities for guinea pigs or hamsters shall be adequately ventilated to provide for the health and comfort of the animals at all times. Such facilities shall be provided with fresh air either by means of windows, doors, vents, or air conditioning, and shall be ventilated so as to minimize drafts, odors, and moisture condensation. The ambient temperature shall not be allowed to rise above 85 °F.
(c) Lighting. Indoor housing facilities for guinea pigs or hamsters shall have ample light, by natural or artificial means, or both, of good quality and well distributed. Such lighting shall provide uniformly distributed illumination of sufficient light intensity to permit routine inspection and cleaning during the entire working period. Primary enclosures shall be so placed as to protect the guinea pigs or hamsters from excessive illumination.
(d) Interior surfaces. The interior building surfaces of indoor housing facilities shall be constructed and maintained so that they are substantially impervious to moisture and may be readily sanitized.
(a) Hamsters shall not be housed in outdoor facilities.
(b) Guinea pigs shall not be housed in outdoor facilities unless such facilities are located in an appropriate climate and prior approval for such outdoor housing is obtained from the Deputy Administrator.
All primary enclosures for guinea pigs and hamsters shall conform to the following requirements:
(a) General. (1) Primary enclosures shall be structurally sound and maintained in good repair to protect the guinea pigs and hamsters from injury. Such enclosures, including their racks, shelving and other accessories, shall be constructed of smooth material substantially impervious to liquids and moisture.
(2) Primary enclosures shall be constructed and maintained so that the guinea pigs or hamsters contained therein have convenient access to clean food and water as required in this subpart.
(3) Primary enclosures having a solid floor shall be provided with clean bedding material.
(4) Primary enclosures equipped with mesh or wire floors shall be so constructed as to allow feces to pass through the spaces of the mesh or wire: Provided, however, That such floors shall be constructed so as to protect the animals' feet and legs from injury.
(b) Space requirements for primary enclosures acquired before August 15, 1990—(1) Guinea pigs and hamsters. Primary enclosures shall be constructed and maintained so as to provide sufficient space for each animal contained therein to make normal postural adjustments with adequate freedom of movement.
(2) Guinea pigs. In addition to the provisions of paragraph (b)(1) of this section, the following space requirements are applicable to primary enclosures for guinea pigs:
(i) The interior height of any primary enclosure used to confine guinea pigs shall be at least 6
(ii) Each guinea pig housed in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
| Weight or stage of maturity | Minimum space per guinea pig (square inches) |
|---|---|
| Weaning to 350 grams | 60 |
| 350 grams or more | 90 |
| Breeders | 180 |
(3) Hamsters. In addition to the provisions of paragraph (b)(1) of this section, the following space requirements are applicable to primary enclosures for hamsters:
(i) The interior height of any primary enclosure used to confine hamsters shall be at least 5
(ii) A nursing female hamster, together with her litter, shall be housed in a primary enclosure which contains no other hamsters and which provides at least 121 square inches of floor space: Provided, however, That in the case of dwarf hamsters such floor space shall be at least 25 square inches.
(iii) The minimum amount of floor space per individual hamster and the maximum number of hamsters allowed in a single primary enclosure, except as provided for nursing females in paragraph (b)(3)(ii) of this section, shall be in accordance with the following table:
| Age | Minimum space per hamster (square inches) | Maximum population per enclosure | |
|---|---|---|---|
| Weaning to 5 wks | 5.0 | 10.0 | 20 |
| 5 to 10 wks | 7.5 | 12.5 | 16 |
| 10 wks. or more | 9 | 15.0 | 13 |
(c) Space requirements for primary enclosures acquired on or after August 15, 1990—(1) Guinea pigs. (i) Primary enclosures shall be constructed and maintained so as to provide sufficient space for each guinea pig contained therein to make normal postural adjustments with adequate freedom of movement.
(ii) The interior height of any primary enclosure used to confine guinea pigs shall be at least 7 inches (17.78 cm).
(iii) Each guinea pig shall be provided a minimum amount of floor space in any primary enclosure as follows:
| Weight or stage of maturity | Minimum floor space | |
|---|---|---|
| in 2 | cm 2 | |
| Weaning to 350 grams | 60 | 387.12 |
| >350 grams | 101 | 651.65 |
| Nursing females with their litters | 101 | 651.65 |
(2) Hamsters. (i) Primary enclosures shall be constructed and maintained so as to provide sufficient space for each hamster contained therein to make normal postural adjustments with adequate freedom of movement.
(ii) The interior height of any primary enclosure used to confine hamsters shall be at least 6 inches (15.24 cm).
(iii) Except as provided in paragraph (c)(2)(iv) of this section, each hamster shall be provided a minimum amount of floor space in any primary enclosure as follows:
| Weight | Minimum floor space per hamster | ||
|---|---|---|---|
| g | ozs | in 2 | cm 2 |
| <60 | <2.1 | 10 | 64.52 |
| 60 to 80 | 2.1-2.8 | 13 | 83.88 |
| 80 to 100 | 2.8-3.5 | 16 | 103.23 |
| >100 | >3.5 | 19 | 122.59 |
(iv) A nursing female hamster, together with her litter, shall be housed in a primary enclosure that contains no other hamsters and that provides at least 121 square inches of floor space: Provided, however, That in the case of nursing female dwarf hamsters such floor space shall be at least 25 square inches.
(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(1) or (c)(2) of this section, but that do provide guinea pigs or hamsters with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator.
(a) Guinea pigs and hamsters shall be fed each day except as otherwise might be required to provide adequate veterinary care. The food shall be free from contamination, wholesome, palatable and of sufficient quantity and nutritive value to meet the normal daily requirements for the condition and size of the guinea pig or hamster.
(b) Food comprising the basic diet shall be at least equivalent in quality and content to pelleted rations produced commercially and commonly available from feed suppliers.
(c) The basic diet of guinea pigs and hamsters may be supplemented with good quality fruits or vegetables consistent with their individual dietary requirements.
(d) Food receptacles, if used, shall be accessible to all guinea pigs or hamsters in a primary enclosure and shall be located so as to minimize contamination by excreta. All food receptacles shall be kept clean and shall be sanitized at least once every 2 weeks. If self-feeders are used for the feeding of pelleted feed, measures must be taken to prevent molding, deterioration or caking of the feed. Hamsters may be fed pelleted feed on the floor of a primary enclosure.
(e) Fruit or vegetable food supplements may be placed upon the bedding within the primary enclosure: Provided, however, That the uneaten portion of such supplements and any bedding soiled as a result of such feeding practices shall be removed from the primary enclosure when such uneaten supplements accumulate or such bedding becomes soiled to a degree that might be harmful or uncomfortable to animals therein.
Unless food supplements consumed by guinea pigs or hamsters supply them with their normal water requirements, potable water shall be provided daily except as might otherwise be required to provide adequate veterinary care. Open containers used for dispensing water to guinea pigs or hamsters shall be so placed in or attached to the primary enclosure as to minimize contamination from excreta. All watering receptacles shall be sanitized when dirty: Provided, however, That such receptacles shall be sanitized at least once every 2 weeks.
(a) Cleaning and sanitation of primary enclosures. (1) Primary enclosures shall be cleaned and sanitized often enough to prevent an accumulation of excreta or debris: Provided, however, That such enclosures shall be sanitized at least once every 2 weeks in the manner provided in paragraph (a)(4) of this section.
(2) In the event a primary enclosure becomes soiled or wet to a degree that might be harmful or uncomfortable to the animals therein due to leakage of the watering system, discharges from dead or dying animals, spoiled perishable foods, or moisture condensation, the guinea pigs or hamsters shall be transferred to clean primary enclosures.
(3) Prior to the introduction of guinea pigs or hamsters into empty primary enclosures previously occupied, such enclosures shall be sanitized in the manner provided in paragraph (a)(4) of this section.
(4) Primary enclosures for guinea pigs or hamsters shall be sanitized by washing them with hot water (180 °F.) and soap or detergent as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam.
(b) Housekeeping. Premises (buildings and grounds) shall be kept clean and in good repair in order to protect the animals from injury and to facilitate the prescribed husbandry practices set forth in this subpart. Premises shall remain free of accumulations of trash.
(c) Pest control. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained.
A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices shall be under the supervision of an animal caretaker who has a background in animal husbandry or care.
Animals housed in the same primary enclosure shall be maintained in compatible groups, with the following additional restrictions:
(a) Except where harem breeding is practiced, preweanling guinea pigs shall not be housed in the same primary enclosure with adults other than their parents.
(b) Guinea pigs shall not be housed in the same primary enclosure with hamsters, nor shall guinea pigs or hamsters be housed in the same primary enclosure with any other species of animals.
(c) Guinea pigs or hamsters under quarantine or treatment for a communicable disease shall be separated from other guinea pigs or hamsters and other susceptible species of animals in such a manner as to minimize dissemination of such disease.
(a) Carriers and intermediate handlers shall not accept any live guinea pig or hamster presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported: Provided, however, That the carrier or intermediate handler and any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government may mutually agree to extend the time of acceptance to not more than 6 hours if specific prior scheduling of the animal shipment to destination has been made.
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce any live guinea pig or hamster in a primary enclosure which conforms to the requirements set forth in § 3.36 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live guinea pig or hamster consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals, or any licensed or registered dealer, research facility, exhibitor, or operator of an auction sale, if such consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with § 3.36 of the standards, unless such primary enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the live guinea pig or hamster without causing suffering or injury to such live guinea pig or hamster. A copy of such certificate shall accompany the shipment to destination. The certificate of compliance shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of guinea pigs or hamsters in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the ____ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live hamster consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such hamster for transportation in commerce, stating that such live hamster is acclimated to air temperatures lower than those prescribed in §§ 3.40 and 3.41. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the following information:
(1) Name and address of the consignor;
(2) The number of hamsters in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.).”); and
(4) The signature of the USDA accredited veterinarian, assigned accreditation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live guinea pig or hamster at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No person subject to the Animal Welfare regulations shall offer for transportation, or transport, in commerce any live guinea pig or hamster in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or crates, used to transport live guinea pigs or hamsters shall be constructed in such a manner that (1) the structural strength of the enclosure shall be sufficient to contain the live guinea pigs or hamsters and to withstand the normal rigors of transportation; (2) the interior of the enclosure shall be free from any protrusions that could be injurious to the live guinea pigs or hamsters contained therein; (3) the inner surfaces of corrugated fiberboard, cardboard, or plastic containers shall be covered or laminated with wire mesh or screen where necessary to prevent escape of the animals; (4) the openings of such enclosures are easily accessible at all times for emergency removal of the live guinea pigs or hamsters; (5) except as provided in paragraph (i) of this section, there are ventilation openings located on two opposite walls of the primary enclosure and the ventilation openings on each such wall shall be at least 16 percent of the total surface area of each such wall, or there are ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each such wall shall be at least 8 percent of the total surface area of each such wall: Provided, however, That at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the lower one-half of the primary enclosure and at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the upper one-half of the primary enclosure; (6) except as provided in paragraph (i) of this section, projecting rims or other devices shall be on the exterior of the outside walls with any ventilation openings to prevent obstruction of the ventilation openings and to provide a minimum air circulation space of 1.9 centimeters (.75 inches) between the primary enclosure and any adjacent cargo or conveyance wall; and (7) except as provided in paragraph (i) of this section, adequate handholds or other devices for lifting shall be provided on the exterior of the primary enclosure to enable the primary enclosure to be lifted without tilting and to ensure that the person handling the primary enclosure will not be in contact with the guinea pigs or hamsters.
(b) Live guinea pigs or hamsters transported in the same primary enclosure shall be of the same species and maintained in compatible groups.
(c) Primary enclosures used to transport live guinea pigs or hamsters shall be large enough to ensure that each animal contained therein has sufficient space to turn about freely and to make normal postural adjustments.
(d) Not more than 15 live guinea pigs shall be transported in the same primary enclosure. No more than 50 live hamsters shall be transported in the same primary enclosure.
(e) In addition to the other provisions of this section, the following requirements shall also apply to primary enclosures used to transport live guinea pigs or hamsters:
(1) Guinea pigs. (i) The interior height of primary enclosures used to transport live guinea pigs weighing up to 500 grams shall be at least 15.2 centimeters (6 inches) and the interior height of primary enclosures used to transport live guinea pigs weighing over 500 grams shall be at least 17.8 centimeters (7 inches).
(ii) Each live guinea pig transported in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
Minimum space per live guinea pig
| Weight (grams) | Square centimeters | Square inches |
|---|---|---|
| Up to 350 | 193.6 | 30 |
| 350 to 600 | 290.3 | 45 |
| Over 600 | 354.8 | 55 |
(2) Hamsters. (i) The interior height of primary enclosures used to transport live hamsters shall be at least 15.2 centimeters (6 inches) except that in the case of dwarf hamsters such interior height shall be at least 12.7 centimeters (5 inches).
(ii) Each live hamster transported in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
Minimum space per live hamster
| Age | Dwarf | Other | ||
|---|---|---|---|---|
| Square centimeters | Square inches | Square centimeters | Square inches | |
| Weaning to 5 wks | 32.2 | 5.0 | 45.2 | 7 |
| 5 to 10 wks | 48.3 | 7.5 | 71.0 | 11 |
| Over 10 wks | 58.1 | 9.0 | 96.8 | 15 |
(f) Primary enclosures used to transport live guinea pigs or hamsters as provided in this section shall have solid bottoms to prevent leakage in shipment and shall be cleaned and sanitized in a manner prescribed in § 3.31 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbent material, which is safe and nontoxic to the guinea pigs or hamsters, in sufficient quantity to absorb and cover excreta, unless the guinea pigs or hamsters are on wire or other nonsolid floors.
(g) Primary enclosures used to transport live guinea pigs or hamsters, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animals” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container.
(h) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(i) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live guinea pigs and hamsters shall be designed and constructed to protect the health, and ensure the safety and comfort of the live guinea pigs and hamsters at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live guinea pig or hamster shall be placed in an animal cargo space that does not have a supply of air sufficient for normal breathing for each live animal contained therein, and the primary enclosures shall be positioned in the animal cargo space in such a manner that each live guinea pig or hamster has access to sufficient air for normal breathing.
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live guinea pigs or hamsters can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live guinea pigs and hamsters shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the guinea pigs and hamsters unless proper precaution is taken to prevent such injury.
(g) The animal cargo space of primary conveyances used to transport guinea pigs or hamsters shall be mechanically sound and provide fresh air by means of windows, doors, vents, or air conditioning so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as fans, blowers, or air conditioners, shall be used in any cargo space containing live guinea pigs or hamsters when the ambient temperature in the animal cargo space is 75 °F (23.9 °C) or higher. The ambient temperature within the animal cargo space shall not exceed 85 °F (29.5 °C) or fall below 45 °F (7.2 °C), except that the ambient temperature in the cargo space may be below 45 °F (7.2 °C) for hamsters if the hamsters are accompanied by a certificate of acclimation to lower temperatures, as provided in § 3.35(c) of this part.
(a) If live guinea pigs or hamsters are to be transported for a period of more than 6 hours, the animals shall have access to food and water or a type of food, which provides the requirements for food and water in quantity and quality sufficient to satisfy their food and water needs, during transit.
(b) Any dealer, research facility, exhibitor or operator of an auction sale offering any live guinea pig or hamster to any carrier or intermediate handler for transportation, in commerce, shall provide an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(c) No carrier or intermediate handler shall accept for transportation, in commerce, any live guinea pig or hamster without an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live guinea pigs or hamsters as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live guinea pigs or hamsters are in obvious physical distress and to provide any needed veterinary care as soon as possible. When transported by air, live guinea pigs and hamsters shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the animal cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live guinea pigs or hamsters whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live guinea pigs or hamsters are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No guinea pig or hamster in obvious physical distress shall be transported in commerce.
(b) During the course of transportation, in commerce, live guinea pigs or hamsters shall not be removed from their primary enclosures unless placed in other primary enclosures or facilities conforming to the requirements provided in this subpart.
No person subject to the Animal Welfare regulations shall commingle shipments of live guinea pigs or hamsters with inanimate cargo. All animal holding areas of a terminal facility where shipments of live guinea pigs or hamsters are maintained shall be cleaned and sanitized as prescribed in § 3.31 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation, and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live guinea pigs or hamsters shall be provided with fresh air by means of windows, doors, vents, or air conditioning and may be ventilated or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning shall be used for any animal holding area containing live guinea pigs and hamsters when the air temperature within such animal holding area is 23.9 °C. (75. °F.) or higher. The air temperature around any live guinea pig or hamster in any animal holding area shall not be allowed to fall below 7.2 °C. (45 °F.) nor be allowed to exceed 29.5 °C. (85 °F.) at any time. To ascertain compliance with the provisions of this paragraph, the air temperature around any live guinea pig or hamster shall be measured and read outside the primary enclosure which contains such guinea pig or hamster at a distance not to exceed .91 meters (3 feet) from any one of the external walls of the primary enclosure and measured on a level parallel to the bottom of such primary enclosure at a point which approximates half the distance between the top and bottom of such primary enclosure.
(a) Any person who is subject to the Animal Welfare regulations and who moves live guinea pigs or hamsters from an animal holding area of a terminal facility to a primary conveyance or vice versa shall do so as quickly and efficiently as possible. Any person subject to the Animal Welfare Act and holding any live guinea pig or hamster in an animal holding area of a terminal facility or transporting any live guinea pig or hamster to or from a terminal facility shall provide the following:
(1) Shelter from sunlight. When sunlight is likely to cause overheating or discomfort, sufficient shade shall be provided to protect the live guinea pigs and hamsters from the direct rays of the sun and such live guinea pigs or hamsters shall not be subjected to surrounding air temperatures which exceed 29.5 °C. (85 °F.), and which shall be measured and read in the manner prescribed § 3.40 of this part, for a period of more than 45 minutes.
(2) Shelter from rain or snow. Live guinea pigs and hamsters shall be provided protection to allow them to remain dry during rain or snow.
(3) Shelter from cold weather. Transporting devices shall be covered to provide protection for live guinea pigs and hamsters when the outdoor air temperature falls below 10 °C. (50 °F.), and such live guinea pigs and hamsters shall not be subjected to surrounding air temperatures which fall below 7.2 °C. (45 °F.), and which shall be measured and read in the manner prescribed in § 3.40 of this part, for a period of more than 45 minutes.
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live guinea pig or hamster contained therein.
(c) Primary enclosures used to transport any live guinea pig or hamster shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
(a) Structural strength. Indoor and outdoor housing facilities for rabbits shall be structurally sound and shall be maintained in good repair, to protect the animals from injury, to contain the animals, and to restrict the entrance of other animals.
(b) Water and electric power. Reliable and adequate electric power, if required to comply with other provisions of this subpart, and adequate potable water shall be available.
(c) Storage. Supplies of food and bedding shall be stored in facilities which adequately protect such supplies against infestation or contamination by vermin. Refrigeration shall be provided for supplies of perishable food.
(d) Waste disposal. Provision shall be made for the removal and disposal of animal and food wastes, bedding, dead animals, and debris. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, and disease hazards.
(e) Washroom and sinks. Facilities, such as washrooms, basins, or sinks, shall be provided to maintain cleanliness among animal caretakers.
(a) Heating. Indoor housing facilities for rabbits need not be heated.
(b) Ventilation. Indoor housing facilities for rabbits shall be adequately ventilated to provide for the health and comfort of the animals at all times. Such facilities shall be provided with fresh air either by means of windows, doors, vents, or air conditioning and shall be ventilated so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or air conditioning, shall be provided when the ambient temperature is 85 °F. or higher.
(c) Lighting. Indoor housing facilities for rabbits shall have ample light, by natural or artificial means, or both, of good quality and well distributed. Such lighting shall provide uniformly distributed illumination of sufficient light intensity to permit routine inspection and cleaning during the entire working period. Primary enclosures shall be so placed as to protect the rabbits from excessive illumination.
(d) Interior surfaces. The interior building surfaces of indoor housing facilities shall be constructed and maintained so that they are substantially impervious to moisture and may be readily sanitized.
(a) Shelter from sunlight. When sunlight is likely to cause overheating or discomfort, sufficient shade shall be provided to allow all rabbits kept outdoors to protect themselves from the direct rays of the sun. When the atmospheric temperature exceeds 90 °F. artificial cooling shall be provided by a sprinkler system or other means.
(b) Shelter from rain or snow. Rabbits kept outdoors shall be provided with access to shelter to allow them to remain dry during rain or snow.
(c) Shelter from cold weather. Shelter shall be provided for all rabbits kept outdoors when the atmospheric temperature falls below 40 °F.
(d) Protection from predators. Outdoor housing facilities for rabbits shall be fenced or otherwise enclosed to minimize the entrance of predators.
(e) Drainage. A suitable method shall be provided to rapidly eliminate excess water.
All primary enclosures for rabbits shall conform to the following requirements:
(a) General. (1) Primary enclosures shall be structurally sound and maintained in good repair to protect the rabbits from injury, to contain them, and to keep predators out.
(2) Primary enclosures shall be constructed and maintained so as to enable the rabbits to remain dry and clean.
(3) Primary enclosures shall be constructed and maintained so that the rabbits contained therein have convenient access to clean food and water as required in this subpart.
(4) The floors of the primary enclosures shall be constructed so as to protect the rabbits' feet and legs from injury. Litter shall be provided in all primary enclosures having solid floors.
(5) A suitable nest box containing clean nesting material shall be provided in each primary enclosure housing a female with a litter less than one month of age.
(b) Space requirements for primary enclosures acquired before August 15, 1990. Primary enclosures shall be constructed and maintained so as to provide sufficient space for the animal to make normal postural adjustments with adequate freedom of movement. Each rabbit housed in a primary enclosure shall be provided a minimum amount of floor space, exclusive of the space taken up by food and water receptacles, in accordance with the following table:
| Category | Individual weights (pounds) | Minimum space per rabbit (square inches) |
|---|---|---|
| Groups | 3 through 5 | 144 |
| 6 through 8 | 288 | |
| 9 or more | 432 | |
| Individual adults | 3 through 5 | 180 |
| 6 through 8 | 360 | |
| 9 through 11 | 540 | |
| 12 or more | 720 | |
| Nursing females | 3 through 5 | 576 |
| 6 through 8 | 720 | |
| 9 through 11 | 864 | |
| 12 or more | 1080 |
(c) Space requirements for primary enclosures acquired on or after August 15, 1990. (1) Primary enclosures shall be constructed and maintained so as to provide sufficient space for the animal to make normal postural adjustments with adequate freedom of movement.
(2) Each rabbit housed in a primary enclosure shall be provided a minimum amount of floor space, exclusive of the space taken up by food and water receptacles, in accordance with the following table:
| Individual weights | Minimum floor space | Minimum interior height | ||||
|---|---|---|---|---|---|---|
| kg | lbs | m 2 | ft 2 | cm | in | |
| Individual rabbits (weaned) | <2
2-4 4-5.4 >5.4 | <4.4
4.4-8.8 8.8-11.9 >11.9 | 0.14
0.28 0.37 0.46 | 1.5
3.0 4.0 5.0 | 35.56
35.56 35.56 35.56 | 14
14 14 14 |
| Weight of nursing female | Minimum floor space/female & litter | Minimum interior height | ||||
|---|---|---|---|---|---|---|
| kg | lbs | m 2 | ft 2 | cm | in | |
| Females with litters | <2
2-4 4-5.4 >5.4 | <4.4
4.4-8.8 8.8-11.9 >11.9 | 0.37
0.46 0.56 0.70 | 4.0
5.0 6.0 7.5 | 35.56
35.56 35.56 35.56 | 14
14 14 14 |
(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(2) of this section, but that do provide rabbits with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator.
(a) Rabbits shall be fed at least once each day except as otherwise might be required to provide adequate veterinary care. The food shall be free from contamination, wholesome, palatable and of sufficient quantity and nutritive value to meet the normal daily requirements for the condition and size of the rabbit.
(b) Food receptacles shall be accessible to all rabbits in a primary enclosure and shall be located so as to minimize contamination by excreta. All food receptacles shall be kept clean and sanitized at least once every 2 weeks. If self feeders are used for the feeding of dry feed, measures must be taken to prevent molding, deterioration or caking of the feed.
Sufficient potable water shall be provided daily except as might otherwise be required to provide adequate veterinary care. All watering receptacles shall be sanitized when dirty: Provided, however, That such receptacles shall be sanitized at least once every 2 weeks.
(a) Cleaning of primary enclosures. (1) Primary enclosures shall be kept reasonably free of excreta, hair, cobwebs and other debris by periodic cleaning. Measures shall be taken to prevent the wetting of rabbits in such enclosures if a washing process is used.
(2) In primary enclosures equipped with solid floors, soiled litter shall be removed and replaced with clean litter at least once each week.
(3) If primary enclosures are equipped with wire or mesh floors, the troughs or pans under such enclosures shall be cleaned at least once each week. If worm bins are used under such enclosures they shall be maintained in a sanitary condition.
(b) Sanitization of primary enclosures. (1) Primary enclosures for rabbits shall be sanitized at least once every 30 days in the manner provided in paragraph (b)(3) of this section.
(2) Prior to the introduction of rabbits into empty primary enclosures previously occupied, such enclosures shall be sanitized in the manner provided in paragraph (b)(3) of this section.
(3) Primary enclosures for rabbits shall be sanitized by washing them with hot water (180 °F.) and soap or detergent as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam or flame.
(c) Housekeeping. Premises (buildings and grounds) shall be kept clean and in good repair in order to protect the animals from injury and to facilitate the prescribed husbandry practices set forth in this subpart. Premises shall remain free of accumulations of trash.
(d) Pest control. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained.
A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices shall be under the supervision of an animal caretaker who has a background in animal husbandry or care.
Animals housed in the same primary enclosure shall be maintained in compatible groups, with the following additional restrictions:
(a) Rabbits shall not be housed in the same primary enclosure with any other species of animals unless required for scientific reasons.
(b) Rabbits under quarantine or treatment for a communicable disease shall be separated from other rabbits and other susceptible species of animals in such a manner as to minimize dissemination of such disease.
(a) Carriers and intermediate handlers shall not accept any live rabbit presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported: Provided, however, That the carrier or intermediate handler and any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government may mutually agree to extend the time of acceptance to not more than 6 hours if specific prior scheduling of the animal shipment to destination has been made.
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live rabbit in a primary enclosure which conforms to the requirements set forth in § 3.61 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live rabbit consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of any auction sale, if such consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with § 3.61 of the standards, unless such primary enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the live rabbit without causing suffering or injury to such live rabbit. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of rabbits in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the ____ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live rabbit consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such rabbit for transportation in commerce, stating that such live rabbit is acclimated to air temperatures lower than those prescribed in §§ 3.65 and 3.66. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of rabbits in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.).)”; and
(4) The signature of the USDA accredited veterinarian, assigned accreditation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live rabbit at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No person subject to the Animal Welfare regulations shall offer for transportation or transport in commerce any live rabbit in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or crates, used to transport live rabbits shall be constructed in such a manner that:
(1) The structural strength of the enclosure shall be sufficient to contain the live rabbits and to withstand the normal rigors of transportation;
(2) The interior of the enclosure shall be free from any protrusions that could be injurious to the live rabbits contained therein;
(3) The openings of such enclosures are easily accessible at all times for emergency removal of the live rabbits;
(4) Except as provided in paragraph (h) of this section, there are ventilation openings located on two opposite walls of the primary enclosure and the ventilation openings on each such wall shall be at least 16 percent of the total surface area of each such wall, or there are ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each such wall shall be at least 8 percent of the total surface area of each such wall: Provided, however, That at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the lower one-half of the primary enclosure and at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the upper one-half of the primary enclosure;
(5) Except as provided in paragraph (h) of this section, projecting rims or other devices shall be on the exterior of the outside walls with any ventilation openings to prevent obstruction of the ventilation openings and to provide a minimum air circulation space 1.9 centimeters (.75 inch) between the primary enclosure and any adjacent cargo or conveyance wall; and
(6) Except as provided in paragraph (h) of this section, adequate handholds or other devices for lifting shall be provided on the exterior of the primary enclosure to enable the primary enclosure to be lifted without tilting and to ensure that the person handling the primary enclosure will not be in contact with the rabbit.
(b) Live rabbits transported in the same primary enclosure shall be maintained in compatible groups and shall not be transported in the same primary enclosure with other species of animals.
(c) Primary enclosures used to transport live rabbits shall be large enough to ensure that each rabbit contained therein has sufficient space to turn about freely and to make normal postural adjustments.
(d) Not more than 15 live rabbits shall be transported in the same primary enclosure.
(e) Primary enclosures used to transport live rabbits as provided in this section shall have solid bottoms to prevent leakage in shipment and shall be cleaned and sanitized in a manner prescribed in § 3.56 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbent material which is safe and nontoxic to the rabbits, in sufficient quantity to absorb and cover excreta, unless the rabbits are on wire or other nonsolid floors.
(f) Primary enclosures used to transport live rabbits, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container.
(g) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(h) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live rabbits shall be designed and constructed to protect the health, and ensure the safety and comfort of the rabbits contained therein at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live rabbit shall be placed in an animal cargo space that does not have a supply of air sufficient for normal breathing for each live animal contained therein, and the primary enclosures shall be positioned in the animal cargo space in such a manner that each rabbit has access to sufficient air for normal breathing.
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live rabbits can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live rabbits shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the rabbits unless proper precaution is taken to prevent such injury.
(g) The animal cargo space of primary conveyances used to transport rabbits shall be mechanically sound and provide fresh air by means of windows, doors, vents, or air conditioning so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as fans, blowers, or air conditioners, shall be used in any cargo space containing live rabbits when the ambient temperature in the animal cargo space is 75 °F (23.9 °C) or higher. The ambient temperature within the animal cargo space shall not exceed 85 °F (29.5 °C) or fall below 45 °F (7.2 °C), except that the ambient temperature in the cargo space may be below 45 °F (7.2 °C) if the rabbits are accompanied by a certificate of acclimation to lower temperatures, as provided in § 3.60(c) of this part.
(a) If live rabbits are to be transported for a period of more than 6 hours, they shall have access to food and water or a type of food, which provides the requirements for food and water in quantity and quality sufficient to satisfy their food and water needs, during transit.
(b) Any dealer, research facility, exhibitor or operator of an auction sale offering any live rabbit to any carrier or intermediate handler for transportation, in commerce, shall provide an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(c) No carrier or intermediate handler shall accept for transportation, in commerce, any live rabbit without an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live rabbits as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live rabbits are in obvious physical distress and to provide any needed veterinary care as soon as possible. When transported by air, live rabbits shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live rabbits whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live rabbits are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No rabbit in obvious physical distress shall be transported in commerce.
(b) During the course of transportation, in commerce, live rabbits shall not be removed from their primary enclosures unless placed in other primary enclosures or facilities conforming to the requirements provided in this subpart.
No person subject to the Animal Welfare regulations shall commingle shipments of live rabbits with inanimate cargo. All animal holding areas of a terminal facility where shipments of rabbits are maintained shall be cleaned and sanitized as prescribed in § 3.56 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation, and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live rabbits shall be provided with fresh air by means of windows, doors, vents, or air conditioning and may be ventilated or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning shall be used for any animal holding area containing live rabbits when the air temperature within such animal holding area is 23.9 °C. (75 °F.) or higher. The air temperature around any live rabbit in any animal holding area shall not be allowed to fall below 7.2 °C. (45 °F.) nor be allowed to exceed 29.5 °C. (85 °F.) at any time. To ascertain compliance with the provisions of this paragraph, the air temperature around any live rabbit shall be measured and read outside the primary enclosure which contains such rabbit at a distance not to exceed .91 meters (3 feet) from any one of the external walls of the primary enclosure and on a level parallel to the bottom of such primary enclosure at a point which approximates half the distance between the top and bottom of such primary enclosure.
(a) Any person who is subject to the Animal Welfare regulations and who moves live rabbits from an animal holding area of a terminal facility to a primary conveyance or vice versa shall do so as quickly and efficiently as possible. Any person subject to the Animal Welfare regulations and holding any live rabbit in an animal holding area of a terminal facility or transporting any live rabbit to or from a terminal facility shall provide the following:
(1) Shelter from sunlight. When sunlight is likely to cause overheating or discomfort, sufficient shade shall be provided to protect the live rabbits from the direct rays of the sun and such live rabbits shall not be subjected to surrounding air temperatures which exceed 29.5 °C. (85 °F.), and which shall be measured and read in the manner prescribed in § 3.65 of this part, for a period of more than 45 minutes.
(2) Shelter from rain or snow. Live rabbits shall be provided protection to allow them to remain dry during rain or snow.
(3) Shelter from cold weather. Transporting devices shall be covered to provide protection for live rabbits when the outdoor air temperature falls below 10 °C. (50 °F.), and such live rabbits shall not be subjected to surrounding air temperatures which fall below 7.2 °C. (45 °F.), and which shall be measured and read in the manner prescribed in § 3.65 of this part, for a period of more than 45 minutes unless such rabbits are accompanied by a certificate of acclimation to lower temperatures as prescribed in § 3.60(c).
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live rabbit contained therein.
(c) Primary enclosures used to transport any live rabbit shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
(a) Structure:
These minimum standards apply only to live nonhuman primates, unless stated otherwise.
(b) Condition and site. Housing facilities and areas used for storing animal food or bedding must be free of any accumulation of trash, waste material, junk, weeds, and other discarded materials. Animal areas inside of housing facilities must be kept neat and free of clutter, including equipment, furniture, or stored material, but may contain materials actually used and necessary for cleaning the area, and fixtures and equipment necessary for proper husbandry practices and research needs. Housing facilities other than those maintained by research facilities and Federal research facilities must be physically separated from any other businesses. If a housing facility is located on the same premises as any other businesses, it must be physically separated from the other businesses so that animals the size of dogs, skunks, and raccoons, are prevented from entering it.
(c) Surfaces—(1) General requirements. The surfaces of housing facilities—including perches, shelves, swings, boxes, houses, dens, and other furniture-type fixtures or objects within the facility—must be constructed in a manner and made of materials that allow them to be readily cleaned and sanitized, or removed or replaced when worn or soiled. Furniture-type fixtures or objects must be sturdily constructed and must be strong enough to provide for the safe activity and welfare of nonhuman primates. Floors may be made of dirt, absorbent bedding, sand, gravel, grass, or other similar material that can be readily cleaned, or can be removed or replaced whenever cleaning does not eliminate odors, diseases, pests, insects, or vermin. Any surfaces that come in contact with nonhuman primates must:
(i) Be free of excessive rust that prevents the required cleaning and sanitization, or that affects the structural strength of the surface; and
(ii) Be free of jagged edges or sharp points that might injure the animals.
(2) Maintenance and replacement of surfaces. All surfaces must be maintained on a regular basis. Surfaces of housing facilities—including houses, dens, and other furniture-type fixtures and objects within the facility—that cannot be readily cleaned and sanitized, must be replaced when worn or soiled.
(3) Cleaning. Hard surfaces with which nonhuman primates come in contact must be spot-cleaned daily and sanitized in accordance with § 3.84 of this subpart to prevent accumulation of excreta or disease hazards. If the species scent mark, the surfaces must be sanitized or replaced at regular intervals as determined by the attending veterinarian in accordance with generally accepted professional and husbandry practices. Floors made of dirt, absorbent bedding, sand, gravel, grass, or other similar material, and planted enclosures must be raked or spot-cleaned with sufficient frequency to ensure all animals the freedom to avoid contact with excreta. Contaminated material must be removed or replaced whenever raking and spot cleaning does not eliminate odors, diseases, insects, pests, or vermin infestation. All other surfaces of housing facilities must be cleaned and sanitized when necessary to satisfy generally accepted husbandry standards and practices. Sanitization may be done by any of the methods provided in § 3.84(b)(3) of this subpart for primary enclosures.
(d) Water and electric power. The housing facility must have reliable electric power adequate for heating, cooling, ventilation, and lighting, and for carrying out other husbandry requirements in accordance with the regulations in this subpart. The housing facility must provide running potable water for the nonhuman primates' drinking needs. It must be adequate for cleaning and for carrying out other husbandry requirements.
(e) Storage. Supplies of food and bedding must be stored in a manner that protects the supplies from spoilage, contamination, and vermin infestation. The supplies must be stored off the floor and away from the walls, to allow cleaning underneath and around the supplies. Food requiring refrigeration must be stored accordingly, and all food must be stored in a manner that prevents contamination and deterioration of its nutritive value. Only the food and bedding currently being used may be kept in animal areas, and when not in actual use, open food and bedding supplies must be kept in leakproof containers with tightly fitting lids to prevent spoilage and contamination. Substances that are toxic to the nonhuman primates but that are required for normal husbandry practices must not be stored in food storage and preparation areas, but may be stored in cabinets in the animal areas.
(f) Drainage and waste disposal. Housing facility operators must provide for regular and frequent collection, removal, and disposal of animal and food wastes, bedding, dead animals, debris, garbage, water, and any other fluids and wastes, in a manner that minimizes contamination and disease risk. Housing facilities must be equipped with disposal facilities and drainage systems that are constructed and operated so that animal wastes and water are rapidly eliminated and the animals stay dry. Disposal and drainage systems must minimize vermin and pest infestation, insects, odors, and disease hazards. All drains must be properly constructed, installed, and maintained. If closed drainage systems are used, they must be equipped with traps and prevent the backflow of gases and the backup of sewage onto the floor. If the facility uses sump ponds, settlement ponds, or other similar systems for drainage and animal waste disposal, the system must be located far enough away from the animal area of the housing facility to prevent odors, diseases, insects, pests, and vermin infestation. If drip or constant flow watering devices are used to provide water to the animals, excess water must be rapidly drained out of the animal areas by gutters or pipes so that the animals stay dry. Standing puddles of water in animal areas must be mopped up or drained so that the animals remain dry. Trash containers in housing facilities and in food storage and food preparation areas must be leakproof and must have tightly fitted lids on them at all times. Dead animals, animal parts, and animal waste must not be kept in food storage or food preparation areas, food freezers, food refrigerators, and animal areas.
(g) Washrooms and sinks. Washing facilities, such as washrooms, basins, sinks, or showers must be provided for animal caretakers and must be readily accessible.
(a) Heating, cooling, and temperature. Indoor housing facilities must be sufficiently heated and cooled when necessary to protect nonhuman primates from temperature extremes and to provide for their health and well-being. The ambient temperature in the facility must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when nonhuman primates are present, and must not rise above 85 °F (29.5 °C) for more than 4 consecutive hours when nonhuman primates are present. The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices.
(b) Ventilation. Indoor housing facilities must be sufficiently ventilated at all times when nonhuman primates are present to provide for their health and well-being and to minimize odors, drafts, ammonia levels, and moisture condensation. Ventilation must be provided by windows, doors, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air conditioning, must be provided when the ambient temperature is 85 °F (29.5 °C) or higher. The relative humidity maintained must be at a level that ensures the health and well-being of the animals housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices.
(c) Lighting. Indoor housing facilities must be lighted well enough to permit routine inspection and cleaning of the facility, and observation of the nonhuman primates. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Primary enclosures must be placed in the housing facility so as to protect the nonhuman primates from excessive light.
(a) Heating, cooling, and temperature. The sheltered part of sheltered housing facilities must be sufficiently heated and cooled when necessary to protect the nonhuman primates from temperature extremes, and to provide for their health and well-being. The ambient temperature in the sheltered part of the facility must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when nonhuman primates are present, and must not rise above 85 °F (29.5 °C) for more than 4 consecutive hours when nonhuman primates are present, unless temperatures above 85 °F (29.5 °C) are approved by the attending veterinarian, in accordance with generally accepted husbandry practices. The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices.
(b) Ventilation. The sheltered part of sheltered animal facilities must be sufficiently ventilated at all times to provide for the health and well-being of nonhuman primates and to minimize odors, drafts, ammonia levels, and moisture condensation. Ventilation must be provided by windows, doors, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air conditioning, must be provided when the ambient temperature is 85 °F (29.5 °C) or higher. The relative humidity maintained must be at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices.
(c) Lighting. The sheltered part of sheltered housing facilities must be lighted well enough to permit routine inspection and cleaning of the facility, and observation of the nonhuman primates. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Primary enclosures must be placed in the housing facility so as to protect the nonhuman primates from excessive light.
(d) Shelter from the elements. Sheltered housing facilities for nonhuman primates must provide adequate shelter from the elements at all times. They must provide protection from the sun, rain, snow, wind, and cold, and from any weather conditions that may occur.
(e) Capacity: multiple shelters. Both the sheltered part of sheltered housing facilities and any other necessary shelter from the elements must be sufficiently large to provide protection comfortably to each nonhuman primate housed in the facility. If aggressive or dominant animals are housed in the facility with other animals, there must be multiple shelters or other means to ensure that each nonhuman primate has access to shelter.
(f) Perimeter fence. On and after February 15, 1994, the outdoor area of a sheltered housing facility must be enclosed by a fence that is of sufficient height to keep unwanted species out. Fences less than 6 feet high must be approved by the Administrator. The fence must be constructed so that it protects nonhuman primates by restricting unauthorized humans, and animals the size of dogs, skunks, and raccoons from going through it or under it and having contact with the nonhuman primates. It must be of sufficient distance from the outside wall or fence of the primary enclosure to prevent physical contact between animals inside the enclosure and outside the perimeter fence. Such fences less than 3 feet in distance from the primary enclosure must be approved by the Administrator. A perimeter fence is not required if:
(1) The outside walls of the primary enclosure are made of a sturdy, durable material such as concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts contact with or entry by humans and animals that are outside the sheltered housing facility; or
(2) The housing facility is surrounded by a natural barrier that restricts the nonhuman primates to the housing facility and protects them from contact with unauthorized humans and animals that are outside the sheltered housing facility, and the Administrator gives written permission
(g) Public barriers. Fixed public exhibits housing nonhuman primates, such as zoos, must have a barrier between the primary enclosure and the public at any time the public is present, that restricts physical contact between the public and the nonhuman primates. Nonhuman primates used in trained animal acts or in uncaged public exhibits must be under the direct control and supervision of an experienced handler or trainer at all times when the public is present. Trained nonhuman primates may be permitted physical contact with the public, as allowed under § 2.131, but only if they are under the direct control and supervision of an experienced handler or trainer at all times during the contact.
(a) Acclimation. Only nonhuman primates that are acclimated, as determined by the attending veterinarian, to the prevailing temperature and humidity at the outdoor housing facility during the time of year they are at the facility, and that can tolerate the range of temperatures and climatic conditions known to occur at the facility at that time of year without stress or discomfort, may be kept in outdoor facilities.
(b) Shelter from the elements. Outdoor housing facilities for nonhuman primates must provide adequate shelter from the elements at all times. It must provide protection from the sun, rain, snow, wind, and cold, and from any weather conditions that may occur. The shelter must safely provide heat to the nonhuman primates to prevent the ambient temperature from falling below 45 °F (7.2 °C), except as directed by the attending veterinarian and in accordance with generally accepted professional and husbandry practices.
(c) Capacity: multiple shelters. The shelter must be sufficiently large to comfortably provide protection for each nonhuman primate housed in the facility. If aggressive or dominant animals are housed in the facility with other animals there must be multiple shelters, or other means to ensure protection for each nonhuman primate housed in the facility.
(d) Perimeter fence. On and after February 15, 1994, an outdoor housing facility must be enclosed by a fence that is of sufficient height to keep unwanted species out. Fences less than 6 feet high must be approved by the Administrator. The fence must be constructed so that it protects nonhuman primates by restricting unauthorized humans, and animals the size of dogs, skunks, and raccoons from going through it or under it and having contact with the nonhuman primates. It must be of sufficient distance from the outside wall or fence of the primary enclosure to prevent physical contact between animals inside the enclosure and outside the perimeter fence. Such fences less than 3 feet in distance from the primary enclosure must be approved by the Administrator. A perimeter fence is not required if:
(1) The outside walls of the primary enclosure are made of a sturdy, durable material such as concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts contact with or entry by humans and animals that are outside the housing facility; or
(2) The housing facility is surrounded by a natural barrier that restricts the nonhuman primates to the housing facility and protects them from contact with unauthorized humans and animals that are outside the housing facility, and the Administrator gives written permission.
(e) Public barriers. Fixed public exhibits housing nonhuman primates, such as zoos, must have a barrier between the primary enclosure and the public at any time the public is present, in order to restrict physical contact between the public and the nonhuman primates. Nonhuman primates used in trained animal acts or in uncaged public exhibits must be under the direct control and supervision of an experienced handler or trainer at all times when the public is present. Trained nonhuman primates may be allowed physical contact with the public, but only if they are under the direct control and supervision of an experienced handler or trainer at all times during the contact.
(a) Heating, cooling, and temperature. Mobile or traveling housing facilities must be sufficiently heated and cooled when necessary to protect nonhuman primates from temperature extremes and to provide for their health and well-being. The ambient temperature in the traveling housing facility must not fall below 45 °F (7.2 °C) for more than 4 consecutive hours when nonhuman primates are present, and must not rise above 85 °F (29.5 °C) for more than 4 consecutive hours when nonhuman primates are present. The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, and in accordance with generally accepted professional and husbandry practices.
(b) Ventilation. Traveling housing facilities must be sufficiently ventilated at all times when nonhuman primates are present to provide for the health and well-being of nonhuman primates and to minimize odors, drafts, ammonia levels, moisture condensation, and exhaust fumes. Ventilation must be provided by means of windows, doors, vents, fans, or air conditioning. Auxiliary ventilation, such as fans, blowers, or air conditioning, must be provided when the ambient temperature in the traveling housing facility is 85 °F (29.5 °C) or higher.
(c) Lighting. Mobile or traveling housing facilities must be lighted well enough to permit routine inspection and cleaning of the facility, and observation of the nonhuman primates. Animal areas must be provided a regular diurnal lighting cycle of either natural or artificial light. Lighting must be uniformly diffused throughout animal facilities and provide sufficient illumination to aid in maintaining good housekeeping practices, adequate cleaning, adequate inspection of animals, and for the well-being of the animals. Primary enclosures must be placed in the housing facility so as to protect the nonhuman primates from excessive light.
(d) Public barriers. There must be a barrier between a mobile or traveling housing facility and the public at any time the public is present, in order to restrict physical contact between the nonhuman primates and the public. Nonhuman primates used in traveling exhibits, trained animal acts, or in uncaged public exhibits must be under the direct control and supervision of an experienced handler or trainer at all times when the public is present. Trained nonhuman primates may be allowed physical contact with the public, but only if they are under the direct control and supervision of an experienced handler or trainer at all times during the contact.
Primary enclosures for nonhuman primates must meet the following minimum requirements:
(a) General requirements. (1) Primary enclosures must be designed and constructed of suitable materials so that they are structurally sound for the species of nonhuman primates contained in them. They must be kept in good repair.
(2) Primary enclosures must be constructed and maintained so that they:
(i) Have no sharp points or edges that could injure the nonhuman primates;
(ii) Protect the nonhuman primates from injury;
(iii) Contain the nonhuman primates securely and prevent accidental opening of the enclosure, including opening by the animal;
(iv) Keep other unwanted animals from entering the enclosure or having physical contact with the nonhuman primates;
(v) Enable the nonhuman primates to remain dry and clean;
(vi) Provide shelter and protection from extreme temperatures and weather conditions that may be uncomfortable or hazardous to the species of nonhuman primate contained;
(vii) Provide sufficient shade to shelter all the nonhuman primates housed in the primary enclosure at one time;
(viii) Provide the nonhuman primates with easy and convenient access to clean food and water;
(ix) Enable all surfaces in contact with nonhuman primates to be readily cleaned and sanitized in accordance with § 3.84(b)(3) of this subpart, or replaced when worn or soiled;
(x) Have floors that are constructed in a manner that protects the nonhuman primates from injuring themselves; and
(xi) Provide sufficient space for the nonhuman primates to make normal postural adjustments with freedom of movement.
(b) Minimum space requirements. Primary enclosures must meet the minimum space requirements provided in this subpart. These minimum space requirements must be met even if perches, ledges, swings, or other suspended fixtures are placed in the enclosure. Low perches and ledges that do not allow the space underneath them to be comfortably occupied by the animal will be counted as part of the floor space.
(1) The minimum space that must be provided to each nonhuman primate, whether housed individually or with other nonhuman primates, will be determined by the typical weight of animals of its species, except for brachiating species and great apes
Group 1—marmosets, tamarins, and infants (less than 6 months of age) of various species.
Group 2—capuchins, squirrel monkeys and similar size species, and juveniles (6 months to 3 years of age) of various species.
Group 3—macaques and African species.
Group 4—male macaques and large African species.
Group 5—baboons and nonbrachiating species larger than 33.0 lbs. (15 kg.).
Group 6—great apes over 55.0 lbs. (25 kg.), except as provided in paragraph (b)(2) of this section, and brachiating species.
| Group | Weight | Floor area/animal | Height | |||
|---|---|---|---|---|---|---|
| lbs. | (kg.) | ft. 2 | (m 2) | in. | (cm.) | |
| 1 | under 2.2 | (under 1) | 1.6 | (0.15) | 20 | (50.8) |
| 2 | 2.2-6.6 | (1-3) | 3.0 | (0.28) | 30 | (76.2) |
| 3 | 6.6-22.0 | (3-10) | 4.3 | (0.40) | 30 | (76.2) |
| 4 | 22.0-33.0 | (10-15) | 6.0 | (0.56) | 32 | (81.28) |
| 5 | 33.0-55.0 | (15-25) | 8.0 | (0.74) | 36 | (91.44) |
| 6 | over 55.0 | (over 25) | 25.1 | (2.33) | 84 | (213.36) |
(2) Dealers. exhibitors, and research facilities, including Federal research facilities, must provide great apes weighing over 110 lbs. (50 kg) an additional volume of space in excess of that required for Group 6 animals as set forth in paragraph (b)(1) of this section, to allow for normal postural adjustments.
(3) In the case of research facilities, any exemption from these standards must be required by a research proposal or in the judgment of the attending veterinarian and must be approved by the Committee. In the case of dealers and exhibitors, any exemption from these standards must be required in the judgment of the attending veterinarian and approved by the Administrator.
(4) When more than one nonhuman primate is housed in a primary enclosure, the minimum space requirement for the enclosure is the sum of the minimum floor area space required for each individual nonhuman primate in the table in paragraph (b)(1) of this section, and the minimum height requirement for the largest nonhuman primate housed in the enclosure. Provided however, that mothers with infants less than 6 months of age may be maintained together in primary enclosures that meet the floor area space and height requirements of the mother.
(c) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraph (b) of this section, but that do provide nonhuman primates with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator.
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following:
(a) Social grouping. The environment enhancement plan must include specific provisions to address the social needs of nonhuman primates of species known to exist in social groups in nature. Such specific provisions must be in accordance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. The plan may provide for the following exceptions:
(1) If a nonhuman primate exhibits vicious or overly aggressive behavior, or is debilitated as a result of age or other conditions (e.g., arthritis), it should be housed separately;
(2) Nonhuman primates that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony as directed by the attending veterinarian. When an entire group or room of nonhuman primates is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control.
(3) Nonhuman primates may not be housed with other species of primates or animals unless they are compatible, do not prevent access to food, water, or shelter by individual animals. and are not known to be hazardous to the health and well-being of each other. Compatibility of nonhuman primates must be determined in accordance with generally accepted professional practices and actual observations, as directed by the attending veterinarian, to ensure that the nonhuman primates are in fact compatible. Individually housed nonhuman primates must be able to see and hear nonhuman primates of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being.
(b) Environmental enrichment. The physical environment in the primary enclosures must be enriched by providing means of expressing noninjurious species-typical activities. Species differences should be considered when determining the type or methods of enrichment. Examples of environmental enrichments include providing perches, swings, mirrors, and other increased cage complexities; providing objects to manipulate; varied food items; using foraging or task-oriented feeding methods; and providing interaction with the care giver or other familiar and knowledgeable person consistent with personnel safety precautions.
(c) Special considerations. Certain nonhuman primates must be provided special attention regarding enhancement of their environment, based on the needs of the individual species and in accordance with the instructions of the attending veterinarian. Nonhuman primates requiring special attention are the following:
(1) Infants and young juveniles;
(2) Those that show signs of being in psychological distress through behavior or appearance;
(3) Those used in research for which the Committee-approved protocol requires restricted activity;
(4) Individually housed nonhuman primates that are unable to see and hear nonhuman primates of their own or compatible species; and
(5) Great apes weighing over 110 lbs. (50 kg). Dealers, exhibitors, and research facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs. (50 kg), including additional opportunities to express species-typical behavior.
(d) Restraint devices. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the Committee at research facilities. Maintenance under such restraint must be for the shortest period possible. In instances where long-term (more than 12 hours) restraint is required, the nonhuman primate must be provided the opportunity daily for unrestrained activity for at least one continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the Committee at research facilities.
(e) Exemptions. (1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian.
(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually.
(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility and must be made available to USDA officials or officials of any pertinent funding Federal agency upon request.
(a) The diet for nonhuman primates must be appropriate for the species, size, age, and condition of the animal, and for the conditions in which the nonhuman primate is maintained, according to generally accepted professional and husbandry practices and nutritional standards. The food must be clean, wholesome, and palatable to the animals. It must be of sufficient quantity and have sufficient nutritive value to maintain a healthful condition and weight range of the animal and to meet its normal daily nutritional requirements.
(b) Nonhuman primates must be fed at least once each day except as otherwise might be required to provide adequate veterinary care. Infant and juvenile nonhuman primates must be fed as often as necessary in accordance with generally accepted professional and husbandry practices and nutritional standards, based upon the animals' age and condition.
(c) Food and food receptacles, if used, must be readily accessible to all the nonhuman primates being fed. If members of dominant nonhuman primate or other species are fed together with other nonhuman primates, multiple feeding sites must be provided. The animals must be observed to determine that all receive a sufficient quantity of food.
(d) Food and food receptacles, if used, must be located so as to minimize any risk of contamination by excreta and pests. Food receptacles must be kept clean and must be sanitized in accordance with the procedures listed in § 3.84(b)(3) of this subpart at least once every 2 weeks. Used food receptacles must be sanitized before they can be used to provide food to a different nonhuman primate or social grouping of nonhuman primates. Measures must be taken to ensure there is no molding, deterioration, contamination, or caking or wetting of food placed in self-feeders.
Potable water must be provided in sufficient quantity to every nonhuman primate housed at the facility. If potable water is not continually available to the nonhuman primates, it must be offered to them as often as necessary to ensure their health and well-being, but no less than twice daily for at least l hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at research facilities. Water receptacles must be kept clean and sanitized in accordance with methods provided in § 3.84(b)(3) of this subpart at least once every 2 weeks or as often as necessary to keep them clean and free from contamination. Used water receptacles must be sanitized before they can be used to provide water to a different nonhuman primate or social grouping of nonhuman primates.
(a) Cleaning of primary enclosures. Excreta and food waste must be removed from inside each indoor primary enclosure daily and from underneath them as often as necessary to prevent an excessive accumulation of feces and food waste, to prevent the nonhuman primates from becoming soiled, and to reduce disease hazards, insects, pests, and odors. Dirt floors, floors with absorbent bedding, and planted areas in primary enclosures must be spot-cleaned with sufficient frequency to ensure all animals the freedom to avoid contact with excreta, or as often as necessary to reduce disease hazards, insects, pests, and odors. When steam or water is used to clean the primary enclosure, whether by hosing, flushing, or other methods, nonhuman primates must be removed, unless the enclosure is large enough to ensure the animals will not be harmed, wetted, or distressed in the process. Perches, bars, and shelves must be kept clean and replaced when worn. If the species of the nonhuman primates housed in the primary enclosure engages in scent marking, hard surfaces in the primary enclosure must be spot-cleaned daily.
(b) Sanitization of primary enclosures and food and water receptacles. (1) A used primary enclosure must be sanitized in accordance with this section before it can be used to house another nonhuman primate or group of nonhuman primates.
(2) Indoor primary enclosures must be sanitized at least once every 2 weeks and as often as necessary to prevent an excessive accumulation of dirt, debris, waste, food waste, excreta, or disease hazard, using one of the methods prescribed in paragraph (b)(3) of this section. However, if the species of nonhuman primates housed in the primary enclosure engages in scent marking, the primary enclosure must be sanitized at regular intervals determined in accordance with generally accepted professional and husbandry practices.
(3) Hard surfaces of primary enclosures and food and water receptacles must be sanitized using one of the following methods:
(i) Live steam under pressure;
(ii) Washing with hot water (at least 180 °F (82.2 °C)) and soap or detergent, such as in a mechanical cage washer;
(iii) Washing all soiled surfaces with appropriate detergent solutions or disinfectants, or by using a combination detergent/disinfectant product that accomplishes the same purpose, with a thorough cleaning of the surfaces to remove organic material, so as to remove all organic material and mineral buildup, and to provide sanitization followed by a clean water rinse.
(4) Primary enclosures containing material that cannot be sanitized using the methods provided in paragraph (b)(3) of this section, such as sand, gravel, dirt, absorbent bedding, grass, or planted areas, must be sanitized by removing the contaminated material as necessary to prevent odors, diseases, pests, insects, and vermin infestation.
(c) Housekeeping for premises. Premises where housing facilities are located, including buildings and surrounding grounds, must be kept clean and in good repair in order to protect the nonhuman primates from injury, to facilitate the husbandry practices required in this subpart, and to reduce or eliminate breeding and living areas for rodents, pests, and vermin. Premises must be kept free of accumulations of trash, junk, waste, and discarded matter. Weeds, grass, and bushes must be controlled so as to facilitate cleaning of the premises and pest control.
(d) Pest control. An effective program for control of insects, external parasites affecting nonhuman primates, and birds and mammals that are pests, must be established and maintained so as to promote the health and well-being of the animals and reduce contamination by pests in animal areas.
Every person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) maintaining nonhuman primates must have enough employees to carry out the level of husbandry practices and care required in this subpart. The employees who provide husbandry practices and care, or handle nonhuman primates, must be trained and supervised by an individual who has the knowledge, background, and experience in proper husbandry and care of nonhuman primates to supervise others. The employer must be certain that the supervisor can perform to these standards.
(a) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce more than 4 hours before the scheduled departure time of the primary conveyance on which the animal is to be transported. However, a carrier or intermediate handler may agree with anyone consigning a nonhuman primate to extend this time by up to 2 hours.
(b) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless they are provided with the name, address, telephone number, and telex number, if applicable, of the consignee.
(c) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the nonhuman primate was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.89 of this subpart. The certification must include the following information for each nonhuman primate:
(1) The consignor's name and address;
(2) The species of nonhuman primate;
(3) The time and date the animal was last fed and watered and the specific instructions for the next feeding(s) and watering(s) for a 24-hour period; and
(4) The consignor's signature and the date and time the certification was signed.
(d) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the primary enclosure meets the requirements of § 3.87 of this subpart. A carrier or intermediate handler must not accept a nonhuman primate for transport if the primary enclosure is obviously defective or damaged and cannot reasonably be expected to safely and comfortably contain the nonhuman primate without suffering or injury.
(e) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless their animal holding area facilities meet the minimum temperature requirements provided in §§ 3.91 and 3.92 of this subpart, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those that are required in §§ 3.91 and 3.92 of this subpart. Even if the carrier or intermediate handler receives this certification, the temperatures the nonhuman primate is exposed to while in the carrier's or intermediate handler's custody must not be lower than the minimum temperature specified by the veterinarian in accordance with paragraph (e)(4) of this section, and must be reasonably within the generally and professionally accepted temperature range for the nonhuman primate, as determined by the veterinarian, considering its age, condition, and species. A copy of the certification must accompany the nonhuman primate to its destination and must include the following information for each primary enclosure:
(1) The consignor's name and address;
(2) The number of nonhuman primates contained in the primary enclosure;
(3) The species of nonhuman primate contained in the primary enclosure;
(4) A statement by a veterinarian that to the best of his or her knowledge, each of the nonhuman primates contained in the primary enclosure is acclimated to air temperatures lower than 50 °F (10 °C), but not lower than a minimum temperature specified on the certificate based on the generally and professionally accepted temperature range for the nonhuman primate, considering its age, condition, and species; and
(5) The veterinarian's signature and the date the certification was signed.
(f) When a primary enclosure containing a nonhuman primate has arrived at the animal holding area of a terminal facility after transport, the carrier or intermediate handler must attempt to notify the consignee upon arrival and at least once in every 6-hour period after arrival. The time, date, and method of all attempted notifications and the actual notification of the consignee, and the name of the person who notifies or attempts to notify the consignee must be written either on the carrier's or intermediate handler's copy of the shipping document or on the copy that accompanies the primary enclosure. If the consignee cannot be notified within 24 hours after the nonhuman primate has arrived at the terminal facility, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. If the consignee is notified of the arrival and does not take physical delivery of the nonhuman primate within 48 hours after arrival of the nonhuman primate, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. The carrier or intermediate handler must continue to provide proper care, feeding, and housing to the nonhuman primate, and maintain the nonhuman primate in accordance with generally accepted professional and husbandry practices until the consignee accepts delivery of the nonhuman primate or until it is returned to the consignor or to whomever the consignor designates. The carrier or intermediate handler must obligate the consignor to reimburse the carrier or intermediate handler for the cost of return transportation and care.
Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a nonhuman primate unless it is contained in a primary enclosure, such as a compartment, transport cage, carton, or crate, and the following requirements are met:
(a) Construction of primary enclosures. Primary enclosures used to transport nonhuman primates may be connected or attached to each other and must be constructed so that:
(1) The primary enclosure is strong enough to contain the nonhuman primate securely and comfortably and to withstand the normal rigors of transportation;
(2) The interior of the enclosure has no sharp points or edges and no protrusions that could injure the animal contained in it;
(3) The nonhuman primate is at all times securely contained within the enclosure and cannot put any part of its body outside the enclosure in a way that could result in injury to the animal, or to persons or animals nearby;
(4) The nonhuman primate can be easily and quickly removed from the enclosure in an emergency;
(5) The doors or other closures that provide access into the enclosure are secured with animal-proof devices that prevent accidental opening of the enclosure, including opening by the nonhuman primate;
(6) Unless the enclosure is permanently affixed to the conveyance, adequate devices such as handles or handholds are provided on its exterior, and enable the enclosure to be lifted without tilting it, and ensure that anyone handling the enclosure will not come into physical contact with the animal contained inside;
(7) Any material, treatment, paint, preservative, or other chemical used in or on the enclosure is nontoxic to the animal and not harmful to the health or well-being of the animal;
(8) Proper ventilation is provided to the nonhuman primate in accordance with paragraph (c) of this section;
(9) Ventilation openings are covered with bars, wire mesh, or smooth expanded metal having air spaces; and
(10) The primary enclosure has a solid, leak-proof bottom, or a removable, leak-proof collection tray under a slatted or wire mesh floor that prevents seepage of waste products, such as excreta and body fluids, outside of the enclosure. If a slatted or wire mesh floor is used in the enclosure, it must be designed and constructed so that the animal cannot put any part of its body between the slats or through the holes in the mesh. It must contain enough previously unused litter to absorb and cover excreta. The litter must be of a suitably absorbent material that is safe and nontoxic to the nonhuman primate and is appropriate for the species transported in the primary enclosure.
(b) Cleaning of primary enclosures. A primary enclosure used to hold or transport nonhuman primates in commerce must be cleaned and sanitized before each use in accordance with the methods provided in § 3.84(b)(3) of this subpart.
(c) Ventilation. (1) If the primary enclosure is movable, ventilation openings must be constructed in one of the following ways:
(i) If ventilation openings are located on two opposite walls of the primary enclosure, the openings on each wall must be at least 16 percent of the total surface area of each such wall and be located above the midline of the enclosure; or
(ii) If ventilation openings are located on all four walls of the primary enclosure, the openings on every wall must be at least 8 percent of the total surface area of each such wall and be located above the midline of the enclosure.
(2) Unless the primary enclosure is permanently affixed to the conveyance, projecting rims or similar devices must be located on the exterior of each enclosure wall having a ventilation opening, in order to prevent obstruction of the openings. The projecting rims or similar devices must be large enough to provide a minimum air circulation space of 0.75 inches (1.9 centimeters) between the primary enclosure and anything the enclosure is placed against.
(3) If a primary enclosure is permanently affixed to the primary conveyance so that there is only a front ventilation opening for the enclosure, the primary enclosure must be affixed to the primary conveyance in such a way that the front ventilation opening cannot be blocked, and the front ventilation opening must open directly to an unobstructed aisle or passageway inside of the conveyance. The ventilation opening must be at least 90 percent of the total area of the front wall of the enclosure, and must be covered with bars, wire mesh, or smooth expanded metal having air spaces.
(d) Compatibility. (1) Only one live nonhuman primate may be transported in a primary enclosure, except as follows:
(i) A mother and her nursing infant may be transported together;
(ii) An established male-female pair or family group may be transported together, except that a female in estrus must not be transported with a male nonhuman primate;
(iii) A compatible pair of juveniles of the same species that have not reached puberty may be transported together.
(2) Nonhuman primates of different species must not be transported in adjacent or connecting primary enclosures.
(e) Space requirements. Primary enclosures used to transport nonhuman primates must be large enough so that each animal contained in the primary enclosure has enough space to turn around freely in a normal manner and to sit in an upright, hands down position without its head touching the top of the enclosure. However, certain larger species may be restricted in their movements, in accordance with professionally accepted standards of care, when greater freedom of movement would be dangerous to the animal, its handler, or to other persons.
(f) Marking and labeling. Primary enclosures, other than those that are permanently affixed to a conveyance, must be clearly marked in English on the top and on one or more sides with the words “Wild Animals,” or “Live Animals,” in letters at least 1 inch (2.5 cm.) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure. Permanently affixed primary enclosures must be clearly marked in English with the words “Wild Animals” or “Live Animals,” in the same manner.
(g) Accompanying documents and records. Shipping documents that must accompany shipments of nonhuman primates may be held by the operator of the primary conveyance, for surface transportation only, or must be securely attached in a readily accessible manner to the outside of any primary enclosure that is part of the shipment, in a manner that allows them to be detached for examination and securely reattached, such as in a pocket or sleeve. Instructions for administration of drugs, medication, and other special care must be attached to each primary enclosure in a manner that makes them easy to notice, to detach for examination, and to reattach securely. Food and water instructions must be attached in accordance with § 3.86(c) of this subpart.
(a) The animal cargo space of primary conveyances used to transport nonhuman primates must be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the animals transported in it, ensures their safety and comfort, and prevents the entry of engine exhaust from the primary conveyance during transportation.
(b) The animal cargo space must have a supply of air that is sufficient for the normal breathing of all the animals being transported in it.
(c) Each primary enclosure containing nonhuman primates must be positioned in the animal cargo space in a manner that provides protection from the elements and that allows each nonhuman primate enough air for normal breathing.
(d) During air transportation, the ambient temperature inside a primary conveyance used to transport nonhuman primates must be maintained at a level that ensures the health and well-being of the species housed, in accordance with generally accepted professional and husbandry practices, at all times a nonhuman primate is present.
(e) During surface transportation, the ambient temperature inside a primary conveyance used to transport nonhuman primates must be maintained between 45 °F (7.2 °C) and 85 °F (30 °C) at all times a nonhuman primate is present.
(f) A primary enclosure containing a nonhuman primate must be placed far enough away from animals that are predators or natural enemies of nonhuman primates, whether the other animals are in primary enclosures or not, so that the nonhuman primate cannot touch or see the other animals.
(g) Primary enclosures must be positioned in the primary conveyance in a manner that allows the nonhuman primates to be quickly and easily removed from the primary conveyance in an emergency.
(h) The interior of the animal cargo space must be kept clean
(i) Nonhuman primates must not be transported with any material, substance (e.g., dry ice), or device in a manner that may reasonably be expected to harm the nonhuman primates or cause inhumane conditions.
(a) Each nonhuman primate that is 1 year of age or more must be offered food
(b) Any dealer, exhibitor, or research facility, including a Federal research facility, offering a nonhuman primate to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the nonhuman primate, written instructions for a 24-hour period for the in-transit food and water requirements of the nonhuman primate(s) contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read.
(c) Food and water receptacles must be securely attached inside the primary enclosure and placed so that the receptacles can be filled from outside of the enclosure without opening the door. Food and water receptacles must be designed, constructed, and installed so that a nonhuman primate cannot leave the primary enclosure through the food or water opening.
(a) Surface transportation (ground and water). Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) transporting nonhuman primates in commerce must ensure that the operator of the conveyance or a person accompanying the operator of the conveyance observes the nonhuman primates as often as circumstances allow, but not less than once every 4 hours, to make sure that they have sufficient air for normal breathing, that the ambient temperature is within the limits provided in § 3.88(d) of this subpart, and that all other applicable standards of this subpart are being complied with. The regulated person transporting the nonhuman primates must ensure that the operator or the person accompanying the operator determines whether any of the nonhuman primates are in obvious physical distress, and obtains any veterinary care needed for the nonhuman primates at the closest available veterinary facility.
(b) Air transportation. During air transportation of nonhuman primates, it is the responsibility of the carrier to observe the nonhuman primates as frequently as circumstances allow, but not less than once every 4 hours if the animal cargo area is accessible during flight. If the animal cargo area is not accessible during flight, the carrier must observe the nonhuman primates whenever they are loaded and unloaded and whenever the animal cargo space is otherwise accessible to make sure that the nonhuman primates have sufficient air for normal breathing, that the ambient temperature is within the limits provided in § 3.88(d) of this subpart, and that all other applicable standards of this subpart are being complied with. The carrier must determine whether any of the nonhuman primates is in obvious physical distress, and arrange for any needed veterinary care for the nonhuman primates as soon as possible.
(c) If a nonhuman primate is obviously ill, injured, or in physical distress, it must not be transported in commerce, except to receive veterinary care for the condition.
(d) During transportation in commerce, a nonhuman primate must not be removed from its primary enclosure unless it is placed in another primary enclosure or a facility that meets the requirements of § 3.80 or § 3.87 of this subpart. Only persons who are experienced and authorized by the shipper, or authorized by the consignor or the consignee upon delivery, if the animal is consigned for transportation, may remove nonhuman primates from their primary enclosure during transportation in commerce, unless required for the health or well-being of the animal.
(e) The transportation regulations contained in this subpart must be complied with until a consignee takes physical delivery of the animal if the animal is consigned for transportation, or until the animal is returned to the consignor.
(a) Placement. Any persons subject to the Animal Welfare regulations (9 CFR parts l, 2, and 3) must not commingle shipments of nonhuman primates with inanimate cargo or with other animals in animal holding areas of terminal facilities. Nonhuman primates must not be placed near any other animals, including other species of nonhuman primates, and must not be able to touch or see any other animals, including other species of nonhuman primates.
(b) Cleaning, sanitization, and pest control. All animal holding areas of terminal facilities must be cleaned and sanitized in a manner prescribed in § 3.84(b)(3) of this subpart, as often as necessary to prevent an accumulation of debris or excreta and to minimize vermin infestation and disease hazards. Terminal facilities must follow an effective program in all animal holding areas for the control of insects, ectoparasites, and birds and mammals that are pests of nonhuman primates.
(c) Ventilation. Ventilation must be provided in any animal holding area in a terminal facility containing nonhuman primates by means of windows, doors, vents, or air conditioning. The air must be circulated by fans, blowers, or air conditioning so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans, vents, fans, blowers, or air conditioning, must be used in any animal holding area containing nonhuman primates when the ambient temperature is 85 °F (29.5 °C) or higher.
(d) Temperature. The ambient temperature in an animal holding area containing nonhuman primates must not fall below 45 °F (7.2 °C) or rise above 85 °F (29.5 °C) for more than four consecutive hours at any time nonhuman primates are present. The ambient temperature must be measured in the animal holding area by the carrier, intermediate handler, or a person transporting nonhuman primates who is subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3), outside any primary enclosure containing a nonhuman primate at a point not more than 3 feet (0.91 m.) away from an outside wall of the primary enclosure, on a level that is even with the enclosure and approximately midway up the side of the enclosure.
(e) Shelter. Any person subject to the Animal Welfare regulations (9 CFR parts l, 2, and 3) holding a nonhuman primate in an animal holding area of a terminal facility must provide the following:
(1) Shelter from sunlight and extreme heat. Shade must be provided that is sufficient to protect the nonhuman primate from the direct rays of the sun.
(2) Shelter from rain or snow. Sufficient protection must be provided to allow nonhuman primates to remain dry during rain, snow, and other precipitation.
(f) Duration. The length of time any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) can hold a nonhuman primate in an animal holding area of a terminal facility upon arrival is the same as that provided in § 3.86(f) of this subpart.
(a) Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) who moves (including loading and unloading) nonhuman primates within, to, or from the animal holding area of a terminal facility or a primary conveyance must do so as quickly and efficiently as possible, and must provide the following during movement of the nonhuman primate:
(1) Shelter from sunlight and extreme heat. Sufficient shade must be provided to protect the nonhuman primate from the direct rays of the sun. A nonhuman primate must not be exposed to an ambient temperature above 85 °F (29.5 °C) for a period of more than 45 minutes while being moved to or from a primary conveyance or a terminal facility, The ambient temperature must be measured in the manner provided in § 3.91(d) of this subpart.
(2) Shelter from rain or snow. Sufficient protection must be provided to allow nonhuman primates to remain dry during rain, snow, and other precipitation.
(3) Shelter from cold temperatures. Transporting devices on which nonhuman primates are placed to move them must be covered to protect the animals when the outdoor temperature falls below 45 °F (7.2 °C). A nonhuman primate must not be exposed to an ambient air temperature below 45 °F (7.2 °C) for a period of more than 45 minutes, unless it is accompanied by a certificate of acclimation to lower temperatures as provided in § 3.86(e) of this subpart. The ambient temperature must be measured in the manner provided in § 3.91(d) of this subpart.
(b) Any person handling a primary enclosure containing a nonhuman primate must use care and must avoid causing physical harm or distress to the nonhuman primate.
(1) A primary enclosure containing a nonhuman primate must not be placed on unattended conveyor belts or on elevated conveyor belts, such as baggage claim conveyor belts and inclined conveyor ramps that lead to baggage claim areas, at any time; except that a primary enclosure may be placed on inclined conveyor ramps used to load and unload aircraft if an attendant is present at each end of the conveyor belt.
(2) A primary enclosure containing a nonhuman primate must not be tossed, dropped, or needlessly tilted, and must not be stacked in a manner that may reasonably be expected to result in its falling. It must be handled and positioned in the manner that written instructions and arrows on the outside of the primary enclosure indicate.
(c) This section applies to movement of a nonhuman primate from primary conveyance to primary conveyance, within a primary conveyance or terminal facility, and to or from a terminal facility or a primary conveyance.
(a) All persons subject to the Animal Welfare Act who maintain or otherwise handle marine mammals in captivity must comply with the provisions of this subpart, except that they may apply for and be granted a variance,
(b) An application for a variance must be made to the Deputy Administrator in writing. The request must include:
(1) The species and number of animals involved,
(2) A statement from the attending veterinarian concerning the age and health status of the animals involved, and concerning whether the granting of a variance would be detrimental to the marine mammals involved,
(3) Each provision of the regulations that is not met,
(4) The time period requested for a variance,
(5) The specific reasons why a variance is requested, and
(6) The estimated cost of coming into compliance, if construction is involved.
(c) After receipt of an application for a variance, the Deputy Administrator may require the submission in writing of a report by two experts recommended by the American Association of Zoological Parks and Aquariums and approved by the Deputy Administrator concerning potential adverse impacts on the animals involved or on other matters relating to the effects of the requested variance on the health and well-being of such marine mammals. Such a report will be required only in those cases when the Deputy Administrator determines that such expertise is necessary to determine whether the granting of a variance would cause a situation detrimental to the health and well-being of the marine mammals involved. The cost of such report is to be paid by the applicant.
(d) Variances granted for facilities because of ill or infirm marine mammals that cannot be moved without placing their well-being in jeopardy, or for facilities within 0.3048 meters (1 foot) of compliance with any space requirement may be granted for up to the life of the marine mammals involved. Otherwise, variances shall be granted for a period not exceeding July 30, 1986, Provided, however, That under circumstances deemed justified by the Deputy Administrator, a maximum extension of 1 year may be granted to attain full compliance. A written request for the extension must be received by the Deputy Administrator by May 30, 1986. Consideration for extension by the Deputy Administrator will be limited to unforeseen or unusual situations such as when necessary public funds cannot be allocated in an appropriate time frame for a facility to attain full compliance by July 30, 1986.
(e) The Deputy Administrator shall deny any application for a variance if he determines that it is not justified under the circumstances or that allowing it will be detrimental to the health and well-being of the marine mammals involved.
(f) Any facility housing marine mammals that does not meet all of the space requirements as of July 30, 1984, must meet all of the requirements by September 28, 1984, or may operate without meeting such requirements until action is taken on an application for a variance if the application is submitted to the Deputy Administrator on or before September 28, 1984.
(g) A research facility may be granted a variance from specified requirements of this subpart when such variance is necessary for research purposes and is fully explained in the experimental design. Any time limitation stated in this section shall not be applicable in such case.
(a) Construction requirements. (1) Indoor and outdoor housing facilities for marine mammals must be structurally sound and must be maintained in good repair to protect the animals from injury, to contain the animals within the facility, and to restrict the entrance of unwanted animals. Lagoon and similar natural seawater facilities must maintain effective barrier fences extending above the high tide water level, or other appropriate measures, on all sides of the enclosure not contained by dry land to fulfill the requirements of this section.
(2) All marine mammals must be provided with protection from abuse and harassment by the viewing public by the use of a sufficient number of uniformed or readily identifiable employees or attendants to supervise the viewing public, or by physical barriers, such as fences, walls, glass partitions, or distance, or any combination of these.
(3) All surfaces in a primary enclosure must be constructed of durable, nontoxic materials that facilitate cleaning, and disinfection as appropriate, sufficient to maintain water quality parameters as designated in § 3.106. All surfaces must be maintained in good repair as part of a regular, ongoing maintenance program. All facilities must implement a written protocol on cleaning so that surfaces do not constitute a health hazard to animals.
(4) Facilities that utilize natural water areas, such as tidal basins, bays, or estuaries (subject to natural tidewater action), for housing marine mammals are exempt from the drainage requirements of paragraph (c)(1) of this section.
(b) Water and power supply. Reliable and adequate sources of water and electric power must be provided by the facility housing marine mammals. Written contingency plans must be submitted to and approved by the Deputy Administrator regarding emergency sources of water and electric power in the event of failure of the primary sources, when such failure could reasonably be expected to be detrimental to the good health and well-being of the marine mammals housed in the facility. Contingency plans must include, but not be limited to, specific animal evacuation plans in the event of a disaster and should describe back-up systems and/or arrangements for relocating marine mammals requiring artificially cooled or heated water. If the emergency contingency plan includes release of marine mammals, the plan must include provision for recall training and retrieval of such animals. Facilities handling marine mammals must also comply with the requirements of § 2.134 of this subchapter.
(c) Drainage. (1) Adequate drainage must be provided for all primary enclosure pools and must be located so that all of the water contained in such pools may be effectively eliminated when necessary for cleaning the pool or for other purposes. Drainage effluent from primary enclosure pools must be disposed of in a manner that complies with all applicable Federal, State, and local pollution control laws.
(2) Drainage must be provided for primary enclosures and areas immediately surrounding pools. All drain covers and strainers must be securely fastened in order to minimize the potential risk of animal entrapment. Drains must be located so as to rapidly eliminate excess water (except in pools). Drainage effluent must be disposed of in a manner that complies with all applicable Federal, State, and local pollution control laws.
(d) Storage. Supplies of food must be stored in facilities that adequately protect such supplies from deterioration, spoilage (harmful microbial growth), and vermin or other contamination. Refrigerators and freezers (or chilled and/or iced coolers for under 12 hours) must be used for perishable food. No substances that are known to be or may be toxic or harmful to marine mammals may be stored or maintained in the marine mammal food storage or preparation areas, except that cleaning agents may be kept in secured cabinets designed and located to prevent food contamination. Food, supplements, and medications may not be used beyond commonly accepted shelf life or date listed on the label.
(e) Waste disposal. Provision must be made for the removal and disposal of animal and food wastes, dead animals, trash, and debris. Disposal facilities must be provided and operated in a manner that will minimize odors and the risk of vermin infestation and disease hazards. All waste disposal procedures must comply with all applicable Federal, State, and local laws pertaining to pollution control, protection of the environment, and public health.
(f) Employee washroom facilities. Washroom facilities containing basins, sinks, and, as appropriate, showers, must be provided and conveniently located to maintain cleanliness among employees, attendants, and volunteers. These facilities must be cleaned and sanitized daily.
(g) Enclosure or pool environmental enhancements. Any nonfood objects provided for the entertainment or stimulation of marine mammals must be of sufficient size and strength to not be ingestible, readily breakable, or likely to cause injury to marine mammals, and be able to be cleaned, sanitized, and/or replaced effectively.
(a) Ambient temperature. The air and water temperatures in indoor facilities shall be sufficiently regulated by heating or cooling to protect the marine mammals from extremes of temperature, to provide for their good health and well-being and to prevent discomfort, in accordance with the currently accepted practices as cited in appropriate professional journals or reference guides, depending upon the species housed therein. Rapid changes in air and water temperatures shall be avoided.
(b) Ventilation. Indoor housing facilities shall be ventilated by natural or artificial means to provide a flow of fresh air for the marine mammals and to minimize the accumulation of chlorine fumes, other gases, and objectionable odors. A vertical air space averaging at least 1.83 meters (6 feet) shall be maintained in all primary enclosures housing marine mammals, including pools of water.
(c) Lighting. Indoor housing facilities for marine mammals shall have ample lighting, by natural or artificial means, or both, of a quality, distribution, and duration which is appropriate for the species involved. Sufficient lighting must be available to provide uniformly distributed illumination which is adequate to permit routine inspections, observations, and cleaning of all parts of the primary enclosure including any den areas. The lighting shall be designed so as to prevent overexposure of the marine mammals contained therein to excessive illumination.
(a) Environmental temperatures. Marine mammals shall not be housed in outdoor facilities unless the air and water temperature ranges which they may encounter during the period they are so housed do not adversely affect their health and comfort. A marine mammal shall not be introduced to an outdoor housing facility until it is acclimated to the air and water temperature ranges which it will encounter therein. The following requirements shall be applicable to all outdoor pools.
(1) The water surface of pools in outdoor primary enclosures housing polar bears and ice or cold water dwelling species of pinnipeds shall be kept sufficiently free of solid ice to allow for entry and exit of the animals.
(2) The water surface of pools in outdoor primary enclosures housing cetaceans and sea otters shall be kept free of ice.
(3) No sirenian or warm water dwelling species of pinnipeds or cetaceans shall be housed in outdoor pools where water temperature cannot be maintained within the temperature range to meet their needs.
(b) Shelter. Natural or artificial shelter which is appropriate for the species concerned, when the local climatic conditions are taken into consideration, shall be provided for all marine mammals kept outdoors to afford them protection from the weather or from direct sunlight.
(c) Perimeter fence. On and after May 17, 2000, all outdoor housing facilities (i.e., facilities not entirely indoors) must be enclosed by a perimeter fence that is of sufficient height to keep animals and unauthorized persons out. Fences less than 8 feet high for polar bears or less than 6 feet high for other marine mammals must be approved in writing by the Administrator. The fence must be constructed so that it protects marine mammals by restricting animals and unauthorized persons from going through it or under it and having contact with the marine mammals, and so that it can function as a secondary containment system for the animals in the facility when appropriate. The fence must be of sufficient distance from the outside of the primary enclosure to prevent physical contact between animals inside the enclosure and animals or persons outside the perimeter fence. Such fences less than 3 feet in distance from the primary enclosure must be approved in writing by the Administrator. For natural seawater facilities, such as lagoons, the perimeter fence must prevent access by animals and unauthorized persons to the natural seawater facility from the abutting land, and must encompass the land portion of the facility from one end of the natural seawater facility shoreline as defined by low tide to the other end of the natural seawater facility shoreline defined by low tide. A perimeter fence is not required:
(1) Where the outside walls of the primary enclosure are made of sturdy, durable material, which may include certain types of concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(2) Where the outdoor housing facility is protected by an effective natural barrier that restricts the marine mammals to the facility and restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(3) Where appropriate alternative security measures are employed and the Administrator gives written approval; or
(4) For traveling facilities where appropriate alternative security measures are employed.
(a) General. Marine mammals must be housed in primary enclosures that comply with the minimum space requirements prescribed by this part. These enclosures must be constructed and maintained so that the animals contained within are provided sufficient space, both horizontally and vertically, to be able to make normal postural and social adjustments with adequate freedom of movement, in or out of the water. (An exception to these requirements is provided in § 3.110(b) for isolation or separation for medical treatment and/or medical training.) Enclosures smaller than required by the standards may be temporarily used for nonmedical training, breeding, holding, and transfer purposes. If maintenance in such enclosures for nonmedical training, breeding, or holding is to last longer than 2 weeks, such extension must be justified in writing by the attending veterinarian on a weekly basis. If maintenance in such enclosures for transfer is to last longer than 1 week, such extension must be justified in writing by the attending veterinarian on a weekly basis. Any enclosure that does not meet the minimum space requirement for primary enclosures (including, but not limited to, medical pools or enclosures, holding pools or enclosures, and gated side pools smaller than the minimum space requirements) may not be used for permanent housing purposes. Rotating animals between enclosures that meet the minimum space requirements and enclosures that do not is not an acceptable means of complying with the minimum space requirements for primary enclosures.
(b) Cetaceans. Primary enclosures housing cetaceans shall contain a pool of water and may consist entirely of a pool of water. In determining the minimum space required in a pool holding cetaceans, four factors must be satisfied. These are MHD, depth, volume, and surface area. For the purposes of this subpart, cetaceans are divided into Group I cetaceans and Group II cetaceans as shown in Table III in this section.
(1)(i) The required minimum horizontal dimension (MHD) of a pool for Group I cetaceans shall be 7.32 meters (24.0 feet) or two times the average adult length of the longest species of Group I cetacean housed therein (as measured in a parallel or horizontal line, from the tip of its upper jaw, or from the most anterior portion of the head in bulbous headed animals, to the notch in the tail fluke
(ii) The MHD of a pool for Group II cetaceans shall be 7.32 meters (24.0 feet) or four times the average adult length of the longest species of cetacean to be housed therein (as measured in a parallel or horizontal line from the tip of its upper jaw, or from the most anterior portion of the head in bulbous headed animals, to the notch in the tail fluke), whichever is greater; except that such MHD measurement may be reduced from the greater number by up to 20 percent if the amount of the reduction is added to the MHD at the 90-degree angle and if the minimum volume and surface area requirements are met based on an MHD of 7.32 meters (24.0 feet) or four times the average adult length of the longest species of Group II cetacean housed therein, whichever is greater.
(iii) In a pool housing a mixture of Group I and Group II cetaceans, the MHD shall be the largest required for any cetacean housed therein.
(iv) Once the required MHD has been satisfied, the pool size may be required to be adjusted to increase the surface area and volume when cetaceans are added. Examples of MHD and volume requirements for Group I cetaceans are shown in Table I, and for Group II cetaceans in Table II.
Table I—Group I Cetaceans 1
| Representative average adult lengths | Minimum horizontal dimension (MHD) | Minimum required
depth | Volume of water required for each additional cetacean in excess of two | ||||
|---|---|---|---|---|---|---|---|
| Meters | Feet | Meters | Feet | Meters | Feet | Cubic meters | feet |
| 1.68 | 5.5 | 7.32 | 24 | 1.83 | 6 | 8.11 | 284.95 |
| 2.29 | 7.5 | 7.32 | 24 | 1.83 | 6 | 15.07 | 529.87 |
| 2.74 | 9.0 | 7.32 | 24 | 1.83 | 6 | 21.57 | 763.02 |
| 3.05 | 10.0 | 7.32 | 24 | 1.83 | 6 | 26.73 | 942.00 |
| 3.51 | 11.5 | 7.32 | 24 | 1.83 | 6 | 35.40 | 1,245.79 |
| 3.66 | 12.0 | 7.32 | 24 | 1.83 | 6 | 38.49 | 1,356.48 |
| 4.27 | 14.0 | 8.53 | 28 | 2.13 | 7 | 60.97 | 2,154.04 |
| 5.49 | 18.0 | 10.97 | 36 | 2.74 | 9 | 129.65 | 4,578.12 |
| 5.64 | 18.5 | 11.28 | 37 | 2.82 | 9.25 | 140.83 | 4,970.33 |
| 5.79 | 19.0 | 11.58 | 38 | 2.90 | 9.50 | 152.64 | 5,384.32 |
| 6.71 | 22.0 | 13.41 | 44 | 3.36 | 11 | 237.50 | 8,358.68 |
| 6.86 | 22.5 | 13.72 | 45 | 3.43 | 11.25 | 253.42 | 8,941.64 |
| 7.32 | 24.0 | 14.63 | 48 | 3.66 | 12 | 307.89 | 10,851.84 |
| 8.53 | 28.0 | 17.07 | 56 | 4.27 | 14 | 487.78 | 17,232.32 |
1 All calculations are rounded off to the nearest hundredth. In converting the length of cetaceans from feet to meters, 1 foot equals .3048 meter. Due to rounding of meter figures as to the length of the cetacean, the correlation of meters to feet in subsequent calculations of MHD and additional volume of water required per cetacean, over two, may vary slightly from a strict feet to meters ratio. Cubic meters is based on: 1 cubic foot = 0.0283 cubic meter.
Table II—Group II Cetaceans 1
| Representative average adult length | Minimum horizontal dimension (MHD) | Minimum required
depth | Volume of water required for each additional cetacean in excess of four | ||||
|---|---|---|---|---|---|---|---|
| Meters | Feet | Meters | Feet | Meters | Feet | Cubic meters 1 | Cubic feet |
| 1.52 | 5.0 | 7.32 | 24 | 1.83 | 6 | 13.28 | 471.00 |
| 1.68 | 5.5 | 7.32 | 24 | 1.83 | 6 | 16.22 | 569.91 |
| 1.83 | 6.0 | 7.32 | 24 | 1.83 | 6 | 19.24 | 678.24 |
| 2.13 | 7.0 | 8.53 | 28 | 1.83 | 6 | 26.07 | 923.16 |
| 2.29 | 7.5 | 9.14 | 30 | 1.83 | 6 | 30.13 | 1,059.75 |
| 2.44 | 8.0 | 9.75 | 32 | 1.83 | 6 | 34.21 | 1,205.76 |
| 2.59 | 8.5 | 10.36 | 34 | 1.83 | 6 | 38.55 | 1,361.19 |
| 2.74 | 9.0 | 10.97 | 36 | 1.83 | 6 | 43.14 | 1,526.04 |
1 Converting cubic feet to cubic meters is based on: 1 cubic foot = 0.0283 of a cubic meter.
Table III—Average Adult Lengths of Marine Mammals Maintained in Captivity 1
| Species | Common name | Average adult length | |
|---|---|---|---|
| In meters | In feet | ||
| Group I Cetaceans: | |||
| Minke whale | 8.50 | 27.9 | |
| Commerson's dolphin | 1.52 | 5.0 | |
| Beluga whale | 4.27 | 14.0 | |
| Narwhale | 3.96 | 13.0 | |
| Long-finned pilot whale | 5.79 | 19.0 | |
| Short-finned pilot whale | 5.49 | 18.0 | |
| Risso's dolphin | 3.66 | 12.0 | |
| Killer whale | 7.32 | 24.0 | |
| False killer whale | 4.35 | 14.3 | |
| Bottlenose dolphin | 2.74 | 9.0 | |
| Bottlenose dolphin | 3.05 | 10.0 | |
| Amazon porpoise | 2.44 | 8.0 | |
| Harbor porpoise | 1.68 | 5.5 | |
| Franciscana | 1.52 | 5.0 | |
| Tucuxi | 1.68 | 5.5 | |
| River dolphin | 2.44 | 8.0 | |
| Group II Cetaceans: | |||
| Common dolphin | 2.59 | 8.5 | |
| Pygmy killer whale | 2.44 | 8.0 | |
| Pygmy sperm whale | 3.96 | 13.0 | |
| Dwarf sperm whale | 2.90 | 9.5 | |
| Atlantic white-sided dolphin | 2.90 | 9.5 | |
| Hourglass dolphin | 1.70 | 5.6 | |
| Pacific white-sided dolphin | 2.29 | 7.5 | |
| White-beaked dolphin | 2.74 | 9.0 | |
| Duskey dolphin | 2.13 | 7.0 | |
| Northern right whale dolphin | 2.74 | 9.0 | |
| Finless porpoise | 1.83 | 6.0 | |
| Melon-headed whale | 2.74 | 9.0 | |
| Dall's porpoise | 2.00 | 6.5 | |
| Spinner dolphin | 2.13 | 7.0 | |
| Striped dolphin | 2.29 | 7.5 | |
| Spotted dolphin | 2.29 | 7.5 | |
| Spotted dolphin | 2.29 | 7.5 | |
| Rough-toothed dolphin | 2.44 | 8.0 | |
1 This table contains the species of marine mammals known by the Department to be presently in captivity or that are likely to become captive in the future. Anyone who is subject to the Animal Welfare Act having species of marine mammals in captivity which are not included in this table should consult the Deputy Administrator with regard to the average adult length of such animals.
| Species | Common name | Average adult length | |||
|---|---|---|---|---|---|
| In meters | In feet | ||||
| Male | Female | Male | Female | ||
| Group I Pinnipeds: | |||||
| Antarctic Fur Seal | 1.80 | 1.20 | 5.9 | 3.9 | |
| Amsterdam Island Fur Seal | 1.80 | 1.45 | 5.9 | 4.75 | |
| South American Fur Seal | 1.88 | 1.42 | 6.2 | 4.7 | |
| Cape Fur Seal | 2.73 | 1.83 | 8.96 | 6.0 | |
| Northern Fur Seal | 2.20 | 1.45 | 7.2 | 4.75 | |
| Steller's Sea Lion | 2.86 | 2.40 | 9.4 | 7.9 | |
| Leopard Seal | 2.90 | 3.30 | 9.5 | 10.8 | |
| Northern Elephant Seal | 3.96 | 2.49 | 13.0 | 8.2 | |
| Southern Elephant Seal | 4.67 | 2.50 | 15.3 | 8.2 | |
| Walrus | 3.15 | 2.60 | 10.3 | 8.5 | |
| South American Sea Lion | 2.40 | 2.00 | 7.9 | 6.6 | |
| Caspian Seal | 1.45 | 1.40 | 4.75 | 4.6 | |
| Ribbon Seal | 1.75 | 1.68 | 5.7 | 5.5 | |
| Harbor Seal | 1.70 | 1.50 | 5.6 | 4.9 | |
| Habor Seal | 1.70 | 1.50 | 5.6 | 4.9 | |
| California Sea Lion | 2.24 | 1.75 | 7.3 | 5.7 | |
| Grar Seal | 2.30 | 1.95 | 7.5 | 6.4 | |
| Baikal Seal | 1.70 | 1.85 | 5.6 | 6.1 | |
| Harp Seal | 1.85 | 1.85 | 6.1 | 6.1 | |
| Weddell Seal | 2.90 | 3.15 | 9.5 | 10.3 | |
| Crabeater Seal | 2.21 | 2.21 | 7.3 | 7.3 | |
| Ross Seal | 1.99 | 2.13 | 6.5 | 7.0 | |
| Group II Pinnipeds: | |||||
| Bearded Seal | 2.33 | 2.33 | 7.6 | 7.6 | |
| Ringed Seal | 1.35 | 1.30 | 4.4 | 4.3 | |
| Hooded Seal | 2.60 | 2.00 | 8.5 | 6.6 | |
| Species | Common name | Average adult length | |
|---|---|---|---|
| In meters | In feet | ||
| Sirenia: | |||
| Dugong dugong | Dugong | 3.35 | 11.0 |
| Trichechus manatus | West Indian Manatee | 3.51 | 11.5 |
| Trichechus inunguis | Amazon Manatee | 2.44 | 8.0 |
| Mustelidae: | |||
| Enhydra lutris | Sea Otter | 1.25 | 4.1 |
(2) The minimum depth requirement for primary enclosure pools for all cetaceans shall be one-half the average adult length of the longest species to be housed therein, regardless of Group I or Group II classification, or 1.83 meters (6.0 feet), whichever is greater, and can be expressed as d = L/2 or 6 feet, whichever is greater. Those parts of the primary enclosure pool which do not meet the minimum depth requirement cannot be included when calculating space requirements for cetaceans.
(3) Pool volume. A pool of water housing cetaceans which satisfies the MHD and which meets the minimum depth requirement, will have sufficient volume and surface area to hold up to two Group I cetaceans or up to four Group II cetaceans. If additional cetaceans are to be added to the pool, the volume as well as the surface area may have to be adjusted to allow for additional space necessary for such cetaceans. See Tables I, II, and IV for volumes and surface area requirements. The additional volume needed shall be based on the number and kind of cetaceans housed therein and shall be determined in the following manner.
(i) The minimum volume of water required for up to two Group I cetaceans is based upon the following formula:
(ii) The minimum volume of water required for up to four Group II cetaceans is based upon the following formula:
(iii) When a mixture of both Group I and Group II cetaceans are housed together, the MHD must be satisfied as stated in § 3.104(b)(1), and the minimum depth must be satisfied as stated in § 3.104(b)(2). Based on these figures, the resulting volume must then be calculated
(4)(i) The minimum surface area requirements for each cetacean housed in a pool, regardless of Group I or Group II classification, are calculated as follows:
(ii) When a mixture of Group I and Group II cetaceans are to be housed in a pool, the required MHD, depth, and volume must be met. Then the required surface area must be determined for each animal in the pool. The sum of these surface areas must then be compared to the surface area which is obtained by a computation based on the required MHD of the pool.
SA = π × (MHD / 2).
(iii) Surface area requirements are given in Table IV.
Table IV—Minimum Surface Area Required for Each Cetacean
| Average adult length of each cetacean | Surface area required for each cetacean | ||
|---|---|---|---|
| Meters | Feet | Sq. meters 1 | Sq. feet |
| 1.68 | 5.5 | 3.31 | 33.62 |
| 2.13 | 7.0 | 5.36 | 57.70 |
| 2.29 | 7.5 | 6.15 | 66.23 |
| 2.59 | 8.5 | 7.90 | 85.07 |
| 2.74 | 9.0 | 8.86 | 95.38 |
| 3.05 | 10.0 | 10.94 | 117.75 |
| 3.51 | 11.5 | 14.47 | 155.72 |
| 3.66 | 12.0 | 15.75 | 169.56 |
| 4.27 | 14.0 | 21.44 | 230.79 |
| 5.49 | 18.0 | 35.44 | 381.51 |
| 5.64 | 18.5 | 37.43 | 403.00 |
| 5.79 | 19.0 | 39.49 | 425.08 |
| 6.71 | 22.0 | 52.94 | 569.91 |
| 6.86 | 22.5 | 55.38 | 596.11 |
| 7.32 | 24.0 | 63.01 | 678.24 |
| 8.53 | 28.0 | 85.76 | 923.16 |
1 Square meter = square feet/9 × 0.8361.
(c) Sirenians. Primary enclosures housing sirenians shall contain a pool of water and may consist entirely of a pool of water.
(1) The required MHD of a primary enclosure pool for sirenians shall be two times the average adult length of the longest species of sirenian to be housed therein. Calculations shall be based on the average adult length of such sirenians as measured in a horizontal line from the tip of the muzzle to the notch in the tail fluke of dugongs and from the tip of the muzzle to the most distal point in the rounded tail of the manatee.
(2) The minimum depth requirements for primary enclosure pools for all sirenians shall be one-half the average adult length of the longest species to be housed therein, or 1.52 meters (5.0 feet), whichever is greater. Those parts of the primary enclosure pool which do not meet the minimum depth requirements cannot be included when calculating space requirements for sirenians.
(3) A pool which satisfies the required MHD and depth shall be adequate for one or two sirenians. Volume and surface area requirements for additional animals shall be calculated using the same formula as for Group I cetaceans, except that the figure for depth requirement for sirenians shall be one-half the average adult length or 1.52 meters (5.0 feet), whichever is greater.
(d) Pinnipeds. (1) Primary enclosures housing pinnipeds shall contain a pool of water and a dry resting or social activity area that must be close enough to the surface of the water to allow easy access for entering or leaving the pool. For the purposes of this subpart, pinnipeds have been divided into Group I pinnipeds and Group II pinnipeds as shown in Table III in this section. In certain instances some Group I pinnipeds shall be considered as Group II pinnipeds. (See Table III).
(2) The minimum size of the dry resting or social activity area of the primary enclosure for pinnipeds (exclusive of the pool of water) shall be based on the average adult length of each pinniped contained therein, as measured in a horizontal or extended position in a straight line from the tip of its nose to the tip of its tail. The minimum size of the dry resting or social activity area shall be computed using the following methods:
(i) Group I pinnipeds. Square the average adult length of each pinniped to be contained in the primary enclosure. Add the figures obtained for each of the pinnipeds in the primary enclosure to determine the dry resting or social activity area required for such pinnipeds. If only a single Group I pinniped is maintained in the primary enclosure, the minimum dry resting or social activity area shall be twice the square of the average adult length of that single Group I pinniped. Examples:
(ii) Group II pinnipeds. List all pinnipeds contained in a primary enclosure by average adult length in descending order from the longest species of pinniped to the shortest species of pinniped. Square the average adult length of each pinniped. Multiply the average adult length squared of the longest pinniped by 1.5, the second longest by 1.4, the third longest by 1.3, the fourth longest by 1.2, and the fifth longest by 1.1, as indicated in the following example. Square the average adult length of the sixth pinniped and each additional pinniped. Add the figures obtained for all the pinnipeds in the primary enclosure to determine the required minimum dry resting or social activity area required for such pinnipeds. If only a single Group II pinniped is maintained in the primary enclosure, the minimum dry resting or social activity area must be computed for a minimum of two pinnipeds.
| 1st pinniped (avg. adult length) 2 × 1.5 = social and DRA required |
| 2nd pinniped (avg. adult length) 2 × 1.4 = social and DRA required |
| 3rd pinniped (avg. adult length) 1 × 1.3 = social and DRA required |
| 4th pinniped (avg. adult length) 2 × 1.2 = social and DRA required |
| 5th pinniped (avg. adult length) 2 × 1.1 = social and DRA required |
| Each pinniped over 5 (avg. adult length) 2 = social and DRA required |
| Total minimum social activity and dry resting area required for all pinnipeds housed in a primary enclosure. |
If all the pinnipeds in the primary enclosure are of the same species, the same descending order of calculation shall apply. Example: Hooded seal—average adult length of male = 8.5 feet and female = 6.6 feet. In a primary enclosure containing 2 males and 2 females, the social or DRA required would be the sum of [(8.5)
If two or more sexually mature males are maintained together in a primary enclosure, the dry resting or social activity area shall be divided into two or more separate areas with sufficient visual barriers (such as fences, rocks, or foliage) to provide relief from aggressive animals.
(iii) Mixture of Group I and Group II pinnipeds. In a primary enclosure where a mixture of Group I and Group II pinnipeds is to be housed, the dry resting or social activity area shall be calculated as for Group II pinnipeds. The dry resting or social activity area shall be divided into two or more separate areas with sufficient visual barriers (such as fences, rocks, or foliage) to provide relief from aggressive animals.
(3)(i) The minimum surface area of a pool of water for pinnipeds shall be at least equal to the dry resting or social activity area required.
(ii) The MHD of the pool shall be at least one and one-half (1.5) times the average adult length of the largest species of pinniped to be housed in the enclosure; except that such MHD measurement may be reduced by up to 20 percent if the amount of the reduction is added to the MHD at the 90-degree angle.
(iii) The pool of water shall be at least 0.91 meters (3.0 feet) deep or one-half the average adult length of the longest species of pinniped contained therein, whichever is greater. Parts of the pool that do not meet the minimum depth requirement cannot be used in the calculation of the dry resting and social activity area, or as part of the MHD or required surface area of the pool.
(e) Polar bears. Primary enclosures housing polar bears shall consist of a pool of water, a dry resting and social activity area, and a den. A minimum of 37.16 square meters (400 square feet) of dry resting and social activity area shall be provided for up to two polar bears, with an additional 3.72 square meters (40 square feet) of dry resting and social activity area for each additional polar bear. The dry resting and social activity area shall be provided with enough shade to accommodate all of the polar bears housed in such primary enclosure at the same time. The pool of water shall have an MHD of not less than 2.44 meters (8.0 feet) and a surface area of at least 8.93 square meters (96.0 square feet) with a minimum depth of 1.52 meters (5.0 feet) with the exception of any entry and exit area. This size pool shall be adequate for two polar bears. For each additional bear, the surface area of the pool must be increased by 3.72 square meters (40 square feet). In measuring this additional surface area, parts of the pool which do not meet minimum depth cannot be considered. The den shall be at least 1.83 meters (6 feet) in width and depth and not less than 1.52 meters (5 feet) in height. It will be so positioned that the viewing public shall not be visible from the interior of the den. A separate den shall be provided for each adult female of breeding age which is permanently housed in the same primary enclosure with an adult male of breeding age. Female polar bears in traveling acts or shows must be provided a den when pregnancy has been determined.
(f) Sea otters. (1) Primary enclosures for sea otters shall consist of a pool of water and a dry resting area. The MHD of the pool of water for sea otters shall be at least three times the average adult length of the sea otter contained therein (measured in a horizontal line from the tip of its nose to the tip of its tail) and the pool shall be not less than .91 meters (3.0 feet) deep. When more than two sea otters are housed in the same primary enclosure, additional dry resting area as well as pool volume is required to accommodate the additional sea otters. (See Table V).
(2) The minimum volume of water required for a primary enclosure pool for sea otters shall be based on the sea otter's average adult length. The minimum volume of water required in the pool shall be computed using the following method: Multiply the square of the sea otter's average adult length by 3.14 and then multiply the total by 0.91 meters (3.0 feet). This volume is satisfactory for one or two otters. To calculate the additional volume of water for each additional sea otter above two in a primary enclosure, multiply one-half of the square of the sea otter's average adult length by 3.14, then multiply by 0.91 meters (3.0 feet). (See Table V).
(3) The minimum dry resting area required for one or two sea otters shall be based on the sea otter's average adult length. The minimum dry resting area for one or two sea otters shall be computed using the following method: Square the average adult length of the sea otter and multiply the total by 3.14. When the enclosure is to contain more than two sea otters, the dry resting area for each additional animal shall be computed by multiplying one-half of the sea otter's average adult length by 3.14. Using 1.25 meters or 4.1 feet (the average adult length of a sea otter), the calculations for additional space will result in the following figures:
Table V—Additional Space Required for Each Sea Otter When More Than Two in a Primary Enclosure
| Average adult length of sea otter | Resting area | Pool Volume | |||
|---|---|---|---|---|---|
| Meters | Feet | Square meters | Square Feet | Cubic meters | Cubic feet |
| 1.25 | 4.1 | 1.96 | 6.44 | 2.23 | 79.17 |
(a) The food for marine mammals must be wholesome, palatable, and free from contamination and must be of sufficient quantity and nutritive value to maintain marine mammals in a state of good health. The diet must be prepared with consideration for factors such as age, species, condition, and size of the marine mammal being fed. Marine mammals must be offered food at least once a day, except as directed by the attending veterinarian.
(b) Food receptacles, if used, must be located so as to be accessible to all marine mammals in the same primary enclosure and must be placed so as to minimize contamination of the food they contain. Such food receptacles must be cleaned and sanitized after each use.
(c) Food, when given to each marine mammal individually, must be given by an employee or attendant responsible to management who has the necessary knowledge to assure that each marine mammal receives an adequate quantity of food to maintain it in good health. Such employee or attendant is required to have the ability to recognize deviations from a normal state of good health in each marine mammal so that the food intake can be adjusted accordingly. Inappetence exceeding 24 hours must be reported immediately to the attending veterinarian. Public feeding may be permitted only in the presence and under the supervision of a sufficient number of knowledgeable, uniformed employees or attendants. Such employees or attendants must assure that the marine mammals are receiving the proper amount and type of food. Only food supplied by the facility where the marine mammals are kept may be fed to the marine mammals by the public. Marine mammal feeding records noting the estimated individual daily consumption must be maintained at the facility for a period of 1 year and must be made available for APHIS inspection. For marine mammals that are individually fed and not subject to public feeding, the feeding records should reflect an accurate account of food intake; for animals fed, in part, by the public, and for large, group-fed colonies of marine mammals where individual rations are not practical or feasible to maintain, the daily food consumption should be estimated as precisely as possible.
(d) Food preparation and handling must be conducted so as to assure the wholesomeness and nutritive value of the food. Frozen fish or other frozen food must be stored in freezers that are maintained at a maximum temperature of −18 °C (0 °F). The length of time food is stored and the method of storage, the thawing of frozen food, and the maintenance of thawed food must be conducted in a manner that will minimize contamination and that will assure that the food retains nutritive value and wholesome quality until the time of feeding. When food is thawed in standing or running water, cold water must be used. All foods must be fed to the marine mammals within 24 hours following the removal of such foods from the freezers for thawing, or if the food has been thawed under refrigeration, it must be fed to the marine mammals within 24 hours of thawing.
(a) General. The primary enclosure shall not contain water which would be detrimental to the health of the marine mammal contained therein.
(b) Bacterial standards. (1) The coliform bacteria count of the primary enclosure pool shall not exceed 1,000 MPN (most probable number) per 100 ml. of water. Should a coliform bacterial count exceed 1,000 MPN, two subsequent samples may be taken at 48-hour intervals and averaged with the first sample. If such average count does not fall below 1,000 MPN, then the water in the pool shall be deemed unsatisfactory, and the condition must be corrected immediately.
(2) When the water is chemically treated, the chemicals shall be added so as not to cause harm or discomfort to the marine mammals.
(3) Water samples shall be taken and tested at least weekly for coliform count and at least daily for pH and any chemical additives (e.g. chlorine and copper) that are added to the water to maintain water quality standards. Facilities using natural seawater shall be exempt from pH and chemical testing unless chemicals are added to maintain water quality. However, they are required to test for coliforms. Records must be kept documenting the time when all such samples were taken and the results of the sampling. Records of all such test results shall be maintained by management for a 1-year period and must be made available for inspection purposes on request.
(c) Salinity. Primary enclosure pools of water shall be salinized for marine cetaceans as well as for those other marine mammals which require salinized water for their good health and well-being. The salinity of the water in such pools shall be maintained within a range of 15-36 parts per thousand.
(d) Filtration and water flow. Water quality must be maintained by filtration, chemical treatment, or other means so as to comply with the water quality standards specified in this section.
(a) Primary enclosures. (1) Animal and food waste in areas other than the pool of water must be removed from the primary enclosures at least daily, and more often when necessary, in order to provide a clean environment and minimize health and disease hazards.
(2) Particulate animal and food waste, trash, or debris that enters the primary enclosure pools of water must be removed at least daily, or as often as necessary, to maintain the required water quality and to minimize health and disease hazards to the marine mammals.
(3) The wall and bottom surfaces of the primary enclosure pools of water must be cleaned as often as necessary to maintain proper water quality. Natural organisms (such as algae, coelenterates, or molluscs, for example) that do not degrade water quality as defined in § 3.106, prevent proper maintenance, or pose a health or disease hazard to the animals are not considered contaminants.
(b) Food preparation. Equipment and utensils used in food preparation must be cleaned and sanitized after each use. Kitchens and other food handling areas where animal food is prepared must be cleaned at least once daily and sanitized at least once every week. Sanitizing must be accomplished by washing with hot water (8 °C, 180 °F, or higher) and soap or detergent in a mechanical dishwasher, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam. Substances such as cleansing and sanitizing agents, pesticides, and other potentially toxic agents must be stored in properly labeled containers in secured cabinets designed and located to prevent contamination of food storage preparation surfaces.
(c) Housekeeping. Buildings and grounds, as well as exhibit areas, must be kept clean and in good repair. Fences must be maintained in good repair. Primary enclosures housing marine mammals must not have any loose objects or sharp projections and/or edges which may cause injury or trauma to the marine mammals contained therein.
(d) Pest control. A safe and effective program for the control of insects, ectoparasites, and avian and mammalian pests must be established and maintained. Insecticides or other such chemical agents must not be applied in primary enclosures housing marine mammals except when deemed essential by an attending veterinarian.
(a) A sufficient number of adequately trained employees or attendants, responsible to management and working in concert with the attending veterinarian, must be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices must be conducted under the supervision of a marine mammal caretaker who has demonstrable experience in marine mammal husbandry and care.
(b) The facility will provide and document participation in and successful completion of a facility training course for such employees. This training course will include, but is not limited to, species appropriate husbandry techniques, animal handling techniques, and information on proper reporting protocols, such as recordkeeping and notification of veterinary staff for medical concerns.
(c) Any training of marine mammals must be done by or under the direct supervision of experienced trainers.
(d) Trainers and handlers must meet professionally recognized standards for experience and training.
Marine mammals, whenever known to be primarily social in the wild, must be housed in their primary enclosure with at least one compatible animal of the same or biologically related species, except when the attending veterinarian, in consultation with the husbandry/training staff, determines that such housing is not in the best interest of the marine mammal's health or well-being. However, marine mammals that are not compatible must not be housed in the same enclosure. Marine mammals must not be housed near other animals that cause them unreasonable stress or discomfort or interfere with their good health. Animals housed separately must have a written plan, approved by the attending veterinarian, developed in consultation with the husbandry/training staff, that includes the justification for the length of time the animal will be kept separated or isolated, information on the type and frequency of enrichment and interaction, if appropriate, and provisions for periodic review of the plan by the attending veterinarian. Marine mammals that are separated for nonmedical purposes must be held in facilities that meet minimum space requirements as outlined in § 3.104.
(a) Newly acquired marine mammals must be isolated from resident marine mammals. Animals with a known medical history must be isolated unless or until the newly acquired animals can be reasonably determined to be in good health by the attending veterinarian. Animals without a known medical history must be isolated until the newly acquired animals are determined to be in good health by the attending veterinarian. Any communicable disease condition in a newly acquired marine mammal must be remedied before it is placed with resident marine mammals, unless, in the judgment of the attending veterinarian, the potential benefits of a resident animal as a companion to the newly acquired animal outweigh the risks to the resident animal.
(b) Holding facilities must be in place and available to meet the needs for isolation, separation, medical treatment, and medical training of marine mammals. Marine mammals that are isolated or separated for nonmedical purposes must be held in facilities that meet minimum space requirements as outlined in § 3.104. Holding facilities used only for medical treatment and medical training need not meet the minimum space requirements as outlined in § 3.104. Holding of a marine mammal in a medical treatment or medical training enclosure that does not meet minimum space requirements for periods longer than 2 weeks must be noted in the animal's medical record and the attending veterinarian must provide a justification in the animal's medical record. If holding in such enclosures for medical treatment and/or medical training is to last longer than 2 weeks, such extension must be justified in writing by the attending veterinarian on a weekly basis. In natural lagoon or coastal enclosures where isolation cannot be accomplished, since water circulation cannot be controlled or isolated, separation of newly acquired marine mammals must be accomplished using separate enclosures situated within the facility to prevent direct contact and to minimize the risk of potential airborne and water cross-contamination between newly acquired and resident animals.
(c) Any holding facility used for medical purposes that has contained a marine mammal with an infectious or contagious disease must be cleaned and/or sanitized in a manner prescribed by the attending veterinarian. No healthy animals may be introduced into this holding facility prior to such cleaning and/or sanitizing procedures. Any marine mammal exposed to a contagious animal must be evaluated by the attending veterinarian and monitored and/or isolated for an appropriate period of time as determined by the attending veterinarian.
(d) Individual animal medical records must be kept and made available for APHIS inspection. These medical records must include at least the following information:
(1) Animal identification/name, a physical description, including any identifying markings, scars, etc., age, and sex; and
(2) Physical examination information, including but not limited to length, weight, physical examination results by body system, identification of all medical and physical problems with proposed plan of action, all diagnostic test results, and documentation of treatment.
(e) A copy of the individual animal medical record must accompany any marine mammal upon its transfer to another facility, including contract or satellite facilities.
(f) All marine mammals must be visually examined by the attending veterinarian at least semiannually and must be physically examined under the supervision of and when determined to be necessary by the attending veterinarian. All cetaceans and sirenians must be physically examined by the attending veterinarian at least annually, unless APHIS grants an exception from this requirement based on considerations related to the health and safety of the cetacean or sirenian. These examinations must include, but are not limited to, a hands-on physical examination, hematology and blood chemistry, and other diagnostic tests as determined by the attending veterinarian.
(g)(1) A complete necropsy, including histopathology samples, microbiological cultures, and other testing as appropriate, must be conducted by or under the supervision of the attending veterinarian on all marine mammals that die in captivity. A preliminary necropsy report must be prepared by the veterinarian listing all pathologic lesions observed. The final necropsy report must include all gross and histopathological findings, the results of all laboratory tests performed, and a pathological diagnosis.
(2) Necropsy records will be maintained at the marine mammal's home facility and at the facility at which it died, if different, for a period of 3 years and must be presented to APHIS inspectors when requested.
Swim-with-the-dolphin programs shall comply with the requirements in this section, as well as with all other applicable requirements of the regulations pertaining to marine mammals.
(a) Space requirements. The primary enclosure for SWTD cetaceans shall contain an interactive area, a buffer area, and a sanctuary area. None of these areas shall be made uninviting to the animals. Movement of cetaceans into the buffer or sanctuary area shall not be restricted in any way. Notwithstanding the space requirements set forth in § 3.104, each of the three areas required for SWTD programs shall meet the following space requirements:
(1) The horizontal dimension for each area must be at least three times the average adult body length of the species of cetacean used in the program;
(2) The minimum surface area required for each area is calculated as follows:
(i) Up to two cetaceans:
(ii) Three cetaceans:
(iii) Additional SA for each animal in excess of three:
(3) The average depth for sea pens, lagoons, and similar natural enclosures at low tide shall be at least 9 feet. The average depth for any manmade enclosure or other structure not subject to tidal action shall be at least 9 feet. A portion of each area may be excluded when calculating the average depth, but the excluded portion may not be used in calculating whether the interactive, buffer, and sanctuary area meet the requirements of paragraphs (a)(1), (a)(2), and (a)(4) of this section.
(4) The minimum volume required for each animal is calculated as follows:
(b) Water clarity. Sufficient water clarity shall be maintained so that attendants are able to observe cetaceans and humans at all times while within the interactive area. If water clarity does not allow these observations, the interactive sessions shall be canceled until the required clarity is provided.
(c) Employees and attendants. Each SWTD program shall have, at the minimum, the following personnel, with the following minimum backgrounds (each position shall be held by a separate individual, with a sufficient number of attendants to comply with § 3.111(e)(4)):
(1) Licensee or manager—at least one full-time staff member with at least 6 years experience in a professional or managerial position dealing with captive cetaceans;
(2) Head trainer/behaviorist—at least one full-time staff member with at least 6 years experience in training cetaceans for SWTD behaviors in the past 10 years, or an equivalent amount of experience involving in-water training of cetaceans, who serves as the head trainer for the SWTD program;
(3) Trainer/supervising attendant—at least one full-time staff member with at least 3 years training and/or handling experience involving human/cetacean interaction programs;
(4) Attendant—an adequate number of staff members who are adequately trained in the care, behavior, and training of the program animals. Attendants shall be designated by the trainer, in consultation with the head trainer/behaviorist and licensee/manager, to conduct and monitor interactive sessions in accordance with § 3.111(e); and
(5) Attending veterinarian—at least one staff or consultant veterinarian who has at least the equivalent of 2 years full-time experience (4,160 or more hours) with cetacean medicine within the past 10 years, and who is licensed to practice veterinary medicine.
(d) Program animals. Only cetaceans that meet the requirements of § 3.111(e)(2) and (3) may be used in SWTD programs.
(e) Handling. (1) Interaction time (i.e., designated interactive swim sessions) for each cetacean shall not exceed 2 hours per day. Each program cetacean shall have at least one period in each 24 hours of at least 10 continuous hours without public interaction.
(2) All cetaceans used in an interactive session shall be adequately trained and conditioned in human interaction so that they respond in the session to the attendants with appropriate behavior for safe interaction. The head trainer/behaviorist, trainer/supervising attendant, or attendant shall, at all times, control the nature and extent of the cetacean interaction with the public during a session, using the trained responses of the program animal.
(3) All cetaceans used in interactive sessions shall be in good health, including, but not limited to, not being infectious. Cetaceans undergoing veterinary treatment may be used in interactive sessions only with the approval of the attending veterinarian.
(4) The ratio of human participants to cetaceans shall not exceed 3:1. The ratio of human participants to attendants or other authorized SWTD personnel (i.e., head trainer/behaviorist or trainer/supervising attendant) shall not exceed 3:1.
(5) Prior to participating in an SWTD interactive session, members of the public shall be provided with oral and written rules and instructions for the session, to include the telephone and FAX numbers for APHIS, Animal Care, for reporting injuries or complaints. Members of the public shall agree, in writing, to abide by the rules and instructions before being allowed to participate in the session. Any participant who fails to follow the rules or instructions shall be removed from the session by the facility.
(6) All interactive sessions shall have at least two attendants or other authorized SWTD personnel (i.e., head trainer/behaviorist or trainer/supervising attendant). At least one attendant shall be positioned out of the water. One or more attendants or other authorized SWTD personnel may be positioned in the water. If a facility has more than two incidents during interactive sessions within a year's time span that have been dangerous or harmful to either a cetacean or a human, APHIS, in consultation with the head trainer/behaviorist, will determine if changes in attendant positions are needed.
(7) All SWTD programs shall limit interaction between cetaceans and humans so that the interaction does not harm the cetaceans, does not remove the element of choice from the cetaceans by actions such as, but not limited to, recalling the animal from the sanctuary area, and does not elicit unsatisfactory, undesirable, or unsafe behaviors from the cetaceans. All SWTD programs shall prohibit grasping or holding of the cetacean's body, unless under the direct and explicit instruction of an attendant eliciting a specific cetacean behavior, and shall prevent the chasing or other harassment of the cetaceans.
(8) In cases where cetaceans used in an interactive session exhibit unsatisfactory, undesirable, or unsafe behaviors, including, but not limited to, charging, biting, mouthing, or sexual contact with humans, such cetaceans shall either be removed from the interactive area or the session shall be terminated. Written criteria shall be developed by each SWTD program, and shall be submitted to and approved by APHIS
(f) Recordkeeping. (1) Each facility shall provide APHIS
(i) Identification of each cetacean in the program, by means of name and/or number, sex, age, and any other means the Administrator determines to be necessary to adequately identify the cetacean;
(ii) A description of the educational content and agenda of planned interactive sessions, and the anticipated average and maximum frequency and duration of encounters per cetacean per day;
(iii) The content and method of pre-encounter orientation, rules, and instructions, including restrictions on types of physical contact with the cetaceans;
(iv) A description of the SWTD facility, including the primary enclosure and other SWTD animal housing or holding enclosures at the facility;
(v) A description of the training, including actual or expected number of hours each cetacean has undergone or will undergo prior to participation in the program;
(vi) The resume of the licensee and/or manager, the head trainer/behaviorist, the trainer/supervising attendant, any other attendants, and the attending veterinarian;
(vii) The current behavior patterns and health of each cetacean, to be assessed and submitted by the attending veterinarian;
(viii) For facilities that employ a part-time attending veterinarian or consultant arrangements, a written program of veterinary care (APHIS form 7002), including protocols and schedules of professional visits; and
(ix) A detailed description of the monitoring program to be used to detect and identify changes in the behavior and health of the cetaceans.
(2) All SWTD programs shall comply in all respects with the regulations and standards set forth in parts 2 and 3 of this subchapter.
(3) Individual animal veterinary records, including all examinations, laboratory reports, treatments, and necropsy reports shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection.
(4) The following records shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection:
(i) Individual cetacean feeding records; and
(ii) Individual cetacean behavioral records.
(5) The following reports shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection:
(i) Statistical summaries of the number of minutes per day that each animal participated in an interactive session;
(ii) A statistical summary of the number of human participants per month in the SWTD program; and
(6) A description of any changes made in the SWTD program, which shall be submitted to APHIS
(7) All incidents resulting in injury to either cetaceans or humans participating in an interactive session, which shall be reported to APHIS within 24 hours of the incident.
(g) Veterinary care. (1) The attending veterinarian shall conduct on-site evaluations of each cetacean at least once a month. The evaluation shall include a visual inspection of the animal; examination of the behavioral, feeding, and medical records of the animal; and a discussion of each animal with an animal care staff member familiar with the animal.
(2) The attending veterinarian shall observe an interactive swim session at the SWTD site at least once each month.
(3) The attending veterinarian shall conduct a complete physical examination of each cetacean at least once every 6 months. The examination shall include a profile of the cetacean, including the cetacean's identification (name and/or number, sex, and age), weight,
Females: Natural log of body mass = −8.44 + 1.34(natural log of girth) + 1.28(natural log of standard length).
Males: Natural log of body mass= −10.3 + 1.62(natural log of girth) + 1.38(natural log of standard length).
(4) The attending veterinarian, during the monthly site visit, shall record the nutritional and reproductive status of each cetacean (i.e., whether in an active breeding program, pregnant, or nursing).
(5) The attending veterinarian shall examine water quality records and provide a written assessment, to remain at the SWTD site for at least 3 years, of the overall water quality during the preceding month. Such records shall be made available to an APHIS official upon request during inspection.
(6) In the event that a cetacean dies, complete necropsy results, including all appropriate histopathology, shall be recorded in the cetacean's individual file and shall be made available to APHIS officials during facility inspections, or as requested by APHIS. The necropsy shall be performed within 48 hours of the cetacean's death, by a veterinarian experienced in marine mammal necropsies. If the necropsy is not to be performed within 3 hours of the discovery of the cetacean's death, the cetacean shall be refrigerated until necropsy. Written results of the necropsy shall be available in the cetacean's individual file within 7 days after death for gross pathology and within 45 days after death for histopathology.
2. At 86 FR 66926, Nov. 24, 2021, § 3.111 was amended; however, the amendment could not be incorporated because the section was suspended at 64 FR 15920, Apr. 2, 1999.
(a) Carriers and intermediate handlers shall not accept any marine mammal that is presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported, and that is not accompanied by a health certificate signed by the attending veterinarian stating that the animal was examined within the prior 10 days and found to be in acceptable health for transport: Provided, however, That the carrier or intermediate handler and any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government may mutually agree to extend the time of acceptance to not more than 6 hours if specific prior scheduling of the animal shipment to destination has been made.
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any marine mammal in a primary transport enclosure that conforms to the requirements in § 3.113 of this subpart: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any marine mammal consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of an auction sale if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary transport enclosure complies with § 3.113 of this subpart, unless such primary transport enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the marine mammal without causing suffering or injury to the marine mammal. A copy of any such certificate must accompany the shipment to destination. The certificate must include at least the following information:
(1) Name and address of the consignor;
(2) The number, age, and sex of animals in the primary transport enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the—(number) primary transport enclosure(s) that are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary transport enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to maintain a temperature within the range of 7.2 °C (45 °F) to 23.9 °C (75 °F) allowed by § 3.117 of this subpart may accept for transportation or transport, in commerce, any marine mammal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by the attending veterinarian on a specified date that is not more than 10 days prior to delivery of the animal for transportation in commerce, stating that the marine mammal is acclimated to a specific air temperature range lower or higher than those prescribed in §§ 3.117 and 3.118. A copy of the certificate must accompany the shipment to destination. The certificate must include at least the following information:
(1) Name and address of the consignor;
(2) The number, age, and sex of animals in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to an air temperature range of ________”); and
(4) The signature of the attending veterinarian and the date.
(d) Carriers and intermediate handlers must attempt to notify the consignee (receiving party) at least once in every 6-hour period following the arrival of any marine mammals at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee must be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No dealer, research facility, exhibitor, or operator of an auction sale shall offer for transportation or transport, in commerce, any marine mammal in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures that are used to transport marine mammals other than cetaceans and sirenians must:
(1) Be constructed from materials of sufficient structural strength to contain the marine mammals;
(2) Be constructed from material that is durable, nontoxic, and cannot be chewed and/or swallowed;
(3) Be able to withstand the normal rigors of transportation;
(4) Have interiors that are free from any protrusions or hazardous openings that could be injurious to the marine mammals contained within;
(5) Be constructed so that no parts of the contained marine mammals are exposed to the outside of the enclosures in any way that may cause injury to the animals or to persons who are nearby or who handle the enclosures;
(6) Have openings that provide access into the enclosures and are secured with locking devices of a type that cannot be accidentally opened;
(7) Have such openings located in a manner that makes them easily accessible at all times for emergency removal and potential treatment of any live marine mammal contained within;
(8) Have air inlets at heights that will provide cross ventilation at all levels (particularly when the marine mammals are in a prone position), are located on all four sides of the enclosures, and cover not less than 20 percent of the total surface area of each side of the enclosures;
(9) Have projecting rims or other devices placed on any ends and sides of the enclosures that have ventilation openings so that there is a minimum air circulation space of 7.6 centimeters (3.0 inches) between the enclosures and any adjacent cargo or conveyance wall;
(10) Be constructed so as to provide sufficient air circulation space to maintain the temperature limits set forth in this subpart; and
(11) Be equipped with adequate handholds or other devices on the exterior of the enclosures to enable them to be lifted without unnecessary tilting and to ensure that the persons handling the enclosures will not come in contact with any marine mammal contained inside.
(b) Straps, slings, harnesses, or other devices used for body support or restraint, when transporting marine mammals such as cetaceans and sirenians must:
(1) Be designed so as not to prevent access to the marine mammals by attendants for the purpose of administering in-transit care;
(2) Be equipped with special padding to prevent trauma or injury at critical weight pressure points on the body of the marine mammals; and
(3) Be capable of keeping the animals from thrashing about and causing injury to themselves or their attendants, and yet be adequately designed so as not to cause injury to the animals.
(c) Primary enclosures used to transport marine mammals must be large enough to assure that:
(1) In the case of pinnipeds, polar bears, and sea otters, each animal has sufficient space to turn about freely in a stance whereby all four feet or flippers are on the floor and the animal can sit in an upright position and lie in a natural position;
(2) In the case of cetaceans and sirenians, each animal has sufficient space for support of its body in slings, harnesses, or other supporting devices, if used (as prescribed in paragraph (b) of this section), without causing injury to such cetaceans or sirenians due to contact with the primary transport enclosure: Provided, however, That animals may be restricted in their movements according to professionally accepted standards when such freedom of movement would constitute a danger to the animals, their handlers, or other persons.
(d) Marine mammals transported in the same primary enclosure must be of the same species and maintained in compatible groups. Marine mammals that have not reached puberty may not be transported in the same primary enclosure with adult marine mammals other than their dams. Socially dependent animals (e.g., sibling, dam, and other members of a family group) must be allowed visual and olfactory contact whenever reasonable. Female marine mammals may not be transported in the same primary enclosure with any mature male marine mammals.
(e) Primary enclosures used to transport marine mammals as provided in this section must have solid bottoms to prevent leakage in shipment and must be cleaned and sanitized in a manner prescribed in § 3.107 of this subpart, if previously used. Within the primary enclosures used to transport marine mammals, the animals will be maintained on sturdy, rigid, solid floors with adequate drainage.
(f) Primary enclosures used to transport marine mammals, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, must be clearly marked on top (when present) and on at least one side, or on all sides whenever possible, with the words “Live Animal” or “Wild Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings to indicate the correct upright position of the container.
(g) Documents accompanying the shipment must be attached in an easily accessible manner to the outside of a primary enclosure that is part of such shipment or be in the possession of the shipping attendant.
(h) When a primary transport enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening must open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening must be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh, or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live marine mammals must be constructed in a manner that will protect the health and assure the safety and comfort of the marine mammals contained within at all times. All primary conveyances used must be sufficiently temperature-controlled to provide an appropriate environmental temperature for the species involved and to provide for the safety and comfort of the marine mammal, or other appropriate safeguards (such as, but not limited to, cooling the animal with cold water, adding ice to water-filled enclosures, and use of fans) must be employed to maintain the animal at an appropriate temperature.
(b) The animal cargo space must be constructed and maintained in a manner that will prevent the ingress of engine exhaust fumes and gases in excess of that ordinarily contained in the passenger compartments.
(c) Marine mammals must only be placed in animal cargo spaces that have a supply of air sufficient for each live animal contained within. Primary transport enclosures must be positioned in the animal cargo spaces of primary conveyances in such a manner that each marine mammal contained within will have access to sufficient air.
(d) Primary transport enclosures must be positioned in primary conveyances in such a manner that, in an emergency, the live marine mammals can be removed from the conveyances as soon as possible.
(e) The interiors of animal cargo spaces in primary conveyances must be kept clean.
(f) Live marine mammals must not knowingly be transported with any material, substance, or device that may be injurious to the health and well-being of the marine mammals unless proper precaution is taken to prevent such injury.
(g) Adequate lighting must be available for marine mammal attendants to properly inspect the animals at any time. If such lighting is not provided by the carrier, provisions must be made by the shipper to supply such lighting.
(a) Those marine mammals that require drinking water must be offered potable water within 4 hours of being placed in the primary transport enclosure for transport in commerce. Marine mammals must be provided water as often as necessary and appropriate for the species involved to prevent dehydration, which would jeopardize the good health and well-being of the animals.
(b) Marine mammals being transported in commerce must be offered food as often as necessary and appropriate for the species involved or as determined by the attending veterinarian.
(a) A licensed veterinarian, employee, and/or attendant of the shipper or receiver of any marine mammal being transported, in commerce, knowledgeable and experienced in the area of marine mammal care and transport, must accompany all marine mammals during periods of transportation to provide for their good health and well-being, to observe such marine mammals to determine whether they need veterinary care, and to obtain any needed veterinary care as soon as possible. Any transport of greater than 2 hours duration requires a transport plan approved by the attending veterinarian that will include the specification of the necessity of the presence of a veterinarian during the transport. If the attending veterinarian does not accompany the animal, communication with the veterinarian must be maintained in accordance with §§ 2.33(b)(3) and 2.40(b)(3) of this chapter.
(b) The following marine mammals may be transported in commerce only when the transport of such marine mammals has been determined to be appropriate by the attending veterinarian:
(1) A pregnant animal in the last half of pregnancy;
(2) A dependent unweaned young animal;
(3) A nursing mother with young; or
(4) An animal with a medical condition requiring veterinary care, that would be compromised by transport. The attending veterinarian must note on the accompanying health certificate the existence of any of the above conditions. The attending veterinarian must also determine whether a veterinarian should accompany such marine mammals during transport.
(c) Carriers must inform the crew as to the presence of the marine mammals on board the craft, inform the individual accompanying the marine mammals of any unexpected delays as soon as they become known, and accommodate, except as precluded by safety considerations, requests by the shipper or his agent to provide access to the animals or take other necessary actions for the welfare of the animals if a delay occurs.
(d) A sufficient number of employees or attendants of the shipper or receiver of cetaceans or sirenians being transported, in commerce, must provide for such cetaceans and sirenians during periods of transport by:
(1) Keeping the skin moist or preventing the drying of the skin by such methods as intermittent spraying of water or application of a nontoxic emollient;
(2) Assuring that the pectoral flippers are allowed freedom of movement at all times;
(3) Making adjustments in the position of the marine mammals when necessary to prevent necrosis of the skin at weight pressure points;
(4) Keeping the animal cooled and/or warmed sufficiently to prevent overheating, hypothermia, or temperature related stress; and
(5) Calming the marine mammals to avoid struggling, thrashing, and other unnecessary activity that may cause overheating or physical trauma.
(e) A sufficient number of employees or attendants of the shipper or receiver of pinnipeds or polar bears being transported, in commerce, must provide for such pinnipeds and polar bears during periods of transport by:
(1) Keeping the animal cooled and/or warmed sufficiently to prevent overheating, hypothermia, or temperature related stress; and
(2) Calming the marine mammals to avoid struggling, thrashing, and other unnecessary activity that may cause overheating or physical trauma.
(f) Sea otters must be transported in primary enclosures that contain false floors through which water and waste freely pass to keep the interior of the transport unit free from waste materials. Moisture must be provided by water sprayers or ice during transport.
(g) Marine mammals may be removed from their primary transport enclosures only by the attendants or other persons capable of handling such mammals safely.
Carriers and intermediate handlers must not commingle marine mammal shipments with inanimate cargo. All animal holding areas of a terminal facility of any carrier or intermediate handler where marine mammal shipments are maintained must be cleaned and sanitized in a manner prescribed in § 3.107 of this subpart to minimize health and disease hazards. An effective program for the control of insects, ectoparasites, and avian and mammalian pests must be established and maintained for all animal holding areas. Any animal holding area containing marine mammals must be ventilated with fresh air or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning must be used for any animal holding area containing marine mammals when the air temperature within such animal holding area is 23.9 °C (75 °F) or higher. The air temperature around any marine mammal in any animal holding area must not be allowed to fall below 7.2 °C (45 °F). The air temperature around any polar bear must not be allowed to exceed 29.5 °C (85 °F) at any time and no polar bear may be subjected to surrounding air temperatures that exceed 23.9 °C (75 °F) for more than 4 hours at any time. The ambient temperature must be measured in the animal holding area upon arrival of the shipment by the attendant, carrier, or intermediate handler. The ambient temperature must be measured halfway up the outside of the primary transport enclosure at a distance from the external wall of the primary transport enclosure not to exceed 0.91 meters (3 feet).
(a) Carriers and intermediate handlers moving marine mammals from the animal holding area of the terminal facility to the primary conveyance or from the primary conveyance to the animal holding area of the terminal facility must provide the following:
(1) Movement of animals as expeditiously as possible.
(2) Shelter from overheating and direct sunlight. When sunlight is likely to cause overheating, sunburn, or discomfort, sufficient shade must be provided to protect the marine mammals. Marine mammals must not be subjected to surrounding air temperatures that exceed 23.9 °C (75 °F) unless accompanied by an acclimation certificate in accordance with § 3.112 of this subpart. The temperature must be measured and read within or immediately adjacent to the primary transport enclosure.
(3) Shelter from cold weather. Marine mammals must be provided with species appropriate protection against cold weather, and such marine mammals must not be subjected to surrounding air temperatures that fall below 7.2 °C (45 °F) unless accompanied by an acclimation certificate in accordance with § 3.112 of this subpart. The temperature must be measured and read within or immediately adjacent to the primary transport enclosure.
(b) Care must be exercised to avoid handling of the primary transport enclosure in a manner that may cause physical harm or distress to the marine mammal contained within.
(c) Enclosures used to transport any marine mammal must not be tossed, dropped, or needlessly tilted and must not be stacked unless properly secured.
(a) Structural strength. The facility must be constructed of such material and of such strength as appropriate for the animals involved. The indoor and outdoor housing facilities shall be structurally sound and shall be maintained in good repair to protect the animals from injury and to contain the animals.
(b) Water and power. Reliable and adequate electric power, if required to comply with other provisions of this subpart, and adequate potable water shall be available on the premises.
(c) Storage. Supplies of food and bedding shall be stored in facilities which adequately protect such supplies against deterioration, molding, or contamination by vermin. Refrigeration shall be provided for supplies of perishable food.
(d) Waste disposal. Provision shall be made for the removal and disposal of animal and food wastes, bedding, dead animals, trash and debris. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, and disease hazards. The disposal facilities and any disposal of animal and food wastes, bedding, dead animals, trash, and debris shall comply with applicable Federal, State, and local laws and regulations relating to pollution control or the protection of the environment.
(e) Washroom and sinks. Facilities, such as washrooms, basins, showers, or sinks, shall be provided to maintain cleanliness among animal caretakers.
(a) Ambient temperatures. Temperature in indoor housing facilities shall be sufficiently regulated by heating or cooling to protect the animals from the extremes of temperature, to provide for their health and to prevent their discomfort. The ambient temperature shall not be allowed to fall below nor rise above temperatures compatible with the health and comfort of the animal.
(b) Ventilation. Indoor housing facilities shall be adequately ventilated by natural or mechanical means to provide for the health and to prevent discomfort of the animals at all times. Such facilities shall be provided with fresh air either by means of windows, doors, vents, fans, or air-conditioning and shall be ventilated so as to minimize drafts, odors, and moisture condensation.
(c) Lighting. Indoor housing facilities shall have ample lighting, by natural or artificial means, or both, of good quality, distribution, and duration as appropriate for the species involved. Such lighting shall be uniformly distributed and of sufficient intensity to permit routine inspection and cleaning. Lighting of primary enclosures shall be designed to protect the animals from excessive illumination.
(d) Drainage. A suitable sanitary method shall be provided to eliminate rapidly, excess water from indoor housing facilities. If drains are used, they shall be properly constructed and kept in good repair to avoid foul odors and installed so as to prevent any backup of sewage. The method of drainage shall comply with applicable Federal, State, and local laws and regulations relating to pollution control or the protection of the environment.
(a) Shelter from sunlight. When sunlight is likely to cause overheating or discomfort of the animals, sufficient shade by natural or artificial means shall be provided to allow all animals kept outdoors to protect themselves from direct sunlight.
(b) Shelter from inclement weather. Natural or artificial shelter appropriate to the local climatic conditions for the species concerned shall be provided for all animals kept outdoors to afford them protection and to prevent discomfort to such animals. Individual animals shall be acclimated before they are exposed to the extremes of the individual climate.
(c) Drainage. A suitable method shall be provided to rapidly eliminate excess water. The method of drainage shall comply with applicable Federal, State, and local laws and regulations relating to pollution control or the protection of the environment.
(d) Perimeter fence. On or after May 17, 2000, all outdoor housing facilities (i.e., facilities not entirely indoors) must be enclosed by a perimeter fence that is of sufficient height to keep animals and unauthorized persons out. Fences less than 8 feet high for potentially dangerous animals, such as, but not limited to, large felines (e.g., lions, tigers, leopards, cougars, etc.), bears, wolves, rhinoceros, and elephants, or less than 6 feet high for other animals must be approved in writing by the Administrator. The fence must be constructed so that it protects the animals in the facility by restricting animals and unauthorized persons from going through it or under it and having contact with the animals in the facility, and so that it can function as a secondary containment system for the animals in the facility. It must be of sufficient distance from the outside of the primary enclosure to prevent physical contact between animals inside the enclosure and animals or persons outside the perimeter fence. Such fences less than 3 feet in distance from the primary enclosure must be approved in writing by the Administrator. A perimeter fence is not required:
(1) Where the outside walls of the primary enclosure are made of sturdy, durable material, which may include certain types of concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(2) Where the outdoor housing facility is protected by an effective natural barrier that restricts the animals to the facility and restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(3) Where appropriate alternative security measures are employed and the Administrator gives written approval; or
(4) For traveling facilities where appropriate alternative security measures are employed; or
(5) Where the outdoor housing facility houses only domesticated farm-type animals, such as, but not limited to, cows, sheep, goats, pigs, horses (for regulated purposes), or donkeys, and the facility has in place effective and customary containment and security measures.
Enclosures shall be constructed and maintained so as to provide sufficient space to allow each animal to make normal postural and social adjustments with adequate freedom of movement. Inadequate space may be indicated by evidence of malnutrition, poor condition, debility, stress, or abnormal behavior patterns.
(a) The food shall be wholesome, palatable, and free from contamination and of sufficient quantity and nutritive value to maintain all animals in good health. The diet shall be prepared with consideration for the age, species, condition, size, and type of the animal. Animals shall be fed at least once a day except as dictated by hibernation, veterinary treatment, normal fasts, or other professionally accepted practices.
(b) Food, and food receptacles, if used, shall be sufficient in quantity and located so as to be accessible to all animals in the enclosure and shall be placed so as to minimize contamination. Food receptacles shall be kept clean and sanitary at all times. If self-feeders are used, adequate measures shall be taken to prevent molding, contamination, and deterioration or caking of food.
If potable water is not accessible to the animals at all times, it must be provided as often as necessary for the health and comfort of the animal. Frequency of watering shall consider age, species, condition, size, and type of the animal. All water receptacles shall be kept clean and sanitary.
(a) Cleaning of enclosures. Excreta shall be removed from primary enclosures as often as necessary to prevent contamination of the animals contained therein and to minimize disease hazards and to reduce odors. When enclosures are cleaned by hosing or flushing, adequate measures shall be taken to protect the animals confined in such enclosures from being directly sprayed with the stream of water or wetted involuntarily.
(b) Sanitation of enclosures. Subsequent to the presence of an animal with an infectious or transmissible disease, cages, rooms, and hard-surfaced pens or runs shall be sanitized either by washing them with hot water (180 F. at source) and soap or detergent, as in a mechanical washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with saturated live steam under pressure. Pens or runs using gravel, sand, or dirt, shall be sanitized when necessary as directed by the attending veterinarian.
(c) Housekeeping. Premises (buildings and grounds) shall be kept clean and in good repair in order to protect the animals from injury and to facilitate the prescribed husbandry practices set forth in this subpart. Accumulations of trash shall be placed in designated areas and cleared as necessary to protect the health of the animals.
(d) Pest control. A safe and effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained.
A sufficient number of adequately trained employees shall be utilized to maintain the professionally acceptable level of husbandry practices set forth in this subpart. Such practices shall be under a supervisor who has a background in animal care.
Animals housed in the same primary enclosure must be compatible. Animals shall not be housed near animals that interfere with their health or cause them discomfort.
(a) Carriers and intermediate handlers shall not accept any live animals presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported: Provided, however, That the carrier or intermediate handler and any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government may mutually agree to extend the time of acceptance to not more than 6 hours if specific prior scheduling of the animal shipment to destination has been made.
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live animal in a primary enclosure which conforms to the requirements set forth in § 3.137 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live animal consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of an auction sale if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with § 3.137 of the standards, unless such primary enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the live animal without causing suffering or injury to such live animal. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of animals in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the ____ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live animal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such animal for transportation in commerce, stating that such live animal is acclimated to air temperatures lower than those prescribed in §§ 3.141 and 3.142. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of animals in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.)”); and
(4) The signature of the USDA accredited veterinarian, assigned accreditation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live animals at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No dealer, research facility, exhibitor, or operator of an auction sale shall offer for transportation or transport, in commerce, any live animal in a primary enclosure which does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or crates, used to transport live animals shall be constructed in such a manner that (1) the structural strength of the enclosure shall be sufficient to contain the live animals and to withstand the normal rigors of transportation; (2) the interior of the enclosure shall be free from any protrusions that could be injurious to the live animals contained therein; (3) the openings of such enclosures are easily accessible at all times for emergency removal of the live animals; (4) except as provided in paragraph (g) of this section, there are ventilation openings located on two opposite walls of the primary enclosure and the ventilation openings on each such wall shall be at least 16 percent of the total surface area of each such wall, or there are ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each such wall shall be at least 8 percent of the total surface area of each such wall: Provided, however, That at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the lower one-half of the primary enclosure and at least one-third of the total minimum area required for ventilation of the primary enclosure shall be located on the upper one-half of the primary enclosure; (5) except as provided in paragraph (g) of this section, projecting rims or other devices shall be on the exterior of the outside walls with any ventilation openings to prevent obstruction of the ventilation openings and to provide a minimum air circulation space of 1.9 centimeters (.75 inch) between the primary enclosure and any adjacent cargo or conveyance wall; and (6) except as provided in paragraph (g) of this section, adequate handholds or other devices for lifting shall be provided on the exterior of the primary enclosure to enable the primary enclosure to be lifted without tilting and to ensure that the person handling the primary enclosure will not be in contact with the animal.
(b) Live animals transported in the same primary enclosure shall be of the same species and maintained in compatible groups. Live animals that have not reached puberty shall not be transported in the same primary enclosure with adult animals other than their dams. Socially dependent animals (e.g., sibling, dam, and other members of a family group) must be allowed visual and olfactory contact. Any female animal in season (estrus) shall not be transported in the same primary enclosure with any male animal.
(c) Primary enclosures used to transport live animals shall be large enough to ensure that each animal contained therein has sufficient space to turn about freely and to make normal postural adjustments: Provided, however, That certain species may be restricted in their movements according to professionally acceptable standards when such freedom of movement would constitute a danger to the animals, their handlers, or other persons.
(d) Primary enclosures used to transport live animals as provided in this section shall have solid bottoms to prevent leakage in shipment and still be cleaned and sanitized in a manner prescribed in § 3.131 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbent material, which is safe and nontoxic to the live animals contained therein, in sufficient quantity to absorb and cover excreta, unless the animals are on wire or other nonsolid floors.
(e) Primary enclosures used to transport live animals, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animal” or “Wild Animal”, whichever is appropriate, in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings to indicate the correct upright position of the container.
(f) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(g) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live animals shall be designed and constructed to protect the health, and ensure the safety and comfort of the live animals contained therein at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live animal shall be placed in an animal cargo space that does not have a supply of air sufficient for normal breathing for each live animal contained therein, and the primary enclosures shall be positioned in the animal cargo space in such a manner that each live animal has access to sufficient air for normal breathing.
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live animals can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live animals shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the animals unless proper precaution is taken to prevent such injury.
(a) All live animals shall be offered potable water within 4 hours prior to being transported in commerce. Dealers, exhibitors, research facilities and operators of auction sales shall provide potable water to all live animals transported in their own primary conveyance at least every 12 hours after such transportation is initiated, and carriers and intermediate handlers shall provide potable water to all live animals at least every 12 hours after acceptance for transportation in commerce: Provided, however, That except as directed by hibernation, veterinary treatment or other professionally accepted practices, those live animals which, by common accepted practices, require watering more frequently shall be so watered.
(b) Each live animal shall be fed at least once in each 24 hour period, except as directed by hibernation, veterinary treatment, normal fasts, or other professionally accepted practices. Those live animals which, by common accepted practice, require feeding more frequently shall be so fed.
(c) A sufficient quantity of food and water shall accompany the live animal to provide food and water for such animals for a period of at least 24 hours, except as directed by hibernation, veterinary treatment, normal fasts, and other professionally accepted practices.
(d) Any dealer, research facility, exhibitor or operator of an auction sale offering any live animal to any carrier or intermediate handler for transportation in commerce shall affix to the outside of the primary enclosure used for transporting such live animal, written instructions concerning the food and water requirements of such animal while being so transported.
(e) No carrier or intermediate handler shall accept any live animals for transportation in commerce unless written instructions concerning the food and water requirements of such animal while being so transported is affixed to the outside of its primary enclosure.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live animals as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live animals are in obvious physical distress and to provide any needed veterinary care as soon as possible. When transported by air, live animals shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the animal cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live animals whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live animals are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No animal in obvious physical distress shall be transported in commerce.
(b) Wild or otherwise dangerous animals shall not be taken from their primary enclosure except under extreme emergency conditions: Provided, however, That a temporary primary enclosure may be used, if available, and such temporary primary enclosure is structurally strong enough to prevent the escape of the animal. During the course of transportation, in commerce, live animals shall not be removed from their primary enclosures unless placed in other primary enclosures or facilities conforming to the requirements provided in this subpart.
Carriers and intermediate handlers shall not commingle live animal shipments with inanimate cargo. All animal holding areas of a terminal facility of any carrier or intermediate handler wherein live animal shipments are maintained shall be cleaned and sanitized in a manner prescribed in § 3.141 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live animals shall be provided with fresh air by means of windows, doors vents, or air conditioning and may be ventilated or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning shall be used for any animal holding area containing live animals when the air temperature within such animal holding area is 23.9 °C. (75.°F.) or higher. The air temperature around any live animal in any animal holding area shall not be allowed to fall below 7.2 °C. (45 °F.) nor be allowed to exceed 29.5 °C. (85 °F.) at any time: Provided, however, That no live animal shall be subjected to surrounding air temperatures which exceed 23.9 °C. (75 °F.) for more than 4 hours at any time. To ascertain compliance with the provisions of this paragraph, the air temperature around any live animal shall be measured and read outside the primary enclosure which contains such animal at a distance not to exceed .91 meters (3 feet) from any one of the external walls of the primary enclosure and on a level parallel to the bottom of such primary enclosure at a point which approximates half the distance between the top and bottom of such primary enclosure.
(a) Carriers and intermediate handlers shall move live animals from the animal holding area of the terminal facility to the primary conveyance and from the primary conveyance to the animal holding area of the terminal facility as expeditiously as possible. Carriers and intermediate handlers holding any live animal in an animal holding area of a terminal facility or in transporting any live animal from the animal holding area of the terminal facility to the primary conveyance and from the primary conveyance to the animal holding area of the terminal facility, including loading and unloading procedures, shall provide the following:
(1) Shelter from sunlight. When sunlight is likely to cause overheating or discomfort, sufficient shade shall be provided to protect the live animals from the direct rays of the sun and such live animals shall not be subjected to surrounding air temperatures which exceed 29.5 °C. (85 °F), and which shall be measured and read in the manner prescribed in § 3.141 of this part, for a period of more than 45 minutes.
(2) Shelter from rain or snow. Live animals shall be provided protection to allow them to remain dry during rain or snow.
(3) Shelter from cold weather. Transporting devices shall be covered to provide protection for live animals when the outdoor air temperature falls below 10 °C. (50 °F) and such live animals shall not be subjected to surrounding air temperatures which fall below 7.2 °C. (45 °F.), and which shall be measured and read in the manner prescribed in § 3.141 of this part, for a period of more than 45 minutes unless such animals are accompanied by a certificate of acclimation to lower temperatures as prescribed in § 3.136(c).
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live animal contained therein.
(c) Primary enclosures used to transport any live animal shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
(a) Structure; construction. Housing facilities for birds must be designed and constructed so that they are structurally sound for the species of bird housed in them. They must be kept in good repair, protect the birds from injury, and restrict other animals from entering that may negatively affect the welfare of the birds within. Housing facilities must employ security measures that contain all birds securely. Such measures may include safety doors, entry/exit doors to the primary enclosure that are double-door, or other equivalent systems designed to prevent escape of the birds. Birds that are flight-restricted or cannot fly and are allowed to roam free within the housing facility or a portion thereof must have access to safety pens, enclosures, or other areas that offer the birds protection during overnight periods and at times when their activities are not monitored.
(b) Condition and site. Housing facilities and areas used for storing animal food or bedding must be free of any accumulation of trash, waste material, other discarded materials, junk, weeds, and brush. Housing facilities must be kept neat and free of clutter, including equipment, furniture, and stored material, but may contain materials actually used and necessary for cleaning the area, and fixtures or equipment necessary for proper husbandry practices or research needs.
(c) Surfaces. The surfaces of housing facilities must be constructed in a manner and made of materials that allow them to be readily cleaned and/or sanitized, or removed and replaced when worn or soiled. Interior surfaces and surfaces that come in contact with birds must be:
(1) Nontoxic to the bird;
(2) Free of rust or damage that affects the structural integrity of the surface or prevents cleaning; and
(3) Free of jagged edges or sharp points that could injure the birds.
(d) Water and electric power. The facility must have reliable electrical power adequate for heating, cooling, ventilation, and lighting, if necessary, or for carrying out other husbandry requirements in accordance with the regulations in this subpart. The facility must provide adequate potable water for the birds' drinking needs and water for cleaning and for carrying out other husbandry requirements in accordance with the regulations in this subpart.
(e) Storage. Supplies of food, including food supplements, bedding, and substrate must be stored in a manner that protects the supplies from deterioration, spoilage (harmful microbial growth), contamination, and vermin infestation. The supplies must be stored off the floor and away from the walls, to allow cleaning underneath and around the supplies. All food must be stored in a manner that prevents deterioration of its nutritive value. Live food must be maintained in a manner to ensure wholesomeness. Substances such as cleaning supplies and disinfectants that are harmful to the birds but that are required for normal husbandry practices must not be stored in food storage and preparation areas but may be stored in cabinets in the animal areas, provided that they are stored in properly labeled containers that are adequately secured to prevent potential harm to the birds. Animal waste and dead animals and animal parts not intended for food must not be kept in food storage or food preparation areas, food freezers, food refrigerators, and animal areas.
(f) Waste disposal. Housing facility operators must provide for regular and frequent collection, removal, and disposal of animal and food wastes, substrate, dead animals, debris, garbage, water, and any other fluids and wastes, in a manner that minimizes contamination and disease risk. Trash containers in housing facilities and in food storage and preparation areas must be able to contain trash securely to minimize odors and be inaccessible to animals and pests.
(g) Drainage. Housing facilities must be equipped with disposal and drainage systems that are constructed and operated so that animal wastes and water, except for water located in pools or other aquatic areas (e.g., ponds, waterfalls, fountains, and other water features), are rapidly eliminated so the animals have the option of remaining dry. Pools and other aquatic areas must be maintained in accordance with the regulations in § 3.157. Disposal and drainage systems must minimize vermin and pest infestation, insects, odors, and disease hazards. All drains must be properly constructed, installed, and maintained so that they effectively drain water. If closed drainage systems are used, they must be equipped with traps and prevent the backflow of gases and the backup of sewage. If the facility uses sump ponds, settlement ponds, or other similar systems for drainage and animal waste disposal, the system must be located a sufficient distance from the bird area of the housing facility to prevent odors, diseases, insects, pests, and vermin infestation in the bird area. If drip or constant flow watering devices are used to provide water to the animals, excess water must be rapidly drained out of the animal areas by gutters, pipes, or other methods so that the animals have the option of remaining dry.
(h) Toilets, washrooms, and sinks. Toilets and washing facilities such as washrooms, basins, sinks, or showers must be provided for animal caretakers and must be readily accessible.
(a) Temperature and humidity. The air temperature and, if present, pool or other aquatic area (e.g., ponds, waterfalls, fountains, and other water features), and air humidity levels in indoor facilities must be sufficiently regulated and appropriate to bird species to protect the birds from detrimental temperature and humidity levels, to provide for their health and well-being, and to prevent discomfort or distress, in accordance with current professionally accepted standards.
(b) Ventilation. Indoor housing facilities must be sufficiently ventilated at all times when birds are present to provide for their health, to prevent their discomfort or distress, and to minimize accumulations of moisture condensation, odors, and levels of ammonia, chlorine, and other noxious gases. The ventilation system must minimize drafts.
(c) Lighting. Indoor housing facilities must have lighting, by natural or artificial means, or both, of appropriate quality, distribution, and duration for the species of birds involved. Such lighting must be sufficient to permit routine inspection and cleaning. Lighting of primary enclosures must be designed to protect the birds from excessive illumination that may cause discomfort or distress.
(d) Indoor pool or other aquatic areas. Indoor pools or other aquatic areas (e.g., ponds, waterfalls, fountains, and other water features) must have sufficient vertical air space above the pool or other aquatic area to allow for behaviors typical to the species of bird under consideration. Such behaviors may include, but are not limited to, diving and swimming.
(a) Acclimation. Birds may not be housed in outdoor facilities unless the air humidity and temperature ranges and, if applicable, pool or other aquatic area (e.g., ponds, waterfalls, fountains, and other water features) temperature ranges do not adversely affect bird health and comfort. Birds may not be introduced to an outdoor housing facility until they are acclimated to the ambient temperature and humidity and, if applicable, pool or other aquatic area temperature range which they will encounter therein.
(b) Shelter from inclement weather. Outdoor housing facilities must provide adequate shelter, appropriate to the species and physical condition of the birds, for the local climatic conditions to protect the birds from any adverse weather conditions. Shelters must be adequately ventilated in hot weather and have one or more separate areas of shade or other effective protection that is large enough to comfortably contain all the birds at one time and prevent their discomfort from direct sunlight, precipitation, or wind. Shelter must also be constructed to provide sufficient space to comfortably hold all of the birds at the same time without adverse intraspecific aggression or grouping of incompatible birds. For birds that form dominance hierarchies and that are maintained in social groupings, shelter(s) must be constructed so as to provide sufficient space to comfortably hold all the birds at the same time, including birds that are low in the hierarchy.
(a) General requirements. Primary enclosures must be designed and constructed of suitable materials so that they are structurally sound. The primary enclosures must be kept in good repair.
(1) Primary enclosures must be constructed and maintained so that they:
(i) Have no sharp points or edges that could injure the birds;
(ii) Protect the birds from injury;
(iii) Contain the birds securely;
(iv) Restrict other animals from entering the enclosure;
(v) Ensure that birds have the option to remain dry and clean;
(vi) Provide shelter and protection for each bird from climatic and environmental conditions that may be detrimental to its health and well-being;
(vii) Provide sufficient shade to comfortably shelter all birds housed in the primary enclosure at one time, including low ranking birds that are maintained in social groupings that form dominance hierarchies;
(viii) Provide all the birds with easy and convenient access to clean food and potable water;
(ix) Ensure that all surfaces in contact with the birds may be readily cleaned and/or sanitized in accordance with § 3.158 or be replaced when worn or soiled; and
(x) Have floors that are constructed in a manner that protects the birds' feet and legs from injury. If flooring material is suspended, it must be sufficiently taut to prevent excessive sagging under the bird's weight. If substrate is used in the primary enclosure, the substrate must be clean and made of a suitably absorbent material that is safe and nontoxic to the birds.
(2) Furniture-type objects, such as perches and other objects that enrich a bird's environment, must be species-appropriate and be designed, constructed, and maintained so as to prevent harm to the bird. If the enclosure houses birds that rest by perching, there must be perches available that are appropriate to the age and species of birds housed therein and a sufficient number of perches of appropriate size, shape, strength, texture, and placement to comfortably hold all the birds in the primary enclosure at the same time, including birds that are ranked low in a dominance hierarchy.
(3) Primary enclosures that are adjacent to one another or that share a common side with another enclosure must be suitably screened from each other or kept at a sufficient distance apart in order to prevent injury of the occupants due to predation, territorial disputes, or aggression.
(b) Space requirements. Primary enclosures must be constructed and maintained so as to allow each bird to make normal postural and social adjustments, such as dust-bathing and foraging, with adequate freedom of movement and freedom to escape from aggression demonstrated by other animals. Both part-time and full-time attending veterinarians at a facility must consult with the facility to ensure that the space in all enclosures housing birds is adequate and allows for normal postural and social adjustments. Inadequate space may be indicated by evidence of malnutrition, poor condition, debility, stress, or abnormal behavior patterns. The normal postural and social adjustments of a bird may be restricted:
(1) When the attending veterinarian determines that making species-typical postural or social adjustments, such as dust-bathing, foraging, or running, would be detrimental to the bird's good health and well-being. The attending veterinarian must document the reason and recommended duration for the restriction and make such records available for review by an APHIS inspector.
(2) When the birds are tethered in accordance with current professionally accepted standards. Birds must not be tethered unless:
(i) It is appropriate for the species of bird;
(ii) It will not cause harm to the birds;
(iii) The birds are maintained on perches appropriate for the species and age of the bird while tethered;
(iv) The birds have sufficient space to fully extend their wings without obstruction; and
(v) The tether does not entangle the birds.
(3) When dealers, exhibitors, and research facilities breed or intend to breed their birds, such birds must be provided with structures and/or materials that meet the reproductive needs of the species during the appropriate season or time periods. A sufficient number of structures and materials must be provided to meet the needs of all breeding birds in an enclosure and to minimize aggression.
(4) Birds intended for breeding, sale, in need of medical care, exhibited in traveling exhibits, or traveling for other reasons must be kept in enclosures that, at minimum, meet the individual specific space, safety, bedding, perch, and physical environment (including, but not limited to, temperature, humidity, sun and wind exposure) requirements for transport enclosures as specified in § 3.162. At all other times, birds must be housed in enclosures that meet the space requirements of this section.
(c) Special space requirements for wading and aquatic birds. Primary enclosures housing wading and aquatic birds must contain a pool or other aquatic area (e.g., ponds, waterfalls, fountains, and other water features) and a dry area that allows easy ingress or egress of the pool or other aquatic area. Pools and other aquatic areas must be of sufficient surface area and depth to allow each bird to make normal postural and social adjustments, such as immersion, bathing, swimming, and foraging, with adequate freedom of movement and freedom to escape from aggression demonstrated by other birds in the enclosure. Dry areas must be of sufficient size to allow each bird to make normal postural and social adjustments with adequate freedom of movement and freedom to escape from aggression demonstrated by other birds in the enclosure. Inadequate space may be indicated by evidence of malnutrition, poor condition, debility, stress, or abnormal behavior patterns.
Dealers, exhibitors, and research facilities must develop, document, and follow a species-appropriate plan for environment enhancement adequate to promote the psychological well-being of birds. The plan must be approved by the attending veterinarian and must be in accordance with the regulations in this subpart and with currently accepted professional standards as cited in appropriate professional journals or reference guides. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following:
(a) Social grouping. The environment enhancement plan must include specific provisions to address the social needs of species of birds known to exist in social groups in nature. Such specific provisions must be in accordance with currently accepted professional standards as cited in appropriate professional journals or reference guides. The plan may provide for the following exceptions:
(1) If a bird exhibits vicious or overly aggressive behavior, or is debilitated as a result of age or other conditions (e.g., arthritis), it can be housed separately;
(2) Additionally, birds that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony as directed by the attending veterinarian. When an entire group or room of birds is known to have been or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control.
(3) Birds may not be housed with other species of birds or animals unless they are compatible, do not prevent access to food, water, or shelter by individual animals, and are not known to be hazardous to the health and well-being of each other. Compatibility of birds must be determined in accordance with generally accepted professional practices and actual observations as directed by the attending veterinarian, to ensure that the birds are in fact compatible. Individually housed social species of birds must be able to see and hear birds of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being. If individually housed social species of birds are unable to see and hear birds of their own or compatible species then special attention regarding enhancement to their environment must be provided as specified in paragraph (c)(4) of this section.
(b) Environmental enrichment. The physical environment in the primary enclosures must be enriched by materials or activities that would provide the birds with the means to express noninjurious species-typical activities. Species differences should be considered when determining the type or methods of enrichment. Examples of environmental enrichments include providing perches, swings, mirrors, and other increased cage complexities; providing objects to manipulate; varied food items; using foraging or task-oriented feeding methods; and providing interaction with the care giver or other familiar and knowledgeable person consistent with personnel safety precautions.
(c) Special considerations. Certain birds must be provided special attention regarding enhancement of their environment, based on the needs of the individual species and/or individual bird and in accordance with the instructions of the attending veterinarian. Birds requiring special attention are the following:
(1) Nestlings, chicks, or fledglings;
(2) Those that show signs of being in psychological distress through behavior or appearance;
(3) Those used in research for which the Institutional Animal Care and Use Committee (IACUC)-approved protocol requires restricted activity; and
(4) Individually housed social species of birds that are unable to see and hear birds of their own or compatible species.
(d) Restraint devices. Birds must not be permitted to be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the IACUC at research facilities. Any restraining actions must be for the shortest period possible. If the bird is to be restrained for more than 12 hours, it must be provided the opportunity daily for unrestrained activity for at least 1 continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the IACUC at research facilities.
(e) Exemptions. (1) The attending veterinarian may exempt an individual bird from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted bird. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian.
(2) For a research facility, the IACUC may exempt an individual bird from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the IACUC, but not less than annually.
(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility for at least 1 year in accordance with § 3.81(e)(3) and must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency.
(a) The diet for birds must be appropriate for the species, size, age, and condition of the bird. The food must be wholesome, palatable to the birds, and free of contamination. It must be of sufficient quantity and nutritive value to maintain a healthy condition and weight range of the bird and to meet its normal daily nutritional requirements. Birds must be fed at least once a day except as directed by the attending veterinarian, normal fasts, or other professionally accepted practices. If birds are maintained in group housing, measures appropriate for the species must be taken to ensure that all the birds receive a sufficient quantity of food.
(b) Food and, if used, food receptacles must be readily accessible to all the birds being fed. Food and any food receptacles must be located so as to minimize any risk of contamination by excreta, precipitation, and pests. Food receptacles and feeding areas must be kept clean and sanitized in accordance with § 3.158. Used food receptacles must be cleaned and sanitized before they can be used to provide food to birds maintained in a separate enclosure. Measures must be taken to ensure there is no molding, deterioration, contamination, or caking or undesirable wetting or freezing of food within or on food receptacles. Food receptacles must be made of a durable material that can be easily cleaned and sanitized or be replaceable when worn or soiled. Group-housed birds must have multiple food receptacles where needed to ensure that all birds have access to sufficient feed.
Potable water must be provided in sufficient quantity to every bird housed at the facility, unless restricted by the attending veterinarian. If potable water is not continually available to the birds, it must be offered to them as often as necessary to ensure their health and well-being. Water receptacles must be kept clean and sanitized in accordance with § 3.158 as often as necessary to keep them clean and free of contamination. Used water receptacles must be cleaned and sanitized before they may be used to provide water to birds maintained in a separate enclosure. Group-housed birds must have multiple water receptacles where needed to ensure that all birds have access to sufficient water.
(a) The primary enclosure or any other area in which birds may enter must not contain pools or other aquatic areas (e.g., ponds, waterfalls, fountains, and other water features) that are detrimental to the health of the birds contained therein.
(1) Particulate animal and food waste, trash, or debris that enters the pool or other aquatic area must be removed as often as necessary to maintain the required water quality and minimize health hazards to the birds.
(2) Pools or other aquatic areas with drainage systems must provide adequate drainage and must be located so that all of the water contained in such pools or other aquatic areas may be effectively eliminated when necessary for cleaning the pool or other aquatic area or for other purposes. Pools or other aquatic areas without drainage systems must be aerated and have an incoming flow of fresh water or be managed in a manner that maintains appropriate water quality in accordance with current professionally accepted standards appropriate for the species.
(b) When the water is chemically treated, the chemicals must be added in a manner that does not cause harm, discomfort, or distress to the animals. Should birds appear to be harmed by water quality, appropriate action must be taken immediately.
(c) Pools and other aquatic areas must be salinized for birds that require such water for their good health and well-being in accordance with current professionally accepted standards.
(a) Cleaning. (1) Excreta and food waste must be removed from primary enclosures and from under and around primary enclosures as often as necessary to prevent excessive accumulation of feces and food waste, to prevent soiling of the birds contained in the primary enclosures, and to reduce disease hazards, insects, pests, and odors. When steam or water is used to clean primary enclosures, measures must be taken to protect birds from being harmed, wetted involuntarily, or distressed in the process. Standing water, except for such water in pools or other aquatic areas (e.g., ponds, waterfalls, fountains, and other water features), must be removed from the primary enclosure.
(2) Scheduled cleaning may be modified or delayed during breeding, egg-sitting, or feeding of chicks for birds that are easily disrupted during such behaviors. Scheduled cleaning must resume when such cleaning no longer disrupts breeding, egg-sitting, or feeding of chicks. A schedule of cleaning must be documented and must include when breeding season began, when the primary enclosure was last cleaned, and when cleaning is expected to resume. Such records must be available for review by an APHIS inspector.
(b) Sanitization. (1) Primary enclosures and food and water receptacles for birds must be sanitized as often as necessary to prevent accumulation of dirt, debris, food waste, excreta, and other disease hazards. Provided, however, that sanitization may be modified or delayed during breeding, egg-sitting, or feeding of chicks for those birds that are easily disrupted during such behaviors. Sanitization must resume when such activity no longer disrupts breeding, egg-sitting, or feeding of chicks. A schedule of sanitization must be documented that includes when breeding season began, when the primary enclosure was last sanitized, and when sanitization is expected to resume. Such records must be available for review by an APHIS inspector.
(2) The hard surfaces of primary enclosures and food and water areas and equipment must be sanitized before a new bird is brought into a housing facility or if there is evidence of infectious disease among the birds in the housing facility.
(3) Primary enclosures using materials that cannot be sanitized using conventional methods, such as gravel, sand, grass, earth, planted areas, or absorbent bedding, must be sanitized by removing all contaminated material as necessary or by establishing a natural composting and decomposition system that is sufficient to prevent wasted food accumulation, odors, disease, pests, insects, and vermin infestation.
(c) Housekeeping for premises. Premises where housing facilities are located, including buildings, surrounding grounds, and exhibit areas, must be kept clean and in good repair in order to protect the birds from injury and disease, to facilitate the husbandry practices required in this subpart, and to reduce or eliminate breeding and living areas for rodents, pests, and vermin. Premises must be kept free of accumulations of trash, junk, waste products, and discarded matter. Weeds, grasses, and bushes must be controlled so as to facilitate cleaning of the premises and pest control, and to protect the health and well-being of the birds.
(d) Pest control. A safe and effective program for the control of insects, ectoparasites, and avian and mammalian pests must be established and maintained so as to promote the health and well-being of the birds and reduce contamination by pests in animal areas. Insecticides, chemical agents, or other pest control products that may be harmful to the birds must not be applied to primary enclosures and other bird contact surfaces unless the application is consistent with manufacturer recommendations or otherwise approved for use and does not harm birds.
A sufficient number of adequately trained employees or attendants must be utilized to maintain the professionally acceptable level of husbandry and handling practices set forth in this subpart. Such practices must be conducted under the supervision of a bird caretaker who has appropriate experience in the husbandry and care of birds that are being managed in a given setting.
(a) Socially dependent birds, such as clutch-mates, must be housed in social groups, except where the attending veterinarian exempts an individual bird because of its health or condition, or in consideration of its well-being, or for specific management needs, or where such social grouping is not in accordance with a research proposal and the proposal has been approved by the research facility IACUC.
(b) Birds may not be housed with other animals, including members of their own species, unless they are compatible, do not prevent access to food, water, or shelter by individual animals, and are not known to be hazardous to the health and well-being of each other. Compatibility must be determined in accordance with generally accepted professional practices and by actual observations to ensure that the birds are, in fact, compatible.
(c) Birds that have or are suspected of having a contagious disease or communicable condition must be separated from healthy animals that are susceptible to the disease as directed by the attending veterinarian.
(a) Carriers and intermediate handlers must not accept a live bird for transport in commerce more than 4 hours before the scheduled departure time of the primary conveyance on which the animal is to be transported. However, a carrier or intermediate handler may agree with anyone consigning a bird to extend this time by up to 2 hours if specific prior scheduling of the animal shipment to a destination has been made, provided that the extension is not detrimental to the health and well-being of the bird as determined by the consignor.
(b) Carriers and intermediate handlers must not accept a live bird for transport in commerce unless they are provided with the name, address, and telephone number of the consignee.
(c) Carriers and intermediate handlers must not accept a live weaned bird for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the bird was offered food and water during the 4 hours prior to delivery to the carrier or intermediate handler; provision for unweaned birds is made in paragraph (g) of this section. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easy to notice and read. The certification must include the following information for each live bird:
(1) The consignor's name, address, telephone number, and email address;
(2) The number of birds;
(3) The species or common names of the birds;
(4) The time and date the bird was last fed and watered and the specific instructions for the next feeding(s) and watering(s) for a 24-hour period; and
(5) The consignor's signature and the date and time the certification was signed.
(d) Carriers and intermediate handlers must not accept a live bird for transport in commerce unless the primary enclosure in which the birds are contained meets the requirements of § 3.162. A carrier or intermediate handler must not accept a live bird for transport if the primary enclosure is defective or damaged and cannot be expected to contain the bird safely and comfortably.
(e) Carriers and intermediate handlers shall not accept a live bird for transport in commerce unless their animal holding area maintains climatic and environmental conditions in accordance with the requirements of § 3.168.
(f) Carriers and intermediate handlers must attempt to notify the consignee at least once in every 6-hour period following the arrival of any live birds at the bird holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee must be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the bird shipment. If delays will cause the shipment to arrive more than 12 hours later than its originally scheduled arrival, the carrier or intermediate handler must contact the consignor or the consignee to notify them of the delay of the live shipment and to determine the necessity or methods to supply fresh food, water, or moisture-providing foods.
(g) Carriers and intermediate handlers must not accept unweaned birds for transport unless transport instructions to ensure the health and well-being of the birds are specified and written by the attending veterinarian, and signed within 10 days of shipment.
Any person subject to the Animal Welfare regulations (this part and parts 1 and 2 of this subchapter) must not transport or deliver for transport in commerce a bird unless the following requirements are met:
(a) Construction of primary enclosures. The bird must be contained in a primary enclosure such as a compartment, transport cage, carton, or crate. Primary enclosures used to transport birds must be constructed so that:
(1) The primary enclosure is strong enough to contain the bird securely and comfortably and to withstand the normal rigors of transportation;
(2) The interior of the enclosure has no sharp points or edges and no protrusions that could injure the bird contained therein;
(3) The bird is at all times securely contained within the enclosure and cannot put any part of its body outside the enclosure in a way that could result in injury to itself, to handlers, or to other persons or to animals nearby;
(4) The bird can be easily and quickly removed from the enclosure in an emergency;
(5) Unless the enclosure is permanently affixed to the conveyance, adequate handholds or other devices such as handles are provided on its exterior, and enable the enclosure to be lifted without tilting it, and ensure that anyone handling the enclosure will not be in contact with the bird contained inside;
(6) Unless the enclosure is permanently affixed to the conveyance, it is clearly marked on top and on one or more sides with the words “Live Animals,” in letters at least 1 inch (2.5 centimeters) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure;
(7) Any material, treatment, paint, preservative, or other chemical used in or on the enclosure is nontoxic to the bird and not harmful to its health or well-being;
(8) A bird that has a fractious or stress-prone disposition must be contained in an enclosure that is padded on the top and sides and has protective substrate on the bottom to prevent injury to the bird during transport;
(9) Proper ventilation is provided to the animal in accordance with paragraph (b) of this section; and
(10) The primary enclosure has a solid, leak-proof bottom or a removable, leak-proof collection tray. If a mesh or other nonsolid floor is used in the enclosure, it must be designed and constructed so that the bird cannot put any part of its body through the holes in the mesh or the openings in the nonsolid floor. If substrate (newspaper, towels, litter, straw, etc.) is used in the primary enclosure, the substrate must be clean and made of a suitably absorbent material that is safe and nontoxic to the birds.
(b) Ventilation. (1) Unless the primary enclosure is permanently affixed to the conveyance, there must be ventilation openings located on two vertical walls of the primary enclosure that are at least 16 percent of the surface area of each such wall or ventilation openings located on all four walls of the primary enclosure that are at least 8 percent of the total surface area of each such wall.
(2) Unless the primary enclosure is permanently affixed to the conveyance, projecting rims or other devices must be on the exterior of the outside walls with any ventilation openings to prevent obstruction of the ventilation openings. The projecting rims or similar devices must be large enough to provide a minimum air circulation space of 0.75 inches (1.9 centimeters) between the primary enclosure and anything the enclosure is adjacent to, unless 90 percent or greater of the surface area of the enclosure wall is open (e.g., cage mesh).
(3) Any visually obscuring mesh used to provide security for the bird in the enclosure must not interfere with proper ventilation.
(4) If a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening must open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening must be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh, or smooth expanded metal.
(c) Cleaning of primary enclosures. A primary enclosure used to hold or transport birds in commerce must be cleaned and sanitized before each use in accordance with § 3.158 by the dealer, research facility, exhibitor, or operator of an auction sale.
(d) Compatibility. Live birds transported in the same primary enclosure must be of the same species or compatible species and maintained in compatible groups. If more than one bird is being transported, socially dependent birds must be able to see and hear each other.
(e) Space and placement. Primary enclosures used to transport live birds must be large enough to ensure that each bird contained therein has sufficient space to turn about freely and to make normal postural adjustments; Provided, however, That certain species may be restricted in their movements according to professionally accepted standards when such freedom of movement would constitute a danger to the birds, their handlers, or other persons.
(f) Accompanying documents and records. Documents accompanying the shipment must be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment and must not obstruct ventilation openings.
(a) The animal cargo space of primary conveyances used in transporting live birds must be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the animals transported in them, ensures their safety and comfort, and prevents the entry of exhaust from the primary conveyance during transportation.
(b) The animal cargo space must have a supply of air that is sufficient for the normal breathing of all the animals being transported in it.
(c) Each primary enclosure containing birds must be positioned in the animal cargo space in a manner that provides protection from the elements and that allows each bird enough air for normal breathing.
(d) During transportation, the climatic conditions in the animal cargo area shall be maintained in accordance with the requirements of § 3.168.
(e) Primary enclosures must be positioned in the primary conveyance in a manner that allows the birds to be quickly and easily removed from the primary conveyance in an emergency.
(f) The interior of the bird cargo space must be kept clean.
(g) Live birds may not be transported with any material, substance (e.g., dry ice), or device which may reasonably be expected to be injurious to the health and well-being of the birds unless proper precaution is taken to prevent such injury.
(a) All weaned birds must be offered food and potable water within 4 hours before being transported in commerce, unless the attending veterinarian approves a delay or a delay is in accordance with professionally accepted standards.
(b) Dealers, exhibitors, research facilities, and operators of auction sales must provide potable water to all weaned birds transported in their own primary conveyance at least every 12 hours after such transportation is initiated, except for birds which, according to professionally accepted standards or under the direction of the attending veterinarian, require watering or feeding more or less frequently. Carriers and intermediate handlers must provide potable water to all live, weaned birds at least every 12 hours after accepting them for transportation in commerce, except for birds which, according to professionally accepted standards or under the direction of the attending veterinarian, require watering or feeding more or less frequently.
(c) All weaned birds must be fed at least once in each 24-hour period, except as directed by veterinary treatment, normal fasts, or other professionally accepted standards. Birds that require feeding more or less frequently must be fed accordingly.
(d) A sufficient quantity of food and water or other source of hydration must accompany the bird to provide food and water for such bird during period of transport, except as directed by veterinary treatment and other professionally accepted standards.
(e) Any dealer, research facility, exhibitor, or operator of an auction sale offering any live bird to any carrier or intermediate handler for transportation in commerce must securely affix to the outside of the primary enclosure used for transporting the bird written instructions for the in-transit food and water requirements of the bird contained in the enclosure. The instructions must be attached in accordance with § 3.162(f) and in a manner that makes them easily noticed and read.
(f) No carrier or intermediate handler may accept any live bird for transportation in commerce unless written instructions concerning the food and water requirements of such bird while being so transported is affixed to the outside of its primary enclosure. The instructions must be attached in accordance with § 3.162(f) and in a manner that makes them easily noticed and read.
(a) Surface transportation (ground and water). During surface transportation, any person subject to the Animal Welfare regulations in this part and parts 1 and 2 of this subchapter transporting birds in commerce must ensure that the operator of the conveyance, or a person accompanying the operator, visually observes the birds as frequently as circumstances may allow, but not less than once every 4 hours, to ensure that the birds are receiving sufficient air for normal breathing, that climatic and environmental conditions are being maintained in accordance with the requirements in § 3.168, and that all other applicable standards are met. The regulated person must ensure that the operator or person accompanying the operator determines whether any of the birds are in physical distress and obtains any veterinary care needed for the birds as soon as possible.
(b) Air transportation. When transported by air, live birds must be visually observed by the carrier as frequently as circumstances may allow, but not less than once every 4 hours, if the animal cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier must visually observe the live birds whenever they are loaded and unloaded and whenever the bird cargo space is otherwise accessible to ensure that they are receiving sufficient air for normal breathing, that climatic and environmental conditions are being maintained in accordance with the requirements in § 3.168, and that all other applicable standards are met. The carrier must determine whether any such live birds are in physical distress and arrange for any needed veterinary care as soon as possible.
(c) Prohibition on the transport of ill, injured, or distressed birds. Any person subject to the Animal Welfare regulations in this part and parts 1 and 2 of this subchapter may not transport in commerce birds that are ill, injured, or in physical distress, except to receive veterinary care for the condition.
(a) Placement. Carriers and intermediate handlers must not commingle shipments of live birds with other animals or inanimate cargo in animal holding areas of terminal facilities.
(b) Cleaning, sanitization, and pest control. All animal holding areas of terminal facilities must be cleaned and sanitized in a manner prescribed in § 3.158 as often as necessary to prevent an accumulation of debris or excreta and to minimize vermin infestation and disease hazards. Terminal facilities must follow an effective program in all animal holding areas for the control of insects, ectoparasites, and other pests of birds.
(c) Ventilation. Ventilation must be provided in any animal holding area in a terminal facility containing birds, by means of windows, doors, vents, or air conditioning. The air must be circulated by fans, blowers, or air conditioning so as to minimize drafts, odors, and moisture condensation.
(d) Climatic and environmental conditions. The climatic and environmental conditions in an animal holding area containing live birds shall be maintained in accordance with the requirements of § 3.168.
(a) Any person subject to the Animal Welfare regulations (this part and parts 1 and 2 of this subchapter) who moves (including loading and unloading) live birds within, to, or from the animal holding area of a terminal facility or a primary conveyance must do so as quickly and efficiently as possible and must provide the following during movement of the live birds:
(1) Shelter from sunlight and extreme heat. Sufficient shade shall be provided to protect the live birds from the direct rays of the sun.
(2) Shelter from rain and snow. Sufficient protection shall be provided to allow the live birds the option to remain dry during rain, snow, and other precipitation.
(3) Climatic and environmental conditions. Climatic and environmental conditions during movement shall be maintained in accordance with the requirements of § 3.168.
(b) Any person handling a primary enclosure containing a live bird must use care and must avoid causing physical harm or distress to the bird.
(c) A primary enclosure containing a live bird must not be tossed, dropped, or tilted, and must not be stacked in a manner which may reasonably be expected to result in its falling.
(a)(1) Transportation of all live birds shall be done in a manner that does not cause overheating, excessive cooling, or adverse environmental conditions that could cause discomfort or stress. When climatic or environmental conditions, including temperature, humidity, exposure, ventilation, pressurization, time, or other environmental conditions, or any combination thereof, present a threat to the health or well-being of a live bird, appropriate measures must be taken immediately to alleviate the impact of those conditions. The different climatic and environmental factors prevailing during a journey must be considered when arranging for the transportation of and when transporting live birds. Corrections may include, but would not be limited to:
(i) The temperature and humidity level of any enclosure used during transportation of live birds must be controlled by adequate ventilation or any other means necessary;
(ii) Appropriate care must be taken to ensure that live birds are not subjected to prolonged drafts detrimental to their health or well-being;
(iii) Appropriate care must be taken to ensure that live birds are not exposed to direct heat or cold if detrimental to their health or well-being; and
(iv) During prolonged air transit stops in local climatic conditions that could produce excessive heat for live birds held in aircraft compartments, the aircraft doors must be opened and, if necessary, equipment must be used to control the condition of the air within compartments containing live birds.
(2) In order to determine what climatic and environmental conditions are appropriate for a live bird, factors such as, but not limited to, the bird's age, species, physiological state, last feeding and watering, and acclimation shall be considered when such information is available.
(b) Birds that are not able to maintain a constant body temperature at ambient temperatures must be transported in a brooder or other temperature-regulating unit that effectively assists the bird in maintaining a constant body temperature during transport.
(1) The temperature of the brooder or other temperature-regulating unit must be monitored during transportation and appropriate for the live bird.
(2) Written instructions for the temperature requirements of birds transported in brooders or other temperature-regulating units must be securely affixed to the outside of the primary enclosure used for transporting the bird. The instructions must be attached in accordance with § 3.162(f) in a manner that makes them easily noticed and read.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under section 19 of the Animal Welfare Act (7 U.S.C. 2149). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) In any situation where the Administrator has reason to believe that any person licensed under the Act has violated or is violating any provision of the Act, or the regulations or standards issued thereunder, and he or she deems it warranted under the circumstances, the Administrator may suspend such person's license temporarily, for a period not to exceed 21 days, effective, except as provided in § 4.10(b), upon written notification given to such person of the suspension of his or her license pursuant to § 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)).
(b) In any case of actual or threatened physical harm to animals in violation of the Act, or the regulations or standards issued thereunder, by a person licensed under the Act, the Administrator may suspend such person's license temporarily, for a period not to exceed 21 days, effective upon oral or written notification, whichever is earlier. In the event of oral notification, a written confirmation thereof shall be given to such person pursuant to § 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)) as promptly as circumstances permit.
(c) The temporary suspension of a license shall be in addition to any sanction which may be imposed against said person by the Secretary pursuant to the Act after notice and opportunity for hearing.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his or her discretion, may enter into a stipulation with any person in which:
(1) The Administrator gives notice of an apparent violation of the Act, or the regulations or standards issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the specified penalty in settlement of the particular matter involved if it is paid within the designated time.
(b) If the specified penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
For the purpose of this part, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The singular form shall also impart the plural and the masculine form shall also impart the feminine. Words of art undefined in the following paragraphs shall have the meaning attributed to them by trade usage or general usage as reflected by definition in a standard dictionary, such as “Webster's.”
Act means the Horse Protection Act of 1970 (Pub. L. 91-540) as amended by the Horse Protection Act Amendments of 1976 (Pub. L. 94-360), 15 U.S.C. 1821 et seq., and any legislation amendatory thereof.
Action device means any boot, collar, chain, roller, or other device which encircles or is placed upon the lower extremity of the leg of a horse in such a manner that it can either rotate around the leg, or slide up and down the leg so as to cause friction, or which can strike the hoof, coronet band or fetlock joint.
Administrator means the Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service (APHIS) means the Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS representative means any employee of APHIS, or any officer or employee of any State agency who is authorized by the Administrator to perform inspections or any other functions authorized by the Act, including the inspection of the records of any horse show, horse exhibition, horse sale or horse auction.
APHIS Show Veterinarian means the APHIS Doctor of Veterinary Medicine responsible for the immediate supervision and conduct of the Department's activities under the Act at any horse show, horse exhibition, horse sale or horse auction.
Department means the United States Department of Agriculture.
Designated Qualified Person or DQP means a person meeting the requirements specified in § 11.7 of this part who has been licensed as a DQP by a horse industry organization or association having a DQP program certified by the Department and who may be appointed and delegated authority by the management of any horse show, horse exhibition, horse sale or horse auction under section 4 of the Act to detect or diagnose horses which are sore or to otherwise inspect horses and any records pertaining to such horses for the purposes of enforcing the Act.
Exhibitor means (1) any person who enters any horse, any person who allows his horse to be entered, or any person who directs or allows any horse in his custody or under his direction, control or supervision to be entered in any horse show or horse exhibition; (2) any person who shows or exhibits any horse, any person who allows his horse to be shown or exhibited, or any person who directs or allows any horse in his custody or under his direction, control, or supervision to be shown or exhibited in any horse show or horse exhibition; (3) any person who enters or presents any horse for sale or auction, any person who allows his horse to be entered or presented for sale or auction, or any person who allows any horse in his custody or under his direction, control, or supervision to be entered or presented for sale or auction in any horse sale or horse auction; or (4) any person who sells or auctions any horse, any person who allows his horse to be sold or auctioned, or any person who directs or allows any horse in his custody or under his direction, control, or supervision to be sold or auctioned.
Horse means any member of the species Equus caballus.
Horse exhibition means a public display of any horses, singly or in groups, but not in competition, except events where speed is the prime factor, rodeo events, parades, or trail rides.
Horse industry organization or association means an organized group of people, having a formal structure, who are engaged in the promotion of horses through the showing, exhibiting, sale, auction, registry, or any activity which contributes to the advancement of the horse.
Horse sale or horse auction means any event, public or private, at which horses are sold or auctioned, regardless of whether or not said horses are exhibited prior to or during the sale or auction.
Horse show means a public display of any horses, in competition, except events where speed is the prime factor, rodeo events, parades, or trail rides.
Inspection means the examination of any horse and any records pertaining to any horse by use of whatever means are deemed appropriate and necessary for the purpose of determining compliance with the Act and regulations. Such inspection may include, but is not limited to, visual examination of a horse and records, actual physical examination of a horse including touching, rubbing, palpating and observation of vital signs, and the use of any diagnostic device or instrument, and may require the removal of any shoe, pad, action device, or any other equipment, substance or paraphernalia from the horse when deemed necessary by the person conducting such inspection.
Lubricant means mineral oil, glycerine or petrolatum, or mixtures exclusively thereof, that is applied to the limbs of a horse solely for protective and lubricating purposes while the horse is being shown or exhibited at a horse show, horse exhibition, horse sale or horse auction.
Management means any person or persons who organize, exercise control over, or administer or are responsible for organizing, directing, or administering any horse show, horse exhibition, horse sale or horse auction and specifically includes, but is not limited to, the sponsoring organization and show manager.
Person means any individual, corporation, company, association, firm, partnership, society, organization, joint stock company, or other legal entity.
Regional Director means the APHIS veterinarian who is assigned by the Administrator to supervise and perform official duties of APHIS under the Act in a specified State or States.
Secretary means the Secretary of Agriculture or anyone who has heretofore or may hereafter be delegated authority to act in his stead.
Show manager means the person who has been delegated primary authority by a sponsoring organization for managing a horse show, horse exhibition, horse sale or horse auction.
Sore when used to describe a horse means:
(1) An irritating or blistering agent has been applied, internally or externally by a person to any limb of a horse,
(2) Any burn, cut, or laceration has been inflicted by a person on any limb of a horse,
(3) Any tack, nail, screw, or chemical agent has been injected by a person into or used by a person on any limb of a horse, or
(4) Any other substance or device has been used by a person on any limb of a horse or a person has engaged in a practice involving a horse, and, as a result of such application, infliction, injection, use, or practice, such horse suffers, or can reasonably be expected to suffer, physical pain or distress, inflammation, or lameness when walking, trotting, or otherwise moving, except that such term does not include such an application, infliction, injection, use, or practice in connection with the therapeutic treatment of a horse by or under the supervision of a person licensed to practice veterinary medicine in the State in which such treatment was given.
Sponsoring organization means any person under whose immediate auspices and responsibility a horse show, horse exhibition, horse sale, or horse auction is conducted.
State means any of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, or the Trust Territory of the Pacific Islands.
(a) General prohibitions. Notwithstanding the provisions of paragraph (b) of this section, no chain, boot, roller, collar, action device, nor any other device, method, practice, or substance shall be used with respect to any horse at any horse show, horse exhibition, or horse sale or auction if such use causes or can reasonably be expected to cause such horse to be sore.
(b) Specific prohibitions. The use of any of the following devices, equipment, or practices on any horse at any horse show, horse exhibition, or horse sale or auction is prohibited:
(1) All beads, bangles, rollers, and similar devices, with the exception of rollers made of lignum vitae (hardwood), aluminum, or stainless steel, with individual rollers of uniform size, weight and configuration, provided each such device may not weigh more than 6 ounces, including the weight of the fastener.
(2) Chains weighing more than 6 ounces each, including the weight of the fastener.
(3) Chains with links that are not of uniform size, weight and configuration; and, chains that have twisted links or double links.
(4) Chains that have drop links on any horse that is being ridden, worked on a lead, or otherwise worked out or moved about.
(5) More than one action device on any one limb of a horse.
(6) Chains or lignum vitae, stainless steel, or aluminum rollers which are not smooth and free of protrusions, projections, rust, corrosion, or rough or sharp edges.
(7)(i) Boots, collars, or any other devices, with protrusions or swellings, or rigid, rough, or sharp edges, seams or any other abrasive or abusive surface that may contact a horse's leg; and
(ii) Boots, collars, or any other devices that weigh more than 6 ounces, except for soft rubber or soft leather bell boots and quarter boots that are used as protective devices.
(8) Pads or other devices on yearling horses (horses up to 2 years old) that elevate or change the angle of such horses' hooves in excess of 1 inch at the heel.
(9) Any weight on yearling horses, except a keg or similar conventional horseshoe, and any horseshoe on yearling horses that weighs more than 16 ounces.
(10) Artificial extension of the toe length, whether accomplished with pads, acrylics or any other material or combinations thereof, that exceeds 50 percent of the natural hoof length, as measured from the coronet band, at the center of the front pastern along the front of the hoof wall, to the distal portion of the hoof wall at the tip of the toe. The artificial extension shall be measured from the distal portion of the hoof wall at the tip of the toe at a 90 degree angle to the proximal (foot/hoof) surface of the shoe.
(11) Toe length that does not exceed the height of the heel by 1 inch or more. The length of the toe shall be measured from the coronet band, at the center of the front pastern along the front of the hoof wall to the ground. The heel shall be measured from the coronet band, at the most lateral portion of the rear pastern, at a 90 degree angle to the ground, not including normal caulks at the rear of a horseshoe that do not exceed
(12) Pads that are not made of leather, plastic, or a similar pliant material.
(13) Any object or material inserted between the pad and the hoof other than acceptable hoof packing, which includes pine tar, oakum, live rubber, sponge rubber, silicone, commercial hoof packing or other substances used to maintain adequate frog pressure or sole consistency.
(14) Single or double rocker-bars on the bottom surface of horseshoes which extend more than 1
(15) Metal hoof bands, such as used to anchor or strengthen pads and shoes, placed less than
(16) Metal hoof bands that can be easily and quickly loosened or tightened by hand, by means such as, but not limited to, a wing-nut or similar fastener.
(17) Any action device or any other device that strikes the coronet band of the foot of a horse except for soft rubber or soft leather bell boots that are used as protective devices.
(18) Shoeing a horse, or trimming a horse's hoof in a manner that will cause such horse to suffer, or can reasonably be expected to cause such horse to suffer pain or distress, inflammation, or lameness when walking, trotting, or otherwise moving.
(19) Lead or other weights attached to the outside of the hoof wall, the outside surface of the horseshoe, or any portion of the pad except the bottom surface within the horseshoe. Pads may not be hollowed out for the purpose of inserting or affixing weights, and weights may not extend below the bearing surface of the shoe. Hollow shoes or artificial extensions filled with mercury or similar substances are prohibited.
(c) Substances. All substances are prohibited on the extremities above the hoof of any Tennessee Walking Horse or racking horse while being shown, exhibited, or offered for sale at any horse show, horse exhibition, or horse sale or auction, except lubricants such as glycerine, petrolatum, and mineral oil, or mixtures thereof: Provided, That:
(1) The horse show, horse exhibition, or horse sale or auction management agrees to furnish all such lubricants and to maintain control over them when used at the horse show, horse exhibition, or horse sale or auction.
(2) Any such lubricants shall be applied only after the horse has been inspected by management or by a DQP and shall only be applied under the supervision of the horse show, horse exhibition, or horse sale, or auction management.
(3) Horse show, horse exhibition, or horse sale or auction management makes such lubricants available to Department personnel for inspection and sampling as they deem necessary.
(d) Competition restrictions—2 Year-Old Horses. Horse show or horse exhibition workouts or performances of 2-year-old Tennessee Walking Horses and racking horses and working exhibitions of 2-year-old Tennessee Walking Horses and racking horses (horses eligible to be shown or exhibited in 2-year-old classes) at horse sales or horse auctions that exceed a total of 10 minutes continuous workout or performance without a minimum 5-minute rest period between the first such 10-minute period and the second such 10-minute period, and, more than two such 10-minute periods per performance, class, or workout are prohibited.
(e) Information requirements—horse related. Failing to provide information or providing any false or misleading information required by the Act or regulations or requested by Department representatives, by any person that owns, trains, shows, exhibits, or sells or has custody of, or direction or control over any horse shown, exhibited, sold, or auctioned or entered for the purpose of being shown, exhibited, sold, or auctioned at any horse show, horse exhibition, or horse sale or auction is prohibited. Such information shall include, but is not limited to: Information concerning the registered name, markings, sex, age, and legal ownership of the horse; the name and address of the horse's training and/or stabling facilities; the name and address of the owner, trainer, rider, any other exhibitor, or other legal entity bearing responsibility for the horse; the class in which the horse is entered or shown; the exhibitor identification number; and, any other information reasonably related to the identification, ownership, control, direction, or supervision of any such horse.
The scar rule applies to all horses born on or after October 1, 1975. Horses subject to this rule that do not meet the following scar rule criteria shall be considered to be “sore” and are subject to all prohibitions of section 5 of the Act. The scar rule criteria are as follows:
(a) The anterior and anterior-lateral surfaces of the fore pasterns (extensor surface) must be free of bilateral granulomas,
(b) The posterior surfaces of the pasterns (flexor surface), including the sulcus or “pocket” may show bilateral areas of uniformly thickened epithelial tissue if such areas are free of proliferating granuloma tissue, irritation, moisture, edema, or other evidence of inflammation.
For the purpose of effective enforcement of the Act:
(a) Each horse owner, exhibitor, trainer, or other person having custody of, or responsibility for, any horse at any horse show, horse exhibition, or horse sale or auction, shall allow any APHIS representative to reasonably inspect such horse at all reasonable times and places the APHIS representative may designate. Such inspections may be required of any horse which is stabled, loaded on a trailer, being prepared for show, exhibition, or sale or auction, being exercised or otherwise on the grounds of, or present at, any horse show, horse exhibition, or horse sale or auction, whether or not such horse has or has not been shown, exhibited, or sold or auctioned, or has or has not been entered for the purpose of being shown or exhibited or offered for sale or auction at any such horse show, horse exhibition, or horse sale or auction. APHIS representatives will not generally or routinely delay or interrupt actual individual classes or performances at horse shows, horse exhibitions, or horse sales or auctions for the purpose of examining horses, but they may do so in extraordinary situations, such as but not limited to, lack of proper facilities for inspection, refusal of management to cooperate with Department inspection efforts, reason to believe that failure to immediately perform inspection may result in the loss, removal, or masking of any evidence of a violation of the Act or the regulations, or a request by management that such inspections be performed by an APHIS representative.
(b) When any APHIS representative notifies the owner, exhibitor, trainer, or other person having custody of or responsibility for a horse at any horse show, horse exhibition, or horse sale or auction that APHIS desires to inspect such horse, it shall not be moved from the horse show, horse exhibition, or horse sale or auction until such inspection has been completed and the horse has been released by an APHIS representative.
(c) For the purpose of examination, testing, or taking of evidence, APHIS representatives may detain for a period not to exceed 24 hours any horse, at any horse show, horse exhibition, or horse sale or auction, which is sore or which an APHIS veterinarian has probable cause to believe is sore. Such detained horse may be marked for identification and any such identifying markings shall not be removed by any person other than an APHIS representative.
(d) Detained horses shall be kept under the supervision of an APHIS representative or secured under an official USDA seal or seals in a horse stall, horse trailer, or other facility to which access shall be limited. It shall be the policy of APHIS to have at least one representative present in the immediate detention area when a horse is being held in detention. The official USDA seal or seals may not be broken or removed by any person other than an APHIS representative, unless:
(1) The life or well-being of the detained horse is immediately endangered by fire, flood, windstorm, or other dire circumstances that are beyond human control.
(2) The detained horse is in need of such immediate veterinary attention that its life may be in peril before an APHIS representative can be located.
(3) The horse has been detained for a maximum 24-hour detention period, and an APHIS representative is not available to release the horse.
(e) The owner, exhibitor, trainer, or other person having custody of or responsibility for any horse detained by APHIS for further examination, testing, or the taking of evidence shall be allowed to feed, water, and provide other normal custodial and maintenance care, such as walking, grooming, etc., for such detained horse: Provided, That:
(1) Such feeding, watering, and other normal custodial and maintenance care of the detained horse is rendered under the direct supervision of an APHIS representative.
(2) Any non-emergency veterinary care of the detained horse requiring the use, application, or injection of any drugs or other medication for therapeutic or other purposes is rendered by a Doctor of Veterinary Medicine in the presence of an APHIS representative and, the identity and dosage of the drug or other medication used, applied, or injected and its purpose is furnished in writing to the APHIS representative prior to such use, application, or injection by the Doctor of Veterinary Medicine attending the horse. The use, application, or injection of such drug or other medication must be approved by the APHIS Show Veterinarian or his appointed representative.
(f) It shall be the policy of APHIS to inform the owner, trainer, exhibitor, or other person having immediate custody of or responsibility for any horse allegedly found to be in violation of the Act or the regulations of such alleged violation or violations before the horse is released by an APHIS representative.
(g) The owner, trainer, exhibitor, or other person having immediate custody of or responsibility for any horse or horses that an APHIS representative determines shall be detained for examination, testing, or taking of evidence pursuant to paragraph (e) of this section shall be informed after such determination is made and shall allow said horse to be immediately put under the supervisory custody of APHIS or secured under official USDA seal as provided in paragraph (d) of this section until the completion of such examination, testing, or gathering of evidence, or until the 24-hour detention period expires.
(h) The owner, trainer, exhibitor, or other person having custody of or responsibility for any horse allegedly found to be in violation of the Act or regulations, and who has been notified of such alleged violation by an APHIS representative as stated in paragraph (f) of this section, may request reexamination and testing of said horse within a 24-hour period: Provided, That:
(1) Such request is made to the APHIS Show Veterinarian immediately after the horse has been examined by APHIS representatives and before such horse has been removed from the APHIS inspection facilities; and
(2) The APHIS Show Veterinarian determines that sufficient cause for reexamination and testing exists; and
(3) The horse is maintained under APHIS supervisory custody as prescribed in paragraph (d) of this section until such reexamination and testing has been completed.
(i) The owner, exhibitor, trainer, or other person having custody of, or responsibility for any horse being inspected shall render such assistance as the APHIS representative may request for purposes of such inspection.
(ii) [Reserved]
Requirements regarding access to premises for inspection of horses and records are as follows:
(a) Management. (1) The management of any horse show, horse exhibition, or horse sale or auction shall, without fee, charge, assessment, or other compensation, provide APHIS representatives with unlimited access to the grandstands, sale ring, barns, stables, grounds, offices, and all other areas of any horse show, horse exhibition, or horse sale or auction, including any adjacent areas under their direction, control, or supervision for the purpose of inspecting any horses, or any records required to be kept by regulation or otherwise maintained.
(2) The management of any horse show, horse exhibition, or horse sale or auction shall, without fee, charge, assessment, or other compensation, provide APHIS representatives with an adequate, safe, and accessible area for the visual inspection and observation of horses while such horses are competitively or otherwise performing at any horse show or horse exhibition, or while such horses are being sold or auctioned or offered for sale or auction at any horse sale or horse auction.
(b) Exhibitors. (1) Each horse owner, exhibitor, or other person having custody of or responsibility for any horse at any horse show, horse exhibition, or horse sale or auction shall, without fee, charge, assessment, or other compensation, admit any APHIS representative or Designated Qualified Person appointed by management, to all areas of barns, compounds, horse vans, horse trailers, stables, stalls, paddocks, or other show, exhibition, or sale or auction grounds or related areas at any horse show, horse exhibition, or horse sale or auction, for the purpose of inspecting any such horse at any and all reasonable times.
(2) Each owner, trainer, exhibitor, or other person having custody of or responsibility for, any horse at any horse show, horse exhibition, or horse sale or auction shall promptly present his horse for inspection upon notification, orally or in writing, by any APHIS representative or Designated Qualified Person appointed by management, that said horse has been selected for examination for the purpose of determining whether such horse is in compliance with the Act and regulations.
The management of every horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, shall provide, without fee, sufficient space and facilities for APHIS representatives to carry out their duties under the Act and regulations at every horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, whether or not management has received prior notification or otherwise knows that such show may be inspected by APHIS. The management of every horse show, horse exhibition, horse sale or auction which does not contain Tennessee Walking Horses or racking horses shall provide, without fee, such sufficient space and facilities when requested to do so by APHIS representatives. With respect to such space and facilities, it shall be the responsibility of management to provide at least the following:
(a) Sufficient space in a convenient location to the horse show, horse exhibition, or horse sale or auction arena, acceptable to the APHIS Show Veterinarian, in which horses may be physically, thermographically, or otherwise inspected.
(b) Protection from the elements of nature, such as rain, snow, sleet, hail, windstorm, etc., if required by the APHIS Show Veterinarian.
(c) A means to control crowds or onlookers in order that APHIS personnel may carry out their duties without interference and with a reasonable measure of safety, if requested by the APHIS Show Veterinarian.
(d) An accessible, reliable, and convenient 110-volt electrical power source, if electrical service is available at the show, exhibition, or sale or auction site and is requested by the APHIS Show Veterinarian.
(e) An appropriate area adjacent to the inspection area for designated horses to wait for inspection, and an area to be used for detention of horses.
(a) Basic qualifications of DQP applicants. DQP's holding a valid, current DQP license issued in accordance with this part may be appointed by the management of any horse show, horse exhibition, horse sale, or horse auction, as qualified persons in accordance with section 4(c) of the Act, to inspect horses to detect or diagnose soring and to otherwise inspect horses, or any records pertaining to any horse for the purpose of enforcing the Act. Individuals who may be licensed as DQP's under this part shall be:
(1) Doctors of Veterinary Medicine who are accredited in any State by the United States Department of Agriculture under part 161 of chapter I, title 9 of the Code of Federal Regulations, and who are:
(i) Members of the American Association of Equine Practitioners, or
(ii) Large animal practitioners with substantial equine experience, or
(iii) Knowledgeable in the area of equine lameness as related to soring and soring practices (such as Doctors of Veterinary Medicine with a small animal practice who own, train, judge, or show horses, or Doctors of Veterinary Medicine who teach equine related subjects in an accredited college or school of veterinary medicine). Accredited Doctors of Veterinary Medicine who meet these criteria may be licensed as DQP's by a horse industry organization or association whose DQP program has been certified by the Department under this part without undergoing the formal training requirements set forth in this section.
(2) Farriers, horse trainers, and other knowledgeable horsemen whose past experience and training would qualify them for positions as horse industry organization or association stewards or judges (or their equivalent) and who have been formally trained and licensed as DQP's by a horse industry organization or association whose DQP program has been certified by the Department in accordance with this section.
(b) Certification requirements for DQP programs. The Department will not license DQP's on an individual basis. Licensing of DQP's will be accomplished only through DQP programs certified by the Department and initiated and maintained by horse industry organizations or associations. Any horse industry organization or association desiring Department certification to train and license DQP's under the Act shall submit to the Administrator
(1) The criteria to be used in selecting DQP candidates and the minimum qualifications and knowledge regarding horses each candidate must have in order to be admitted to the program.
(2) A copy of the formal training program, classroom and practical, required to be completed by each DQP candidate before being licensed by such horse industry organization or association, including the minimum number of hours, classroom and practical, and the subject matter of the training program. Such training program must meet the following minimum standards in order to be certified by the Department under the Act.
(i) Two hours of classroom instruction on the anatomy and physiology of the limbs of a horse. The instructor teaching the course must be specified, and a resume of said instructor's background, experience, and qualifications to teach such course shall be provided to the Administrator.
(ii) Two hours of classroom instruction on the Horse Protection Act and regulations and their interpretation. Instructors for this course must be furnished or recommended by the Department. Requests for instructors to be furnished or recommended must be made to the Administrator
(iii) Four hours of classroom instruction on the history of soring, the physical examination procedures necessary to detect soring, the detection and diagnosis of soring, and related subjects. The instructor teaching the course must be specified and a summary of said instructor's background, experience, and qualifications to teach such course must be provided to the Administrator.
(iv) Four hours of practical instruction in clinics and seminars utilizing live horses with actual application of the knowledge gained in the classroom subjects covered in paragraphs (b)(2)(i), (ii), and (iii) of this section. Methods and procedures required to perform a thorough and uniform examination of a horse shall be included. The names of the instructors and a resume of their background, academic and practical experience, and qualifications to present such instruction shall be provided to the Administrator.
(v) One hour of classroom instruction regarding the DQP standards of conduct promulgated by the licensing organization or association pursuant to paragraph (d)(7) of this section.
(vi) One hour of classroom instruction on recordkeeping and reporting requirements and procedures.
(3) A sample of a written examination which must be passed by DQP candidates for successful completion of the program along with sample answers and the scoring thereof, and proposed passing and failing standards.
(4) The criteria to be used to determine the qualifications and performance abilities of DQP candidates selected for the training program and the criteria used to indicate successful completion of the training program, in addition to the written examination required in paragraph (b)(3) of this section.
(5) The criteria and schedule for a continuing education program and the criteria and methods of monitoring and appraising performance for continued licensing of DQP's by such organization or association. A continuing education program for DQP's shall consist of not less than 4 hours of instruction per year.
(6) Procedures for monitoring horses in the unloading, preparation, warmup, and barn areas, or other such areas. Such monitoring may include any horse that is stabled, loaded on a trailer, being prepared for show, exhibition, sale, or auction, or exercised, or that is otherwise on the grounds of, or present at, any horse show, horse exhibition, or horse sale or auction.
(7) The methods to be used to insure uniform interpretation and enforcement of the Horse Protection Act and regulations by DQP's and uniform procedures for inspecting horses for compliance with the Act and regulations;
(8) Standards of conduct for DQP's promulgated by the organization or association in accordance with paragraph (d)(7) of this section; and
(9) A formal request for Department certification of the DQP program.
(c) Licensing of DQP's. Each horse industry organization or association receiving Department certification for the training and licensing of DQP's under the Act shall:
(1) Issue each DQP licensed by such horse industry organization or association a numbered identification card bearing the name and personal signature of the DQP, a picture of the DQP, and the name and address, including the street address or post office box and zip code, of the licensing organization or association;
(2) Submit a list to the Administrator
(3) Notify the Department of any additions or deletions of names of licensed DQP's from the licensed DQP list submitted to the Department or of any change in the address of any licensed DQP or any warnings and license revocations issued to any DQP licensed by such horse industry organization or association within 10 days of such change;
(4) Not license any person as a DQP if such person has been convicted of any violation of the Act or regulations occurring after July 13, 1976, or paid any fine or civil penalty in settlement of any proceeding regarding a violation of the Act or regulations occurring after July 13, 1976, for a period of at least 2 years following the first such violation, and for a period of at least 5 years following the second such violation and any subsequent violation;
(5) Not license any person as a DQP until such person has attended and worked two recognized or affiliated horse shows, horse exhibitions, horse sales, or horse auctions as an apprentice DQP and has demonstrated the ability, qualifications, knowledge and integrity required to satisfactorily execute the duties and responsibilities of a DQP;
(6) Not license any person as a DQP if such person has been disqualified by the Secretary from making detection, diagnosis, or inspection for the purpose of enforcing the Act, or if such person's DQP license is canceled by another horse industry organization or association.
(d) Requirements to be met by DQP's and Licensing Organizations or Associations. (1) Any licensed DQP appointed by the management of any horse show, horse exhibition, horse sale or auction to inspect horses for the purpose of detecting and determining or diagnosing horses which are sore and to otherwise inspect horses for the purpose of enforcing the Act and regulations, shall keep and maintain the following information and records concerning any horse which said DQP recommends be disqualified or excused for any reason at such horse show, horse exhibition, horse sale or auction, from being shown, exhibited, sold or auctioned, in a uniform format required by the horse industry organization or association that has licensed said DQP:
(i) The name and address, including street address or post office box and zip code, of the show and the show manager.
(ii) The name and address, including street address or post office box and zip code, of the horse owner.
(iii) The name and address, including street address or post office box and zip code, of the horse trainer.
(iv) The name and address, including street address or post office box and zip code, of the horse exhibitor.
(v) The exhibitors number and class number, or the sale or auction tag number of said horse.
(vi) The date and time of the inspection.
(vii) A detailed description of all of the DQP's findings and the nature of the alleged violation, or other reason for disqualifying or excusing the horse, including said DQP's statement regarding the evidence or facts upon which the decision to disqualify or excuse said horse was based.
(viii) The name, age, sex, color, and markings of the horse; and
(ix) The name or names of the show manager or other management representative notified by the DQP that such horse should be excused or disqualified and whether or not such manager or management representative excused or disqualified such horse.
(2) The DQP shall inform the custodian of each horse allegedly found in violation of the Act or its regulations, or disqualified or excused for any other reason, of such action and the specific reasons for such action.
(3) Each horse industry organization or association having a Department certified DQP program shall submit a report to the Department containing the following information, from records required in paragraph (d)(1) of this section and other available sources, to the Department on a monthly basis:
(i) The identity of all horse shows, horse exhibitions, horse sales, or horse auctions that have retained the services of DQP's licensed by said organization or association during the month covered by the report. Information concerning the identity of such horse shows, horse exhibitions, horse sales, or horse auctions shall include:
(A) The name and location of the show, exhibition, sale, or auction.
(B) The name and address of the manager.
(C) The date or dates of the show, exhibition, sale, or auction.
(ii) The identity of all horses at each horse show, horse exhibition, horse sale, or horse auction that the licensed DQP recommended be disqualified or excused for any reason. The information concerning the identity of such horses shall include:
(A) The registered name of each horse.
(B) The name and address of the owner, trainer, exhibitor, or other person having custody of or responsibility for the care of each such horse disqualified or excused.
(4) Each horse industry organization or association having a Department certified DQP program shall provide, by certified mail if personal service is not possible, to the trainer and owner of each horse allegedly found in violation of the Act or its regulations or otherwise disqualified or excused for any reason, the following information;
(i) The name and date of the show, exhibition, sale, or auction.
(ii) The name of the horse and the reason why said horse was excused, disqualified, or alleged to be in violation of the Act or its regulations.
(5) Each horse industry organization or association having a Department certified DQP program shall provide each of its licensed DQP's with a current list of all persons that have been disqualified by order of the Secretary from showing or exhibiting any horse, or judging or managing any horse show, horse exhibition, horse sale, or horse auction. The Department will make such list available, on a current basis, to organizations and associations maintaining a certified DQP program.
(6) Each horse industry organization or association having a Department certified DQP program shall develop and provide a continuing education program for licensed DQP's which provides not less than 4 hours of instruction per year to each licensed DQP.
(7) Each horse industry organization or association having a Department certified DQP program shall promulgate standards of conduct for its DQP's, and shall provide administrative procedures within the organization or association for initiating, maintaining, and enforcing such standards. The procedures shall include the causes for and methods to be utilized for canceling the license of any DQP who fails to properly and adequately carry out his duties. Minimum standards of conduct for DQP's shall include the following;
(i) A DQP shall not exhibit any horse at any horse show or horse exhibition, or sell, auction, or purchase any horse sold at a horse sale or horse auction at which he or she has been appointed to inspect horses;
(ii) A DQP shall not inspect horses at any horse show, horse exhibition, horse sale or horse auction in which a horse or horses owned by a member of the DQP's immediate family or the DQP's employer are competing or are being offered for sale;
(iii) A DQP shall follow the uniform inspection procedures of his certified organization or association when inspecting horses; and
(iv) The DQP shall immediately inform management of each case regarding any horse which, in his opinion, is in violation of the Act or regulations.
(e) Prohibition of appointment of certain persons to perform duties under the Act. The management of any horse show, horse exhibition, horse sale, or horse auction shall not appoint any person to detect and diagnose horses which are sore or to otherwise inspect horses for the purpose of enforcing the Act, if that person:
(1) Does not hold a valid, current DQP license issued by a horse industry organization or association having a DQP program certified by the Department.
(2) Has had his DQP license canceled by the licensing organization or association.
(3) Is disqualified by the Secretary from performing diagnosis, detection, and inspection under the Act, after notice and opportunity for a hearing,
(f) Cancellation of DQP license. (1) Each horse industry organization or association having a DQP program certified by the Department shall issue a written warning to any DQP whom it has licensed who violates the rules, regulations, by-laws, or standards of conduct promulgated by such horse industry organization or association pursuant to this section, who fails to follow the procedures set forth in § 11.21 of this part, or who otherwise carries out his duties and responsibilities in a less than satisfactory manner, and shall cancel the license of any DQP after a second violation. Upon cancellation of his DQP license, the DQP may, within 30 days thereafter, request a hearing before a review committee of not less than three persons appointed by the licensing horse industry organization or association. If the review committee sustains the cancellation of the license, the DQP may appeal the decision of such committee to the Administrator within 30 days from the date of such decision, and the Administrator shall make a final determination in the matter. If the Administrator finds, after providing the DQP whose license has been canceled with a notice and an opportunity for a hearing,
(2) Each horse industry organization or association having a Department certified DQP program shall cancel the license of any DQP licensed under its program who has been convicted of any violation of the Act or regulations or of any DQP who has paid a fine or civil penalty in settlement of any alleged violation of the Act or regulations if such alleged violation occurred after July 13, 1976.
(g) Revocation of DQP program certification of horse industry organizations or associations. Any horse industry organization or association having a Department certified DQP program that has not received Department approval of the inspection procedures provided for in paragraph (b)(6) of this section, or that otherwise fails to comply with the requirements contained in this part, may have such certification of its DQP program revoked, unless, upon written notification from the Department of such failure to comply with the requirements in this section, such organization or association takes immediate action to rectify such failure and takes appropriate steps to prevent a recurrence of such noncompliance within the time period specified in the Department notification, or otherwise adequately explains such failure to comply to the satisfaction of the Department. Any horse industry organization or association whose DQP program certification has been revoked may appeal such revocation to the Administrator
APHIS will authorize HPIs after the successful completion of training by APHIS. The management of any horse show, horse exhibition, horse sale, or horse auction may appoint HPIs holding a current authorization to detect and diagnose horses that are sore or to otherwise inspect horses and any records pertaining to such horses for the purposes of determining compliance with the Act and regulations.
(a) Authorization process. All persons wishing to become HPIs must submit an application to APHIS. Guidance regarding submitting applications is located on the APHIS Horse Protection website. Applicants will be required to show that they meet the Tier 1 qualifications in paragraph (a)(1) of this section in order for the application to be evaluated. If the applicant meets the qualifications in paragraph (a)(1) of the section, the applicant will be further evaluated based on the Tier 2 qualifications in paragraph (a)(2) of this section. In order for APHIS to consider the applicant as a candidate to be an HPI, all qualifications must be met.
(1) Tier 1 qualifications. The applicant must be a veterinarian, except that veterinary technicians and persons employed by State and local government agencies to enforce laws or regulations pertaining to animal welfare may also be authorized if APHIS determines that there is an insufficient pool of veterinarians among current HPIs and applicants to be HPIs.
(2) Tier 2 qualifications. (i) The applicant must demonstrate sufficient knowledge and experience of equine husbandry and science and applicable principles of equine science, welfare, care, and health for APHIS to determine that the applicant can consistently identify equine soring and soring practices.
(ii) The applicant must not have been found to have violated any provision of the Act or the regulations in this part occurring after July 13, 1976, or have been assessed any civil penalty, or have been the subject of a disqualification order in any proceeding involving an alleged violation of the Act or regulations occurring after July 13, 1976.
(iii) The applicant must not have been disqualified by the Secretary from performing diagnosis, detection, and inspection under the Act.
(iv) The applicant must not have acted in a manner that calls into question the applicant's honesty, professional integrity, reputation, practices, and reliability relative to possible authorization as an HPI. APHIS will base this on a review of:
(A) Criminal conviction records, if any, indicating that the applicant may lack the honesty, integrity, and reliability to appropriately and effectively perform HPI duties.
(B) Official records of the person's actions while participating in Federal, State, or local veterinary programs when those actions reflect on the honesty, reputation, integrity, and reliability of the applicant.
(C) Judicial determinations in any type of litigation adversely reflecting on the honesty, reputation, integrity, and reliability of the applicant.
(D) Any other evidence reflecting on the honesty, reputation, integrity, and reliability of the applicant.
(b) Training. All applicants selected as candidates must complete a formal training program administered by APHIS prior to authorization. Continual training as APHIS determines to be necessary is a condition of maintaining authorization to inspect horses.
(c) Listing. APHIS will maintain a list of all HPIs on the APHIS Horse Protection website. The list is also available by contacting APHIS by email or U.S. mail.
Send email to horseprotection@usda.gov, or U.S. mail to USDA/APHIS/AC, 2150 Centre Ave., Building B, Mailstop 3W11, Fort Collins, CO 80526-8117.
(d) Denial of an HPI application and disqualification of HPIs—(1) Denial. APHIS may deny an application for authorization of an HPI, or deny continuation in the program to an HPI trainee not yet authorized, for any of the reasons outlined in paragraph (a) of this section. In such instances, the applicant shall be provided written notification of the grounds for the denial. The applicant may appeal the decision, in writing, within 30 days after receiving the written denial notice. The appeal must state all of the facts and reasons that the person wants the Administrator to consider in deciding the appeal. As soon as practicable, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision.
(2) Disqualification. APHIS may permanently disqualify any HPI who fails to inspect horses in accordance with the procedures prescribed by APHIS or otherwise fails to perform duties necessary for APHIS to enforce the Act and regulations, after notice and opportunity for a hearing. Requests for hearings and the hearings themselves shall be in accordance with the Uniform Rules of Practice for the Department of Agriculture in subpart H of 7 CFR part 1.
(a) The management of any horse show, horse exhibition, or horse sale or auction which does not appoint and retain a DQP shall be responsible for identifying all horses that are sore or otherwise in violation of the Act or regulations, and shall disqualify or disallow any horses which are sore or otherwise in violation of the Act or regulations from participating or competing in any horse show, horse exhibition, horse sale, or horse auction. Horses entered for sale or auction at a horse sale or horse auction must be identified as sore or otherwise in violation of the Act or regulations prior to the sale or auction and prohibited from entering the sale or auction ring. Sore horses or horses otherwise in violation of the Act or regulations that have been entered in a horse show or horse exhibition for the purpose of show or exhibition must be identified and excused prior to the show or exhibition. Any horses found to be sore or otherwise in violation of the Act or regulations during actual participation in the show or exhibition, must be removed from further participation prior to the tyeing of the class or the completion of the exhibition. All horses tyed first in each Tennessee Walking Horse or racking horse class or event at any horse show or horse exhibition shall be inspected after being shown or exhibited to determine if such horses are sore or otherwise in violation of the Act or regulations.
(b)(1) The management of any horse show, horse exhibition, horse sale or auction which designates and appoints a Designated Qualified Person (or persons) to inspect horses shall accord said DQP access to all records and areas of the grounds of such show, exhibition, sale, or auction and the same right to inspect horses and records as is accorded to any APHIS representative. Further, management shall not take any action which would interfere with or influence said DQP in carrying out his duties or making decisions concerning whether or not any horse is sore or otherwise in violation of the Act or regulations. In the event management is dissatisfied with the performance of a particular DQP, including disagreement with decisions concerning violations, management shall not dismiss or otherwise interfere with said DQP during the DQP's appointed tour of duty.
(2) The DQP shall physically inspect: (i) All Tennessee Walking Horses and racking horses entered for sale or auction, (ii) all Tennessee Walking Horses and racking horses entered in any animated gait class (whether under saddle, horse to cart, or otherwise), (iii) all Tennessee Walking Horses and racking horses entered for exhibition before they are admitted to be shown, exhibited, sold, or auctioned, and (iv) all Tennessee Walking Horses and racking horses tyed first in their class or event at any horse show, horse exhibition, horse sale, or horse auction. Such inspection shall be for the purpose of determining whether any such horses are in violation of the Act or regulations. Such physical examination shall be conducted in accordance with the inspection procedures provided for in § 11.21 of this part. The DQP shall observe horses in the warmup ring and during actual performances whenever possible, and shall inspect any Tennessee Walking Horse or racking horse at any time he deems necessary to determine whether any such horse shown, exhibited, sold, or auctioned is in violation of the Act or regulations. If present at other shows, he shall examine any horse which he determines should be examined for compliance with the Act and regulations.
(3) The DQP shall immediately report, to the management of any horse show, horse exhibition, or horse sale or auction, any horse which, in his opinion, is sore or otherwise in violation of the Act or regulations. Such report shall be made, whenever possible, before the show class or exhibition involving said horse has begun or before said horse is offered for sale or auction.
(c) The management of any horse show, exhibition, sale, or auction that designates and appoints a DQP to inspect horses shall appoint and designate at least two DQP's when more than 150 horses are entered.
(a)(1) During the preshow inspection, the DQP shall direct the custodian of the horse to walk and turn the horse in a manner that allows the DQP to determine whether the horse exhibits signs of soreness. The DQP shall determine whether the horse moves in a free and easy manner and is free of any signs of soreness.
(2) The DQP shall digitally palpate the front limbs of the horse from knee to hoof, with particular emphasis on the pasterns and fetlocks. The DQP shall examine the posterior surface of the pastern by picking up the foot and examining the posterior (flexor) surface. The DQP shall apply digital pressure to the pocket (sulcus), including the bulbs of the heel, and continue the palpation to the medial and lateral surfaces of the pastern, being careful to observe for responses to pain in the horse. While continuing to hold onto the pastern, the DQP shall extend the foot and leg of the horse to examine the front (extensor) surfaces, including the coronary band. The DQP may examine the rear limbs of all horses inspected after showing, and may examine the rear limbs of any horse examined preshow or on the showgrounds when he deems it necessary, except that the DQP shall examine the rear limbs of all horses exhibiting lesions on, or unusual movement of, the rear legs. While carrying out the procedures set forth in this paragraph, the DQP shall also inspect the horse to determine whether the provisions of § 11.3 of this part are being complied with, and particularly whether there is any evidence of inflammation, edema, or proliferating granuloma tissue.
(3) The DQP shall observe and inspect all horses for compliance with the provisions set forth in § 11.2(a) through § 11.2(c) of this part. All action devices, pads, and other equipment shall be observed and/or examined to assure that they are in compliance with the regulations. All such equipment on horses examined postshow, and on horses examined preshow that are not clearly in compliance, shall be weighed and/or measured.
(4) The DQP shall instruct the custodian of the horse to control it by holding the reins approximately 18 inches from the bit shank. The DQP shall not be required to examine a horse if it is presented in a manner that might cause the horse not to react to a DQP's examination, or if whips, cigarette smoke, or other actions or paraphernalia are used to distract a horse during examination. All such incidents shall be reported to the show management and the DQP licensing organization.
(b) The DQP shall inspect horses no more than three classes ahead of the time the inspected horses are to be shown, except that, in shows with fewer than 150 horses, the DQP shall inspect horses no more than 2 classes ahead of the time the inspected horses are to be shown. Inspected horses shall be held in a designated area that is under observation by the DQP or APHIS representative. Horses shall not be permitted to leave the designated area before showing. Only the horse, the rider, the groom, the trainer, the DQP(s) and APHIS representatives shall be allowed in the designated area.
(c) The DQP may carry out additional inspection procedures as he deems necessary to determine whether the horse is sore.
(d) The HIO that licensed the DQP shall assess and enforce penalties for violations in accordance with § 11.25 and shall report all violations in accordance with § 11.20(b)(3).
(a) The management of any horse show, horse exhibition, or horse sale or auction, that contains Tennessee Walking Horses or racking horses, shall maintain for a period of at least 90 days following the closing date of said show, exhibition, or sale or auction, all pertinent records containing:
(1) The dates and place of the horse show, horse exhibition, horse sale, or horse auction.
(2) The name and address (including street address or post office box number and ZIP code) of the sponsoring organization.
(3) The name and address of the horse show, exhibition, horse sale or horse auction management.
(4) The name and address (including street address or post office box number and ZIP code) of the DQP, if any, employed to conduct inspections under § 11.20; and, the name of the horse industry organization or association certifying the DQP.
(5) The name and address (including street address or post office box number, and ZIP code) of each show judge.
(6) A copy of each class or sale sheet containing the names of horses, the names and addresses (including street address, post office box and ZIP code) of horse owners, the exhibitor number and class number, or sale number assigned to each horse, the show class or sale lot number, and the name and address (including street address, post office box, and ZIP code) of the person paying the entry fee and entering the horse in a horse show, horse exhibition, or horse sale or auction.
(7) A copy of the official horse show, horse exhibition, horse sale, or horse auction program, if any such program has been prepared.
(8) The identification of each horse, including the name of the horse, the name and address (including street address, post office box, and ZIP code) of the owner, the trainer, the rider or other exhibitor, and the location (including street address, post office box, and ZIP code) of the home barn or other facility where the horse is stabled.
(b) The management of any horse show, horse exhibition, or horse sale or auction containing Tennessee Walking Horses or racking horses shall designate a person to maintain the records required in this section.
(c) The management of any horse show, horse exhibition, or horse sale or auction containing Tennessee Walking Horses or racking horses shall furnish to any APHIS representative, upon request, the name and address (including street address, or post office box, and ZIP code) of the person designated by the sponsoring organization or manager to maintain the records required by this section.
(d) The Administrator may, in specific cases, require that a horse show, horse exhibition, or horse sale or auction records be maintained by management for a period in excess of 90 days.
(a) The management of any horse show, horse exhibition, or horse sale or auction shall permit any APHIS representative, upon request, to examine and make copies of any and all records pertaining to any horse, either required in any part of the regulations, or otherwise maintained, during ordinary business hours or such other times as may be mutually agreed upon. A room, table, or other facilities necessary for proper examination of such records shall be made available to the APHIS representative.
(b) Horse industry organizations or associations who train, maintain, and license DQP's under a certified DQP program shall permit any APHIS representative, upon request, to examine and copy any and all records relating to the DQP program which are required by any part of the regulations. Such requests shall be made during ordinary business hours or such other times as mutually agreed upon. A room, table or other facilities necessary for proper examination shall be made available upon the request of the APHIS representative.
(a) Within 5 days following the conclusion of any horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, the managements of such show, exhibition, sale or auction shall submit to the Regional Director
(b) Within 5 days following the conclusion of any horse show, horse exhibition, or horse sale or auction which does not contain Tennessee Walking Horses or racking horses, the management of such show, exhibition, sale or auction shall inform the Regional Director for the State in which the show, exhibition, sale or auction was held, of any case where a horse was excused or disqualified by management or its representatives from being shown, exhibited, sold or auctioned because it was found to be sore.
(a) Rulebook. Each HIO that licenses DQPs in accordance with § 11.7 must include in its rulebook, and enforce, penalties for the violations listed in this section that equal or exceed the penalties listed in paragraph (c) of this section and must also enforce the requirement in paragraph (d) of this section.
(b) Suspensions. (1) For the violations listed in paragraph (c) of this section that require a suspension, any individuals who are responsible for showing the horse, exhibiting the horse, entering or allowing the entry of the horse in a show or exhibition, selling the horse, auctioning the horse, or offering the horse for sale or auction must be suspended. This may include, but may not be limited to, the manager, trainer, rider, custodian, or seller, as applicable. In addition, if the owner allowed any activity listed in this paragraph, the owner must be suspended as well.
(2) Any person who is responsible for the shipping, moving, delivering, or receiving of any horse that is found to be bilaterally sore or unilaterally sore as defined in paragraph (c) of this section, in violation of the scar rule in § 11.3, or in violation of the prohibition against the use of foreign substances in § 11.2(c), with reason to believe that such horse was to be shown, exhibited, entered for the purpose of being shown or exhibited, sold, auctioned, or offered for sale in any horse show, horse exhibition, or horse sale or auction, must be suspended; Provided, that this requirement does not apply if the horse was transported by a common or contract carrier or an employee thereof in the usual course of the carrier's business or the employee's employment, unless the carrier or employee had reason to believe that the horse was sore.
(3) A person who is suspended must not be permitted to show or exhibit any horse or judge or manage any horse show, horse exhibition, or horse sale or auction for the duration of the suspension.
(4) Any person with multiple suspensions must serve them consecutively, not concurrently.
(c) Minimum penalties—(1) Bilateral sore. A horse is found to be sore in both its forelimbs or hindlimbs. The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction. First offense: Suspension for 1 year. Second offense: Suspension for 2 years. Third offense and any subsequent offenses: Suspension for 4 years.
(2) Unilateral sore. A horse is found to be sore in one of its forelimbs or hindlimbs. The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction. First offense: Suspension for 60 days. Second offense: Suspension for 120 days. Third offense and any subsequent offenses: Suspension for 1 year.
(3) Scar rule violation. A horse is found to be in violation of the scar rule in § 11.3. The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction. First offense: Suspension for 2 weeks (14 days). Second offense: Suspension for 60 days. Third offense and any subsequent offenses: Suspension for 1 year.
(4) Foreign substance violations. Violations of the prohibition against the use of foreign substances in § 11.2(c).
(i) Before or during the show, exhibition, sale, or auction. The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(ii) After the show, exhibition, sale, or auction. Suspension for 2 weeks (14 days). The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(5) Equipment violation. Violations of the equipment-related prohibitions in § 11.2(b)(1) through (b)(10) and (b)(12) through (b)(17).
(i) Before or during the show, exhibition, sale, or auction. The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(ii) After the show, exhibition, sale, or auction. Suspension for 2 weeks (14 days). The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(6) Shoeing violation. Violation of the shoeing-related prohibitions in § 11.2(b)(18) and (b)(19). The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(7) Heel-toe ratio. Violation of the heel-toe ratio requirement in § 11.2(b)(11). The horse must be dismissed from the remainder of the horse show, exhibition, sale, or auction.
(8) Suspension violation. A violation of any suspension penalty previously issued. Suspension for an additional 6 months (180 days) for each occurrence.
(d) Unruly or fractious horse. A horse that cannot be inspected in accordance with § 11.21. The horse must be dismissed from the individual class for which it was to be inspected.
(e) Appeals. The HIO must provide a process in its rulebook for alleged violators to appeal penalties. The process must be approved by the Department. For all appeals, the appeal must be granted and the case heard and decided by the HIO or the violator must begin serving the penalty within 60 days of the date of the violation. The HIO must submit to the Department all decisions on penalty appeals within 30 days of the completion of the appeal. When a penalty is overturned on appeal, the HIO must also submit evidence composing the record of the HIO's decision on the appeal.
(f) Departmental prosecution. The Department retains the authority to initiate enforcement proceedings with respect to any violation of the Act, including violations for which penalties are assessed in accordance with this section, and to impose the penalties authorized by the Act if the Department determines that such actions are necessary to fulfill the purpose of the Act and this part. In addition, the Department reserves the right to inform the Attorney General of any violation of the Act or of this part, including violations for which penalties are assessed in accordance with this section.
(a) Each person who ships, transports, or otherwise moves, or delivers or receives for movement, any horse with reason to believe such horse may be shown, exhibited, sold or auctioned at any horse show, horse exhibition, or horse sale or auction, shall allow and assist in the inspection of such horse at any such show, exhibition, sale, or auction to determine compliance with the Act as provided in § 11.4 of the regulations and shall furnish to any APHIS representatives upon his request the following information:
(1) Name and address (including street address, post office box, and ZIP code) of the horse owner and of the shipper, if different from the owner or trainer.
(2) Name and address (including street address, post office box, and ZIP code) of the horse trainer.
(3) Name and address (including street address, post office box, and ZIP code) of the carrier transporting the horse, and of the driver of the means of conveyance used.
(4) Origin of the shipment and date thereof, and,
(5) Destination of shipment.
(b) [Reserved]
Each horse industry organization or association which sponsors, or which sanctions any horse show, horse exhibition, or horse sale or auction, shall furnish the Department
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under section 6(a) of the Horse Protection Act of 1970 (15 U.S.C. 1825(a)) and sections 6 (b) and (c) of the Horse Protection Act (15 U.S.C. 1825 (b) and (c)). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administration gives notice of an apparent violation of the Act or the regulations issued thereunder by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to a specified order including an agreement to pay a specified civil penalty within a designated time; and
(3) The Administrator agrees to accept the specified order including a civil penalty in settlement of the particular matter involved if it is paid within the designated time.
(b) If the specified penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 49.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
For the purposes of this part, the following terms mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
APHIS representative. A veterinarian or other person employed by APHIS in animal health activities, who is authorized to perform the function involved.
Approved herd plan. A herd management and testing plan based on the disease history and movement patterns of an individual herd, designed by the herd owner and a State representative or APHIS representative to determine the disease status of livestock in the herd and to eradicate tuberculosis within the herd. The plan must be jointly approved by the State animal health official and the Veterinarian in Charge.
Captive cervid. All species of deer, elk, moose, and all other members of the family Cervidae raised or maintained in captivity for the production of meat and other agricultural products, for sport, or for exhibition, including time such animals are moved interstate; or any wild cervid that is moved interstate, during the period of time from capture until release into the wild. A captive cervid that escapes will continue to be considered a captive cervid as long as it bears an official eartag or other identification approved by the Administrator as unique and traceable with which to trace the animal back to its herd of origin.
Department. The United States Department of Agriculture.
Designated tuberculosis epidemiologist (DTE). A State or Federal epidemiologist designated by the Administrator to make decisions concerning the use and interpretation of diagnostic tests for tuberculosis and the management of tuberculosis affected herds. A DTE has the responsibility to determine the scope of epidemiologic investigations, determine the status of animals and herds, assist in the development of individual herd plans, and coordinate disease surveillance and eradication programs within the geographic area of the DTE's responsibility.
Destroyed. Condemned under State authority and destroyed by slaughter or by death otherwise.
Heifer. A female dairy cow that has not given birth.
Herd. Except for livestock assembled at feedlots, any group of livestock maintained for at least 4 months on common ground for any purpose, or two or more groups of livestock under common ownership or supervision, geographically separated but that have an interchange or movement of livestock without regard to health status, as determined by the Administrator.
Herd depopulation. Removal by slaughter or other means of destruction of all cattle, bison, and captive cervids in a herd, as well as any other exposed livestock in the herd, prior to restocking with new livestock.
Livestock. Cattle, bison, captive cervids, swine, dairy goats, and other hoofed animals (such as llamas, alpacas, and antelope) raised or maintained in captivity for the production of meat and other products, for sport, or for exhibition.
Milking cow. A female dairy cow that has given birth and is being used for milk production.
Mortgage. Any mortgage, lien or other security or interest that is recorded under State law or identified in the indemnity claim form filed under § 50.12 and held by any person other than the one claiming indemnity.
Net salvage. The amount received for animals destroyed because of tuberculosis, after deducting freight, trucking, yardage, commission, slaughtering charges, and similar costs to the owner.
Owner. Any person who has a legal or rightful title to livestock whether or not they are subject to a mortgage.
Permit. A permit for movement of livestock directly to slaughter, listing the disease status and identification of the animal, where consigned, cleaning and disinfection requirements, and proof of slaughter certification.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or any organized group of any of the foregoing.
Quarantined feedlot. A confined area under the direct supervision and control of a State livestock official who shall establish procedures for the accounting of all livestock entering or leaving the area. The quarantined feedlot shall be maintained for finish feeding of livestock in drylot with no provision for pasturing and grazing. All livestock leaving such feedlot must only move directly to slaughter in accordance with established procedures for handling quarantined livestock.
Reactor cattle, bison, and captive cervids. Cattle, bison, and captive cervids are classified as reactors for tuberculosis in accordance with the “Uniform Methods and Rules Bovine Tuberculosis Eradication,” based on a positive response to an official tuberculin test.
Registered livestock. Livestock for which individual records of ancestry are maintained, and for which individual registration certificates are issued and recorded by a recognized breed association whose purpose is the improvement of the breed.
State. Any State, territory, the District of Columbia, or Puerto Rico.
State animal health official. The individual employed by a State who is responsible for livestock and poultry disease control and eradication programs in that State.
State representative. A veterinarian or other person who is employed in livestock sanitary work of a State or a political subdivision of a State and who is authorized by the State or political subdivision to perform the function involved under a memorandum of understanding with the Department.
Tuberculosis. The contagious, infectious, and communicable disease caused by Mycobacterium bovis.
Veterinarian in Charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform official animal health work of APHIS in the State concerned.
(a) The provisions of this subpart apply to all payments made by the Department for the destruction of animals because of tuberculosis, except as specifically provided in subpart B of this part.
(b) The Administrator cooperates with the proper State authorities in the eradication of tuberculosis and pays Federal indemnities for the destruction of cattle, bison, captive cervids, or swine affected with or exposed to tuberculosis.
(a) The Administrator is authorized to agree on the part of the Department to pay indemnity to owners of the following animals:
(1) Cattle, bison, or captive cervids destroyed because the animals are infected with or exposed to tuberculosis;
(2) Cattle, bison, or captive cervids that have been classified as suspect for tuberculosis, except that the payment of indemnity for the destruction of suspect cattle, bison, and captive cervids will be withheld until the tuberculosis status of the suspect animal has been determined and, if the cattle, bison, or captive cervid is found to be infected with tuberculosis, until all cattle, bison, and captive cervids 12 months of age or older in the claimant's herd have been tested for tuberculosis under APHIS or State supervision; and
(3) Other livestock destroyed because they are classified as exposed to tuberculosis by the designated tuberculosis epidemiologist by reason of an association with an affected herd of cattle, bison, or captive cervids.
(b) In each case, the joint State-Federal indemnity paid, together with the amount for net salvage the owner receives, may not exceed the appraised value of the animal, as determined in accordance with § 50.9. Additionally, the Department will in no case pay more than $3,000 for an animal that is destroyed.
(a) Cattle, bison, and captive cervids are classified as infected with tuberculosis on the basis of an intradermal tuberculin test applied by a Federal, State, or an accredited veterinarian or by other diagnostic procedure approved in advance by the Administrator.
(b) Cattle, bison, and captive cervids are classified as exposed to tuberculosis when such cattle, bison, and captive cervids (1) are part of a known infected herd, or (2) are found to have moved from an infected herd before the time infection was disclosed in such herd and after the time such herd had apparently become infected, or (3) are found to have been exposed by virtue of nursing a reactor dam: Provided, That cattle, bison, and captive cervids classified as exposed to tuberculosis shall be removed direct to slaughter.
(c) Cattle and bison are classified as suspects for tuberculosis based on a positive response to an official tuberculin test, in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (incorporated into the regulations by reference in part 77). Captive cervids are classified as suspects for tuberculosis in the same manner as cattle and bison.
(d) The designated tuberculosis epidemiologist will determine whether livestock other than cattle, bison, or captive cervids are classified as exposed to tuberculosis by reason of association with an affected herd of cattle, bison, or captive cervids.
When any cattle, bison, or captive cervid in a herd is classified by an APHIS or State representative or accredited veterinarian as a reactor to a test for tuberculosis, a complete test record shall be made for such herd, including the reactor tag number of each reacting animal and the registration name and number of each reacting registered animal. VS Form 6-22 or an equivalent State form shall be used for the record of any herd having any reactor to a tuberculin test. A copy of the applicable test record shall be given to the owner of any such herd, and one copy of each such record shall be furnished to the appropriate State veterinarian's office.
(a) Livestock to be destroyed because of tuberculosis must be identified as follows:
(1) Livestock classified as reactors for tuberculosis must be identified within 15 days after being classified as reactors, except that the veterinarian in charge may extend the time limit for identification to 30 days when he or she receives a request for such an extension prior to the expiration date of the original 15-day period allowed and circumstances beyond the control of the owner warrant such an extension, and the Administrator may extend the time limit for identification beyond 30 days upon request in specific cases when circumstances beyond the control of the owner warrant such an extension.
(2) Livestock other than reactors for tuberculosis that are to be destroyed because of tuberculosis must be identified prior to movement from the premises of origin to the place of destruction.
(b) Reactor cattle, bison, and captive cervids. Reactor cattle, bison, and captive cervids must be identified by branding the letter “T,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead and by attaching to the left ear an approved metal eartag bearing a serial number and the inscription “U.S. Reactor,” or a similar State reactor tag. Reactor cattle, bison, and captive cervids may be moved interstate to slaughter without branding if they are permanently identified by the letters “TB” tattooed legibly in the left ear, they are sprayed on the left ear with yellow paint, and they are either accompanied by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. The official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(c) Exposed cattle, bison, and captive cervids. Exposed cattle, bison, and captive cervids must be identified by branding the letter “S,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead and by attaching to either ear an approved metal eartag bearing a serial number. Exposed cattle, bison, and captive cervids may be moved interstate to slaughter without branding if they are either accompanied by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. The official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(d) Other exposed livestock. Livestock other than cattle, bison, or captive cervids that are destroyed under the provisions of § 50.3 must be identified by tagging with a serially numbered metal eartag attached to either ear. All such animals to be destroyed must be transported to the place of destruction in vehicles closed with seals provided by APHIS or shall be accompanied to the place of destruction by an APHIS or State representative: Provided, however, that animals destroyed and disposed of under the direct supervision of an APHIS or State representative on the premises where they were exposed do not require individual identification.
(a) Slaughter or disposal. Livestock to be destroyed because of tuberculosis must be shipped direct to slaughter under permit to a Federal or State inspected slaughtering establishment or be disposed of by rendering, burial, or incinerating in an approved manner under supervision of an APHIS or State employee.
(b) Time limit for destruction of animals. Livestock for which Federal indemnity may be paid because of tuberculosis must be destroyed and carcass disposal completed within 15 days after the date of appraisal, except that the appropriate Veterinarian in Charge, for reasons satisfactory to him, may extend the time limit for slaughter to 30 days when request for such extension is received by him prior to the expiration of the original 15-day period allowed, and the Administrator may extend the time limit for slaughter beyond 30 days, upon request in specific cases and for reasons satisfactory to him.
The Department may pay, when approved in advance in writing by the Veterinarian in Charge, one half the expenses of transporting infected, exposed, or suspect livestock to slaughter or to the point where disposal will take place, and one half the expenses of destroying, burying, incinerating, rendering, or otherwise disposing of infected, exposed, or suspect livestock; Provided that, the Department may pay more than one-half of the expenses when the Administrator determines that doing so will contribute to the tuberculosis eradication program. For reimbursement to be made, the owner of the animals must present the Veterinarian in Charge with a copy of either a receipt for expenses paid or a bill for services rendered. Any bill for services rendered by the owner must not be greater than the normal fee for similar services provided by a commercial hauler or renderer.
(a) Livestock to be destroyed because of tuberculosis under § 50.3 must be appraised within 15 days after being classified as infected with tuberculosis, except that the veterinarian in charge may extend the time limit for appraisal to 30 days when he or she receives a request for such an extension before the end of the expiration date of the original 15-day period allowed and circumstances beyond the control of the owner warrant such an extension, and the Administrator may extend the time limit for appraisal beyond 30 days upon request in specific cases when circumstances beyond the control of the owner warrant such an extension.
(b) Animals for which indemnity is to be paid under this part must be appraised at their fair market value by an appraiser selected by APHIS. APHIS may decline to accept any appraisal that appears to it to be unreasonable or out of proportion to the value of like animals of a like quality. Should the appraisal made by the appraiser selected by APHIS be deemed inadequate by the owner of the animals, the owner will have 15 days from the receipt of the appraisal to submit to the Administrator a request for a review of the appraisal, along with the reasons why the animals should be appraised at a higher value. The decision by the Administrator regarding the value of the animals is final.
(c) When livestock to be destroyed because of tuberculosis are appraised, due consideration will be given to their breeding value as well as to their dairy or meat value. Livestock presented for payment as registered must be accompanied by their registration papers. If the registration papers are temporarily not available, or if the livestock are less than 3 years old and unregistered, the veterinarian in charge may grant a reasonable time for the presentation of their registration papers.
Appraisals of livestock made in accordance with § 50.9 shall be recorded on forms furnished by APHIS. The appraisal form shall be signed by the appraiser and by the owner certifying his acceptance of the appraisal. The “date of appraisal” shall be the date that the owner signs the appraisal form. The original of the appraisal form and as many copies thereof as may be required for APHIS, the State, and the owner of the animals shall be sent to the appropriate Veterinarian in Charge.
A report of the salvage derived from the sale of each animal on which a claim for indemnity may be made under the provisions of § 50.3 shall be made on a salvage form acceptable to APHIS which shall be signed by the purchaser or his agent or by the selling agent handling the animals. If the livestock are sold by the pound, the salvage form shall show the weight, price per pound, gross receipts, expenses if any, and net proceeds. If the livestock are not sold on a per pound basis, the net purchase price of each animal must be stated on the salvage form and an explanation showing how the amount was arrived at must be submitted. In the event the animals are not disposed of through regular slaughterers or through selling agents, the owner shall furnish, in lieu of the salvage form, an affidavit showing the amount of salvage obtained by him and shall certify that such amount is all that he has received or will receive as salvage for said animals. In an emergency, a certificate executed by the appropriate Veterinarian in Charge will be acceptable in lieu of the owner's affidavit. The salvage shall be considered to be the net amount received for an animal after deducting freight, truckage, yardage, commission, slaughtering charges, and similar costs. The original of the salvage form or the affidavit of the owner or certificate of the appropriate Veterinarian in Charge, furnished in lieu thereof, shall be furnished to the Veterinarian in charge if it is not already in his possession. Additional copies may be furnished to the State officials, if required. Destruction of livestock by burial, incineration or other disposal of carcasses shall be supervised by an APHIS or State representative who shall prepare and transmit to the Veterinarian in Charge a report identifying the animals and showing the disposition thereof.
Claims for Federal indemnity for livestock destroyed because of tuberculosis shall be presented on indemnity claim forms furnished by APHIS on which the owner of the animals covered thereby shall certify that the animals are or are not, subject to any mortgage as defined in this Part. If the owner states there is a mortgage, the APHIS indemnity claim form shall be signed by the owner and by each person holding a mortgage on the animals consenting to the payment of any indemnity allowed to the person specified thereon. Payment will be made only if the APHIS indemnity claim form has been approved by a proper State official and if payment of the claim has been recommended by the appropriate Veterinarian in Charge or an official designated by him. On claims for indemnity made under the provisions of § 50.3, the Veterinarian in Charge or official designated by him shall record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals shall be furnished a copy of the APHIS indemnity claim form. The Veterinarian in Charge or official designated by him shall then forward the APHIS indemnity claim form to the appropriate official for further action on the claim. No charges for holding the livestock on the farm pending slaughter or for trucking by the owner shall be so deducted or otherwise paid by the Department.
All premises, including all structures, holding facilities, conveyances, or materials which are determined by the appropriate Veterinarian in Charge to constitute a health hazard to humans or animals because of tuberculosis shall be properly cleaned and disinfected, in accordance with procedures approved by the Department, within 15 days after the removal of tuberculosis infected or exposed livestock except that the Veterinarian in Charge, for reasons satisfactory to him, may extend the time limit for disinfection to 30 days when request for such extension is received by him prior to the expiration date of the original 15-day period allowed.
Claims for compensation for livestock destroyed because of tuberculosis will not be allowed in any of the following cases:
(a) The claimant has failed to comply with any of the requirements of this part:
(b) All cattle, bison, and captive cervids 12 months of age or over in the claimant's herd have not been tested for tuberculosis under APHIS or State supervision: Provided, however, that cattle, bison, and captive cervids destroyed because of tuberculosis are exempt from this testing requirement if the cattle, bison, and captive cervids are subjected to a postmortem examination for tuberculosis by a Federal or State veterinarian.
(c) There is substantial evidence that the owner of the animals or the agent of the owner has in any way been responsible for any attempt to obtain indemnity funds for the animals unlawfully or improperly.
(d) At the time the cattle, bison, or captive cervids in the claimant's herd were tested for tuberculosis, the cattle, bison, captive cervids, or other livestock in the herd belonged to or were on the premises of any person to whom they had been sold, shipped, or delivered for slaughter unless or until all of the cattle, bison, captive cervids, and other livestock remaining on the premises or in the herd from which the tested cattle, bison, or captive cervids originated are tested or otherwise examined for tuberculosis in a manner satisfactory to the Administrator or his or her designated representative.
(e) If the cattle, bison, or captive cervids were added to a herd while the herd was quarantined for tuberculosis, unless an approved herd plan was in effect at the time the claim was filed. As part of the approved herd plan, cattle, bison, or captive cervids added to a herd quarantined for tuberculosis must:
(1) Be from an accredited herd, as defined in § 77.1 of this chapter; or
(2)(i) Be from a herd that tested negative to an official tuberculin test, as defined in § 77.1 of this chapter, during the 60 days before the cattle, bison, or captive cervids were added to the claimant's herd; and
(ii) Have been found negative to an official tuberculin test, as defined in § 77.1 of this chapter, during the 60 days before the cattle, bison, or captive cervids were added to the claimant's herd.
(f) For exposed cattle, bison, or captive cervids destroyed during herd depopulation, if a designated tuberculosis epidemiologist has determined that other livestock in the herd have been exposed to tuberculosis by reason of association with tuberculous livestock, and those other livestock determined to have been exposed to tuberculosis have not been destroyed.
(g) For livestock other than cattle, bison, and captive cervids that are destroyed because of association with herds of affected cattle, bison, or captive cervids:
(1) If the livestock did not reside among the herd for a period of 4 months or more;
(2) If the livestock have not received a postmortem examination for tuberculosis; or
(3) If the livestock were added to a herd that was under quarantine for tuberculosis at the time the livestock were added to the herd, unless an approved herd plan was in effect at that time.
(a) Eligibility for payment. Owners of dairy operations, including owners of dairy cattle and other property used in connection with a dairy business or fluid milk processing plant, are eligible to receive payment from the Department under this subpart in connection with a buffer zone depopulation program due to tuberculosis, provided the owners meet all applicable requirements of this subpart and the dairy cattle herd is within the area circumscribed by the following boundaries: Beginning at the point where the Hudspeth-El Paso County line intersects U.S. Highway 62; then west along U.S. Highway 62 to the El Paso Toll Bridge; then southeast along the Rio Grande River to the Fort Hancock-El Porvenir Bridge; then northeast along spur 148 to Interstate 10; then northwest along Interstate 10 to the Hudspeth-El Paso County line; then north along the Hudspeth-El Paso County line to the point of beginning.
(b) To be eligible for payment, each of the owners of dairy cattle and other property within the area described in paragraph (a) of this section must sign and adhere to an agreement with APHIS to do the following:
(1) Cease all dairy cattle operations within the described area and dispose of all sexually intact cattle on the dairy operation premises no later than 3 years after all eligible owners have signed their respective agreements;
(2) Conduct no dairy farming or other dairy activity, including the rearing of breeding cattle, but not including the grazing or feeding of steers and spayed heifers intended for terminal market, within the area described in paragraph (a) of this section until the described area and the adjoining area of Mexico have been declared free of bovine tuberculosis, as determined epidemiologically by APHIS, but in any event for a period of not less than 20 years after all eligible owners have signed their respective agreements.
(3) Allow a covenant to be placed on their properties where dairy operations have been conducted that will prevent the establishment of any breeding cattle operations (not including the grazing or feeding of steers and spayed heifers intended for terminal market) on the premises until the described area and the adjoining area of Mexico have been declared free of bovine tuberculosis, as determined epidemiologically by APHIS, but in any event for a period of not less than 20 years after all eligible owners have signed their respective agreements.
(4) Maintain responsibility for all cattle on the premises used in the dairy operation until those animals are removed from the premises;
(5) Make all arrangements for the removal of sexually intact cattle from the premises;
(6) Notify APHIS officials of the intended removal of all sexually intact cattle from the premises and provide APHIS officials with the opportunity to monitor and evaluate the removal operations; and
(7) Such other terms, provisions, and conditions as agreed by each owner and APHIS.
(c) Amount of payment for cattle and other property. Upon approval of a claim submitted in accordance with § 50.20 of this subpart, owners eligible for payments under paragraph (a) of this section will receive payments for cattle and other property, the amount of which is determined by the following rates:
(1) For milking cows, an amount not to exceed $2,922 per animal; and
(2) For heifers, an amount not to exceed $834 per animal.
(d) Any dairy cattle added to a premises after the date an owner has signed the agreement required under paragraph (b) of this section will not be included in the rate calculation in paragraph (c) of this section and must be disposed of within 3 years after all eligible owners have signed their respective agreements.
(e) Amount of payment for certain other property. In addition to the amounts paid under paragraph (c) of this section, amounts will be paid as follows:
(1) For expenses in relocating equipment of a reverse osmosis plant in El Paso County, TX, an amount equal to the costs of relocating the plant's equipment, not to exceed $675,000.
(2) In conjunction with the permanent closure of a fluid milk processing plant in El Paso County, TX, an amount not to exceed $950,000, with payment to be made in the same manner and at the same times, on a pro rata basis, as payments are made to such owners for their dairy cattle and other property.
(a) All dairy cattle disposed of under this subpart must travel from the premises of origin to their final destination with an approved metal eartag, supplied by APHIS or the State representative, bearing a serial number and attached to each animal's left ear.
(b) Dairy cattle disposed of under this subpart must be shipped under permit either:
(1) Directly to slaughter at a Federal or State inspected slaughtering establishment; or
(2) Under permit directly to a livestock market and, under the supervision of an APHIS representative or State representative, through a livestock market pen that is dedicated to and marked exclusively for use for animals moved to slaughter, and then directly to slaughter at a Federal or State inspected slaughtering establishment.
A report of the salvage derived from the sale of each animal for which a claim for payment is made under this subpart must be made on a salvage form acceptable to APHIS that must be signed by the purchaser or by the selling agent handling the animals. If the cattle are sold by the pound, the salvage form must show the weight, price per pound, gross receipts, expenses if any, and net proceeds. If the cattle are not sold on a per-pound basis, the net purchase price of each animal must be stated on the salvage form and an explanation showing how the amount was arrived at must be submitted. In the event the animals are not disposed of through regular slaughterers or through selling agents, the owner must furnish, in lieu of the salvage form, an affidavit showing the amount of salvage obtained by him or her and must certify that such amount is all he or she has received or will receive as salvage for the animals. The original of the salvage form or the affidavit of the owner must be furnished to the veterinarian in charge within 3 months of destruction of the animals, if such document is not already in his or her possession. Disposal of cattle by burial, incineration, or other means must be supervised by an APHIS or State representative, who will prepare and transmit to the veterinarian in charge a report identifying the animals and showing their disposition, or be documented by an affidavit of the owner that identifies the animals and describes their disposition. The owner must provide a copy of the affidavit to the veterinarian in charge within 3 months of destruction of the animals. The salvage form, disposal certificate, or affidavit will be for information purposes only and will have no effect on the amount of any payment due.
Claims for payment, other than for reimbursement of relocation expenses of the reverse osmosis dairy plant, must be presented on payment claim forms furnished by APHIS.
(a) The Department will make payment, other than for reimbursement of relocation expenses of the equipment of the reverse osmosis plant, at 90-day intervals. The first payment will be made no earlier than 30 days after all owners eligible for payment have signed their agreements required under § 50.17(b). The Department will determine the amount to be paid to each owner in each payment by multiplying the total agreement amount for that owner by a fraction that is arrived at by dividing the initial census number of dairy cattle for the respective owner into the number of dairy cattle that have been removed from the owner's herd during that payment period. From this amount, 10 percent will be withheld until all animals in the herd have been disposed of and the requirements of this subpart have been met. The payments to other property owners will be determined by multiplying the total agreement amount for that other property times the same ratio as for the herd related to that other property, minus 10 percent. The Department will make payment for reimbursement of relocation expenses of the reverse osmosis plant within 30 days after the relocation of the plant is completed and the owner of the plant has submitted to APHIS all documentation of the costs of the relocation.
(b) The Department will not make final payments until the premises used for dairy operations have been without sexually intact cattle for at least 30 days and until APHIS has inspected the premises and has found them to be free of manure, except for non-solid areas such as lagoons, and free of all feedstuffs that are not in barns, containers or feeders.
The Department will not allow claims for payment if the claimant has failed to comply with any of the requirements of this subpart, or there is substantial evidence, as determined by the Administrator, that the claimant has been responsible for any attempt to obtain payment funds for such cattle or other dairy property unlawfully or improperly.
For the purposes of this part, the following terms shall be construed, respectively, to mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animals. Cattle, bison, and breeding swine.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Appraisal. An estimate of the fair market value of an animal to be destroyed because of brucellosis. The estimate shall be based upon the meat, dairy, or breeding value of the animal.
Brucellosis exposed animal. Except for a brucellosis reactor animal, any animal that: (1) Is part of or has been in contact with a herd known to be affected; or (2) has been in contact with a brucellosis reactor animal for a period of 24 hours or longer; or (3) has been in contact with a brucellosis reactor animal which has aborted, calved or farrowed within the past 30 days, or has a vaginal or uterine discharge.
Brucellosis reactor animal. Any animal classified as a brucellosis reactor as provided in the definition of official test in § 78.1 of this chapter.
Claimant. A person who files a claim for indemnity under § 51.7 for animals destroyed under this part.
Complete herd test. An official test for brucellosis (as defined in 9 CFR 78.1) performed under APHIS supervision in a cattle or bison herd on all cattle or bison that are (1) 6 months of age or more and not official vaccinates, except steers and spayed heifers; or (2) Official calfhood vaccinates of any age that are parturient or postparturient; or (3) Official calfhood vaccinates of beef breeds or bison with the first pair of permanent incisors fully erupted (2 years of age or more); or (4) Official calfhood vaccinates of dairy breeds with partial eruption of the first pair of permanent incisors (20 months of age or more).
Condemn. The determination made by an APHIS representative, State representative, or accredited veterinarian that animals for which indemnity is sought under this Part shall be destroyed.
Dairy cattle. A female bovine of a recognized dairy breed over 20 months of age, which has calved or is within 90 days of parturition and which is a member of a dairy herd used to produce milk for commercial use.
Destroyed. Condemned under State authority and slaughtered or otherwise dies.
Herd. Any group of animals of the same species maintained on common ground for any purpose, or two or more groups of animals (of the same species) under common ownership or supervision, geographically separated but which have an interchange or movement of animals without regard to health status.
Herd Depopulation. Removal by slaughter or other means of destruction of all cattle, bison, or swine in a herd or from a specific premises or under common ownership prior to restocking such premises with new animals, except that steers and spayed heifers or barrows and gilts maintained for feeding purposes may be retained on the premises if the Veterinarian in Charge finds such retention to be compatible with eradication efforts. The Veterinarian in Charge may also permit removal of nonpregnant heifers, without payment of indemnity, to Quarantined Feedlots in lieu of immediate slaughter.
Herd known to be affected. Any herd in which any animal has been classified as a brucellosis reactor and which has not been released from quarantine.
Inbred or hybrid swine. Any breeding swine which are the progeny of two or more breeds of registered swine and which are maintained to produce inbred or hybrid swine, and for which records of ancestry exist through which such swine can be individually identified as progeny of said registered swine.
Mortgage. Any mortgage, lien, or other security or interest that is recorded under State law or identified in the indemnity claim form filed under § 51.7 and held by any person other than the one claiming indemnity.
Official seal. A serially numbered metal strip consisting of a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged, which cannot be reused if opened, and is applied by a representative of the Veterinarian in Charge or the State animal health official.
Owner. Any person who has a legal or rightful title to animals whether or not they are subject to a mortgage.
Permit. An official document for movement of animals under this subpart issued by an APHIS representative, state representative, or accredited veterinarian listing the disease status and identification of the animal, where consigned, cleaning and disinfecting requirements, and proof of slaughter certification.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other legal entity.
Recognized slaughtering establishment. Any slaughtering establishment operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.)or a State meat inspection act.
Registered breed association. An association formed and perpetuated for the maintenance of records of purebreeding of animal species for a specific breed whose characteristics are set forth in Constitutions, By-Laws, and other rules of the association. The records maintained by such an association shall include an Official Herd Book or other recordkeeping format and Certificates of Registration or Recordation which identify an animal as a registered animal of that registered breed association. Known registered breed associations are: American Angus Association, American Beefalo Association, Inc., The American Black Maine-Anjou Association, American Blonde d'Aquitaine Association, American Brahman Breeders Association, American Brahmental Association, American Breed Association, Inc., American Chianina Association, American Dexter Cattle Association, American Galloway Breeders Association, American Gelbvieh Association, American Guernsey Cattle Club, American Hereford Association, American International Charolais Association, American (International Marchigiana Society, American Jersey Cattle Club, American Maine-Anjou Association, American Milking Shorthorn Society, American Murray Grey Association, American Normande Association, American Pinzgauer Association, American Polled Hereford Association, American Red Brangus Association, American Red Poll Association, American Salers Association, American Scotch Highland Breeders Association, American Shorthorn Association, American Simmental Association, Inc., American Tarentaise Association, Ankina Breeders, Inc., Ayrshire Breeders Association, Barzona Breed Association of America, Beefmaster Breeders Universal, Belted Galloway Society, Brahmanstein Breeders Association, Brown Swiss Beef International, Inc., Brown Swiss Cattle Breeders Association of U.S.A., Char-Swiss Breeders Association, Devon Cattle Association, Inc., Dutch Belted Cattle Association of America, Inc., Foundation Beefmaster Association, Galloway Cattle Society of America, Inc., Galloway Performance International, Holstein-Friesian Association of America, International Braford Association, International Brangus Breeders Association, Inc., International Maine-Anjou Association, Marky Cattle Association, Mid America RX
Registered cattle. Cattle for which individual records of ancestry are recorded and maintained by a breed association whose purpose is the improvement of the bovine species, and for which individual registration certificates are issued and recorded by such breed association.
Registered swine. Any breeding swine for which a certificate of pure breeding has been issued by a purebred swine association.
Sexually intact exposed female calf. A female bovine less than 6 months of age that is nursed by a brucellosis reactor at the time such reactor is condemned, and that has not been altered to make it incapable of reproduction.
Specifically approved stockyard. Premises approved by the Administrator, in accordance with § 71.20 of this chapter, for assembling cattle or bison for sale.
State. Any State, the District of Columbia, Puerto Rico, the Virgin Islands of the United States, Guam, the Northern Mariana Islands, or any other territory or possession of the United States.
State animal health official. The individual employed by a State who is responsible for livestock and poultry disease control and eradication programs in that State.
State representative. An individual employed in animal health activities by a State or a political subdivision thereof, and who is authorized by such State or political subdivision to perform the function involved under a cooperative agreement with the United States Department of Agriculture.
Unofficial vaccinate. Any cattle or bison which have been vaccinated for brucellosis other than in accordance with the provisions for official vaccinates set forth in § 78.1 of this chapter.
Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform official animal health work of the Animal and Plant Health Inspection Service, in the State concerned.
The Administrator has been delegated the authority to cooperate with the proper State authorities in the eradication of brucellosis and to pay indemnities for the destruction of brucellosis-reactor animals or brucellosis-exposed animals.
(a) Cattle and bison. The Administrator may authorize the payment of Federal indemnity by the U.S. Department of Agriculture to any owner whose cattle or bison are destroyed after having been approved for destruction by APHIS under the brucellosis eradication program.
(1) Eligibility for indemnity. Owners of the following types of animals destroyed because of brucellosis are eligible to receive Federal indemnity for their animals:
(i) Cattle and bison identified as reactors as a result of a complete herd test and any sexually intact exposed female calves;
(ii) Cattle and bison in a herd that has been approved for depopulation; and
(iii) Brucellosis-exposed cattle and brucellosis-exposed bison that were previously sold or traded from any herd that was, subsequent to the sale or trade, found to be affected with brucellosis. Epidemiological information such as test results, herd history, and related evidence will be used to establish a probable date when the herd was first affected with brucellosis. Animals sold after that date will be considered to be exposed; those sold before that date will not.
(2) Maximum per-head indemnity amounts. Owners of the types of animals described in § 51.3(a)(1) are eligible to receive Federal indemnity for their animals in the following amounts:
(i) Brucellosis reactors and sexually intact exposed female calves. Except for brucellosis reactors and sexually intact exposed female calves destroyed as part of a whole-herd depopulation, the indemnity for cattle and bison that are brucellosis reactors shall not exceed $250 for any registered cattle and nonregistered dairy cattle or $50 for any bison or nonregistered cattle other than dairy cattle, and the indemnity for sexually intact exposed female calves shall not exceed $50.
(ii) Herd depopulations and individual exposed animals. Owners of herds that have been approved for depopulation and owners of brucellosis-exposed cattle and brucellosis-exposed bison that meet the conditions of § 51.3 (a)(1)(iii) may choose either of the two methods described in paragraphs (a)(2)(ii)(A) and (a)(2)(ii)(B) of this section, involving fair market value of the animal to be destroyed or a fixed rate, for determining the maximum amounts of indemnity they may receive.
(A) Appraisal method. Each eligible animal will be appraised to determine its fair market value. The indemnity shall be the appraised value, minus the salvage value.
(B) Fixed-rate method. The indemnity shall not exceed $250 per animal for bison and nonregistered cattle other than dairy cattle and $750 per animal for registered cattle and nonregistered dairy cattle.
(b) Swine—(1) Brucellosis reactor swine. The Administrator may authorize
(2) Herd depopulation. The Administrator may authorize
(3) Exposed swine. The Administrator may authorize
The claimant shall be responsible for providing information to an APHIS representative, State representative, or accredited veterinarian so that a complete test record may be made by such person on an APHIS approved form for each herd known to be affected, including the reactor tag number of each brucellosis reactor animal and the registration name and number of each brucellosis reactor registered animal. A copy of the applicable test record shall be given to the owner of any such herd, and one copy of each such record shall be furnished to the appropriate State veterinarian's office by such person who completes the test record.
(a) The claimant shall be responsible for insuring that any animal for which indemnity is claimed shall be identified in accordance with the provisions of this section within 15 days after having been classified as a reactor or for any other animal subject to this part within 15 days after having been condemned. The veterinarian in charge may extend the time limit to 30 days when a request for such extension is received by him prior to the expiration date of the original 15 day period allowed, and when he determines that the extension will not adversely affect the brucellosis eradication program; and except further, that the Administrator shall upon request in specific cases, extend the time limit beyond the 30-day period when unusual or unforeseen circumstances occur which prevent or hinder the identification of the animals within the 30-day period, such as, but not limited to, floods, storms, or other Acts of God which are beyond the control of the owner, or when identification is delayed due to requirements of another Federal Agency.
(b) Except as provided in paragraph (b)(4) of this section, cattle and bison to be destroyed because of brucellosis shall be individually identified prior to moving interstate by attaching to the left ear a metal tag bearing a serial number and the inscription “U.S. Reactor,” or a similar State reactor tag, and must be:
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(4) Reactor and exposed cattle and bison in herds scheduled for herd depopulation may be moved interstate without eartagging or branding if they are identified by USDA approved backtags and either accompanied directly to slaughter by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(c) Swine shall be individually identified by tagging with a metal tag bearing a serial number and inscription “U.S. Reactor” or a similar State reactor tag or other identification approved by the Administrator, upon request in specific cases, attached to the left ear of each animal.
(a) Cattle. The claimant shall be responsible for ensuring that cattle subject to this part shall be sold under permit to a recognized slaughtering establishment or to a specifically approved stockyard for sale to a recognized slaughtering establishment.
(b) Bison. The claimant shall be responsible for insuring that bison subject to this part shall be sold under permit to a State or Federal slaughtering establishment approved by the Administrator for this purpose or to a stockyard approved by the Administrator for sale to such a slaughtering establishment, Provided, However, That the Administrator may approve such other bison slaughtering establishments as may be deemed necessary to accomplish destruction of bison subject to this part.
(c) Swine. The claimant shall be responsible for insuring that swine subject to this part shall be sold under permit to a slaughtering establishment where State or Federal Meat inspection is available, or to a market approved by the State Animal Health Official, or to a market approved by the Administrator, for sale to such slaughtering establishment;
(d) Time limit for destruction of animals. Payment of indemnity shall be made under this part only if the animals are destroyed within 15 days after the date of identification, pursuant to § 51.5 of the regulations in this part, except that the appropriate Veterinarian in Charge may extend the time limit to 30 days when request for such extension is received from the owner prior to the expiration date of the original 15-day period allowed, or when the animals were sold for slaughter prior to the expiration date of the original 15-day period, and when the Veterinarian in Charge determines that such extension will not adversely affect the Brucellosis Eradication Program; and except further, that the Administrator shall, upon request in specific cases, extend the time limit beyond the 30-day period when unusual and unforeseen circumstances occur which prevent or hinder the destruction of the animals within the 30-day period, such as, but not limited to, floods, storms, or other Acts of God which are beyond the control of the owner, or when destruction is delayed due to requirements of another Federal Agency.
(a) Claims for indemnity for animals destroyed because of brucellosis shall be presented on indemnity claim forms furnished by APHIS on which the owner of the animals covered thereby shall certify that the animals are or are not subject to any mortgage as defined in this part. If the owner states there is a mortgage, the APHIS indemnity claim form shall be signed by the owner and by each person holding a mortgage on the animals, consenting to the payment of any indemnity allowed to the person specified thereon. Payment will be made only if the claimant has submitted a complete indemnity claim form to, and such claim has been approved by the Veterinarian in Charge or by an APHIS representative designated by him. On claims for indemnity made under the provisions of § 51.3, the Veterinarian in Charge or an APHIS representative designated by him shall record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals shall be furnished a copy of the completed APHIS indemnity claim form. The Veterinarian in Charge or an APHIS representative designated by him shall then forward the completed APHIS indemnity claim form to the Administrator for further action on the claim. No charges for holding the animals on the farm pending slaughter or for trucking by the owner shall be so deducted or otherwise paid by the United States Department of Agriculture.
(b) Claims for indemnity for registered cattle shall be accompanied by the cattle's registration papers issued in the name of the owner. If the registration papers are unavailable or if the cattle are less than 1 year old and are not registered at the time the claim for indemnity is submitted, the Veterinarian in Charge may grant a 60-day extension or the Administrator may grant an extension longer than 60 days for the presentation of registration papers.
All premises, including all structures, holding facilities, conveyances, and materials, contaminated because of occupation or use by brucellosis reactor or exposed animals shall be properly cleaned and disinfected with a disinfectant permitted by APHIS in accordance with recommendations of the APHIS or State representative within 15 days from the date reactors were removed from the premises, except that the appropriate Veterinarian in Charge may extend the time limit for disinfection to 30 days when request for such extension is received by him prior to the expiration date of the original 15-day period allowed, and when he determines that such extension will not adversely affect the Brucellosis Eradication Program; and except further, that the Administrator may, upon request in specific cases, extend the time limit beyond the 30-day period when unusual and unforeseen circumstances occur, such as but not limited to floods, storms, or other Acts of God, which are beyond the control of the owner, preventing or hindering the disinfection of premises, conveyances, and materials. Certain premises may be exempted from such cleaning and disinfecting requirements by approval of the appropriate Veterinarian in Charge on written recommendations by the APHIS or State representative or when a written report by the APHIS or State representative determines that there are no buildings, holding facilities, conveyances, or other materials on the premises that would require such cleaning and disinfection.
Claims for compensation for animals destroyed because of brucellosis shall not be allowed if any of the following circumstances exist:
(a) If the claimant has failed to comply with any of the requirements of this part.
(b) If the existence of brucellosis in the animal was determined based on the results of an official test, as defined in § 78.1 of this chapter, and specific instructions for the administration of the official test had not previously been issued to the individual performing the test by APHIS and the State animal health official.
(c) If all cattle, bison, and swine eligible for testing in the claimant's herd have not been tested for brucellosis under APHIS or State supervision.
(d) If the animals are:
(1) Barrows or gilts maintained for feeding purposes; or
(2) Spayed heifers or steers, unless the steers are work oxen, or unless the spayed heifers or steers are unweaned animals in a herd approved for depopulation in accordance with § 51.3 of this part.
(e) If the animals are classified as reactors and are unofficial vaccinates, unless there is either a record of a negative official test made not less than 30 days following the date of unofficial vaccination or unless other APHIS approved tests show the unofficial vaccinates are affected with virulent Brucella.
(f) If there is substantial evidence that the owner or his agent has in any way been responsible for any unlawful or improper attempt to obtain indemnity funds for such animal.
(g) If, at the time of test or condemnation, the animals belonged to or were upon the premises of any person to whom they had been sold for slaughter; shipped for slaughter, or delivered for slaughter.
(h) If any known brucellosis reactor animal remains in the herd, unless, in the opinion of the Veterinarian in Charge, a reasonable search has been made for the brucellosis reactor animal and the brucellosis reactor animal could not be found and removed.
(i) If the animals are brucellosis reactor animals which are slaughtered other than as part of a herd depopulation, and which are from a herd: (1) That was already classified as a “herd known to be affected” at the time the animals were identified as brucellosis reactor animals and (2) for which an approved action plan or approved individual herd plan (as defined in § 78.1 of this chapter) was not in effect at the time the claim was filed.
No claim for indemnity for animals destroyed because of brucellosis shall hereafter be paid under the regulations contained in part 53 of this chapter, but all such claims shall be presented and paid pursuant to and in compliance with regulations contained in this part.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Affected herd/flock. Any herd or flock in which any cattle, bison, breeding swine, sheep, or goat has been classified as a brucellosis reactor and which has not been released from quarantine.
Animal. Sheep, goats, and horses.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Appraisal. An estimate of the fair market value of an animal to be destroyed because of brucellosis.
Brucellosis exposed. Except for brucellosis reactors, animals that are part of a herd known to be affected, or are in a quarantined feedlot or a quarantined pasture, or are brucellosis suspects, or that have been in contact with a brucellosis reactor for a period of 24 hours or more, or for a period of less than 24 hours if the brucellosis reactor has aborted, calved, or farrowed within the past 30 days or has a vaginal or uterine discharge.
Brucellosis reactor animal. (1) Any sheep or goat that has been determined by a designated brucellosis epidemiologist
(2) Any horse that has been determined by a designated brucellosis epidemiologist to be affected with brucellosis, based on epidemiological information or culture results, or positive results for brucellosis in accordance with one of the following tests:
| Test | Positive results |
|---|---|
| Standard plate test (SPT) | If antibody titer positive at 1:100 dilution or higher. |
| Standard tube test (STT) | If antibody titer positive at 1:100 dilution or higher. |
| Rivanol test | If antibody titer positive at 1:50 dilution or higher. |
| Particle concentration fluorescence immunoassay (PCFIA) | If reading is 0.3 or lower. |
| Complement fixation test (CF) | If reading is 2 + :20 dilution. |
(3) Any cattle, bison, or swine classified as a brucellosis reactor as provided in the definition of official test in § 78.1 of this chapter.
Condemn. The determination made by an APHIS representative, State representative, or accredited veterinarian that animals for which indemnity is sought under this subpart will be destroyed.
Designated brucellosis epidemiologist. An epidemiologist selected by the State animal health official and the Veterinarian in Charge to perform the functions required. The regional epidemiologist and the APHIS brucellosis staff must concur in the selection and appointment of the designated epidemiologist.
Destroyed. Condemned under State authority and slaughtered or otherwise dies.
Flock. Any group of sheep maintained on common ground for any purpose, or two or more groups of sheep under common ownership or supervision, geographically separated but which have an interchange or movement of animals without regard to health status.
Herd. Any group of goats, or mixed sheep and goats, maintained on common ground for any purpose, or two or more groups of goats, or two or more groups of mixed sheep and goats, under common ownership or supervision, geographically separated but which have an interchange or movement of animals without regard to health status.
Herd/flock depopulation. Removal by slaughter or other means of destruction of all sheep or goats in a flock or herd, or from a specific premises or under common ownership prior to restocking such premises with new animals.
Mortgage. Any mortgage, lien, or interest that is recorded under State law or identified in the indemnity claim form filed in accordance with this subpart, and held by any person other than the one claiming indemnity.
Official seal. A serially numbered metal strip consisting of a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged and which cannot be reused if opened, and is applied by a representative of the Veterinarian in Charge or the State animal health official.
Owner. Any person who has legal or rightful title to sheep, goats, and horses, whether or not the animals are subject to a mortgage.
Permit. An official document for movement of animals under this subpart issued by an APHIS representative, State representative, or accredited veterinarian listing the disease status and identification of the animal, where consigned, cleaning and disinfecting requirements, and proof of slaughter certification.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other legal entity.
Registered sheep and goats. Sheep and goats for which individual records of ancestry are recorded and maintained by a breed association whose purpose is the improvement of the species, and for which individual registration certificates are issued and recorded by such breed association.
State. Any State, the District of Columbia, Puerto Rico, the Virgin Islands of the United States, Guam, the Northern Mariana Islands, or any other territory or possession of the United States.
State representative. An individual employed in animal health activities by a State or a political subdivision thereof, and who is authorized by such State or political subdivision to perform the function involved under a cooperative agreement with the United States Department of Agriculture.
Veterinarian in Charge. The APHIS veterinary official who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State or area concerned, or any person authorized to act for the Veterinarian in Charge.
The Administrator has been delegated the authority to cooperate with the proper State authorities in the eradication of brucellosis and to pay indemnities for the destruction of brucellosis-reactor animals or brucellosis-exposed animals.
(a) The Administrator may authorize the payment of Federal indemnity by the U.S. Department of Agriculture to any owner whose goats, sheep, or horses are destroyed after having been approved for destruction by APHIS.
(b) The amount of Federal indemnity will be determined in accordance with the regulations in this part that were in effect on the date infected animals were found, or the date that the whole-herd/flock depopulation or destruction of individual animals was approved.
(c) Prior to payment of indemnity, proof of destruction must be furnished to the Veterinarian in Charge.
Owners of animals destroyed because of brucellosis are eligible to receive Federal indemnity for their animals if the animals are:
(a) Sheep and goats in an affected herd or flock;
(b) Sheep and goats that were obtained from a herd or flock that was subsequently found to be an affected herd or flock. Epidemiological information such as test results, herd/flock history, and related evidence will be used to establish a probable date when the herd or flock was first affected with brucellosis. Animals removed from the herd or flock after that date will be considered exposed to the disease and eligible for indemnity; those removed before that date will not;
(c) Individual horses that have been found to be brucellosis reactor animals.
Owners of the types of animals listed in § 51.22 of this subpart are eligible to receive Federal indemnity for their animals. All animals must be individually appraised to determine their fair market value. The indemnity amount will be the appraised value minus the salvage value of the animal, up to a maximum of $20,000 per animal in the case of horses. An independent appraiser selected by the Administrator will conduct appraisals. APHIS will pay the cost of appraisals.
The Veterinarian in Charge will accept any of the following documents as proof of destruction:
(a) A postmortem report;
(b) A meat inspection certification of slaughter;
(c) A written statement by a State representative, APHIS representative, or accredited veterinarian attesting to the destruction of the animals;
(d) A written, sworn statement by the owner or caretaker of the animal attesting to the destruction of the animals;
(e) A permit (VS Form 1-27) consigning the animal from a farm or livestock market directly to a slaughter establishment; or
(f) In unique situations where none of the documents listed above are available, other similarly reliable forms of proof of destruction.
An APHIS representative, State representative, or accredited veterinarian will compile, on an APHIS-approved form, a complete test record for each animal. The claimant must provide any information necessary to complete the form. The test record must include the type of test and the test results for each animal. It must also include the individual identification of each tested animal. Any unique, individually numbered identification is acceptable. The animal's owner and the appropriate State veterinarian's office will each receive a copy of the test record.
The claimant must ensure that any goats, sheep, and horses for which indemnity is claimed are marked with unique, individually numbered identification showing they are to be destroyed. This must be done within 15 days after the animals are condemned. The Veterinarian in Charge may extend the time limit to 30 days when the Veterinarian in Charge receives a request for extension prior to the expiration date of the original 15-day period, and when the Veterinarian in Charge determines that the extension will not adversely affect the brucellosis eradication program. However, the Administrator may extend the time limit beyond 30 days when unusual or unforeseen circumstances occur that prevent or hinder the identification of the animal within 30 days, such as, but not limited to, floods, storms, or other Acts of God, which are beyond the control of the owner, or when identification is delayed due to requirements of another Federal agency.
Goats, sheep, and horses to be destroyed because of brucellosis must be accompanied by a permit and either:
(a) Accompanied directly to slaughter by an APHIS or State representative; or
(b) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(a) The claimant must ensure that goats, sheep, and horses infected with or exposed to B. abortus are either:
(1) Sold under permit to a recognized slaughtering establishment;
(2) Moved to an approved stockyard for sale to a recognized slaughtering establishment; or
(3) Destroyed and buried, incinerated, or rendered in accordance with applicable State law.
(b) The claimant must ensure that goats and sheep destroyed because of B. melitensis are destroyed and buried, incinerated, or rendered in accordance with applicable State law.
(c) Indemnity will be paid under this part only if the animals are destroyed within 15 days after the date they are marked with identification showing they are to be destroyed. However, the Veterinarian in Charge may extend the time limit to 30 days if:
(1) The animals' owner asks the Veterinarian in Charge for an extension before the initial 15-day period expires, or the animals were sold for slaughter before the original 15-day period expires; and
(2) The Veterinarian in Charge determines that extending the time limit will not adversely affect the Brucellosis Eradication Program.
(d) The Administrator may extend the time limit beyond 30 days when unusual and unforeseen circumstances occur that prevent or hinder the destruction of the animals within 30 days, such as, but not limited to, floods, storms, or other Acts of God, which are beyond the control of the owner, or when destruction is delayed due to requirements of another Federal agency.
(a) Claims for indemnity for goats, sheep, and horses destroyed because of brucellosis must be made using an indemnity claim form furnished by APHIS. On the form, the owner of the animals must certify whether the animals are subject to a mortgage. If the owner states there is a mortgage, the claim form must be signed by the owner and by each mortgage holder, consenting to the payment of any indemnity allowed to the owner. Payment will be made only if the claimant has submitted a complete indemnity claim form to the Veterinarian in Charge and the claim has been approved by the Veterinarian in Charge or by an APHIS representative designated by him or her. The Veterinarian in Charge or an APHIS representative designated by the Veterinarian in Charge will record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals will receive a copy of the completed APHIS indemnity claim form. The owner is responsible for paying all fees for holding the animals on the farm pending disposal and for all trucking fees.
(b) Claims for indemnity for registered sheep and registered goats must be accompanied by the animal's registration papers, issued in the name of the owner. If the registration papers are unavailable or if the animal is less than 1 year old and not registered at the time the claim for indemnity is submitted, the Veterinarian in Charge may grant a 60-day extension or the Administrator may grant an extension longer than 60 days for the presentation of registration papers. Any animal that is not registered but is eligible for registration at the time the claim is submitted will be considered unregistered unless the animal has been in the flock for less than 12 months.
All premises, including all structures, holding facilities, conveyances, and materials contaminated because they have been used by animals destroyed because of brucellosis, must be properly cleaned and disinfected in accordance with recommendations of the APHIS or State representative. Cleaning and disinfecting must be completed within 15 days from the date the animals were removed from the premises, except that the Veterinarian in Charge may extend the time limit for disinfection to 30 days when he or she receives a request prior the expiration date of the original 15 days, and when the Veterinarian in Charge determines that an extension will not adversely affect the Brucellosis Eradication Program. The Administrator may extend the time limit beyond 30 days when unusual and unforeseen circumstances occur that prevent or hinder disinfection of the premises, conveyances, and materials within 30 days, such as, but not limited to floods, storms, or other Acts of God, which are beyond the control of the owner. A premises may be exempted from such cleaning and disinfecting requirements if the APHIS or State representative recommends it in writing and the Veterinarian in Charge approves.
Claims for indemnity for goats, sheep, and horses destroyed because of brucellosis will not be allowed if any of the following circumstances exist:
(a) The claimant has failed to comply with any of the requirements of this part;
(b) The claim is based on a brucellosis test, and the person who administered the test was not properly trained, authorized, or certified at the time of the test;
(c) Testing of goats, sheep, and horses in the herd or flock for brucellosis was not done under APHIS or State supervision, or by an accredited veterinarian;
(d) There is substantial evidence that the claim is an unlawful or improper attempt to obtain indemnity; or
(e) If, at the time of test or condemnation, the animals belonged to or were upon the premises of any person to whom they had been sold for slaughter, shipped for slaughter, or delivered for slaughter.
APHIS has indemnity programs for several other livestock diseases. However, if a claim is paid for indemnity for animals destroyed because of brucellosis, no other claims for indemnity will be paid for the same animals.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.
Approved differential pseudorabies test. Any test for the diagnosis of pseudorabies that can distinguish vaccinated swine from infected swine; is produced under license from the Secretary of Agriculture under the Virus-Serum-Toxin Act of March 4, 1913, and subsequent amendments (21 U.S.C. 151 et seq.) with indications for use in the Cooperative State-Federal Pseudorabies Eradication Program; and is conducted in a laboratory approved by the Administrator.
Department. The United States Department of Agriculture.
Herd. Any group of swine maintained on common ground for any purpose, or two or more groups of swine under common ownership or supervision that are geographically separated but that are determined by an official pseudorabies epidemiologist to have an interchange or movement of animals that could cause the transmission of pseudorabies from one group to another.
Inspector in charge. An APHIS employee who is designated by the Administrator to take charge of work in connection with the control and eradication of disease.
Known infected breeding sow. Any breeding sow that has been determined to be infected with pseudorabies based on an official pseudorabies test or an approved differential pseudorabies test, or as diagnosed by an official pseudorabies epidemiologist as having pseudorabies.
Known infected herd. Any herd in which swine have been determined to be infected with pseudorabies based on an official pseudorabies test or an approved differential pseudorabies test, or based on a diagnosis by an official pseudorabies epidemiologist.
Materials. Parts of barns or other structures, straw, hay, and other feed for animals, farm products or equipment, clothing, and articles stored in or adjacent to barns or other structures.
Mortgage. Any mortgage, lien, or other security or beneficial interest held by any person other than the one claiming indemnity.
Net salvage. The amount received for swine destroyed because of pseudorabies, after deducting freight, trucking, yardage, commission, slaughtering charges, and similar costs to the owner.
Official pseudorabies epidemiologist. A State or Federally employed veterinarian designated by the State animal health official and the veterinarian in charge to investigate and diagnose pseudorabies in livestock.
Official pseudorabies test. Any test for the diagnosis of pseudorabies approved by the Administrator and conducted in a laboratory approved by the Administrator. The following tests for the diagnosis of pseudorabies have been approved by the Administrator: Microtitration Serum-Virus Neutralization Test; Virus Isolation and Identification Test; Fluorescent Antibody Tissue Section Test; Enzyme-Linked Immunosorbent Assay (ELISA) Test, except for approved differential pseudorabies tests other than the glycoprotein I (gpI) ELISA test; Latex Agglutination Test (LAT); and Particle Concentration Fluorescence Immunoassay (PCFIA) Test.
Official seal. A serially numbered metal or plastic strip, consisting of a self-locking device on one end and a slot on the other end, that forms a loop when the ends are engaged and that cannot be reused if opened, or a serially numbered, self-locking button that can be used for this purpose.
Permit. An official document for movement of swine under this part that is issued by an APHIS employee, State representative, or accredited veterinarian and that lists the disease status and individual identification of the animal, where consigned, cleaning and disinfection requirements, and proof of slaughter certification by a recognized slaughtering establishment.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Pseudorabies. The contagious, infectious, and communicable disease of livestock and other animals, also known as Aujeszky's disease, mad itch, or infectious bulbar paralysis.
Recognized slaughtering establishment. A slaughtering establishment operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act.
Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department delegated to act in the Secretary's stead.
State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
State representative. A person regularly employed in the animal health work of a State and who is authorized by that State to perform the function involved under a cooperative agreement with the United States Department of Agriculture.
Veterinarian in charge. The veterinary official of Veterinary Services, APHIS, who is assigned by the Administrator to supervise and perform official animal health work for APHIS in the State concerned.
(a) Except as provided in paragraph (b) of this section, the Administrator is authorized to agree on the part of the Department to pay indemnity to the owner of herds of swine destroyed because the herds are known to be infected with pseudorabies, or individual breeding sows destroyed because they are known to be infected with pseudorabies. The amount of indemnity paid, together with the amount for net salvage the owner receives when the animals are slaughtered, shall not exceed the fair market value of the swine. Such swine must be sent directly to slaughter under permit in a conveyance closed with an official seal applied and removed by either an APHIS employee, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS employee. The swine must be sent to a recognized slaughtering establishment.
(b) If swine from herds that are destroyed because the herds are known to be infected with pseudorabies are not accepted at a recognized slaughtering establishment, or the owner and an APHIS employee or State representative agree they will not be accepted by a recognized slaughtering establishment, the Administrator is authorized to pay 100 percent of the expenses of the purchase, destruction, and disposition of such swine.
(a) Herds of swine and individual breeding sows to be destroyed because they are known to be infected with pseudorabies will be appraised by an APHIS employee and a representative of the State jointly, a representative of the State alone, or, if the State authorities approve, by an APHIS employee alone.
(b) The appraisal of swine will be based on the fair market value as determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that where appraisal is by the head, each animal in the group is the same value per head, and where appraisal is by the pound, each animal in the group is the same value per pound.
(c) Appraisals of swine must be reported on forms furnished by APHIS and signed by the owner of the swine. Reports of appraisals must show the number of swine and the value per head or the weight and value by pound.
(a) When swine have been destroyed under § 52.2(a), any claim for indemnity must be presented, along with the report of net salvage proceeds required under § 52.5, to the veterinarian in charge on a form furnished by APHIS.
(b) When swine have been destroyed under § 52.2(b), any claim for indemnity must be presented, through the inspector in charge, to APHIS on a form furnished by APHIS.
(c) For all claims for indemnity, the owner of the swine must certify on the claim form that the swine covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the swine must sign, consenting to the payment of indemnity to the person specified on the form.
A report of the amount for net salvage derived from the sale of each animal for which a claim for indemnity is made under § 52.2(a) must be made on a salvage form that shows the gross receipts, expenses if any, and net proceeds. The original or a copy of the salvage form must be furnished by the owner to the veterinarian in charge.
(a) The Department will not allow claims arising out of the destruction of swine unless the swine have been appraised as prescribed in this part and the owners have signed a written agreement to the appraisals.
(b) The Department will not allow claims arising out of the destruction of swine that have been moved or handled by the owner or a representative of the owner in violation of a law or regulation administered by the Secretary regarding animal disease, or in violation of a law or regulation for which the Secretary has entered into a cooperative agreement.
All premises, including barns, stockyards and pens, and all cars and other conveyances, and the materials on any premises or conveyances used to house or transport swine for which indemnity is paid under this part must be cleaned and disinfected under the supervision of an APHIS employee after removal of the swine from the known infected herd. Premises may be restocked with swine 30 days following an approved cleaning and disinfection, unless an official pseudorabies epidemiologist determines that a shorter or longer period of time is adequate or necessary to protect new animals against infection. The owner to whom the indemnity is paid will be responsible for expenses incurred in connection with the cleaning and disinfection, except for cleaning and disinfection of the conveyances used to transport the swine to the location of disposal.
For non-applicability of part 53 with respect to certain claims for indemnity, see § 51.10 of this chapter.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of subchapter A of this chapter and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
Animals. Livestock, poultry, and all other members of the animal kingdom, including birds whether domesticated or wild, but not including man.
APHIS employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.
Bird. Any member of the class aves other than poultry.
Buffer zone. The zone within a control area that immediately surrounds an infected zone.
Control area. The area around a premises infected with highly pathogenic avian influenza and consisting of an infected zone and a buffer zone, the bounds of which are determined and communicated to producers by Federal or State officials.
Department. The United States Department of Agriculture.
Disease. Foot-and-mouth disease, contagious pleuropneumonia, Newcastle disease, highly pathogenic avian influenza, infectious salmon anemia, spring viremia of carp, or any other communicable disease of livestock or poultry that in the opinion of the Secretary constitutes an emergency and threatens the livestock or poultry of the United States.
Infected zone. The zone within a control area that immediately surrounds a premises infected with highly pathogenic avian influenza, up to the beginning of the buffer zone.
Highly pathogenic avian influenza. (1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 ml of a 1:10 dilution of a bacteria-free, infectious allantoic fluid;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the hemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five chickens and grows in cell culture in the absence of trypsin.
Inspector in charge. An APHIS employee who is designated by the Administrator to take charge of work in connection with the control and eradication of disease.
ISA Program veterinarian. The APHIS veterinarian assigned to manage the infectious salmon anemia program for APHIS in the State of Maine and who reports to the Area Veterinarian in Charge.
Materials. Parts of barns or other structures, straw, hay, and other feed for animals, farm products or equipment, clothing, and articles stored in or adjacent to barns or other structures.
Mortgage. Any mortgage, lien, or other security or beneficial interest held by any person other than the one claiming indemnity.
Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residues between residues 113 and 116. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Pet bird. Any bird that is kept for personal pleasure and is not for sale.
Poultry. Chickens, ducks, geese, swans, turkeys, pigeons, doves, pheasants, grouse, partridges, quail, guinea fowl, and pea fowl.
Poultry biosecurity plan. A document utilized by an owner and/or contractor describing the management practices and principles that are used to prevent the introduction and spread of infectious diseases of poultry at a specific facility.
Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has been or may be delegated to act in the Secretary's stead.
State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
(a) The Administrator is hereby authorized to invite the proper State authorities to cooperate with the Department in the control and eradication of any disease within the meaning of § 53.1.
(b) Upon agreement of the authorities of the State to enforce quarantine restrictions and orders and directives properly issued in the control and eradication of such a disease, the Administrator is hereby authorized to agree, on the part of the Department, to cooperate with the State in the control and eradication of the disease, and to pay 50 percent (and in the case of Newcastle disease or highly pathogenic avian influenza, up to 100 percent, and in the case of infectious salmon anemia, up to 60 percent) of the expenses of purchase, destruction and disposition of animals, eggs, and materials required to be destroyed because of being contaminated by or exposed to such disease: Provided, however, that if the animals or eggs were exposed to such disease prior to or during interstate movement and the owners or parties contracting with the owners to raise or care for the animals or eggs are not eligible to receive indemnity from any State, the Department may pay up to 100 percent of the purchase, destruction, and disposition of animals, eggs, and materials required to be destroyed; Provided further, that the cooperative program for the purchase, destruction, and disposition of birds shall be limited to birds which are identified in documentation pursuant to Agreements between the Department and the particular State involved relating to cooperative animal (including poultry) disease prevention, control, and eradication, as constituting a threat to the poultry industry of the United States; And provided further, that the Secretary may authorize other arrangements for the payment of such expenses upon finding that an extraordinary emergency exists.
(a) Animals or eggs affected by or exposed to disease, and materials required to be destroyed because of being contaminated by or exposed to disease shall be appraised by an APHIS employee and a representative of the State jointly, or, if the State authorities approve, by an APHIS employee alone.
(b) The appraisal of animals shall be based on the fair market value and shall be determined by the meat, egg production, dairy or breeding value of such animals. Animals may be appraised in groups providing they are the same species and type and providing that where appraisal is by the head each animal in the group is the same value per head or where appraisal is by the pound each animal in the group is the same value per pound.
(c) Appraisals of animals shall be reported on forms furnished by APHIS. Reports of appraisals shall show the number of animals of each species and the value per head or the weight and value by pound.
(d) Appraisals of materials shall be reported on forms furnished by APHIS. Reports of appraisals of materials shall, when practicable, show the number, size or quantity, unit price, and total value of each kind of material appraised.
(e) Indemnity for eggs required to be destroyed due to an outbreak of highly pathogenic avian influenza will be based on the fair market value of the eggs, as determined by an appraisal. Appraisals of eggs shall be reported on forms furnished by APHIS. The amount of indemnity paid, together with the amount for net salvage the owner or contractor received, if any, shall not exceed the appraised fair market value of the eggs.
(a) Except as provided in paragraph (b) of this section, animals infected with or exposed to disease shall be killed promptly after appraisal and disposed of by burial or burning, unless otherwise specifically provided by the Administrator, at his or her discretion. In the case of animals depopulated due to spring viremia of carp or infectious salmon anemia, salvageable fish may be sold for rendering, processing, or any other purpose approved by the Administrator. The proceeds gained from the sale of the fish will be subtracted from any payment from APHIS for which the producer or owner is eligible under § 53.2(b) or § 53.11.
(b) Eggs infected with, exposed to, or contaminated by highly pathogenic avian influenza shall be disposed of pursuant to the regulations in this part under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a report identifying all eggs disposed thereof.
(c) The killing of animals and the burial, burning, or other disposal of carcasses of animals pursuant to the regulations in this part shall be supervised by an APHIS employee who shall prepare and transmit to the Administrator a report identifying the animals and showing the disposition thereof.
(a) In order to prevent the spread of disease, materials contaminated by or exposed to disease shall be disinfected: Provided, however, That in all cases in which the cost of disinfection would exceed the value of the materials or disinfection would be impracticable for any reason, the materials shall be destroyed, after appraisal as provided in § 53.3.
(b) The disinfection or destruction of materials under this section shall be under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a certificate identifying all materials which are destroyed, showing the disposition thereof.
Animals of species not susceptible to the disease for which a quarantine has been established, but which have been exposed to the disease, shall be disinfected when necessary by such methods as the Administrator shall prescribe from time to time.
All premises, including barns, corrals, stockyards and pens, and all cars, vessels, aircraft, and other conveyances, and the materials thereon, shall be cleaned and disinfected under supervision of an APHIS employee whenever necessary for the control and eradication of disease. Expenses incurred in connection with such cleaning and disinfection shall be shared according to the agreement reached under § 53.2 with the State in which the work is done. In the case of low pathogenic avian influenza related to the 2002 disease situations in Virginia and Texas associated with the H5 or H7 virus, premises may not be restocked with poultry until at least 7 days following such cleaning and disinfection, unless the Administrator determines that a shorter or longer period of time is adequate or necessary to protect new poultry against infection.
(a) Claims for the following must be presented to APHIS, through the inspector in charge, on a form approved by the Administrator:
(1) Compensation for the value of animals;
(2) The cost of burial, burning, or other disposition of animals;
(3) The value of material destroyed; and
(4) The expenses of destruction.
(b) [Reserved]
When animals, eggs, or materials have been destroyed pursuant to the requirements contained in this part, any claim for indemnity shall be presented on forms furnished by APHIS on which the owner of the animals, eggs, or materials shall certify that the animals, eggs, or materials covered thereby, are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, forms furnished by APHIS shall be signed by the owner and by each person holding a mortgage on the animals, eggs, or materials, consenting to the payment of any indemnity allowed to the person specified thereon.
(a) The Department will not allow claims arising under the terms of this part if the payee has not complied with all quarantine requirements.
(b) Expenses for the care and feeding of animals held for destruction will not be paid by the Department, unless the payment of such expense is specifically authorized or approved by the Administrator.
(c) The Department will not allow claims arising out of the destruction of animals, eggs, or materials unless they shall have been appraised as prescribed in this part and the owners thereof shall have executed a written agreement to the appraisals.
(d) The Department will not allow claims arising out of the destruction of animals, eggs, or materials which have been moved or handled by the owner thereof or its officer, employee, or agent, acting within the scope of his or its office, employment or agency, in violation of a law or regulation administered by the Secretary for the prevention of the introduction into or the dissemination within the United States of any communicable disease of livestock or poultry for which the animal or material was destroyed, or in violation of a law or regulation for the enforcement of which the Secretary enters or has entered into a cooperative agreement for the control and eradication of such disease.
(e) The Department will not allow claims arising out of the destruction of fish due to infectious salmon anemia (ISA) unless the claimants have agreed in writing to participate fully in the cooperative ISA control program administered by APHIS and the State of Maine. Participants in the ISA control program must:
(1) Establish and maintain a veterinary client-patient relationship with an APHIS accredited veterinarian and inform the ISA Program Veterinarian in writing of the name of their accredited veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in accredited veterinarians.
(2) Cooperate with and assist in periodic on-site disease surveillance, testing, and reporting activities for ISA, which will be conducted by their APHIS accredited veterinarian or a State or Federal official as directed by the ISA Program Veterinarian.
(3) Develop and implement biosecurity protocols for use at all participant-leased finfish sites and participant-operated vessels engaged in aquaculture operations throughout Maine. A copy of these protocols shall be submitted to the ISA Program Veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in the protocols.
(4) Develop, with the involvement of the participant's accredited veterinarian and the fish site health manager, a site-specific ISA action plan for the control and management of ISA. A copy of the action plan shall be submitted to APHIS for review at the time the participant enrolls in the ISA program and within 15 days of any change in the action plan.
(5) Participate in the State of Maine's integrated pest management (IPM) program for the control of sea lice on salmonids. A copy of the management plan developed by the participant for the State IPM program shall be submitted to APHIS for review at the time the participant enrolls in the ISA program and within 15 days of any change in the management plan.
(6) Submit to the ISA Program Veterinarian at the time the participant enrolls in the ISA program a complete and current fish inventory information for each participant-leased finfish site with site and cage identifiers. Fish inventory information must include the numbers, age, date of saltwater transfer, vaccination status, and previous therapeutant history for all fish in each participant-leased finfish site.
(7) Maintain, and make available to the ISA Program Veterinarian upon request, mortality data for each participant-leased finfish site and pen in production.
(8) Cooperate with and assist APHIS in the completion of biosecurity audits at all participant-leased finfish sites and participant-operated vessels involved in salmonid aquaculture.
(f) The Department will not allow claims arising out of the destruction of fish due to spring viremia of carp (SVC) unless the claimants have done the following:
(1) Depopulated all SVC-infected and SVC-exposed fish on their property under the supervision of USDA or State officials;
(2) Thoroughly cleaned and disinfected all affected sites and all affected equipment under the supervision of USDA or State officials;
(3) If an affected site is to be restocked after cleaning and disinfection, the claimant must have done the following:
(i) Restocked with fish certified free of SVC by an APHIS-approved laboratory or in accordance with the diagnostic procedures described in the Office of International des Epizooties Manual of Diagnostic Tests For Aquatic Animals;
(ii) Demonstrated that their water sources are from first-use spring water, spring water without fish, well water, ozone or ultraviolet treated surface water, or bore-hole water and are free of wild carp and any other SVC-susceptible species; and
(iii) Prevented the migration of wild carp and any other wild SVC-susceptible species into their farming establishment.
(g)(1) Except as provided in paragraph (g)(2) of this section, the Department will not allow claims arising out of the destruction of poultry or eggs destroyed due to an outbreak of highly pathogenic avian influenza unless the following conditions apply:
(i) Approved biosecurity plan. The owner of the poultry or eggs and, if applicable, any party that enters into a contract with the owner to grow or care for the poultry or eggs, had in place, at the time of detection of highly pathogenic avian influenza, and was following a poultry biosecurity plan that meets the requirements of § 53.11(e).
(ii) Buffer zone movement audit. For indemnity claims for poultry moved onto a premises located in a buffer zone of a control area for highly pathogenic avian influenza, the premises receiving the poultry must pass a biosecurity audit conducted in accordance with § 53.11(f)(1)(i) prior to the movement of poultry onto the premises; unless the premises receiving the poultry passed a biosecurity audit within the preceding six (6) months. Provided, that the Administrator may, upon request by a producer and upon his or her determination that such action will not result in the dissemination of highly pathogenic avian influenza within the United States, allow a premises to pass a biosecurity audit in accordance with § 53.11(f)(1)(i) after the placement of poultry onto the premises. The producer must make such a request in writing and state in the request all the facts and reasons justifying the request. If the request is denied, the premises must pass a biosecurity audit in accordance with § 53.11(f)(1)(i) prior to the placement of poultry onto the premises to be eligible to receive future indemnity payment if the poultry is later infected with highly pathogenic avian influenza.
(iii) Previously infected premises audit. For indemnity claims for poultry moved onto any premises that was previously infected with highly pathogenic avian influenza during the same outbreak, the premises must pass a biosecurity audit conducted in accordance with § 53.11(f)(1)(ii) prior to the movement of poultry onto the premises; unless the movement occurs after the United States declares freedom from highly pathogenic avian influenza. In addition, all previously infected premises must pass virtually conducted biosecurity audits every six (6) months until the State in which the premises is located declares freedom from highly pathogenic avian influenza.
(2) Owners and contractors are exempted from the requirements of paragraph (g)(1) of this section if the facilities where the poultry or eggs are raised or cared for falls under one of the following categories:
(i) Commercial table-egg laying premises with fewer than 75,000 birds;
(ii) Egg-type game bird and egg-type waterfowl premises with fewer than 25,000 birds.
(iii) Premises on which fewer than 100,000 broilers are raised annually; and
(iv) Premises on which fewer than 30,000 meat turkeys are raised annually.
(3) Notwithstanding the conditions in paragraphs (g)(1) and (2) of this section, the Department will not pay claims arising out of the destruction of poultry destroyed due to an outbreak of highly pathogenic avian influenza if the poultry was moved onto a premises in an infected zone and if the poultry becomes infected with HPAI within 14 days following the dissolution of the control area in which the infected zone is located.
(a) When poultry or eggs have been destroyed pursuant to this part, the Administrator may pay claims to any party with whom the owner of the poultry or eggs has entered into a contract for the growing or care of the poultry or eggs. The indemnity the Administrator may pay to such a party or parties shall be determined as by the following method:
(1) Divide the value in dollars of the contract the owner entered into with the contractor by the duration in days of the contract as it was signed prior to the highly pathogenic avian influenza outbreak;
(2) Multiply this figure by the time in days between the date the contractor began to provide services relating to the destroyed poultry or eggs under the contract and the date the poultry or eggs were destroyed due to highly pathogenic avian influenza.
(b) If a contractor receiving indemnity under this section has received any payment under his or her contract from the owner of the poultry or eggs at the time the poultry or eggs are destroyed, the amount of indemnity for which the contractor is eligible will be reduced by the amount of the payment the contractor has already received.
(c) If indemnity is paid to a contractor under this section, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the contractors and the total amount of indemnity that may be paid for the poultry or eggs.
(d) In the event that determination of indemnity due a contractor using the method described in paragraph (a) of this section is determined to be impractical or inappropriate, APHIS may use any other method that the Administrator deems appropriate to make that determination.
(e)(1) The owner and, if applicable, the contractor, unless exempted under § 53.10(g)(2), must have a poultry biosecurity plan that is approved by the Administrator. Approved biosecurity principles are listed in the NPIP Program Standards, as defined in § 147.51 of this chapter. Alternative biosecurity principles may also be approved by the Administrator in accordance with § 147.53(d)(2) of this chapter.
(2)(i) The biosecurity plan shall be audited at least once every 2 years or a sufficient number of times during that period to satisfy the owner and/or contractor's Official State Agency that the plan is in compliance with the biosecurity principles contained in the NPIP Program Standards. The audit will include, but may not be limited to, a review of the biosecurity plan, as well as documentation that it is being implemented.
(ii) To be recognized as being in compliance with the biosecurity principles and eligible for indemnity, owners and contractors who fail the initial audit conducted by the NPIP Official State Agency must have a check audit performed by a team appointed by National NPIP Office and must demonstrate that they have implemented applicable biosecurity measures. The team will consist of an APHIS poultry subject matter expert, the Official State Agency, and a licensed, accredited, industry poultry veterinarian.
(f)(1) The Department requires that a biosecurity audit be conducted by an auditing team comprised of an auditor and a reviewer using the biosecurity audit tool available at https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf. The auditor makes the initial determination of whether a premises passes a biosecurity audit and will be a State employee. If the State lacks the human resources to fill the position, an APHIS employee can fill the position. The reviewer makes the final determination of whether a premises passes a biosecurity audit and will be an APHIS employee. The audit will be conducted as follows:
(i) Biosecurity audits for premises in a buffer zone as described in § 53.10(g)(1)(ii), shall be conducted virtually by an auditor unless the State Animal Health Official, in the State where the premises is located, requests an in-person audit.
(ii) Biosecurity audits for previously infected premises as described in § 53.10(g)(1)(iii), shall be conducted in-person by an auditor unless the State Animal Health Official determines that extenuating circumstances warrant a virtual audit instead. Extenuating circumstances include, but are not limited to, severe adverse weather conditions, employee safety considerations, and lack of necessary equipment on the premises to conduct a virtual audit.
(2) To assist auditors in conducting the biosecurity audit, producers must allow auditors access to their premises and access to documentation to review and verify whether the premises meets the minimum requirements of the biosecurity audit criteria described in the biosecurity audit tool. A premises will initially pass a biosecurity audit if the auditor determines that the minimum requirements are met for all biosecurity audit criteria in the biosecurity audit tool. Auditors will communicate all identified deficiencies to producers and collaborate, where appropriate, to identify solutions to resolve the identified deficiencies. Producers must provide timelines to auditors for remediation of all identified deficiencies. Auditors will submit the audit package to a reviewer based in the State where the premises is located.
(3) The reviewer will review the audit package for completeness, accuracy, and consistency with other audits and render a final audit determination of pass or fail. The reviewer must be afforded the same access to the premises previously afforded to the auditor, if requested.
(4) If the producer disagrees with the final audit determination, the producer may send a request for reconsideration to APHIS.HPAI.BCAP.audits@usda.gov or by postal mail to: Biosecurity Audit Reconsideration, 920 Main Campus Drive, Raleigh, NC 27606. The request for reconsideration must be in writing, state all the facts and reasons upon which the producer relies to show that the producer wrongfully failed the biosecurity audit, and be received by the Biosecurity Compliance Audit Program Manager within 14 calendar days of communication of the reviewer's final audit determination. After receipt of the reconsideration request, the process proceeds as follows:
(i) The Biosecurity Compliance Audit Program Manager will review the reconsideration request, the audit package prepared by the auditor, and the reviewer's final audit determination. If the Biosecurity Compliance Audit Program Manager determines that the producer wrongfully failed the biosecurity audit, he or she will change the final audit determination from fail to pass. The auditor will notify the producer of the change in writing, and the Biosecurity Compliance Audit Program Manager will close the reconsideration request. If the Biosecurity Compliance Audit Program Manager agrees that the producer failed the biosecurity audit, the reconsideration process will continue to a panel review.
(ii) A panel consisting of the State Animal Health Official of the State where the premises is located, the APHIS Area Veterinarian in Charge, and the Biosecurity Compliance Audit Program Manager will review the reconsideration request, the audit package prepared by the auditor, and the reviewer's final audit determination. The panel's decision is final and will be communicated to the producer as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(5) A final audit determination of pass for a premises that had a biosecurity audit conducted in accordance with paragraph (f)(1)(i) or (ii) of this section will be valid for six (6) months, unless the premises changes its poultry biosecurity plan, biosecurity coordinator, ownership, or infrastructure. If such premises makes any of the aforementioned changes, the premises must pass a new biosecurity audit conducted in accordance with paragraph (f)(1)(i) or (ii) of this section, as applicable, prior to the movement of poultry onto the premises.
(6) The biosecurity audit tool referenced in paragraph (f)(1) of this section will be reviewed by APHIS on an annual basis and revised as follows:
(i) Standard process for revising the biosecurity audit tool. If the Administrator determines that revisions to the biosecurity audit tool are necessary, APHIS will publish a notice in the
(ii) Immediate process for revising the biosecurity audit tool. If the Administrator determines that the biosecurity audit tool is no longer sufficient for auditors to use to conduct biosecurity audits pursuant to paragraph (f)(1)(i) or (ii) of this section, APHIS will immediately update the biosecurity audit tool. APHIS will publish a notice in the
(g) Proposed updates to the NPIP Program Standards will be announced to the public through a
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any employee of the United States Department of Agriculture authorized to act for the Administrator.
Animal. A sheep or goat.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS representative. An individual employed by APHIS in animal health activities who is authorized by the Administrator to perform the function involved.
Approved laboratory. A laboratory approved by the Administrator in accordance with § 54.11 to conduct one or more scrapie tests, or genotype tests, on one or more tissues.
Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned.
Breed association and registries. Organizations that maintain the permanent records of ancestry or pedigrees of animals (including the animal's sire and dam), individual identification of animals, and ownership of animals.
Classification or reclassification investigation. An epidemiological investigation conducted or directed by a DSE for the purpose of designating or redesignating the status (e.g., scrapie-positive, exposed, high-risk, suspect, infected, noncompliant, source, etc.) of a flock or animal. In conducting such an investigation, the DSE will evaluate the available records for flocks and individual animals and conduct or direct any testing needed to assess the status of a flock or animal. The status of an animal or flock will be determined based on the applicable definitions in this section and, when needed to make a designation under § 79.4 of this chapter, official genotype test results, exposure risk, scrapie type involved, results of official scrapie testing on live or dead animals, or any combination of these.
Commingle, commingled, commingling. Animals grouped together and having physical contact with each other, including contact through a fence, but not limited contacts. Commingling also includes sharing the same section in a transportation unit where there is physical contact.
Designated scrapie epidemiologist DSE. An epidemiologist who has demonstrated the knowledge and ability to perform the functions required and who has been selected by the State animal health official and the area veterinarian in charge. The regional epidemiologist and the APHIS National Scrapie Program Coordinator must concur in the selection and appointment of the designated scrapie epidemiologist. The designated scrapie epidemiologist must satisfactorily complete training designated by APHIS.
Destroyed. Euthanized and the carcass disposed of by means authorized by the Administrator that will prevent its use as feed or food.
Electronic implant. Any radio frequency identification implant device approved for use in the scrapie program by the Administrator. The Administrator will approve an electronic implant after determining that it is tamper resistant, not harmful to the animal, and readable by equipment available to APHIS and State representatives.
Exposed animal. Any animal or embryo that:
(1) Has been in a flock with a scrapie-positive female animal;
(2) Has been in an enclosure with a scrapie-positive female animal at any location;
(3) Resides in a noncompliant flock; or
(4) Has resided on the premises of a flock before or while it was designated by a DSE an infected or source flock and before a flock plan was completed. An animal shall not be designated an exposed animal if it only resided on the premises before the date that infection was most likely introduced to the premises as determined by a Federal or State representative. If the probable date of infection cannot be determined based on the epidemiologic investigation, a date 2 years before the birth of the oldest scrapie-positive animal born in that flock will be used. If the actual birth date is unknown, the date of birth will be estimated based on examination of the teeth and any available records. If an age estimate cannot be made, the animal will be assumed to have been 48 months of age on the date samples were collected for scrapie diagnosis. Exposed animals will be further designated as genetically resistant exposed sheep, genetically less susceptible exposed sheep, genetically susceptible exposed animals, or low-risk exposed animals. An animal will no longer be an exposed animal if it is redesignated in accordance with § 79.4 of this chapter.
Exposed flock. (1) Any flock that was designated by a DSE as an infected or source flock that has completed a flock plan, and that retained a female genetically susceptible exposed animal;
(2) Any flock under investigation that retains a female genetically susceptible exposed animal or a suspect animal, or whose owner declines to complete genotyping and live-animal and/or post-mortem scrapie testing required by the APHIS or State representative investigating the flock; or
(3) Any noncompliant flock or any flock for which a PEMMP is required that is not in compliance with the conditions of the PEMMP.
Flock. All animals that are maintained on a single premises and all animals under common ownership or supervision on two or more premises with animal interchange between the premises. Changes in ownership of part or all of a flock do not change the identity of the flock or the regulatory requirements applicable to the flock. Animals maintained temporarily on a premises for activities such as shows and sales or while in marketing channels are not a flock. More than one flock may be maintained on a single premises if:
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart at all times or are separated by a solid wall through, over, or under which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including buildings and pastures, and a pasture or building used for lambing by one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and disinfection in accordance with § 54.7(e). Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Free Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules.
Flock of origin. The flock in which an animal most recently resided in which it either was born, gave birth, or was used for breeding purposes. The determination of an animal's flock of origin may be based either on the physical presence of the animal in the flock, the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records.
Flock plan. A written flock management agreement signed by the owner of a flock, the accredited veterinarian, if one is employed by the owner, and a State or APHIS representative in which each participant agrees to undertake actions specified in the flock plan to control the spread of scrapie from, and eradicate scrapie in, an infected flock or source flock or to reduce the risk of the occurrence of scrapie in a flock that contains a high-risk or an exposed animal. As part of a flock plan, the flock owner must provide the facilities and personnel needed to carry out the requirements of the flock plan. The flock plan must include the requirements in § 54.8(a) through (j).
Flock sire. A sexually intact male animal that has produced offspring in the preceding 12 months or that was used for breeding during the current breeding cycle.
Flock under investigation. Any flock in which an APHIS or State representative has determined that a scrapie-suspect animal, high-risk animal, or scrapie-positive animal resides or may have resided.
Genetically less susceptible exposed sheep. Any sheep or sheep embryo that is:
(1) An exposed sheep or sheep embryo of genotype AA QR, unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are not less susceptible; or
(2) An exposed sheep or sheep embryo of genotype AV QR, unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to another scrapie type to which AV QR sheep are not less susceptible; or
(3) An exposed sheep or sheep embryo of a genotype that has been exposed to a scrapie type to which the Administrator has determined that genotype is less susceptible. In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136.
Genetically resistant exposed sheep. Any exposed sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type to which RR sheep are not resistant.
Genetically resistant sheep. Any sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type that affects RR at codon 171 sheep.
Genetically susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a genotype other than RR or QR, where Q represents any genotype other than R at codon 171 or sheep or sheep embryo of undetermined genotype.
Genetically susceptible exposed animal. Excluding low-risk exposed animals, any exposed animal or embryo that is also:
(1) A genetically susceptible animal; or
(2) A sheep or sheep embryo of genotype AV QR that the Administrator determines is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to a scrapie type to which AV QR sheep are susceptible; or
(3) A sheep or sheep embryo of genotype AA QR that the Administrator determines is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are susceptible; or
(4) A sheep or sheep embryo of genotype RR that the Administrator determines is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type to which RR sheep are susceptible.
(5) Note: In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136.
High-risk animal. The female offspring or embryo of a scrapie-positive female animal, or any suspect animal, or a female genetically susceptible exposed animal, or any exposed animal that the Administrator determines to be a potential risk. The Administrator may base the determination that an exposed animal poses a potential risk on the scrapie type, the epidemiology of the flock or flocks with which it is epidemiologically linked, including genetics of the positive sheep, the prevalence of scrapie in the flock, any history of recurrent infection, and other flock or animal characteristics. An animal will no longer be a high-risk animal if it is redesignated in accordance with § 79.4 of this chapter.
Infected flock. The flock of origin of a female animal that a State or APHIS representative has determined to be a scrapie-positive animal; or any flock in which a State or APHIS representative has determined that a scrapie-positive female animal has resided unless an epidemiologic investigation conducted by a State or APHIS representative shows that the animal did not lamb or abort in the flock. A flock will no longer be considered an infected flock after it has completed the requirements of a flock plan.
Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement or other uses as described in this part and in accordance with § 79.5 of this chapter.
Limited contacts. Incidental contacts between animals from different flocks off the flock's premises such as at fairs, shows, exhibitions and sales; between ewes being inseminated, flushed, or implanted; or between rams at ram test or collection stations. Embryo transfer and artificial insemination equipment and surgical tools must be sterilized between animals for these contacts to be considered limited contacts. Limited contacts do not include any contact, incidental or otherwise, with animals in the same flock or with a female animal during or up to 30 days after she lambed, kidded or aborted or when there is any visible vaginal discharge. Limited contacts do not include any activity where uninhibited contact occurs, such as sharing an enclosure, sharing a section of a transport vehicle, or residing in other flocks for breeding or other purposes. Examples of limited contacts may be found in the Scrapie Free Flock Certification Program standards.
Live-animal screening test. Any test for the diagnosis of scrapie in a live animal that is approved by the Administrator as usually reliable but not definitive for diagnosing scrapie, and that is conducted in a laboratory approved by the Administrator.
Low-risk exposed animal. Any exposed animal to which the Administrator has determined one or more of the following applies:
(1) The positive animal that was the source of exposure was not born in the flock and did not lamb in the flock or in an enclosure where the exposed animal resided;
(2) The Administrator and State representative concur that the animal is unlikely to be infected due to factors such as, but not limited to, where the animal resided or the time period the animal resided in the flock;
(3) The exposed animal is male and was not born in an infected or source flock;
(4) The exposed animal is a castrated male;
(5) The exposed animal is an embryo of a genetically resistant exposed sheep or a genetically less susceptible exposed sheep unless placed in a recipient that was a genetically susceptible exposed animal; or
(6) The animal was exposed to a scrapie type and/or is of a genotype that the Administrator has determined poses low risk of scrapie transmission.
Mortgage. Any mortgage, lien, or other security or interest held by any person other than the one claiming indemnity.
National Scrapie Database. A database designated by the Administrator in which APHIS and State animal health agencies cooperatively enter data concerning scrapie outbreaks, flocks and premises affected by scrapie, individual animal identification and premises identification data, and other data to support the Scrapie Eradication Program and the Scrapie Free Flock Certification Program.
National Veterinary Services Laboratories (NVSL). The National Veterinary Services Laboratories, APHIS, U.S. Department of Agriculture, or an NVSL cooperating or contract laboratory.
Noncompliant flock. (1) Any source, infected, or exposed flock or flock under investigation whose owner declines to enter into a flock plan or post-exposure management and monitoring plan agreement within 30 days of being so designated, or whose owner is not in compliance with either agreement;
(2) Any exposed flock or flock under investigation whose owner fails to make animals available for testing within 60 days of notification, or as mutually agreed, or whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a person who has misrepresented, the scrapie status of an animal or any other information on a certificate, permit, owner/hauler statement, or other official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a person who has moved, an animal in violation of this chapter within the last 5 years.
Official genotype test. A test to determine the genotype of a live or dead animal conducted at either the National Veterinary Services Laboratories or at an approved laboratory. The test subject must be an animal that is officially identified and the test accurately recorded on an official form supplied or approved by APHIS, with the samples collected and shipped to the laboratory using a shipping method specified by the laboratory by:
(1) An accredited veterinarian;
(2) A State or APHIS representative; or
(3) The animal's owner or owner's agent, using a tamper-resistant sampling kit approved by APHIS for this purpose.
Official test. Any test for the diagnosis of scrapie in a live or dead animal that is approved by the Administrator for that use and conducted either at an approved laboratory or at the National Veterinary Services Laboratories.
Owner. A person, partnership, company, corporation, or any other legal entity who has legal or rightful title to animals, whether or not they are subject to a mortgage.
Post-exposure management and monitoring plan. A written agreement signed by the owner of a flock, any accredited veterinarian employed by the owner, and a State or APHIS representative in which each participant agrees to undertake actions specified in the agreement to monitor for the occurrence of scrapie in the flock for at least 5 years after the last high-risk or scrapie-positive animal is removed from the flock or after the last exposure of the flock to a scrapie-positive animal, unless otherwise specified by a State or APHIS representative. As part of a post-exposure management and monitoring plan, the flock owner must provide the facilities and personnel needed to carry out the requirements of the plan. The plan must include the requirements in § 54.8.
Program approved test. A test for the diagnosis of scrapie approved by the Administrator for use in the scrapie eradication or certification program in accordance with § 54.10.
Restricted animal sale or restricted livestock facility. A sale where any animals in slaughter channels are maintained separate from other animals not in slaughter channels unless they are from the same flock of origin and are sold in lots that consist entirely of animals sold for slaughter only, or a livestock facility at which all animals are in slaughter channels, and where the sale or facility manager maintains a copy of, or maintains a record of, the information from the owner/hauler statement for all animals entering and leaving the sale or facility. A restricted animal sale may be held at a livestock facility that is not restricted.
Scrapie control pilot project. A pilot project authorized by the Administrator in writing, designed to test or improve program procedures or to facilitate research, in order to control and eradicate scrapie. In addition to APHIS, participants may include State animal health agencies, flock owners, and other parties as necessary.
Scrapie Eradication Program. The cooperative State-Federal program administered by APHIS and Consistent States to control and eradicate scrapie.
Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative procedures and standards adopted by APHIS and Consistent States for controlling and eradicating scrapie. The UM&R will be reviewed at least annually by representatives of the livestock industry and appropriate State and Federal agencies and the public and will be revised, and published as needed by APHIS.
Scrapie Free Flock Certification Program (SFCP). The cooperative Federal-State-industry voluntary program for the control of scrapie conducted in accordance with this subpart.
Scrapie Free Flock Certification Program standards. Cooperative procedures and standards adopted by APHIS and State scrapie certification boards for reducing the incidence and controlling the spread of scrapie through flock certification.
Scrapie-positive animal. An animal for which a diagnosis of scrapie has been made by the National Veterinary Services Laboratories or another laboratory authorized by the Administrator to conduct scrapie tests in accordance with this part, through:
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of scrapie;
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry, and/or ELISA, and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal for which a given method has been approved by the Administrator for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron microscopy; or
(5) Any other method or combination of methods approved by the Administrator in accordance with § 54.10.
Slaughter channels. Animals in slaughter channels include any animal that is sold, transferred, or moved either directly to or through a restricted animal sale or restricted livestock facility to an official slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot.
Source flock. A flock in which a State or APHIS representative has determined that at least one animal was born that was diagnosed as a scrapie-positive animal at an age of 72 months or less. The determination that an animal was born in a flock will be based on such information as the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records, to show that a scrapie-positive animal was born in the flock, combined with the absence of records indicating that the animal was purchased from outside and added to the flock. If DNA from the animal was previously collected by an accredited veterinarian and stored at an approved genotyping laboratory, or if DNA collection and storage are required for breed registration and the breed registration has appropriate safeguards in place to ensure the integrity of the banking process, the owner may request verification of the animal's identity based on DNA comparison if adequate records and identification have been maintained by the owner and the repository to show that the archived DNA is that of the animal that has been traced to the flock. The owner will be responsible for all costs for the DNA comparison. A flock will no longer be a source flock after it has completed the requirements of a flock plan.
State. Each of the 50 States, the District of Columbia, the Northern Mariana Islands, Puerto Rico, and all territories or possessions of the United States.
State representative. An individual employed in animal health activities by a State or a political subdivision of a State and who is authorized by the State or political subdivision to perform the function involved.
Suspect animal. An animal will be designated a suspect animal in accordance with § 79.4 of this chapter if it is:
(1) A mature sheep or goat as evidenced by eruption of the first incisor that has been condemned by FSIS or a State inspection authority for central nervous system (CNS) signs, or that exhibits any of the following clinical signs of scrapie and has been determined to be suspicious for scrapie by an accredited veterinarian or a State or USDA representative, based on one or more of the following signs and the severity of the signs: Weakness of any kind including, but not limited to, stumbling, falling down, or having difficulty rising, not including those with visible traumatic injuries and no other signs of scrapie; behavioral abnormalities; significant weight loss despite retention of appetite or in an animal with adequate dentition; increased sensitivity to noise and sudden movement; tremors; star gazing; head pressing; bilateral gait abnormalities such as but not limited to incoordination, ataxia, high stepping gait of forelimbs, bunny-hop movement of rear legs, or swaying of back end, but not including abnormalities involving only one leg or one front and one back leg; repeated intense rubbing with bare areas or damaged wool in similar locations on both sides of the animal's body or, if on the head, both sides of the poll; abraded, rough, thickened, or hyperpigmented areas of skin in areas of wool/hair loss in similar locations on both sides of the animal's body or, if on the head, both sides of the poll; or other signs of CNS disease. An animal will no longer be a suspect animal if it is redesignated in accordance with § 79.4 of this chapter.
(2) A sheep or goat that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test, unless the animal is designated a scrapie-positive animal.
(3) A sheep or goat that has tested inconclusive or suggestive on an official test for scrapie.
Tamper-resistant sampling kit. A device or method for collecting DNA samples from sheep or goats that is approved by the Administrator and that identifies both the sample and the animal at the time the sample is collected. These devices or methods must ensure that the sample, its corresponding label, and the official ID device or method applied to the animal meets the requirements of § 79.2(k) of this chapter and that the sample is from the same animal to which the official ID device or method was applied. The kit must include an APHIS-approved official form or another form, device, or method acceptable to APHIS for transmitting the information required to APHIS and the approved laboratory.
Terminal feedlot. (1) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where animals in the terminal feedlot are separated from all other animals by at least 30 feet at all times or are separated by a solid wall through, over, or under which fluids cannot pass and contact cannot occur and must be cleaned of all organic material prior to being used to contain sheep or goats that are not in slaughter channels, where only castrated males are maintained with female animals and from which animals are moved only to another terminal feedlot or directly to slaughter; or
(2) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where only animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, and all animals in the terminal feedlot are separated from all other animals such that physical contact cannot occur including through a fence and from which animals are moved only to another terminal feedlot or directly to slaughter; or
(3) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, where there is no direct fence-to-fence contact with another flock, and from which animals are moved only to another terminal feedlot or directly to slaughter.
(4) Records of all animals entering and leaving a terminal feedlot must be maintained for 5 years after the animal leaves the feedlot and must meet the requirements of § 79.2 of this chapter, including either a copy of the required owner/hauler statements for animals entering and leaving the facility or the information required to be on the statements. Records must be made available for inspection and copying by an APHIS or State representative upon request.
Unofficial test. Any test for the diagnosis of scrapie or for the detection of the proteinase resistant protein associated with scrapie in a live or dead animal that either has not been approved by the Administrator or that was not conducted at an approved laboratory or at the National Veterinary Services Laboratories.
APHIS will execute cooperative agreements and/or memoranda of understanding with the animal health agency of any State in order to cooperatively administer the Scrapie Eradication Program and the Scrapie Free Flock Certification Program within that State. These agreements will describe the respective roles of APHIS and State personnel in implementing the Scrapie Eradication Program and the Scrapie Free Flock Certification Program. Each agreement may specify the financial, material, and personnel resources to be committed to these programs and other scrapie control measures by APHIS and the State; assign specific activities related to the control of scrapie within a State to APHIS or State personnel; establish schedules for APHIS representatives or State representatives to visit flocks; establish procedures for maintaining and sharing program records specified in this part, and specify other responsibilities of State representatives and APHIS representatives in support of the Scrapie Eradication Program and the Scrapie Free Flock Certification Program.
(a) Indemnity may be paid for an animal only after the owner of the animal has applied for indemnification and been approved in accordance with § 54.4. Indemnity may be paid only for the following:
(1) Destruction of high-risk animals;
(2) Destruction of animals based on an epidemiologic investigation, when the Administrator determines that the destruction of these animals will contribute to the eradication of scrapie;
(3) Destruction of live scrapie-positive animals;
(4) Destruction of animals that test positive on a live-animal screening test; and
(5) Destruction of suspect animals that are destroyed at the request of an APHIS representative.
(b) Indemnity will be paid to an owner only for animals actually in a flock at the time indemnity is first offered in writing, and for offspring born to animals in that flock within 60 days after the time indemnity is first offered in writing. Animals removed from the flock as part of an investigation or a post-exposure management and monitoring plan (PEMMP) will be paid indemnity based on the calculated prices at the time an APHIS representative designates, in writing, the animals for removal. If an owner declines to remove an animal within 60 days of when indemnity is first offered the owner will receive the lower value of when indemnity was first offered in writing or when the animal was actually removed. APHIS may withdraw an indemnity offer if an owner does not make animals available for inventory, gestational assessment, and testing within 30 days, does not remove an animal within 60 days of the written indemnity offer or by the date specified in a flock plan or PEMMP, or fails to provide APHIS animal registration certificates, sale and movement records, or other records requested in accordance with § 54.5. No indemnity will be paid for any animal, or the progeny of any animal, that has been moved or handled by the owner in violation of the requirements of the Animal Health Protection Act or the regulations promulgated thereunder. No indemnity will be paid for an animal added to the premises while a flock is under investigation or while it is an infected or source flock other than natural additions. No indemnity will be paid for natural additions born more than 60 days after the owner is notified they are eligible for indemnity unless the Administrator makes a determination that the dam could not be removed within the allowed time as a result of conditions outside the control of the owner. No indemnity will be paid unless the owner has signed and is in compliance with the requirements of a flock plan or post-exposure management and monitoring plan (PEMMP) as described in § 54.8 unless the requirement for a flock plan or PEMMP has been waived by the Administrator. No indemnity will be paid until the premises, including all structures, holding facilities, conveyances, and materials contaminated because of occupation or use by the depopulated animals, have been properly cleaned and disinfected in accordance with § 54.7(e), unless premises or portions of premises have been exempted from the cleaning and disinfecting requirements per § 54.8(j)(1); Except that, partial indemnity may be paid when the Administrator determines that weather or other factors outside the control of the owner make immediate disinfection impractical. No indemnity will be paid to an owner for any animals if the owner established or increased his flock for the purpose of collecting or increasing indemnity.
(a) Normally, an application for indemnification will be initiated by a State or APHIS representative who is working with the owner of a flock that has already been determined to be an infected flock or source flock, or that is already under a State movement restriction. In such cases, the flock owner will confirm information about the flock's eligibility for indemnity that is contained in the application submitted by the State or APHIS representative. However, the owner of any flock may apply directly to receive indemnification by submitting to the Administrator a written request containing the following information:
(1) Name, address, and social security number of the flock owner;
(2) Number and breed(s) of animals in the flock, including a current inventory;
(3) Location of flock premises;
(4) Reasons the owner believes animals in his or her flock may be eligible for indemnification, including any diagnosis of scrapie made for animals in the flock; any signs of scrapie observed in the flock by the owner; and any movement of animals into the flock from flocks infected with or exposed to scrapie;
(5) A copy of the registration papers issued in the name of the owner for any registered animals in the flock (registration papers are not required for the payment of indemnity for animals that are not registered); and
(6) Signed release letters addressed to any sheep or goat registry associations that maintain records of the owner's sheep or goats requesting the associations to release to APHIS all records maintained by the association on sheep or goats currently or formerly owned by the applicant.
(b) APHIS will evaluate each application to determine whether the owner's flock contains animals eligible for indemnity in accordance with § 54.3.
Before any indemnity is paid to an owner, the owner must sign a written agreement with APHIS, certifying the following:
(a) The owner will make available for review upon request by a State or APHIS representative all bills of sale, pedigree registration certificates, and other records regarding movement of animals into and from the flock;
(b) If the owner maintains any flock after the payment of indemnity or acquires a new flock that is housed on the same premises within 5 years after the last high-risk or scrapie-positive animal is removed, the owner will maintain the flock in accordance with a post-exposure management and monitoring plan for 5 years;
(c) If the animal for which indemnity is paid is subject to any mortgage, the owner consents to the payment of the indemnity, up to the value of the mortgage, to the person(s) holding the mortgage;
(d) That the animal may be removed to a U.S. Department of Agriculture facility or a quarantined research facility, or euthanized and necropsied and tissues removed for diagnostic or other purposes.
(a) Indemnity. Indemnity paid for sheep and goats in accordance with § 54.3 will be the fair market value of the animals. APHIS' determination of fair market value will be based on available price report data that most accurately reflect the type of animal being indemnified and the time at which the animal was indemnified. Premiums will be paid for certain types of sheep and goats, including, but not limited to: Registered animals, flock sires, pregnant animals and early-maturing ewes; Except that, no premium will be added for animals of any age that were in slaughter channels when indemnity was offered. To calculate indemnity, APHIS will use price information provided by the Agricultural Marketing Service (AMS) or other available price information and any other data necessary to establish the value of different types of sheep and goats. A detailed description of the methods APHIS uses to calculate indemnity for sheep and goats is available at http://www.aphis.usda.gov/animal-health/scrapie.
(b) Age and number of animals. If records and identification are inadequate to determine the actual age of animals, an APHIS or State representative will count all sexually intact animals that are apparently under 1 year of age, and those that are apparently at least 1 and under 2 years of age, based on examination of their teeth, and the indemnity for these animals will be calculated. The total number of these animals will be subtracted from the total number of sexually intact animals in the group to be indemnified, and indemnity for the remainder will be calculated based on the assumption that the remainder of the flock is 80 percent aged 2 to 6 years and 20 percent aged 6 to 8 years.
(c) Animal weights. If the owner disagrees with the average weight estimate, he may have the animals weighed at a public scale at his own expense, provided that the animals may not come in contact with other sheep or goats during movement to the public scales, and will be paid based on the actual weight multiplied by the price per pound for the class of animal as calculated in paragraph (a) of this section.
(a) Animals for which indemnification is sought must be destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved or moved to an approved research facility, unless the APHIS representative involved approves in advance of destruction moving the animals to another location for destruction.
(b) The carcasses of animals destroyed in accordance with this section are authorized by the Administrator to be buried, incinerated, or disposed of by other methods in accordance with local, State, and Federal laws. The carcasses of scrapie-positive and suspect animals may not be processed for human or animal food.
(c) The destruction of animals and disposition of their carcasses in accordance with this part must be monitored by an APHIS representative who will prepare and transmit to the Administrator a report identifying the animals and showing their disposition.
(d) APHIS may pay the reasonable costs of disposal for animals that are indemnified. To obtain reimbursement for disposal costs, animal owners must obtain written approval of the disposal costs from APHIS, prior to disposal. For reimbursement to be made, the owner of the animals must present the Veterinary Services, Field Operations, Area Veterinarian in Charge (AVIC) responsible for the State involved with a copy of either a receipt for expenses paid or a bill for services rendered. Any bill for services rendered by the owner must not be greater than the normal fee for similar services provided by a commercial hauler or disposal facility.
(e) Cleaning and disinfection of premises and equipment. When required, cleaning and disinfection shall be conducted under the supervision of a State or APHIS representative as follows. Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Program Standards Volume 1: National Scrapie Eradication Program and Scrapie Program Standards Volume 2: Scrapie Free Flock Certification Program (SFCP):
(1) Drylot areas. When required, remove the manure and top 1-2 inches of soil to reduce contamination. Bury, till under, or compost the removed material in areas not accessed by domestic or wild ruminants.
(2) Cement, wood, metal and other non-earth surfaces, tools, equipment, instruments, feed, hay, bedding, and other materials. Organic and/or inorganic materials may be disposed of by incineration or burial. Inorganic material and wood structures may be cleaned and disinfected. To disinfect, remove all organic material and incinerate, bury, till under, or compost the removed organic material in areas not accessed by domestic or wild ruminants until it can be incinerated, buried, or tilled under. Clean and wash all surfaces, tools, equipment, and instruments using hot water and detergent. Allow all surfaces, tools, equipment, and instruments to dry completely before disinfecting and sanitizing using one of the following methods:
(i) Autoclave instruments, small tools, and other items at 136 °C for 1 hour;
(ii) To clean dry surfaces, apply a 2-percent chlorine bleach solution at room temperature (at least 18.3 °C for 1 hour, or apply a 1-molar solution of sodium hydroxide (approximately 5 oz. of sodium hydroxide dissolved in l gallon water) at room temperature for at least 1 hour. Note: A 2-molar solution is more effective than a 1-molar solution and should be used when circumstances permit.
(iii) Use a product registered by the U.S. Environmental Protection Agency (EPA) specifically for reduction of prion infectivity at these sites in accordance with the label.
(iv) Use a product in accordance with an emergency exemption issued by the EPA for reduction of prion infectivity at these sites.
(a) For animals in a flock under investigation, flock plan, or post-exposure management and monitoring plan (PEMMP), the official identification must provide a unique identification number that is applied by the owner of the flock or his or her agent and must be linked to that flock in the National Scrapie Database. APHIS may specify the type of official identification that may be used in order to maximize retention of the means of identification, identify restricted or test positive animals or to facilitate the testing or inventory of the animals. The owner of the flock or his or her agent must officially identify and maintain the identity of:
(1) All animals in the flock while it is subject to a flock plan or PEMMP;
(2) Any high-risk or genetically susceptible exposed animals in the flock and any other restricted animals;
(3) Any animals designated for testing by an APHIS representative or State representative until testing is completed, results reported, and animals classified; and
(4) All sexually intact animals, all exposed animals, and animals 18 months of age and older (as evidenced by the eruption of the second incisor) prior to a change in ownership and before they are moved off the premises of the flock.
(b) For flocks under a flock plan or PEMMP, the flock owner must maintain the following records for 5 years or until the flock plan and/or PEMMP is completed, whichever is longer.
(1) For acquired animals, the date of acquisition, name and address of the person from whom the animal was acquired, any identifying marks, or identification devices present on the animal including but not limited to the animal's individual official identification number(s) from its electronic implant, flank tattoo, ear tattoo, tamper-resistant eartag, or, in the case of goats, tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain and the records required by § 79.2 of this chapter.
(2) For animals leaving the premises of the flock, the disposition of the animal, including, any identifying marks or identification devices present on the animal, including but not limited to the animal's individual official identification number from its electronic implant, flank tattoo, ear tattoo, tamper-resistant eartag, or, in the case of goats, a tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain, the date and cause of death, if known, or date of removal from the flock and name and address of the person to whom the animal was transferred and the records required by § 79.2 of this chapter.
(c) Upon request by a State or APHIS representative or as required in a PEMMP, the owner of the flock or his or her agent must have an accredited veterinarian collect tissues from animals for scrapie diagnostic purposes and submit them to a laboratory designated by a State or APHIS representative or collect and submit samples by another method acceptable to APHIS.
(d) Upon request by a State or APHIS representative, the owner of the flock or his or her agent must make animals in the flock available for inspection and or testing and the records required to be kept as a part of these plans available for inspection and copying.
(e) The owner of the flock or his or her agent must meet requirements found necessary by a DSE to monitor for scrapie and to prevent the recurrence of scrapie in the flock and to prevent the spread of scrapie from the flock. These other requirements may include, but are not limited to: Utilization of a live-animal screening test; reporting animals found dead and collecting and submitting test samples from them; restrictions on the animals that may be moved from the flock; use of genetically resistant rams; segregated lambing; cleaning and disinfection of lambing facilities; and/or education of the owner of the flock and personnel working with the flock in techniques to recognize clinical signs of scrapie and to control the spread of scrapie.
(f) The owner of the flock or his or her agent must immediately report the following animals to a State representative, APHIS representative, or an accredited veterinarian; ensure that samples are properly collected for testing if the animal dies; allow the animals to be tested, and not remove them from a flock without written permission of a State or APHIS representative:
(1) Any sheep or goat exhibiting weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; wool loss; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor; star gazing; head pressing; recumbency; rubbing, or other signs of neurological disease or chronic wasting illness; and
(2) Any sheep or goat in the flock that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test.
(g) An epidemiologic investigation must be conducted to identify high-risk and exposed animals that currently reside in the flock or that previously resided in the flock, and all high-risk animals, scrapie-positive animals, and suspect animals must be removed from the flock except as provided in paragraph (h) of this section. The animals must be removed either by movement to an approved research facility or by euthanasia and disposal of the carcasses by burial, incineration, or other methods approved by the Administrator and in accordance with local, State, and Federal laws, or upon request in individual cases by another means determined by the Administrator to be sufficient to prevent the spread of scrapie.
(h) The Administrator may allow high-risk animals that are not suspect animals to be retained under restriction if they are not genetically susceptible animals or if they have tested “PrPsc not detected” on a live animal scrapie test approved for this purpose by the Administrator and are maintained in a manner that the Administrator determines minimizes the risk of scrapie transmission, e.g., bred only to genetically resistant sheep, segregated for lambing, and cleaning and disinfection of the lambing area. Such animals may be retained only if the exempted animal's official identification and the requirements for minimizing the risk of scrapie transmission are documented in the PEMMP and the owner is in compliance with the PEMMP. All such animals must be tested for scrapie when they are euthanized or die or if they are later determined to be suspect animals.
(i) The owner of the flock, or his or her agent, must request breed associations and registries, livestock facilities, and packers to disclose records to APHIS representatives or State representatives, to be used to identify source flocks and trace exposed animals, including high-risk animals.
(j) The flock plan will include a description of the types of animals that must be removed from a flock, the timeframes in which they must be removed and any other actions that must be accomplished in order for the flock plan to be completed. Flock plans shall require an owner to agree to:
(1) Clean and disinfect the premises in accordance with § 54.7(e). Premises or portions of premises may be exempted from the cleaning and disinfecting requirements if a designated scrapie epidemiologist determines, based on an epidemiologic investigation, that cleaning and disinfection of such buildings, holding facilities, conveyances, or other materials on the premises will not significantly reduce the risk of the spread of scrapie, either because effective disinfection is not possible or because the normal operations on the premises prevent transmission of scrapie. No confined area where a scrapie-positive animal was born, lambed or aborted may be exempted;
(2) Agree to conduct a post-exposure management and monitoring plan (PEMMP); and
(3) Comply with any other conditions in the flock plan;
(k) A PEMMP will be required for exposed flocks and may be required for flocks under investigation that were not source or infected flocks. A PEMMP may also be required for flocks that formerly were exposed flocks or flocks under investigation as a condition for being redesignated. A designated scrapie epidemiologist shall determine when to require a PEMMP and the monitoring requirements for these flocks based on the findings of the classification or reclassification investigation.
(l) Provided that, the Administrator may waive the requirement for a flock plan or PEMMP or waive any of the requirements in a flock plan or PEMMP after determining that the flock poses a low risk of scrapie transmission.
The Administrator may waive the following requirements of this part for participants in a scrapie control pilot project by recording the requirements waived in the scrapie control pilot project plan:
(a) The determination that an animal is a high-risk animal, if the scrapie control pilot project plan contains testing or other procedures that indicate that an animal, despite meeting the definition of high-risk animal, is unlikely to spread scrapie; and
(b) The requirement that high-risk animals must be removed from a flock if the scrapie control pilot project plan contains alternative procedures to prevent the further spread of scrapie without removing high-risk animals from the flock.
(a) The Administrator may approve new tests or test methods for the diagnosis of scrapie conducted on live or dead animals for use in the Scrapie Eradication Program and/or the Scrapie Free Flock Certification Program. The Administrator will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of:
(1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures;
(2) Data to support repeatability, that is, the ability to reproduce the same result repeatedly on a given sample;
(3) Data to support reproducibility, that is, data to show that similar results can be produced when the test is run at other laboratories;
(4) Data to support the diagnostic and in the case of assays the analytical sensitivity and specificity of the test; and
(5) Any other data or information requested by the Administrator to determine the suitability of the test for program use. This may include but is not limited to past performance, cost of test materials and equipment, ease of test performance, generation of waste, and potential use of existing equipment.
(b) To be approved for program use, a scrapie test must be able to be readily and successfully performed at the National Veterinary Services Laboratories.
(c) The test must have a reliable, timely, and cost effective method of proficiency testing.
(d) The Administrator may decline to evaluate any test kit for program approval that has not been licensed for the intended use and may decline to evaluate any test or test method for program use unless the requester can demonstrate that the new method offers a significant advantage over currently approved methods.
(e) A test or combination of tests may be approved for the identification of suspect animals, or scrapie-positive animals, or for other purposes such as flock certification. For a test to be approved for the identification of scrapie-positive animals, the test must demonstrate a diagnostic specificity comparable to that of current program-approved tests, and the sensitivity of the test will also be considered in determining the approved uses of the test within the program. For a test to be approved for the removal of high-risk, exposed, or suspect animal designations the test must have a diagnostic sensitivity at least comparable to that of current program-approved tests used for this purpose. Since the purpose of a screening test is usually to identify a subset of animals for further testing, for a test to be approved as a screening test for the identification of suspect animals, the test must be usually reliable but need not be definitive for diagnosing scrapie.
(f) Specific guidelines for use of program-approved tests within the Scrapie Eradication Program or Scrapie Free Flock Certification Program will be made available on the scrapie website at http://www.aphis.usda.gov/animal-health/scrapie. Guidelines will be based on the characteristics of the test, including specificity, sensitivity, and predictive value in defined groups of animals.
(g) If an owner elects to have an unofficial test conducted on an animal for scrapie, or for the proteinase resistant protein associated with scrapie, and that animal tests positive to such a test, the animal will be designated a suspect animal, unless the test is conducted as part of a research protocol and the protocol includes appropriate measures to prevent the spread of scrapie.
(h) The Administrator may withdraw or suspend approval of any test or test method if the test or method does not perform at an acceptable level following approval or if a more effective test or test method is subsequently approved. The Administrator shall give written notice of the suspension or proposed withdrawal to the director of the laboratories using the test or method or in the case of test kits to the manufacturer and shall give the director or manufacturer an opportunity to respond. Such action shall become effective upon oral or written notification, whichever is earlier, to the laboratory or manufacturer. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing may be requested in accordance with the procedure in § 79.4(c)(3) of this chapter. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The Administrator's final determination constitutes final agency action.
(a) State, Federal, and university laboratories, or in the case of genotype tests, private laboratories will be approved by the Administrator when he or she determines that the laboratory:
(1) Employs personnel assigned to supervise and conduct the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by the National Veterinary Services Laboratories (NVSL) or who have completed equivalent training approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
(3) Follows standard test protocols that are approved or provided by NVSL;
(4) Meets check test proficiency requirements and consistently produces accurate test results as determined by NVSL review;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases and DNA from all genotype tests for at least 5 years and will forward copies of records and any of these materials to NVSL within 5 business days of request; Except that, NVSL may authorize a shorter retention time in a standard operating procedure or contract;
(7) Will allow APHIS to inspect the laboratory without notice during normal business hours. An inspection may include, but is not limited to, review and copying of records, examination of slides, review of quality control procedures, observation of sample handling/tracking procedures, observation of the test being conducted, and interviewing of personnel;
(8) Will report all test results to State and Federal animal health officials and record them in the National Scrapie Database within timeframes and in the manner and format specified by the Administrator; and
(9) Complies with any other written guidance provided to the laboratory by the Administrator.
(b) A laboratory may request approval to conduct one or more types of program-approved scrapie test or genotype test on one or more types of tissue. To be approved, a laboratory must meet the requirements in paragraph (a) of this section for each type of test and for each type of tissue for which they request approval.
(c) The Administrator may suspend or withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (a) of this section. The Administrator shall give written notice of the suspension or the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. Such action shall become effective upon oral or written notification, whichever is earlier, to the laboratory or manufacturer. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing may be requested in accordance with the procedure in § 79.4(c)(3) of this chapter. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The Administrator's final determination constitutes final agency action.
(d) The Administrator may require approved laboratories to reimburse APHIS for part or all of the costs associated with the approval and monitoring of the laboratory.
The Scrapie Flock Certification Program is a cooperative effort between APHIS; members of the sheep and goat industry, including owners of flocks, slaughtering and rendering establishments, and breed associations and registries; accredited veterinarians; and State governments. APHIS coordinates with State scrapie certification boards and State animal health agencies to encourage flock owners to certify their flocks as free of scrapie by being in continuous compliance with the Scrapie Flock Certification Program standards.
Any owner of a sheep or goat flock may apply to enter the Scrapie Free Flock Certification Program by sending a written request to a State scrapie certification board or to the Veterinary Services, Field Operations, AVIC responsible for the State involved. A notice containing a current list of flocks participating in the Scrapie Free Flock Certification Program, and the certification status of each flock, may be obtained from the APHIS website at http://www.aphis.usda.gov/animal-health/scrapie. A list of noncompliant flocks and a list of flocks that sold exposed animals that could not be traced may also be obtained from this site, and these lists may be obtained by writing to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
An area veterinarian in charge, after consulting with a State representative and industry representatives, may appoint a State scrapie certification board for the purpose of coordinating activities for the Scrapie Flock Certification Program, including making decisions to admit flocks to the Scrapie Flock Certification Program and to change flock status in accordance with the Scrapie Flock Certification Program standards. These boards are not appointed for the purpose of providing APHIS with consensus advice or policy recommendations. No more than one State scrapie certification board may be formed in each State. Each State scrapie certification board shall include as members the area veterinarian in charge, one or more State representatives, one or more accredited veterinarians, when possible, and one or more owners of flocks, and, at the discretion of the area veterinarian in charge, may include other members.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal. Any farmed or captive deer, elk, or moose.
Animal identification. A device or means of animal identification approved for use under this part by APHIS. Examples of animal identification devices that APHIS has approved are listed in § 55.25.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States. The AIN contains 15 digits, with the first 3 being the country code (840 for the United States), the alpha characters USA, or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.
Approved State CWD Herd Certification Program. A program operated by a State government for certification of cervid herds with respect to CWD that the Administrator has determined to meet the requirements of § 55.23(a).
Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species. For the purposes of this part, the term “cervid” refers specifically to cervids susceptible to CWD. These are animals in the genera Odocoileus, Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
Commingled, commingling. Animals are commingled if they have direct contact with each other, have less than 10 feet of physical separation, or share equipment, pasture, or water sources/watershed. Animals are considered to have commingled if they have had such contact with a positive animal or contaminated premises within the last 5 years.
CWD-exposed animal. An animal that is part of a CWD-positive herd, or that has been exposed to a CWD-positive animal or contaminated premises within the previous 5 years.
CWD-exposed herd. A herd in which a CWD-positive animal has resided within 5 years prior to that animal's diagnosis as CWD-positive, as determined by an APHIS employee or State representative.
CWD Herd Certification Program. The Chronic Wasting Disease Herd Certification Program established by this part. This program includes both herds that are directly enrolled in the CWD Herd Certification Program and herds that are included based on their participation in Approved State CWD Herd Certification Programs.
CWD-positive animal. An animal that has had a diagnosis of CWD established through official confirmatory testing conducted by the National Veterinary Services Laboratories.
CWD positive herd. A herd in which a CWD positive animal resided at the time it was diagnosed and which has not been released from quarantine.
CWD-source herd. A herd that is identified through testing, tracebacks, and/or epidemiological evaluations to be the source of CWD-positive animals identified in other herds.
CWD-suspect animal. An animal for which an APHIS employee or State representative has determined that unofficial CWD test results, laboratory evidence or clinical signs suggest a diagnosis of CWD, but for which official laboratory results have been inconclusive or not yet conducted.
CWD-suspect herd. A herd for which unofficial CWD test results, laboratory evidence, or clinical signs suggest a diagnosis of CWD, as determined by an APHIS employee or State representative, but for which official laboratory results have been inconclusive or not yet conducted.
Deer, elk, and moose. All animals in the genera Odocoileus, Cervus, and Alces and their hybrids.
Department. The United States Department of Agriculture.
Farmed or captive. Privately or publicly maintained or held for economic or other purposes within a perimeter fence or confined area, or captured from a free-ranging population for interstate movement and release.
Herd. One or more animals that are:
(1) Under common ownership or supervision and are grouped on one or more parts of any single premises (lot, farm, or ranch) or
(2) All animals under common ownership or supervision on two or more premises which are geographically separated but on which animals have been interchanged or had direct or indirect contact with one another.
Herd plan. A written herd and/or premises management agreement developed by APHIS in collaboration with the herd owner, State representatives, and other affected parties. The herd plan will not be valid until it has been reviewed and signed by the Administrator, the State representative, and the herd owner. A herd plan sets out the steps to be taken to control the spread of CWD from a CWD-positive herd, to control the risk of CWD in a CWD-exposed or CWD-suspect herd, or to prevent introduction of CWD into that herd or any other herd. A herd plan will require specified means of identification for each animal in the herd; regular examination of animals in the herd by a veterinarian for clinical signs of disease; reporting to a State or APHIS representative of any clinical signs of a central nervous system disease or chronic wasting condition in the herd; maintaining records of the acquisition and disposition of all animals entering or leaving the herd, including the date of acquisition or removal, name and address of the person from whom the animal was acquired or to whom it was disposed; and the cause of death, if the animal died while in the herd. A herd plan may also contain additional requirements to prevent or control the possible spread of CWD, depending on the particular circumstances of the herd and its premises, including but not limited to depopulation of the herd, specifying the time for which a premises must not contain cervids after CWD-positive, -exposed, or -suspect animals are removed from the premises; fencing requirements; selective culling of animals; restrictions on sharing and movement of possibly contaminated livestock equipment; premises cleaning and disinfection requirements; or other requirements. A herd plan may be reviewed and changes to it suggested at any time by any party signatory to it, in response to changes in the situation of the herd or premises or improvements in understanding of the nature of CWD epidemiology or techniques to prevent its spread. The revised herd plan will become effective after it is reviewed by the Administrator and signed by the Administrator, the State representative, and the herd owner.
Herd status. The status of a herd assigned under the CWD Herd Certification Program in accordance with § 55.24, indicating a herd's relative risk for CWD. Herd status is based on the number of years of monitoring without evidence of the disease and any specific determinations that the herd has contained or has been exposed to a CWD-positive, -exposed or -suspect animal.
Materials. Parts of barns or other structures, straw, hay, and other feed for animals, farm products or equipment, clothing, and any other articles on the premises that have been in contact with captive cervids.
Mortgage. Any mortgage, lien, or other security or beneficial interest held by any person other than the one claiming indemnity.
National Uniform Eartagging System. A numbering system for the official identification of individual animals in the United States providing a nationally unique identification number for each animal. The National Uniform Eartagging System employs an eight- or nine-character alphanumeric format, consisting of a two-number State or territory code, followed by two or three letters and four additional numbers. Official APHIS disease control programs may specify which format to employ.
Official animal identification. A device or means of animal identification approved for use under this part by APHIS to uniquely identify individual animals. Examples of approved official animal identification devices are listed in § 55.25. The official animal identification must include a nationally unique animal identification number that adheres to one of the following numbering systems:
(1) National Uniform Eartagging System. The CWD program allows the use of either the eight-character or nine-character format for cervids.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
Official appraiser (APHIS official appraiser, State official appraiser). A person authorized by APHIS (an APHIS official appraiser) or a State (a State official appraiser) to appraise animals for the purposes of this part. An official appraiser may be an APHIS employee, a State employee, or a professional livestock appraiser working under contract to APHIS or a State.
Official CWD test. Any test for the diagnosis of CWD approved by the Administrator and conducted in a laboratory approved by the Administrator in accordance with § 55.8 of this part.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority, a geographically distinct location from other premises. The premises identification number is associated with an address, geospatial coordinates, and/or location descriptors which provide a verifiably unique location. The premises identification number may be used in conjunction with a producer's own livestock production numbering system to provide a unique identification number for an animal. It may also be used as a component of a group/lot identification number. The premises identification number may consist of:
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department delegated to act in the Secretary's stead.
State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
State representative. A person regularly employed in the animal health work of a State and who is authorized by that State to perform the function involved.
Trace back herd. A herd in which a CWD-positive animal formerly resided.
Trace forward herd. A herd that has received exposed animals from a CWD-positive herd within 5 years prior to the diagnosis of CWD in the positive herd or from the identified date of entry of CWD into the positive herd.
Veterinarian in charge. The veterinary official of Veterinary Services, APHIS, who is assigned by the Administrator to supervise and perform official animal health work for APHIS in the State concerned.
The Administrator is authorized to pay for the purchase and destruction of CWD positive animals, CWD exposed animals, and CWD suspect animals. Subject to available funding, the amount of the Federal payment for any such animals will be 95 percent of the appraised value established in accordance with § 55.3 of this part, but the Federal payment shall not exceed $3,000 per animal. If a non-Federal source makes a payment for an animal for which a Federal indemnity is paid, and the non-Federal payment exceeds 5 percent of the appraised value established in accordance with § 55.3 of this part, the amount of the Federal payment for any such animals will be reduced by the amount by which the non-Federal payment exceeds 5 percent of the appraised value. The Administrator is also authorized to reimburse State governments or State animal health agencies for payments they make for the purchase and destruction, on or after October 1, 2001, of CWD positive animals, CWD exposed animals, and CWD suspect animals, and for State expenditures for associated carcass disposal and cleaning and disinfection costs resulting from such purchase and destruction, in accordance with cooperative agreements signed by the Administrator and the duly authorized agent of the State.
(a) CWD positive herds, or individual CWD suspect animals or exposed animals removed by APHIS from a herd for testing, will be appraised by an APHIS official appraiser and a State official appraiser jointly, or, if APHIS and State authorities agree, by either a State official appraiser or an APHIS official appraiser alone.
(b) The appraisal of cervids will be the fair market value as determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that where appraisal is by the head, each animal in the group is the same value per head, and where appraisal is by the pound, each animal in the group is the same value per pound.
(c) Appraisals of cervids must be reported on forms furnished by APHIS and signed by the appraisers, and signed by the owner of the cervids to indicate agreement with the appraisal amount. Reports of appraisals must show the number of cervids and the value per head or the weight and value by pound.
(d) In accordance with instructions from an APHIS employee, cervids for which indemnification is sought must be:
(1) Destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved;
(2) Moved to another location for destruction under conditions specified by the APHIS employee; or
(3) Moved to an approved research facility under conditions specified by the APHIS employee.
(e) The carcasses of any cervids destroyed in accordance with this part are authorized by the Administrator to be incinerated, destroyed in an alkaline hydrolysis tissue digestor, or disposed of by any other method authorized by an APHIS employee and in accordance with local, State, and Federal laws. APHIS will pay the reasonable costs of destruction and carcass disposal for animals that are indemnified. To obtain reimbursement for disposal costs, animal owners must obtain written approval of the disposal costs from APHIS, prior to disposal. Except in cases where APHIS or a State directly arranges for disposal, the owner of the animals must present an APHIS employee with a written contract or estimate of disposal costs. Prior to receiving reimbursement, the owner must also present an APHIS employee with a copy of either a receipt for expenses paid by the owner or a bill for services rendered to the owner. Any bill for services rendered presented by the owner must not be greater than the normal fee for similar services provided by commercial entities. The carcasses of cervids destroyed in accordance with this section may not be sold to be processed for human or animal food, including dietary supplements.
After cervids are destroyed in accordance with this part, all premises, including barns, stockyards and pens, all cars and other conveyances, and all other materials on any premises or conveyances used to house or transport such cervids must be cleaned and disinfected under the supervision of an APHIS employee or a State representative, using methods specified by the APHIS employee or a State representative. Premises may not be restocked with cervids until after the date specified in the herd plan required by § 55.7(b) of this part. The owner to whom the indemnity is paid will be responsible for expenses incurred in connection with the cleaning and disinfection, except that APHIS or a State will pay for cleaning and disinfection of the conveyances used to transport the cervids to the location of disposal. However, APHIS may also decide to pay the cost of cleaning and disinfecting premises when the procedures needed to conduct effective cleaning and disinfection are unusually extensive and require methods that are not normally available on a premises. For example, normal procedures would include washing surfaces with high-pressure hoses and disinfectants and burying or burning contaminated materials. Unusually extensive procedures would include disposing of contaminated materials by digestive disposal or high-temperature incineration.
Claims for indemnity for the value of animals destroyed must be documented on a form furnished by APHIS and presented to an APHIS employee or a State representative authorized to accept the claims.
When cervids have been destroyed under this part, any claim for indemnity must be presented on forms furnished by APHIS. The owner of the cervids must certify on the forms that the cervids covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the cervids must sign, consenting to the payment of indemnity to the person specified on the form.
(a) The Department will not allow claims arising out of the destruction of cervids unless the cervids have been appraised as prescribed in this part and the owners have signed the appraisal form indicating agreement with the appraisal amount as required by § 55.3(c) of this part.
(b) The Department will not allow claims arising out of the destruction of cervids unless the owners have signed a written agreement with APHIS in which they agree that if they maintain cervids in the future on the premises used for cervids for which indemnity is paid, they will maintain the cervids in accordance with a herd plan and will not introduce cervids onto the premises until after the date specified in that herd plan. Persons who violate this written agreement may be subject to civil and criminal penalties.
(c) The Department will not allow claims arising out of the destruction of cervids that have been moved or handled by the owner or a representative of the owner in violation of a law or regulation administered by the Secretary regarding animal disease, or in violation of a law or regulation for which the Secretary has entered into a cooperative agreement.
(a) An official CWD test is:
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of CWD, using test protocols provided by the National Veterinary Services Laboratories (NVSL);
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal, using test protocols provided by NVSL; or
(3) Any other test method approved by the Administrator in accordance with this section.
(b) The Administrator may approve new tests for the diagnosis of CWD conducted on live or dead animals, and will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of:
(1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures;
(2) Data to support reproducibility, that is, the ability to reproduce the same result repeatedly on a given sample;
(3) Data to support suitability, that is, data to show that similar results can be produced when the test is run at other laboratories;
(4) Data to support the sensitivity and specificity of the test; and
(5) Any other data requested by the Administrator to determine the suitability of the test for program use.
(c) Specific protocols for official CWD tests are available upon request to NVSL.
(d) State, Federal, and university laboratories will be approved by the Administrator to conduct official CWD tests when he or she determines that the laboratory:
(1) Employs personnel assigned to supervise the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by NVSL or who have completed equivalent training approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
(3) Follows standard test protocols;
(4) Meets check test proficiency requirements;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases for 5 years;
(7) Will allow APHIS to inspect
(8) Will report all test results to State and Federal animal health officials within agreed timeframes.
(e) The Administrator may withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (d) of this section. The Administrator shall give written notice of the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing will be held to resolve the conflicts. The hearing will be conducted in accordance with rules of practice that will be adopted by the Administrator for the proceeding.
The CWD Herd Certification Program is a cooperative effort between APHIS, State animal health and wildlife agencies, and deer, elk, and moose owners. APHIS coordinates with these State agencies to encourage deer, elk, and moose owners to certify their herds as low risk for CWD by being in continuous compliance with the CWD Herd Certification Program standards.
(a) Participation by States. Any State that operates a State program to certify the CWD status of deer, elk, or moose may request the Administrator to designate the State program as an Approved State CWD Herd Certification Program. The Administrator will approve or disapprove a State program in accordance with § 55.23(a). In States with an Approved State CWD Herd Certification Program, program activities will be conducted in accordance with the guidelines of that program as long as the State program meets the minimum requirements of this part. A list of Approved State CWD Herd Certification Programs may be obtained by writing to the National Center for Animal Health Program, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
(b) Participation by owners. Any owner of a farmed or captive deer, elk, or moose herd may apply to enroll in an Approved State CWD Herd Certification Program by sending a written request to the appropriate State agency. Subject to the availability of appropriated funds for a Federal CWD Herd Certification Program, the owner may apply to the APHIS veterinarian in charge if no Approved State CWD Herd Certification Program exists in the herd's State. APHIS or the State will determine the herd's eligibility, and if needed will require the owner to submit more details about the herd animals and operations. An application for participation may be denied if APHIS or the State determines that the applicant has previously violated State or Federal laws or regulations for livestock, and that the nature of the violation indicates that the applicant may not faithfully comply with the requirements of the CWD Herd Certification Program. If the enrolling herd is a CWD-positive herd or CWD-exposed herd, immediately after enrollment it must begin complying with a herd plan developed in accordance with § 55.24. After determining that the herd is eligible to participate in accordance with this paragraph, APHIS or the appropriate State agency will send the herd owner a notice of enrollment that includes the herd's enrollment date. Inquiries regarding which herds are participating in the CWD Herd Certification Program and their certification should be directed to the State representative of the relevant State.
(1) Enrollment date. With the exceptions listed in this paragraph, the enrollment date for any herd that joins the CWD Herd Certification Program after August 13, 2012 will be the date the herd is approved for participation.
(i) For herds already participating in State CWD programs, the enrollment date will be the first day that the herd participated in a State program that APHIS subsequently determines qualifies as an Approved State CWD Herd Certification Program in accordance with § 55.23(a) of this part.
(ii) For herds that enroll directly in the Federal CWD Herd Certification Program, which is allowed only when there is no Approved State CWD Herd Certification Program in their State and which is subject to the availability of appropriated funds, the enrollment date will be the earlier of:
(A) The date APHIS approves enrollment; or
(B) If APHIS determines that the herd owner has maintained the herd in a manner that substantially meets the conditions specified in § 55.23(b) for herd owners, the first day that the herd participated in such a program. However, in such cases the enrollment date may not be set at a date more than 3 years prior to the date that APHIS approved enrollment of the herd.
(iii) For new herds that were formed from and contain only animals from herds enrolled in the CWD Herd Certification Program, the enrollment date will be the latest enrollment date for any source herd for the animals.
(2) [Reserved]
(a) Approval of State programs and responsibilities of States. In reviewing a State program's eligibility to be designated an Approved State CWD Herd Certification Program, the Administrator will evaluate a written statement from the State that describes the State's CWD control and deer, elk, and moose herd certification activities and that cites relevant State statutes, regulations, and directives pertaining to animal health activities and reports and publications of the State. In determining whether the State program qualifies, the Administrator will determine whether the State:
(1) Has the authority, based on State law or regulation, to restrict the intrastate movement of all CWD-positive, CWD-suspect, and CWD-exposed animals.
(2) Has the authority, based on State law or regulation, to require the prompt reporting of any animal suspected of having CWD and test results for any animals tested for CWD to State or Federal animal health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a memorandum of understanding with APHIS that delineates the respective roles of the State and APHIS in CWD Herd Certification Program implementation.
(4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect animals and herds under movement restrictions, with movement of animals from them only for destruction or under permit.
(5) Has effectively implemented policies to:
(i) Promptly investigate all animals reported as CWD-suspect animals;
(ii) Designate herds as CWD-positive, CWD-exposed, or CWD-suspect and promptly restrict movement of animals from the herd after an APHIS employee or State representative determines that the herd contains or has contained a CWD-positive animal;
(iii) Remove herd movement restrictions only after completion of a herd plan agreed upon by the State representative, APHIS, and the owner;
(iv) Conduct an epidemiologic investigation of CWD-positive, CWD-exposed, and CWD-suspect herds that includes the designation of suspect and exposed animals and that identifies animals to be traced;
(v) Conduct tracebacks of CWD-positive animals and traceouts of CWD-exposed animals and report any out-of-State traces to the appropriate State promptly after receipt of notification of a CWD-positive animal; and
(vi) Conduct tracebacks based on slaughter or other sampling promptly after receipt of notification of a CWD-positive animal at slaughter.
(6) Effectively monitors and enforces State quarantines and State reporting laws and regulations for CWD.
(7) Has designated at least one State animal health official, or has worked with APHIS to designate an APHIS official, to coordinate CWD Herd Certification Program activities in the State.
(8) Has programs to educate those engaged in the interstate movement of deer, elk, and moose regarding the identification and recordkeeping requirements of this part.
(9) Requires, based on State law or regulation, and effectively enforces identification of all animals in herds participating in the CWD Herd Certification Program;
(10) Maintains in the CWD National Database administered by APHIS, or in a State database approved by the Administrator as compatible with the CWD National Database, the State's:
(i) Premises information and assigned premises numbers;
(ii) Individual animal information on all deer, elk, and moose in herds participating in the CWD Herd Certification Program in the State;
(iii) Individual animal information on all out-of-State deer, elk, and moose to be traced; and
(iv) Accurate herd status data.
(11) Requires that tissues from all CWD-exposed or CWD-suspect animals that die or are depopulated or otherwise killed be submitted to a laboratory authorized by the Administrator to conduct official CWD tests and requires appropriate disposal of the carcasses of CWD-positive, CWD-exposed, and CWD-suspect animals.
(b) Responsibilities of enrolled herd owners. Herd owners who enroll in the CWD Herd Certification Program agree to maintain their herds in accordance with the following conditions:
(1) Each animal in the herd must be identified using means of animal identification specified in § 55.25. All animals in an enrolled herd must be identified before reaching 12 months of age. In addition, all animals of any age in an enrolled herd must be identified before being moved from the herd premises. In addition, all animals in an enrolled herd must be identified before the inventory required under paragraph (b)(4) of this section, and animals found to be in violation of this requirement during the inventory must be identified during or after the inventory on a schedule specified by the APHIS employee or State representative conducting the inventory;
(2) The herd premises must have perimeter fencing adequate to prevent ingress or egress of cervids. This fencing must also comply with any applicable State regulations;
(3) The owner must immediately report to an APHIS employee or State representative all animals that escape or disappear, and all deaths (including animals killed on premises maintained for hunting and animals sent to slaughter) of deer, elk, and moose in the herd aged 12 months or older; Except that, APHIS employees or State representatives may approve reporting schedules other than immediate notification when herd conditions warrant it in the opinion of both APHIS and the State. The report must include the identification numbers of the animals involved and the estimated time and date of the death, escape, or disappearance. For animals that die (including animals killed on premises maintained for hunting and animals sent to slaughter), the owner must inform an APHIS or State representative and must make the carcasses of the animals available for tissue sampling and testing in accordance with instructions from the APHIS or State representative. In cases where animals escape or disappear and thus are not available for tissue sampling and testing, or when the owner provides samples that are of such poor quality that they cannot be tested for CWD, an APHIS representative will investigate whether the unavailability of animals or usable samples for testing constitutes a failure to comply with program requirements and will affect the herd's status in the CWD Herd Certification Program;
(4) The owner must maintain herd records that include a complete inventory of animals that states the species, age, and sex of each animal, the date of acquisition and source of each animal that was not born into the herd, the date of disposal and destination of any animal removed from the herd, and all individual identification numbers (from tags, tattoos, electronic implants, etc.) associated with each animal. Upon request by an APHIS employee or State representative, the owner must allow either of these officials or a designated accredited veterinarian access to the premises and herd to conduct an inventory. The owner will be responsible for assembling, handling, and restraining the animals and for all costs incurred to present the animals for inspection. The APHIS employee or State representative may order either an inventory that consists of review of herd records with visual examination of an enclosed group of animals, or a complete physical herd inventory with verification to reconcile all animals and identifications with the records maintained by the owner. In the latter case, the owner must present the entire herd for inspection under conditions where the APHIS employee, State representative, or accredited veterinarian can safely read all identification on the animals. During inventories, the owner must cooperate with the inspector to resolve any discrepancies to the satisfaction of the person performing the inventory. Inventory of a herd will be conducted no more frequently than once per year, unless an APHIS employee, State representative, or accredited veterinarian determines that more frequent inventories are needed based on indications that the herd may not be in compliance with CWD Herd Certification Program requirements. A complete physical herd inventory must be performed on a herd in accordance with this paragraph at the time a herd is enrolled in the CWD Herd Certification Program; Except that, APHIS may accept a complete physical herd inventory performed by an APHIS employee, State representative, or accredited veterinarian not more than 1 year before the herd's date of enrollment in the CWD Herd Certification Program as fulfilling the requirement for an initial inventory. In addition, a complete physical herd inventory must be performed for all herds enrolled in the CWD Herd Certification Program no more than 3 years after the last complete physical herd inventory for the herd;
(5) If an owner wishes to maintain separate herds, he or she must maintain separate herd inventories, records, working facilities, water sources, equipment, and land use. There must be a buffer zone of at least 30 feet between the perimeter fencing around separate herds, and no commingling of animals may occur. Movement of animals between herds must be recorded as if they were separately owned herds;
(6) New animals may be introduced into the herd only from other herds enrolled in the CWD Herd Certification Program. If animals are received from an enrolled herd with a lower program status, the receiving herd will revert to that lower program status. If animals are obtained from a herd not participating in the program, then the receiving herd will be required to start over in the program.
(a) Initial and subsequent status. When a herd is first enrolled in the CWD Herd Certification Program, it will be placed in First Year status; except that, if the herd is composed solely of animals obtained from herds already enrolled in the Program, the newly enrolled herd will have the same status as the lowest status of any herd that provided animals for the new herd. If the herd continues to meet the requirements of the CWD Herd Certification Program, each year, on the anniversary of the enrollment date the herd status will be upgraded by 1 year; i.e., Second Year status, Third Year status, Fourth Year status, and Fifth Year status. One year from the date a herd is placed in Fifth Year status, the herd status will be changed to Certified, and the herd will remain in Certified status as long as it is enrolled in the program, provided its status is not lost or suspended in accordance with this section.
(b) Loss or suspension of herd status. (1) If a herd is designated a CWD-positive herd or a CWD-exposed herd, it will immediately lose its program status and may only reenroll after entering into a herd plan.
(2) If a herd is designated a CWD-suspect herd, a trace back herd, or a trace forward herd, it will immediately be placed in Suspended status pending an epidemiologic investigation by APHIS or a State animal health agency. If the epidemiologic investigation determines that the herd was not commingled with a CWD-positive animal, the herd will be reinstated to its former program status, and the time spent in Suspended status will count toward its promotion to the next herd status level.
(i) If the epidemiologic investigation determines that the herd was commingled with a CWD-positive animal, the herd will lose its program status and will be designated a CWD-exposed herd.
(ii) If the epidemiological investigation is unable to make a determination regarding the exposure of the herd, because the necessary animal or animals are no longer available for testing (i.e., a trace animal from a known positive herd died and was not tested) or for other reasons, the herd status will continue as Suspended unless and until a herd plan is developed for the herd. If a herd plan is developed and implemented, the herd will be reinstated to its former program status, and the time spent in Suspended status will count toward its promotion to the next herd status level; Except that, if the epidemiological investigation finds that the owner of the herd has not fully complied with program requirements for animal identification, animal testing, and recordkeeping, the herd will be reinstated into the CWD Herd Certification Program at the First Year status level, with a new enrollment date set at the date the herd entered into Suspended status. Any herd reinstated after being placed in Suspended status must then comply with the requirements of the herd plan as well as the requirements of the CWD Herd Certification Program. The herd plan will require testing of all animals that die in the herd for any reason, regardless of the age of the animal, may require movement restrictions for animals in the herd based on epidemiologic evidence regarding the risk posed by the animals in question, and may include other requirements found necessary to control the risk of spreading CWD.
(3) If an APHIS or State representative determines that animals from a herd enrolled in the program have commingled with animals from a herd with a lower program status, the herd with the higher program status will be reduced to the status of the herd with which its animals commingled.
(c) Cancellation of enrollment by Administrator. The Administrator may cancel the enrollment of an enrolled herd by giving written notice to the herd owner. In the event of such cancellation, any herd enrolled in the CWD Herd Certification Program by that herd owner may not reach Certified status until 5 years after the herd owner's new application for enrollment is approved by APHIS, regardless of the status of the animals of which the herd is composed. The Administrator may cancel enrollment after determining that the herd owner failed to comply with any requirements of this subpart. Before enrollment is canceled, an APHIS representative will inform the herd owner of the reasons for the proposed cancellation.
(1) Herd owners may appeal designation of an animal as CWD-positive, cancellation of enrollment of a herd, or loss or suspension of herd status by writing to the Administrator within 10 days after being informed of the reasons for the action. The appeal must include all of the facts and reasons upon which the herd owner relies to show that the reasons for the action are incorrect or do not support the action. Specifically, to appeal designation of an animal as CWD-positive, the owner may present as evidence the results of a DNA test requested and paid for by the owner to determine whether previous official CWD test results were correctly associated with an animal that belonged to the owner. If the owner intends to present such test results as evidence, he or she shall request the tests and state this in the written notice sent to the Administrator. In such cases the Administrator may postpone a decision on the appeal for a reasonable period pending receipt of such test results. To this end, laboratories approved under § 55.8 are authorized to conduct DNA tests to compare tissue samples tested for CWD to samples from tissues that were collected at the same time from the same animal and are attached to an official identification device. Such DNA tests are available only if the animal owner arranged to submit animal tissue attached to an official identification device along with the other tissues that were collected for the official CWD test. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If the Administrator grants an appeal of the status of a CWD-positive animal, the animal shall be redesignated as CWD-suspect pending further investigation to establish the final status of the animal and its herd. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(2) [Reserved]
(d) Herd status of animals added to herds. A herd may add animals from herds with the same or a higher herd status in the CWD Herd Certification Program with no negative impact on the certification status of the receiving herd.
Each animal required to be identified by this subpart must have at least two forms of animal identification attached to the animal. One of the animal identifications must be official animal identification as defined in this part, with a nationally unique animal identification number that is linked to that animal in the CWD National Database or in an approved State database. The second animal identification must be unique for the individual animal within the herd and also must be linked to that animal and herd in the CWD National Database or in an approved State database. The means of animal identification must be approved for this use by APHIS, and must be an electronic implant, flank tattoo, ear tattoo, tamper-resistant ear tag, or other device approved by APHIS.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any other employee of the Animal and Plant Health Inspection Service delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Breeding flock. A flock that is composed of stock that has been developed for commercial egg or meat production and is maintained for the principal purpose of producing progeny for the ultimate production of eggs or meat for human consumption.
Classification. A designation earned by participation in a Plan program.
Cleaning. The removal of gross contamination, organic material, and debris from the premises or respective structures, via mechanical means like sweeping (dry cleaning) and/or the use of water and soap or detergent (wet cleaning), in order to minimize organic material to prepare for effective disinfection.
Commercial flock or slaughter plant. A commercial poultry flock or slaughter plant that is required because of its size to participate in the special provisions in part 146 of this chapter in order to participate in the Plan.
Compensation. In the case of H5/H7 LPAI detection, compensation specifically refers to reimbursement for the activities associated with the depopulation of infected or exposed poultry, including the disposal of contaminated carcasses and materials and the cleaning and disinfection of premises, conveyances, and materials that came into contact with infected or exposed poultry. In the case of contaminated materials, if the cost of cleaning and disinfection would exceed the value of the materials, or cleaning and disinfection would be impracticable for any reason, APHIS' Veterinary Services will base compensation on the fair market value (depreciated value) of those materials. Compensation does not include payment for depopulated birds or eggs destroyed (see definition of Indemnity in this section).
Cooperating State Agency. Any State authority recognized by the Department to cooperate in the administration of the provisions of this part 56. This may include the State animal health authority or the Official State Agency.
Department. The U.S. Department of Agriculture.
Disinfection. Methods used on surfaces to destroy or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical (e.g., disinfectant) means. A combination of methods may be required.
Domesticated. Propagated and maintained under the control of a person.
Flock plan. A written flock management agreement developed by APHIS and the Official State Agency with input from the flock owner and other affected parties. A flock plan sets out the steps to be taken to eradicate H5/H7 LPAI from a positive flock, or to prevent introduction of H5/H7 LPAI into another flock. A flock plan shall include, but is not necessarily limited to, poultry and poultry product movement and geographically appropriate infected and control/monitoring zones. Control measures in the flock plan should include detailed plans for safe handling of conveyances, containers, and other associated materials that could serve as fomites; disposal of flocks; cleaning and disinfection; downtime; and repopulation.
H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry caused by an influenza A virus of H5 or H7 subtype that has an intravenous pathogenicity index in 6-week-old chickens less than or equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-old chickens infected intravenously, or an infection with influenza A viruses of H5 or H7 subtype with a cleavage site that is not consistent with a previously identified highly pathogenic avian influenza virus.
H5/H7 LPAI virus actively infected (infectious). (1) Poultry will be considered to be actively infected with H5/H7 LPAI for the purposes of this part if:
(i) H5/H7 LPAI virus has been isolated and identified as such from poultry; or
(ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry.
(2) The official determination that H5/H7 LPAI virus has been isolated and identified, or viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, may only be made by the National Veterinary Services Laboratories.
H5/H7 LPAI virus exposed (non-infectious). (1) Poultry will be considered to be exposed (non-infectious) to H5/H7 LPAI for the purposes of this part if:
(i) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry; and
(ii) Samples collected from the flock using real-time reverse transcription polymerase chain reaction (RT-PCR) or virus isolation are determined to be not infectious for H5/H7 LPAI.
(2) The official determination that H5/H7 LPAI virus exposure has occurred is by the identification of antibodies to the H5 or H7 subtype of AI virus detected and may only be made by the National Veterinary Services Laboratories.
Indemnity. Payments representing the fair market value of destroyed birds and eggs. Indemnity does not include reimbursements for depopulation, disposal, destroyed materials, or cleaning and disinfection (virus elimination) activities; these activities are covered under compensation (see definition of Compensation in this section).
Mortgage. Any mortgage, lien, or other security or beneficial interest held by any person other than the one claiming indemnity for the destruction of poultry or eggs due to H5/H7 LPAI.
National Poultry Improvement Plan (NPIP) Program Standards. A document that contains tests and sanitation procedures approved by the Administrator pursuant to § 147.53 of this chapter. This document may be obtained from the National Poultry Improvement Plan website at https://www.poultryimprovement.org/ or by writing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 301, Conyers, GA 30094.
Official appraiser (APHIS official appraiser, State official appraiser). A person authorized by APHIS to appraise poultry for the purposes of this part. A State official appraiser is selected by a State and authorized by APHIS.
Official State Agency. The State authority recognized by the Department to cooperate in the administration of the Plan.
Plan. The provisions of the National Poultry Improvement Plan contained in parts 145, 146, and 147 of this chapter.
Poultry. Domesticated fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, waterfowl, and game birds, except doves and pigeons, which are bred for the primary purpose of producing eggs or meat.
Secretary. The Secretary of the United States Department of Agriculture, or any officer or employee of the Department delegated to act in the Secretary's stead.
State. Any of the States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands of the United States, or any territory or possession of the United States.
Table-egg layer. A domesticated chicken grown for the primary purpose of producing eggs for human consumption.
United States. All of the States.
Virus elimination (VE). Cleaning and disinfection or other measures conducted to destroy or eliminate all AI virus on the premises.
(a) The Administrator has been delegated the authority to cooperate with Cooperating State Agencies in the eradication of H5/H7 LPAI. This cooperation may include, but is not necessarily limited to, the following activities:
(1) Payment to Cooperating State Agencies for surveillance and monitoring associated with poultry that have been infected with or exposed to H5/H7 LPAI;
(2) Transfer of vaccine for H5/H7 LPAI to Cooperating State Agencies if provided for in the initial State response and containment plan approved by APHIS under § 56.10; and
(3) Payment for vaccine administration by Cooperating State Agencies, if provided for in the initial State response and containment plan approved by APHIS under § 56.10.
(b)(1) Any payment made to a State or an Official State Agency for the activities listed in paragraphs (a)(1) and (a)(3) of this section must be made through a cooperative agreement between the Cooperating State Agency and APHIS. The payment for which the Cooperating State Agency is eligible will be determined in the cooperative agreement.
(i) For any Cooperating State Agency that participates in the National Poultry Improvement Plan diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS, as described in § 56.10 of this part, the cooperative agreement will provide that the Cooperating State Agency is eligible for payment of 100 percent of the costs of surveillance and monitoring and 100 percent of the costs of vaccine administration, as determined in the cooperative agreement.
(ii) For any Cooperating State Agency that does not meet the criteria in paragraph (b)(1)(i) of this section, the cooperative agreement will provide that the Cooperating State Agency is eligible for payment of 25 percent of the costs of surveillance and monitoring and 25 percent of the costs of vaccine administration, as determined in the cooperative agreement.
(2) Transfer of vaccine under paragraph (a)(2) of this section must be accomplished through a cooperative agreement between the Cooperating State Agency and APHIS.
(c) Cooperating State Agencies will be responsible for making the determination to request Federal assistance under this part in the event of an outbreak of H5/H7 LPAI.
(a) Activities eligible for indemnity and/or compensation. The Administrator may pay indemnity and/or compensation for the activities listed in this paragraph (a), as provided in paragraph (b) of this section:
(1) Destruction and disposal of poultry that were infected with or exposed to H5/H7 LPAI;
(2) Destruction of any eggs destroyed during testing of poultry for H5/H7 LPAI during an outbreak of H5/H7 LPAI; and
(3) Virus elimination (VE) measures taken on premises, conveyances, and materials that came into contact with poultry that were infected with or exposed to H5/H7 LPAI; or, in the case of materials, if the cost of the VE measures would exceed the value of the materials or the VE measures would be impracticable for any reason, the destruction and the disposal of the materials.
(b) Percentage of costs eligible for indemnity and/or compensation. The Administrator is authorized to pay 100 percent of the costs eligible for indemnity and/or compensation, as determined in accordance with § 56.4, of the activities described in paragraphs (a)(1) through (3) of this section, provided that the conditions in paragraph (b)(1) or (2) of this section apply. For infected or exposed poultry that are not described in the categories below, the Administrator is authorized to pay 25 percent of the costs eligible for indemnity and/or compensation of the activities described in paragraphs (a)(1) through (3) of this section:
(1)(i) The poultry are from:
(A) A commercial table-egg laying premises with at least 75,000 birds; or
(B) A meat-type chicken slaughter plant that slaughters at least 200,000 meat-type chickens in an operating week; or
(C) A meat-type turkey slaughter plant that slaughters at least 2 million meat-type turkeys in a 12-month period; or
(D) A meat-type game bird and waterfowl slaughter plant that slaughters at least 50,000 birds annually; or
(E) A raised-for-release game bird premises, raised-for-release waterfowl premises, and egg-type game bird or waterfowl producing eggs for human consumption premises that raise at least 25,000 birds annually and have at least 5,000 birds onsite; or
(F) A breeder flock premises with at least 5,000 birds; and
(ii) The breeding flock, commercial flock, or slaughter plant participates in the U.S. Avian Influenza Clean, H5/H7 Avian Influenza Clean, or U.S. H5/H7 Avian Influenza Monitored program of the Plan available to the flock in part 145 or 146 of this chapter; and
(iii) The owner of the poultry or eggs, and, if applicable, any party that enters into a contract with the owner to grow or care for the poultry or eggs, had in place and was following a biosecurity plan that was in compliance with biosecurity principles approved by the Administrator (within the National Poultry Improvement Plan (NPIP) Program Standards, Standard E pertains to Biosecurity Principles) and has been audited by the Official State Agency to ensure that the biosecurity plan is in compliance at the time of detection of H5/H7 LPAI; or
(2) The flock does not meet the size requirements as described in paragraph (b)(1) of this section, regardless of whether the infected or exposed poultry participate in the Plan.
(3) The Administrator is authorized to pay 25 percent of the costs eligible for indemnity and/or compensation, as determined in accordance with § 56.4, of the activities described in paragraphs (a)(1) through (3) of this section, for flocks that:
(i) Do not meet the conditions described in paragraph (b)(1) or (2) of this section; or
(ii) Are located in a State that does not participate in the diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, or that does not have an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10, unless such poultry participate in the Plan with another State that does participate in the diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10 surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, or that does not have an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10, unless such poultry participate in the Plan with another State that does participate in the diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10.
(c) Other sources of payment. If the recipient of indemnity and/or compensation for any of the activities listed in paragraphs (a)(1) through (3) of this section also receives payment for any of those activities from a State or from other sources, the indemnity and/or compensation provided under this part may be reduced by the total amount of payment received from the State or other sources to the extent that total payments do not exceed 100 percent of total reimbursable indemnity and/or compensation amounts.
(a) Destruction and disposal of poultry. (1) Indemnity for the destruction of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on the fair market value of the poultry and/or eggs, as determined by an appraisal. Poultry infected with or exposed to H5/H7 LPAI that are removed by APHIS or a Cooperating State Agency from a flock will be appraised by an APHIS official appraiser and a State official appraiser jointly, or, if APHIS and State authorities agree, by either an APHIS official appraiser or a State official appraiser alone. For laying hens, the appraised value should include the hen's projected future egg production. Appraisals of poultry must be reported on forms furnished by APHIS and signed by the appraisers and must be signed by the owners of the poultry to indicate agreement with the appraisal amount. Appraisals of poultry must be signed by the owners of the poultry prior to the destruction of the poultry, unless the owners, APHIS, and the Cooperating State Agency agree that the poultry may be destroyed immediately. Reports of appraisals must show the number of birds and the value per head.
(2) Compensation for disposal of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Any disposal of poultry infected with or exposed to H5/H7 LPAI for which compensation is requested must be performed under a compliance agreement between the claimant and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. If disposal is performed by the Cooperating State Agency, APHIS will compensate the Cooperating State Agency for disposal under a cooperative agreement.
(3) The destruction and disposal of the poultry and/or eggs must be conducted in accordance with the initial State response and containment plan for H5/H7 LPAI, as described in § 56.10.
(b) Cleaning and disinfection (virus elimination). (1) Compensation for cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are infected with or exposed to H5/H7 LPAI will be determined using the current APHIS flat-rate virus elimination (VE) calculator in effect at the time of the infection, except in instances when the claimant and APHIS jointly agree the VE calculator is not applicable to the premises type.
(2) For premises types for which a flat-rate VE calculator is not applicable, reimbursement will be based on receipts or other documentation maintained by the claimant verifying expenditures for cleaning and disinfection (virus elimination) activities authorized by this part. Any cleaning and disinfection (virus elimination) of premises, conveyances, and materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for cleaning and disinfection (virus elimination) to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10.
(i) In the case of materials, if the cost of cleaning and disinfection (virus elimination) would exceed the value of the materials or cleaning and disinfection (virus elimination) would be impracticable for any reason, compensation for the destruction of the materials will be based on the fair market value (depreciated value) of those materials, as determined by an appraisal. Materials will be appraised by an APHIS official appraiser. Compensation for disposal of the materials will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Appraisals of materials must be reported on forms furnished by APHIS and must be signed by the appraisers and by the owners of the materials to indicate agreement with the appraisal amount. Appraisals of materials must be signed and received by APHIS prior to the disassembly or destruction of the materials, unless the owners, APHIS, and the Cooperating State Agency agree in writing that the materials may be disassembled and/or destroyed immediately. Any disposal of materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10.
(ii) [Reserved]
(c) Requirements for compliance agreements. The compliance agreement is a comprehensive document that describes the depopulation, disposal, and cleaning and disinfection plans for poultry that were infected with or exposed to H5/H7 LPAI, or a premises that contained such poultry. The compliance agreement must set out cost estimates that include labor, materials, supplies, equipment, personal protective equipment, and any additional information deemed necessary by APHIS. A compliance agreement is comparable to a statement of work and must indicate what tasks will be completed, who will be responsible for each task, and how much the work is expected to cost. A compliance agreement may also be referred to as a detailed financial plan. Once work associated with the compliance agreement is completed, receipts and documentation detailing the activities specified in the agreement should be forwarded to APHIS for review, approval, and final payment. This documentation should be submitted to APHIS no later than 30 days after the quarantine release of the affected or exposed premises.
(a) Destruction of poultry. Poultry that are infected with or exposed to H5/H7 LPAI may be required to be destroyed at the discretion of the Cooperating State Agency and APHIS and in accordance with the initial State response and containment plan described in § 56.10. The Cooperating State Agency and APHIS will select a method to use for the destruction of such poultry based on the following factors:
(1) The species, size, and number of the poultry to be destroyed;
(2) The environment in which the poultry are maintained;
(3) The risk to human health or safety of the method used;
(4) Whether the method requires specialized equipment or training;
(5) The risk that the method poses of spreading the H5/H7 LPAI virus;
(6) Any hazard the method could pose to the environment;
(7) The degree of bird control and restraint required to administer the destruction method;
(8) The speed with which destruction must be conducted; and
(9) Consistency of the method with humane euthanasia guidelines.
(b) Disposal of poultry. Carcasses of poultry that have died from H5/H7 LPAI infection or poultry that have been humanely slaughtered to fulfill depopulation requirements must be disposed of promptly and efficiently in accordance with the initial State response and containment plan described in § 56.10 to prevent the spread of H5/H7 LPAI infection. Disposal methods will be selected by the Cooperating State Agency and APHIS and may include one or more of the following: Burial, incineration, composting, or rendering. Regardless of the method used, strict biosecurity procedures must be implemented and enforced for all personnel and vehicular movement into and out of the area in accordance with the initial State response and containment plan to prevent dissemination of the H5/H7 LPAI virus.
(c) Controlled marketing. (1) At the discretion of the Cooperating State Agency and APHIS, poultry that has been infected with or exposed to H5/H7 LPAI may be allowed to move for controlled marketing and maintain their current National Poultry Improvement Plan (NPIP) certifications in accordance with the initial State response and containment plan described in § 56.10 and in accordance with the following requirements:
(i) Poultry infected with or exposed to H5/H7 LPAI must not be transported to a market for controlled marketing until approved by the Cooperating State Agency in accordance with the initial State response and containment plan described in § 56.10.
(ii) Poultry will be monitored daily for the development of additional and/or increased severity of clinical signs with scheduled flock observation, tracking, and recording flock(s) mortality, taking action as directed by the Official State Agency.
(iii) Within 7 days prior to slaughter, each flock to be moved for controlled marketing must be tested for H5/H7 LPAI using a test approved by the Cooperating State Agency and found to be free of the virus.
(iv) Routes to slaughter must avoid other commercial poultry operations whenever possible. All load-out equipment, trailers, and trucks used on the premises that have housed poultry that were infected with or exposed to H5/H7 LPAI must undergo virus elimination procedures and not enter other poultry premises or facilities for 48 hours after the virus elimination procedures have been completed.
(v) Flocks moved for controlled marketing must be the last poultry marketed during the week they are marketed.
(2) Poultry moved for controlled marketing will not be eligible for indemnity under § 56.3. However, any costs related to cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are moved for controlled marketing will be eligible for compensation under § 56.3.
(d) Cleaning and disinfection (virus elimination) of premises, conveyances, and materials. Premises, conveyances, and materials that came into contact with poultry infected with or exposed to H5/H7 LPAI must be cleaned and disinfected; Provided, that materials for which the cost of cleaning and disinfection would exceed the value of the materials or for which cleaning and disinfection would be impracticable for any reason may be destroyed and disposed. Cleaning and disinfection must be performed in accordance with the initial State response and containment plan described in § 56.10, which must be approved by APHIS. Cleaning and disinfection must also be performed in accordance with any applicable State and local environmental regulations.
Claims for the following must be documented on a form furnished by APHIS and presented to an APHIS employee or the State representative authorized to accept the claims:
(a) Indemnity for the value of poultry to be destroyed due to infection with or exposure to H5/H7 LPAI;
(b) Indemnity for the value of eggs to be destroyed due to infection or exposure to H5/H7 LPAI; and
(c) Compensation for the cost of cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry infected with or exposed to H5/H7 LPAI, or, in the case of materials, if the cost of cleaning and disinfection (virus elimination) would exceed the value of the materials or cleaning and disinfection (virus elimination) would be impracticable for any reason, the cost of destruction and disposal for the materials.
When poultry or eggs have been destroyed under this part, any claim for indemnity must be presented on forms furnished by APHIS. The owner of the poultry or eggs must certify on the forms that the poultry or eggs covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the poultry or eggs must sign the APHIS-furnished form, consenting to the payment of indemnity to the person specified on the form.
(a) When poultry or eggs have been destroyed pursuant to this part, the Administrator shall pay claims to any party with which the owner of the poultry or eggs has entered into a contract for the growing or care of the poultry or eggs. The indemnity the Administrator shall pay to such a party or parties shall be determined as follows:
(1) Divide the value of the contract the owner of the poultry or eggs entered into with another party for the growing and care of the poultry or eggs in dollars by the duration of the contract as it was signed prior to the H5/H7 LPAI outbreak in days;
(2) Multiply this figure by the time in days between the date the other party began to provide services relating to the destroyed poultry or eggs under the contract and the date the poultry or eggs were destroyed due to H5/H7 LPAI.
(b)(1) If indemnity for the destroyed poultry or eggs is being provided for 100 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity under this section 100 percent of the amount determined in paragraph (a) of this section.
(2) If indemnity for the destroyed poultry or eggs is being provided for 25 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity under this section 25 percent of the amount determined in paragraph (a) of this section.
(c) If a contractor receiving indemnity under this section has received any payment under his or her contract from the owner of the poultry or eggs at the time the poultry or eggs are destroyed, the amount of indemnity for which the contract grower is eligible will be reduced by the amount of the payment the contract grower has already received.
(d) If indemnity is paid to a contractor under this section, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the growers and the total amount of indemnity that may be paid for the poultry or eggs.
(e) In the event that determination of indemnity to a party with which the owner of destroyed poultry or eggs has entered into a contract for the growing or care of the poultry or eggs using the method described in paragraph (a) of this section is determined to be impractical or inappropriate, APHIS may use any other method that the Administrator deems appropriate to make that determination.
(a) The Department will not allow claims arising out of the destruction of poultry unless the poultry have been appraised as prescribed in this part and the owners have signed the appraisal form indicating agreement with the appraisal amount as required by § 56.4(a).
(b) The Department will not allow claims arising out of the destruction of poultry unless the owners have signed a written agreement with APHIS in which they agree that if they maintain poultry in the future on the premises used for poultry for which indemnity and/or compensation is paid, they will maintain the poultry in accordance with a plan set forth by the Cooperating State Agency and will not introduce poultry onto the premises until after the date specified by the Cooperating State Agency. Persons who do not maintain their poultry and premises in accordance with this written agreement will not be eligible to receive indemnity and/or compensation under this part.
(c) The Department will not allow claims arising out of the destruction of poultry unless the poultry have been moved or handled by the owner in accordance with an agreement for the control and eradication of H5/H7 LPAI and in accordance with part 56, for any progeny of any poultry unless the poultry have been moved or handled by the owner in accordance with an agreement for the control and eradication of H5/H7 LPAI and in accordance with part 56, or for any poultry that become or have become infected with or exposed to H5/H7 LPAI because of actions not in accordance with an agreement for the control and eradication of H5/H7 LPAI or a violation of this part.
(a) In order for poultry owners within a State to be eligible for indemnity and/or compensation for 100 percent of eligible costs under § 56.3(b), the State in which the poultry participate in the Plan must have in place an initial State response and containment plan that has been approved by APHIS. The initial State response and containment plan must be developed by the Official State Agency. In States where the Official State Agency is different than the Cooperating State Agency, the Cooperating State Agency must also participate in the development of the initial State response and containment plan. The initial State response and containment plan must be administered by the Cooperating State Agency of the relevant State. This response and containment plan must include:
(1) Provisions for a standing emergency disease management committee, regular meetings, and exercises, including coordination with any tribal governments that may be affected;
(2) A biosecurity plan for poultry owners based on their flock size as stated in § 56.3 and, if applicable, any party that enters into a contract with the owner to grow or care for the poultry or eggs that had in place and was following a biosecurity plan that was audited by the Official State Agency to ensure that the biosecurity plan was in compliance according to the Program Standards, Standard E pertaining to the Biosecurity Principles as approved by the Administrator;
(3) Provisions for adequate diagnostic resources;
(4) Detailed, specific procedures for initial handling and investigation of suspected cases of H5/H7 LPAI;
(5) Detailed, specific procedures for reporting test results to APHIS. These procedures must be developed after appropriate consultation with poultry producers in the State and must provide for the reporting only of confirmed cases of H5/H7 LPAI in accordance with § 146.13 of this chapter;
(6) Detailed, strict quarantine measures for presumptive and confirmed index cases;
(7) Provisions for developing flock plans for infected and exposed flocks;
(8) Detailed plans for disposal of infected flocks, including preexisting agreements with regulatory agencies and detailed plans for carcass disposal, disposal sites, and resources for conducting disposal, and detailed plans for disposal of materials that come into contact with poultry infected with or exposed to H5/H7 LPAI;
(9) Detailed plans for cleaning and disinfection of premises, repopulation, and monitoring after repopulation;
(10) Provisions for appropriate control/monitoring zones, contact surveys, and movement restrictions;
(11) Provisions for monitoring activities in control zones;
(12) If vaccination is considered as an option, a written plan for use in place with proper controls and provisions for APHIS approval of any use of vaccine;
(13) Plans for H5/H7 LPAI-negative flocks that provide for quarantine, testing, and controlled marketing; and
(14) Public awareness and education programs regarding avian influenza.
(b) If a State is designated a U.S. Avian Influenza Monitored State, Layers under 146.24 (a) of this chapter or a U.S. Avian Influenza Monitored State, Turkeys under § 146.44(a) of this chapter, it will lose that status during any outbreak of H5/H7 LPAI and for 90 days after the destruction and disposal of all infected or exposed birds and cleaning and disinfection of all affected premises are completed.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 70.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
As used in this part, the following terms shall have the meanings set forth in this section.
Accredited veterinarian. A veterinarian who is approved by the Administrator, in accordance with part 161 of this chapter, to perform official animal health work of the Animal and Plant Health Inspection Service specified in subchapters A, B, C, and D of this chapter and to perform work required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal. The AIN consists of 15 digits, with the first 3 being the country code (840 for the United States or a unique country code for any U.S. territory that has such a code and elects to use it in place of the 840 code). The alpha characters USA or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording may be used as an alternative to the 840 or other prefix representing a U.S territory; however, only the AIN beginning with the 840 or other prefix representing a U.S. territory will be recognized as official for use on AIN tags applied to animals on or after March 11, 2015. The AIN beginning with the 840 prefix may not be applied to animals known to have been born outside the United States.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Approved laboratory. A laboratory approved by the Administrator to conduct official testing in accordance with the regulations in § 71.22.
Approved livestock facility. A stockyard, livestock market, buying station, concentration point, or any other premises under State or Federal veterinary supervision where livestock are assembled and that has been approved under § 71.20.
Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.
Breeding sheep and goats. Any sexually intact sheep or goat that is not moving either directly to slaughter or through one or more restricted sales and/or terminal feedlots and then directly to slaughter.
Breeder swine. Sexually intact swine over 6 months of age.
Commingling. The mixing or assembling of swine from one premises with swine from any other premises, including, but not limited to, loading swine from more than one premises on the same truck, trailer, vessel, or railroad car, unless swine from different premises are kept separate on the means of conveyance by dividers.
Consistent States. Those States listed as consistent States in § 79.1 of this subchapter because they meet certain standards, as provided in § 79.6 of this subchapter, for conducting an active State scrapie program involving the identification of scrapie in sheep and goats for the purpose of controlling the spread of scrapie.
Department. The United States Department of Agriculture.
Feeder swine. Swine under 6 months of age that are not slaughter swine.
Flock-based number system. The flock-based number system combines a flock identification number (FIN) with a producer's unique livestock production numbering system to provide a nationally unique identification number for an animal.
Flock identification number (FIN). A nationally unique number assigned by a State, Tribal, or Federal animal health authority to a group of animals that are managed as a unit on one or more premises and are under the same ownership.
Food Safety and Inspection Service (FSIS). The Food Safety and Inspection Service, United States Department of Agriculture.
Free area. The States, Territories, or the District of Columbia or portions thereof not quarantined by the Secretary of Agriculture for the specific contagious, infectious, or communicable animal disease mentioned in each part.
Group/lot identification number (GIN). The identification number used to uniquely identify a “unit of animals” of the same species that is managed together as one group throughout the preharvest production chain. When a GIN is used, it is recorded on documents accompanying the animals moving interstate; it is not necessary to have the GIN attached to each animal.
Horses. Horses, asses, mules, ponies, and zebras.
Inconsistent States. Those States not included in the list of consistent States appearing in § 79.1 of this subchapter.
Interstate. From one State into or through any other State.
Interstate commerce. Trade, traffic, transportation, or other commerce between a place in a State and any place outside of that State, or between points within a State but through any place outside of that State.
Interstate swine movement report. A paper or electronic document signed by a producer moving swine giving notice that a group of animals is being moved across State lines in a swine production system. This document must contain the name of the swine production system; the name, location, and premises identification number of the premises from which the swine are to be moved; the name, location, and premises identification number of the premises to which the swine are to be moved; the date of movement; and the number, age, and type of swine to be moved. This document must also contain a description of any individual or group identification associated with the swine, the name of the swine production system accredited veterinarian(s), the health status of the herd from which the swine are to be moved, including any disease of regulatory concern to APHIS or to the States involved, and an accurate statement that swine on the premises from which the swine are to be moved have been inspected by the swine production system accredited veterinarian(s) within 30 days prior to the interstate movement and consistent with the dates specified by the premises' swine production health plan and found free from signs of communicable disease.
Livestock. All farm-raised animals.
Livestock market. A stockyard, buying station, concentration point, or any other premises where livestock are assembled for sale or sale purposes.
Move. To carry, enter, import, mail, ship, or transport; to aid, abet, cause, or induce carrying, entering, importing, mailing, shipping, or transporting; to offer to carry, enter, import, mail, ship, or transport; to receive in order to carry, enter, import, mail, ship, or transport; or to allow any of these activities.
National Animal Health Laboratory Network (NAHLN). The NAHLN is a nationally coordinated network and partnership of primarily Federal, State, and university-associated animal health laboratories that provide animal health diagnostic testing, methods research and development, and expertise for education and extension to detect biological threats to the nation's animal agriculture, thus protecting animal health, public health, and the nation's food supply.
National Uniform Eartagging System (NUES). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal.
Official Brand Inspection Agency. The duly constituted body elected, appointed, or delegated or granted authority by a State or governmental subdivision thereof, to administer laws, regulations, ordinances or rules pertaining to the brand identification of livestock.
Official brand inspection certificate. A certificate issued by an official brand inspection agency in any State in which such certificates are required for movement of livestock.
Official eartag. An identification tag approved by APHIS that bears an official identification number for individual animals. The design, size, shape, color, and other characteristics of the official eartag will depend on the needs of the users, subject to the approval of the Administrator. The official eartag must be tamper-resistant and have a high retention rate in the animal.
Official eartag shield. The shield-shaped graphic of the U.S. Route Shield with “U.S.” or the State postal abbreviation or Tribal alpha code imprinted within the shield.
Official identification device or method. A means approved by the Administrator of applying an official identification number to an animal of a specific species or associating an official identification number with an animal or group of animals of a specific species.
Official identification number. A nationally unique number that is permanently associated with an animal or group of animals and that adheres to one of the following systems:
(1) National Uniform Eartagging System (NUES).
(2) Animal identification number (AIN).
(3) Location-based number system.
(4) Flock-based number system.
(5) Any other numbering system approved by the Administrator for the official identification of animals.
Official swine tattoo. A tattoo, conforming to the six-character alpha-numeric National Tattoo System, that provides a unique identification for each herd or lot of swine.
Official testing. Testing to determine the disease status of animals for use in State-Federal programs. Tests are approved by the Administrator and conducted by qualified analysts in an approved laboratory.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other legal entity.
Premises. A location where livestock or poultry are housed or kept.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority a geographically distinct location from other premises. The PIN may be used in conjunction with a producer's own unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may be used as a component of a group/lot identification number (GIN).
Purebred registry association. A swine breed association formed and perpetuated for the maintenance of records of purebreeding of swine species for a specific breed whose characteristics are set forth in constitutions, by-laws, and other rules of the association.
Quarantined area. The States, Territories, or the District of Columbia or portions thereof quarantined by the Secretary of Agriculture for the specific contagious, infectious, or communicable animal disease mentioned in each part.
Slaughter swine. Swine being sold or moved for slaughter purposes only.
State. Any of the 50 States, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the District of Columbia, and any territories and possessions of the United States.
State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.
State representative. An individual employed in animal health work by a State or a political subdivision thereof and authorized by such State or political subdivision to perform the function involved.
Swine production health plan. A written agreement developed for a swine production system designed to maintain the health of the swine and detect signs of communicable disease.
The plan must identify all premises that are part of the swine production system and that receive or send swine in interstate commerce and must provide for health monitoring of all swine within the system. Such health monitoring must include inspections by the swine production system accredited veterinarian(s). Inspections of all identified premises that contain swine that are or will be in the process of moving interstate within the swine production system and of all swine on those premises must be conducted by the accredited veterinarian(s) at intervals of no greater than 30 days. Inspections of all identified receiving premises that contain only swine that have completed their interstate movement within a single swine production system and of all swine on those premises must be conducted in accordance with State regulations. The plan must also describe the recordkeeping system of the swine production system. The plan will not be valid unless it is signed by an official of each swine production system identified in the plan, the swine production system accredited veterinarian(s), an APHIS representative, and the State animal health official from each State in which the swine production system has premises. In the plan, the swine production system must acknowledge that it has been informed of and has notified the managers of all its premises listed in the plan that any failure of the participants in the swine production system to abide by the provisions of the plan and the applicable provisions of this part and part 85 of this chapter constitutes a basis for the cancellation of the swine production health plan, as well as other administrative or criminal sanctions, as appropriate.
Swine production system. A swine production enterprise that consists of multiple sites of production; i.e., sow herds, nursery herds, and growing or finishing herds, but not including slaughter plants or livestock markets, that are connected by ownership or contractual relationships, between which swine move while remaining under the control of a single owner or a group of contractually connected owners.
Swine production system accredited veterinarian. An accredited veterinarian who is named in a swine production health plan for a premises within a swine production system and who performs inspection of such premises and animals and other duties related to the movement of swine in a swine production system.
Tick infested. Infested with the ticks Boophilus annulatus (Margaropus annulatus), Boophilus microplus, or Rhipicephalus evertsi evertsi.
United States. All of the States.
United States Department of Agriculture (USDA) approved backtag. A backtag issued by APHIS that provides a temporary unique identification for each animal.
When the Secretary of Agriculture shall determine the fact that poultry or other animals in any State, Territory, or the District of Columbia are affected with any contagious, infectious, or communicable disease of livestock or poultry for which, in his opinion, a quarantine should be established or that other basis for a quarantine exists, notice will be given of that fact, and a rule will be issued accordingly, placing in quarantine such State, Territory, or the District of Columbia, or specified portion thereof. This rule will either absolutely forbid the interstate movement of the quarantined animals from the quarantined area or will indicate the regulations under which interstate movements may be made.
(a) Animals or poultry affected with any of the following diseases, which are endemic to the United States: Equine piroplasmosis, bovine piroplasmosis or splenetic fever, scabies in cattle, pseudorabies, acute swine erysipelas, tuberculosis, Johne's disease, brucellosis, scrapie, bluetongue, anthrax, chlamydiosis, and Newcastle disease, or any other communicable disease which is endemic to the United States, or which are cattle fever tick infested, shall not be moved interstate.
(b) Animals or poultry affected with any of the following diseases, not known to exist in the United States: foot-and-mouth disease, African swine fever, classical swine fever, Teschen disease, contagious bovine pleuropneumonia, highly pathogenic avian influenza, dourine, contagious equine metritis, vesicular exanthema, screwworms and glanders, scabies in sheep or any other communicable foreign disease not known to exist in the United States, shall not be moved interstate.
(c) Notwithstanding the provisions of paragraphs (a) and (b) of this section:
(1) Domestic animals that have reacted to an official test for brucellosis, are not affected with any other disease referred to in this section, and are not tick infested may be moved interstate in accordance with part 78 of this chapter.
(2) Domestic animals that are positive to an official Johne's disease test, are not affected with any other disease referred to in this section, and are not tick infested may be moved interstate in accordance with part 80 of this chapter.
(3) Cattle which have reacted to the tuberculin test, which are not affected with any other disease referred to in this section and are not tick infested, may be moved interstate in accordance with the provisions of § 77.17 of this subchapter.
(4) Swine infected with or exposed to pseudorabies may be moved interstate in accordance with part 85 of this chapter.
(5) [Reserved]
(6) Sheep or goats designated, with regard to scrapie, as exposed animals, high-risk animals, suspect animals, or scrapie-positive animals, as those terms are defined in part 79 of this subchapter, may be moved interstate only in accordance with part 79 of this subchapter.
(d) Notwithstanding the provisions of paragraphs (a) and (b) of this section, livestock which is found to be diseased may be moved interstate in accordance with paragraphs (d)(1) through (6) of this section: Provided, That such livestock is not tick infested or affected with any disease referred to in this section other than the diseases named in this paragraph: And provided further, That such livestock is accompanied by a certificate, issued by an APHIS or State representative or accredited veterinarian stating the destination of the animals; the purpose for which they are to be moved; the number of animals covered by the certificate; the point from which the animals are moved interstate; and the name and address of the owner or shipper.
(1) Livestock affected with one or more of the following diseases may be moved interstate for immediate slaughter to a slaughtering establishment where State or Federal meat inspection is maintained; Actinomycosis, actinobacillosis, anaplasmosis, atrophic rhinitis, contagious ecthyma, foot rot, infectious keratitis, ram epididymitis, ringworm, swine influenza, arthritis (simple lesions only), and shipping fever.
(2) Cattle with slight unopened cases of actinomycosis or actinobacillosis (or both) may be moved interstate to a feed lot in the State of destination: Provided, That such cattle are not affected with any other disease named in this paragraph.
(3) Sheep affected with or exposed to contagious ecthyma may be moved interstate to a feed lot located in a State the laws, rules, or regulations of which require that such sheep be segregated or quarantined under a permit from an official of such State: Provided, That such sheep are not affected with any other disease named in this paragraph.
(4) Livestock affected with one or more of the following diseases may be moved interstate for any purpose to a State the laws, rules, or regulations of which require that such livestock be segregated or quarantined under a permit from the appropriate livestock sanitary official of such State: actinomycosis, actinobacillosis, contagious ecthyma, foot rot, and shipping fever: Provided, That such livestock is not affected with any other disease named in this paragraph.
(5) Livestock affected with infectious keratitis or ringworm (or both) may be moved interstate for any purpose if treated under the supervision of an APHIS or State representative or an accredited veterinarian prior to movement: Provided, That such livestock is not affected with any other disease named in this paragraph. Livestock affected with infectious keratitis or ringworm (or both) and also with another disease named in this paragraph may be moved interstate only under the applicable provisions of paragraphs (d)(1) through (4) of this section after being so treated for infectious keratitis or ringworm (or both). Such livestock will be subject to further treatment at destination, if required.
(6) Fish affected with spring viremia of carp may be moved interstate only if they are being moved directly to a facility to be processed into food for human consumption.
(7) Other movements. The Administrator may provide for the movement, not otherwise provided for in this paragraph, of animals affected with the diseases named in paragraph (d)(1) of this section, under such conditions as he may prescribe to prevent the spread of disease. The Administrator will promptly notify the appropriate livestock sanitary officials of the States involved of any such action.
(e) Notwithstanding the provisions of paragraphs (a) and (b) of this section, the Administrator in specific cases and under such conditions as he may prescribe to prevent the dissemination of disease may provide for the interstate movement of individual animals affected with contagious, infectious, or communicable disease to a designated diagnostic or research facility when accompanied by a permit from the appropriate livestock sanitary official in the State of destination: Provided, That animals so moved shall be maintained in quarantine at such designated facility until freed of disease as determined by tests recognized by the Department, until natural death, or until disposal by euthanasia.
(f) Before offering cattle or other livestock or poultry for interstate transportation, transporting them interstate, or introducing them into any stockyards or upon routes of traffic for interstate transportation, all persons, companies, or corporations are required to exercise reasonable diligence to ascertain whether such animals or poultry are affected with any contagious, infectious, or communicable disease, or have been exposed to the contagion or infection of any such disease by contact with other animals or poultry so diseased or by location in pens, cars, or other vehicles, or upon premises that have contained animals or poultry so diseased.
(a) Yards, pens, chutes, alleys, and other facilities and premises which are used in connection with the interstate movement of livestock or poultry shall be maintained by the person in possession of the facilities and premises in a clean and sanitary condition, in accordance with good animal husbandry practices, and shall be subject to inspection by an APHIS or State representative. When an APHIS or State representative determines that such facilities or premises are not in such clean and sanitary condition and gives written notice of his determination to such person, the facilities and premises shall be cleaned and disinfected in accordance with §§ 71.7 and 71.10 through 71.12 by such person under the supervision of an APHIS or State representative or an accredited veterinarian before such premises are again used for livestock or poultry.
(b) Yards, pens, chutes, alleys, and other facilities and premises which have contained interstate shipments of cattle, sheep, swine, poultry, or other animals affected with, or carrying the infection of, any contagious, infectious, or communicable disease of livestock or poultry other than slight unopened cases of actinomycosis or actinobacillosis (or both), bovine foot rot, atrophic rhinitis, ram epididymitis, ringworm, infectious keratitis, and arthritis (simple lesions only), shall be cleaned and disinfected under the supervision of an APHIS or State representative or an accredited veterinarian in accordance with §§ 71.7 and 71.10 through 71.12 before such premises are again used for animals, and any poultry or other animals unloaded into such yards or premises before they have been so cleaned and disinfected shall thereafter be classed as “exposed” within the meaning of the regulations in this subchapter and shall not be moved interstate except in compliance with the provisions of such regulations applicable to “exposed” animals.
No person who receives notice from an APHIS representative that a railroad car, truck, boat, aircraft or other means of conveyance owned or operated by such person is not in a clean and sanitary condition in accordance with good animal husbandry practices, shall thereafter use such means of conveyance in connection with the interstate movement of livestock or poultry, or move said means of conveyance interstate, until it has been cleaned and disinfected under the supervision of an APHIS or State representative or an accredited veterinarian in accordance with §§ 71.7 and 71.10 through 71.12.
(a) Railroad cars, trucks, boats, aircraft, and other means of conveyance which have been used in the interstate transportation of cattle, sheep, goats, swine, poultry, or other animals affected with, or carrying the infection of, any contagious, infectious, or communicable disease of livestock or poultry, other than slight unopened cases of actinomycosis or actinobacillosis (or both), atrophic rhinitis, bovine foot rot, brucellosis, ram epididymitis, ringworm, infectious keratitis, and arthritis (simple lesions only), shall be cleaned and disinfected under APHIS supervision in accordance with §§ 71.7 and 71.10 through 71.12 at the point where the animals are unloaded and the final carrier shall be responsible for such cleaning and disinfecting: Provided, That when APHIS supervision is not available at such point, the means of conveyance may be cleaned and disinfected under the supervision of a State representative or an accredited veterinarian.
(b) No railroad car, truck, boat, aircraft or other means of conveyance from which poultry or other animals affected with an infectious, contagious or communicable disease of livestock or poultry, other than those specified in § 71.4(b), have been unloaded shall thereafter be used in connection with the interstate movement of animals, including poultry, or be moved interstate until it has been cleaned and disinfected by the final carrier under the supervision of an APHIS or State representative or an accredited veterinarian in accordance with §§ 71.7 and 71.10 through 71.12.
(c) If APHIS supervision or other supervision as required by paragraph (a) or (b) of this section or proper cleaning and disinfecting facilities are not available at the point where the animals are unloaded, upon permission first received from the Animal and Plant Health Inspection Service, the means of conveyance may be forwarded empty to a point at which such supervision and facilities are available, and there be cleaned and disinfected under supervision in accordance with §§ 71.7 and 71.10 through 71.12.
(a) Railroad cars, trucks, aircraft, or other means of conveyance, except boats, required by the regulations in this subchapter to be cleaned and disinfected shall be treated in the following manner: Remove all litter and manure from all portions of the conveyance, including any external ledges and framework; clean the exterior and interior of the conveyance; and saturate the entire interior surface, including the inner surface of the doors of the conveyance, with a permitted disinfectant specified in §§ 71.10 through 71.12.
(b) Boats required by the regulations in this subchapter to be cleaned and disinfected shall be treated in the following manner: Remove all litter and manure from the decks and stalls, and all other parts of the boat occupied or traversed by any poultry or other animals and from the portable chutes or other appliances or fixtures used in loading and unloading the animals, and saturate with a permitted disinfectant the entire surface of the deck, stalls, or other parts of the boat occupied or traversed by any animals or with which they may come in contact or which have contained litter or manure.
(c) Yards, pens, chutes, alleys, cages, and other equipment required by the regulations in this subchapter to be disinfected shall be treated in the following manner: Empty all troughs, racks, or other feeding or watering appliances; remove all litter and manure from the floors, posts, or other parts; and saturate the entire surface of the fencing, troughs, chutes, floors, walls, and other parts with a permitted disinfectant specified in §§ 71.10 through 71.12.
(a) Disinfectants permitted for use on cars, boats, and other vehicles, premises, and cages and other equipment are as follows:
(1) “Cresylic disinfectant” in the proportion of at least 4 fluid ounces to 1 gallon of water.
(2) Liquefied phenol (U.S.P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to 1 gallon of water.
(3) Chlorinated lime (U.S.P. strength, 30 percent available chlorine) in the proportion of 1 pound to 3 gallons of water.
(4) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(5) Disinfectants which are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq.), with tuberculocidal claims, as disinfectants for general use, may be used for the purpose of this part in accordance with directions on the labels accepted in connection with their registration. However, disinfectants which fall in this category are not permitted for use in outbreaks of foreign animal diseases unless in specific cases such use is approved in advance by the Administrator.
(b) The use of “cresylic disinfectant” is permitted subject to the following conditions:
(1) The manufacturer thereof shall have obtained specific permission from APHIS for the use of his products in official disinfection. To obtain such permission manufacturers shall first submit a sample of at least 8 ounces for examination, together with a statement of the formula employed and a guaranty that the product will be maintained of a quality uniform with the sample submitted.
(2) To prevent confusion, the product of each manufacturer and distributor shall bear a distinctive trade name or brand, together with the name of the manufacturer or distributor.
(3) The product shall at all times conform to specifications for composition and performance issued by the Administrator.
The following specifications will be employed for determining the suitability of cresylic disinfectant for use under the provisions of § 71.10(b)(3):
(a) The product shall remain a uniform liquid when held at 0 °C. (32 °F.) for 3 hours (chill test).
(b) The product shall dissolve completely in 30 parts of distilled water at 25 °C. (77 °F.) within 2 minutes (solution-rate test), producing a solution entirely free from globules and not more than faintly opalescent (solubility-degree test).
(c) The product shall contain not more than 25 percent of inert ingredients (water and glycerin), not more excess alkali than the equivalent of 0.5 percent of sodium hydroxide, and not less than 21 percent of soap exclusive of water, glycerin, and excess alkali.
(d) The product shall contain not less than 50 percent and not more than 53 percent of total phenols. It shall contain less than 5 percent of benzophenol (C
(e) The methods of determining compliance with the specifications in paragraphs (a) to (d) of this section will be those described in United States Department of Agriculture Bulletin 1308, Chemical and Physical Methods for the Control of Saponified Cresol Solutions, so far as they are applicable.
(f) Any suitable glyceride, fat acid, or resin acid may be used in preparing the soap, but not all are suitable nor are all grades of a single product equally suitable, Also various grades of commercial cresylic acid differ in suitability. Therefore, manufacturers are cautioned to prepare a trial laboratory batch from every set of ingredients and to prove its conformity with paragraphs (a) and (b) of this section, before proceeding with manufacture on a factory scale.
(a) A permitted brand of sodium orthophenylphenate in a proportion of at least one pound to 12 gallons of water is permitted in tuberculosis eradication work for disinfecting infected premises following the removal of cattle that reacted to the tuberculin test.
(b) It is absolutely necessary that the solution be applied at a temperature of 60 °F. or over. Whenever the temperature of the building to be disinfected is below 60 °F., as indicated by a wall thermometer, the solution shall be heated to 120 °F. and higher in very cold weather, to insure effective disinfection.
All persons and corporations having control of the interstate transportation of livestock or poultry shall, when directed by an APHIS inspector so to do, stop the same in transit for inspection, and if any of such poultry or other animals are found upon such inspection to be infected with any contagious, infectious, or communicable disease or to have been exposed to such infection, the person or corporation having control of the transportation of such poultry or other animals shall, upon receipt of an order from an APHIS representative so to do, cease the carriage, transportation, or moving of such poultry or other animals unless such carriage, transportation, or moving can be accomplished in accordance with the regulations in this subchapter governing the interstate movement of poultry or other animals infected with or which have been exposed to the infection of such disease, and in all cases after the discovery of such infection or exposure thereto such poultry or other animals shall be handled in accordance with such regulations.
When, in order to prevent the spread of any contagious, infectious, or communicable disease, it becomes necessary to slaughter any diseased or exposed animals, including poultry, and the purchase of such animals, including poultry, by the United States is authorized by law and an appropriation is available therefor, the value of the animals, including poultry shall be ascertained and compensation made therefor in accordance with the orders or regulations of the Secretary of Agriculture.
No livestock or poultry shall be shipped, trailed, driven, or hauled in private conveyance from the quarantined area in any State, Territory, or the District of Columbia to the free area in the same State, Territory, or the District of Columbia and subsequently delivered to a transportation company for shipment or moved to any other State, Territory, or the District of Columbia without complying with all Federal and State regulations pertaining to such movements.
(a) Assistance and facilities. When poultry or other animals are to be inspected and certified by an APHIS representative, assistance and proper facilities for restraining them shall be provided in order that a careful inspection may be made, and the representative while making the inspection shall not be interfered with in any manner; otherwise inspection will be immediately discontinued.
(b) Certificates and other statements to accompany shipments. Whenever inspection or treatment and the issuance of a certificate, statement, test chart, or other writing showing the performance of such inspection or treatment and the result thereof is required by any of the regulations in this subchapter as a condition precedent to the movement interstate of any poultry or other animal or class of poultry or other animals, or any poultry or other animal or class of poultry or other animals is so required to be accompanied in interstate movement by such certificate, statement, test chart, or other writing, no such poultry or other animal or poultry or other animals shall be moved interstate unless and until the following requirements are also complied with:
(1) In the case of such movement by a common carrier issuing waybills or other form or forms of billing covering the movement, the said certificate, statement, test chart, or other writing shall be delivered to such carrier at the time the poultry or other animal or poultry or other animals are delivered for shipment, and shall become the property of the carrier, and be by such carrier attached to the billing covering the transportation of such poultry or other animal or poultry or other animals, and accompany such billing to destination, and be filed with such billing for future reference.
(2) In case of such movement otherwise than by common carrier issuing waybills or other form or forms of billing, the said certificate, statement, test chart, or other writing shall accompany the poultry or other animal or poultry or other animals to destination and be delivered to the consignees, or, in case the consignor and consignee is the same person, to the first purchaser purchasing during or after such movement in interstate commerce, or to the person to whom the poultry or other animal or poultry or other animals are delivered.
No dead poultry or other animals shall be offered or accepted for transportation or transported in the same car with live poultry or other animals from the original point of shipment in any State or Territory or the District of Columbia to or through any other State, Territory, or the District of Columbia.
(a)(1) Except as provided in paragraphs (c) and (g) of this section, no swine may be sold, transported, received for transportation, or offered for sale or transportation, in interstate commerce, unless each swine is identified at whichever of the following comes first:
(i) The point of first commingling of the swine in interstate commerce with swine from any other source;
(ii) Upon unloading of the swine in interstate commerce at any livestock market;
(iii) Upon transfer of ownership of the swine in interstate commerce; or
(iv) Upon arrival of the swine in interstate commerce at their final destination.
(2) The identification shall be by means of identification approved by the Administrator and listed in paragraph (b) of this section. All swine shall remain so identified while they are in interstate commerce.
(3) Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles swine in interstate commerce, is responsible for the identification of the swine as provided by this section.
(b) Means of swine identification approved by the Administrator are:
(1) Official eartags, when used on any swine;
(2) United States Department of Agriculture (USDA) approved backtag, when used on swine moving to slaughter;
(3) Official swine tattoos, when used on swine moving to slaughter, when the use of the official swine tattoo has been requested by a user or the State animal health official, and the Administrator authorizes its use in writing based on a determination that the tattoo will be retained and visible on the carcass of the swine after slaughter, so as to provide identification of the swine;
(4) Tattoos of at least 4-characters when used on swine moving to slaughter, except sows and boars as provided in § 78.33 of this chapter;
(5) Ear notching when used on any swine, if the ear notching has been recorded in the book of record of a purebred registry association;
(6) Tattoos on the ear or inner flank of any swine, if the tattoos have been recorded in the book of record of a swine registry association;
(7) For slaughter swine and feeder swine, an eartag or tattoo bearing the premises identification number assigned by the State animal health official to the premises on which the swine originated; and
(8) Any other official identification device or method that is approved by the Administrator.
(c) Swine that are kept as a group are not required to be individually identified when in interstate commerce if:
(1) They were born on the same premises;
(2) They were raised on the same premises where they were born;
(3) They are moved in a group directly to a slaughtering establishment from the place where they were raised;
(4) They are not mixed with swine from any other premises, between the time they are born and the time they arrive at the slaughtering establishment; and
(5) They are slaughtered one after another, as a group, and not mixed with other swine at slaughter; or approved identification is applied to the swine after entry into the slaughtering establishment.
(d) Serial numbers of United States Department of Agriculture (USDA) approved backtag and official swine tattoos will be assigned to each person who applies to the State animal health official or the area veterinarian in charge for the State in which that person maintains his/her or its place of business. Serial numbers of official eartags will be assigned to each accredited veterinarian or State or Federal representative who requests official eartags from the State animal health official or the area veterinarian in charge, whoever is responsible for issuing official eartags in that State. Persons assigned serial numbers of United States Department of Agriculture (USDA) approved backtag, official swine tattoos, and official eartags must:
(1) Record the following information on a document:
(i) All serial numbers applied to the swine;
(ii) Any other serial numbers and approved identification appearing on the swine that are needed to identify the swine to its previous owner and location;
(iii) The street address, including the city and state, or the township, county, and state, of the premises where the approved means of identification were applied; and
(iv) The telephone number, if available, of the person who owns or possesses the swine.
(2) Maintain these records at the person's place of business for 2 years; and
(3) Make these records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) upon request by any authorized employee of the United States Department of Agriculture, upon that employee's request and presentation of his or her official credentials.
(e)(1) Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles swine in interstate commerce, must keep records relating to the transfer of ownership, shipment, or handling of the swine, such as yarding receipts, sale tickets, invoices, and waybills upon which is recorded:
(i) All serial numbers and other approved means of identification appearing on the swine that are necessary to identify it to the person from whom it was purchased or otherwise obtained; and
(ii) The street address, including city and state, or the township, county, and state, and the telephone number, if available, of the person from whom the swine were purchased or otherwise obtained.
(2) Each person required to keep records under this paragraph must maintain the records at his/her or its place of business for at least 2 years after the person has sold or otherwise disposed of the swine to another person, and for such further period as the Administrator may require by written notice to the person, for purposes of any investigation or action involving the swine identified in the records. The person shall make the records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized employee of the United States Department of Agriculture, upon that employee's request and presentation of his or her official credentials.
(f) No person may remove or tamper with any approved means of identification required to be on swine pursuant to this section while it is in interstate commerce, except at the time of slaughter as provided in 9 CFR 309.16(e).
(g) Swine moving interstate within a swine production system. Swine moving within a swine production system to other than slaughter or a livestock market are not required to be individually identified when moved in interstate commerce under the following conditions:
(1) The swine may be moved interstate only to another premises identified in a valid swine production health plan for that swine production system.
(2) The swine production system must operate under a valid swine production health plan, in which both the sending and receiving States have agreed to allow the movement.
(3) The swine must have been found free from signs of any communicable disease during the most recent inspection of the premises by the swine production system accredited veterinarian(s) within 30 days prior to movement.
(4) Prior to the movement of any swine, the producer(s) moving swine must deliver the required interstate swine movement report to the following individuals identified in the swine production health plan:
(i) The swine production system accredited veterinarian for the premises from which the swine are to be moved, and
(ii) The State animal health officials for the sending and receiving States, and any other State employees designated by the State animal health officials.
(5) The receiving premises must not commingle swine received from different premises in a manner that prevents identification of the premises that sent the swine or groups of swine. This may be achieved by use of permanent premises or individual identification marks on animals, by keeping groups of animals received from one premises physically separate from animals received from other premises, or by any other effective means.
(6) Each premises must maintain, for 3 years after their date of creation, records that will allow an APHIS representative or State animal health official to trace any animal on the premises back to its previous premises, and must maintain copies of each swine production health plan signed by the producer, all interstate swine movement reports issued by the producer, and all reports the swine production system accredited veterinarian(s) issue documenting the health status of the swine on the premises.
(7) Each premises must allow APHIS representatives and State animal health officials access to the premises upon request to inspect animals and review records.
(8) Once a month, each swine production system must send APHIS a written summary based on the interstate swine movement report data that shows how many animals were moved in the past month, the premises from which they were moved, and the premises to which they were moved.
(h) Cancellation of and withdrawal from a swine production health plan. The following procedures apply to cancellation of, or withdrawal from, a swine production health plan:
(1) A State animal health official may cancel his or her State's participation in a swine production health plan by giving written notice to all swine producers, APHIS representatives, accredited veterinarians, and other State animal health officials listed in the plan. Withdrawal shall be effective upon the date specified by the State animal health official in the notice, but for shipments in transit, withdrawal shall become effective 7 days after the date of such notice. Upon withdrawal of a State, the swine production health plan may continue to operate among the other States and parties signatory to the plan.
(2) A swine production system may withdraw one or more of its premises from participation in the plan upon giving written notice to the Administrator, the accredited veterinarian(s), all swine producers listed in the plan, and State animal health officials listed in the plan. Withdrawal shall be effective upon the date specified by the swine production system in the written notice, but for shipments in transit, withdrawal shall become effective 7 days after the date of such notice.
(3) The Administrator may cancel a swine production health plan by giving written notice to all swine producers, accredited veterinarians, and State animal health officials listed in the plan. The Administrator shall cancel a swine production health plan after determining that swine movements within the swine production system have occurred that were not in compliance with the swine production health plan or with other requirements of this chapter. Before a swine health production plan is canceled, an APHIS representative will inform a representative of the swine production system of the reasons for the proposed cancellation. The swine production system may appeal the proposed cancellation in writing to the Administrator within 10 days after being informed of the reasons for the proposed cancellation. The appeal must include all of the facts and reasons upon which the swine production system relies to show that the reasons for the proposed cancellation are incorrect or do not support the cancellation. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, cancellation of the disputed swine production health plan shall become effective pending final determination in the proceeding if the Administrator determines that such action is necessary to protect the public's health, interest, or safety. Such cancellation shall become effective upon oral or written notification, whichever is earlier, to the swine production system representative. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This cancellation shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
(a) To qualify for approval by the Administrator as an approved livestock facility
[Name of facility]
[Address and telephone number of facility]
I, [name of the individual legally responsible for the day-to-day operations of the livestock facility], operator of [name of facility], hereby agree to maintain and operate the livestock facility located at [address of premises] in accordance with the applicable provisions of this agreement and Chapter I, Title 9, of the Code of Federal Regulations (9 CFR).
(1) The State animal health official and the area veterinarian in charge shall be provided with a schedule of the facility's sale days, which shall indicate the types of animals that will be handled at the facility on each sale day, and shall be apprised of any changes to that schedule prior to the implementation of the changes.
(2) An accredited veterinarian, State representative, or APHIS representative shall be on the facility premises on all sale days to perform duties in accordance with State and Federal regulations.
(3) State representatives and APHIS representatives shall be granted access to the facility during normal business hours to evaluate whether the facility and its operations are in compliance with the applicable provisions of this agreement and 9 CFR parts 71, 75, 78, 79, and 85.
(4) An APHIS representative, State representative, or accredited veterinarian shall be immediately notified of the presence at the facility of any livestock that are known to be infected, exposed, high-risk and scrapie-positive or suspect, or that show signs of possibly being infected, with any infectious, contagious, or communicable disease.
(5) Any reactor, suspect, exposed, high-risk, or scrapie positive livestock shall be held in quarantined pens apart from all other livestock at the facility. This requirement shall not apply to scrapie-exposed sheep that are not also designated high-risk animals or to sheep or goats designated under 9 CFR part 79 as scrapie-exposed or high-risk animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or a certificate issued by an accredited veterinarian stating the animals are open; or that the animals are under 12 months of age and are not visibly pregnant and are maintained in the same pen only with other animals that will be moved directly to slaughter or to a terminal feedlot in accordance with 9 CFR parts 71 and 79.
(6) No reactor, suspect, exposed, high-risk, or scrapie-positive livestock, nor any livestock that show signs of being infected with any infectious, contagious, or communicable disease, may be sold at or moved from the facility, except in accordance with 9 CFR parts 71, 75, 78, 79, and 85.
(7) Documents such as weight tickets, sales slips, and records of origin, identification, and destination that related to livestock that are in, or that have been in, the facility shall be maintained by the facility. For poultry and swine, such documents must be kept for at least 2 years, and for cattle and bison, sheep and goats, cervids, and equines, for at least 5 years. APHIS representatives and State representatives shall be permitted to review and copy those documents during normal business hours.
(8) All livestock must be officially identified in accordance with the applicable regulations in 9 CFR parts 71, 75, 78, 79, 85, and 86 at the time of, or prior to, entry into the facility.
(9) The facility, including all yards, docks, pens, alleys, sale rings, chutes, scales, means of conveyance, and their associated equipment, shall be maintained in a clean and sanitary condition. The operator of the facility shall be responsible for the cleaning and disinfection of the facility in accordance with 9 CFR part 71 and for maintaining an adequate supply of disinfectant and serviceable equipment for cleaning and disinfection.
(10) All facilities and equipment shall be maintained in a state of good repair. The facility shall contain well-constructed and well-lighted livestock handling chutes, pens, alleys, and sales rings for the inspection, identification, vaccination, testing, and branding of livestock.
(11) Quarantined pens shall be clearly labeled with paint or placarded with the word “Quarantined” or the name of the disease of concern, and shall be cleaned and disinfected in accordance with 9 CFR part 71 as well as 9 CFR 54.7(e)(2) if the disease of concern is scrapie and the quarantined animal gave birth or aborted at the facility, before being used to pen livestock that are not reactor, suspect, exposed, high-risk, or scrapie-positive animals.
(12) Quarantined pens shall have adequate drainage, and the floors and those parts of the walls of the quarantined pens with which reactor, suspect, exposed, high-risk, or scrapie-positive livestock, their excrement, or discharges may have contact shall be constructed of materials that are substantially impervious to moisture and able to withstand continued cleaning and disinfection.
(13) Electrical outlets shall be provided at the chute area for branding purposes.
(14) Cattle and bison:
(i) Cattle and bison shall be received, handled, and released by the facility only in accordance with 9 CFR parts 71 and 78.
(ii) All brucellosis reactor, brucellosis suspect, and brucellosis exposed cattle or bison arriving at the facility shall be placed in quarantined pens and consigned from the facility only in accordance with 9 CFR part 78.
(iii) Any cattle or bison classified as brucellosis reactors at the facility shall be identified in accordance with 9 CFR part 78, placed in quarantined pens, and consigned from the facility only to a recognized slaughtering establishment or an approved intermediate handling facility in accordance with 9 CFR part 78.
(iv) Any cattle or bison classified as brucellosis exposed at the facility shall be identified in accordance with 9 CFR part 78, placed in quarantined pens, and consigned from the facility only to a recognized slaughtering establishment, approved intermediate handling facility, quarantined feedlot, or farm of origin in accordance with 9 CFR part 78.
(v) The identity of cattle from Class Free States or areas and Class A States or areas shall be maintained.
(vi) The identity of cattle from Class B States or areas shall be maintained, and test-eligible cattle from Class B States or areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(vii) The identity of cattle from Class C States or areas shall be maintained, and test-eligible cattle from Class C States or areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(viii) The identity of cattle from quarantined areas shall be maintained, and test-eligible cattle from quarantined areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(ix) Test-eligible cattle that are penned with test-eligible cattle from a lower class State or area, in violation of this agreement, shall have the status of the State or area of lower class for any subsequent movement.
(x) Laboratory space shall be furnished and maintained for conducting diagnostic tests. All test reagents, testing equipment, and documents relating to the State-Federal cooperative eradication programs on the facility's premises shall be secured to prevent misuse and theft. Adequate heat, cooling, electricity, water piped to a properly drained sink, and sanitation shall be provided for properly conducting diagnostic tests.
(15) Swine:
(i) Swine shall be received, handled, and released by the livestock facility only in accordance with 9 CFR parts 71, 78, and 85.
(ii) Pens, alleys, and sales rings for holding, inspecting, and otherwise handling swine shall be imperviously surfaced.
(iii) Slaughter swine may be handled only on days when no feeder swine or breeder swine are present at the facility, unless the facility has provisions to keep slaughter swine physically separated from feeder swine and breeder swine or unless those areas of the facility used by slaughter swine have been cleaned and disinfected before being used by feeder swine or breeder swine.
(iv) No feeder swine or breeder swine may remain in the livestock facility for more than 72 hours, and no slaughter swine may remain in the livestock market for more than 120 hours.
(v) Feeder swine shall be kept separate and apart from other swine while in the livestock facility.
(vi) No release shall be issued for the removal of slaughter swine from the livestock facility unless the slaughter swine are consigned for immediate slaughter or to another slaughter market and the consignee is identified on the release document.
(16) Horses:
(i) Horses shall be received, handled, and released by the livestock facility only in accordance with 9 CFR parts 71 and 75.
(ii) Any horses classified as EIA reactors and accepted by the facility for sale shall be placed in quarantined pens at least 200 yards from all non-EIA-reactor horses.
(iii) Any horses classified as EIA reactors and accepted by the facility for sale shall be consigned from the facility only to a slaughtering establishment or to the home farm of the reactor in accordance with 9 CFR part 75.
(iv) Fly Control Program: The livestock facility shall have in effect a fly control program utilizing at least one of the following: Baits, fly strips, electric bug killers (“Fly Zappers,” “Fly Snappers,” or similar equipment), or the application of a pesticide effective against flies, applied according to the schedule and dosage recommended by the manufacturer for fly control.
(17) Sheep and goats:
(i) All sheep and goats must be received, handled, and released by the facility only in accordance with 9 CFR parts 71 and 79.
(ii) All sheep and goats at the facility must be officially identified and relevant records related to those identified animals must be maintained by the facility operator, as required under 9 CFR part 79.
(iii) The identity of sheep and goats from consistent States and inconsistent States must be maintained by the facility operator.
(iv) Sexually intact animals that do not meet the requirements of part 79 to be sold as breeding animals must be maintained in separated enclosures at all times from animals that may be offered for sale as breeding animals unless all animals maintained in an enclosure arrived at the facility as part of the same consignment and are separated prior to sale.
(v) Any sheep or goats that are designated, with regard to scrapie, as high-risk, suspect or scrapie-positive animals, and goats designated with regard to scrapie as exposed animals, excluding slaughter sheep or goats that are designated as exposed or high-risk animals and are not pregnant, must be held in quarantined pens while at the facility.
(18) Request for approval:
I hereby request approval for this facility to operate as an approved livestock facility for the classes of livestock indicated in paragraphs (14) through (17) of this agreement. I acknowledge that I have received a copy of 9 CFR parts 71, 75, 78, 79, and 85, and acknowledge that I have been informed and understand that failure to abide by the provisions of this agreement and the applicable provisions of 9 CFR parts 71, 75, 78, 79, and 85 constitutes a basis for the withdrawal of this approval. [Printed name and signature of operator, date of signature]
(19) Pre-approval inspection of livestock facility conducted by [printed name and title of APHIS representative] on [date of inspection].
(20) Recommend approval:
[Printed name and signature of State animal health official, date of signature]
[Printed name and signature of area veterinarian in charge, date of signature]
(21) Approval granted:
[Printed name and signature of the Administrator, Animal and Plant Health Inspection Service, date of signature]
(b) Denial and withdrawal of approval. The Administrator may deny or withdraw the approval of a livestock facility to receive livestock moved interstate under this subchapter upon a determination that the livestock facility is not or has not been maintained and operated in accordance with the agreement set forth in paragraph (a) of this section.
(1) In the case of a denial, the operator of the facility will be informed of the reasons for the denial and may appeal the decision in writing to the Administrator within 10 days after receiving notification of the denial. The appeal must include all of the facts and reasons upon which the person relies to show that the livestock facility was wrongfully denied approval to receive livestock moved interstate under this subchapter. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(2) In the case of withdrawal, before such action is taken, the operator of the facility will be informed of the reasons for the proposed withdrawal. The operator of the facility may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the approval of the livestock facility to receive livestock moved interstate under this subchapter. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This withdrawal shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
(3) Approval for a livestock facility to handle livestock under this subchapter will be automatically withdrawn by the Administrator when:
(i) The operator of the facility notifies the Administrator, in writing, that the facility no longer handles livestock moved interstate under this subchapter; or
(ii) The person who signed the agreement executed in accordance with paragraph (a) of this section is no longer responsible for the day-to-day operations of the facility.
(a) Any person moving livestock or poultry interstate for slaughter or rendering may only move the animals to a slaughtering establishment or a rendering establishment that has been listed by the Administrator
(1) The owner or operator of the establishment must agree, in writing, to meet the requirements for a listed facility under this section by signing a listing agreement.
(2) The establishment provides space and equipment in accordance with paragraph (b) of this section
(3) The establishment allows APHIS, FSIS, or APHIS contractors to take blood and tissue samples from all livestock or poultry at the facility without cost to the United States, and specifically allows these personnel access to the processing line to collect samples; and
(4) The establishment allows APHIS, FSIS, or APHIS contractors to record the identification of individual animals and retain any external or internal identification devices.
(5) The management of the slaughtering or rendering establishment agrees that weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or have been in, the establishment will be maintained by the establishment. For poultry and swine, such documents must be kept for at least 2 years, and for cattle and bison, sheep and goats, cervids, and equines, for at least 5 years. APHIS, APHIS contractors, and State animal health representatives will be permitted to review and copy or scan these documents during normal business hours.
(b) The establishment must provide office and sample collection space, including necessary furnishings, light, heat, and janitor service, rent free, for the use by APHIS, FSIS, or APHIS contractors collecting samples for blood and tissue testing under this section. The Administrator will inform each establishment of the exact amount and type of space required, taking into account whether APHIS will be conducting complete tests at the facility, or only collecting samples and sending them elsewhere for testing. At the discretion of the Administrator, small plants need not furnish facilities as prescribed in this section if adequate facilities exist in a nearby convenient location. In granting or denying listing of an establishment, the Administrator will consider whether the space at the facility:
(1) Is conveniently located, properly ventilated, and provided with lockers suitable for the protection and storage of supplies;
(2) Has sufficient light to be adequate for proper conduct of sample collection and processing;
(3) Includes racks, receptacles, or other suitable devices for retaining such parts as the head, glands, and viscera, and all parts and blood to be collected, until after the post-mortem examination is completed;
(4) Includes tables, benches, and other equipment on which sample collection and processing are to be performed, of such design, material, and construction as to enable sample collection and processing in a safe, ready, efficient, and clean manner;
(5) Has adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, dissection tools, floors, and other articles and places that may be contaminated by diseased carcasses or otherwise; and
(6) Has adequate facilities, including denaturing materials, for the proper disposal in accordance with this chapter of tissue, blood, and other waste generated during test sample collection.
(c) The Administrator will give the operator of the establishment actual notice that APHIS, FSIS, or an APHIS contractor will be taking blood and/or tissue samples at the establishment. The Administrator may give the operator of the establishment notice in any form or by any means that the Administrator reasonably believes will reach the operator of the establishment prior to the start of sample collection.
(1) The notice will include the anticipated date and time sample collection will begin. The notice will also include the anticipated ending date and time.
(2) The Administrator will give the operator of the establishment as much advance notice as possible. However, the actual amount of notice will depend on the specific situation.
(d) Denial and withdrawal of listing. The Administrator may deny or withdraw the listing of an establishment upon a determination that the establishment is not in compliance with the requirements of this section.
(1) In the case of a denial, the operator of the establishment will be informed of the reasons for the denial and may appeal the decision in writing to the Administrator within 10 days after receiving notification of the denial. The appeal must include all of the facts and reasons upon which the person relies to show that the establishment was wrongfully denied listing. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(2) In the case of withdrawal, before such action is taken, the operator of the establishment will be informed of the reasons for the proposed withdrawal. The operator of the establishment may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the listing. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the operator of the establishment. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This withdrawal shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
(a) Approvals. State, university, and private laboratories must obtain APHIS approval to conduct official testing for those diseases covered by subchapters B, C, and D of this chapter. Laboratories seeking approval must meet the requirements of this section.
(b) Facilities. Official testing must be performed in laboratory facilities with controlled conditions, instrumentation appropriate for the testing being conducted, and biosecurity measures commensurate with the disease of diagnostic concern; each of these facility requirements must be acceptable to APHIS. Approved laboratories must agree to periodic, unannounced inspection by APHIS personnel or other APHIS-approved inspectors following an APHIS-approved checklist.
(c) Quality system. Laboratories must operate under a quality system acceptable to APHIS. Components of such systems include acceptable documentation of procedures, recordkeeping, training, reporting, and corrective actions taken if standards and procedures are not reached or maintained. Adherence to certain nationally or internationally established quality systems recognized by APHIS may be used to meet all or part of this requirement.
(d) Procedures. All official testing must be conducted using APHIS-approved assay methods,
(e) Training. Official testing must be conducted only by those individuals who have completed APHIS-approved training and have passed proficiency tests administered by APHIS or its official designee. These tests will be administered annually or as necessary at an interval stipulated by APHIS. Supervisory oversight of official testing must be performed by qualified individuals, as determined by APHIS.
(f) Reporting. Approved laboratories must report test results to APHIS and State animal health officials using an individualized (by disease) timeline established by APHIS at the time of laboratory approval.
(g) Applications for approval. (1) Laboratories must use APHIS application forms, including an agreement to meet the obligations to APHIS listed in this section, and submit completed forms to the NVSL Director. The Director will make a preliminary determination of the application's acceptability, based on initial review of submitted materials and, when appropriate, a needs assessment for diagnostic capacity. These determinations are made on an annual basis, or as needed based on the number of applications received.
(2) Applicants will be informed of the preliminary determination. If positive, applicants will then be able to request a facility inspection and personnel training, conducted in accordance with this section. If negative, APHIS will provide a rationale for the denial. Denied applicants may appeal any denials in accordance with the regulations in paragraph (j) of this section;
(3) When all requirements in this section have been met, the NVSL Director will issue a final approval. Approvals are specific to those lab personnel working at the inspected, approved laboratory who have met the eligibility and proficiency requirements. Denied applicants may appeal any denials in accordance with the regulations in paragraph (j) of this section.
(h) Maintenance of approved status. (1) Previously approved laboratories that wish to maintain their approved status must reapply for APHIS approval at least 1 month before their approval term expires, or at least every 2 years, whichever comes first. Laboratories wishing to maintain approved status must submit a renewal application form, as supplied by APHIS, to the NVSL Director.
(2) Approved laboratories must have at least one individual with the required training and unexpired proficiency certification in their employ at all times.
(3) Approved laboratories must perform the minimum number of tests to maintain proficiency, as stipulated by APHIS in the guidance documents developed for individual test types.
(i) Probation, suspension, and rescission of laboratory approval. (1) Laboratories not conducting the minimum number of tests as required by paragraph (h)(3) of this section during a single reporting period will be assigned probationary status. A reporting period is less than or equal to the time for which the laboratory has been approved to conduct testing by APHIS. Laboratories on probation may continue to conduct official testing. If the minimum required number of tests are not performed during two consecutive reporting periods, the laboratory will not be eligible for renewal of APHIS approval. Exceptions to this requirement may be granted by the NVSL Director upon request.
(2) Approval to conduct official testing will be suspended in the event that a laboratory experiences changes that may impact its ability to provide quality testing services. These changes include: No longer employing an individual approved to conduct official testing, a move to different facilities, or a natural disaster that impacts power or water systems. Laboratories with suspended status will not be approved to conduct official testing. Laboratories will be restored to approved status upon training and/or testing new personnel, successful inspection of new facilities, and/or correction of noncompliance issues. Reapproval will involve resubmitting those sections of the application materials required by the NVSL Director.
(3) Approval may be rescinded at any time, at the discretion of the NVSL Director, if a laboratory fails to meet its obligations to APHIS, as listed in the agreement signed by the laboratory during the application process. The NVSL Director will issue a notice to the laboratory, providing the justification for the proposed removal. Laboratories will have 30 days to respond in writing to the concerns provided before the NVSL Director finalizes the removal decision.
(j) Appeals. Appeal of any denial, probation, suspension, or rescission of laboratory approval must be made in writing to the APHIS Administrator or the Administrator's official designee within 30 days of the laboratory's receipt of the NVSL Director's decision. Responses to these appeals will be provided within 60 days of receipt by APHIS.
No animals infested with ticks [Boophilus annulatus or Rhipicephalus (Boophilus) annulatus, Margaropus annulatus, Boophilus microplus or Rhipicephalus (Boophilus) microplus, or Babesiasis (Babesiosis) species vectors of Margaropus, Rhipicephalus, Amblyomma, Demacentor, or Ixodes] or exposed to tick infestation may be moved interstate, except as provided in this part.
Notice is hereby given that the contagious, infectious, and communicable disease known as bovine piroplasmosis, bovine babesiosis, redwater, or splenetic, southern, cattle, Texas or tick fever exists in cattle in portions of the State of Texas and the Virgin Islands of the United States. Notice is also hereby given that ticks which are vectors of said disease exist in the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the Island of Guam. Therefore, portions of the State of Texas, the Virgin Islands of the United States, the Northern Mariana Islands, the Commonwealth of Puerto Rico and the Island of Guam are hereby quarantined as provided in §§ 72.3 and 72.5, and the movement of cattle therefrom into any other State or Territory or the District of Columbia shall be made only in accordance with the provisions of this part and part 71 of this chapter.
The entire Territories of the Virgin Islands of the United States and the Island of Guam, the Northern Mariana Islands, and the Commonwealth of Puerto Rico are quarantined.
The area quarantined in Texas is the quarantined area described in the regulations of the Texas Animal Health Commission (TAHC) contained in §§ 41.14 through 41.22 of title 4, part II, of the Texas Administrative Code (4 TAC 41.14 through 41.22), effective June 23, 2002, which is incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of 4 TAC 41.14 through 41.22 may be obtained from the TAHC at 2105 Kramer Lane, Austin, TX 78758, and from area offices of the TAHC, which are listed in local Texas telephone directories. The TAHC also maintains a copy of its regulations on its Internet homepage at http://www.tahc.state.tx.us/. Copies may be inspected at the Animal and Plant Health Inspection Service, Veterinary Services, suite 3B08, 4700 River Road, Riverdale, MD, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Cattle in quarantined areas where tick eradication is not being conducted
Cattle in areas where tick eradication is being conducted in cooperation with State authorities,
Cattle located in areas where tick eradication is being conducted in co- operation with the State authorities, and which are on premises shown by the official records of tick eradication to be free from ticks, may, upon inspection and certification by an APHIS inspector, be shipped or transported interstate for any purpose without dipping upon compliance with the requirements set forth under §§ 72.9, 72.10, 72.12.
All interstate movements of inspected and certified and dipped and certified cattle shall be accompanied to final destination by a certificate of an APHIS inspector (which certificate shall show that the cattle so being moved have been dipped as required by § 72.6 or by § 72.7 and are free of ticks, or have been inspected as required by § 72.8 and are free of ticks); all such certificates shall be handled, delivered, kept, and preserved in accordance with the provisions of § 72.16; and all such cattle shall be handled through noninfectious pens, alleys, and chutes, and when shipped shall be loaded into clean and disinfected cars or trucks, and shall not be unloaded in the quarantined area except at such points reserved for noninfested cattle as may from time to time be authorized by APHIS.
All such interstate movements of inspected or dipped and certified cattle are subject to such restrictions, which are not inconsistent with the regulations in this subchapter, as may be imposed at destination by the officials of the State, Territory, or the District of Columbia.
Cattle of the quarantined area shall be considered infested and shall not be placed in noninfectious pens or premises until after the final inspection or dipping.
The cattle shall not be exposed to tick infestation after treatment and/or inspection.
(a) Dipping requirements; facilities; handling. The dipping of cattle for interstate movement shall be done only with a permitted dip and at places where proper equipment is provided for dipping and for handling the cattle in a manner to prevent exposure to infection after the final dipping. Cattle which are to be dipped shall be given an opportunity to drink sufficient water to quench their thirst prior to dipping, be carefully handled, and not dipped while they are in a heated or exhausted condition. Dipped cattle shall not be loaded for shipment until dry.
(b) Permitted dips. The dips at present permitted by the U.S. Department of Agriculture in official dipping for interstate movement are:
(1) Approved proprietary brands of coumaphos (Co-Ral ®), 25 percent wettable powder or flowable form labeled for use as a 0.25 percent dip and used at a concentration of 0.125 to 0.250.
(2) [Reserved]
(c) Approval of dips. Proprietary brands of dips are permitted to be used for purposes of this part only when approved by the Administrator, APHIS. Before a dip will be specifically approved as a permitted dip for the eradication of ticks, APHIS will require that the product be registered under the provisions of the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135 et seq.); that its efficacy and stability have been demonstrated; that trials have been conducted to determine that its concentration can be maintained and that under actual field conditions the dipping of cattle with a solution of definite strength will effectually eradicate ticks without injury to the animals dipped.
(d) Tissue residues; restriction on slaughter. Tissue residues are created following use of certain dips. Animals treated with such dips should not be slaughtered for food purposes until the expiration of such period as may be required under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.). The length of this period shall be specified on each certificate issued by the inspector who supervises the dipping.
When the cattle are to be dipped under APHIS supervision the owner of the cattle, offered for shipment, or his agent duly authorized thereto, shall first execute and deliver to an APHIS inspector an application for inspection and supervised dipping wherein he shall agree to waive all claims against the United States for any loss or damage to said cattle occasioned by or resulting from dipping or other treatment under this part, or resulting from any subsequent treatment prior to their interstate shipment, or resulting from the fact that they are later found to be still tick infested, and also for all subsequent loss or damage to any other cattle in the possession or control of such owner which may come into contact with the cattle so dipped or treated.
When deemed advisable and upon recommendation by the proper livestock sanitary authorities, designated dipping stations may be approved by the Administrator, APHIS as points at which cattle of the quarantined area of the State in which said station is located may be inspected, dipped, and certified for interstate movement. The facilities furnished shall include proper dipping equipment, noninfectious pens constructed in accordance with § 72.17 and a roofed or covered section of pens of sufficient size to protect all dipped animals from exposure to rain or hot sun. All alleys, chutes, and pens shall be paved or properly floored.
(a) Specifications for construction and maintenance. Cattle of the free area, and cattle of the quarantined area when properly dipped, inspected, and certified in accordance with this part, which are transported interstate by rail through the quarantined area shall not be unloaded therein for rest, feed, and water unless they are unloaded into the properly equipped, noninfectious pens set apart for such cattle at such points as may from time to time be authorized by APHIS. Such noninfectious pens and the platforms, chutes, and alleys leading thereto shall be constructed and maintained in accordance with the specifications set out in paragraphs (a)(1) to (6) of this section.
(1) The outside fences enclosing such pens, and the fences on either side of the alleys, chutes, and platforms leading thereto, shall be tight board fences not less than 6 feet high on the inside.
(2) If such pens, alleys, chutes, and platforms are adjacent to pens, alleys, chutes, and platforms used by cattle of the quarantined area, there shall be between them a space not less than 10 feet wide, which shall be inaccessible to livestock. This space shall be limited on each side by the 6-foot fence required by paragraph (a)(1) of this section. The remaining space around such yards shall be limited as in paragraph (a)(3) of this section.
(3) If such pens, alleys, chutes, and platforms are isolated from other pens, alleys, chutes, or platforms, there shall be built and maintained outside thereof on all sides to which cattle of the vicinity might otherwise approach a cattle-proof fence not less than 5 feet high and not less than 15 feet from the 6-foot fence required by paragraph (a)(1) of this section.
(4) The only means of egress from such pens shall be by way of the alleys, chutes, and platforms inclosed by 6-foot fences as required by paragraph (a)(1) of this section, to cars for reforwarding; and under no circumstances shall there exist any connection between such pens and other adjacent premises.
(5) Such noninfectious premises shall be so located, or such drainage facilities shall be provided therefor, that water from the surrounding area will not flow on to or through them.
(6) Such pens shall be marked by a conspicuous sign bearing the words “Noninfectious Pens” in letters not less than 10 inches in height.
(b) Materials for use in noninfectious pens; source, shipment, handling. The hay, straw, or similar materials required for feed and bedding in such noninfectious pens shall be shipped in noninfectious cars from points outside of the quarantined area so handled that they may not become infectious.
(a) Tick-infested cattle. Cattle of the free area which are tick-infested may be moved interstate for any purpose after they have been treated in the same manner as cattle under § 72.6: Provided, however, That when dipping equipment is not available at the place where the cattle are, said treatment shall be given at a place and in the manner specified by the Administrator, APHIS.
(b) Tick-exposed cattle. Cattle of the free area which have been exposed to tick infestation may be moved interstate for any purpose after they have been treated in the same manner as cattle under § 72.7: Provided, however, That when dipping equipment is not available at the place where the cattle are, said treatment shall be given at a place and in the manner specified by the Administrator, APHIS.
(c) Cattle moved contrary to regulations. Cattle which have been moved from the quarantined area to the free area without first having been treated in the manner provided in either § 72.6 or § 72.7 or inspected in the manner provided in § 72.8 shall not be shipped or moved interstate until they have been treated in the same manner as cattle under § 72.6: Provided, however, That when dipping equipment is not available at the place where the cattle are, said treatment shall be given at a place and in the manner specified by the Administrator, APHIS.
Pine straw, grass, or similar litter collected from tick-infested pastures, ranges, or premises may disseminate the contagion of splenetic, southern, or Texas fever; therefore pine straw, grass, or similar litter originating in the quarantined area shall not be transported or moved interstate therefrom or used as packing material or car bedding for commodities or livestock to be transported or moved from the quarantined area of any State, Territory, or the District of Columbia, to or through the free area of any other State, Territory, or the District of Columbia, unless such material is first disinfected in accordance with the provisions of § 72.24.
The exhibition of noninfected cattle at fairs or exhibitions in the quarantined area and their reshipment to the free area without dipping may, by written order of the Administrator, APHIS be permitted: Provided, That the cattle shall be handled under such conditions as may be prescribed in each case to preclude any danger of the spread of infection.
Animals other than cattle which are infested with ticks [Boophilus annulatus (Margaropus annulatus), Boophilus microplus, or Rhipicephalus evertsi evertsi] or exposed to tick infestation shall not be moved interstate unless they are treated, handled, and moved in accordance with the requirements specified in §§ 72.9 through 72.15 and § 72.18 of this part governing the interstate movement of cattle.
Cars and other vehicles, and yards, pens, chutes, or other premises or facilities, which have contained interstate shipments of animals infested with or exposed to ticks, shall be cleaned and treated within 72 hours of use and prior to further use in the required concentration with a permitted dip listed in § 72.13 under supervision of a State or Federal inspector or an accredited veterinarian.
Cars or others vehicles which have carried cattle exposed to or infested with ticks within the quarantined area of any State shall be cleaned and treated in the required concentration with a permitted dip listed in § 72.13 before being moved interstate under supervision of a State or Federal inspector or an accredited veterinarian.
The litter and manure removed from cars, boats, or other vehicles and from pens, chutes, alleys, or other premises or inclosures which have contained interstate shipments of tick-infested animals, shall be destroyed or treated by the transportation or yard company, or other owner thereof, under APHIS supervision, by saturating it in the required concentration with a permitted dip listed in § 72.13, or shall be otherwise disposed of under prior permission received from the Administrator, APHIS.
Dipping is accomplished by thoroughly wetting the entire skin by either immersion in a chemical solution in a dip vat, or by spraying with a chemical solution using a spray-dip machine or a hand-held sprayer.
(a) Cattle affected with scabies. No cattle affected with scabies shall be shipped, trailed, driven, or otherwise moved interstate for any purpose except as provided in this part.
(b) Cattle affected with or exposed to scabies. No cattle which, just prior to movement, were affected with or exposed to scabies shall be shipped, trailed, driven, or otherwise moved interstate for any purpose except as provided in this part.
(c) Cattle from area quarantined for scabies. No cattle shall be shipped, trailed, driven, or otherwise moved interstate from the area quarantined for the disease of scabies in cattle except as provided in this part.
Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary may promulgate regulations and may prohibit or restrict the movement in interstate commerce of any animal, article, or means of conveyance as the Secretary determines necessary to prevent the introduction or dissemination of any pest or disease of livestock. Pursuant to this authority, the Department has quarantined various areas because of cattle scabies and has issued the regulations in this part governing the interstate movement of cattle from such areas. It is the policy of the Department to quarantine those portions of any State that are clearly identifiable, and in which exist animals affected with cattle scabies, or mites which are the contagion of said disease and not to quarantine an entire State for cattle scabies if the State adopts and enforces requirements for the intrastate movement of cattle that are at least as stringent as the requirements in the regulations in this part for interstate movements of cattle. Further, it is the policy of the Department to remove the quarantine from any quarantined area when it is determined that scabies-affected animals and the mites which are the contagion of scabies no longer exist in such areas.
For purposes of this part the following terms shall have the meaning set forth in this section.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
APHIS Inspector. A veterinarian or livestock inspector employed by the Animal and Plant Health Inspection Service, U.S. Department of Agriculture, in animal health activities, who is authorized to perform the function involved.
State Inspector. A veterinarian or livestock inspector regularly employed in animal health activities by a State or a political subdivision thereof, authorized by such State or political subdivision to perform the function involved under a cooperative agreement with the U.S. Department of Agriculture.
(a) Conditions under which permitted after one dipping. Cattle which, just prior to shipment, were affected with scabies but have been dipped once in a permitted dip (other than a toxaphene dip), under the supervision of an APHIS inspector or State inspector, within 10 days prior to the date of shipment may be shipped or transported interstate for immediate slaughter to a recognized slaughtering center, upon compliance with the following conditions:
(1) They shall not be diverted en route.
(2) The means of conveyance shall be placarded and the billing shall be marked “Treated Scabby Cattle,” in accordance with § 73.6.
(b) After one dipping; to be slaughtered within 14 days or redipped by owner. Cattle shipped interstate subject to the provisions of paragraph (a) of this section shall be slaughtered within 14 days from the date of the dipping or shall be again dipped by the owner.
(c) When part of diseased herd not visibly affected. Cattle of the free area not visibly diseased with scabies, but which may be part of a diseased herd, may be shipped or transported interstate for immediate slaughter to any recognized slaughtering center where separate pens are provided for yarding exposed cattle: Provided, That means of conveyance in which the cattle are transported shall be placarded and the billing accompanying the shipment shall be marked “Cattle Exposed to Scabies” in accordance with § 73.6.
(d) Undiseased herds in quarantined area; conditions under which permitted. Cattle of herds of the quarantined area which are not diseased with scabies may be shipped, transported, or otherwise moved interstate for immediate slaughter, upon inspection by an APHIS or State inspector within 10 days prior to the date of shipment and when accompanied by a certificate from such inspector showing the cattle to be free from disease.
Cattle affected with scabies may be shipped interstate for any purpose if dipped twice in a permitted dip, 10 to 14 days apart, under the supervision of an APHIS inspector or State inspector, and so certified by such inspector, or such cattle may be so shipped if dipped once in a permitted dip under APHIS supervision or State supervision at the point of origin, provided arrangements have been made for the second dipping, under APHIS supervision, en route or at destination within 10 to 14 days after the first dipping. If shipped in the latter manner the means of conveyance containing the cattle shall be placarded and the billing shall be marked “Treated Scabby Cattle,” in accordance with § 73.6.
Cattle not visibly diseased with scabies, but which are known to be part of a diseased herd or to have come in contact with diseased cattle or infectious means of conveyance or premises, may be shipped interstate for any purpose if dipped at the point of origin, under the supervision of an APHIS inspector or State inspector, in a permitted dip, or the cattle may be dipped en route by special permission first had and obtained from the Administrator; but in such event the means of conveyance shall be placarded and the billing shall be marked “Cattle Exposed to Scabies,” in accordance with § 73.6, and the cattle shall not be permitted to mingle with other cattle until disposed of in accordance with the regulations in this part.
Cattle of any herd in any quarantined area, which herd is not diseased with scabies, may be shipped, transported, or otherwise moved interstate for any purpose upon inspection by an APHIS or State inspector within 10 days prior to the date of shipment and when accompanied by a certificate from such inspector showing the cattle to be free from such disease or exposure thereto. When it is determined by the Administrator that all cattle of all herds in any quarantined area have been inspected for scabies by an APHIS or State inspector, that all the infected or exposed herds have been identified, and that all the infected herds have been dipped twice, and all the exposed herds have been dipped in a permitted dip as prescribed in § 73.10, under supervision of an APHIS or APHIS-approved inspector, cattle of herds in such area which are not diseased with or exposed to scabies may be moved interstate in accordance with this section, without further APHIS inspection or certification, directly to a slaughtering plant where Federal Meat Inspection is maintained: Provided further, that treatment with ivermectin may be used in lieu of dipping for a herd of cattle treated together if the herd is physically separated for 14 days following treatment from all cattle not a part of the herd treated together with ivermectin. Information may be obtained from an APHIS inspector whether a determination as required by this section is currently applicable to authorize such movement. Cattle moved interstate under this section shall not be diverted en route and must be accompanied by a waybill or similar document, or a statement signed by the owner or shipper of the cattle, stating: (a) That the cattle are not known to be infected with scabies or exposed thereto; (b) [Reserved]; (c) the purpose for which the cattle are to be moved; (d) the number of the cattle; (e) the point from which the cattle are to be moved interstate; (f) that the cattle shall not be diverted en route; and (g) the name and address of the owner or shipper of the cattle.
When cattle are shipped as “Treated Scabby Cattle,” or “Cattle Exposed to Scabies,” the transportation companies shall securely affix to and maintain upon both sides of each means of conveyance carrying such cattle a durable, conspicuous placard, not less than 5
No person, firm, or corporation shall deliver for transportation, transport, drive on foot, or otherwise move interstate from the free area of any State, Territory, or the District of Columbia any cattle which have been moved from the quarantined area of the same State, Territory, or the District of Columbia into such free area: Provided, however, That such cattle may be delivered for transportation, transported, driven on foot, or otherwise moved interstate for the purposes for which the shipment, transportation, or other movement interstate of cattle of the quarantined area is permitted by this part, Provided, That in such shipment and transportation or other movement the requirements of this part governing the shipment and transportation or other movement of cattle of the quarantined area are strictly complied with: And provided further, That this section shall not apply to cattle of the quarantined area which, before being moved into the free area, are certified by an APHIS inspector or State inspector as free from disease and are accompanied by such certificate in their shipment by transportation or other movement interstate.
(a) Healthy cattle from unquarantined State exposed en route. Should healthy cattle in transit from a State not quarantined by the Secretary of Agriculture for scabies in cattle be unloaded en route and placed in infectious premises, they shall be treated as exposed cattle, and their further movement shall be subject to the provisions of this part with respect to the movement of exposed cattle.
(b) Interstate shipments of cattle under APHIS or State certificate found affected or exposed en route. Cattle shipped interstate under a certificate from an APHIS inspector or State inspector or other cattle which are found en route to be affected with scabies or to have been exposed thereto, shall thereafter be handled in the same manner as diseased or exposed cattle are required by this part to be handled, and the means of conveyance and the chutes, alleys, and pens which have been occupied by diseased animals shall be cleaned and disinfected as provided in §§ 71.4 through 71.11 of this subchapter.
When the cattle are to be dipped under APHIS supervision or control, the owner of the cattle offered for shipment, or his agent duly authorized thereto, shall first execute and deliver to an APHIS inspector an application for inspection and supervised dipping wherein he shall agree to waive all claims against the United States for any loss or damage to said cattle occasioned by or resulting from dipping or other treatment under this part, or resulting from any subsequent treatment prior to their interstate shipment, or resulting from the fact that they are later found to be still scabies infested, and also for all subsequent loss or damage to any other cattle in the possession or control of such owner which may come into contact with the cattle so dipped or treated.
(a) The dips at present permitted by the Department for the treatment, as required in this part, of cattle affected with or exposed to scabies, are as follows:
(1) Lime-sulphur dip, other than proprietary brands thereof, made in the proportion of 12 pounds of unslaked lime (or 16 pounds of commercial hydrated lime, not airslaked lime) and 24 pounds of flowers of sulphur or sulphur flour to 100 gallons of water; or a specifically permitted proprietary brand of lime-sulphur dip.
(2) Dips made from specifically permitted proprietary brand emulsions of toxaphene and maintained throughout the dipping operation at a concentration between 0.50 and 0.60 percent toxaphene. Animals treated by such dips should not be slaughtered for food purposes until the expiration of such period as may be required under the Federal Meat Inspection Act (21 U.S.C., Supp. III, 601 et seq.). The length of this required period shall be specified on each certificate issued by the APHIS inspector or State inspector who supervises the dipping with such dips.
(3) Approved proprietary brands of coumaphos (Co-Ral ®), 25 percent wettable powder or flowable form used at a concentration of 0.30 percent.
(4) Approved proprietary brands of organophosphorous insecticides (Prolate ®) used at a concentration of 0.15 percent to 0.25 percent.
(b) The dipping bath for lime-sulphur dip must be used at a temperature of 95° to 105 °F., and must be maintained through the dipping operation at a concentration of not less than 2 percent of “sulphide sulphur”, as indicated by the field test for lime-sulphur dipping baths approved by the APHIS.
(c) Proprietary brands of lime-sulphur or toxaphene dips may be used in official dipping only after specific permission therefor has been granted by the Administrator. Before a dip will be specifically approved as a permitted dip for the eradication of scabies in cattle, the APHIS
Means of conveyance, yards, pens, sheds, chutes, or other premises or facilities which have contained cattle of a consignment in which scabies is found shall be treated within 72 hours of use and prior to further use in the required concentration with a permitted dip listed in § 73.10 under supervision of a State or Federal inspector or an accredited veterinarian.
(a) Cattle affected with scabies or which just prior to movement were affected with or exposed to scabies may be moved interstate from a nonquarantined area after being treated with ivermectin under the supervision of an APHIS inspector or State inspector in accordance with the directions on the label of the drug if the following conditions are met:
(1) Such cattle are kept physically separated for 14 days following treatment from all cattle not part of the group treated together with ivermectin (regardless of whether the cattle are moved interstate before the end of the 14-day period); and
(2) If such cattle are moved interstate before the end of the 14th day following treatment, at the time of interstate movement they are accompanied by a certificate issued and signed by an APHIS inspector or State inspector identifying the group of cattle treated with ivermectin and stating the date on which the cattle were treated with ivermectin; and
(3) If such cattle are moved interstate before the end of the 14th day following treatment, at the time of interstate movement the means of conveyance carrying them is placarded and the billing marked in accordance with § 73.6.
Cattle from nonquarantined areas which are not affected with scabies or which just prior to movement were not affected with or exposed to scabies may be moved interstate without restrictions under this part. Accordingly, cattle from nonquarantined areas which had been treated with ivermectin more than 14 days before movement interstate may be moved interstate without restriction under this part unless following treatment they become affected with scabies or just prior to movement become affected with or exposed to scabies.
(b) Cattle may be moved interstate from a quarantined area after being treated with ivermectin under the supervision of an APHIS inspector or State inspector in accordance with the directions on the label of the drug if the following conditions are met:
(1) Such cattle are moved interstate within 21 days following treatment with ivermectin; and
(2) Such cattle are kept physically separated for 14 days following treatment from all cattle not part of the group treated together with ivermectin (regardless of whether the cattle are moved interstate before the end of the 14 day period); and, if such cattle are moved within the 15- to 21-day period following treatment, they remain kept physically separated from all cattle not a part of the group treated together with ivermectin until after they are moved interstate; and
(3) Such cattle are accompanied at the time of interstate movement by a certificate issued and signed by an APHIS inspector or State inspector identifying the group of cattle treated with ivermectin and stating the date on which the cattle were treated with ivermectin; and
(4) If such cattle are moved interstate before the end of the 14 day period following treatment, at the time of interstate movement the means of conveyance carrying them is placarded and the billing marked in accordance with § 73.6.
The interstate movement of leopard tortoise (Geochelone pardalis), African spurred tortoise (Geochelone sulcata), and Bell's hingeback tortoise (Kinixys belliana) is prohibited except when tortoises are accompanied by either a health certificate or a certificate of veterinary inspection. The health certificate or certificate of veterinary inspection must be signed by an accredited veterinarian within 30 days prior to the interstate movement and must state that the tortoises have been examined by that veterinarian and found free of ticks.
(a) Definitions. For the purpose of this section, the following terms have the meanings set forth in this paragraph.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
APHIS representative. An individual employed by APHIS who is authorized to perform the functions involved.
Approved stockyard. A stockyard, livestock market, or other premises, under state or federal veterinary supervision where horses or other equines are assembled for sale purposes, and which has been approved by the Administrator under § 71.20 of this chapter.
Certificate. An official document issued by a State representative, APHIS representative, or an accredited veterinarian at the point of origin of the interstate movement on which are listed: (1) The description, including age, breed, color, sex, and distinctive markings when present (such as brands, tattoos, scars or blemishes), of each reactor to be moved; (2) the number of reactors covered by the document; (3) the purpose for which the reactors are to be moved; (4) the points of origin and destination; (5) consignor; and (6) the consignee; and which states that each reactor identified on the certificate meets the requirements of § 75.4(b).
Interstate. From any State into or through any other State.
Official seal. A serially numbered metal or plastic strip, or a serially numbered button, consisting of a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged and which cannot be reused if opened. It is applied by an APHIS representative or State representative.
Officially identified. The permanent identification of a reactor using the National Uniform Tag code number assigned by the United States Department of Agriculture to the State in which the reactor was tested, followed by the letter “A”,
Operator. The individual responsible for the day-to-day operations of the specifically approved stockyard.
Permit. An official document (VS Form 1-27 or a State form which contains the same information, but not a “permit for entry”) issued by an APHIS representative, State representative, or accredited veterinarian which lists the owner's name and address, points of origin and destination, number of animals covered, purpose of the movement, and one of the following: The individual animal registered breed association registration tattoo, individual animal registered breed association registration number, or similar individual identification, including name, age, sex, breed, color, and markings.
Reactor. Any horse, ass, mule, pony or zebra which is subjected to an official test in accordance with the regulations in § 71.22 of this subchapter and found positive.
State. Any State, the District of Columbia, Puerto Rico, the Virgin Islands of the United States, Guam, the Northern Mariana Islands, or any other territory or possession of the United States.
State animal health official. The individual employed by a State who is responsible for livestock and poultry disease control and eradication programs.
State representative. An individual employed in animal health activities of a State or a State's political subdivision, who is authorized by that State to perform the function involved under a cooperative agreement with the United States Department of Agriculture.
Veterinarian in Charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the animal health activities of APHIS in the State concerned.
(b) Interstate movement. No reactor may be moved interstate unless the reactor is officially identified, is accompanied by a certificate, and meets the conditions of either paragraph (b)(1), (b)(2), (b)(3), or (b)(4) of this section: Provided, That official identification is not necessary if the reactor is moved directly to slaughter under a permit and in a conveyance sealed with an official seal:
(1) The reactor is moved interstate for immediate slaughter, either to a Federally inspected slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or to a State-inspected slaughtering establishment that has inspection by a State representative at time of slaughter; or
(2) The reactor is moved interstate to a diagnostic or research facility after the individual issuing the certificate has consulted with the State animal health official in the State of destination and has determined that the reactor to be moved interstate will be maintained in isolation sufficient to prevent the transmission of equine infectious anemia to other horses, asses, ponies, mules, or zebras, and will remain quarantined under State authority at the diagnostic or research facility until natural death, slaughter, or until disposed of by euthanasia; or
(3) The reactor is moved interstate to its home farm after the individual issuing the certificate has consulted with the State animal health official in the State of destination and has determined that the reactor to be moved interstate will be maintained in isolation sufficient to prevent the transmission of equine infectious anemia to other horses, asses, ponies, mules, or zebras, and will remain quarantined under State authority on the reactor's home farm until natural death, slaughter, or until disposed of by euthanasia; and
(4) The reactor is moved interstate through no more than one approved stockyard for sale for immediate slaughter, and is moved within five days of its arrival at the approved stockyard directly to:
(i) Slaughter at a federally inspected slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), or,
(ii) Slaughter at a state-inspected slaughtering establishment that has inspection by a state representative at the time of slaughter, or,
(iii) The home farm of the reactor in accordance with paragraph (b)(3) of this section.
Uniform Methods and Rules—Bovine Tuberculosis Eradication. The Uniform Methods and Rules—Bovine Tuberculosis Eradication (January 22, 1999, edition) has been approved for incorporation by reference into the Code of Federal Regulations by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(a) The procedures specified in the Uniform Methods and Rules—Bovine Tuberculosis Eradication (January 22, 1999, edition) must be followed for the interstate movement of certain animals regulated under this part.
(b) Availability. Copies of the Uniform Methods and Rules—Bovine Tuberculosis Eradication:
(1) Are available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html;
(2) Are available for inspection at the APHIS reading room, room 1141, USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC; or
(3) May be obtained from the National Animal Health Programs, Veterinary Services, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231.
As used in this part, the following terms shall have the meanings set forth in this section except as otherwise specified.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of subchapter J to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Affected herd. A herd of livestock in which there is strong and substantial evidence that Mycobacterium bovis exists. This evidence should include, but is not limited to, any of the following: Histopathology, polymerase chain reaction (PCR) assay, bacterial isolation or detection, testing data, or epidemiologic evidence such as contact with known sources of infection.
Animal. All species of animals except man, birds, or reptiles.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal. The AIN consists of 15 digits, with the first 3 being the country code (840 for the United States or a unique country code for any U.S. territory that has such a code and elects to use it in place of the 840 code). The alpha characters USA or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording may be used as an alternative to the 840 or other prefix representing a U.S territory; however, only the AIN beginning with the 840 or other prefix representing a U.S. territory will be recognized as official for use on AIN tags applied to animals on or after March 11, 2015. The AIN beginning with the 840 prefix may not be applied to animals known to have been born outside the United States.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned.
Cooperating State and Federal animal health officials. The State and Federal animal health officials responsible for overseeing and implementing the National Cooperative State/Federal Bovine Tuberculosis Eradication Program.
Depopulate. To destroy all livestock in a herd by slaughter or by death otherwise.
Directly. Moved in a means of conveyance, without stopping to unload while en route, except for stops of less than 24 hours to feed, water, or rest the animals being moved, and with no commingling of animals at such stops.
Epidemiologic investigation. An investigation that is conducted by a State in conjunction with APHIS representatives, in which an official test for tuberculosis is conducted on all livestock in any tuberculosis-affected herd in a State or zone, all livestock in any herd into which livestock from the affected herd have been moved, all potential tuberculosis source herds, and all livestock herds and animals that are likely to have been exposed to the affected herd.
Herd. Except for livestock assembled at feedlots, any group of livestock maintained for at least 4 months on common ground for any purpose, or two or more groups of livestock under common ownership or supervision, geographically separated but that have an interchange or movement of livestock without regard to health status, as determined by the Administrator.
Interstate. From one State into or through any other State.
Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement.
(1) The ICVI must show:
(i) The species of animals covered by the ICVI;
(ii) The number of animals covered by the ICVI;
(iii) The purpose for which the animals are to be moved;
(iv) The address at which the animals were loaded for interstate movement;
(v) The address to which the animals are destined; and
(vi) The names of the consignor and the consignee, and their addresses if different from the address at which the animals were loaded or the address to which the animals are destined.
(vii) Additionally, unless the species-specific requirements for ICVIs provide an exception, the ICVI must list the official identification number of each animal, except as provided in paragraph (2) of this definition, or group of animals moved that is required to be officially identified, or, if an alternative form of identification has been agreed upon by the sending and receiving States, the ICVI must include a record of that identification. If animals moving under a GIN also have individual official identification, only the GIN must be listed on the ICVI. An ICVI may not be issued for any animal that is not officially identified, if official identification is required. If the animals are not required by the regulations to be officially identified, the ICVI must state the exemption that applies (e.g., the cattle and bison do not belong to one of the classes of cattle and bison to which the official identification requirements of this part apply). If the animals are required to be officially identified but the identification number does not have to be recorded on the ICVI, the ICVI must state that all animals to be moved under the ICVI are officially identified.
(2) As an alternative to recording individual animal identification on an ICVI, if agreed to by the receiving State or Tribe, another document may be attached to provide this information, but only under the following conditions:
(i) The document must be a State form or APHIS form that requires individual identification of animals, or a printout of official identification numbers generated by computer or other means;
(ii) A legible copy of the document must be attached to the original and each copy of the ICVI;
(iii) Each copy of the document must identify each animal to be moved with the ICVI. The document must not contain any information pertaining to other animals; and
(iv) The following information must be included in the identification column on the original and each copy of the ICVI:
(A) The name of the document; and
(B) Either the unique serial number on the document or both the name of the person who prepared the document and the date the document was signed.
Livestock. All farm-raised animals.
Location-based numbering system. The location-based number system combines a State or Tribal issued location identification (LID) number or a premises identification number (PIN) with a producer's unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal.
Location identification (LID) number. A nationally unique number issued by a State, Tribal, and/or Federal animal health authority to a location as determined by the State or Tribe in which it is issued. The LID number may be used in conjunction with a producer's own unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may also be used as a component of a group/lot identification number (GIN).
Move. To carry, enter, import, mail, ship, or transport; to aid, abet, cause, or induce carrying, entering, importing, mailing, shipping, or transporting; to offer to carry, enter, import, mail, ship, or transport; to receive in order to carry, enter, import, mail, ship, or transport; or to allow any of these activities.
National Uniform Eartagging System (NUES). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal.
Official eartag. An identification tag approved by APHIS that bears an official identification number for individual animals. The design, size, shape, color, and other characteristics of the official eartag will depend on the needs of the users, subject to the approval of the Administrator. The official eartag must be tamper-resistant and have a high retention rate in the animal.
Official eartag shield. The shield-shaped graphic of the U.S. Route Shield with “U.S.” or the State postal abbreviation or Tribal alpha code imprinted within the shield.
Official identification number. A nationally unique number that is permanently associated with an animal or group of animals and that adheres to one of the following systems:
(1) National Uniform Eartagging System (NUES).
(2) Animal identification number (AIN).
(3) Flock-based number system.
(4) Location-based number system.
(5) Any other numbering system approved by the Administrator for the official identification of animals.
Official seal. A seal issued by a State or APHIS representative, consisting of a serially numbered, metal or plastic strip, with a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged and that cannot be reused if opened, or a serially numbered, self-locking button that can be used for this purpose.
Officially identified. Identified by means of an official eartag or by means of an individual tattoo or hot brand that provides unique identification for each animal.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority a geographically distinct location from other premises. The PIN may be used in conjunction with a producer's own livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may be used as a component of a group/lot identification number (GIN).
Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts that is approved in accordance with 9 CFR 71.21.
State. Any State, the District of Columbia, Puerto Rico, or any territory of the United States.
State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.
State representative. A veterinarian or other person employed in livestock sanitary work of a State or a political subdivision of a State and who is authorized by such State or political subdivision of a State to perform the function involved under a memorandum of understanding with APHIS.
Transportation document. Any document accompanying the interstate movement of livestock, such as an owner's statement, manifest, switch order, or vehicle record, on which is stated the point from which the animals are moved interstate, the destination of the animals, the number of animals covered by the document, and the name and address of the owner or shipper.
Tuberculosis. The contagious, infectious, and communicable disease caused by Mycobacterium bovis. (Also referred to as bovine tuberculosis.)
United States. All of the States.
United States Department of Agriculture (USDA) approved backtag. A backtag issued by APHIS that provides a temporary unique identification for each animal.
Zone. A defined geographic land area identifiable by geological, political, manmade, or surveyed boundaries, with mechanisms of disease spread, epidemiological characteristics, and the ability to control the movement of animals across the boundaries of the zone taken into account.
The Administrator shall classify each State for tuberculosis in accordance with this part. A zone comprising less than an entire State will be given a particular classification upon request of the State only if the Administrator determines that:
(a) The State meets the requirements of this part for establishment of zones;
(b) The State has adopted and is enforcing regulations that impose restrictions on the intrastate movement of cattle, bison, and captive cervids that are substantially the same as those in place under this part for the interstate movement of cattle, bison, and captive cervids; and
(c) The designation of part of a State as a zone will otherwise be adequate to prevent the interstate spread of tuberculosis.
(a) A State animal health official may request at any time that the Administrator designate part of a State as having a different tuberculosis classification under this part than the rest of the State. The requested zones must be delineated by the State animal health authorities, subject to approval by the Administrator. The request from the State must demonstrate that the State complies with the following requirements:
(1) The State must have the legal and financial resources to implement and enforce a tuberculosis eradication program and must have in place an infrastructure, laws, and regulations that require and ensure that State and Federal animal health authorities are notified of tuberculosis cases in domestic livestock or outbreaks in wildlife;
(2) The State in which the intended zones are located must maintain, in each intended zone, clinical and epidemiologic surveillance of animal species at risk of tuberculosis at a rate that allows detection of tuberculosis in the overall population of livestock at a 2 percent prevalence rate with 95 percent confidence. The designated tuberculosis epidemiologist must review reports of all testing for each zone within the State within 30 days of the testing; and
(3) The State must enter into a memorandum of understanding with APHIS in which the State agrees to adhere to any conditions for zone recognition particular to that request.
(b) Retention of APHIS recognition of a zone is subject to annual review by the Administrator. To retain recognition of a zone, a State must continue to comply with the requirements of paragraphs (a)(1), (a)(2), and (a)(3) of this section, as well as the requirements for maintaining or improving the tuberculosis risk classification of each zone in the State, and must retain for at least 2 years all certificates required under this part for the movement of cattle, bison, and captive cervids.
As used in subpart B, the following terms shall have the meanings set forth in this section except as otherwise specified.
Accreditation preparatory State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis is prevalent in less than 0.5 percent of the total number of herds of cattle and bison in the State or zone.
Accredited-free State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected cattle and bison herds, and has had no findings of tuberculosis in any cattle or bison herds in the State or zone for the previous 5 years. Except that: The requirement of freedom from tuberculosis in herds is 2 years from the depopulation of the last affected herd in States or zones that were previously accredited free and in which all herds affected with tuberculosis were depopulated, 3 years in all other States or zones that have depopulated all affected herds, and 3 years in States or zones that have conducted surveillance that demonstrates that other livestock herds and wildlife are not at risk of being infected with tuberculosis, as determined by the Administrator based on a risk assessment conducted by APHIS.
Accredited herd. To establish or maintain accredited herd status, the herd owner must comply with all of the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” regarding accredited herds. All cattle and bison in a herd must be free from tuberculosis.
Approved feedlot. A confined area approved jointly by the State animal health official and the Administrator for feeding cattle and bison for slaughter, with no provisions for pasturing or grazing.
Cattle and bison not known to be affected. All cattle and bison except those originating from tuberculosis affected herds or from herds containing tuberculosis suspect cattle or bison.
Department. The U.S. Department of Agriculture (USDA).
Exposed cattle and bison. Cattle and bison, except reactor cattle and bison, that are part of an affected herd.
Feedlot. A facility for congregating finished fed cattle prior to their being shipped to slaughter.
Finished fed cattle. Cattle fattened on a ration of feed concentrates to reach a slaughter condition equivalent to that which would be attained on full feed with a high concentrate grain ration for 90 days.
Modified accredited advanced State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis has been prevalent in less than 0.01 percent of the total number of herds of cattle and bison in the State or zone for each of the most recent 2 years. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 30,000 herds to have up to 3 affected herds for each of the most recent 2 years, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Modified accredited State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis has been prevalent in less than 0.1 percent of the total number of herds of cattle and bison in the State or zone for the most recent year. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 10,000 herds to have up to 10 affected herds for the most recent year, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Negative cattle and bison. Cattle and bison that are classified negative for tuberculosis in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” based on the results of an official tuberculin test.
Nonaccredited State or zone. A State or zone that is or is part of a State that does not meet the standards of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” or in which tuberculosis is prevalent in 0.5 percent or more of the total number of herds of cattle and bison in the State or zone.
Official tuberculin test. Any test for tuberculosis conducted on cattle or bison in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.”
Permit. An official document issued for movement of cattle or bison under this part by an APHIS representative, State representative, or an accredited veterinarian at the point of origin of a shipment of cattle or bison to be moved directly to slaughter, that shows the tuberculosis status of each animal (reactor, suspect, or exposed), the eartag number of each animal and the name of the owner of such animal, the establishment to which the animals are to be moved, the purpose for which the animals are to be moved, and that they are eligible for such movement under the applicable provisions of §§ 77.17 and 77.18.
Quarantined feedlot. A confined area under the direct supervision and control of a State livestock official who shall establish procedures for the accounting of all livestock entering or leaving the area. The quarantined feedlot shall be maintained for finish feeding of livestock in drylot with no provision for pasturing and grazing. All livestock leaving such feedlot must only move directly to slaughter in accordance with established procedures for handling quarantined livestock.
Reactor cattle and bison. Cattle and bison that are classified as reactors for tuberculosis in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.”
Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts that is approved in accordance with 9 CFR 71.21.
Suspect cattle and bison. Cattle and bison that are classified as suspects for tuberculosis in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.”
Uniform Methods and Rules—Bovine Tuberculosis Eradication. Uniform methods and rules for eradicating bovine tuberculosis in the United States, approved by APHIS on January 22, 1999, which is incorporated by reference at § 77.1.
Whole herd test. An official tuberculin test of all cattle and bison in a herd that are 12 months of age or older, and of all cattle and bison in the herd that are less than 12 months of age and were not born into the herd, except those cattle and bison that are less than 12 months of age and were born in and originated from an accredited herd.
Zero percent prevalence. No finding of tuberculosis in any cattle, bison, or goat herd in a State or zone.
All references in this subpart to the tuberculosis status of States and zones pertain to such status for cattle and bison only.
(a) The following are accredited-free States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, the Virgin Islands of the United States, Washington, West Virginia, Wisconsin, and Wyoming.
(b) The following are accredited-free zones:
(1) All of the State of Michigan except for the zone that comprises those counties in Michigan described in § 77.11(b)(1).
(2) [Reserved]
(c) If an affected herd is detected in a State or zone classified as accredited-free, and the herd is depopulated and an epidemiologic investigation is completed within 90 days of the detection of the affected herd with no evidence of the spread of tuberculosis, the State or zone may retain its accredited-free status. If two or more affected herds are detected in an accredited-free State or zone within a 48-month period, the State or zone will be removed from the list of accredited-free States or zones and will be reclassified as modified accredited advanced.
(d) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, to those other livestock in the same manner as to cattle and bison. Failure to do so will result in reclassification of the State or zone as modified accredited advanced.
(e) If tuberculosis is diagnosed within an accredited-free State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will lose its accredited-free status and will be reclassified as modified accredited advanced.
(f) Accredited-free State or zone status must be renewed annually. To qualify for renewal of accredited-free State or zone status, a State must submit an annual report to APHIS certifying that the State or zone within the State complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
Cattle or bison that originate in an accredited-free State or zone may be moved interstate in accordance with 9 CFR part 86 without further restriction under this part.
(a) The following are modified accredited advanced States: None.
(b) The following are modified accredited advanced zones: None.
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of modified accredited advanced States or zones and its being reclassified as modified accredited.
(d) If tuberculosis is diagnosed within a modified accredited advanced State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as modified accredited.
(e) Modified accredited advanced State or zone status must be renewed annually. To qualify for renewal of a modified accredited advanced State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for accredited-free status, a modified accredited advanced State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected cattle and bison herds, and has had no findings of tuberculosis in any cattle or bison in the State or zone for the previous 5 years. Except that: The requirement of freedom from tuberculosis is 2 years from the depopulation of the last affected herd in States or zones that were previously accredited free and in which all herds affected with tuberculosis were depopulated, 3 years in all other States or zones that have depopulated all affected herds, and 3 years in States or zones that have conducted surveillance that demonstrates that other livestock herds and wildlife are not at risk of being infected with tuberculosis, as determined by the Administrator based on a risk assessment conducted by APHIS.
Cattle or bison that originate in a modified accredited advanced State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers, and are officially identified.
(b) The cattle or bison are from an accredited herd, are officially identified, and are accompanied by an ICVI stating that the accredited herd completed the testing necessary for accredited status with negative results within 1 year prior to the date of movement.
(c) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by an ICVI stating that they were negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(a) The following are modified accredited States: None.
(b) The following are modified accredited zones:
(1) A zone in Michigan that comprises Alcona, Alpena, Montmorency, and Oscoda Counties.
(2) [Reserved]
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of modified accredited States or zones and its being reclassified as accreditation preparatory.
(d) If tuberculosis is diagnosed within a modified accredited State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as accreditation preparatory.
(e) Modified accredited State or zone status must be renewed annually. To qualify for renewal of a modified accredited State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited advanced status, a modified accredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.01 percent of the total number of herds of cattle and bison in the State or zone for the most recent 2 years. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 30,000 herds to have up to 3 affected herds for each of the most recent 2 years, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Cattle or bison that originate in a modified accredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers; are officially identified, and are accompanied by an ICVI stating that they were classified negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(b) The cattle or bison are from an accredited herd, are officially identified, and are accompanied by an ICVI stating that the accredited herd completed the testing necessary for accredited status with negative results within 1 year prior to the date of movement.
(c) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 60 days prior to the date of movement, except that the additional test is not required if the animals are moved interstate within 60 days following the whole herd test.
(a) The following are accreditation preparatory States: None.
(b) The following are accreditation preparatory zones: None.
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of accreditation preparatory States or zones and its being reclassified as nonaccredited.
(d) If tuberculosis is diagnosed within an accreditation preparatory State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as nonaccredited.
(e) Accreditation preparatory State or zone status must be renewed annually. To qualify for renewal of accreditation preparatory State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited status, an accreditation preparatory State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.1 percent of the total number of herds of cattle and bison in the State or zone for the most recent year. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 10,000 herds to have up to 10 affected herds for the most recent year, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Cattle or bison that originate in an accreditation preparatory State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers; are officially identified; and are accompanied by an ICVI stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 60 days prior to the date of movement; Except that: The additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(b) The cattle or bison are from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the accredited herd completed the testing necessary for accredited status with negative results within 1 year prior to the date of movement and that the animals to be moved were negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(c) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to two additional official tuberculin tests conducted at least 60 days apart and no more than 6 months apart, with the second test conducted within 60 days prior to the date of movement; Except that: The second additional test is not required if the animals are moved interstate within 60 days following the whole herd test.
(a) The following are nonaccredited States: None.
(b) The following are nonaccredited zones: None.
(c) To qualify for accreditation preparatory status, a nonaccredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis is prevalent in less than 0.5 percent of the total number of herds of cattle and bison in the State or zone.
Cattle or bison that originate in a nonaccredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only if the cattle or bison are accompanied by VS Form 1-27 and are moved interstate for slaughter in an officially sealed means of conveyance directly to a recognized slaughtering establishment.
(a) Reactor cattle and bison. Cattle or bison that have been classified as reactor cattle or bison may be moved interstate only if they are moved directly to slaughter at a recognized slaughtering establishment and only in accordance with the following conditions:
(1) Reactor cattle and bison must be individually identified by attaching to the left ear an approved metal eartag bearing a serial number and the inscription “U.S. Reactor,” or a similar State reactor tag, and must be:
(i) Branded with the letter “T,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead; or
(ii) Permanently identified with the letters “TB” tattooed legibly in the left ear and sprayed with yellow paint on the left ear and either accompanied directly to slaughter by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(2) The reactor cattle or bison must be accompanied by a permit; and
(3) The reactor cattle or bison may not be moved interstate in a means of conveyance containing any animals susceptible to tuberculosis unless all of the animals are being moved directly to slaughter; and
(4) Any person who moves reactor cattle or bison interstate under this paragraph must plainly write or stamp upon the face of the VS Form 1-27 the words “Tuberculin Reactor” and the following statement: “This conveyance must be cleaned and disinfected in accordance with 9 CFR 77.17(a)(5).”; and
(5) Each means of conveyance in which reactor cattle or bison have been transported interstate under this paragraph must be cleaned and disinfected by the carrier, in accordance with the provisions of §§ 71.6, 71.7, and 71.10 of this subchapter, under the supervision of an APHIS representative or State representative or an accredited veterinarian or other person designated by the Administrator. If, at the point where the cattle or bison are unloaded, such supervision or proper cleaning and disinfecting facilities are not available, and permission is obtained from an APHIS representative or State representative, the empty means of conveyance may be moved to a location where such supervision and facilities are available for cleaning and disinfecting. Permission will be granted if such movement does not present a risk of disseminating tuberculosis.
(b) Exposed cattle and bison. Except for the movement of exposed cattle to a quarantined feedlot in accordance with § 50.16 of this chapter, exposed cattle or bison may be moved interstate only if they are moved directly to slaughter to a recognized slaughtering establishment and only in accordance with the following conditions:
(1) Exposed cattle and bison must be individually identified by attaching to either ear an approved metal eartag bearing a serial number and must be:
(i) Branded with the letter “S,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead; or
(ii) Accompanied directly to slaughter by an APHIS or State representative; or
(iii) Moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(2) The exposed cattle and bison must be moved in accordance with paragraphs (a)(2), (a)(3), and (a)(5) of this section.
(c) Suspect cattle and bison. Suspect cattle or bison from herds in which no reactor cattle or bison have been disclosed on an official tuberculin test, as well as negative cattle or bison from such herds, may be moved interstate only if they are moved directly to slaughter to a recognized slaughtering establishment in accordance with 9 CFR part 86.
The Administrator may, with the concurrence of the State animal health official of the State of destination, upon request in specific cases, allow the interstate movement of cattle or bison not otherwise provided for in this part that have not been classified as reactor cattle or bison and are not otherwise known to be affected with tuberculosis, under such conditions as the Administrator may prescribe in each specific case to prevent the spread of tuberculosis. The Administrator shall promptly notify the appropriate State animal health official of the State of destination of any such action.
All conveyances and associated equipment, premises, and structures that are used for receiving, holding, shipping, loading, unloading, and delivering cattle or bison in connection with their interstate movement and that are determined by cooperating State and Federal animal health officials to be contaminated because of occupation or use by tuberculous or reactor livestock must be cleaned and disinfected under the supervision of the cooperating State or Federal animal health officials. Such cleaning and disinfecting must be done in accordance with procedures approved by the cooperating State or Federal animal health officials. Cleaning and disinfection must be completed before the premises, conveyances, or materials may again be used to convey, hold, or in any way come in contact with any livestock.
As used in subpart C, the following terms shall have the meanings set forth in this section except as otherwise specified.
Accreditation preparatory State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis is prevalent in less than 0.5 percent of the total number of herds of captive cervids in the State or zone.
Accredited herd. A herd of captive cervids that has tested negative to at least two consecutive official tuberculosis tests of all eligible captive cervids in accordance with § 77.33(f) and that meets the standards set forth in § 77.35. The tests must be conducted at 9-15 month intervals.
Accredited-free State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected captive cervid herds, and has had no findings of tuberculosis in any captive cervid herds in the State or zone for the previous 5 years. Except that: The requirement of freedom from tuberculosis in herds is 2 years from the depopulation of the last affected herd in States or zones that were previously accredited free and in which all herds affected with tuberculosis were depopulated, 3 years in all other States or zones that have depopulated all affected herds, and 3 years in States or zones that have conducted surveillance that demonstrates that other livestock herds and wildlife are not at risk of being infected with tuberculosis, as determined by the Administrator based on a risk assessment conducted by APHIS.
Captive cervid. All species of deer, elk, moose, and all other members of the family Cervidae raised or maintained in captivity for the production of meat and other agricultural products, for sport, or for exhibition, including time such animals are moved interstate; or any wild cervid that is moved interstate, during the period of time from capture until release into the wild. A captive cervid that escapes will continue to be considered a captive cervid as long as it bears an official eartag or other identification approved by the Administrator as unique and traceable with which to trace the animal back to its herd of origin.
Comparative cervical tuberculin (CCT) test. The intradermal injection of biologically balanced USDA bovine PPD tuberculin and avian PPD tuberculin at separate sites in the mid-cervical area to determine the probable presence of bovine tuberculosis (M. bovis) by comparing the response of the two tuberculins at 72 hours (plus or minus 6 hours) following injection.
Designated accredited veterinarian. An accredited veterinarian who is trained and approved by cooperating State and Federal animal health officials to conduct the single cervical tuberculin (SCT) test or draw blood for the DPP® test on captive cervids.
Dual Path Platform (DPP®) test. A serological assay to determine the presence of antibodies to bovine tuberculosis (M. bovis) in elk, red deer, white-tailed deer, fallow deer, and reindeer, in which a blood sample taken from a captive cervid and a buffer solution are placed on a strip. The diluted sample then migrates to another strip, which contains an antibody-detecting reagent. This latter strip indicates if antibodies are present in the sample.
Exposed captive cervid. Any captive cervid that has been exposed to tuberculosis by reason of associating with captive cervids, cattle, bison, or other livestock from which M. bovis has been isolated.
Modified accredited State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis has been prevalent in less than 0.1 percent of the total number of herds of captive cervids in the State or zone for the most recent year. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 10,000 herds to have up to 10 affected herds for the most recent year, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Modified accredited advanced State or zone. A State or zone that is or is part of a State that has the authority to enforce and complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and in which tuberculosis has been prevalent in less than 0.01 percent of the total number of herds of captive cervids in the State or zone for the most recent 2 years. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 30,000 herds to have up to 3 affected herds for each of the most recent 2 years, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Monitored herd. A herd on which identification records are maintained on captive cervids inspected for tuberculosis at an approved slaughtering establishment or an approved diagnostic laboratory and on captive cervids tested for tuberculosis in accordance with interstate movement requirements, and which meets the standards set forth in § 77.37.
Negative. Showing no response to an official tuberculosis test or classified negative for tuberculosis by the testing veterinarian based upon history, supplemental tests, examination of the carcass, and histopathology and culture of selected tissues.
No gross lesions (NGL). Having no visible lesions indicative of bovine tuberculosis detected upon necropsy or slaughter inspection.
Nonaccredited State or zone. A State or zone that is or is part of a State or zone that does not meet the standards of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” or in which tuberculosis is prevalent in 0.5 percent or more of the total number of herds of captive cervids in the State or zone.
Official tuberculosis test. Any of the following tests for bovine tuberculosis in captive cervids, applied and reported in accordance with this part:
(1) The single cervical tuberculin (SCT) test.
(2) The comparative cervical tuberculin test (CCT) test.
(3) The Dual Path Platform (DPP®) test.
Permit. An official document issued by a representative of APHIS, a State representative, or an accredited veterinarian that must accompany any reactor, suspect, or exposed captive cervid moved interstate.
Purified protein derivative (PPD). Protein extract from an M. bovis culture that is resuspended in solution at a standard concentration of 1 mg protein per 1 mL of solution.
Qualified herd. A herd of captive cervids that has tested negative to at least one official tuberculosis test of all eligible captive cervids (see § 77.33(f)) within the past 12 months and that is not classified as an accredited herd.
Quarantine. Prohibition from interstate movement, except for slaughter or necropsy.
Reactor. Any captive cervid that shows a response to an official tuberculosis test and is classified a reactor by the testing veterinarian; or any suspect captive cervid that is classified a reactor upon slaughter inspection or necropsy after histopathology and/or culture of selected tissues by the USDA or State veterinarian performing or supervising the slaughter inspection or necropsy.
Regular-kill slaughter animal. An animal that is slaughtered for food or any reason other than because of a disease regulated under 9 CFR chapter I (such as tuberculosis, brucellosis, or any other livestock disease for which movement of animals is restricted under 9 CFR chapter I).
Single cervical tuberculin (SCT) test. The intradermal injection of 0.1 mL (5,000 tuberculin units) of USDA PPD bovis tuberculin in the mid-cervical area with a reading by visual observation and palpation at 72 hours (plus or minus 6 hours) following injection.
Suspect. Any captive cervid that is not negative to an official tuberculosis test and that is not classified as a reactor by the testing veterinarian.
Tuberculin. A product that is approved by and produced under USDA license for injection into cervids and other animals for the purpose of detecting bovine tuberculosis.
Tuberculous. Having lesions indicative of tuberculosis, infected with tuberculosis based on isolation of M. bovis, or being from a herd in which M. bovis has been isolated.
USDA. The United States Department of Agriculture.
Whole herd test. An official tuberculosis test of all captive cervids in a herd that are 12 months of age or older, and of all captive cervids in the herd that are less than 12 months of age and were not born into the herd, except those captive cervids that are less than 12 months of age and were born in and originated from an accredited herd.
Zero percent prevalence. No finding of tuberculosis in any herd of captive cervids in a State or zone.
All references in this subpart to the tuberculosis status of States and zones pertain to such status for captive cervids.
(a) The following are accredited-free States: None.
(b) The following are accredited-free zones: None.
(c) If an affected herd is detected in a State or zone classified as accredited-free, and the herd is depopulated and a complete epidemiologic investigation is completed within 120 days of the detection of the affected herd with no evidence of the spread of tuberculosis, the State or zone may retain its accredited-free status. If two or more affected herds are detected in an accredited-free State or zone within a 48-month period, the State or zone will be removed from the list of accredited-free States or zones and will be reclassified as modified accredited advanced.
(d) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, to those other livestock in the same manner as to captive cervids. Failure to do so will result in reclassification of the State or zone as modified accredited advanced.
(e) If tuberculosis is diagnosed within an accredited-free State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will lose its accredited-free status and will be reclassified as modified accredited advanced.
(f) Accredited-free State or zone status must be renewed annually. To qualify for renewal of accredited-free State or zone status, a State must submit an annual report to APHIS certifying that the State or zone within the State complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
Notwithstanding any other provisions of this part, captive cervids that originate in an accredited-free State or zone may be moved interstate in accordance with 9 CFR part 86 and without further restriction under this part.
(a) The following are modified accredited advanced States: None.
(b) The following are modified accredited advanced zones: None.
(c) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of modified accredited advanced States or zones and its being reclassified as modified accredited.
(d) If tuberculosis is diagnosed within a modified accredited advanced State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as modified accredited.
(e) Modified accredited advanced State or zone status must be renewed annually. To qualify for renewal of a modified accredited advanced State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with all the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” regarding modified accredited advanced States. The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for accredited-free status, a modified accredited advanced State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected captive cervid herds, and has had no findings of tuberculosis in any captive cervids in the State or zone for the previous 5 years. Except that: The requirement of freedom from tuberculosis is 2 years from the depopulation of the last affected herd in States or zones that were previously accredited-free and in which all herds affected with tuberculosis were depopulated, 3 years in all other States or zones that have depopulated all affected herds, and 3 years in States or zones that have conducted surveillance that demonstrates that other livestock herds and wildlife are not at risk of being infected with tuberculosis, as determined by the Administrator based on a risk assessment conducted by APHIS.
Captive cervids that originate in a modified accredited advanced State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The captive cervids are from an accredited herd, qualified herd, or monitored herd; are officially identified; and are accompanied by an ICVI stating that the herd completed the requirements for accredited herd, qualified herd, or monitored herd status within 24 months prior to the date of movement.
(b) The captive cervids are officially identified and are accompanied by an ICVI stating that they were negative to an official tuberculin test conducted within 90 days prior to the date of movement.
(a) States listed in paragraph (b) of this section must submit to APHIS
(b) The following are modified accredited States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, the Virgin Islands of the United States, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
(c) The following are modified accredited zones: None.
(d) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of modified accredited States or zones and its being reclassified as accreditation preparatory.
(e) If tuberculosis is diagnosed within a modified accredited State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as accreditation preparatory.
(f) Modified accredited State or zone status must be renewed annually. To qualify for renewal of a modified accredited State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(g) To qualify for modified accredited advanced status, a modified accredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.01 percent of the total number of captive cervids in the State or zone for the most recent 2 years. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 30,000 herds to have up to 3 affected herds for each of the most recent 2 years, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Except for captive cervids from a qualified herd or monitored herd, as provided in §§ 77.36 and 77.37, respectively, captive cervids that originate in a modified accredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The captive cervids are from an accredited herd, are officially identified, and are accompanied by an ICVI stating that the accredited herd completed the testing necessary for accredited status with negative results within 24 months prior to the date of movement.
(b) The captive cervids are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 90 days prior to the date of movement; Except that: The additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(a) The following are accreditation preparatory States: None.
(b) The following are accreditation preparatory zones: None.
(c) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of accreditation preparatory States or zones and its being reclassified as nonaccredited.
(d) If tuberculosis is diagnosed within an accreditation preparatory State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as nonaccredited.
(e) Accreditation preparatory State or zone status must be renewed annually. To qualify for renewal of accreditation preparatory State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited status, an accreditation preparatory State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.1 percent of the total number of herds of captive cervids in the State or zone for the most recent year. Except that: The Administrator, upon his or her review, may allow a State or zone with fewer than 10,000 herds to have up to 10 affected herds for the most recent year, depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone.
Except for captive cervids from a qualified herd or monitored herd, as provided in §§ 77.36 and 77.37, respectively, captive cervids that originate in an accreditation preparatory State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only in accordance with 9 CFR part 86 and, if moved anywhere other than directly to slaughter at a recognized slaughtering establishment, under one of the following additional conditions:
(a) The captive cervids are from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the accredited herd completed the testing necessary for accredited status with negative results within 24 months prior to the date of movement and that the individual animals to be moved were negative to an official tuberculin test conducted within 90 days prior to the date of movement.
(b) The captive cervids are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by an ICVI stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to two additional official tuberculin tests conducted at least 90 days apart and no more than 6 months apart, with the second test conducted within 90 days prior to the date of movement; Except that: The second additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(a) The following are nonaccredited States: None.
(b) The following are nonaccredited zones: None.
(c) To qualify for accreditation preparatory status, a nonaccredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis is prevalent in less than 0.5 percent of the total number of herds of captive cervids in the State or zone.
Captive cervids that originate in a nonaccredited State or zone and that are not known to be infected with or exposed to tuberculosis may not be moved interstate only if they are accompanied by VS Form 1-27 and are moved interstate in an officially sealed means of conveyance directly to slaughter at a recognized slaughtering establishment.
(a) Except for movement from accredited-free States and zones in accordance with § 77.23, movement from accredited herds in accordance with § 77.35, and movement to slaughter in accordance with 9 CFR part 86, no captive cervid may be moved interstate unless it has been tested using an official tuberculosis test, and it is moved in compliance with this part.
(b) No captive cervid with a response to any official tuberculosis test is eligible for interstate movement unless the captive cervid subsequently tests negative to a supplemental official tuberculosis test or is moved interstate directly to slaughter or necropsy in accordance with § 7.40.
(c) Except for captive cervids moving interstate under permit directly to slaughter or necropsy under § 77.40, each captive cervid or shipment of captive cervids to be moved interstate must be officially identified and accompanied by an ICVI issued within 30 days of the movement by a State or Federal animal health official or an accredited veterinarian.
(d) Captive cervids in zoological parks that have been accredited by the American Zoo and Aquarium Association (AZA) are exempt from the regulations in this part when the captive cervids are moved directly interstate between AZA member facilities. Any captive cervids moved interstate that are not moved directly from an AZA member facility to another AZA member facility must be moved in accordance with the regulations in this subpart.
(a) Approved testers. Except as explained in paragraphs (a)(1) or (a)(2) of this section, official tuberculosis tests may only be given by a veterinarian employed by the State in which the test is administered or by a veterinarian employed by USDA.
(1) A designated accredited veterinarian may conduct the SCT test, except as provided in § 77.34(a)(1)(ii) and § 77.39(e) and (f).
(2) A designated accredited veterinarian may draw blood for the DPP® test.
(b) Approved diagnostic laboratories. (1) With one exception, histopathology and culture results for all tuberculosis diagnoses will be accepted only from the National Veterinary Services Laboratories (NVSL) in Ames, IA. The exception is that results will be accepted from a laboratory of the Food Safety and Inspection Service, USDA, for tissue examination of regular-kill slaughter animals in those cases where no submission is made to NVSL.
(2) [Reserved]
(c) Identification. Any captive cervid tested with an official tuberculosis test must bear official identification in the form of an official eartag, or another identification device or method approved by the Administrator as unique and traceable, at the time of the official tuberculosis test. Use of any identification device or method other than an official eartag must first be approved by the Administrator as unique and traceable. Written requests for approval must be sent to National Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231.
(d) Reporting of tests—(1) SCT and CCT tests. For the SCT and CCT tests, the testing veterinarian must submit a report to cooperating State and Federal animal health officials of the State in which the captive cervid is tested. The report must include the following information for all SCT and CCT tests administered: The number of the individual eartag or other identification approved by the Administrator; the age, sex, and breed of each captive cervid tested; a record of all responses; the size of each response for the CCT test; and the test interpretation.
(2) DPP® test. The veterinarian who draws blood from the captive cervid must submit a form specified by APHIS for such requests to NVSL to perform the DPP® test on the blood sample. The form is available at the following Web site: http://www.aphis.usda.gov/wps/portal/footer/resources/forms; click on the “VS forms” link on that Web page. The veterinarian must also fill out the relevant portions of a test record. This form may be obtained by contacting the local district VS office, information regarding which is available at: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalhealth?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fsa_animal_health%2Fsa_contact_us%2Fsa_map%2Fct_state_contacts_map. This record must be sent to the offices of the State and Federal animal health officials in the State.
(e) Test interpretation. (1) Interpretation of an SCT test will be based upon the judgment of the testing veterinarian after observation and palpation of the injection site, in accordance with the classification requirements described in § 77.34(a).
(2) Interpretation of a CCT test will be in accordance with the classification requirements described in § 77.34(b).
(3) Interpretation of DPP® test results will be in accordance with the classification requirements described in § 77.34.
(f) Captive cervids eligible for testing. Except as provided in § 77.35(a)(1) and § 77.36(a)(1), testing of herds for individual herd classification must include all captive cervids 1 year of age or over and any captive cervids other than natural additions (captive cervids born into the herd) under 1 year of age.
(a) Primary tests—(1) Single cervical tuberculin (SCT) test. (i) The SCT test is a primary test that may be used in individual captive cervids and in herds of unknown tuberculous status. Each captive cervid that responds to the SCT test must be classified as a suspect until it is retested with the CCT test and is either found negative for tuberculosis or is classified as a reactor, unless, with exception of a designated accredited veterinarian, the testing veterinarian determines that the captive cervid should be classified as a reactor based on its response to the SCT test. A designated accredited veterinarian must classify a responding captive cervid as a suspect, unless APHIS determines, based on epidemiological evidence, that the captive cervid should be classified as a reactor. A captive cervid that responds to the SCT test must not be retested using the DPP® test.
(ii) The SCT test is a primary test that may be used in affected herds and in herds that have received captive cervids from an affected herd. When used with affected herds or in herds that have received a captive cervid from an affected herd, the SCT test may only be administered by a veterinarian employed by the State in which the test is administered or employed by USDA. In affected herds or herds that have received captive cervids from an affected herd, each captive cervid that responds to the SCT test must be classified as a reactor, unless APHIS determines, based on epidemiological evidence, that the cervid should be classified as a suspect because of possible exposure to a tuberculous animal.
(2) DPP® test. (i) The DPP® test is a primary test that may be used in individual captive elk, red deer, white-tailed deer, fallow deer, and reindeer, and in herds of these species that are of unknown tuberculous status. Except as specified in paragraph (a)(2)(ii) of this section, each captive cervid that has non-negative test results to this initial DPP® test will be classified as a suspect and retested with the DPP® test. A captive cervid that has non-negative test results to the DPP® test must not be retested using the SCT or CCT test.
(ii) The DPP® test is a primary test that may be used in affected herds of captive elk, red deer, white-tailed deer, fallow deer, and reindeer, and in herds of these species that have received captive cervids from an affected herd. In such herds, each captive cervid that has non-negative test results to the DPP® test will be classified as a reactor, unless APHIS determines that the captive cervid should be classified as a suspect because of possible exposure to a tuberculous animal.
(b) Supplemental tests—(1) Comparative cervical tuberculin (CCT) test. (i) The CCT test is a supplemental test that may only be used in order to retest captive cervids that have been classified as suspects after being tested with the SCT test. The CCT test may be used in affected herds only after the herd has tested negative to at least two whole herd SCT tests and only with the prior written consent of APHIS. The CCT test may not be used as a primary test.
(ii) A captive cervid tested with the CCT test must be classified as negative if it has a response to the bovine PPD tuberculin that is less than 1 mm.
(iii) Unless the testing veterinarian determines that the captive cervid should be classified as a reactor because of possible exposure to a tuberculous animal, a captive cervid tested with the CCT test must be classified as a suspect if:
(A) It has a response to the bovine PPD tuberculin that is greater than 2 mm and that is equal to the response to the avian PPD tuberculin; or
(B) It has a response to the bovine PPD tuberculin that is equal to or greater than 1 mm and equal to or less than 2 mm and that is equal to or greater than the response to the avian PPD tuberculin.
(iv) A captive cervid tested with the CCT test must be classified as a reactor if:
(A) It has a response to the bovine PPD tuberculin that is greater than 2 mm and that is at least 0.5 mm greater than the response to the avian PPD tuberculin; or
(B) It has been classified as a suspect on two successive CCT tests.
(C) Any exceptions to the reactor classification under the conditions in paragraph (b)(1)(iv) of this section must be justified by the testing veterinarian in writing and have the concurrence of APHIS.
(2) DPP® test. The DPP® test may be used as a supplemental test in order to retest captive cervids that have been classified as suspects based on an initial DPP® test. In such instances, the supplemental DPP® test must evaluate a new serum sample drawn from the cervid no sooner than 30 days after the initial DPP® test. A captive cervid that has non-negative test results on two successive DPP® tests will be classified as a reactor, unless APHIS determines that another disease classification is warranted.
(a) Qualifications. To be recognized as an accredited herd:
(1) All captive cervids in the herd eligible for testing in accordance with § 77.33(f) must have tested negative to at least two consecutive official tuberculosis tests, conducted at 9-15 month intervals. However, captive cervids under 1 year of age that are not natural additions to the herd do not have to be tested if they were born in and originate from an accredited herd.
(2) The owner of the herd must have a document issued by cooperating State or Federal animal health officials stating that the herd has met the requirements in paragraph (a)(1) of this section and is classified as an accredited herd.
(b) Movement allowed. Except as provided in § 77.23 with regard to captive cervids that originate in an accredited-free State or zone, and except as provided in § 77.31 with regard to captive cervids that originate in a nonaccredited State or zone, a captive cervid from an accredited herd may be moved interstate without further tuberculosis testing only if it is officially identified and is accompanied by an ICVI, as provided in § 77.32(c), that includes a statement that the captive cervid is from an accredited herd. If a group of captive cervids from an accredited herd is being moved interstate together to the same destination, all captive cervids in the group may be moved under one ICVI.
(c) Herd additions allowed. No captive cervid may be added to an accredited herd except in accordance with paragraphs (c)(4) and (c)(5), and either paragraph (c)(1), (c)(2), or (c)(3) of this section, as follows:
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days prior to movement to the premises of the accredited herd. Any captive cervid moved from a qualified or monitored herd must also be isolated from all members of the accredited herd until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the accredited herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other livestock during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the accredited herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and have been released from isolation; or
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other members of the herd of origin and must test negative to two official tuberculosis tests. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the accredited herd. The captive cervid must also be isolated from all members of the accredited herd until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the accredited herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other animals during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the accredited herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and have been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d) Maintenance of accredited herd status. To maintain status as an accredited herd, the herd must test negative to an official tuberculosis test within 33-39 months from the anniversary date of the second consecutive test with no evidence of tuberculosis disclosed (that is, the test on which the herd was recognized as accredited or the accrediting test). Each time the herd is tested for reaccreditation, it must be tested 33-39 months from the anniversary date of the accrediting test, not from the last date of reaccreditation (for example, if a herd is accredited on January 1 of a given year, the anniversary date will be January 1 of every third year). Accredited herd status is valid for 36 months (1,095 days) from the anniversary date of the accrediting test. If the herd is tested between 36 and 39 months after the anniversary date, its accredited herd status will be suspended for the interim between the anniversary date and the reaccreditation test. During the suspension period, the herd will be considered “unclassified” and captive cervids may be moved interstate from the herd only in accordance with the movement requirements for the State or zone in which the herd is located.
(a) Qualifications. To be recognized as a qualified herd:
(1) All captive cervids in the herd eligible for testing in accordance with § 77.33(f) must have tested negative to one official tuberculosis test that was administered to the herd within a 7-month period. However, captive cervids under 1 year of age that are not natural additions do not have to be tested if they were born in and originate from an accredited, qualified, or monitored herd.
(2) The owner of the herd must have a document issued by cooperating State and Federal animal health officials stating that the herd has met the requirement in paragraph (a)(1) of this section and is classified as a qualified herd.
(b) Movement allowed. Except as provided in § 77.23 with regard to captive cervids that originate in an accredited-free State or zone, and except as provided in § 77.31 with regard to captive cervids that originate in a nonaccredited State or zone, a captive cervid from a qualified herd may be moved interstate only if:
(1) The captive cervid is not known to be infected with or exposed to tuberculosis; and
(2) The captive cervid is officially identified and is accompanied by an ICVI, as provided in § 77.32(c), that includes a statement that the captive cervid is from a qualified herd. Except as provided in paragraphs (b)(3) and (b)(4) of this section, the ICVI must also state that the captive cervid has tested negative to an official tuberculosis test conducted within 90 days prior to the date of movement. If a group of captive cervids from a qualified herd is being moved interstate together to the same destination, all captive cervids in the group may be moved under one ICVI.
(3) Captive cervids under 1 year of age that are natural additions to the qualified herd or that were born in and originate from a classified herd may move without testing, provided that they are officially identified and that the ICVI accompanying them states that the captive cervids are natural additions to the qualified herd or were born in and originated from a classified herd and have not been exposed to captive cervids from an unclassified herd.
(4) Captive cervids being moved interstate for the purpose of exhibition only may be moved without testing, provided they are returned to the premises of origin no more than 90 days after leaving the premises, have no contact with other livestock during movement and exhibition, are officially identified, and are accompanied by an ICVI that includes a statement that the captive cervid is from a qualified herd and will otherwise meet the requirements of this paragraph.
(c) Herd additions allowed. No captive cervid may be added to a qualified herd except in accordance with paragraph (c)(4) and either paragraph (c)(1), (c)(2), or (c)(3) of this section, as follows:
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days prior to movement to the premises of the accredited herd;
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other animals in its herd of origin and must test negative to two official tuberculosis tests prior to movement. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the qualified herd. The captive cervid must then be kept in isolation from all animals until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the qualified herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other livestock during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the qualified herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d) Maintenance of qualified herd status. To maintain status as a qualified herd, the herd must test negative to an official tuberculosis test within 9-15 months from the anniversary date of the first test with no evidence of tuberculosis disclosed (this is the qualifying test). Each time the herd is retested for qualified status, it must be tested 9-15 months from the anniversary date of the qualifying test, not from the last date of requalification (for example, if a herd is qualified on January 1 of a given year, the anniversary date will be January 1 of each consecutive year). Qualified herd status remains in effect for 12 months (365 days) following the anniversary date of the qualifying test. Qualified herd status will be suspended between the anniversary date and the requalifying test, if the herd is not tested within 12 months. During the suspension period, the herd will be considered “unclassified” and captive cervids may be moved interstate from the herd only in accordance with the movement requirements for the State or zone in which the herd is located.
(a) Qualifications. To be recognized as a monitored herd:
(1) Identification records must be maintained by the person, firm, or corporation responsible for the management of the herd for as long as status as a monitored herd is desired. Such records must be maintained on all captive cervids in the herd that are slaughtered, inspected, and found negative for tuberculosis at an approved slaughtering establishment or necropsied at an approved diagnostic laboratory. Identification records may also include captive cervids from the herd that tested negative for tuberculosis in accordance with requirements for interstate movement. No less than one-half of the captive cervids on which records are kept must be slaughter inspected; and
(2) A sufficient number of captive cervids in the herd must be slaughter inspected or tested for interstate movement to ensure that tuberculosis infection at a prevalence level of 2 percent or more will be detected with a confidence level of 95 percent.
(b) Movement allowed. Except as provided in § 77.23 with regard to captive cervids that originate in an accredited-free State or zone, and except as provided in § 77.31 with regard to captive cervids that originate in a nonaccredited State or zone, a captive cervid from a monitored herd may be moved interstate only if:
(1) The captive cervid is not known to be infected with or exposed to tuberculosis; and
(2) The captive cervid is officially identified and is accompanied by an ICVI, as provided in § 77.32(c), that includes a statement that the captive cervid is from a monitored herd. Except as provided in paragraph (b)(3) of this section, the ICVI must also state that the captive cervid has tested negative to an official tuberculosis test conducted within 90 days prior to the date of movement. If a group of captive cervids from a monitored herd is being moved interstate together to the same destination, all captive cervids in the group may be moved under one ICVI.
(3) Captive cervids under 1 year of age that are natural additions to the monitored herd or that were born in and originate from a classified herd may move without testing, provided that they are officially identified and that the ICVI accompanying them states that the captive cervids are natural additions to the monitored herd or were born in and originated from a classified herd and have not been exposed to captive cervids from an unclassified herd.
(c) Herd additions allowed. No captive cervid may be added to a monitored herd except in accordance with paragraph (c)(4) and either paragraph (c)(1), (c)(2), or (c)(3) of this section, as follows:
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days prior to movement to the premises of the monitored herd; or
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other animals and must test negative to two official tuberculosis tests. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the monitored herd. The captive cervid must then be kept in isolation from all animals until it tests negative to an official tuberculosis test conducted at least 90 days following the date it arrives at the premises of the monitored herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other animals during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the monitored herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d) Maintenance of monitored herd status. The person, firm, or corporation responsible for the management of the herd must submit an annual report to cooperating State or Federal animal health officials prior to the anniversary date of classification. This report must give the number of captive cervids currently in the herd; the number of captive cervids from the herd 1 year of age and older identified, slaughtered, and inspected at an approved slaughtering establishment or necropsied at an approved diagnostic laboratory during the preceding year; and the number of captive cervids that have tested negative for tuberculosis in accordance with interstate movement requirements. The number of slaughter inspections or negative testing captive cervids reported in any given year must be at least 25 percent of the total number required over a 3-year period to qualify a herd for monitored herd status. During each consecutive 3-year period, 100 percent of the qualifying total must be reported.
The Administrator may, with the concurrence of the cooperating State animal health officials of the State of destination, and upon request in specific cases, permit the movement of captive cervids not otherwise provided for in this part which have not been classified as reactors and are not otherwise known to be affected with tuberculosis, under such conditions as the Administrator may prescribe in each specific case to prevent the spread of tuberculosis. The Administrator shall promptly notify the appropriate cooperating State animal health officials of the State of destination of any such action.
(a) Herds containing a suspect—(1) The suspect. (i) A captive cervid classified as a suspect on the SCT test must be quarantined until it is slaughtered or retested by the CCT test and found negative for tuberculosis. Retesting must be as follows:
(A) The first CCT test must be administered within the first 10 days following the SCT test or, if not, must be administered at least 90 days after the SCT test. If the CCT test is administered within 10 days of the SCT test, the injection must be on the side of the neck opposite the injection for the SCT test.
(B) [Reserved]
(ii) A captive cervid classified as a suspect on the first CCT test must be quarantined until the following has occurred:
(A) A suspect on the first CCT test is tested with a second CCT test at least 90 days after the first CCT test and is found negative for tuberculosis.
(B) [Reserved]
(iii) A captive cervid classified as a suspect on an initial DPP® test must be slaughtered or otherwise must be quarantined until it is retested using the DPP® test. A captive cervid that has negative test results to this second DPP® test may be released from quarantine. A captive cervid that has non-negative test results to this second DPP® test must be classified as a reactor and may only be moved in accordance with paragraph (b) of this section.
(2) The remainder of the herd. Any herd containing a suspect to an official tuberculosis test must be quarantined until the suspect is retested by the CCT test, DPP® test, or the BTB test and found negative for tuberculosis, or the suspect is inspected at slaughter or necropsied and found negative for tuberculosis after histopathology and culture of selected tissues. If the suspect is found negative for tuberculosis upon testing, or after slaughter inspection or necropsy and histopathology and culture of selected tissues, the herd may be released from quarantine and will return to the herd classification status in effect before the herd was quarantined. If the suspect is classified as a reactor upon testing, or after slaughter inspection or necropsy and histopathology and/or culture of selected tissues, the herd may be released from quarantine only in accordance with paragraph (b) of this section for herds containing a reactor.
(b) Herds containing a reactor. The following requirements apply to herds containing a reactor, except for herds that have received captive cervids from an affected herd. Herds that have received captive cervids from an affected herd must be quarantined and tested in accordance with paragraph (e) of this section.
(1) The reactor. Captive cervids classified as reactors must be quarantined.
(2) The remainder of the herd. Any herd containing reactors must be quarantined until the reactors are slaughtered or necropsied in accordance with § 77.40 and:
(i) If, upon slaughter inspection or necropsy, any reactors exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of M. bovis, the remainder of the herd may be released from quarantine in accordance with the provisions of paragraph (c) of this section.
(ii) If M. bovis is isolated from any reactors, the remainder of the herd will be considered an affected herd, and will be subject to the provisions for affected herds in paragraph (d) of this section.
(iii) If upon slaughter inspection or necropsy all reactors exhibit no gross lesions (NGL) of tuberculosis and no evidence of tuberculosis infection is found by histopathology and culture of M. bovis on specimens taken from the NGL animals, the remainder of the herd may be released from quarantine, and captive cervids from the herd may be moved interstate in accordance with the herd classification status in effect before the herd was quarantined if one of the following conditions is met:
(A) The remainder of the herd is given a whole herd test and is found negative for tuberculosis.
(B) The remainder of the herd is given a whole herd test, and all reactors to the whole herd test exhibit no gross lesions (NGL) of tuberculosis upon slaughter inspection or necropsy and no evidence of tuberculosis infection is found by histopathology or culture of M. bovis on specimens taken from the NGL animals.
(iv) If no evidence of tuberculosis is found in any reactor upon slaughter inspection or necropsy, but it is not possible to conduct a whole herd test on the remainder of the herd, the herd will be evaluated, based on criteria such as the testing history of the herd and the State history of tuberculosis infection, by APHIS to determine whether the herd may be released from quarantine.
(c) Herds found to have only lesions of tuberculosis. A herd in which captive cervids with lesions compatible with or suggestive of tuberculosis are found by histopathology without the isolation of M. bovis may be released from quarantine and return to the herd classification status in effect before the herd was quarantined, with the concurrence of APHIS, if the herd tests negative to tuberculosis on a whole herd test conducted 90 days following the removal of the lesioned captive cervid, provided the herd has not been exposed to M. bovis during the 90 days. To maintain its herd classification status, the herd must test negative to two annual whole herd tests beginning 10-12 months after the herd is released from quarantine. If any captive cervids in the herd respond to one of the tests, the herd will be subject to the provisions of paragraph (a) or (b) of this section. If the herd is not given the two annual whole herd tests, it will become an unclassified herd.
(d) Affected herds. A herd determined to be an affected herd must be quarantined until the herd has tested negative to three whole herd tests in succession, with the first test given 90 days or more after the last test yielding a reactor and the last two tests given at intervals of not less than 180 days. If the herd tests negative to the three whole herd tests, it will be released from quarantine, but will be considered an unclassified herd, and captive cervids may only be moved interstate from the herd in accordance with the movement requirements for the State or zone in which the herd is located. In addition, the herd must be given five consecutive annual whole herd tests after release from quarantine. (These five tests will count toward qualifying the herd for herd classification.) As an alternative to testing, the herd may be depopulated.
(e) Herds that have received captive cervids from an affected herd. If a herd has received captive cervids from an affected herd, the captive cervids from the affected herd of origin will be considered exposed to tuberculosis. The exposed captive cervids and the receiving herd must be quarantined. The exposed captive cervids must be slaughtered, necropsied, or tested with the SCT test by a veterinarian employed by the State in which the test is administered or employed by USDA, or tested with the DPP® test. Any exposed captive cervid that responds to the SCT test must be classified as a reactor and must be inspected at slaughter or necropsied. Any exposed captive cervid that has non-negative test results to the DPP® test must be classified as a reactor and must be inspected at slaughter or necropsied. Any exposed captive cervid that tests negative to the SCT or DPP® test will be considered as part of the affected herd of origin for purposes of testing, quarantine, and the five annual whole herd tests required for affected herds in paragraph (d) of this section.
(1) If bovine tuberculosis is confirmed in any of the exposed captive cervids by bacterial isolation of M. bovis, the receiving herd will be classified as an affected herd and will be subject to the provisions for affected herds in paragraph (d) of this section.
(2) If any of the exposed captive cervids are found to exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of M. bovis, the receiving herd will be subject to appropriate testing as determined by APHIS.
(3) If all the exposed captive cervids test negative for tuberculosis, the receiving herd will be released from quarantine if it is given a whole herd test and is found negative for tuberculosis and will return to the herd classification in effect before the herd was quarantined. In addition, the receiving herd will must be retested with the SCT or DPP® test 1 year after release from quarantine in order for captive cervids from the herd to continue to be moved interstate. Supplemental diagnostic tests may be used if any captive cervids in the herd show a response to the SCT test or have non-negative test results to the DPP® test.
(f) Source herds. A herd suspected of being the source of tuberculous captive cervids based on a slaughter traceback investigation must be quarantined upon notification (by the person conducting the investigation) to the USDA area veterinarian in charge for the State in which the herd resides, and a herd test must be scheduled. If the herd is suspected of being the source of slaughter captive cervids having lesions of tuberculosis, the herd test must be done by a veterinarian employed by the State in which the test is administered or employed by USDA.
(1) If the herd is identified as the source of captive cervids having lesions of tuberculosis and M. bovis has been confirmed by bacterial isolation from the slaughter animal, all captive cervids in the herd that respond to the SCT must be classified as reactors. All captive cervids in the herd that respond to the DPP® test must be classified as reactors. If none respond to the SCT test or have non-negative test results to the DPP® test, the herd may be released from quarantine and will return to the herd classification status in effect before the herd was quarantined, unless APHIS determines that additional testing is appropriate to ensure the herd's freedom from tuberculosis.
(2) If the herd is identified as the source of captive cervids that exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of M. bovis, all captive cervids in the herd that respond to the SCT test or the DPP® test must be classified as suspects, and supplemental tests must be applied.
(3) If the herd is not identified as the source herd, the herd will be released from quarantine if the herd is given a whole herd test and is found negative for tuberculosis. The herd will then return to the herd classification status in effect before the herd was quarantined.
(g) Newly assembled herds. (1) A newly assembled herd will be classified as having the herd status of the herd from which the captive cervids originated. If the herd is assembled from captive cervids from more than one herd, it will be classified as having the herd status of the originating herd with the lowest status. A newly assembled herd will also assume the testing schedule of the herd status it is given. Captive cervids in the herd must have no exposure to captive cervids from a herd of lesser status than the herd of origin determining the status of the newly assembled herd or to any tuberculous livestock.
(2) A herd newly assembled on premises where a tuberculous herd has been depopulated must be given two consecutive annual whole herd tests. The first test must be administered at least 6 months after the assembly of the new herd. If the whole herd tests are not conducted within the indicated timeframe, the herd will be quarantined. If the herd tests negative to the two whole herd tests, there are no further requirements. If any captive cervid in the herd responds on one of the whole herd tests, the herd will be subject to the provisions of paragraph (a) or (b) of this section. If the premises has been vacant for more than 1 year preceding the assembly of the new herd on the premises, these requirements may be waived if the risk of tuberculosis transmission to the newly assembled herd is deemed negligible by cooperating State and Federal animal health officials.
(a) Procedures for necropsy and slaughter. (1) A necropsy must be performed by or under the supervision of a veterinarian who is employed by USDA or employed by the State in which the captive cervid was classified, and who is trained in tuberculosis necropsy procedures.
(2) If, upon necropsy, a captive cervid is found without evidence of M. bovis infection by histopathology and culture, the captive cervid will be considered negative for tuberculosis.
(3) Reactors, suspects, and exposed captive cervids may be slaughtered only at a recognized slaughtering establishment, as defined in § 77.20.
(b) Interstate movement to necropsy or slaughter—(1) Permit. Any reactor, suspect, or exposed captive cervid to be moved interstate to necropsy or slaughter must be accompanied by a permit issued by a representative of APHIS, a State representative, or an accredited veterinarian. The captive cervid must remain on the premises where it was identified as a reactor, suspect, or exposed captive cervid until a permit for its movement is obtained. No stopover or diversion from the destination listed on the permit is allowed. If a change in destination becomes necessary, a new permit must be obtained from a cooperating State or Federal animal health official or an accredited veterinarian before the interstate movement begins. The permit must list:
(i) The classification of the captive cervid (reactor, suspect, or exposed);
(ii) The reactor eartag number or, for suspects and exposed captive cervids, the official eartag or other approved identification number;
(iii) The owner's name and address;
(iv) The origin and destination of the captive cervids;
(v) The number of captive cervids covered by the permit; and
(vi) The purpose of the movement.
(2) Identification of reactors. Reactors must be tagged with an official eartag attached to the left ear and bearing a serial number and the inscription “U.S. Reactor,” and either:
(i) Branded with the letter “T” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size; or
(ii) Permanently identified by the letters “TB” tattooed legibly in the left ear, sprayed on the left ear with yellow paint, and either accompanied directly to necropsy or slaughter by an APHIS or State representative or moved directly to necropsy or slaughter in a vehicle closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(3) Identification of exposed captive cervids. Exposed captive cervids must be identified by an official eartag or other approved identification and either:
(i) Branded with the letter “S” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size; or
(ii) Either accompanied directly to necropsy or slaughter by an APHIS or State representative or moved directly to necropsy or slaughter in a vehicle closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
All conveyances and associated equipment, premises, and structures that are used for receiving, holding, shipping, loading, unloading, and delivering captive cervids in connection with their interstate movement and that are determined by cooperating State and Federal animal health officials to be contaminated because of occupation or use by tuberculous or reactor livestock must be cleaned and disinfected under the supervision of the cooperating State or Federal animal health officials. Such cleaning and disinfecting must be done in accordance with the procedures approved by the cooperating State or Federal animal health officials. Cleaning and disinfection must be completed before the premises, conveyances, or materials may again be used to convey, hold, or in any way come in contact with any livestock.
The following terms are defined in this section:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animals. Cattle, bison, and swine.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal. The AIN consists of 15 digits, with the first 3 being the country code (840 for the United States or a unique country code for any U.S. territory that has such a code and elects to use it in place of the 840 code). The alpha characters USA or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording may be used as an alternative to the 840 or other prefix representing a U.S territory; however, only the AIN beginning with the 840 or other prefix representing a U.S. territory will be recognized as official for use on AIN tags applied to animals on or after March 11, 2015. The AIN beginning with the 840 prefix may not be applied to animals known to have been born outside the United States.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Approved brucella vaccine. A Brucella product approved by and produced under license of the United States Department of Agriculture for injection into cattle or bison to enhance their resistance to brucellosis.
Approved individual herd plan. A herd management and testing plan designed by the herd owner, the owner's veterinarian if so requested, and a State representative or APHIS representative to determine the disease status of animals in the herd and to control and eradicate brucellosis within the herd. The plan must be jointly approved by the State animal health official and the Veterinarian in Charge.
Approved intermediate handling facility. Premises approved by the Administrator and the State animal health official for receiving and handling cattle and bison for release only to recognized slaughtering establishments and quarantined feedlots. Cattle and bison may be held at an approved intermediate handling facility for a maximum of 7 days and may not change ownership during this time. No cattle or bison, except cattle or bison moved directly from a farm of origin, shall be permitted to enter an approved intermediate handling facility unless they are accompanied by a permit or “S” brand permit. Cattle or bison transported in vehicles closed with official seals are prohibited from entering the approved intermediate handling facility. No cattle or bison shall be permitted to leave an approved intermediate handling facility unless they are accompanied by a permit or “S” brand permit which lists a recognized slaughtering establishment or a quarantined feedlot as the point of destination. To qualify for and retain approval, the following conditions must be met: (a) The facility must be separate and apart from other livestock handling facilities for breeding cattle and breeding bison; (b) Serviceable equipment for cleaning and disinfection shall be furnished and maintained with adequate disinfectant on hand; (c) The facility must be cleaned and disinfected in accordance with § 71.4(a) of this chapter; (d) Any document relating to cattle or bison which are or have been in the facility shall be maintained by the facility for a period of 2 years; (e) State representatives and APHIS representatives shall be granted, at reasonable hours, access to all documents required to be maintained by the facility and authority to reproduce the documents; and (f) Each entrance and exit to the facility must prominently display a sign bearing the following words: “All cattle and bison entering this facility must go directly to slaughter or a quarantined feedlot”. The Administrator may withdraw or deny approval of any intermediate handling facility in accordance with § 71.20 of this chapter.
Area. That portion of any State which has a separate brucellosis classification under this part.
“B” branded. Branding with a hot iron the letter “B” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size.
Boar. An uncastrated male swine 6 months of age or over which is or has been capable of being used for breeding purposes.
Brucellosis. The contagious, infectious, and communicable disease caused by bacteria of the genus Brucella. It is also known as Bangs disease, undulant fever, and contagious abortion.
Brucellosis exposed. Except for brucellosis reactors, animals that are part of a herd known to be affected, or are in a quarantined feedlot or a quarantined pasture, or are brucellosis suspects, or that have been in contact with a brucellosis reactor for a period of 24 hours or more, or for a period of less than 24 hours if the brucellosis reactor has aborted, calved, or farrowed within the past 30 days or has a vaginal or uterine discharge.
Brucellosis negative. An animal subjected to one or more official tests resulting in a brucellosis negative classification or reclassified as brucellosis negative by a designated epidemiologist as provided for in the definition of official test.
Brucellosis reactor. An animal subjected to an official test resulting in a brucellosis reactor classification or subjected to a bacteriological examination for field strain Brucella abortus and found positive or reclassified as a brucellosis reactor by a designated epidemiologist as provided for in the definition of official test.
Brucellosis ring test. The brucellosis ring test is conducted on composite milk or cream samples from dairy herds and is interpreted as either negative or suspicious (positive). Herds which are negative to the brucellosis ring test and which are not quarantined as brucellosis affected are classified as brucellosis negative for public health ordinances and surveillance purposes. Herds classified as suspicious require a herd blood test to determine animal and herd status.
Brucellosis suspect. An animal subjected to an official test resulting in a brucellosis suspect classification or reclassified as a brucellosis suspect by a designated epidemiologist as provided for in the definition of official test.
Certified brucellosis-free herd. A herd of cattle or bison which has qualified for and whose owner has been issued a certified brucellosis-free herd certificate signed by the appropriate State animal health official and the Veterinarian in Charge.
(a) Certification. The following methods may be used to qualify a herd:
(1) By conducting at least two consecutive negative herd blood tests not less than 10 months nor more than 14 months apart; or
(2) As an alternative for dairy cattle, by conducting a minimum of four consecutive negative brucellosis ring tests, or other official brucellosis milk test approved by the Administrator, at not less than 90-day intervals, followed by a negative herd blood test within 90 days after the last negative brucellosis ring test or other official brucellosis milk test approved by the Administrator.
(b) Maintaining certification. Certified brucellosis-free herd status will remain in effect for 1 year beginning with the date of issuance of the certified brucellosis-free herd certificate. The following methods may be used to maintain herd certification:
(1) A negative herd blood test must be conducted within 10 to 12 months of the last certification date for continuous status. Lapsed certification may be reinstated if a herd blood test is conducted within 14 months of the last certification date. A new recertification test date may be established if requested by the owner and if the herd is negative to a herd blood test on that date, provided that date is within 1 year of the previous certification date.
(2) As an alternative for dairy cattle, a minimum of four consecutive negative brucellosis ring tests, or other official brucellosis milk test approved by the Administrator, must be conducted at approximately 90-day intervals, with the fourth test conducted within 60 days before the 1-year anniversary of the previous certification date.
(3) The Administrator may allow another testing protocol to be used if the Administrator determines that such a protocol is adequate to determine there is no evidence of brucellosis in the herd.
(c) Loss of certification. A herd which loses certified brucellosis-free herd status because a brucellosis reactor is found in the herd may be recertified only by repeating the certification process, except that certified brucellosis-free herd status may be reinstated without repeating the certification process if epidemiological studies and bacteriological cultures conducted by an APHIS representative or State representative show that the herd was not affected with Brucella abortus.
Class A State or area. A State or area which meets standards for classification as a Class A State or area and is certified as such on initial classification or on reclassification by the State animal health official, the Veterinarian in Charge, and the Administrator. Any reclassification will be made in accordance with § 78.40 of this part. The following are the standards to attain and maintain Class A status.
(a) Surveillance—(1) Brucellosis ring test. The brucellosis ring test shall be conducted in the State or area at least four times per year at approximately 90-day intervals. All herds producing milk for sale shall be included in at least three of the four brucellosis ring tests per year.
(2) Market Cattle Identification (MCI) program—(i) Coverage. All recognized slaughtering establishments in the State or area must participate in the MCI program. Blood samples shall be collected from at least 95 percent of all cows and bulls 2 years of age or over at each recognized slaughtering establishment and subjected to an official test;
(ii) Brucellosis reactors—(A) Tracebacks. At least 90 percent of all brucellosis reactors found in the course of MCI testing must be traced to the farm of origin.
(B) Successfully closed cases. The State or area must successfully close at least 95 percent of the MCI reactor cases traced to the farm of origin during the 12-consecutive-month period immediately prior to the most recent anniversary of the date the State or area was classified Class A. To successfully close an MCI reactor case, State representatives or APHIS representatives must conduct an epidemiologic investigation at the farm of origin within 15 days after notification by the cooperative State-Federal laboratory that brucellosis reactors were found on the MCI test. Herd blood tests must be conducted or the herd must be confined to the premises under quarantine within 30 days after notification that brucellosis reactors were found on the MCI test, unless a designated epidemiologist determines that:
(1) The brucellosis reactor is located in a herd in a different State than the State where the MCI blood sample was collected. In such cases a State representative or APHIS representative must give written notice of the MCI test results to the State animal health official in the State where the brucellosis reactor is located; or
(2) Evidence indicates that the brucellosis reactor is from a herd that no longer presents a risk of spreading brucellosis, or is from a herd that is unlikely to be infected with brucellosis. Such evidence could include, but is not limited to, situations where:
(i) The brucellosis reactor is traced back to a herd that has been sold for slaughter in entirety;
(ii) The brucellosis reactor is traced back to a herd that is certified brucellosis free and is 100-percent vaccinated; or
(iii) The brucellosis reactor showed a low titer in the MCI test and is traced back to a dairy herd that is 100 percent vaccinated and has tested negative to the most recent brucellosis ring test required by this section for herds producing milk for sale.
(3) Epidemiologic surveillance—(i) Adjacent herds. All adjacent herds or other herds having contact with cattle or bison in a herd known to be affected shall have an approved individual herd plan in effect within 15 days of notification of brucellosis in the herd known to be affected;
(ii) Epidemiologically traced herds. All herds from which cattle or bison are moved into a herd known to be affected and all herds which have received cattle or bison from a herd known to be affected shall have an approved individual herd plan in effect within 15 days of locating the source herd or recipient herd.
(iii) Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(b) Herd infection rate—(1) Percentage of herds affected. States or areas must not exceed a cattle or bison herd infection rate, based on the number of herds found to have brucellosis reactors within the State or area during any 12 consecutive months due to field strain Brucella abortus, of 0.25 percent or 2.5 herds per 1,000, except in States with 10,000 or fewer herds. A special review by the Administrator will be made to determine if such small herd population States would qualify for Class A status. Locations of herds, sources of brucellosis, and brucellosis control measures taken by the State will be considered.
(2) Epidemiologic investigation. Within 15 days after notification by the cooperative State-Federal laboratory that brucellosis reactors have been found in any herd, State representatives or APHIS representatives shall investigate that herd to identify possible sources of brucellosis. All possible sources of brucellosis identified shall be contacted within an additional 15 days to determine appropriate action.
(3) All herds known to be affected shall have approved individual herd plans in effect within 15 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
Class B State or area. A State or area which meets standards for classification as a Class B State or area and is certified as such on initial classification or on reclassification by the State animal health official, the Veterinarian in Charge, and the Administrator. Any reclassification will be made in accordance with § 78.40 of this part. The following are the standards to attain and maintain Class B status.
(a) Surveillance—(1) Brucellosis ring test. The brucellosis ring test shall be conducted in the State or area at least four times per year at approximately 90-day intervals. All herds producing milk for sale shall be included in at least three of the four brucellosis ring tests per year.
(2) Market Cattle Identification (MCI) program—(i) Coverage. All recognized slaughtering establishments in the State or area must participate in the MCI program. Blood samples shall be collected from at least 95 percent of all cows and bulls 2 years of age or over at each recognized slaughtering establishment and subjected to an official test;
(ii) Brucellosis reactors—(A) Tracebacks. At least 80 percent of all brucellosis reactors found in the course of MCI testing must be traced to the farm of origin.
(B) Successfully closed cases. The State or area must successfully close at least 90 percent of the MCI reactor cases traced to the farm of origin during the 12-consecutive-month period immediately prior to the most recent anniversary of the date the State or area was classified Class B. To successfully close an MCI reactor case, State representatives or APHIS representatives must conduct an epidemiologic investigation at the farm of origin within 30 days after notification by the cooperative State-Federal laboratory that brucellosis reactors were found on the MCI test. Herd blood tests must be conducted or the herd must be confined to the premises under quarantine within 30 days after notification that brucellosis reactors were found on the MCI test, unless a designated epidemiologist determines that:
(1) The brucellosis reactor is located in a herd in a different State than the State where the MCI blood sample was collected. In such cases a State representative or APHIS representative must give written notice of the MCI test results to the State animal health official in the State where the brucellosis reactor is located; or
(2) Evidence indicates that the brucellosis reactor is from a herd that no longer presents a risk of spreading brucellosis, or is from a herd that is unlikely to be infected with brucellosis. Such evidence could include, but is not limited to, situations where:
(i) The brucellosis reactor is traced back to a herd that has been sold for slaughter in entirety;
(ii) The brucellosis reactor is traced back to a herd that is certified brucellosis free and is 100-percent vaccinated; or
(iii) The brucellosis reactor showed a low titer in the MCI test and is traced back to a dairy herd that is 100 percent vaccinated and has tested negative to the most recent brucellosis ring test required by this section for herds producing milk for sale.
(3) Epidemiologic surveillance—(i) Adjacent herds. All adjacent herds or other herds having contact with cattle or bison in a herd known to be affected shall have an approved individual herd plan in effect within 45 days of notification of brucellosis in the herd known to be affected;
(ii) Epidemiologically traced herds. All herds from which cattle or bison are moved into a herd known to be affected and all herds which have received cattle or bison from a herd known to be affected shall have an approved individual herd plan in effect within 45 days of locating the source herd or recipient herd.
(iii) Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(b) Herd infection rate—(1) Percentage of herds affected. States or areas must not exceed a cattle or bison herd infection rate, based on the number of herds found to have brucellosis reactors within the State or area during any 12 consecutive months due to field strain Brucella abortus, of 1.5 percent or 15 herds per 1,000, except in States with 1,000 or fewer herds. A special review by the Administrator will be made to determine if such small herd population States would qualify for Class B status. Locations of herds, sources of brucellosis, and brucellosis control measures taken by the State will be considered.
(2) Epidemiologic investigation. Within 45 days after notification by the cooperative State-Federal laboratory that brucellosis reactors have been found in any herd, State representatives or APHIS representatives shall investigate that herd to identify possible sources of brucellosis. All possible sources of brucellosis identified shall be contacted within an additional 30 days to determine appropriate action.
(3) All herds known to be affected shall have approved individual herd plans in effect within 45 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
Class C State or area. A State or area which meets standards for classification as a Class C State or area and is certified as such on initial classification or on reclassification by the State animal health official, the Veterinarian in Charge, and the Administrator. Any reclassification will be made in accordance with § 78.40 of this part. The following are the standards to attain and maintain Class C status.
(a) Surveillance—(1) Brucellosis ring test. The brucellosis ring test shall be conducted in the State or area at least four times per year at approximately 90-day intervals. All herds producing milk for sale shall be included in at least three of the four brucellosis ring tests per year.
(2) Market Cattle Identification (MCI) program—(i) Coverage. All recognized slaughtering establishments in the State or area must participate in the MCI program. Blood samples shall be collected from at least 95 percent of all cows and bulls 2 years of age or over at each recognized slaughtering establishment and subjected to an official test;
(ii) Brucellosis reactors—(A) Tracebacks. At least 80 percent of all brucellosis reactors found in the course of MCI testing must be traced to the farm of origin.
(B) Successfully closed cases. The State or area must successfully close at least 90 percent of the MCI reactor cases traced to the farm of origin during the 12-consecutive-month period immediately prior to the most recent anniversary of the date the State or area was classified Class C. To successfully close an MCI reactor case, State representatives or APHIS representatives must conduct an epidemiologic investigation at the farm of origin within 30 days after notification by the cooperative State-Federal laboratory that brucellosis reactors were found on the MCI test. Herd blood tests must be conducted or the herd must be confined to the premises under quarantine within 30 days after notification that brucellosis reactors were found on the MCI test, unless a designated epidemiologist determines that:
(1) The brucellosis reactor is located in a herd in a different State than the State where the MCI blood sample was collected. In such cases a State representative or APHIS representative must give written notice of the MCI test results to the State animal health official in the State where the brucellosis reactor is located; or
(2) Evidence indicates that the brucellosis reactor is from a herd that no longer presents a risk of spreading brucellosis, or is from a herd that is unlikely to be infected with brucellosis. Such evidence could include, but is not limited to, situations where:
(i) The brucellosis reactor is traced back to a herd that has been sold for slaughter in entirety;
(ii) The brucellosis reactor is traced back to a herd that is certified brucellosis free and is 100-percent vaccinated; or
(iii) The brucellosis reactor showed a low titer in the MCI test and is traced back to a dairy herd that is 100 percent vaccinated and has tested negative to the most recent brucellosis ring test required by this section for herds producing milk for sale.
(3) Epidemiologic surveillance—(i) Adjacent herds. All adjacent herds or other herds having contact with cattle or bison in a herd known to be affected shall have an approved individual herd plan in effect within 45 days of notification of brucellosis in the herd known to be affected;
(ii) Epidemiologically traced herds. All herds from which cattle or bison are moved into a herd known to be affected and all herds which have received cattle or bison from a herd known to be affected shall have an approved individual herd plan in effect within 45 days of locating the source herd or recipient herd.
(iii) Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(b) Herd infection rate—(1) Percentage of herds affected. States or areas exceed a cattle or bison herd infection rate, based on the number of herds found to have brucellosis reactors within the State or area during any 12 consecutive months due to field strain Brucella abortus, of 1.5 percent or 15 herds per 1,000, except in States with 1,000 or fewer herds. A special review by the Administrator will be made to determine if such small herd population States should be classified as a Class C State. Locations of herds, sources of brucellosis, and brucellosis control measures taken by the State will be considered.
(2) Epidemiologic investigation. Within 45 days after notification by the cooperative State-Federal laboratory that brucellosis reactors have been found in any herd, State representatives or APHIS representatives shall investigate that herd to identify possible sources of brucellosis. All possible sources of brucellosis identified shall be contacted within an additional 30 days to determine appropriate action.
(3) All herds known to be affected shall have approved individual herd plans in effect within 45 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(c) Compliance with minimum procedural standards. (1) A State must implement and maintain minimum procedural standards.
(2) A State or area must make continued progress over a 2-year period in reducing the prevalence of brucellosis as determined by epidemiologic evaluation or it will be placed under Federal quarantine.
Class Free State or area. A State or area which meets standards for classification as a Class Free State or area and is certified as such on initial classification or on reclassification by the State animal health official, the Veterinarian in Charge, and the Administrator. For initial classification or reclassification, all cattle herds in the State or area must have remained free of Brucella abortus for 12 consecutive months, based on surveillance and epidemiologic investigations as required for Class A States or areas, and the State or area must have a cattle herd infection rate, based on the number of herds found to have brucellosis reactors within the State or area during any 12 consecutive months due to Brucella abortus, of 0.0 percent or 0 herds per 1,000. The Administrator may reclassify a State or area to a lower status upon finding that continued detection of brucellosis presents a risk that the disease will spread. Any reclassification will be made in accordance with § 78.40 of this part. All cattle herds in the State or area in which brucellosis has been known to exist must be released from any State or Federal brucellosis quarantine prior to classification. In addition, if any herds of other species of domestic livestock have been found to be affected with brucellosis, they must be subjected to an official test and found negative, slaughtered, or quarantined so that no foci of brucellosis in any species of domestic livestock are left uncontrolled. The following are the standards to maintain Class Free status.
(a) Surveillance—(1) Testing requirements—(i) States or areas that have been Class Free for 5 consecutive years or longer and that do not have B. abortus in wildlife. All recognized slaughtering establishments in the State or area, upon request by APHIS, must agree to participate in market cattle identification (MCI) testing as part of the national brucellosis surveillance plan.
(ii) States or areas that have not been Class Free for 5 consecutive years or longer or that have B. abortus in wildlife. The State or area must carry out testing as provided in paragraphs (a)(1)(ii)(A) and (a)(1)(ii)(B) or (a)(1)(ii)(C) of this definition:
(A) Brucellosis ring test. The State or area shall conduct as many brucellosis ring tests per year as are necessary to ensure that all herds producing milk for sale are tested at least twice per year at approximately 6-month intervals. Another official brucellosis milk test may be used as approved by the Administrator.
(B) Market Cattle Identification (MCI) program. All recognized slaughtering establishments in the State or area must participate in the MCI program. Blood samples shall be collected from at least 95 percent of all cows and bulls 2 years of age or over at each recognized slaughtering establishment and subjected to an official test.
(C) Alternative surveillance plan. As an alternative to the testing described in paragraphs (a)(1)(ii)(A) and (a)(1)(ii)(B) of this definition, the State or area may develop an alternative surveillance plan that would have to meet or exceed the level of disease detection provided by combined brucellosis ring testing and collection of blood samples from at least 95 percent of test eligible slaughter cattle slaughtered within the State. The alternative surveillance plan must be developed in conjunction with the State animal health official and the area veterinarian in charge.
(2) Brucellosis reactors. All Class Free States or areas must comply with the following requirements upon detection of a brucellosis reactor:
(i) Tracebacks. The State or area must trace at least 90 percent of all brucellosis reactors found in the course of MCI testing to the farm of origin.
(ii) Successfully closed cases. The State or area must successfully close at least 95 percent of the MCI reactor cases traced to the farm of origin during the 12-consecutive-month period immediately prior to the most recent anniversary of the date the State or area was classified Class Free. To successfully close an MCI reactor case, State representatives or APHIS representatives must conduct an epidemiologic investigation at the farm of origin within 15 days after notification by the cooperative State-Federal laboratory that brucellosis reactors were found on the MCI test. Herd blood tests must be conducted or the herd must be confined to the premises under quarantine within 30 days after notification that brucellosis reactors were found on the MCI test, unless a designated epidemiologist determines that:
(A) The brucellosis reactor is located in a herd in a different State than the State where the MCI blood sample was collected. In such cases a State representative or APHIS representative must give written notice of the MCI test results to the State animal health official in the State where the brucellosis reactor is located; or
(B) Evidence indicates that the brucellosis reactor is from a herd that no longer presents a risk of spreading brucellosis, or is from a herd that is unlikely to be infected with brucellosis. Such evidence could include, but is not limited to, situations where:
(1) The brucellosis reactor is traced back to a herd that has been sold for slaughter in entirety;
(2) The brucellosis reactor is traced back to a herd that is certified brucellosis free and is 100-percent vaccinated; or
(3) The brucellosis reactor showed a low titer in the MCI test and is traced back to a dairy herd that is 100 percent vaccinated and has tested negative to the most recent brucellosis ring test required by this section for herds producing milk for sale.
(iii) Epidemiologic surveillance—(A) Adjacent herds. All adjacent herds or other herds having contact with cattle or bison in a herd known to be affected shall be placed under quarantine and have an approved individual herd plan in effect within 15 days after notification of brucellosis in the herd known to be affected;
(B) Epidemiologically traced herds. All herds from which cattle or bison are moved into a herd known to be affected and all herds which have received cattle or bison from a herd known to be affected shall be placed under quarantine and have an approved individual herd plan in effect within 15 days of locating the source herd or recipient herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(b) Herd infection rate—(1) Affected herds. Except as provided in paragraph (b)(4) of this definition, all cattle and bison herds in the State or area must remain free of Brucella abortus.
(2) Epidemiologic investigation. Within 15 days after notification by the cooperative State-Federal laboratory that brucellosis reactors have been found in any herd, State representatives or APHIS representatives shall investigate that herd to identify possible sources of brucellosis. All possible sources of brucellosis identified shall be contacted within an additional 15 days to determine appropriate action.
(3) Approved herd plans. All herds known to be affected shall have approved individual herd plans in effect within 15 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(4) Affected herd. If any herd in a Class Free State or area is found to be affected with brucellosis, the State or area may retain its Class Free status if it meets the conditions of this paragraph.
(i) The affected herd. (A) The affected herd must be quarantined immediately, and, within 60 days, tested for brucellosis and depopulated; or
(B) The affected herd must be quarantined immediately and tested for brucellosis as required by the Administrator until there is no evidence of brucellosis in the herd; and
(ii) Other herds. An epidemiological investigation must be performed within 60 days of the detection of an infected animal in a herd. All herds on premises adjacent to the affected herd (adjacent herds), all herds from which animals may have been brought into the affected herd (source herds), and all herds that may have had contact with or accepted animals from the affected herd (contact herds) must be epidemiologically investigated, and each of those herds must be placed under an approved individual herd plan. If the investigating epidemiologist determines that a herd blood test for a particular adjacent herd, source herd, or contact herd is not warranted, the epidemiologist must include that determination, and the reasons supporting it, in the individual herd plan.
(iii) APHIS review. After the close of the 60-day period following the date an animal in the herd is determined to be infected, APHIS will conduct a review to confirm that the requirements of paragraphs (b)(4)(i) and (b)(4)(ii) of this definition have been satisfied and that the State or area is in compliance with all other applicable provisions.
(c) Brucellosis management plans. (1) Any State in which the Administrator has determined wildlife are infected with B. abortus must develop and implement a brucellosis management plan approved by the Administrator. The existence of B. abortus in wildlife will be determined by the Administrator, based on, but not limited to, histopathology, testing data, or epidemiology. The Administrator may also require a Class Free State or area to develop and implement a brucellosis management plan under any other circumstances if the Administrator determines it is necessary to prevent the spread of brucellosis. The State must sign a memorandum of understanding (MOU) with the Administrator that describes its brucellosis management plan. The MOU must be updated annually. The Administrator may reclassify to a lower status any State or area that has not implemented an approved brucellosis management plan within 6 months of being required to develop one.
(2) The brucellosis management plan reflected in the MOU must:
(i) Define and explain the basis for the geographic area in which a disease risk exists from B. abortus and to which the brucellosis management plan activities apply;
(ii) Describe epidemiologic assessment and surveillance activities to identify occurrence of B. abortus in domestic livestock and wildlife and potential risks for spread of disease; and
(iii) Describe mitigation activities to prevent the spread of B. abortus from domestic livestock and/or wildlife, as applicable, within or from the brucellosis management area.
Commuter herd. A herd of cattle or bison moved interstate during the course of normal livestock management operations and without change of ownership directly between two premises, as provided in a commuter herd agreement.
Commuter herd agreement. A written agreement between the owner(s) of a herd of cattle or bison and the animal health officials for the States or Tribes of origin and destination specifying the conditions required for the interstate movement from one premises to another in the course of normal livestock management operations and specifying the time period, up to 1 year, that the agreement is effective. A commuter herd agreement may be renewed annually.
Complete herd test (CHT). An official swine brucellosis test of all swine on a premises that are 6 months of age or older and maintained for breeding purposes.
Confirmatory test. A follow-up test to verify any official test results. Confirmatory tests include the standard tube test, the Rivanol test, the complement fixation test (CF), the fluorescence polarization assay (FP assay), the particle concentration fluorescence immunoassay (PCFIA), the semen plasma test, and the standard plate test.
Dairy cattle. All cattle, regardless of age or sex or current use, that are of a breed(s) or offspring of a breed used to produce milk or other dairy products for human consumption, including, but not limited to, Ayrshire, Brown Swiss, Holstein, Jersey, Guernsey, Milking Shorthorn, and Red and Whites.
Designated epidemiologist. An epidemiologist selected by the State animal health official and the Veterinarian in Charge to perform the functions required. The regional epidemiologist and the APHIS brucellosis staff must concur in the selection and appointment of the designated epidemiologist.
Directly. Moved in a means of conveyance, without stopping to unload while en route, except for stops of less than 24 hours to feed, water or rest the animals being moved, and with no commingling of animals at such stops.
Epidemiologist. A veterinarian who has received a master's degree in epidemiology or completed a course of study in epidemiology sponsored by the Animal and Plant Health Inspection Service, United States Department of Agriculture.
Epidemiology. A branch of medical science that deals with the incidence, distribution, and control of disease in the animal population.
Farm of origin. (a) Premises where cattle or bison are born and remain prior to movement from the premises but which are not used to assemble cattle or bison from any other premises for 4 months before such movement; or
(b) Premises where cattle or bison remain for not less than 4 months immediately before movement from the premises but which are not used to assemble cattle or bison from any other premises for 4 months before such movement.
Feral swine. Free-roaming swine. Formerly free-roaming swine could qualify for reclassification as domestic swine upon testing negative to an official swine brucellosis test after a period of at least 60 days' confinement in isolation from other feral swine.
Finished fed cattle. Cattle fattened on a ration of feed concentrates to reach a slaughter condition equivalent to that which would be attained on full feed with a high concentrate grain ration for 90 days.
Herd. (a) All animals under common ownership or supervision that are grouped on one or more parts of any single premises (lot, farm, or ranch); or
(b) All animals under common ownership or supervision on two or more premises which are geographically separated but on which animals from the different premises have been interchanged or had contact with each other.
(c) For the purposes of this part, the term herd does not include animals that are contained within a federally approved research facility.
Herd blood test. A blood test for brucellosis conducted in a herd on all cattle and bison 18 months of age or older, except for steers and spayed heifers, and except when conducting herd blood tests as part of affected herd investigations or other epidemiological investigations or when the Administrator determines testing at a younger age is necessary to prevent the spread of brucellosis.
Herd known to be affected. Any herd in which any animal has been classified as a brucellosis reactor and which has not been released from quarantine.
Herd not known to be affected. Any herd in which no animal has been classified as a brucellosis reactor or any herd in which one or more animals have been classified as brucellosis reactors but which has been released from quarantine.
Herd of origin of swine. Any herd in which swine are farrowed and remain until movement or any herd in which swine remain for 30 days immediately prior to movement.
Interstate. From any State into or through any other State.
Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement.
(1) The ICVI must show:
(i) The species of animals covered by the ICVI;
(ii) The number of animals covered by the ICVI;
(iii) The purpose for which the animals are to be moved;
(iv) The address at which the animals were loaded for interstate movement;
(v) The address to which the animals are destined; and
(vi) The names of the consignor and the consignee and their addresses if different from the address at which the animals were loaded or the address to which the animals are destined.
(vii) Additionally, unless the species-specific requirements for ICVIs provide an exception, the ICVI must list the official identification number of each animal, except as provided in paragraph (2) of this definition, or group of animals moved that is required to be officially identified, or, if an alternative form of identification has been agreed upon by the sending and receiving States, the ICVI must include a record of that identification. If animals moving under a GIN also have individual official identification, only the GIN must be listed on the ICVI. An ICVI may not be issued for any animal that is not officially identified, if official identification is required. If the animals are not required by the regulations to be officially identified, the ICVI must state the exemption that applies (e.g., the cattle and bison do not belong to one of the classes of cattle and bison to which the official identification requirements of this part apply). If the animals are required to be officially identified but the identification number does not have to be recorded on the ICVI, the ICVI must state that all animals to be moved under the ICVI are officially identified.
(2) As an alternative to recording individual animal identification on an ICVI, if agreed to by the receiving State or Tribe, another document may be attached to provide this information, but only under the following conditions:
(i) The document must be a Tribal or State form or APHIS form that requires individual identification of animals, or a printout of official identification numbers generated by computer or other means;
(ii) A legible copy of the document must be attached to the original and each copy of the ICVI;
(iii) Each copy of the document must identify each animal to be moved with the ICVI. The document must not contain any information pertaining to other animals; and
(iv) The following information must be included in the identification column on the original and each copy of the ICVI:
(A) The name of the document; and
(B) Either the unique serial number on the document or both the name of the person who prepared the document and the date the document was signed.
Location-based number system. The location-based number system combines a State or Tribal issued location identification (LID) number or a premises identification number (PIN) with a producer's unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal.
Location identification (LID) number. A nationally unique number issued by a State, Tribal, and/or Federal animal health authority to a location as determined by the State or Tribe in which it is issued. The LID number may be used in conjunction with a producer's own unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may also be used as a component of a group/lot identification number (GIN).
Market cattle identification test cattle. Cows and bulls 18 months of age or over which have been moved to recognized slaughtering establishments, and test-eligible cattle which are subjected to an official test for the purposes of movement at farms, ranches, auction markets, stockyards, quarantined feedlots, or other assembly points. Such cattle must be identified with an official identification device as specified in § 86.4(a) of this chapter prior to or at the first market, stockyard, quarantined feedlot, or slaughtering establishment they reach.
Market swine test (MST) reactor. Market swine test swine with a positive reaction to a swine brucellosis confirmatory test or other official test, if no confirmatory test is performed.
Market swine test swine. Sows and boars which have been moved to slaughtering establishments and sows and boars which are subjected to an official test for the purposes of movement at farms, ranches, auction markets, stockyards, or other assembly points.
Monitored-negative feral swine population. Feral swine indicating no evidence of infection (indicators would include positive blood tests or clinical signs, such as abortion) and originating from a specified, geographically isolated area (a forest area, hunting preserve, or swamp, for example) may be classified by the designated epidemiologist as a monitored-negative feral swine population.
Moved. Shipped, transported, delivered, or received for movement, or otherwise aided, induced, or caused to be moved.
Moved (movement) in interstate commerce. Moved from the point of origin of the interstate movement to the animals' final destination, such as a slaughtering establishment or a farm for breeding or raising, and including any temporary stops for any purpose along the way, such as at a stockyard or dealer premises for feed, water, rest, or sale.
National Uniform Eartagging System (NUES). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal.
Official adult vaccinate. (a) Female cattle or female bison older than the specified ages defined for official calfhood vaccinate and vaccinated by an APHIS representative, State representative, or accredited veterinarian with a reduced dose approved brucella vaccine, diluted so as to contain at least 300 million and not more than 1 billion live cells per 2 mL dose of Brucella abortus Strain 19 vaccine or at the dosage indicated on the label instructions for other approved brucella vaccines, as part of a whole herd vaccination plan authorized jointly by the State animal health official and the Veterinarian in Charge; and
(b)(1) Permanently identified by a “V” hot brand high on the hip near the tailhead at least 5 by 5 centimeters (2 by 2 inches) in size, or by an official AV (adult vaccination) tattoo in the right ear preceded by the quarter of the year and followed by the last digit of the year; and
(2) Identified with an official eartag or individual animal registered breed association registration brand or individual animal registered breed association tattoo.
Official brand inspection certificate. A document issued by an official brand inspection agency in any State which requires such documents for movement of cattle or bison.
Official brand recording agency. The duly constituted body authorized by a State or governmental subdivision thereof to administer laws, regulations, ordinances or rules pertaining to the brand identification of cattle or bison.
Official calfhood vaccinate. (a) Female cattle or female bison vaccinated while from 4 through 12 months of age by an APHIS representative, State representative, or accredited veterinarian with a reduced dose approved brucella vaccine containing at least 2.7 billion and not more than 10 billion live cells per 2 mL dose of Brucella abortus Strain 19 vaccine or at the dosage indicated on the label instructions for other approved brucella vaccines; and
(b) Permanently identified by a tattoo and by an official vaccination eartag in the right ear. However, if already identified with an official eartag prior to vaccination, an additional tag is not required. The tattoo must include the U.S. Registered Shield and “V,” preceded by the quarter of the year and followed by the last digit of the year of vaccination. Individual animal registered breed association registration brands or individual animal registered breed association registration tattoos may be substituted for official eartags.
Official eartag. An identification tag approved by APHIS that bears an official identification number for individual animals. The design, size, shape, color, and other characteristics of the official eartag will depend on the needs of the users, subject to the approval of the Administrator. The official eartag must be tamper-resistant and have a high retention rate in the animal.
Official eartag shield. The shield-shaped graphic of the U.S. Route Shield with “U.S.” or the State postal abbreviation or Tribal alpha code imprinted within the shield.
Official identification number. A nationally unique number that is permanently associated with an animal or group of animals and that adheres to one of the following systems:
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Location-based number system.
(4) Flock-based number system.
(5) Any other numbering system approved by the Administrator for the official identification of animals.
Officially identified. Identified by means of an official identification device or method approved by the Administrator.
Official seal. A serially numbered, metal or plastic strip, consisting of a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged and which cannot be reused if opened, or a serially numbered, self-locking button which can be used for this purpose.
Official swine tattoo. A tattoo, conforming to the six-character alpha-numeric National Tattoo System, that provides a unique identification for each herd or lot of swine.
Official test—(a) Classification of cattle and bison—(1) Standard card test. (i) A test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS and the State in which the test is to be conducted and when conducted under the following circumstances:
(A) When conditions and time are such that no other test is available; or
(B) When the owner or the owner's agent requests it because of time or situation constraints; or
(C) In specifically approved stockyards when the State animal health official either:
(1) Designates the standard card test as the official test for determining the brucellosis disease status of cattle and bison in all specifically approved stockyards in the State. In these States, no other official test except the Buffered Acidified Plate Antigen test shall be used in specifically approved stockyards; or
(2) Designates the standard card test as the official test for determining the brucellosis disease status of non-vaccinated cattle or bison (the CITE ® test may be designated as a supplemental test for non-vaccinated cattle or bison that test positive to the standard card test); and designates the standard card test as the official test for determining the brucellosis disease status of official vaccinates and the CITE ® test, the standard plate test, or the Rivanol test as supplemental tests for official vaccinates that test positive to the standard card test. If supplemental tests are conducted, cattle or bison that are positive to the standard card test shall be classified as brucellosis suspects if all of the supplemental tests conducted disclose a negative or suspect reaction, and shall be classified as brucellosis reactors if any one of the supplemental tests conducted has a positive reaction; or
(D) To test market cattle identification (MCI) program test samples. Cattle and bison which test positive to the BAPA test or RST under the MCI program must be retested using the standard card test or the standard plate or tube agglutination test.
(ii) Results of the standard card test also may be used to supplement the results of other official tests conducted in the cooperative State-Federal laboratory to give the designated epidemiologist additional information when classifying cattle and bison.
(iii) Standard card test results are interpreted as either negative or positive. A moderate to marked clumping agglutination reaction is a positive result. Test-eligible cattle and bison positive to the standard card test are classified as brucellosis reactors. Test-eligible cattle and bison negative to the standard card test are classified as brucellosis negative.
(2) Standard tube test (STT) or standard plate test (SPT). A test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. Cattle and bison are classified according to the following agglutination reactions:
SPT OR STT Classification—Official Vaccinates Vaccinated With a Brucella Abortus Strain 19 Approved Brucella Vaccine
| Titer | Classification | ||
|---|---|---|---|
| 1:50 | 1:100 | 1:200 | |
| − | − | − | Negative. |
| I | − | − | Do. |
| + | − | − | Do. |
| + | I | − | Suspect. |
| + | + | − | Do. |
| + | + | I | Do. |
| + | + | + | Reactor. |
− No agglutination.
I Incomplete agglutination.
+ Complete agglutination.
Official Vaccinates Vaccinated With an Approved Brucella Vaccine Other Than a Brucella Abortus Strain 19 Approved Brucella Vaccine
| Titer | Classification | ||
|---|---|---|---|
| 1:50 | 1:100 | 1:200 | |
| − | − | − | Negative. |
| I | − | − | Suspect. |
| + | − | − | Do. |
| + | I | − | Do. |
| + | + | − | Reactor. |
| + | + | I | Do. |
| + | + | + | Do. |
− No agglutination.
I Incomplete agglutination.
+ Complete agglutination.
All Cattle and Bison Which Are Not Official Vaccinates
| Titer | Classification | ||
|---|---|---|---|
| 1:50 | 1:100 | 1:200 | |
| − | − | − | Negative. |
| I | − | − | Suspect. |
| + | − | − | Do. |
| + | I | − | Do. |
| + | + | − | Reactor. |
| + | + | I | Do. |
| + | + | + | Do. |
− No agglutination.
I Incomplete agglutination.
+ Complete agglutination.
(3) Manual complement-fixation (CF) test. A test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. Cattle and bison are classified according to the following reactions:
(i) Cattle and bison which are not official vaccinates:
(A) Fifty percent fixation (2 plus) in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 50 percent fixation (2 plus) in a dilution of 1:20—brucellosis suspect;
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative;
(ii) Official vaccinates vaccinated with a Brucella abortus Strain 19 approved brucella vaccine:
(A) Twenty-five percent fixation (1 plus) in a dilution of 1:40 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 25 percent fixation (1 plus) in a dilution of 1:40—brucellosis suspect;
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative.
(iii) Official vaccinates vaccinated with an approved brucella vaccine other than a Brucella abortus Strain 19 approved brucella vaccine:
(A) Fifty percent fixation (2 plus) in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 50 percent fixation (2 plus) in a dilution of 1:20—brucellosis suspect;
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative.
(4) Technicon automated complement-fixation test. A test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. Cattle and bison are classified according to the following reactions:
(i) Cattle and bison which are not official vaccinates:
(A) Fixation in a dilution of 1:10 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:5 but no fixation in a dilution of 1:10—brucellosis suspect;
(C) No fixation in a dilution of 1:5 or lower—brucellosis negative;
(ii) Official vaccinates vaccinated with a Brucella abortus Strain 19 approved brucella vaccine:
(A) Fixation in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:10 but no fixation in a dilution of 1:20—brucellosis suspect;
(C) Fixation in a dilution of 1:5 or less but no fixation in a dilution of 1:10—brucellosis negative.
(iii) Official vaccinates vaccinated with an approved brucella vaccine other than a Brucella abortus Strain 19 approved brucella vaccine:
(A) Fixation in a dilution of 1:10 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:5 but no fixation in a dilution of 1:10—brucellosis suspect;
(C) No fixation in a dilution of 1:5 or lower—brucellosis negative.
(5) Rivanol test. A test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. Cattle and bison are classified according to the following agglutination reactions:
(i) Cattle and bison which are not official vaccinates:
(A) Complete agglutination at a titer of 1:25 or higher—brucellosis reactor;
(B) Less than complete agglutination at a titer of 1:25—brucellosis negative;
(ii) Official adult vaccinates more than 5 months after vaccination with a Brucella abortus Strain 19 approved brucella vaccine and official calfhood vaccinates vaccinated with a Brucella abortus Strain 19 approved brucella vaccine:
(A) Incomplete agglutination at a titer of 1:100 or higher—brucellosis reactor;
(B) Complete agglutination at a titer of 1:25 or higher when the manual or technicon automated complement-fixation test is not conducted—brucellosis reactor;
(C) Complete agglutination at a titer of 1:50 or less when the manual complement-fixation test or the technicon automated complement-fixation test is conducted and results in a classification of brucellosis suspect or brucellosis negative—brucellosis suspect;
(D) Less than complete agglutination at a titer of 1:25—brucellosis negative;
(iii) Official adult vaccinates less than 5 months after vaccination with a Brucella abortus Strain 19 approved brucella vaccine: Less than complete agglutination at the 1:50 titer—brucellosis negative.
(iv) Official vaccinates vaccinated with an approved brucella vaccine other than a Brucella abortus Strain 19 approved brucella vaccine:
(A) Complete agglutination at a titer of 1:25 or higher—brucellosis reactor;
(B) Less than complete agglutination at a titer of 1:25—brucellosis negative.
(6) Semen plasma test. A test to determine the brucellosis disease status of bulls used for artificial insemination when conducted in conjunction with an official serological test and according to instructions approved by APHIS and the State in which the test is to be conducted. The classification of such bulls shall be based on the maximum agglutination titer of either the official serological test or the semen plasma test.
(7) Buffered acidified plate antigen (BAPA) test. A test to determine the brucellosis disease status of test-eligible cattle and bison at recognized slaughtering establishments and specifically approved stockyards when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. BAPA test results are interpreted as either negative or positive. Cattle and bison negative to the BAPA test are classified as brucellosis negative. Cattle and bison positive to the BAPA test shall be subjected to other official tests to determine their brucellosis classification.
(8) Rapid screening test (RST). A test to determine the brucellosis disease status of test-eligible cattle and bison in cooperative State-Federal laboratories when conducted according to instructions approved by APHIS and the State in which the test is to be conducted. RST results are interpreted as either negative or positive. Cattle and bison negative to the RST are classified as brucellosis negative. Cattle and bison positive to the RST shall be subjected to other official tests to determine their brucellosis classification.
(9) Concentration immunoassay technology (CITE ®) test. An enzyme immunoassay that may be used as a diagnostic supplement to the standard card test by designated epidemiologists determining the brucellosis disease status of cattle and bison. The test must be done in accordance with the CITE ® Brucella abortus Antibody Test Kit instructions, licensed by the United States Department of Agriculture and approved as of December 31, 1987, and incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from AgriTech Systems, Inc., 100 Fore Street, Portland, ME 04101. Copies may be inspected at the Animal and Plant Health Inspection Service, Veterinary Services, Operational Support, 4700 River Road Unit 33, Riverdale, Maryland 20737-1231, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(10) Particle concentration fluorescence immunoassay (PCFIA) test. An automated serologic test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS. Cattle and bison are classified according to the following ratio between the test sample and a known negative sample (S/N ratio):
| S/N ratio | Classification |
|---|---|
| Greater than .60 | Negative. |
| Greater than .30 but less than or equal to .60 | Suspect. |
| .30 or less | Positive. |
(11) D-Tec ® Brucella A test. An automated serologic test to determine the brucellosis disease status of test-eligible cattle and bison when conducted according to instructions approved by APHIS. The degree of reactivity is measured by the ratio of the average optical density of the sample to that of the Negative Control (S/N) and is expressed as Percent Inhibition (1-S/N) × 100. The brucellosis disease status of the animals is classified according to the following established criteria:
| Percent inhibition | Classification |
|---|---|
| Less than or equal to 40 percent | Negative. |
| Greater than 40 percent and less than or equal to 70 percent | Suspect. |
| Greater than 70 percent | Reactor. |
(12) Rapid Automated Presumptive (RAP) test. An automated serologic test to detect the presence of Brucella antibodies in test-eligible cattle and bison. RAP test results are interpreted as either positive or negative; the results are interpreted and reported by a scanning autoreader that measures alterations in light transmission through each test well and the degree of agglutination present. Cattle and bison negative to the RAP test are classified as brucellosis negative; cattle and bison positive to the RAP test shall be subjected to other official tests to determine their brucellosis disease classification.
(13) Fluorescence polarization assay (FP assay). An automated serologic test to determine the brucellosis status of test-eligible cattle and bison when conducted according to instructions approved by APHIS. FP assays are interpreted as either positive, negative, or suspect. A 10-microliter sample is used. If a sample reads <10 millipolarization units (mP) above the mean negative control, the sample is considered negative. If a sample reads >20 mP above the mean negative control, the sample is considered positive. Samples that read between 10 and 20 mP above the negative control mean should be retested using 20 microliters of sample. If the 20-microliter sample is >20 mP above the mean negative control, the sample is considered positive. If the 20-microliter sample is still in the 10 to 20 mP range above the mean negative control, the sample is considered suspect. If the 20-microliter sample is <10 mP above the mean negative control, the sample is considered negative. Cattle and bison negative to the FP assay are classified as brucellosis negative. Cattle and bison with positive FP assay results are classified as brucellosis reactors, while cattle and bison with suspect FP assay results are classified as brucellosis suspects.
(14) The evaluation of test results for all cattle and bison shall be the responsibility of a designated epidemiologist in each State. The designated epidemiologist shall consider the animal and herd history and other epidemiologic factors when determining the brucellosis classification of cattle and bison. Deviations from the brucellosis classification criteria as provided in this definition of official test are acceptable when made by the designated epidemiologist.
(i) The designated epidemiologist may consider the results of CITE ® tests when evaluating the results of standard card tests of cattle and bison.
(b) Classification of swine—(1) Standard card test. A test to determine the brucellosis disease status of swine. Standard card test results are interpreted as either negative or positive. A moderate to marked clumping agglutination reaction is a positive result. Swine negative to the standard card test are classified as brucellosis negative. Swine positive to the standard card test in a herd not known to be affected but negative to any other official test or bacteriological culture for brucella are classified as brucellosis suspects. Other swine positive to the standard card test are classified as brucellosis reactors.
(2) Standard tube test. A test to determine the brucellosis disease status of swine.
(i) If all of the following apply: (A) The swine are part of a herd not known to be affected; (B) No swine tested, individually or as part of a group, has a complete agglutination reaction at a dilution of 1:100 or higher; and (C) the swine are tested as part of a herd blood test or are part of a validated brucellosis-free herd, then the swine are classified according to the following agglutination reactions:
| Titer | Classification | ||
|---|---|---|---|
| 1:25 | 1:50 | 1:100 | |
| I | ]— | − | Negative. |
| + | − | − | Do. |
| + | I | − | Do. |
| + | + | − | Do. |
| + | + | I | Do. |
− No agglutination.
I Incomplete agglutination.
+ Complete agglutination.
(ii) If any of the following apply: (A) The swine are part of a herd known to be affected; (B) Any swine tested, individually or as part of a group, has a complete agglutination reaction at a dilution of 1:100 or higher or; (C) The swine are not part of a validated brucellosis-free herd and are not being tested as part of a herd blood test, then the swine are classified according to the following agglutination reactions:
| Titer | Classification | ||
|---|---|---|---|
| 1:25 | 1:50 | 1:100 | |
| I | − | − | Negative. |
| + | − | − | Reactor. |
| + | I | − | Do. |
| + | + | − | Do. |
| + | + | I | Do. |
| + | + | + | Do. |
− No agglutination.
I Incomplete agglutination.
+ Complete agglutination.
(3) Particle concentration fluoresence immunoassay (PCFIA). An automated serologic test to determine the brucellosis disease status of test-eligible swine when conducted according to instructions approved by the Animal and Plant Health Inspection Service. Swine are classified according to the following ratios between the test sample and a known negative sample (S/N ratio):
| S/N Ratio | Classification |
|---|---|
| 0.71 or greater | Negative. |
| 0.51 to 0.70 | Suspect. |
| 0.50 or less | Reactor. |
(4) Rapid Automated Presumptive (RAP) test. An automated serologic test to detect the presence of Brucella antibodies in test-eligible swine. RAP test results are interpreted as either positive or negative; the results are interpreted and reported by a scanning autoreader that measures agglutination based on alterations in light transmission through each test well. Swine negative to the RAP test are classified as brucellosis negative; swine positive to the RAP test shall be subjected to other official tests to determine their brucellosis disease classification.
(5) Fluorescence polarization assay (FP assay). An automated serologic test to determine the brucellosis status of test-eligible swine when conducted according to instructions approved by APHIS. FP assays are interpreted as either positive, negative, or suspect. A 40-microliter sample is used. If a sample reads <10 millipolarization units (mP) above the mean negative control, the sample is considered negative. If a sample reads >20 mP above the mean negative control, the sample is considered positive. Samples that read between 10 and 20 mP above the negative control mean must be retested using 40 microliters of sample. If the 40-microliter sample is >20 mP above the mean negative control, the sample is considered positive. If the 40-microliter sample is still in the 10 to 20 mP range above the mean negative control, the sample is considered suspect. If the 40-microliter sample is <10 mP above the mean negative control, the sample is considered negative. Swine with negative FP assay results are classified as brucellosis negative. Swine with positive FP assay results are classified as brucellosis reactors, while swine with suspect FP assay results are classified as brucellosis suspects.
(6) The evaluation of test results for all swine shall be the responsibility of a designated epidemiologist in each State. The designated epidemiologist shall consider the animal and herd history and other epidemiologic factors when determining the brucellosis classification of swine. Deviations from the brucellosis classification criteria as provided in this definition of official test are acceptable when made by the designated epidemiologist.
Official vaccinate. An official calfhood vaccinate or an official adult vaccinate. The accredited veterinarian, State representative or APHIS representative who performs the vaccination must forward a completed official vaccination certificate for each animal vaccinated to the State animal health official of the State in which the animal was vaccinated.
Official vaccination eartag. An APHIS approved identification eartag conforming to the alpha-numeric National Uniform Eartagging System which provides unique identification for each animal. The eartag shall have a “V” followed by 2 letters and 4 numbers. States which require more official vaccination eartags than the number of combinations available in the “V” series of tags shall use a “T” or “S” followed by 2 letters and 4 numbers. Duplicate reissue of official vaccination eartags shall not be made more often than once each 15 years.
Originate. (a) Animals will have the status of the herd from which they are moved if:
(1) They were born and maintained in the herd since birth; or
(2) They have been in the herd for at least 120 days.
(b) Animals will have the status of the State or area from which they are moved if:
(1) They were born and maintained in the State or area since birth; or
(2) They were previously moved from a State or area of equal or higher class to the State or area; or
(3) They were previously moved from a State or area of lower class to the State or area where they are now located and have been in the new State or area for at least 120 days.
(c) Cattle or bison penned in a specifically approved stockyard with cattle or bison from a lower class State or area, in violation of the requirements set forth in § 71.20 of this chapter, shall have the status of the State or area of lower class for any subsequent movement.
Parturient. Visibly prepared to give birth or within 2 weeks of giving birth (springers).
Permit. An official document (VS Form 1-27 or a State form which contains the same information but not a “permit for entry” or “ ‘S’ brand permit”) issued by an APHIS representative, State representative, or accredited veterinarian which lists the owner's name and address, points of origin and destination, number of animals covered, purpose of the movement, any reactor tag number, and one of the following: The official eartag number, individual animal registered breed association registration tattoo, individual animal registered breed association registration brand, United States Department of Agriculture backtag (when applied serially, only the beginning and the ending numbers need be recorded), individual animal registered breed association registration number, or similar individual identification. (A new permit is required for each change in destination. However, permits accompanying cattle or bison to an approved intermediate handling facility may list either the approved intermediate handling facility, a quarantined feedlot or a recognized slaughtering establishment as the point of destination. If the permit lists a quarantined feedlot or a recognized slaughtering establishment as the point of destination, then the permit must list the approved intermediate handling facility as a temporary stopping point, and no additional permit is required for the subsequent movement of the cattle or bison to the quarantined feedlot or to the recognized slaughtering establishment.)
Permit for entry. A premovement authorization for entry of cattle into a State from the State animal health official of the State of destination. It may be oral or written.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company or other legal entity.
Postparturient. Having given birth.
Purebred registry association. A swine breed association formed and perpetuated for the maintenance of records of purebreeding of swine species for a specific breed whose characteristics are set forth in Constitutions, By-Laws, and other rules of the association.
Qualified herd—(a) Qualification. (1) Any herd of cattle or bison which is in a quarantined area, not known to be affected, and negative to two consecutive herd blood tests. The first of these two herd blood tests shall be conducted not more than 240 days nor less than 120 days prior to the date of classification as a qualified herd. The second herd blood test may not be conducted less than 90 days nor more than 150 days after the first test. Additionally, the second herd blood test must be within 120 days of the date of classification as a qualified herd; or
(2) Any certified brucellosis-free herd in a quarantined area which is negative to a herd blood test 120 days before or after designation of the area as a quarantined area.
(b) Requalification. In order to remain a qualified herd, a herd must be negative to successive requalifying herd blood tests. Each requalifying test shall be conducted not more than 120 days from the date of the preceding herd blood test. All cattle or bison added to a qualified herd must be included in two successive herd blood tests of the qualified herd to qualify as cattle or bison from the qualified herd.
Quarantined area. An area that does not meet the criteria for classification as Class Free, Class A, Class B, or Class C.
Quarantined feedlot.
(a) All cattle and bison, except steers and spayed heifers, leaving the quarantined feedlot must (1) Be accompanied by a permit and move directly to a recognized slaughtering establishment; or (2) Be “S” branded and accompanied by an “S” brand permit and move directly to an approved intermediate handling facility and then directly to another quarantined feedlot or a recognized slaughtering establishment; or (3) Be accompanied by a permit issued by the State animal health official and move directly to another quarantined feedlot; or (4) After being “S” branded at the quarantined feedlot, be accompanied by an “S” brand permit and move directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and bison and then directly to a recognized slaughtering establishment or another quarantined feedlot; or (5) After being “S” branded at the quarantined feedlot, be accompanied by an “S” brand permit and move directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and bison and then directly to an approved intermediate handling facility and then directly to another quarantined feedlot or a recognized slaughtering establishment. However, finished fed cattle moving directly to a recognized slaughtering establishment are exempt from the permit/”S” brand permit requirement.
(b) The State animal health official and the Veterinarian in Charge shall establish procedures for accounting for all cattle and bison entering or leaving quarantined feedlots.
Quarantined pasture. A confined grazing area under State quarantine approved by the State animal health official, Veterinarian in Charge and the Administrator. A justification of the need for the quarantined pasture must be prepared by the State animal health official and/or Veterinarian in Charge and submitted to the Administrator. An intensified brucellosis eradication effort which produces large numbers of brucellosis exposed cattle or bison or official adult vaccinates needing the grazing period to reach slaughter condition would be an acceptable justification. Approval will be granted only after a State representative or APHIS representative inspects the confined grazing area and determines that all cattle and bison are secure and isolated from contact with all other cattle and bison, that there are facilities for identifying the cattle and bison, and that there is no possibility of brucellosis being mechanically transmitted from the confined grazing area. The quarantined pasture shall be for utilizing available forage for growth or to improve flesh condition of cattle or bison. No cattle or bison may be moved interstate into these quarantined pastures, which shall be restricted for use by cattle or bison originating within the State. All cattle or bison shall be of the same sex, except that neutered cattle and bison may share the quarantined pasture. All cattle and bison, except steers and spayed heifers, must be “S” branded upon entering the quarantined pasture. All cattle and bison, except steers and spayed heifers, leaving the quarantined pasture must move directly to a recognized slaughtering establishment or quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment. The movement shall be in accordance with established procedures for handling brucellosis exposed cattle and bison, including issuance of “S” brand permits prior to movement. The State animal health official and Veterinarian in Charge shall establish procedures for accounting for all cattle and bison entering and leaving the quarantined pasture. All brucellosis exposed cattle and bison must vacate the premises on or before the expiration of approval, which may not last longer than 10 months.
Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts that is approved in accordance with 9 CFR 71.21.
Rodeo cattle. Cattle used at rodeos or competitive events.
“S” branded. Branding with a hot iron the letter “S” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size.
“S” brand permit. A document prepared at the point of origin which lists the points of origin and destination, the number of animals covered, the purpose of movement, and one of the following: The official eartag number, individual animal registered breed association registration tattoo, individual animal registered breed association registration brand, individual animal registered breed association registration number, United States Department of Agriculture backtag (when applied serially, only the beginning and the ending numbers need be recorded), or similar individual identification. If the document is prepared at a quarantined feedlot, it shall be prepared by an accredited veterinarian, a State representative, or an individual designated for that purpose by the State animal health official. If the document is prepared at any other point of origin, it shall be prepared by an accredited veterinarian, State representative, or APHIS representative. (A new “S” brand permit is required for each change in destination. However, “S” brand permits accompanying cattle or bison to approved intermediate handling facilities may list either the approved intermediate handling facility, a quarantined feedlot, or a recognized slaughtering establishment as the point of destination. If the “S” brand permit lists a quarantined feedlot or a recognized slaughtering establishment as the point of destination, the “S” brand permit must list the approved intermediate handling facility as a temporary stopping point, and no additional “S” brand permit is required for the subsequent movement of the cattle or bison from the approved intermediate handling facility to the quarantined feedlot or to the recognized slaughtering establishment. Subsequent movements from the quarantined feedlot shall be subject to requirements set forth in the definition of “quarantined feedlot” in this section.)
Sow. A female swine which is parturient or postparturient.
Specifically approved stockyard.
State. Any State, the District of Columbia, Puerto Rico, the Virgin Islands of the United States, Guam, the Northern Mariana Islands or any other territory or possession of the United States.
State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.
State representative. An individual employed in animal health work by a State or a political subdivision thereof and authorized by such State or political subdivision to perform the function involved under a memorandum of understanding with the United States Department of Agriculture.
Successfully closed case. Follow up of an MCI reactor traceback with an epidemiologic investigation which results in brucellosis testing or quarantine of the herd of origin, or a determination by a designated brucellosis epidemiologist that justification exists for not testing or quarantining the herd of origin.
Swine brucellosis. The communicable disease of swine caused by Brucella suis (B. suis) biovar 1 or 3.
Test-eligible cattle and bison. For purposes of interstate movement, test-eligible cattle and bison are:
(a) Cattle and bison which are not official vaccinates and which have lost their first pair of temporary incisors (18 months of age or over), except steers and spayed heifers;
(b) Official calfhood vaccinates 18 months of age or over which are parturient or postparturient;
(c) Official calfhood vaccinates of beef breeds or bison with the first pair of permanent incisors fully erupted (2 years of age or over); and
(d) Official calfhood vaccinates of dairy breeds with partial eruption of the first pair of permanent incisors (20 months of age or over).
United States. All of the States.
United States Department of Agriculture backtag. A backtag issued by APHIS that provides unique identification for each animal.
Validated brucellosis-free herd. (a) A swine herd not known to be infected with swine brucellosis, located in a validated brucellosis-free State; or
(b) A swine herd in a State that has not been validated as brucellosis-free, provided the herd meets the conditions for validation, as follows:
(1) Validation. A swine herd may be validated as brucellosis-free if it has been found brucellosis negative after either a complete-herd test (CHT) or an incremental CHT. The incremental CHT may be conducted by testing all breeding swine 6 months of age or older with negative results within 365 days, either in four 25-percent increments, with those tests being conducted on the 90th, 180th, 270th, and 360th days of the testing cycle, or in 10-percent increments every 25-35 days until 100 percent of those swine have been tested. In cases where unforeseen circumstances warrant such action, the Administrator may approve an extension of up to 15 days of the date on which a test under the 25-percent incremental herd test is to be conducted, thus allowing a test to be conducted no later than the 105th, 195th, 285th, or 375th day of the testing cycle. No swine may be tested twice during the testing cycle to comply with either the 25 percent requirement or the 10 percent requirement. No further testing is required once 100 percent of the breeding swine have been tested. After all breeding swine have tested brucellosis negative, a herd may be validated as brucellosis-free. Unless the Administrator has approved an alternative testing schedule, which might extend the testing cycle, a herd retains validated brucellosis-free status for a maximum of 365 days.
(2) Maintaining validation. Validation may be continuously maintained if a complete herd test (CHT) is performed once every 365 days, with negative results, or an incremental CHT is performed. The incremental CHT may be conducted by testing all breeding swine 6 months of age or older, with negative results, within 365 days in either four 25-percent increments, with those tests being conducted on the 90th, 180th, 270th, and 360th days of the testing cycle, or in 10-percent increments every 25-35 days until 100 percent of those swine have been tested. In cases where unforeseen circumstances warrant such action, the Administrator may approve an alternative testing schedule under which the 25 percent or 10 percent incremental CHT would be completed, with negative results, within 420 days, during which time the herd's validated brucellosis-free status would be continued. No swine may be tested twice during the testing cycle to comply with these requirements. No further testing is required once 100 percent of the breeding swine have been tested.
Validated brucellosis-free State. A State may apply for validated-free status when:
(a) Any herd found to have swine brucellosis during the 2-year qualification period preceding the application has been depopulated. More than one finding of a swine brucellosis-infected herd during the qualification period disqualifies the State from validation as brucellosis-free; and
(b) During the 2-year qualification period, the State has completed surveillance, annually, as follows:
(1) Complete herd testing. Subjecting all swine in the State that are 6 months of age or older and maintained for breeding purposes to an official swine brucellosis test; or
(2) Market swine testing. Subjecting 20 percent of the State's swine 6 months of age or older and maintained for breeding purposes to an official swine brucellosis test, and demonstrating successful traceback of at least 80 percent of market swine test (MST) reactors to the herd of origin. Blood samples may be collected from MST swine if the swine can be identified to their herd of origin, in accordance with § 71.19(b) of this subchapter. All MST reactor herds are subject to a CHT within 30 days of the MST laboratory report date, as determined by a designated epidemiologist; or
(3) Statistical analysis. Demonstrating, by a statistical analysis of all official swine brucellosis test results (including herd validation, MST, change-of-ownership, diagnostic) during the 2-year qualification period, a surveillance level equivalent or superior to CHT and MST testing programs discussed in this paragraph.
(c) To maintain validation, a State must annually survey at least 5 percent of its breeding swine, and demonstrate traceback to herd of origin of at least 80 percent of all MST reactors. A State must demonstrate its continuing ability to meet the criteria set forth in paragraph (c) of this definition within 36-40 months of receiving validated brucellosis-free State status to retain that status.
Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.
Whole herd vaccination. The vaccination of all female cattle and female bison 4 months of age or over in a herd when authorized by the State animal health official and the Veterinarian in Charge, and conducted in accordance with the definitions of official adult vaccinate and official calfhood vaccinate.
(a) Any ICVI, other interstate movement document used in lieu of an ICVI, permit, or “S” brand permit required by this part for the interstate movement of animals shall be delivered to the person moving the animals by the shipper or shipper's agent at the time the animals are delivered for movement and shall accompany the animals to their destination and be delivered to the consignee or the person receiving the animals.
(b) The APHIS representative, State representative, Tribal representative, or accredited veterinarian issuing an ICVI or other interstate movement document used in lieu of an ICVI or a permit, except for permits for entry and “S” brand permits, that is required for the interstate movement of animals under this part shall forward a copy of the ICVI, other interstate movement document used in lieu of an ICVI, or permit to the State animal health official of the State of origin within 5 working days. The State animal health official of the State of origin shall forward a copy of the ICVI, other interstate movement document used in lieu of an ICVI, or permit to the State animal health official of the State of destination within 5 working days.
Cattle and bison moving interstate, except cattle and bison moved directly to a recognized slaughtering establishment, approved intermediate handling facility, or quarantined feedlot, shall be moved only in a means of conveyance which has been cleaned in accordance with §§ 71.5, 71.7, 71.10, and 71.11 of this chapter and, if unloaded in the course of such movement, shall be handled only in pens cleaned in accordance with the provisions of §§ 71.4, 71.7, 71.10, and 71.11 of this chapter.
Cattle may not be moved interstate except in compliance with this subpart and with 9 CFR part 86. Cattle moved interstate under permit in accordance with this subpart are not required to be accompanied by an interstate certificate of veterinary inspection or owner-shipper statement.
Steers and spayed heifers may be moved interstate in accordance with 9 CFR part 86 and without further restriction under this subpart.
(a) Destination. Brucellosis reactor cattle may be moved interstate only for immediate slaughter as follows:
(1) Directly to a recognized slaughtering establishment;
(2) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(3) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis reactors and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b) Identification. Brucellosis reactor cattle must be individually identified prior to moving interstate by attaching to the left ear a metal tag bearing a serial number and the inscription “U.S. Reactor,” or a metal tag bearing a serial number designated by the State animal health official for identifying brucellosis reactors, and must be:
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(c) Permit. Brucellosis reactor cattle moving interstate shall be accompanied to destination by a permit.
(d) Marking of records. Each person moving brucellosis reactor cattle interstate shall, in the course of interstate movement, plainly write or stamp the words “Brucellosis Reactor” upon the face of any document that person prepares in connection with such movement.
(e) Segregation en route. Brucellosis reactor cattle shall not be moved interstate in any means of conveyance containing animals which are not brucellosis reactors unless all the animals are for immediate slaughter or unless the brucellosis reactor cattle are kept separate from the other animals by a partition securely affixed to the sides of the means of conveyance.
Brucellosis exposed cattle may be moved interstate only as follows:
(a) Movement to recognized slaughtering establishments. (1) Finished fed cattle from a quarantined feedlot may be moved interstate
(i) Directly to a recognized slaughtering establishment without further restriction under this part; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if accompanied by a permit or “S” brand permit.
(2) Brucellosis exposed cattle may be moved interstate directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Accompanied directly to slaughter by an APHIS or State representative; or
(E) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(3) Brucellosis exposed cattle may be moved interstate directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(4) Brucellosis exposed cattle moving to slaughter from a farm of origin may be moved directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(5) Brucellosis exposed cattle moving to slaughter from a farm of origin may be moved directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(b) Movement to quarantined feedlots. Brucellosis exposed cattle for which no claim for indemnity is being made by the owner under part 51 of this chapter may be moved interstate directly to a quarantined feedlot, or from a farm of origin directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to a quarantined feedlot, or from a farm of origin directly to an approved intermediate handling facility and then directly to a quarantined feedlot, or from a farm of origin directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are:
(1) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(2) Accompanied by a permit or “S” brand permit; and
(3)(i) “S” branded before leaving the premises from which they are to be moved interstate; or
(ii) Official adult vaccinates; or
(iii) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(c) Movement other than in accordance with paragraphs (a) and (b) of this section. Brucellosis exposed cattle for which no claim for indemnity is being made by the owner under part 51 of this chapter also may be moved interstate in accordance with § 78.10 and as follows:
(1) Such brucellosis exposed cattle from herds known to be affected other than female cattle which originate in Class B States or areas or Class C States or areas may be moved interstate if the cattle are:
(i) Under 6 months of age and weaned from brucellosis reactors or brucellosis exposed cows not less than 30 days immediately preceding interstate movement; or
(ii) Under 6 months of age and nursing brucellosis exposed cows in a herd subjected to a herd blood test within 10 days prior to interstate movement; or
(iii) Official vaccinates under 1 year of age from a herd following an approved individual herd plan.
(2) Cattle moved interstate from a farm of origin directly to a specifically approved stockyard in accordance with § 78.9(b)(3)(iii), 78.9(c)(3)(iii), or 78.9(d)(3) of this part and subsequently determined to be brucellosis exposed may be moved interstate directly back to the farm of origin under the following conditions:
(i) Prior to interstate movement, State representatives of the State in which the cattle are located and the State of destination advise APHIS that such movement would not be contrary to the laws and regulations of their respective States;
(ii) Prior to interstate movement, the State representative of the State of destination agrees to quarantine the cattle on arrival and to require that all test-eligible cattle on the farm of origin be subjected to an official test; and
(iii) The cattle are accompanied to the farm of origin by a permit.
Male cattle which are not test eligible and are from herds not known to be affected may be moved interstate without further restriction under this subpart. Female cattle which are not test eligible and are from herds not known to be affected may be moved interstate only in accordance with § 78.10 of this part and this section. Test-eligible cattle which are not brucellosis exposed and are from herds not known to be affected may be moved interstate only in accordance with § 78.10 and as follows:
(a) Class Free States/areas. Test-eligible cattle which originate in Class Free States or areas, are not brucellosis exposed, and are from a herd not known to be affected may be moved interstate from Class Free States or areas only as specified below:
(1) Movement to recognized slaughtering establishments. (i) Such cattle may be moved interstate directly to a recognized slaughtering establishment or directly to a specifically approved stockyard and then directly to a recognized slaughtering establishment without restriction under this subpart.
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if accompanied by a permit.
(iii) Such cattle may be moved interstate from other than a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if such cattle are accompanied by a permit.
(2) Movement to quarantined feedlots. Such cattle may be moved interstate without restriction under this subpart directly to a quarantined feedlot, or directly to a specifically approved stockyard and then directly to a quarantined feedlot, or directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot.
(3) Movement other than in accordance with paragraphs (a)(1) and (2) of this section. Such cattle may be moved interstate other than in accordance with paragraphs (a)(1) and (2) of this section only if:
(i) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard; or
(ii) Such cattle are moved interstate as part of a commuter herd in accordance with a commuter herd agreement or other documents as agreed to by the shipping and receiving States or Tribes.
(iii) Such cattle are moved interstate accompanied by an ICVI which states, in addition to the items specified in § 78.1, that the cattle originated in a Class Free State or area.
(b) Class A States/areas. Test-eligible cattle which originate in Class A States or areas, are not brucellosis exposed, and are from a herd not known to be affected may be moved interstate from Class A States or areas only as specified below:
(1) Movement to recognized slaughtering establishments. (i) Such cattle may be moved interstate from a farm of origin or nonquarantined feedlot directly to a recognized slaughtering establishment or directly to a specifically approved stockyard and then directly to a recognized slaughtering establishment without restriction under this subpart.
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without restriction under this subpart.
(iii) Such cattle from other than a farm of origin or nonquarantined feedlot may be moved interstate directly to a recognized slaughtering establishment or directly to a specifically approved stockyard and then directly to a recognized slaughtering establishment if identity to the Class A State or area is maintained by means of identification tag numbers appearing on sale records showing the consignor or by penning cattle from the farm or State or area apart from other animals.
(iv) Such cattle from other than a farm of origin may be moved interstate accompanied by a permit.
(A) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(B) Directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(2) Movement to quarantined feedlots. (i) Such cattle may be moved interstate from a farm of origin directly to a quarantined feedlot, or directly to a specifically approved stockyard and then directly to a quarantined feedlot, or directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the identity of the farm of origin of the cattle is maintained by means of identification tag numbers appearing on sale records showing the consignor or by penning cattle from the farm of origin apart from other animals.
(ii) Such cattle from other than a farm of origin may be moved interstate directly to a quarantined feedlot or directly to a specifically approved stockyard and then directly to a quarantined feedlot if identity to the Class A State or area is maintained by means of identification tag numbers appearing on sale records showing the consignor or by penning cattle from one farm or State or area apart from other animals.
(3) Movement other than in accordance with paragraphs (b)(1) and (2) of this section. Such cattle may be moved interstate other than in accordance with paragraphs (b)(1) and (2) of this section only if:
(i) Such cattle originate in a certified brucellosis-free herd and are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, that the cattle originated in a certified brucellosis-free herd; or
(ii) Such cattle are negative to an official test within 30 days prior to such interstate movement and are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard and are subjected to an official test upon arrival at the specifically approved stockyard prior to losing their identity with the farm of origin; or
(iv) Such cattle are moved as part of a commuter herd in accordance with a commuter herd agreement or other documents as agreed to by the shipping and receiving States or Tribes..
(c) Class B States/areas. Test-eligible cattle which originate in Class B States or areas, are not brucellosis exposed, and are from a herd not known to be affected may be moved interstate from Class B States or areas only under the conditions specified below:
(1) Movement to recognized slaughtering establishments. (i) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a recognized slaughtering establishment without further restriction under this subpart.
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without further restriction under this subpart.
(iii) Such cattle may be moved interstate from a nonquarantined feedlot directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if they are accompanied by a permit or “S” brand permit.
(iv) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied to slaughter by an ICVI or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are moved from the specifically approved stockyard accompanied by an “S” brand permit and in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(v) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(vi) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by an ICVI or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or by an individual authorized for this purpose by an APHIS representative.
(vii) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to an approved intermediate handling facility and then directly to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(2) Movement to quarantined feedlots. (i) Such cattle may be moved interstate from a farm of origin directly to:
(A) A quarantined feedlot if such cattle are “S” branded upon arrival at the quarantined feedlot; or
(B) A specifically approved stockyard and then directly to a quarantined feedlot or directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the specifically approved stockyard and are accompanied to the quarantined feedlot by an “S” brand permit; or
(C) An approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the approved intermediate handling facility and are accompanied to the quarantined feedlot by an “S” brand permit; or
(D) A quarantined feedlot, a specifically approved stockyard and then directly to a quarantined feedlot, or an approved intermediate handling facility and then directly to a quarantined feedlot if the cattle are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(ii) Such cattle from other than a farm of origin may be moved interstate to a quarantined feedlot if:
(A) They are negative to an official test within 30 days prior to such movement and are accompanied by an ICVI which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a quarantined feedlot; or
(C) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(3) Movement other than in accordance with paragraphs (c)(1) and (2) of this section. Such cattle may be moved interstate other than in accordance with paragraphs (c)(1) and (2) of this section only if:
(i) Such cattle originate in a certified brucellosis-free herd and are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, that the cattle originated in a certified brucellosis-free herd; or
(ii) Such cattle are negative to an official test within 30 days prior to interstate movement, have been issued a permit for entry, and are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard and are subjected to an official test upon arrival at the specifically approved stockyard prior to losing their identity with the farm of origin; or
(iv) Such cattle are moved interstate as part of a commuter herd in accordance with a commuter herd agreement or other documents as agreed to by the shipping and receiving States or Tribes, and
(A) The cattle being moved originate from a herd in which:
(1) All the cattle were negative to a herd blood test within 1 year prior to the interstate movement;
(2) Any cattle added to the herd after such herd blood test were negative to an official test within 30 days prior to the date the cattle were added to the herd;
(3) None of the cattle in the herd have come in contact with any other cattle; and
(B) The cattle are accompanied interstate by a document which states the dates and results of the herd blood test and the name of the laboratory in which the official tests were conducted.
(v) The State animal health officials of the State of origin and State of destination may waive the requirements of paragraph (c)(3)(iv) of this section in writing.
(d) Class C States/areas. All female cattle and test-eligible male cattle which originate in Class C States or areas, are not brucellosis exposed, and are from a herd not known to be affected may be moved interstate from Class C States or areas only under the conditions specified below:
(1) Movement to recognized slaughtering establishments. (i) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a recognized slaughtering establishment without further restriction under this subpart.
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without further restriction under this subpart.
(iii) Such cattle may be moved interstate from a nonquarantined feedlot directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if they are accompanied by a permit or “S” brand permit.
(iv) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by an ICVI or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are moved from the specifically approved stockyard accompanied by an “S” brand permit and in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(v) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(vi) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by an ICVI or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or by an individual authorized for this purpose by the APHIS representative.
(vii) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to an approved intermediate handling facility and then directly to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(2) Movement to quarantined feedlots. (i) Such cattle may be moved interstate from a farm of origin directly to:
(A) A quarantined feedlot if such cattle are “S” branded upon arrival at the quarantined feedlot; or
(B) A specifically approved stockyard and then directly to a quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the specifically approved stockyard and are accompanied to the quarantined feedlot by an “S” brand permit; or
(C) An approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the approved intermediate handling facility and are accompanied to the quarantined feedlot by an “S” brand permit; or
(D) A quarantined feedlot, a specifically approved stockyard and then directly to a quarantined feedlot, or an approved intermediate handling facility and then directly to a quarantined feedlot if the cattle are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(ii) Such cattle from other than a farm of origin may be moved interstate to a quarantined feedlot if:
(A) They are negative to an official test within 30 days prior to such movement and are accompanied by an ICVI which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a quarantined feedlot; or
(C) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(3) Movement other than in accordance with paragraphs (d)(1) or (2) of this section. Such cattle may be moved interstate other than in accordance with paragraphs (d)(1) or (2) of this section only if such cattle originate in a certified brucellosis-free herd and are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, that the cattle originated in a certified brucellosis-free herd.
(a) Female dairy cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move interstate into or out of a Class B State or area
(b) Female cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move into a Class C State or area
(c) Female cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move interstate out of a Class C State or area
Cattle, except brucellosis reactors and brucellosis exposed cattle, which are moved interstate to a specifically approved stockyard but fail to comply with the requirements of this part for release from the specifically approved stockyard may be moved from the specifically approved stockyard only as follows:
(a) With the concurrence of the State animal health officials of the State of origin and State of destination, directly back to the farm of origin accompanied by a permit; or
(b) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if such cattle are “S” branded and accompanied by an “S” brand permit; or
(c) Directly to a recognized slaughtering establishment if such cattle are
(1) “S” branded and accompanied by an “S” brand permit; or
(2) Accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(d) Directly to a quarantined feedlot if such cattle are “S” branded and accompanied by an “S” brand permit.
Not withstanding any provisions in the regulations to the contrary, cattle may be moved interstate from a quarantined area only in accordance with § 78.10, 9 CFR part 86, and this section.
(a) Steers and spayed heifers. Steers and spayed heifers may be moved interstate without further restriction under this section.
(b) Brucellosis reactor cattle. Brucellosis reactor cattle may be moved interstate in accordance with § 78.7.
(c) Brucellosis exposed cattle. Brucellosis exposed cattle may be moved interstate in accordance with § 78.8(a) or (b).
(d) Movement from qualified herds. Cattle from qualified herds in any quarantined area may be moved interstate only as follows:
(1) Movement to recognized slaughtering establishments. (i) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to a recognized slaughtering establishment or directly to a specifically approved stockyard and then directly to a recognized slaughtering establishment if they are negative to an official test within 30 days prior to such interstate movement and are accompanied by an ICVI or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(ii) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if they are negative to an official test within 30 days prior to such interstate movement and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if they are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iv) Cattle from qualified herds in a quarantined area may be moved interstate in accordance with § 78.8(a).
(2) Movement to quarantined feedlots. (i) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to a quarantined feedlot, or directly to a specifically approved stockyard and then directly to a quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot if the cattle are negative to an official test within 30 days prior to such interstate movement and are accompanied by an ICVI which states, in addition to the items specified in § 78.1 of this part, the test dates and results of the official tests; or
(ii) Cattle from qualified herds in a quarantined area may be moved in accordance with § 78.8(b).
(3) Movement other than in accordance with paragraph (d)(1) or (2) of this section. Cattle from qualified herds in a quarantined area may be moved interstate other than in accordance with paragraph (d)(1) or (2) of this section, either directly from a farm of origin or from a farm of origin through no more than one specifically approved stockyard if
(i) The cattle, except official vaccinates less than 1 year of age and cattle less than 6 months of age, are negative to an official test within 30 days prior to such interstate movement; and
(ii) The cattle are accompanied interstate by an ICVI which states, in addition to the items specified in § 78.1, the test dates and results of the official tests when such tests are required.
(e) Movement from herds which are not qualified. Cattle from herds known to be affected or from herds which are not qualified in any quarantined area may be moved interstate only in accordance with § 78.8(a) or (b).
The Administrator may, upon request in specific cases, permit the interstate movement of cattle not otherwise provided for in this subpart, under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The Administrator shall promptly notify the State animal health officials of the States involved of any such action.
(a) Rodeo cattle that are test-eligible and that are from a herd not known to be affected may be moved interstate if:
(1) They are classified as brucellosis negative based upon an official test conducted less than 365 days before the date of interstate movement: Provided, however, That: The official test is not required for rodeo cattle that are moved only between Class Free States;
(2) The cattle are identified with an official eartag or any other official identification device or method approved by the Administrator in accordance with § 78.5;
(3) There is no change of ownership since the date of the last official test;
(4) An ICVI accompanies each interstate movement of the cattle; and
(5) A permit for entry is issued for each interstate movement of the cattle.
(b) Cattle that would qualify as rodeo cattle, but that are used for breeding purposes during the 365 days following the date of being tested, may be moved interstate only if they meet the requirements for cattle in this subpart and in 9 CFR part 86.
Bison may not be moved interstate except in compliance with this subpart and with 9 CFR part 86.
Bison steers and spayed heifers may be moved interstate without further restriction under this subpart.
(a) Destination. Brucellosis reactor bison may be moved interstate only for immediate slaughter as follows:
(1) Directly to a recognized slaughtering establishment;
(2) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(3) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis reactors and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b) Identification. Brucellosis reactor bison must be individually identified prior to moving interstate by attaching to the left ear a metal tag bearing a serial number and the inscription “U.S. Reactor,” or a metal tag bearing a serial number designated by the State animal health official for identifying brucellosis reactors, and must be:
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(c) Permit. Brucellosis reactor bison moving interstate shall be accompanied to destination by a permit.
(d) Marking of records. Each person moving brucellosis reactor bison interstate shall, in the course of interstate movement, plainly write or stamp the words “Brucellosis Reactor” upon the face of any document that person prepares in connection with such movement.
(e) Segregation en route. Brucellosis reactor bison shall not be moved interstate in any means of conveyance containing animals which are not brucellosis reactors unless all of the animals are for immediate slaughter or unless the brucellosis reactor bison are kept separate from the other animals by a partition securely affixed to the sides of the means of conveyance.
Brucellosis exposed bison may be moved interstate only as follows:
(a) Movement to recognized slaughtering establishments. Brucellosis exposed bison may be moved interstate for slaughter accompanied by a permit or “S” brand permit and as follows:
(1) Directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(2) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis exposed bison and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b) Movement to quarantined feedlots. Brucellosis exposed bison may be moved directly to a quarantined feedlot or, from a farm of origin, directly to a specifically approved stockyard approved to receive brucellosis exposed bison and then directly to a quarantined feedlot. Such bison shall be accompanied by a permit or “S” brand permit.
(c) Movement other than in accordance with paragraphs (a) or (b) of this section. Brucellosis exposed bison which are from herds known to be affected, but which are not part of a herd being depopulated under part 51 of this chapter, may move without further restriction under this subpart if the bison:
(1) Are under 6 months of age and were weaned from brucellosis reactor or brucellosis exposed bison not less than 30 days immediately preceding interstate movement; or
(2) Are under 6 months of age and nursing brucellosis exposed bison in a herd subjected to a herd blood test within 10 days prior to interstate movement; or
(3) Are official vaccinates under 1 year of age from a herd following an approved individual herd plan.
Bison from herds not known to be affected may be moved interstate only as follows:
(a) Movement to recognized slaughtering establishments. Bison from herds not known to be affected may be moved directly to a recognized slaughtering establishment without further restriction under this subpart.
(b) Movement to quarantined feedlots. Bison from herds not known to be affected may be moved directly to a quarantined feedlot without further restriction under this subpart.
(c) Movement from public zoo to public zoo. Bison from herds not known to be affected may be moved from a zoo owned by a governmental agency to another such zoo if handled in accordance with § 78.3.
(d) Movement other than in accordance with paragraphs (a), (b), or (c) of this section. Bison from herds not known to be affected may be moved interstate other than in accordance with paragraphs (a), (b), or (c) of this section only as follows:
(1) Such bison under 6 months of age may be moved interstate when accompanied by an ICVI.
(2) Such bison which are official vaccinates under 2 years of age and are not parturient or postparturient may be moved interstate when accompanied by an ICVI.
(3) Such bison may be moved interstate if they are negative to an official test within 30 days prior to such movement and are accompanied by an ICVI which states, in addition to the items specified in § 78.1, the dates and results of the official tests.
(4) Such bison may be moved interstate if they originate in a certified brucellosis-free herd and are accompanied by an ICVI which states, in addition to the items specified in § 78.1, that the bison originated in a certified brucellosis-free herd.
The Administrator may, upon request in specific cases, permit the interstate movement of bison not otherwise provided for in this subpart, under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The Administrator shall promptly notify the State animal health officials of the States involved of any such action.
(a) Brucellosis reactor swine, brucellosis exposed swine, feral swine, sows, and boars may not be moved interstate or in interstate commerce except in compliance with this subpart.
(b) Each person who causes the movement of swine in interstate commerce is responsible for the identification of the swine as required by this subpart. No such person shall remove or tamper with or cause the removal of or tampering with an identification tattoo or approved swine identification tag required in this subpart except at the time of slaughter, or as may be authorized by the Administrator upon request in specific cases and under such conditions as the Administrator may impose to ensure continuing identification.
(c)(1) Feral swine may be moved interstate directly to slaughter if they do not come into physical contact with any domestic swine or other livestock.
(2) Feral swine from monitored-negative populations may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin.
(3) Feral swine found negative to an official test within the 30 days prior to the interstate movement may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin.
(a) Destination. Brucellosis reactor swine may be moved interstate only for immediate slaughter as follows:
(1) Directly to a recognized slaughtering establishment; or
(2) Directly to a stockyard posted under the Packers and Stockyards Act, as amended (7 U.S.C. 181 et seq.), or directly to a market agency or dealer registered under the Packers and Stockyards Act, for sale to a recognized slaughtering eatablishment in accordance with the following requirements:
(b) Identification. Brucellosis reactor swine shall be individually identified by attaching to the left ear a metal tag bearing a serial number and the inscription, “U.S. Reactor,” or a metal tag bearing a serial number designated by the State animal health official for identifying brucellosis reactors.
(c) Permit. Brucellosis reactor swine shall be accompanied to destination by a permit.
(d) Marking of records. Each person moving brucellosis reactor swine interstate shall, in the course of interstate movement, plainly write or stamp the words “Brucellosis Reactor” upon the face of any document that person prepares in connection with such movement.
(e) Segregation en route. Brucellosis reactor swine shall not be moved interstate in any means of conveyance containing animals which are not brucellosis reactors unless all of the animals in the shipment are for immediate slaughter, or unless the brucellosis reactor swine are kept separate from other animals by a partition securely affixed to the sides of the means of conveyance.
(a) Brucellosis exposed swine may be moved interstate only if accompanied by a permit and only for immediate slaughter as follows:
(1) Directly to a recognized slaughtering establishment; or
(2) Directly to a stockyard posted under the Packers and Stockyards Act, as amended (7 U.S.C. 181 et seq.), or directly to a market agency or dealer registered under the Packers and Stockyards Act, for sale to a recognized slaughtering establishment.
(b) Brucellosis exposed swine from a herd known to be affected with brucellosis may be moved interstate from the herd known to be affected only if such swine are individually identified by attaching to the left ear a metal tag bearing a serial number and the inscription, “U.S. Reactor,” or a metal tag bearing a serial number designated by the State animal health official for identifying brucellosis reactors.
(a) Sows and boars may be moved in interstate commerce for slaughter or for sale for slaughter if they are identified in accordance with § 71.19 of this chapter either:
(1) Before being moved in interstate commerce and before being mixed with swine from any other source; or
(2) After being moved in interstate commerce but before being mixed with swine from any other source only if they have been moved directly from their herd of origin to:
(i) A recognized slaughtering establishment; or
(ii) A stockyard, market agency, or dealer operating under the Packers and Stockyards Act, as amended (7 U.S.C. 181 et seq.).
(b) Sows and boars may be moved in interstate commerce for breeding only if they are identified in accordance with § 71.19 of this chapter before being moved in interstate commerce and before being mixed with swine from any other source, and the sows and boars either:
(1) Are from a validated brucellosis-free herd or a validated brucellosis-free State and are accompanied by a certificate that states, in addition to the items specified in § 78.1, that the swine originated in a validated brucellosis-free herd or a validated brucellosis-free State; or
(2) Have tested negative to an official test conducted within 30 days prior to interstate movement and are accompanied by a certificate that states, in addition to the items specified in § 78.1, the dates and results of the official tests.
(c) Sows and boars may be moved in interstate commerce for purposes other than slaughter or breeding without restriction under this subpart if they are identified in accordance with § 71.19 of this chapter.
The Administrator may, upon request in specific cases, permit the movement in interstate commerce of swine not otherwise provided for in this subpart under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The Administrator shall promptly notify the State animal health officials of the States involved of any such action.
The Administrator may amend §§ 78.41 and 78.42 to reclassify States and areas as Class Free, Class A, Class B, Class C, or quarantined when the Administrator determines that the States or areas meet the appropriate definitions in § 78.1. The Administrator may approve the division of a State into two brucellosis classification areas upon finding that: (a) The State has legislative and regulatory authority for maintaining separate areas; (b) The State has committed resources to enforcing the different requirements in each area; (c) The State has an effective method for monitoring and controlling movement of cattle across the intrastate boundary; (d) The State has defined the intrastate boundary by county lines or by recognizable geographic features, such as rivers and highways; and (e) Each area of the State meets the standards for the brucellosis classification requested. The Administrator may amend § 78.43 to reclassify States as validated brucellosis-free States or remove such status when the Administrator determines that such States meet or do not meet the standards of a validated brucellosis-free State as defined in § 78.1. In the case of any reclassification to a lower class, reclassification as a quarantined State or area, or removal of validated brucellosis-free status, the State animal health official of the State involved will be notified of such reclassification or removal, and will be given an opportunity to present objections and arguments to the Administrator prior to the reclassification or removal taking place.
(a) Class Free. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virgin Islands, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
(b) Class A. None.
(c) Class B. None.
None.
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virgin Islands, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any employee of the United States Department of Agriculture authorized to act for the Administrator.
Animal. A sheep or goat.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal identification number (AIN). This term has the meaning set forth in § 86.1 of this subchapter, except that only AIN devices approved and distributed in accordance with § 79.2(k) and methods approved for use in sheep and goats in accordance with § 79.2(a)(2) are included.
APHIS representative. An individual employed by APHIS in animal health activities who is authorized by the Administrator to perform the function involved.
Approved laboratory. A laboratory approved by the Administrator in accordance with § 54.11 of this chapter to conduct one or more scrapie tests, or genotype tests, on one or more tissues.
Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned.
Blackfaced sheep. Any purebred suffolk, hampshire, shropshire or cross thereof, any non-purebred sheep known to have suffolk, hampshire, or shropshire ancestors, and any non-purebred sheep of unknown ancestry with a black face, except commercial hair sheep.
Breed association and registries. Organizations that maintain the permanent records of ancestry or pedigrees of animals (including the animal's sire and dam), individual identification of animals, and ownership of animals.
Classification or reclassification investigation. An epidemiological investigation conducted or directed by a DSE for the purpose of designating or redesignating the status (e.g., exposed, high-risk, infected, source, suspect, etc.) of a flock or animal. In conducting such an investigation, the DSE will evaluate the available records for flocks and individual animals and conduct or direct any testing needed to assess the status of a flock or animal. The status of an animal or flock will be determined based on the applicable definitions in this section and, when needed to make a designation under § 79.4, official genotype test results, exposure risk, scrapie type involved, and/or results of official scrapie testing on live or dead animals.
Commercial hair sheep. Any commercial sheep with hair rather than wool that is either a full-blooded hair sheep or that resulted from the cross of a hair sheep with a whitefaced wool sheep.
Commercial sheep or goat. Any animal from a flock from which animals are moved only either directly to slaughter or through slaughter channels to slaughter or any animal that is raised only for meat or fiber production and that is not registered with a sheep or goat registry or used for exhibition.
Commingle, commingled, commingling. Animals grouped together and having physical contact with each other, including contact through a fence, but not limited contacts. Commingling also includes sharing the same section in a transportation unit where there is physical contact.
Consistent State. (1) A State that the Administrator has determined conducts an active State scrapie control program that meets the requirements of § 79.6 or effectively enforces a State designed plan that the Administrator determines is at least as effective in controlling scrapie as the requirements of § 79.6.
(2) A list of Consistent States can be found on the internet at http://www.aphis.usda.gov/animal-health/scrapie.
Designated scrapie epidemiologist. An epidemiologist who has demonstrated the knowledge and ability to perform the functions required and who has been selected by the State animal health official and the area veterinarian in charge. The regional epidemiologist and the APHIS National Scrapie Program Coordinator must concur in the selection and appointment of the designated scrapie epidemiologist. The designated scrapie epidemiologist must satisfactorily complete training designated by APHIS.
Direct movement to slaughter. Transported to a facility for slaughter, without stops or unloading except for feeding and watering during which the animals are not commingled with any other animals.
Electronic implant. Any radio frequency identification implant device approved for use in the scrapie program by the Administrator. The Administrator will approve an electronic implant after determining that it is tamper resistant, not harmful to the animal, and readable by equipment available to APHIS and State representatives.
Exposed animal. Any animal or embryo that:
(1) Has been in a flock with a scrapie-positive female animal;
(2) Has been in an enclosure with a scrapie-positive female animal at any location;
(3) Resides in a noncompliant flock; or
(4) Has resided on the premises of a flock before or while it was designated an infected or source flock and before a flock plan was completed. An animal shall not be designated an exposed animal if it only resided on the premises before the date that infection was most likely introduced to the premises as determined by a Federal or State representative. If the probable date of infection cannot be determined based on the epidemiologic investigation, a date 2 years before the birth of the oldest scrapie-positive animal born in that flock will be used. If the actual birth date is unknown, the date of birth will be estimated based on examination of the teeth and any available records. If an age estimate cannot be made, the animal will be assumed to have been 48 months of age on the date samples were collected for scrapie diagnosis. Exposed animals will be further designated as genetically resistant exposed sheep, genetically less susceptible exposed sheep, genetically susceptible exposed animals, or low-risk exposed animals. An animal will no longer be an exposed animal if it is redesignated in accordance with § 79.4.
Exposed flock. (1) Any flock that was designated an infected or source flock that has completed a flock plan and that retained a female genetically susceptible exposed animal;
(2) Any flock under investigation that retains a female genetically susceptible exposed animal or a suspect animal, or whose owner declines to complete genotyping and live-animal and/or post-mortem scrapie testing required by the APHIS or State representative investigating the flock; or
(3) Any noncompliant flock or any flock for which a PEMMP is required that is not in compliance with the conditions of the PEMMP. A flock will no longer be an exposed flock if it is redesignated in accordance with § 79.4.
Flock. All animals that are maintained on a single premises and all animals under common ownership or supervision on two or more premises with animal interchange between the premises. Changes in ownership of part or all of a flock do not change the identity of the flock or the regulatory requirements applicable to the flock. Animals maintained temporarily on a premises for activities such as shows and sales or while in marketing channels are not a flock. More than one flock may be maintained on a single premises if:
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart at all times or are separated by a solid wall through, over, or under which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including buildings and pastures, and a pasture or building used for lambing by one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and disinfection in accordance with § 54.7(e) of this chapter. Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules.
Flock identification (ID) number. A nationally unique number assigned by a State, federally recognized Tribal or Federal animal health authority to a group of animals that are managed as a unit on one or more premises and are under the same ownership. The flock ID number must begin with the State postal abbreviation or APHIS-assigned Tribal code, must have no more than nine alphanumeric characters, and must not contain the characters “I”, “O”, or “Q” other than as part of the State postal abbreviation or another standardized format authorized by the administrator and recorded in the National Scrapie Database. APHIS may assign Tribal codes to any federally recognized Tribe that maintains sheep or goats on Tribal lands. The flock ID number must be recorded in and linked to one or more PINs or LIDs in the National Scrapie Database.
Flock of origin. The flock in which an animal most recently resided in which it either was born, gave birth, or was used for breeding purposes. The determination of an animal's flock of origin may be based either on the physical presence of the animal in the flock, the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records.
Flock plan. A written flock management agreement signed by the owner of a flock, the accredited veterinarian, if one is employed by the owner, and a State or APHIS representative in which each participant agrees to undertake actions specified in the flock plan to control the spread of scrapie from, and eradicate scrapie in, an infected flock or source flock or to reduce the risk of the occurrence of scrapie in a flock that contains a high-risk or an exposed animal. As part of a flock plan, the flock owner must provide the facilities and personnel needed to carry out the requirements of the flock plan. The flock plan must include the requirements in § 54.8(a) through (j) of this chapter.
Flock under investigation. Any flock in which an APHIS or State representative has determined that a scrapie suspect animal, high-risk animal, or scrapie-positive animal resides or may have resided. A flock will no longer be a flock under investigation if it is redesignated in accordance with § 79.4.
Genetically less susceptible exposed sheep. Any sheep or sheep embryo that is:
(1) An exposed sheep or sheep embryo of genotype AA QR, unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are not less susceptible; or
(2) An exposed sheep or sheep embryo of genotype AV QR, unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to another scrapie type to which the Administrator has determined AV QR sheep are not less susceptible; or
(3) An exposed sheep or sheep embryo of a genotype that has been exposed to a scrapie type to which the Administrator has determined that genotype is less susceptible.
(4) Note: In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136.
Genetically resistant exposed sheep. Any exposed sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type to which RR sheep are not resistant.
Genetically resistant sheep. Any sheep or sheep embryo of genotype RR at codon 171 unless it is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type that affects RR at codon 171 sheep.
Genetically susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a genotype other than RR or QR, where Q represents any genotype other than R at codon 171 or sheep or sheep embryo of undetermined genotype.
Genetically susceptible exposed animal. Excluding low-risk exposed animals, any exposed animal or embryo that is also:
(1) A genetically susceptible animal; or
(2) A sheep or sheep embryo of genotype AV QR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to a scrapie type to which AV QR sheep are susceptible; or
(3) A sheep or sheep embryo of genotype AA QR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are susceptible; or
(4) A sheep or sheep embryo of genotype RR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type to which RR sheep are susceptible.
(5) Note: In this definition, R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136.
Group/lot identification number (GIN). The identification number used to uniquely identify a unit of animals that is managed together as one group. The format of the GIN may be either as defined in § 86.1 of this chapter, or the flock identification number followed by a six-digit representation of the date on which the group or lot of animals was assembled (MM/DD/YY). If more than one group is created on the same date a sequential number will be added to the end of the GIN. A group lot comprised of animals from a single flock of origin may be subdivided after leaving the premises on which the group lot was formed by adding an S followed by a sequential number to the end of the GIN to create a GIN for each sub group. If a flock identification number is used, the flock identification number, date, and sequential number(s) will be separated by hyphens.
High-risk animal. The female offspring or embryo of a scrapie-positive female animal, or any suspect animal, or a female genetically susceptible exposed animal, or any exposed animal that the Administrator determines to be a potential risk. The Administrator may base the determination that an exposed animal poses a potential risk on the scrapie type, the epidemiology of the flock or flocks with which it is epidemiologically linked, including genetics of the positive sheep, the prevalence of scrapie in the flock, any history of recurrent infection, and other animal or flock characteristics. An animal will no longer be a high-risk animal if it is redesignated in accordance with § 79.4.
Inconsistent State. Any State other than a Consistent State.
Infected flock. The flock of origin of a female animal that a State or APHIS representative has determined to be a scrapie-positive animal; or any flock in which a State or APHIS representative has determined that a scrapie-positive female animal has resided unless an epidemiologic investigation conducted by a State or APHIS representative shows that the animal did not lamb or abort in the flock. A flock will no longer be considered an infected flock after it has completed the requirements of a flock plan.
Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement or other uses as described in this part and in accordance with § 79.5.
Interstate commerce. Trade, traffic, transportation, or other commerce between a place in a State and any place outside of that State, or between points within a State but through any place outside that State.
Limited contacts. Incidental contacts between animals from different flocks off the flock's premises such as at fairs, shows, exhibitions and sales; between ewes being inseminated, flushed, or implanted; or between rams at ram test or collection stations. Embryo transfer and artificial insemination equipment and surgical tools must be sterilized between animals for these contacts to be considered limited contacts. Limited contacts do not include any contact, incidental or otherwise, with animals in the same flock or with an animal during or up to 30 days after she lambed, kidded or aborted or when there is any visible vaginal discharge. Limited contacts do not include any activity where uninhibited contact occurs, such as sharing an enclosure, sharing a section of a transport vehicle, or residing in other flocks for breeding or other purposes. Examples of limited contacts may be found in the Scrapie Flock Certification Program standards.
Live-animal screening test. Any test for the diagnosis of scrapie in a live animal that is approved by the Administrator as usually reliable but not definitive for diagnosing scrapie, and that is conducted in a laboratory approved by the Administrator.
Low-risk commercial flock. A flock composed of commercial whitefaced, whitefaced cross, or commercial hair sheep or commercial goats that were born in, and have resided throughout their lives in, flocks with no known risk factors for scrapie, including any exposure to female blackfaced sheep other than whiteface crosses born on the premises; that has never contained a scrapie-positive female, suspect female, or high-risk animal; and that has never been an infected, exposed, or source flock or a flock under investigation. The animals are identified with a legible permanent brand or ear notch pattern registered with an official brand registry or with an official flock identification eartag. The term “brand” includes official brand registry brands on eartags in those States whose brand law or regulation recognizes brands placed on eartags as official brands. Low-risk commercial flocks may exist only in a State where in the previous 10 years no flock that had met the definition of a low-risk commercial flock prior to a classification investigation was designated a source or infected flock.
Low-risk exposed animal. Any exposed animal to which the Administrator has determined one or more of the following applies:
(1) The positive animal that was the source of exposure was not born in the flock and did not lamb in the flock or in an enclosure where the exposed animal resided;
(2) The Administrator and State representative concur that the animal is unlikely to be infected due to factors such as, but not limited to, where the animal resided or the time period the animal resided in the flock;
(3) The exposed animal is male and was not born in an infected or source flock;
(4) The exposed animal is a castrated male;
(5) The exposed animal is an embryo of a genetically resistant exposed sheep or a genetically less susceptible exposed sheep unless placed in a recipient that was a genetically susceptible exposed animal; or
(6) The animal was exposed to a scrapie type and/or is of a genotype that the Administrator has determined poses low risk of transmission.
National Scrapie Database. A database designated by the Administrator in which APHIS and State animal health agencies cooperatively enter data concerning scrapie outbreaks, flocks and premises affected by scrapie, individual animal identification and premises identification data, and other data to support the Scrapie Eradication Program and the Scrapie Flock Certification Program.
National Uniform Eartagging System (NUES). This term has the meaning set forth in § 86.1 of this subchapter.
Noncompliant flock. (1) Any source or infected flock whose owner declines to enter into a flock plan or post-exposure management and monitoring plan agreement within 30 days of being so designated, or whose owner is not in compliance with either agreement;
(2) Any exposed flock whose owner fails to make animals available for testing within 60 days of notification, or as mutually agreed, or whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a person who has misrepresented, the scrapie status of an animal or any other information on a certificate, permit, owner/hauler statement, or other official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a person who has moved, an animal in violation of this chapter within the last 5 years.
Official eartag. This term has the meaning set forth in § 86.1 of this subchapter, except that only eartags approved and distributed in accordance with § 79.2(k) are included.
Official genotype test. A test to determine the genotype of a live or dead animal conducted at either the National Veterinary Services Laboratories or at an approved laboratory. The test subject must be an animal that is officially identified and the test accurately recorded on an official form supplied or approved by APHIS, with the samples collected and shipped to the laboratory using a shipping method specified by the laboratory by:
(1) An accredited veterinarian;
(2) A State or APHIS representative; or
(3) The animal's owner or owner's agent, using a tamper-resistant sampling kit approved by APHIS for this purpose.
Official identification. Identification mark or device approved by APHIS for use in the Scrapie Eradication Program. Examples are listed in § 79.2(a)(2).
Official identification device or method. This term has the meaning set forth in § 86.1 of this subchapter, except that only devices approved and distributed in accordance with § 79.2(k) and methods approved for use in sheep and goats in accordance with § 79.2(a)(2) are included.
Official identification number. This term has the meaning set forth in § 86.1 of this subchapter.
Officially identified. Identified by means of an official identification device or method approved by the Administrator for use in sheep and goats in accordance with this part.
Official test. Any test for the diagnosis of scrapie in a live or dead animal that is approved by the Administrator for that use and conducted either at an approved laboratory or at the National Veterinary Services Laboratories.
Owner. A person, partnership, company, corporation, or any other legal entity who has legal or rightful title to animals, whether or not they are subject to a mortgage.
Owner/hauler statement. (1) A signed written statement by the owner or hauler that includes:
(i) The name, address, and phone number of the owner and, if different, the hauler;
(ii) The date the animals were moved;
(iii) The flock identification number or PIN assigned to the flock or premises of the animals;
(iv) If moving individually unidentified animals or other animals required to move with a group/lot identification number, the group/lot identification number and any information required to officially identify the animals;
(v) The number of animals;
(vi) The species, breed, and class of animals. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead; and
(vii) The name and address of point of origin, if different from the owner's address, and the destination name and address.
(2) An existing document that includes the information required in paragraphs (1)(i) to (vii) of this definition and that is signed by the owner or the hauler may be used as an owner/hauler statement.
Ownership brand. A unique permanent legible brand or earnotch pattern applied to an animal that indicates ownership by a particular person when the brand pattern is registered with a State's official brand recording agency.
Permit. An official document issued in connection with the interstate movement of animals (VS Form 1-27 or a State form that contains the same information) that is issued by an APHIS representative, State representative, or an accredited veterinarian authorized to sign such permits. A new permit is required for each change in destination for an animal. A permit lists the owner's name and address; points of origin and destination; number of animals covered; purpose of the movement; whether the animals are from an exposed, noncompliant, infected, or source flock; whether the animal is a high-risk, exposed, scrapie-positive, or scrapie suspect animal; transportation vehicle license number or other identification number; and seal number (if a seal is required). A permit also lists all official identification on the animals covered, including the official eartag number, individual animal registered breed association registration tattoo, individual animal registered breed association registration brand, United States Department of Agriculture backtag (when applied serially, only the beginning and the ending numbers need be recorded), individual animal registered breed association registration number, or any other form of official identification present on the animal.
Person. An individual, partnership, company, corporation, or any other legal entity.
Premises identification. An APHIS approved eartag, backtag, or legible tattoo bearing the premises identification number (PIN), as defined in this section, or a flock identification number, or a legible permanent brand or ear notch pattern registered with an official brand registry. Premises identification may be used when official individual animal identification is required, if the premises identification method either includes a unique animal number or is used in conjunction with the producer's livestock production numbering system to provide a unique identification number and where, if brands or ear notches are used, the animals are accompanied by an official brand inspection certificate. Clearly visible and/or legible paint brands may be used on animals moving directly to slaughter and on animals moving for grazing or other management purposes without change in ownership.
Premises identification number (PIN). This term has the meaning set forth in § 86.1 of this subchapter. APHIS may also maintain historical and/or State premises numbers and link them to the premises identification number in records and databases. Such secondary or historical numbers are typically the State's two-letter postal abbreviation followed by a number assigned by the State.
Restricted animal sale or restricted livestock facility. A sale where any animals in slaughter channels are maintained separate from other animals not in slaughter channels other than animals from the same flock of origin and are sold in lots that consist entirely of animals sold for slaughter only or a livestock facility at which all animals are in slaughter channels and where the sale or facility manager maintains a copy of, or maintains a record of, the information from, the owner/hauler statement for all animals entering and leaving the sale or facility. A restricted animal sale may be held at a livestock facility that is not restricted.
Scrapie Eradication Program. The cooperative State-Federal program administered by APHIS and Consistent States to control and eradicate scrapie.
Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative procedures and standards adopted by APHIS and Consistent States for controlling and eradicating scrapie. The UM&R will be reviewed at least annually by representatives of the livestock industry, appropriate State and Federal agencies, and the public and will be drafted, revised, and published as needed by APHIS.
Scrapie Free Flock Certification Program (SFCP). The cooperative Federal-State-industry voluntary program for the control of scrapie conducted in accordance with subpart B of part 54 of this chapter.
Scrapie Free Flock Certification Program standards. Cooperative procedures and standards adopted by APHIS and State Scrapie Certification Boards for reducing the incidence and controlling the spread of scrapie through flock certification.
Scrapie-positive animal. An animal for which a diagnosis of scrapie has been made by the National Veterinary Services Laboratories or another laboratory authorized by the Administrator to conduct scrapie tests in accordance with this chapter, through:
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of scrapie;
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry, and/or ELISA, and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal for which a given method has been approved by the Administrator for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron microscopy; or
(5) Any other method or combination of methods approved by the Administrator in accordance with § 54.10 of this chapter.
Slaughter channels. Animals in slaughter channels include any animal that is sold, transferred, or moved either directly to or through a restricted animal sale or restricted livestock facility to an official slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot.
Source flock. A flock in which a State or APHIS representative has determined that at least one animal was born that was diagnosed as a scrapie-positive animal at an age of 72 months or less. The determination that an animal was born in a flock will be based on such information as the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records, to show that a scrapie-positive animal was born in the flock, combined with the absence of records indicating that the animal was purchased from outside and added to the flock. If DNA from the animal was previously collected by an accredited veterinarian and stored at an approved genotyping laboratory, or if DNA collection and storage are required for breed registration and the breed registration has appropriate safeguards in place to ensure the integrity of the banking process, the owner may request verification of the animal's identity based on DNA comparison if adequate records and identification have been maintained by the owner and the repository to show that the archived DNA is that of the animal that has been traced to the flock. The owner will be responsible for all costs for the DNA comparison. A flock will no longer be a source flock after it has completed the requirements of a flock plan.
State. Each of the 50 States, the District of Columbia, the Northern Mariana Islands, Puerto Rico, and all territories or possessions of the United States.
State representative. An individual employed in animal health activities by a State or a political subdivision of a State and who is authorized by the State or political subdivision to perform the function involved.
Suspect animal. An animal will be designated a suspect animal in accordance with § 79.4 if it is:
(1) A mature sheep or goat as evidenced by eruption of the first incisor that has been condemned by FSIS or a State inspection authority for central nervous system (CNS) signs, or that exhibits any of the following clinical signs of scrapie and has been determined to be suspicious for scrapie by an accredited veterinarian or a State or USDA representative, based on one or more of the following signs and the severity of the signs: Weakness of any kind including, but not limited to, stumbling, falling down, or having difficulty rising, not including those with visible traumatic injuries and no other signs of scrapie; behavioral abnormalities; significant weight loss despite retention of appetite or in an animal with adequate dentition; increased sensitivity to noise and sudden movement; tremors; star gazing; head pressing; bilateral gait abnormalities such as but not limited to incoordination, ataxia, high stepping gait of forelimbs, bunny-hop movement of rear legs, or swaying of back end, but not including abnormalities involving only one leg or one front and one back leg; repeated intense rubbing with bare areas or damaged wool in similar locations on both sides of the animal's body or, if on the head, both sides of the poll; abraded, rough, thickened, or hyperpigmented areas of skin in areas of wool/hair loss in similar locations on both sides of the animal's body or, if on the head, both sides of the poll; or other signs of CNS disease. An animal will no longer be a suspect animal if it is redesignated in accordance with § 79.4.
(2) A sheep or goat that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test, unless the animal is designated a scrapie-positive animal.
(3) A sheep or goat that has tested inconclusive or suggestive on an official test for scrapie.
Terminal feedlot. (1) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where animals in the terminal feedlot are separated from all other animals by at least 30 feet at all times or are separated by a solid wall through, over, or under which fluids cannot pass and contact cannot occur and must be cleaned of all organic material prior to being used to contain sheep or goats that are not in slaughter channels, where only castrated males are maintained with female animals and from which animals are moved only to another terminal feedlot or directly to slaughter; or
(2) A dry lot approved by a State or APHIS representative or an accredited veterinarian authorized by the Administrator to perform this function where only animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, and all animals in the terminal feedlot are separated from all other animals such that physical contact cannot occur including through a fence and from which animals are moved only to another terminal feedlot or directly to slaughter; or
(3) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, where there is no direct fence-to-fence contact with another flock, and from which animals are moved only to another terminal feedlot or directly to slaughter.
(4) Records of all animals entering and leaving a terminal feedlot must be maintained for 5 years after the animal leaves the feedlot and must meet the requirements of § 79.2, including either a copy of the required owner/hauler statements for animals entering and leaving the facility or the information required to be on the statements. Records must be made available for inspection and copying by an APHIS or State representative upon request.
Test eligible. An animal that meets a test protocol's age and post-exposure elapsed time requirements for the test to be meaningfully applied.
United States. All of the States.
Unofficial test. Any test for the diagnosis of scrapie or for the detection of the proteinase resistant protein associated with scrapie in a live or dead animal that either has not been approved by the Administrator or that was not conducted at an approved laboratory or at the National Veterinary Services Laboratories.
(a) No sheep or goat that is required to be individually identified or group identified by § 79.3 may be sold, disposed of, acquired, exhibited, transported, received for transportation, offered for sale or transportation, loaded, unloaded, or otherwise handled in interstate commerce or commingled with such animals or be loaded or unloaded at a premises or animal concentration point (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce unless each sheep or goat has been identified in accordance with this section.
(1) The sheep or goat must be identified to its flock of origin and to its flock of birth
(i) Prior to the point of first commingling of the sheep or goats with sheep or goats from any other flock of origin;
(ii) Upon unloading of the sheep or goats at a livestock facility approved in accordance with § 71.20 of this subchapter and that has agreed to act as an agent for the owner to apply official identification and prior to commingling with animals from another flock of origin. Such facilities may identify animals after sale if the facility maintains unidentified animals from different flocks of origin or, when required, different flocks of birth in separate enclosures until officially identified. The animals must be accompanied by an owner/hauler statement that contains the information needed for the livestock facility to officially identify the animals to their flock of origin and, when required, their flock of birth;
(iii) Upon transfer of ownership of the sheep or goats;
(iv) If the owner of the premises or the owner of the animal engages in the interstate commerce of animals, then prior to moving a sheep or goat from the premises on which it resides, unless the animals are moving to a livestock facility approved to handle the species and class of animal to be moved as described in § 71.20 of this subchapter that has agreed to act as an agent for the owner to apply official identification and in accordance with paragraph (a)(1)(ii) of this section or to a slaughter plant listed in accordance with § 71.21 of this subchapter as part of a group lot. Unless prohibited by State law or regulation, this does not preclude a person from moving animals as part of a group lot directly to another site in the same State to have official eartags that have been assigned to the animal's flock of origin in the National Scrapie Database applied to the animals;
(v) In the case of animals that have only resided on premises and in flocks owned by persons that do not engage in interstate commerce, upon unloading a sheep or goat at a livestock facility or other premises where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce and prior to commingling with animals from another flock of origin. Such animals must be accompanied by an owner/hauler statement that contains the information needed to officially identify the animals to their flock of origin and, when required, their flock of birth; or
(vi) Before moving a sheep or goat across a State line, unless moving to an approved livestock facility that is approved to handle that species and class of animals as described in § 71.20 of this subchapter that has agreed to act as an agent for the owner to apply official identification, and prior to commingling with animals from another flock of origin. Such animals must be accompanied by an owner/hauler statement that contains the information needed for the livestock facility to officially identify the animals to their flock of origin and, when required, their flock of birth.
(2) The sheep or goats must be identified and remain identified using a device or method approved in accordance with paragraph (k) of this section. All animals required to be individually identified by § 79.3 shall be identified with official identification devices or methods. A list of approved identification devices and methods, including restrictions on their use, is available at http://www.aphis.usda.gov/animal-health/scrapie. Written requests for approval of sheep or goat identification device types or methods not listed at http://www.aphis.usda.gov/animal-health/scrapie should be sent to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235. If the Administrator determines that an identification device or method will provide an effective means of tracing sheep and goats in interstate commerce, APHIS will provide public notice that the device type or method, along with any restrictions on its use, has been added to the list of approved devices and methods of official sheep and goat identification.
(3) No person shall buy or sell, for his or her own account or as the agent of the buyer or seller, transport, receive for transportation, offer for sale or transportation, load, unload, or otherwise handle any animal that is in or has been in interstate commerce that has not been identified as required by this section including loading or unloading at a premises (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce. No person shall commingle animals with any animal that is in or has been in interstate commerce that has not been identified as required by this section. If the person transporting animals is aware of any animal in the shipment that loses its identification to its flock of origin while in interstate commerce, the person transporting the animal is required to inform the receiving party of this fact, and it is the responsibility of the person who has control or possession of the animal upon unloading/delivery to identify the animal or have the animal identified prior to commingling it with any other animals. This shall be done by applying individual animal identification to the animal as required in paragraph (a)(2) of this section and recording the means of identification and the corresponding animal identification number on the waybill or other shipping document. If the flock of origin cannot be determined, all possible flocks of origin shall be listed on the record, or if this cannot be done, the animal must be identified with a slaughter only eartag and may only move in slaughter channels or, in the case of sheep, may be officially identified and moved for other purposes if the animal is inspected by an accredited veterinarian, found free of evidence of infectious or contagious disease and officially genotyped as AA QR or AA RR.
(b) The State Animal Health Official or Veterinary Services, Field Operations, Area Veterinarian in Charge (AVIC) responsible for the State involved, whoever is responsible for issuing official identification devices or numbers in that State and for assigning flock identification numbers and premises identification numbers in that State in the National Scrapie Database, may issue sets of unique serial numbers or flock identification/production numbers for use on official individual identification devices (such as eartags or tattoos). Flock identification/production numbers may only be assigned to owners of breeding flocks.
(1) Animals not in slaughter channels. Official identification numbers for use on animals not in slaughter channels may only be assigned either directly to the owner of a breeding flock for application to animals that originated in a breeding flock owned by them or, in the case of official serial numbers or serial number devices, to APHIS or State representatives or accredited veterinarians or other responsible individuals as described in paragraphs (b)(2) and (3) of this section APHIS or State representatives may apply official identification to animals or issue official identification to owners of breeding flocks for application to animals in those flocks. APHIS and State personnel who apply or issue official identification must provide to APHIS, in a manner acceptable to APHIS, assignment data associating the serial numbers applied to animals or issued to owners, to the flock of origin and, when required, the flock of birth. Accredited veterinarians who apply official serial numbers or devices when requested by APHIS a must provide to APHIS, in a manner acceptable to APHIS, assignment data associating the serial sequences applied to animals to the flock of origin and, when required, the flock of birth. One such method would be to enter the data into the National Scrapie Database. Such requests may be made directly to a person or persons or to accredited veterinarians as a group through amendment of the Scrapie Program Standards Volume 1: National Scrapie Eradication Program.
(2) Assignment of serial numbers. The official responsible for issuing eartags in a State may also assign serial numbers of official eartags to other responsible persons, such as 4-H leaders, if the State Animal Health Official and Veterinary Services, Field Operations, AVIC responsible for the State involved agree that such assignments will improve scrapie control and eradication within the State. Such persons assigned serial numbers may either directly apply eartags to animals, or may reassign eartag numbers to producers. Such persons must maintain appropriate records in accordance with paragraph (g) of this section that permit traceback of animals to their flock of origin, or flock of birth when required, and must either reassign the tags in the National Scrapie Database or, if permitted by the Veterinary Services, Field Operations, AVIC responsible for the State involved, provide a written record of the reassignment to the Field Office or the State Office for entry into the National Scrapie Database.
(3) Persons handling sheep and goats in commerce. Sets of unique individual identification serial numbers may be assigned to persons who handle sheep and goats, that did not originate in a breeding flock owned by them, if they apply to and are approved by the State Animal Health Official or the Veterinary Services, Field Operations, AVIC responsible for the State in which the person maintains his or her business location, whichever is responsible for issuing official identification devices or numbers in that State and for assigning flock identification numbers and premises identification numbers in that State in the National Scrapie Database. When requested by APHIS, persons who apply official identification to sheep or goats that did not originate in a breeding flock owned by them must provide, in a manner acceptable to APHIS, assignment data associating assigned serial sequences to the flock of origin and, when required, the flock of birth. One such method would be to enter the data into the National Scrapie Database. The request may be made directly to a person or persons or to a class of persons through amendment of the Scrapie Program Standards Volume 1: National Scrapie Eradication Program. The State Animal Health Official or the Administrator may limit the assignment of official identification devices or numbers to persons, or classes of persons, for use on animals that did not originate in a breeding flock owned by them to slaughter only devices or numbers.
(4) Breed registries. Sets of unique individual identification numbers may also be assigned by the Administrator to breed registries that agree to reassign the sequences to the flock of origin and, and when required, the flock of birth and to provide associated registry identifiers such as registry tattoo numbers to APHIS in the National Scrapie Database.
(5) Noncompliance. In addition to any applicable criminal or civil penalties any person who fails to comply with the requirements of this section or that makes false statements in order to acquire official identification numbers or devices shall not be assigned official identification numbers or official identification devices for a period of at least 1 year. If a person who is not in compliance with these requirements has already been assigned such numbers, the Administrator may withdraw the assignment by giving notice to such person. Such withdrawal or failure to assign official identification numbers may be appealed in accordance with § 79.4(c)(3). A person shall be subject to criminal and civil penalties if he or she continues to use assigned numbers that have been withdrawn from his or her use.
(c) No person shall apply a premises or flock identification number or a brand or earnotch pattern to an animal that did not originate on the premises or flock to which the number was assigned by a State or APHIS representative or to which the brand or earnotch pattern has been assigned by an official brand registry. This includes individual identification such as USDA eartags that have been assigned to a premises or flock and registration tattoos that contain prefixes that have been assigned to a premises or flock for use as premises or flock identification. Unless the number sequence was issued specifically for use on animals born in a flock, this would not preclude the owner of a flock from using an official premises or flock identification number tag assigned to that flock on an animal owned by him or her that resides in that flock but that was born or previously resided on a different premises as long as the records required in paragraph (g) of this section are maintained.
(d) No person shall sell or transfer an official identification device or number assigned to his or her premises or flock except when it is transferred with a sheep or goat to which it has been applied as official identification or as directed in writing by an APHIS or State representative.
(e) No person shall use an official identification device or number provided for the identification of sheep and goats other than for the identification of a sheep or goat.
(f) Persons who engage in the interstate commerce of animals including persons that handle or own animals that have been in interstate commerce or that purchase, acquire, sell, or dispose of sheep and/or goats from or to persons who engage in the interstate commerce of animals, whether or not the animals are required to be officially identified, must maintain business records (such as yarding receipts, sale tickets, invoices, and waybills) for 5 years. These persons must make the records available for inspection and copying by any authorized USDA or State representative upon that representative's request and presentation of his or her official credentials. The records must include the following information:
(1) The number of animals purchased or sold (or transferred without sale);
(2) The date of purchase, sale, or other transfer;
(3) The name and address of the person from whom the animals were purchased or otherwise acquired or to whom they were sold or otherwise transferred;
(4) The species, breed, and class of animal. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead;
(5) A copy of the brand inspection certificate for animals officially identified with brands or ear notches;
(6) A copy of any certificate or owner/hauler statement required for movement of the animals purchased, sold, or otherwise transferred; and
(7) If the flock of origin or the receiving flock is under a flock plan or post-exposure management and monitoring plan, any additional records required by the plan.
(g) Persons who apply official individual or group/lot identification to animals must maintain records for 5 years. These persons must make the records available for inspection and copying by any authorized USDA or State representative upon that representative's request and presentation of his or her official credentials. The records must include the following information:
(1) The flock identification number of the flock of origin, the name and address of the person who currently owns the animals, and the name and address of the owner of the flock of origin if different;
(2) The name and address of the owner of the flock of birth, if known, for animals in another flock and not already identified to flock of birth;
(3) The date the animals were officially identified;
(4) The number of sheep and the number of goats identified;
(5) The breed and class of the animals. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead;
(6) The official identification numbers applied to animals by species or the GIN applied in the case of a group lot;
(7) Whether the animals were identified with “Slaughter Only” or “Meat” identification devices; and
(8) Any GIN with which the animal was previously identified.
(h) Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices, including devices applied to imported animals in their countries of origin and recognized by the Administrator as official, is prohibited except at the time of slaughter, at any other location upon the death of the animal, or as otherwise approved by the State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved when a device needs to be replaced.
(1) All man-made identification devices affixed to sheep or goats moved interstate must be removed at slaughter and correlated with the carcasses through final inspection by means approved by the Food Safety and Inspection Service (FSIS). If diagnostic samples, including whole heads, are taken, the identification devices must be packaged with the samples and must be left attached to approximately 1 inch of tissue or to the whole head to allow for identity testing and be correlated with the carcasses through final inspection by means approved by FSIS. Devices collected at slaughter must be made available to APHIS and FSIS.
(2) All official identification devices affixed to sheep or goat carcasses moved interstate for rendering must be removed at the rendering facility and made available to APHIS. If diagnostic samples, including whole heads, are taken, the identification devices must be packaged with the samples and must be left attached to approximately 1 inch of tissue or to the whole head to allow for identity testing.
(3) If a sheep or goat loses an official identification device except while in interstate commerce as described in paragraph (a)(3) of this section and needs a new one, the person applying the new official identification device must record the official identification number from the old device, if known, in addition to the information required to be recorded in accordance with paragraph (g) of this section.
(i) Replacement of official identification devices for reasons other than loss include:
(1) Circumstances under which a State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved may authorize replacement of an official identification device include, but are not limited to:
(i) Deterioration of the device such that loss of the device appears likely or the number can no longer be read;
(ii) Infection at the site where the device is attached, necessitating application of a device at another location (e.g., a slightly different location of an eartag in the ear);
(iii) Malfunction of the electronic component of a radio frequency identification (RFID) device; or
(iv) Incompatibility or inoperability of the electronic component of an RFID device with the management system or unacceptable functionality of the management system due to use of an RFID device.
(2) Any time an official identification device is replaced, as authorized by the State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved, the person replacing the device must record the following information about the event and maintain the record for 5 years:
(i) The date when the device was removed;
(ii) The address of the location and the name, phone number and email address of the person responsible for the location where the device was removed;
(iii) The official identification number (to the extent possible) on the device removed;
(iv) The type of device removed (e.g., metal eartag, RFID eartag);
(v) The reason for the removal of the device;
(vi) The new official identification number on the replacement device; and
(vii) The type of replacement device applied.
(j) Beginning on April 24, 2019, no more than one official eartag may be applied to an animal; except that:
(1) Another official eartag may be applied providing it bears the same official identification number as an existing one.
(2) In specific cases when the need to maintain the identity of an animal is intensified (e.g., such as for export shipments, quarantined herds, field trials, experiments, or disease surveys), a State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved may approve the application of a second official eartag. The person applying the second official eartag must record the following information about the event and maintain the record for 5 years: The date the second official eartag is added; the reason for the additional official eartag device; and the official identification numbers of both official eartags.
(3) An eartag with an animal identification number (AIN) beginning with the 840 prefix (either radio frequency identification or visual-only tag) may be applied to an animal that is already officially identified with another eartag. The person applying the AIN eartag must record the date the AIN tag is added and the official identification numbers of all official eartags on the animal and must maintain those records for 5 years.
(4) An official eartag that utilizes a flock identification number may be applied to a sheep or goat that is already officially identified with an official eartag if the animal has resided in the flock to which the flock identification number is assigned.
(k) Requirements for approval of official identification devices include:
(1) The Administrator may approve companies to produce official identification devices for use on sheep or goats. Devices may be plastic, metal, or other suitable materials and must be an appropriate size for use in sheep and goats. Devices must be able to legibly accommodate the required alphanumeric sequences. Devices must resist removal and be difficult to place on another animal once removed unless the construction of the device makes such tampering evident, but need not be tamper-proof. Devices must be readily distinguishable as USDA official sheep and goat identification devices; must carry the alphanumeric sequences, symbols, or logos specified by APHIS; must be an allowed color for the intended use, and must have a means of discouraging counterfeiting, such as use of a unique copyrighted logo or trade mark. Devices for use only on animals in slaughter channels must be medium blue and marked with the words “Meat” or “Slaughter Only”. Devices that use RFID must conform to ISO 11784 and ISO 11785 standards unless otherwise approved. The Administrator may specify the color, shape or size of a device for an intended use to make them readily identifiable.
(2) Written requests for approval of official identification devices for sheep and goats should be sent to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235. The request must include:
(i) The materials used in the device and in the case of RFID the transponder type and data regarding the lifespan and read range.
(ii) Any available data regarding the durability of the device, durability and legibility of the identification numbers, rate of adverse reactions such as ear infections, and retention rates of the devices in animals, preferably sheep and/or goats.
(iii) A signed statement agreeing to:
(A) Send official identification devices only to a State or APHIS representative, to the owner of a premises or to the contact person for a premises at the address listed in the National Scrapie Database, or as directed by APHIS;
(B) When requested by APHIS, provide a report by State of all tags produced, including the tag sequences produced and the name and address of the person to whom the tags were shipped, and provide supplemental reports of this information when requested by APHIS;
(C) Maintain the security and confidentiality of all tag recipient information acquired as a result of being an approved tag manufacturer and utilize the information only to provide official identification tags; and
(D) Enter the sequences of tags shipped in the National Scrapie Database through an internet web page interface or other means specified by APHIS prior to shipping the identification device.
(iv) Twenty-five sample devices. Additional tags must be submitted if requested by APHIS.
(3) Approval will only be given for devices for which data have been provided supporting high legibility, readability (visual and RFID), and retention rates in sheep and goats that minimize injury throughout their lifespan, or for which there is a reasonable expectation of such performance. Approval to produce official identification devices will be valid for 1 year and must be renewed annually. The Administrator may grant provisional approval to produce devices for periods of less than 1 year in cases where there is limited or incomplete data. The Administrator may decline to renew a company's approval or suspend or withdraw approval if the devices do not show adequate retention and durability or cause injury in field use or if any of the requirements of this section are not met by the tag company. Companies shall be given 60 days' written notice of intent to withdraw approval. Any person who is approved to produce official identification tags in accordance with this section and who knowingly produces tags that are not in compliance with the requirements of this section, and any person who is not approved to produce such tags but does so, shall be subject to such civil penalties and such criminal liabilities as are provided by 18 U.S.C. 1001, 7 U.S.C. 8313, or other applicable Federal statutes. Such action may be in addition to, or in lieu of, withdrawal of approval to produce tags.
The following prohibitions and movement conditions apply to the movement of or commingling with sheep and goats in interstate commerce, and no sheep or goat may be sold, disposed of, acquired, exhibited, transported, received for transportation, offered for sale or transportation, loaded, unloaded, or otherwise handled in interstate commerce, or commingled with such animals, or be loaded or unloaded at a premises or animal concentration point (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce except in compliance with this part.
(a) No sexually intact animal of any age or castrated animal 18 months of age and older (as evidenced by the eruption of the second incisor) may be moved or commingled with animals in interstate commerce unless it is individually identified to its flock of birth
(1) Animals in slaughter channels that are under 18 months of age (as evidenced by the eruption of the second incisor);
(2) Animals in slaughter channels at 18 months and older (as evidenced by the eruption of the second incisor) if the animals were kept as a group on the same premises on which they were born and have not been maintained in the same enclosure with unidentified animals from another flock at any time, including throughout the feeding, marketing, and slaughter process;
(3) An owner/hauler statement may be used instead of an ICVI for mixed source animals in slaughter channels 18 months of age and older (as evidenced by the eruption of the second incisor) that are identified with official individual identification or in the case of animals from flocks that are low-risk commercial flocks that are identified using identification methods or devices approved for this purpose;
(4) Animals moving for grazing or other management purposes between two premises both owned or leased by the flock owner and recorded in the National Scrapie Database as additional flock premises and where commingling will not occur with unidentified animals that were born in another flock or any animal that is not part of the flock. A request to APHIS to enter additional flock premises in the National Scrapie Database is required before animals are first moved to the premises. Notification is not required for each subsequent movement of animals to that premises. Neither group lot ID nor an owner/hauler statement is required for movements of a flock or its members for flock management purposes within a contiguous premises spanning two or more States. This provision does not include the transiting or sale of animals through such a premises in circumvention of the other requirements of this part; and
(5) Animals moving to a livestock facility approved in accordance with § 71.20 of this subchapter and that has agreed to act as an agent for the owner to apply official identification if the animals have been in the same flock in which they were born and have not been maintained in the same enclosure with unidentified animals born in another flock at any time. Such facilities may identify animals after sale if the facility maintains unidentified animals from different flocks of origin or when required birth in separate enclosures until officially identified.
(b) No scrapie-positive or suspect animal may be moved other than by permit to an APHIS approved research or quarantine facility or for destruction under APHIS or State supervision. Such animals must be individually identified and listed on the permit.
(c) No indemnified high-risk animal or indemnified sexually intact genetically susceptible exposed animal may be moved other than by permit to an APHIS approved research or quarantine facility or for destruction at another site. Such animals that are not indemnified and are not scrapie-positive or suspect animals may be moved to slaughter under permit. Animals moved in accordance with this paragraph must be individually identified and listed on the permit.
(d) No exposed animal may be moved unless it is officially individually identified.
(e) No animal may be moved from an infected flock or source flock except as allowed by an approved flock plan.
(f) No animal may be moved from an exposed flock, a flock under investigation or a flock subject to a PEMMP except as allowed in a PEMMP or where a PEMMP is not required, as allowed by written instructions from an APHIS or State representative.
(g) Animals moved to slaughter:
(1) Once an animal enters slaughter channels the animal may not be removed from slaughter channels. An animal is in slaughter channels if it was sold through a restricted animal sale, resided in a terminal feedlot, was sold with a bill of sale marked for slaughter only, was identified with an identification device or tattoo marked “Slaughter Only” or “MEAT” or was moved in a manner not permitted for other classes of animals. Animals in slaughter channels may move either directly to a slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot, or may move indirectly to such a destination through a restricted animal sale or restricted livestock facility. Once an animal has entered slaughter channels it may only be officially identified with an official blue eartag marked with the words “Meat” or “Slaughter Only” or an ear tattoo reading “Meat.” Animals in slaughter channels must be accompanied by an owner/hauler statement. The statement must also include the name and address of the person or livestock facility from which and where they were acquired, if different from the owner; the slaughter establishment, restricted animal sale, restricted livestock facility or terminal feedlot to which they are being moved, and a statement that the animals are in slaughter channels. A copy of the owner/hauler statement must be provided to the slaughter establishment, restricted animal sale, restricted livestock facility or terminal feedlot to which the animals are moved. Any bill of sale regarding the animals must indicate that the animals were sold for slaughter only.
(2) Animals that were in slaughter channels before arriving at a sale and animals that cannot meet the ID and ICVI requirements for unrestricted movement prior to leaving a sale may not be sold at an unrestricted sale. This does not preclude animals sold at an unrestricted sale from being moved in slaughter channels after sale if identified as required for animals in slaughter channels.
(3) Animals in slaughter channels may not be held in the same enclosure with sexually intact animals from another flock of origin that are not in slaughter channels.
(h) No animals designated for testing as part of a classification or reclassification investigation may be moved until testing is completed and results reported, except for movement by permit for testing, slaughter, research, or destruction. Such animals must be individually identified and listed on the permit.
(i) The following animals, if not restricted as part of a flock plan or PEMMP, may be moved to any destination without further restriction after being officially identified and designated or redesignated by a DSE to be:
(1) Genetically resistant exposed sheep;
(2) Genetically less susceptible exposed sheep; or
(3) Low-risk exposed animals.
(j) Animals moved from Inconsistent States must meet the following requirements in addition to other requirements of this section.
(1) Sheep and goats not in slaughter channels must be enrolled in the Scrapie Free Flock Certification Program or an equivalent APHIS recognized program or be sheep that are officially genotyped and determined to be AA QR or AA RR, be officially identified, and be accompanied by an ICVI that also states the individual animal identification numbers, the flock of origin, and the flock of birth, if different.
(2) Animals in slaughter channels must be officially identified with an official blue eartag marked with the words “Meat” or “Slaughter Only” and may move only directly to slaughter or to a terminal feedlot. Animals 18 months of age and older (as evidenced by the eruption of the second incisor) in slaughter channels must also be accompanied by an ICVI that states the individual animal identification numbers, and the flock of birth (and the flock of origin, if different).
(k) APHIS may enter into compliance agreements with persons such as dealers and owners of slaughter establishments and markets whereby animals may be received unidentified or without a required owner/hauler statement even if they cannot be identified to their flock of birth or origin because they were moved or commingled while unidentified, in violation of this part or a State requirement as provided by § 79.6. Provided that, the agreement requires the person signing the agreement to report the violation to the Veterinary Services, Field Operations, AVIC responsible for the State involved so that corrective action can be taken against the principal violator. In such cases the animal must be identified with a slaughter only tag, and is moved only in slaughter channels or, in the case of sheep, moved for other purposes if the animal is inspected by an accredited veterinarian, found free of evidence of infectious or contagious disease, and officially genotyped as AA QR or AA RR where Q and R refer to codon 171 and A refers to codon 136. APHIS may also enter into compliance agreements with persons or in the case of approved livestock facilities may amend an approved livestock facility agreement to establish alternative methods to maintain the traceability of animals in slaughter channels to their flock of origin or waive the requirement for individual official identification of animals in slaughter channels if adequate surveillance has been conducted on the flock of origin or an alternative plan is in place to conduct surveillance on animals from the flock of origin when the Administrator and the State Animal Health Official agree that the application of an allowed official identification device or method is unsuitable for a specific circumstance. An example of a specific circumstance could be large unruly horned male goats moving through approved livestock facilities.
(a) Designation. Based on a classification investigation as defined in § 79.1, including testing of animals, if needed, a designated scrapie epidemiologist will designate a flock to be an exposed flock, an infected flock, a source flock, a flock under investigation, and/or a non-compliant flock, or designate an animal to be a scrapie-positive animal, high-risk animal, exposed animal, genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, and/or a suspect animal after determining that the flock or animal meets the criteria of the relevant definition in § 79.1.
(b) Redesignation. A reclassification investigation as defined in § 79.1 may be conducted to determine whether the current designated status of a flock or animal may be changed or removed. Reclassification investigations will be initiated and conducted, and redesignation decisions will be made, in accordance with procedures approved by the Administrator. These procedures are available at http://www.aphis.usda.gov/animal-health/scrapie.
(c) Testing and notification procedures. Any animal that may be a high-risk animal, any animal that may have been exposed to the lambing of a high-risk animal, any suspect animal, and any animal that was born in the flock after a high-risk animal may have lambed may be selected for testing by the DSE or an APHIS or State representative working under the direction of a DSE or the Administrator. Which animals are selected and the method of testing selected animals will be based on the risk associated with the flock and the type and number of animals available for test. When flock records are adequate to determine that all high-risk animals that lambed in the flock are available for testing, the testing may be limited to postmortem testing of all high-risk and suspect animals. Testing may also include an official genotype test, live-animal testing using a live-animal official test, the postmortem examination and testing of genetically susceptible animals in the flock that cannot be evaluated by a live animal test, postmortem examination of other animals, and postmortem examination and testing of animals found dead or cull animals at slaughter. Animals may not be tested for scrapie to establish the designation of the flock until they are test eligible. Animals are generally considered test eligible when the animals are over 14 months of age if born after the exposure or are 18 months post exposure. If testing these animals is necessary to establish the status of a flock they must be held for later testing unless sent directly to slaughter or a terminal feedlot.
(1) Noncooperation. If an owner does not make his or her animals available for testing within 60 days of notification by an APHIS or State representative, within 60 days of becoming test eligible, or as mutually agreed in writing by the Administrator and the owner, or fails to submit required postmortem samples, the flock will be designated a source, infected, or exposed flock, whichever definition applies and a noncompliant flock.
(2) Notice to owner. As soon as possible after making a designation or redesignation determination, a State or APHIS representative will attempt to notify the owner(s) of the flock(s) or animal(s) in writing of the designation.
(3) Appeal. The owner of an animal may appeal the designation of an animal as a scrapie-positive animal, high-risk animal, exposed animal, genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, or a suspect animal. The owner of a flock may appeal the designation of the flock as an exposed flock, an infected flock, a source flock, a flock under investigation, or a non-compliant flock. The owner of a laboratory or test manufacturing facility may appeal the suspension or withdrawal of approval for a laboratory or a test. To do so, the owner must appeal by writing to the Administrator within 10 days after being informed of the reasons for the proposed action. The appeal must include all of the facts and reasons upon which the owner relies to show that the proposed action is incorrect or is not supported. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The final determination of the Administrator shall become effective upon oral or written notification, whichever is earlier, to the owner. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. The Administrator's final determination constitutes final agency action.
(a) ICVIs are required as specified by § 79.3 for certain interstate movements of sheep or goats and may be used to meet the requirements for entry into terminal feedlots. An ICVI and all copies must be legible and must show the following information, except when § 79.3 states that the information is not required for the specific type of interstate movement:
(1) The ICVI must show the species, breed or, if breed is unknown, the face color of sheep or the type of goats (milk, fiber, or meat), and class of animal, such as replacement ewe lambs, slaughter lambs or kids, cull ewes, club lambs, bred ewes, etc.; the number of animals covered by the ICVI; the purpose for which the animals are to be moved; the address at which the animals were loaded for interstate movement or for movement to a terminal feedlot when an ICVI is required; the address to which the animals are destined; and the names of the consignor and the consignee and their addresses if different from the address at which the animals were loaded or the address to which the animals are destined; and if different the current owner;
(2) Each animal's official individual identification numbers: Provided, that, in the case of animals identified with official identifications devices or methods that include the flock identification number(s) assigned to the flock(s) of origin in the National Scrapie Database and an individual animal number unique within the flock, the flock identification number(s) may be recorded instead of the individual identification numbers, and for animals allowed by § 79.3 to move with group lot identification, the group lot number may be recorded instead of the individual identification numbers. An ICVI may not be issued for any animal that is not officially identified if official identification is required. If the animals are not required by the regulations to be officially identified, the ICVI must state the exemption that applies (e.g., sheep and goats moving for grazing without change of ownership). If the animals are required to be officially identified but the identification number is not required to be recorded on the ICVI, the ICVI must state that all animals to be moved under the ICVI are officially identified and state the exemption that applies (e.g. the ewes are identified with flock of origin tags so only the flock ID must be recorded on the ICVI); and
(3) A statement by the issuing accredited, State, or Federal veterinarian to the effect that on the date of issuance the animals were free of evidence of infectious or contagious disease and insofar as can be determined exposure thereto. This statement may be made with respect to scrapie for animals exposed to scrapie that's movement is not restricted that have been designated genetically resistant or less susceptible sheep or low-risk exposed animals. Except as provided in paragraphs (b) and (c) of this section, all information required by this paragraph must be typed or legibly written on the ICVI. Note that in accordance with paragraphs (a), (b), and (e) of § 79.3, scrapie-positive, suspect, and high-risk animals, some exposed animals, and some animals that originated in an infected or source flock require permits rather than ICVIs.
(4) The ICVI must be signed by the issuing State, Federal, Tribal or accredited veterinarian and must be legible on all copies.
(b) As an alternative to typing or writing individual animal identification on an ICVI, if agreed to by the receiving State or Tribe, another document may be used to provide this information, but only under the following conditions:
(1) The document must be a State form or APHIS form that requires individual identification of animals or a printout of official identification numbers generated by computer or other means;
(2) A legible copy of the document must be stapled to the original and each copy of the ICVI;
(3) Each copy of the document must identify each animal to be moved with the ICVI, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and
(4) The following information must be written in ink in the identification column on the original and each copy of the ICVI and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the document; and
(ii) Either the unique serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who prepared the document and the date the document was signed.
(c) Ownership brands documents attached to ICVIs. As an alternative to typing or writing ownership brands on an ICVI, an official brand inspection certificate may be used to provide this information, but only under the following conditions:
(1) A legible copy of the official brand inspection certificate must be stapled to the original and each copy of the ICVI;
(2) Each copy of the official brand inspection certificate must show the ownership brand of each animal to be moved with the ICVI, but any other ownership brands, and any unused space for recording ownership brands, must be crossed out in ink; and
(3) The following information must be typed or written in ink in the official identification column on the original and each copy of the ICVI and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the attached document; and
(ii) Either the serial number on the official brand inspection certificate or, if the official brand inspection certificate is not imprinted with a serial number, both the name of the person who prepared the official brand inspection certificate and the date it was signed.
(d) If more than one page is used each page must be sequentially numbered with the page number and the total number of pages (for example 1 of 2, 2 of 2).
(a) In reviewing a State for Consistent State status, the Administrator will evaluate the State statutes, regulations, and directives pertaining to animal health activities; reports and publications of the State animal health agency; and a written statement from the State animal health agency describing State scrapie control activities, including scrapie surveillance activities, and certifying that these activities meet the requirements of this section. In determining whether a State is a Consistent State, the Administrator will determine whether the State:
(1) Has the authority, based on State law or regulation, to restrict the movement of all scrapie-infected and source flocks.
(2) Has the authority, based on State law or regulation, to require the reporting of any animal suspected of having scrapie and test results for any animals tested for scrapie to State or Federal animal health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a memorandum of understanding between APHIS and the State that delineates the respective roles of each in the National Scrapie Program implementation.
(4) Has placed all known scrapie-infected and source flocks under movement restrictions, with movement of animals only to slaughter, to feedlots under permit and movement restrictions that ensure later movement to slaughter, for destruction, or for research. Scrapie-positive and suspect animals may be moved only for transport to an approved research facility or for purposes of destruction.
(5) Has effectively implemented policies to:
(i) Investigate all animals reported as scrapie suspect animals within 7 days of notification;
(ii) Designate a flock's status, within 15 days of notification that the flock contains a scrapie-positive animal, based on an investigation by State or Federal animal health authorities and in accordance with this part;
(iii) Restrict the movement, in accordance with paragraph (a)(4) of this section, of newly designated scrapie-infected and source flocks within 7 days after they are designated in accordance with § 79.4;
(iv) Relieve infected and source flock movement restrictions only after completion of a flock plan created in accordance with § 54.14 of this chapter or a flock plan created in accordance with an approved scrapie control pilot project, or as permitted by the conditions of such a flock plan, and after agreement by the owner to comply with a 5-year post-exposure management and monitoring plan;
(v) Conduct an epidemiologic investigation of source and infected flocks that includes the designation of high-risk and exposed animals and that identifies animals to be traced;
(vi) Conduct tracebacks of scrapie-positive animals and traceouts of high-risk and exposed animals and report any out-of-State traces to the appropriate State within 45 days of receipt of notification of a scrapie-positive animal; and
(vii) Conduct tracebacks based on slaughter sampling within 15 days of receipt of notification of a scrapie-positive animal at slaughter.
(6) Effectively monitors and enforces quarantines.
(7) Effectively enforces State reporting laws and regulations for scrapie.
(8) Has designated at least one APHIS or State animal health official to coordinate scrapie program activities in the State and to serve as the designated scrapie epidemiologist in the State.
(9) Has educated those engaged in the interstate movement of sheep and goats regarding the identification and recordkeeping requirements of this part.
(10) Has effectively implemented ongoing scrapie surveillance that meets the following criteria:
(i) Collects and submits surveillance samples from targeted animals slaughtered in State-inspected establishments and from slaughter establishments within the State that are not covered under § 71.21 of this subchapter, or allows and facilitates the collection of such samples by USDA personnel or contractors; and
(ii) Transmits required submission and epidemiological information for all scrapie samples using the electronic submission system provided by APHIS for inclusion in the National Scrapie Database and for transmission of the submission information to an approved laboratory; and
(iii) Achieves the annual State-level scrapie surveillance minimums for sheep and goats originating from the State as determined annually by the Administrator with input from the States and made available to the public at http://www.aphis.usda.gov/animal-health/scrapie at least 6 months before the start of the collection period; or
(iv) Conducts annual surveillance at a level that will detect scrapie if it is present at a prevalence of 0.1 percent in the population of targeted animals originating in the State, with a 95 percent confidence.
(11) If a State does not meet the requirements of paragraph (a)(10) of this section as of April 24, 2019, the State must provide APHIS with a plan and a timeline for complying with all the requirements of paragraph (a)(10) by April 24, 2020, and must meet the requirements of paragraph (a)(10) of this section by April 26, 2021.
(12) Requires, based on State law or regulation, and effectively enforces official identification upon change of ownership of all animals of any age not in slaughter channels and any sheep over 18 months of age as evidenced by eruption of the second incisor such that the animal may be traced to its flock of birth; provided that:
(i) A State may exempt commercial goats in intrastate commerce that have not been in contact with sheep from this identification requirement if there has been in that State no case of scrapie in a commercial goat in the past 10 years that originated in that State and cannot be attributed to exposure to infected sheep, and there are no exposed commercial goat herds in that State; and
(ii) A State may exempt commercial whitefaced sheep or commercial hair sheep under 18 months of age in intrastate commerce from this identification requirement if there has been in that State no case of scrapie in the exempted class that originated from that State, and there are no exposed commercial whitefaced or hair sheep flocks in that State that have been exposed by a female animal.
(iii) States that exempt these types of commercial animals must put in place the regulations necessary to require identification of these animals within 90 days of these conditions no longer existing.
(13) Maintains in the National Scrapie Database administered by APHIS, or in a State database approved by the Administrator as compatible with the National Scrapie Database, the State's:
(i) Premises information and assigned premises numbers and individual identification number sequences assigned for use as premises identification;
(ii) Individual animal information on all scrapie-positive, suspect, high-risk, and exposed animals in the State;
(iii) Individual animal information on all out-of-State animals to be traced; and
(iv) Accurate flock status data.
(14) Requires official individual identification of any live scrapie-positive, suspect, or high-risk animal of any age and of any sexually intact exposed animal of more than 1 year of age or any sexually intact exposed animal of less than 1 year of age upon change of ownership (except for exposed animals moving in slaughter channels at less than 1 year of age), whether or not the animal resides in a source or infected flock.
(15) Effectively enforces movement restrictions on all scrapie-positive, suspect, and high-risk animals throughout their lives unless they are moved in accordance with § 79.3.
(16) Requires that tissues from all scrapie-positive or suspect animals and female high-risk animals that have lambed (when they have died or have been destroyed) be submitted to a laboratory authorized by the Administrator to conduct scrapie tests and requires complete destruction of the carcasses of scrapie-positive and suspect animals.
(17) Prohibits any animal from being removed from slaughter channels unless it is identified to the flock of birth, is not from an Inconsistent State, and is not scrapie-exposed or from an infected or source flock.
(b) If the Administrator determines that statutory changes are needed to bring a State into full compliance, the Administrator may grant up to a 2-year extension from the date the State is notified of the deficiency to allow a State to acquire additional authorities before removing a State's Consistent Status. The decision to grant an extension will be based on the State's ability to prevent the movement of scrapie-infected animals out of the State and on the progress being made in making the needed statutory changes.
(c) When the Administrator determines that a State should be added to or removed from the list of Consistent States, APHIS will publish a notice in the
(a) The Administrator may waive the following requirements of this part for participants in a scrapie control pilot project by recording the requirements waived in the scrapie control pilot project plan:
(1) The determination that an animal is a high-risk animal, if the scrapie control pilot project plan contains testing or other procedures that indicate that an animal, despite meeting the definition of high-risk animal, is unlikely to spread scrapie; and
(2) The requirement that high-risk animals must be removed from a flock, if the scrapie control pilot project plan contains alternative procedures to prevent the further spread of scrapie without removing high-risk animals from the flock.
(b) [Reserved]
The following definitions apply to this part:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States providing a nationally unique identification number for each animal. The AIN contains 15 digits, with the first 3 being the country code (840 for the United States), the alpha characters USA, or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording. The AIN beginning with the 840 prefix may be used only on animals born in the United States.
APHIS. The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Approved livestock facility. A stockyard, livestock market, buying station, concentration point, or any other premises that has been approved under § 71.20 of this chapter.
Area veterinarian in charge. An APHIS veterinarian authorized by the Administrator to supervise and manage the animal health work of APHIS in a specified area of the United States.
Interstate. From one State into or through any other State.
Johne's disease. An infectious and communicable disease that primarily affects cattle, sheep, goats, and other domestic, exotic, and wild ruminants, also known as paratuberculosis, caused by Mycobacterium paratuberculosis.
Moved. Shipped, transported, delivered, or received for movement, or otherwise aided, induced, or caused to be moved.
Official eartag. An identification tag providing unique identification for individual animals. An official eartag which contains or displays an AIN with an 840 prefix must bear the U.S. shield. The design, size, shape, color, and other characteristics of the official eartag will depend on the needs of the users, subject to the approval of the Administrator. The official eartag must be tamper-resistant and have a high retention rate in the animal. Official eartags must adhere to one of the following numbering systems:
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
Official Johne's disease test. An organism detection test approved by the Administrator and conducted in a laboratory approved by the Administrator.
Owner-shipper statement. A statement signed by the owner or shipper of animals, which states: The number of animals to be moved, the official eartag number of each animal, the species of the animals, points of origin and destination, the consignor and consignee, a statement that the animals are positive to an official Johne's disease test, and any additional information required by this part.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority, a geographically distinct location from other premises. The premises identification number is associated with an address, geospatial coordinates, and/or other location descriptors which provide a verifiably unique location. The premises identification number may be used in conjunction with a producer's own livestock production numbering system to provide a unique identification number for an animal. The premises identification number may consist of:
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
Recognized slaughtering establishment. A slaughtering establishment
State. Any of the 50 States, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the District of Columbia, and any territories and possessions of the United States.
State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.
State representative. An individual employed in animal health work by a State or political subdivision of a State, and who is authorized by the State or political subdivision to perform tasks required by this part.
United States. All of the States.
Domestic animals that are positive to an official Johne's disease test may not be moved interstate except in compliance with this part.
(a) Movement of domestic animals for slaughter. Domestic animals that are positive to an official Johne's disease test may be moved interstate for slaughter if:
(1) The animals are moved directly to a recognized slaughtering establishment or to an approved livestock facility for sale to a recognized slaughtering establishment;
(2) An owner-shipper statement that identifies the animals as positive to an official Johne's disease test accompanies the animals during the movement and is delivered to the consignee;
(3) Each animal bears an official eartag; and
(4) The animals are moved to the destination in one continuous movement without unloading.
(b) Other movements. The Administrator may, upon request in specific cases, allow domestic animals that are positive to an official Johne's disease test to be moved interstate other than as provided in paragraph (a) of this section, under such conditions as the Administrator may prescribe in each case to prevent the spread of Johne's disease. The Administrator will promptly notify the State animal health officials of the States involved of any such action.
(c) Cleaning and disinfecting. Each means of conveyance used to transport the animals must be cleaned and disinfected in accordance with § 71.6 of this chapter. The facilities in which the animals were maintained must be cleaned and disinfected in accordance with § 71.7 of this chapter.
Animals that are positive to an official Johne's disease test may not be moved interstate in a railroad car, boat, truck, or other vehicle containing healthy animals susceptible to Johne's disease unless all of the animals are for immediate slaughter, or unless the positive animals are kept separate from the other animals by a partition that is securely affixed to the sides of the vehicle and prevents the transfer of fecal matter from the animals positive to an official Johne's disease test to the healthy animals in the vehicle.
These definitions are applicable to this part:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal. Any farmed or captive deer, elk, or moose.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal identification. A device or means of animal identification approved for use under this part by APHIS. Examples of animal identification devices that APHIS has approved are listed in § 55.25 of this chapter.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States. The AIN contains 15 digits, with the first 3 being the country code (840 for the United States), the alpha characters USA, or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording.
APHIS employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.
Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species. For the purposes of this part, the term “cervid” refers specifically to cervids susceptible to CWD. These are animals in the genera Odocoileus, Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
Chronic wasting disease (CWD). A transmissible spongiform encephalopathy of cervids. Clinical signs in affected animals include, but are not limited to, loss of body condition, behavioral changes, excessive salivation, increased drinking and urination, depression, and eventual death.
CWD Herd Certification Program. The Chronic Wasting Disease Herd Certification Program established in part 55 of this chapter.
Deer, elk, and moose. All animals in the genera Odocoileus, Cervus, and Alces and their hybrids.
Farmed or captive. Privately or publicly maintained or held for economic or other purposes within a perimeter fence or confined area, or captured from a wild population for interstate movement and release.
National Uniform Eartagging System. A numbering system for the official identification of individual animals in the United States providing a nationally unique identification number for each animal. The National Uniform Eartagging System employs an eight- or nine-character alphanumeric format, consisting of a two-number State or territory code, followed by two or three letters and four additional numbers. Official APHIS disease control programs may specify which format to employ.
Official animal identification. A device or means of animal identification approved for use under this part by APHIS to uniquely identify individual animals. Examples of approved official animal identification devices are listed in § 55.25 of this chapter. The official animal identification must include a nationally unique animal identification number that adheres to one of the following numbering systems:
(1) National Uniform Eartagging System. The CWD program allows the use of either the eight-character or nine-character format for cervids.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority, a geographically distinct location from other premises. The premises identification number is associated with an address, geospatial coordinates, and/or location descriptors which provide a verifiably unique location. The premises identification number may be used in conjunction with a producer's own livestock production numbering system to provide a unique identification number for an animal. It may also be used as a component of a group/lot identification number. The premises identification number may consist of:
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
Recognized slaughtering establishment. An establishment where slaughtering operations are regularly carried out under Federal or State inspection and which has been approved by the Animal and Plant Health Inspection Service to receive animals for slaughter.
Each animal required to be identified by this part must have at least two forms of animal identification attached to the animal. The means of animal identification must be approved for this use by APHIS, and must be an electronic implant, flank tattoo, ear tattoo, tamper-resistant ear tag, or other device approved by APHIS. One of the animal identifications must be an official animal identification as defined in this part, with a nationally unique animal identification number that is linked to that animal in the CWD National Database or in an approved State database. The second animal identification must be unique for the individual animal within the herd and also must be linked to that animal and herd in the CWD National Database or in an approved State database.
No farmed or captive deer, elk, or moose may be moved interstate unless it meets the requirements of this section.
(a) Animals in the CWD Herd Certification Program. The captive deer, elk, or moose is:
(1) Enrolled in the CWD Herd Certification Program and the herd has achieved Certified status in accordance with § 55.24 of this chapter; and
(2) Is accompanied by a certificate issued in accordance with § 81.4 that identifies its herd of origin and that states that the animal's herd has achieved Certified status and that the animal does not show clinical signs associated with CWD.
(b) Animals captured for interstate movement and release. If the captive deer, elk, or moose was captured from a wild population for interstate movement and release, each animal must have two forms of animal identification, one of which is official animal identification, and the certificate issued in accordance with § 81.4 that accompanies the animal must state that the source population has been documented to be low risk for CWD, based on a CWD surveillance program in wild cervid populations that is approved by the State Government of the receiving State and by APHIS.
(c) Animals moved to slaughter. The farmed or captive deer, elk, or moose must be moved directly to a recognized slaughtering establishment for slaughter, must have two forms of animal identification, one of which is official animal identification, and must be accompanied by a certificate issued in accordance with § 81.4.
(d) Research animal movements and permits. A research animal permit is required for the interstate movement of cervids for research purposes. The permit will specify any special conditions of the movement determined by the Administrator to be necessary to prevent the dissemination of CWD. The Administrator may, at his or her discretion, issue the permit if he or she determines that the destination facility has adequate biosecurity and that the movement authorized will not result in the interstate dissemination of CWD.
(1) To apply for a research animal permit, contact an APHIS employee or State representative and provide the following information:
(i) The name and address of the person to whom the special permit is issued, the address at which the research cervids to be moved interstate are being held, and the name and address of the person receiving the cervids to be moved interstate;
(ii) The number and type of cervids to be moved interstate;
(iii) The reason for the interstate movement;
(iv) Any safeguards in place to prevent transmission of CWD during movement or at the receiving location; and
(v) The date on which movement will occur.
(2) A copy of the research animal permit must accompany the cervids moved, and copies must be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination at least 72 hours prior to the arrival of the cervids at the destination listed on the research animal permit.
(e) Interstate movements approved by the Administrator. Notwithstanding any other provision of this part, interstate movement of farmed or captive deer, elk, and moose may be allowed on a case-by-case basis when the Administrator determines that adequate survey and mitigation procedures are in place to prevent dissemination of CWD and issues a permit for the movement.
(a) Information required on certificates. A certificate must show any official animal identification numbers of each animal to be moved. A certificate must also show the number of animals covered by the certificate; the purpose for which the animals are to be moved; the points of origin and destination; the consignor; and the consignee. The certificate must include a statement by the issuing accredited veterinarian, State veterinarian, or Federal veterinarian that the animals were not exhibiting clinical signs associated with CWD at the time of examination. The certificate must also include a statement that the animals are from a herd that has achieved Certified status in the CWD Herd Certification Program, and must provide the herd's program status, with the following exceptions:
(1) Certificates issued for animals captured from a wild population for interstate movement and release do not need to state that the animals are from a herd that has achieved Certified status in the CWD Herd Certification Program but must include the statement required in § 81.3(b); and
(2) Certificates issued for animals moved directly to slaughter do not need to state that the animals are from a herd that has achieved Certified status in the CWD Herd Certification Program and must state that an APHIS employee or State representative has been notified in advance of the date the animals are being moved to slaughter.
(b) Animal identification documents attached to certificates. As an alternative to typing or writing individual animal identification on a certificate, another document may be used to provide this information, but only under the following conditions:
(1) The document must be a State form or APHIS form that requires individual identification of animals;
(2) A legible copy of the document must be stapled to the original and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved with the certificate, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and
(4) The following information must be typed or written in ink in the identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who issued the document and the date the document was issued.
Farmed or captive deer, elk, or moose may be moved through a State or locality whose laws or regulations on the movement of those animals are more restrictive than this part to another State under the following conditions:
(a) The farmed or captive deer, elk, or moose must be eligible to move interstate under § 81.3.
(b) The farmed or captive deer, elk, or moose must meet the entry requirements of the destination State listed on the certificate or permit accompanying the animal.
(c) Except in emergencies, the farmed or captive deer, elk, or moose must not be unloaded until their arrival at their destination.
State and local laws and regulations on farmed or captive deer, elk, or moose with respect to CWD that are more restrictive than the regulations in this part are not preempted by this part, except as described in § 81.5.
As used in connection with this subpart, the following terms shall have the meaning set forth in this section.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any individual authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Bird. Any member of the class aves other than poultry.
Commercial birds. Birds that are moved or kept for resale, breeding, public display, or any other purpose, except pet birds.
Dressed carcasses. Carcasses of birds or poultry that have been eviscerated, with heads and feet removed, or parts or products of such carcasses.
Exposed. At risk of developing Newcastle disease because of association with birds or poultry infected with Newcastle disease, excrement from birds or poultry infected with Newcastle disease, or other material touched by birds or poultry infected with Newcastle disease, or because there is reason to believe that association has occurred with Newcastle disease or vectors of Newcastle disease, as determined by either a Federal veterinarian or a State veterinarian.
Federal representative. An individual employed and authorized by the Federal government to perform the tasks required by this subpart.
Federal veterinarian. A veterinarian employed and authorized by the Federal government to perform the tasks required by this subpart.
Hatching eggs. Eggs in which birds or poultry are allowed to develop.
Infected. Affected by the virus or bacterium that causes the specified disease.
Interstate. From one State into or through any other State.
Known to be exposed. Determined by either a Federal veterinarian or a State veterinarian to be at risk of developing Newcastle disease because of association with birds or poultry infected with Newcastle disease, excrement from birds or poultry infected with Newcastle disease, or other material touched by birds or poultry infected with Newcastle disease, or because there is reason to believe that association has occurred with Newcastle disease or vectors of Newcastle disease, as determined by either a Federal veterinarian or a State veterinarian.
Known to be infected. Determined by either a Federal veterinarian or a State veterinarian to be affected by the virus or bacterium that causes the specified disease.
Litter. Material that is used to collect and absorb bodily wastes from birds or poultry.
Moved. Shipped, transported or otherwise moved, or delivered or received for movement, by any person.
Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residues between residues 113 and 116. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.
Official seal. A serially numbered metal or plastic strip, consisting of a self-locking device on one end and a slot on the other end, that forms a loop when the ends are engaged and that cannot be reused if opened, or a serially numbered, self-locking button that can be used for this purpose.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Pet birds. Birds, except ratites, that are kept for the personal pleasure of their individual owners and are not intended for resale.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys.
Ratites. Cassowaries, emus, kiwis, ostriches, and rheas.
Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts.
Render. Reduce, convert, or melt down by heating to a temperature of at least 230 °F so that oil is removed.
State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
State animal health official. The State official responsible for livestock- and poultry-disease control and eradication programs.
State representative. An individual employed in animal health work and authorized by a State or political subdivision of a State to perform the tasks required by this subpart.
State veterinarian. A veterinarian employed and authorized by a State or political subdivision of a State to perform the tasks required by this subpart.
Veterinarian in charge. A Federal veterinarian employed by the Animal and Plant Health Inspection Service and authorized by the Administrator to supervise and manage the animal health work of the Animal and Plant Health Inspection Service in a specified area of the United States.
(a) The determination that birds or poultry are infected with Newcastle disease must be made by either a Federal veterinarian or a State veterinarian.
(b) The determination that birds or poultry are exposed to Newcastle disease must be made by either a Federal veterinarian or a State veterinarian. They will base that determination on an evaluation of all related circumstances, including: the proximity of the birds or poultry to birds or poultry infected with Newcastle disease, to excrement from birds or poultry infected with Newcastle disease, and to other material touched by birds or poultry infected with Newcastle disease; the number of birds or poultry infected with Newcastle disease to which the birds or poultry were exposed; the species involved; the virulence of the Newcastle disease to which the birds or poultry were exposed; and the length of time the birds or poultry were in contact with birds or poultry infected with Newcastle disease, and to material touched by birds or poultry infected with Newcastle disease. Birds or poultry determined to be exposed to Newcastle disease will continue to be treated as exposed unless they are subsequently determined to be infected with Newcastle disease or until either a Federal veterinarian or a State veterinarian finds them to be free of Newcastle disease based on one or more of the factors listed in paragraph (a) of this section.
(a) Any area where birds or poultry infected with Newcastle disease are located will be designated as a quarantined area. A quarantined area is any geographical area, which may be a premises or all or part of a State, deemed by epidemiological evaluation to be sufficient to contain all birds or poultry known to be infected with or exposed to Newcastle disease. Less than an entire State will be designated as a quarantined area only if the State enforces restrictions on intrastate movements from the quarantined area that are at least as stringent as this subpart.
(b) Any area designated as a quarantined area because of Newcastle disease will remain designated as a quarantined area until all of the requirements of § 82.14 have been met.
(c) The following areas are quarantined because of Newcastle disease: There are no areas in the United States quarantined because of Newcastle disease.
(a) Prohibitions. The following articles may not be moved interstate from a quarantined area:
(1) Dead birds and dead poultry, including any parts of the birds or poultry, that are infected with Newcastle disease, or are from a flock of birds or poultry infected with Newcastle disease;
(2) Litter used by or manure generated by birds or poultry, or a flock of birds or poultry, infected with Newcastle disease, except as provided in § 82.7(b);
(3) Any eggs from birds or poultry, or a flock of birds or poultry, infected with Newcastle disease;
(4) Hatching eggs from flocks of birds or poultry exposed to Newcastle disease; and
(5) Live birds or live poultry from flocks infected with or exposed to Newcastle disease.
(b) Restrictions. The following articles may be moved interstate from a quarantined area only in accordance with this subpart:
(1) Live birds or live poultry not known to be infected with or exposed to Newcastle disease;
(2) Dressed carcasses of birds and poultry, and other dead birds and dead poultry, including any parts of the birds or poultry, that are not known to be infected with Newcastle disease;
(3) Litter used by or manure generated by birds or poultry not known to be infected with Newcastle disease;
(4) Eggs, other than hatching eggs, from birds or poultry from flocks not known to be infected with Newcastle disease;
(5) Hatching eggs from birds or poultry not known to be infected with or exposed to Newcastle disease; and
(6) Cages, coops, containers, troughs, vehicles, or other equipment used for birds, poultry, eggs, manure, or litter.
(c) Exceptions. This subpart does not apply to the interstate movement of birds, poultry, or other articles from a quarantined area if the interstate movement is made by the United States Department of Agriculture for purposes of research or diagnosis.
(a) Pet birds. An individual may move his or her pet birds interstate from a quarantined area only if the birds are not known to be infected with or exposed to Newcastle disease and the following requirements are fulfilled:
(1) Epidemiological and testing requirements. For all pet birds moved interstate, epidemiological evidence must indicate that the birds are not infected with any communicable disease.
(i) Pet birds that have been under the control and ownership of the owner for at least 90 days. Pet birds that have been under the ownership and control of the individual to whom the permit is issued for the 90 days before interstate movement, show no clinical signs of sickness (such as diarrhea, nasal discharge, ocular discharge, ruffled feathers, or lack of appetite) during the 90 days before interstate movement, and have been maintained apart from other birds and poultry in the quarantined area during the 90 days before interstate movement may be moved to a location outside the quarantined area for subsequent examination. The individual to whom the permit is issued must maintain ownership and control of the birds and maintain them apart from other birds and poultry from the time they arrive at the place to which the individual is taking them until a Federal representative or State representative
(ii) All other pet birds. Pet birds that do not meet the criteria in paragraph (a)(2)(i) of this section may only be moved to a USDA-approved quarantine facility outside the quarantined area for a 30-day quarantine before being released. The individual to whom the permit is issued must maintain ownership and control of the birds and maintain them isolated from other birds or poultry until the time they arrive at the USDA-approved quarantine facility. The pet bird owner is responsible for all costs associated for keeping his or her pet birds at the USDA-approved quarantine facility for the 30-day quarantine period.
(2) Movement restrictions. All pet birds must be moved interstate from a quarantined area under the following conditions:
(i) The birds are accompanied by a permit obtained in accordance with § 82.11.
(ii) The birds are moved interstate by the individual to whom the permit is issued.
(iii) The birds are caged while being moved interstate.
(iv) Within 24 hours of a bird's dying or showing clinical signs of sickness (such as diarrhea, nasal discharge, ocular discharge, ruffled feathers, or lack of appetite), the individual to whom the permit is issued notifies the veterinarian in charge or the State animal health official
(v) The individual to whom the permit is issued submits copies of the permit so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the birds at the destination listed on the permit.
(b) Other birds (including commercial birds) and poultry. Except as provided for pet birds in paragraph (a) of this section, a person may move live birds (including commercial birds) and live poultry that are not known to be infected with or exposed to Newcastle disease interstate from a quarantined area only if:
(1) The birds and poultry are accompanied by a permit obtained in accordance with § 82.11;
(2) The birds or poultry are covered in such a way as to prevent feathers and other debris from blowing or falling off the means of conveyance;
(3) The birds or poultry are moved in a means of conveyance either under official seal or are accompanied by a Federal representative;
(4) Except for emergencies, the birds or poultry are not unloaded until their arrival at the destination listed on the permit required by paragraph (b)(1) of this section;
(5) If poultry or ratites, the poultry or ratites are moved interstate to a recognized slaughtering establishment
(6) If birds other than poultry, the birds are moved to a site approved by the Administrator; and
(7) The permit required by paragraph (b)(1) of this section is presented upon arrival at the recognized slaughtering establishment or approved site to a State representative or Federal representative. Copies of the permit must also be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of arrival at the recognized slaughtering establishment.
(a) Except as provided in paragraph (b) of this section for dressed carcasses, dead birds and dead poultry, including any parts of the birds and poultry, that are not known to be infected with Newcastle disease may be moved interstate from a quarantined area only if:
(1) The dead birds and dead poultry are accompanied by a permit obtained in accordance with § 82.11;
(2) The dead birds and dead poultry are covered in such a way as to prevent feathers and other debris from blowing or falling off the means of conveyance;
(3) The dead birds and dead poultry are moved in a means of conveyance either under official seal or accompanied by a Federal representative;
(4) The dead birds and dead poultry are not unloaded until their arrival at the destination listed on the permit required by paragraph (a)(1) of this section;
(5) The dead birds and dead poultry are moved, without stopping, to the destination listed on the permit required by paragraph (a)(1) of this section, except for normal traffic conditions, such as traffic lights and stop signs;
(6) The dead birds and dead poultry are disposed of, within 24 hours after being loaded for interstate movement, by burial or composting in accordance with the procedures set forth in § 82.14(c)(1) and (c)(2), or by rendering, incineration, or other means approved by the Administrator as being adequate to prevent the dissemination of Newcastle disease; and
(7) Copies of the permit accompanying the dead birds and dead poultry interstate are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the dead birds and dead poultry at the destination listed on the permit required by paragraph (a)(1) of this section.
(b) Dressed carcasses from birds and poultry that are not known to be infected with Newcastle disease may be moved interstate from a quarantined area only if:
(1) The dressed carcasses are from birds or poultry that were slaughtered in a recognized slaughtering establishment;
(2) The dressed carcasses have been processed in one of the following ways:
(i) They are packed in hermetically sealed containers and cooked by a commercial method after such packing to produce articles which are shelf-stable without refrigeration; or
(ii) They have been thoroughly cooked and have a thoroughly cooked appearance throughout;
(3) If the dressed carcasses are from poultry, the processing establishment that treats the dressed carcasses in accordance with paragraph (b)(2) of this section employs the following safeguards:
(i) If receiving or handling any live poultry, there must be complete separation between the slaughter portion of the establishment and the portions of the establishment in which further processing takes place;
(ii) If the plant processes dressed carcasses from both quarantined and nonquarantined areas, all areas, utensils, and equipment likely to contact the poultry carcasses to be processed, including skimming, deboning, cutting, and packing areas, are cleaned and disinfected in accordance with part 71 of this chapter between the processing of dressed poultry carcasses from the quarantined area and the processing of dressed poultry carcasses from nonquarantined areas;
(iii) The dressed carcasses are stored in a manner that ensures that no cross-contamination with potentially infectious materials, such as raw or unprocessed products, occurs;
(4) The dressed carcasses are accompanied by a permit obtained in accordance with § 82.11;
(5) The dressed carcasses are moved in a means of conveyance either under official seal or accompanied by a Federal representative;
(6) The dressed carcasses are not unloaded until their arrival at the destination listed on the permit required by paragraph (b)(4) of this section;
(7) The dressed carcasses are moved, without stopping, to the destination listed on the permit required by paragraph (b)(4) of this section, except for normal traffic conditions, such as traffic lights and stop signs; and
(8) Copies of the permit accompanying the dressed carcasses are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the dressed carcasses at the destination listed on the permit required by paragraph (b)(4) of this section.
(a) Manure generated by and litter used by birds or poultry not known to be infected with Newcastle disease may be moved interstate from a quarantined area only if:
(1) The manure and litter is accompanied by a permit obtained in accordance with § 82.11;
(2) The manure and litter has been heated throughout, in the quarantined area, to a temperature of not less than 175 °F (79.4 °C) or subjected to any other treatment approved by the Administrator as being adequate to prevent the dissemination of Newcastle disease, and then placed either in a previously unused container or in a container that has been cleaned and disinfected, since last being used, in accordance with part 71 of this chapter;
(3) The declaration or affidavit required by § 82.11(b) lists the location of the poultry or birds that generated the manure or used the litter, and the name and address of the owner of the poultry or birds that generated the manure or used the litter; and
(4) Copies of the permit accompanying the manure and litter interstate are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the manure and litter at the destination listed on the permit.
(b) Compost derived from manure generated by and litter used by birds or poultry known to be infected with Newcastle disease may be moved interstate from a quarantined area only if:
(1) The manure and litter is accompanied by a permit obtained in accordance with § 82.11;
(2) All birds and poultry have been removed from the premises where the manure or litter is held;
(3) After all birds are removed from the premises where the manure or litter is held, all manure and litter inside and outside the bird or poultry house remains undisturbed for at least 28 days before being moved from the infected premises for composting;
(4) Composting is done at a site approved by the Administrator and under a protocol approved by the Administrator as being adequate to prevent the dissemination of Newcastle disease. All manure and litter from the infected premises must be moved to the composting site at the same time;
(5) Following the composting process, the composted manure or litter remains undisturbed for an additional 15 days before movement;
(6) After this 15-day period, all of the composted manure or litter from the infected site is removed at the same time;
(7) The resulting compost must be transported either in a previously unused container or in a container that has been cleaned and disinfected, since last being used, in accordance with part 71 of this chapter;
(8) The vehicle in which the resulting compost is to be transported has been cleaned and disinfected, since last being used, in accordance with part 71 of this chapter; and
(9) Copies of the permit accompanying the compost derived from the manure and the litter are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of arrival of the compost at the destination listed on the permit.
(a) Eggs, other than hatching eggs, from birds or poultry from flocks not known to be infected with Newcastle disease may be moved interstate from a quarantined area only if:
(1) The eggs are accompanied by a permit obtained in accordance with § 82.11;
(2) The eggs have been cleaned and sanitized in accordance with 9 CFR part 590;
(3) The establishment that processes the eggs, other than hatching eggs, for sale establishes procedures adequate to ensure that the eggs are free of Newcastle disease, including:
(i) The establishment separates processing and layer facilities, the incoming and outgoing eggs at the establishment, and any flocks that may reside at the establishment;
(ii) The establishment implements controls to ensure that trucks, shipping companies, or other visitors do not expose the processing plant to Newcastle disease;
(iii) Equipment used in the establishment is cleaned and disinfected in accordance with part 71 of this chapter at intervals determined by the Administrator to ensure that the equipment cannot transmit Newcastle disease to the eggs, other than hatching eggs, being processed; and
(iv) The eggs are packed either in previously unused flats or cases, or in used plastic flats that were cleaned or disinfected since last being used, in accordance with part 71 of this chapter;
(4) The eggs are moved to a facility where they are examined to ensure they have been cleaned and sanitized in accordance with paragraph (a)(2) of this section; and
(5) Copies of the permit accompanying the eggs interstate are submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the eggs at the facility.
(b) Any flats or cases intended for reuse after being used to move eggs interstate to a facility under this section must be cleaned and disinfected in accordance with part 71 of this chapter before being moved to a premises where birds or poultry are kept.
Hatching eggs from birds or poultry not known to be infected with or exposed to Newcastle disease may be moved interstate from a quarantined area only if:
(a) The hatching eggs are accompanied by a permit obtained in accordance with § 82.11;
(b) Copies of the permit accompanying the hatching eggs are submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the hatching eggs at the premises described in paragraph (c) of this section;
(c) The hatching eggs have been kept in accordance with the sanitation practices specified in §§ 147.22 and 147.25 of the National Poultry Improvement Plan; and
(d) The hatching eggs are held in the State of destination at a premises designated jointly by the veterinarian in charge and the State animal health official from the time of arrival until hatch and the birds and poultry hatched from the eggs are held at the designated premises for not less than 30 days following hatch. During this holding period, the eggs and any birds or poultry hatched from the eggs are subject to any inspections, disinfections, and tests as may be required by the Administrator to determine their freedom from Newcastle disease.
(a) This section does not apply to cages, coops, or other containers or equipment used by or to move pet birds moved interstate in accordance with § 82.5(a).
(b) Vehicles, cages, coops, containers, troughs, and other equipment that have held or that have otherwise been used in a quarantined area in the handling of birds or poultry or their eggs, or for manure generated by or litter used by the birds or poultry, may be moved interstate from a quarantined area only in accordance with the following conditions:
(1) They are made of hard plastic or metal, and the other conditions of this section are met; or
(2) They are made of a disposable material, such as cardboard, fiber, or waxed cardboard, are previously unused, and are disposed of by incineration without being reused after being moved interstate.
(c) Before moving interstate any vehicles, cages, coops, containers, troughs, or other equipment described in paragraph (b)(1) of this section, and after using these items to move birds, poultry, eggs, manure, or litter interstate from a quarantined area, the vehicles, cages, coops, containers, troughs, and other equipment must be cleaned and disinfected in accordance with paragraphs (c)(1) through (c)(5) of this section:
(1) Clean and disinfect the vehicles, cages, coops, containers, troughs, and other equipment at the place where the birds, poultry, eggs, manure, and litter are unloaded or where the equipment is used, no more than 2 hours after the birds, poultry, eggs, manure, and litter are unloaded or the equipment is used;
(2) Clean the items in accordance with part 71 of this chapter;
(3) Have a Federal representative or State representative
(4) Disinfect the items in the presence of a Federal representative or State representative; and
(5) Disinfect the items in accordance with part 71 of this chapter and by using a disinfectant as specified in part 71 of this chapter.
(d) If the place where the cleaning and disinfection would otherwise be required has no facilities for cleaning and disinfecting, the items may be moved to a place where facilities are available for cleaning and disinfecting, provided a Federal representative or State representative has determined that such movement will not cause a risk of the spread of Newcastle disease.
(e) Vehicles, cages, coops, containers, troughs, and other equipment that are moved interstate under this section must be accompanied by a permit obtained in accordance with § 82.11, and copies of the permit accompanying the vehicles, cages, coops, containers, troughs, and other equipment interstate must be submitted so that a copy is received by the State animal health official and the veterinarian in charge
(a) Application for the permits required by this subpart to move interstate from a quarantined area birds, eggs, poultry, or other items requiring a permit under this part must be in writing. The application must be submitted to a Federal representative or State representative and must include the following:
(1) The applicant's name and mailing address;
(2) The name and mailing address of the person who will receive the birds, eggs, poultry, or other items;
(3) The addresses of both the origin and destination of the birds, eggs, poultry, or other items;
(4) The number and types of birds, poultry, eggs, and other items intended for interstate movement; and
(5) The reason for the interstate movement.
(b) In addition to the information required by paragraph (a) of this section, to obtain permits to move birds, poultry, eggs, manure, litter, cages, coops, containers, troughs, vehicles or other equipment interstate from a quarantined area, an applicant for a permit must submit to a Federal representative or State representative a declaration or affidavit listing the requirements of § 82.5 for live birds or live poultry, § 82.6 for dead birds and dead poultry, § 82.7 for litter or manure, § 82.8 for eggs other than hatching eggs, § 82.9 for hatching eggs, or § 82.10 for cages, coops, containers, troughs, vehicles, and other equipment, and stating that the applicant will move the items interstate only if all of the listed requirements are met.
(a) A special permit is required for the interstate movement of birds, poultry, or other items whose movement is restricted under this subpart, from a quarantined area in a manner or to a destination other than is specifically prescribed by this subpart, under special conditions determined by the Administrator to be necessary to prevent the dissemination of Newcastle disease. A special permit is required for the disposal of dead birds or dead poultry that are infected with Newcastle disease, or dead birds or dead poultry from flocks infected with Newcastle disease, or manure generated by or eggs from birds or poultry infected with Newcastle disease, in a manner other than is specifically prescribed in this subpart, and for cleaning and disinfection carried out in a manner other than is specifically prescribed in this subpart, under special conditions determined by the Administrator to be necessary to prevent the dissemination of Newcastle disease. To apply for a special permit, contact the veterinarian in charge
(b) The special permit will list the name and address of the person to whom the special permit is issued, and the special conditions under which the interstate movement, disposal, or cleaning and disinfection may be carried out.
(1) For an interstate movement, the special permit will also include the following:
(i) The name and mailing address of the person who will receive the birds, poultry, or other items;
(ii) The addresses of both the origin and destination of the birds, poultry, or other items;
(iii) The number and type of birds, poultry, or other items to be moved interstate; and
(iv) The reason for the interstate movement.
(2) For destruction or cleaning and disinfection, the special permit will also include the following:
(i) The address of the place where the dead birds, dead poultry, manure, or eggs are located; and
(ii) The number and type of birds, poultry, or other items involved.
(c) For an interstate movement, a copy of the special permit must accompany the items moved, and copies must be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the birds, poultry, or other items at the destination listed on the special permit.
(a) Denial. If the Administrator determines that the applicant for a permit or special permit is not complying with or could not comply with this subpart or any special conditions needed to prevent the dissemination of Newcastle disease, or, in the case of a special permit, that the special permit is not required under this subpart, the Administrator may deny the request for a permit or special permit. If the request is denied, the Administrator will send the applicant a written notice explaining why the permit or special permit was denied.
(b) Withdrawal. The Administrator may withdraw a permit or special permit, orally or in writing, if he or she determines the person to whom the permit or special permit has been issued is violating either this subpart or some condition specified in the permit or special permit. The Administrator may withdraw the permit or special permit without advance notice if he or she determines that the person to whom the permit or special permit has been issued is violating either this subpart or some condition specified in the permit or special permit in a way that threatens the public health, interest, or safety. The Administrator will send the person to whom the permit or special permit has been issued a written explanation of why the permit or special permit is to be or was withdrawn.
(c) Appeals. Denial or withdrawal of a permit or special permit may be appealed to the Administrator within 10 days after receipt of the written notice of denial or withdrawal. The appeal must be in writing
An area will be removed from quarantine only when all of the following requirements have been met:
(a) All birds and poultry exposed to Newcastle disease in the quarantined area have been found to be free of Newcastle disease;
(b) All birds and poultry infected with Newcastle disease in the quarantined area have been euthanized;
(c) All birds and poultry, including any parts of the birds and poultry, euthanized in accordance with paragraph (b) of this section, and all birds and poultry in the quarantined area, including any parts of the birds and poultry, that died from any cause other than slaughter, have been buried, reduced to ashes by incineration, rendered, or reduced to dust by composting:
(1) If the birds and poultry are buried, all birds and poultry infected with Newcastle disease must be buried in the quarantined area. The birds and poultry must be buried in a location that meets all United States Environmental Protection Agency, State, and local requirements for landfills. They must be buried at least 6 feet deep and be covered at the time of burial with soil; and
(2) If the birds and poultry are composted, all birds and poultry infected with Newcastle disease must be composted in the quarantined area. The birds and poultry must be composted according to the following instructions or according to another procedure approved by the Administrator as being adequate to prevent the dissemination of Newcastle disease:
(i) Place a 1-foot layer of litter and manure in a free-standing composter bin, unless the compost pile will be covered in accordance with paragraph (c)(2)(ii) of this section. Add a 6-inch layer of straw, peanut hulls, or wood chips. Add a layer of dead birds or dead poultry, leaving 6 inches between the carcasses and the bin walls. Add water sparingly and cover with 6 inches of a dry mixture of litter and manure. Repeat the layering process two more times and cap with a double layer of dry manure cake. After the bin is capped off and covered, monitor the temperature in the compost pile daily, using a 36-inch probe-type thermometer. The temperature of the compost pile must reach at least 140 °F. After 30 days from the date the compost pile is created, turn over to aerate the entire mixture. Allow mixture to reach at least 140 °F once again. After completion of the second cycle, the mixture must remain covered with any material that prevents penetration of air and moisture until spread or otherwise utilized. The composted material may not be spread or otherwise utilized until at least 30 days following completion of the second heating cycle.
(ii) Composting of birds and poultry may be accomplished outside of covered bins by following the layering and temperature requirements set forth in paragraph (c)(2)(i) of this section, then covering the compost pile with tarpaulins or 6-mm polyethylene sheets anchored with tires or straw bales. The mixture must be kept moist. The final product may not be spread or otherwise utilized until at least 30 days following completion of the second heating cycle.
(iii) Composting of birds and poultry must be carried out at least 50 yards from any building or pen where poultry and birds are housed and be inaccessible to birds and poultry. Composted material may not be commingled with, or otherwise be brought into contact with, non-composted manure cake;
(d) All eggs produced by birds or poultry infected with or exposed to Newcastle disease in the quarantined area have been buried, reduced to ashes by incineration, or rendered. If the eggs are buried, the eggs must be buried in the quarantined area in a location that meets all United States Environmental Protection Agency requirements and all State and local requirements for landfills. The eggs must be buried at least 6 feet deep and be covered at the time of burial with soil;
(e) All manure generated by or litter used by birds or poultry infected with or exposed to Newcastle disease in the quarantined area has been reduced to ashes by incineration, or has been buried, composted, or spread on a field and turned under, as follows:
(1) Burial. If the manure or litter is buried, the manure and litter must be buried at least 6 feet deep and covered at the time of burial with soil. The manure and litter must be buried in the quarantined area in a location that meets all United States Environmental Protection Agency and State and local requirements for landfills;
(2) Composting. If the manure and litter is composted, the manure and litter must be composted in the quarantined area. The manure and litter must be composted according to the following method, or according to another procedure approved by the Administrator as being adequate to prevent the dissemination of Newcastle disease: Place the manure and litter in rows 3 to 5 feet high and 5 to 10 feet at the base. The area where the manure, litter, and other material used in composting are placed must be such that there is no runoff from the composted material out of the area, no saturation into the ground, and no moisture, except for that required by this paragraph, onto the composted material from above. The composting area must be at least 50 yards from any building or pen where birds or poultry are housed and be inaccessible to birds and poultry. The manure and litter must be mixed so as to attain a carbon to nitrogen ratio of approximately 30:1, a moisture content of between 40 to 50 percent, and a supply of oxygen to the composted material. If a carbon source other than manure or litter is needed, wood chips, straw, or peanut hulls may be used. The manure and litter must be covered with tarpaulin or 6-mm polyethylene sheets, be anchored with tires or straw bales, and be mixed to ensure adequate ventilation every 10 to 15 days. The composted material must rise to a temperature of 140 °F, as determined by use of a 36-inch probe-type thermometer. The composted material may not be spread or otherwise utilized for at least 30 days from the time the 140 °F temperature is reached; and
(3) Spreading and turning under. Spreading and turning under of manure or litter may be used as a means of disposal only if carried out under the direct supervision of a Federal representative or a State representative. If the manure or litter is spread on a field and turned under, the field must be in the quarantined area, at least 50 yards away from any building or pen where poultry or birds are housed, and inaccessible to birds and poultry. The manure or litter must be turned under within 24 hours of being spread on the field, and the field must be left undisturbed for at least 30 days;
(f) All vehicles with which the birds or poultry infected with or exposed to Newcastle disease or their excrement or litter have had physical contact have been cleaned and disinfected in accordance with part 71 of this chapter. The vehicles have been inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then have been disinfected in the presence of a Federal representative or State representative with a disinfectant listed in part 71 of this chapter;
(g) All cages, coops, containers, troughs, and other equipment used for birds or poultry infected with or exposed to Newcastle disease, or their excrement or litter have been reduced to ashes by incineration, or have been cleaned and disinfected in accordance with part 71 of this chapter. The items must be inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then must be disinfected in the presence of a Federal representative or State representative, with a disinfectant listed in part 71 of this chapter; and
(h) The premises where birds or poultry infected with or exposed to Newcastle disease were located have been cleaned and disinfected in accordance with part 71 of this chapter. The premises have been inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then have been disinfected in the presence of a Federal representative or State representative with a disinfectant listed in part 71 of this chapter.
(i) After the other conditions of this section are fulfilled, an area will not be released from quarantine until followup surveillance over a period of time determined by the Administrator indicates Newcastle disease is not present in the quarantined area.
Birds and poultry that have been destroyed because of a quarantine for Newcastle disease may not be replaced by birds or poultry moved interstate into the quarantined area until the Administrator decides that Newcastle disease has been eradicated and that replacement birds or poultry will not become infected with Newcastle disease.
When, in accordance with sec. 10407 of the Animal Health Protection Act (7 U.S.C. 8306), the Secretary of Agriculture determines that an extraordinary emergency exists because of Newcastle disease, the regulations in this subpart regarding interstate movement shall be applicable to intrastate movement within any State or portion of a State subject to the Secretary's declaration of extraordinary emergency until such time as the Secretary terminates that declaration.
As used in connection with this subpart, the following terms shall have the meaning set forth in this section.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any individual authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Bird. Any member of the class aves other than poultry.
Chlamydiosis. A contagious bacterial disease of birds and poultry, characterized by respiratory and systemic infection. The disease is also known as psittacosis in psittacine birds and as ornithosis in poultry.
Federal representative. An individual employed and authorized by the Federal government to perform the tasks required by this subpart.
Federal veterinarian. A veterinarian employed and authorized by the Federal government to perform the tasks required by this subpart.
Infected. Affected by the virus or bacterium that causes the specified disease.
Interstate. From one State into or through any other State.
Moved. Shipped, transported or otherwise moved, or delivered or received for movement, by any person.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys.
State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
State animal health official. The State official responsible for livestock- and poultry-disease control and eradication programs.
State representative. An individual employed in animal health work and authorized by a State or political subdivision of a State to perform the tasks required by this subpart.
Veterinarian in charge. A Federal veterinarian employed by the Animal and Plant Health Inspection Service and authorized by the Administrator to supervise and manage the animal health work of the Animal and Plant Health Inspection Service in a specified area of the United States.
The following items may not be moved interstate:
(a) Live poultry infected with chlamydiosis;
(b) Dead poultry that were infected with chlamydiosis when they died, and parts of dead poultry that were infected with chlamydiosis when they died; and
(c) Offal from poultry infected with chlamydiosis.
(a) Before moving vehicles, cages, coops, containers, troughs, and other equipment interstate that have held or have otherwise been used in the handling of poultry infected with chlamydiosis, and after using these items to move poultry infected with chlamydiosis interstate, the vehicles, cages, coops, containers, troughs, and other equipment must be cleaned and disinfected in accordance with paragraphs (a)(1) through (a)(5) of this section:
(1) Clean and disinfect the vehicles, cages, coops, containers, troughs, and other equipment at the place where the poultry are unloaded or where the equipment is used, no more than 2 hours after the poultry infected with chlamydiosis are unloaded or the equipment is used;
(2) Clean the items in accordance with part 71 of this chapter;
(3) Have a Federal representative, State representative,
(4) Disinfect the items in the presence of a Federal representative, State representative, or an accredited veterinarian; and
(5) Disinfect the items in accordance with part 71 of this chapter and by using a disinfectant as specified in part 71 of this chapter.
(b) If the place where the cleaning and disinfection would otherwise be required has no facilities for cleaning and disinfecting, the items may be moved to a place where facilities are available for cleaning and disinfecting, provided a Federal representative or State representative has determined that such movement will not cause a risk of the spread of chlamydiosis.
(c) Vehicles, cages, coops, containers, troughs, and other equipment moved interstate under this section must be accompanied by a permit obtained in accordance with § 82.23, and copies of the permit accompanying the vehicles, cages, coops, containers, troughs, and other equipment interstate must be submitted so that a copy is received by both the State animal health official and the veterinarian in charge
Premises that contained poultry that were infected with chlamydiosis must be cleaned and disinfected in accordance with this section before any poultry are moved interstate onto the premises.
(a) The premises must be cleaned in accordance with part 71 of this chapter;
(b) After being cleaned, the premises must be inspected by a Federal representative, State representative, or an accredited veterinarian; and
(c) After being inspected, the premises must be disinfected in the presence of a Federal representative, State representative, or an accredited veterinarian, in accordance with part 71 of this chapter, using a disinfectant listed in part 71 of this chapter.
(a) Application for the permit required by this subpart to move vehicles, cages, coops, containers, troughs, or other equipment interstate must be in writing, and must be submitted to a Federal representative or State representative. The application must include the following:
(1) The applicant's name and mailing address;
(2) The name and mailing address of the person who will receive the items;
(3) The addresses of both the origin and destination of the items;
(4) The number and types of items intended for interstate movement; and
(5) The reason for the interstate movement.
(b) Exceptions. This subpart does not apply to the interstate movement of poultry, vehicles, cages, coops, containers, troughs, or other equipment or material if the interstate movement is made by the United States Department of Agriculture for the purposes of research or diagnosis.
(a) A special permit is required for the interstate movement of items whose movement interstate is restricted under this subpart in a manner or to a destination other than is specifically prescribed by this subpart. A special permit is required for the disinfection of vehicles, premises, cages, coops, containers, troughs, and other equipment by a method other than is specifically prescribed by this subpart. To apply for a special permit, contact the veterinarian in charge for the State in which the items are located. The Administrator may, at his or her discretion, issue special permits if he or she determines the activity authorized will not increase the risk of spreading chlamydiosis interstate.
(b) The special permit will list the name and address of the person to whom the special permit is issued, and the special conditions under which the interstate movement, or cleaning and disinfection, may be carried out.
(1) For an interstate movement, the special permit will also include the following:
(i) The name and mailing address of the person who will receive the items;
(ii) The addresses of both the origin and destination of the items;
(iii) The number and type of items to be moved interstate; and
(iv) The reason for the interstate movement.
(2) For cleaning and disinfection, the special permit will also include the following:
(i) The address of the place where the items are located; and
(ii) The number and type of items involved.
(c) For an interstate movement, a copy of the special permit must accompany the items moved, and copies must be submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the items at the destination listed on the special permit.
(a) Denial. If the Administrator determines that the applicant for a permit or special permit is not complying with or could not comply with this subpart or any special conditions needed to prevent the spread of chlamydiosis, or, in the case of a special permit, that the special permit is not required under this subpart, the Administrator may deny the request for a permit or special permit. If the request is denied, the Administrator will send the applicant a written notice explaining why the permit or special permit was denied.
(b) Withdrawal. The Administrator may withdraw a permit or special permit, orally or in writing, if he or she determines the person to whom the permit or special permit has been issued is violating either this subpart or some condition specified in the permit or special permit. The Administrator may withdraw the permit or special permit without advance notice if he or she determines that the person to whom the permit or special permit has been issued is violating either this subpart or some condition specified in the permit or special permit in a way that threatens the public health, interest, or safety. The Administrator will send the person to whom the permit or special permit has been issued a written explanation of why the permit or special permit is to be or was withdrawn.
(c) Appeals. Denial or withdrawal of a permit or special permit may be appealed to the Administrator within 10 days after receipt of the written notice of denial or withdrawal. The appeal must be in writing
For purposes of this part, the following terms mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Approved differential pseudorabies test. Any test for the diagnosis of pseudorabies that: (a) Can distinguish vaccinated swine from infected swine; (b) Is produced under license from the Secretary of Agriculture under the Virus-Serum-Toxin Act of March 4, 1913, and subsequent amendments (21 U.S.C. 151 et seq.) with indications for use in the Cooperative State-Federal Pseudorabies Eradication Program; and (c) Is conducted in a laboratory approved by the Administrator.
Approved livestock market. A stockyard, livestock market, buying station, concentration point or any other premises under State or Federal veterinary supervision where swine are assembled for sale or sale purposes, and which has been approved by the Administrator under § 71.20 of this chapter.
Certificate. An official document issued by an Animal and Plant Health Inspection Service representative, State representative, or accredited veterinarian for and prior to the interstate movement of swine that are not known to be infected with or exposed to pseudorabies, and are not pseudorabies vaccinates, except for official gene-altered pseudorabies vaccinates vaccinated with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine or from a qualified negative gene-altered vaccinated herd. The document must state: (a) The number and description of the swine to be moved; (b) That the swine to be moved are not known to be infected with or exposed to pseudorabies; (c) The purpose for which the swine are to be moved; (d) The points of origin and destination; (e) The consignor and consignee; and (f) Any additional information required by this part.
Common ground. The ground, areas, buildings or equipment communally shared by any specific group or groups of livestock.
Contact. Direct access to other swine, their excrement, or discharges; or sharing a building with a common ventilation system with other swine, or being within ten feet of other swine if not sharing a building with a common ventilation system.
Exposed livestock. Any livestock that has been in contact with an animal infected with pseudorabies, including all livestock in a known infected herd; except that livestock, other than swine, that have not been exposed to a clinical case of the disease for a period of 10 consecutive days shall no longer be considered to be exposed livestock.
Exposed swine. Any swine that has been in contact with an animal infected with pseudorabies, including all swine in a known infected herd.
Farm of origin. A farm where the swine were born, or on which they have resided for at least 90 consecutive days immediately prior to the interstate shipment.
Feedlot. A premises where swine are fed physically separated from swine kept for breeding or other purposes and from which such swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment, quarantined herd, or quarantined feedlot.
Herd. Any group of livestock maintained on common ground for any purpose, or two or more groups of livestock under common ownership or supervision, geographically separated, but which have an interchange or movement of animals without regard to whether the animals are infected with or exposed to pseudorabies.
Infected livestock. Any livestock determined to be infected with pseudorabies by an official pseudorabies test, or diagnosed by an official pseudorabies epidemiologist as having pseudorabies.
Interstate. From any State into or through any other State.
Isolation. Separation of swine by a physical barrier in such a manner that other swine do not have access to the isolated swine's body, excrement, or discharges; not allowing the isolated swine to share a building with a common ventilation system with other swine; and not allowing the isolated swine to be within ten feet of other swine if not sharing a building with a common ventilation system.
Known infected herd. Any herd in which any livestock has been determined to be infected with pseudorabies by an official pseudorabies test, an approved differential pseudorabies test, or diagnosed by an official pseudorabies epidemiologist as having pseudorabies.
(a) A herd of livestock, other than swine, shall no longer be classified as a known infected herd after 10 days since the last clinical case of pseudorabies in the herd.
(b) A herd of swine which has been released from pseudorabies quarantine in accordance with the following provisions shall no longer be classified as a known infected herd if:
(1) All swine positive to an official pseudorabies test have been removed from the premises; all swine which remain in the herd, except swine nursing from their mothers, are subjected to an official pseudorabies serologic test and found negative 30 days or more after removal of swine positive to an official pseudorabies test; and no livestock on the premises have shown clinical signs of pseudorabies after removal of the positive swine; or
(2) All swine have been depopulated for 30 days and the herd premises have been cleaned and disinfected in accordance with § 85.13; or
(3) In a herd of swine in which swine are positive to an official pseudorabies serologic test but no swine are positive at titers greater than 1:8, all titered swine are subjected to another official pseudorabies serologic test and found negative; and all other swine in the herd which an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, requires to be subjected to an official pseudorabies serologic test are tested and found negative.
(4) In a herd of swine containing official gene-altered pseudorabies vaccinates:
(i) All vaccinates have been vaccinated with the same official gene-altered pseudorabies vaccine; and
(ii) All swine positive to an approved differential pseudorabies test have been gone from the herd for at least 60 days; and
(iii) No livestock on the same premises as the herd have shown clinical signs of pseudorabies since removal of the positive swine; and
(iv) The herd has been tested for pseudorabies and found negative in accordance with one of the following two provisions:
(A) All swine in the herd, except suckling swine, are tested with an approved differential pseudorabies test. If all tested swine are found negative, no further testing is required. If any swine test positive, they may be retested with an approved differential pseudorabies test within 30 days of the first test if they are isolated from the remainder of the herd until the retest shows them to be negative.
(B) All swine in the herd over 6 months of age and a random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age are tested with an approved differential pseudorabies test. Not less than 30 days nor more than 60 days after this first test, another random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age is tested with an approved differential pseudorabies test. If all swine are negative on these tests, no further testing is required. If any swine test positive on either of these tests, the positive swine may be retested with an approved differential test within 30 days of the initial test if they are isolated from the remainder of the herd until the retest shows them to be negative.
Livestock. Swine, cattle, sheep or goats.
Moved. Shipped, transported, or otherwise moved, or delivered or received for movement by land, water, or air.
Official gene-altered pseudorabies vaccinate. Swine vaccinated with an official gene-altered pseudorabies vaccine, in accordance with directions on the label.
Official gene-altered pseudorabies vaccine. Any official pseudorabies vaccine for which there is an approved differential pseudorabies test.
Official pseudorabies epidemiologist. A state or federally employed veterinarian designated by the State animal health official and the veterinarian in charge to investigate and diagnose pseudorabies in livestock.
Official pseudorabies serologic test. An official pseudorabies test, as defined in this section, conducted on swine serum to detect the presence or absence of pseudorabies antibodies.
Official pseudorabies test. Any test for the diagnosis of pseudorabies approved by the Administrator conducted in a laboratory approved by the Administrator as listed in a Veterinary Services Notice listing such laboratories.
Official pseudorabies vaccine. Any pseudorabies virus vaccine produced under license from the Secretary of Agriculture under the Virus, Serum and Toxin Act of March 4, 1913, and any legislation amendatory thereof (21 U.S.C. 151 et seq.).
Official vaccinate. Any swine which have been: (a) Vaccinated with an official pseudorabies vaccine by an accredited veterinarian or a State or Federal veterinarian in accordance with recommendations on the vaccine label and the laws and regulations of the State in which the swine are vaccinated; (b) identified by a numbered pink eartag approved by the State in which such swine are vaccinated;
Owner-shipper statement. A statement signed by the owner or shipper of swine which states: (a) The number of swine to be moved; (b) the points of origin and destination; (c) the consignor and consignee; and (d) any additional information required by this part.
Permit. An official document issued for and prior to the interstate movement of pseudorabies infected, exposed or vaccinated swine under this part by an Animal and Plant Health Inspection Service representative, State representative, or an accredited veterinarian which states: (a) The number of swine to be moved; (b) the purpose for which the swine are to be moved; (c) the points of origin and destination; (d) the consignor and the consignee; and (e) any additional information required by this part.
Pseudorabies. The contagious, infectious, and communicable disease of livestock and other animals also known as Aujeszky's disease, mad itch, or infectious bulbar paralysis.
Pseudorabies controlled vaccinated herd. (a) Pseudorabies controlled vaccinated herd status is attained by subjecting all swine over 6 months of age to an official pseudorabies serologic test and finding all swine so tested negative. The herd must not have been a known infected herd within the past 30 days. Any swine in the herd over 6 months of age may be vaccinated for pseudorabies within 15 days after being subjected to an official pseudorabies serologic test and found negative.
(b) If on the qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, pseudorabies controlled vaccinated herd status is attained or regained by: removing all positive swine; cleaning and disinfecting the herd premises in accordance with § 85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative.
(c)(1) Pseudorabies controlled vaccinated herd status is maintained by: subjecting 25 percent of all the offspring to an official pseudorabies serologic test when they are between 16 and 20 weeks of age and finding all swine so tested negative, or by leaving 10 percent of the swine over 6 months of age in the herd unvaccinated and subjecting all such unvaccinated swine to an official pseudorabies serologic test every 80-105 days and finding all swine so tested negative.
(2) Any swine in the herd over 6 months of age may be vaccinated for pseudorabies within 15 days after being subjected to an official pseudorabies serologic test and found negative; Provided That, if pseudorabies controlled vaccinated herd status is to be maintained by testing unvaccinated swine over 6 months of age, at least 10 percent of the swine in the herd over 6 months of age shall remain unvaccinated.
(3) All swine intended to be added to a pseudorabies controlled vaccinated herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted 30 days or more after the swine have been placed in isolation. Not more than 90 percent of the swine over 6 months of age added to the herd may be vaccinated for pseudorabies. All additions to the herd which are to be vaccinated for pseudorabies shall be vaccinated within 15 days after being subjected to such official pseudorabies serologic test. All additions to the herd shall be added to the herd within 30 days after such official pseudorabies serologic test.
(4) Swine which have not been vaccinated for pseudorabies and which are to be tested to maintain pseudorabies controlled vaccinated herd status shall be maintained in the herd so that the pseudorabies vaccinates can physically touch nonvaccinates or so that the pseudorabies vaccinates are within 10 feet of nonvaccinates while sharing a direct common ventilation system with such nonvaccinates.
Pseudorabies vaccinate. Any swine that have been vaccinated with any product containing antigens for pseudorabies.
Qualified negative gene-altered vaccinated herd. (a) Any herd in which no swine are known to be infected with or exposed to pseudorabies, and in which no swine are vaccinated for pseudorabies, may achieve status as a qualified negative gene-altered vaccinated herd under the following conditions:
(1) All swine in the herd over 6 months of age must be tested with an official pseudorabies serologic test. For a minimum of 30 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd, or must have entered the herd directly from a qualified pseudorabies negative herd. If any of the tested swine are found positive on this or any other official pseudorabies test prior to vaccination with the official gene-altered pseudorabies vaccine, the requirements in paragraph (a)(2) must be met.
(2) All swine that are positive on an official pseudorabies test must be removed from the herd, or must be isolated until another official pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (a)(3). If the results of the second test are positive, all swine that tested positive must be removed from the herd. Not less than 30 days after any positive swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an official pseudorabies serologic test and found negative. Not less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (a)(1).
(3) Not more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (a)(1), all swine in the herd over 6 months of age must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(b) Any herd designated as a qualified pseudorabies negative herd may achieve new status as a qualified negative gene-altered vaccinated herd if all swine in the herd over 6 months of age are vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(c) Any herd in which no swine are known to be infected with or exposed to pseudorabies, and in which the only swine vaccinated for pseudorabies are official gene-altered pseudorabies vaccinates, may achieve status as a qualified negative gene-altered vaccinated herd under the following conditions:
(1) Only one official gene-altered pseudorabies vaccine may be used in the herd.
(2) All swine in the herd over 6 months of age must be tested with an approved differential pseudorabies test. For a minimum of 60 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd or must have entered the herd directly from a qualified pseudorabies negative herd or a qualified negative gene-altered vaccinated herd. If any of the tested swine are found positive on this test, the requirements in paragraph (c)(3) must be met.
(3) All swine positive on an approved differential pseudorabies test must be removed from the herd, or must be isolated until another approved differential pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (c)(4). If the results of the second test are positive, all swine that tested positive must be removed from the herd. No less than 30 days after any negative swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an approved differential pseudorabies test and found negative. No less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (c)(2).
(4) No more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (c)(2), all swine in the herd over 6 months of age that are not already official gene-altered pseudorabies vaccinates must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(d) Qualified negative gene-altered vaccinated herd status is maintained under the following conditions:
(1) All swine over 6 months of age in the herd must be official gene-altered pseudorabies vaccinates, and only one official gene-altered pseudorabies vaccine may be used in the herd.
(2) All swine over 6 months of age in the herd must be tested at least once a year with an approved differential pseudorabies test and found negative; except that, if any swine are positive, the herd may maintain its status if the positive swine are isolated from the rest of the herd until they are found negative to a second approved differential pseudorabies test conducted within 30 days of the first. The requirement for annual testing of all swine in the herd over 6 months of age may be met by testing 25 percent of the swine over 6 months of age every 80-105 days, or by testing 10 percent of the swine over 6 months of age each month. No swine may be tested twice in 1 year to comply with the 25 percent requirement, or twice in 10 months to comply with the 10 percent requirement.
(3) Swine may be added to a qualified negative gene-altered vaccinated herd only under one of the following conditions:
(i) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, or from a qualified pseudorabies negative herd, without having any contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd.
(ii) The swine are moved to the qualified negative gene-altered vaccinated herd from a qualified pseudorabies negative herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an official pseudorabies serologic test conducted 30 days or more after the swine are isolated.
(iii) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an approved differential pseudorabies test conducted 30 days or more after the swine are isolated.
(iv) The swine are removed to the qualified negative gene-altered vaccinated herd from a herd other than a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to two official pseudorabies serologic tests, one conducted at the time the swine are isolated, and the second conducted 30 days or more after the swine are isolated.
Qualified pseudorabies negative herd. (a) Qualified pseudorabies negative herd status is attained by subjecting all swine over 6 months of age to an official pseudorabies serologic test and finding all swine so tested negative. The herd must not have been a known infected herd within the past 30 days. A minimum of 90 percent of the swine in the herd must have been on the premises and a part of the herd for at least 90 days prior to the qualifying official pseudorabies serologic test or have entered directly from another qualified pseudorabies negative herd.
(b)(1) If on a qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, qualified pseudorabies negative herd status is attained or regained by: Removing all positive swine and cleaning and disinfecting the herd premises in accordance with § 85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative; or
(2) If on any qualifying official pseudorabies serologic test or any subsequent official pseudorabies serologic test, any swine so tested are positive, but no swine are positive at titers greater than 1:8, qualified pseudorabies negative herd status is attained or regained by: Subjecting all titered swine and all other swine required to be tested by an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, to an official pseudorabies serologic test and finding all such swine negative.
(c) Qualified pseudorabies negative herd status is maintained by subjecting all swine over 6 months of age in the herd to an official pseudorabies serologic test at least once each year (this must be accomplished by testing 25 percent of swine over 6 months of age every 80-105 days and finding all swine so tested negative, or by testing 10 percent of the swine over 6 months of age each month and finding all swine so tested negative; no swine shall be tested twice in 1 year to comply with the 25 percent requirement or twice in 10 months to comply with the 10 percent requirement). All swine intended to be added to a qualified pseudorabies negative herd shall be isolated until the swine have been found negative to two official pseudorabies serologic tests, one conducted 30 days or more after the swine have been placed in isolation, the second test being conducted 30 days or more after the first test; except (1) swine intended to be added to a qualified pseudorabies negative herd directly from another qualified pseudorabies negative herd may be added without isolation or testing; (2) swine intended to be added to a qualified pseudorabies negative herd from another qualified pseudorabies negative herd, but with interim contact with swine other than those from a single qualified pseudorabies negative herd, shall be isolated until the swine have been found negative to an official pseudorabies serologic test, conducted 30 days or more after the swine have been placed in isolation; (3) swine returned to the herd after contact with swine other than those from a single qualified pseudorabies negative herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted 30 days or more after the swine have been placed in isolation.
Quarantined feedlot. A premises where pseudorabies infected or exposed swine are fed under the supervision and control of the State animal health official, and from which such swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment in accordance with the provisions of this part.
Quarantined herd. A herd in which pseudorabies infected or exposed swine are bred, reared, and fed under the supervision and control of the State animal health official, and from which such swine are moved interstate directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment, or from which exposed officially vaccinated swine which were negative to an official pseudorabies serologic test may be moved only to a quarantined herd or quarantined feedlot.
Recognized slaughtering establishment. A slaughtering establishment operated under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State inspected slaughtering establishment.
Slaughter market. A livestock market approved in accordance with § 71.20 of this chapter, at which swine for sale and shipment for slaughter are handled only on days when no swine are handled for sale and shipment for feeding or breeding purposes unless facilities are provided to keep slaughter swine physically separated from feeder and breeder swine, and feeder and breeder swine use no facilities previously used by slaughter swine on the day these classes of swine are at the market. The facilities used by slaughter swine shall be cleaned and disinfected in accordance with the requirements of this part before being used for feeding or breeding swine.
State. Any State or Territory of the United States, the District of Columbia, Puerto Rico, Guam or the Northern Mariana Islands.
State animal health official. The State animal health official who is responsible for the livestock and poultry disease control and eradication programs in the official's State or his designated representative.
State representative. A person regularly employed in animal health work of a State and who is authorized by such State to perform the function involved under a Cooperative Agreement with the United States Department of Agriculture.
Swine not known to be infected with or exposed to pseudorabies. Any swine from a herd of swine in which no animal has been classified as a reactor to an official pseudorabies test, or has been diagnosed as having pseudorabies or suspected of having pseudorabies by a veterinarian; or any swine from a herd of swine which has been released from quarantine or has met the requirements of release from quarantine in accordance with the definition of known infected herd in § 85.1.
Veterinarian in charge. The veterinary official of Veterinary Services, Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform official animal health work of the Animal and Plant Health Inspection Service in the State concerned.
Veterinary Services. Veterinary Services, Animal and Plant Health Inspection Service, United States Department of Agriculture.
Veterinary Services representative. A person employed by Veterinary Services, Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the function involved.
Notice is hereby given that there is reason to believe that the contagion of pseudorabies may exist in each State and that to prevent the spread and dissemination of the contagion thereof, and to protect the livestock of the United States, the regulations in this part are promulgated.
Livestock shall not be moved interstate except in compliance with the regulations in this part.
(a) Livestock showing clinical evidence of pseudorabies shall not be moved interstate.
(b) Livestock that have been exposed to an animal showing clinical evidence of pseudorabies shall not be moved interstate within 10 days of such exposure.
(c) Except as provided in paragraphs (a) and (b) of this section, livestock other than swine may be moved interstate without restriction under this part.
(d) Except as provided in paragraphs (a) and (b) of this section, swine, swine semen, and swine embryos shall be moved interstate only in compliance with the regulations in this part.
Infected swine or exposed swine, other than swine described in § 85.4 (a) or (b), shall only be moved interstate in accordance with the following provisions:
(a) Movement of infected or exposed swine for slaughter. Infected or exposed swine shall be moved interstate for slaughter only if:
(1) The swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment;
(2) The swine are accompanied by a permit or owner-shipper statement and such permit or owner-shipper statement is delivered to the consignee;
(3) The permit, in addition to the information in § 85.1, or the owner-shipper statement, in addition to the information in § 85.1, lists the identification of the swine as required by § 71.19 of this chapter; except if the swine are moved interstate and the identity of the farm of origin of each swine is maintained, the permit or the owner-shipper statement need not list the identification required by § 71.19 of this chapter, if such swine are identified to the farm of origin at the recognized slaughtering establishment or the first slaughter market; and
(4) The swine are moved to destination in one continuous movement without unloading enroute.
(b) Movement of exposed swine to a quarantined herd or a quarantined feedlot. Exposed swine shall be moved interstate directly to a quarantined herd or quarantined feedlot only if:
(1) The swine are negative to an official pseudorabies serologic test 21 days or more after last being exposed to any livestock showing clinical evidence of pseudorabies;
(2) The swine are officially vaccinated for pseudorabies within 15 days after the negative test;
(3) The swine are moved interstate within 30 days after the negative test;
(4) The swine are accompanied by a permit and such permit is delivered to the consignee; and
(5) The permit, in addition to the information described in § 85.1, states: (i) The present pseudorabies quarantine status of the farm of origin; (ii) the identification of the swine as required by § 71.19 of this chapter; (iii) the date of the official pseudorabies serologic test and the name of the laboratory where the test was conducted; (iv) the date of the official vaccination for pseudorabies; and (v) that approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine.
Pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, not known to be infected with or exposed to pseudorabies shall only be moved interstate in accordance with the following provisions:
(a) Movement of pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, for slaughter. Pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, not known to be infected with or exposed to pseudorabies shall be moved interstate for slaughter only if:
(1) The swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment;
(2) The swine are accompanied by a permit or owner-shipper statement and such permit or owner-shipper statement is delivered to the consignee; and
(3) The swine are moved to destination in one continuous movement without unloading enroute.
(b) Movement of pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, to a quarantined herd or quarantined feedlot. Pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, not known to be infected with or exposed to pseudorabies shall be moved interstate directly to a quarantined herd or quarantined feedlot only if:
(1) The swine are accompanied by a permit and such permit is delivered to the consignee; and
(2) The permit in addition to information described in § 85.1 states: (i) The pseudorabies status of the herd; (ii) the identification of the swine required by § 71.19 of this chapter; (iii) the date of the vaccination for pseudorabies; and (iv) that approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine.
(c) General movements. Swine vaccinated for pseudorabies with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine and not known to be infected with or exposed to pseudorabies, but that are not from a qualified negative gene-altered vaccinated herd, may be moved interstate to destinations other than those set forth in paragraphs (a) and (b) of this section only if:
(1) The swine are accompanied by a certificate and such certificate is delivered to the consignee; and
(2) The certificate, in addition to the information described in § 85.1, states:
(i) The identification required by § 71.19 of this chapter;
(ii) That each animal to be moved was vaccinated for pseudorabies with a gpI-deleted gene-altered pseudorabies vaccine;
(iii) That each animal to be moved was subjected to a gpI enzyme-linked immunosorbent assay (ELISA) or a gpI Particle Concentration Fluorescence Immunoassay (PCFIA) approved differential pseudorabies test no more than 30 days prior to the interstate movement and was found negative;
(iv) The date of the gpI ELISA or the gpI PCFIA approved differential pseudorabies test; and
(v) The name of the laboratory that conducted the gpI ELISA or the gpI PCFIA approved differential pseudorabies test.
Swine not vaccinated for/pseudorabies and not known to be infected with or exposed to pseudorabies shall only be moved interstate in accordance with the following provisions:
(a) Movement for slaughter. Swine not vaccinated for pseudorabies and not known to be infected with or exposed to pseudorabies may be moved interstate for slaughter without further restriction under this part directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment.
(b) Movement to a feedlot, quarantined feedlot, quarantined herd, or approved livestock market. Swine not vaccinated for pseudorabies and not known to be infected with or exposed to pseudorabies may be moved interstate only if:
(1) The swine are moved from a qualified pseudorabies negative herd directly to a feedlot, quarantined feedlot, quarantined herd, or approved livestock market; or
(2) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd, or to an approved livestock market for subsequent movement to a feedlot or quarantined feedlot, quarantined herd in accordance with paragraph (c) of this section; or
(3) The swine are moved from a State which requires the State animal health official of that State to be immediately notified of any suspected or confirmed case of pseudorabies in that State and which requires that exposed or infected livestock be quarantined, such quarantine to be released only after having met quarantine release standards no less restrictive than those in the definition of known infected herd in § 85.1, and
(i) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by an owner-shipper statement and are moved from a farm of origin directly to an approved livestock market; and
(A) The owner-shipper statement is delivered to the consignee, and
(B) The swine are identified at the approved livestock market to the farm of origin by the identification required by § 71.19 of this chapter.
(ii) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by a certificate and such certificate is delivered to the consignee; the certificate, in addition to the information in § 85.1, states the identification of the farm of origin of each swine being moved by a means of identification required by § 71.19 of this chapter, and approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine, and
(A) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd or approved livestock market from a farm of origin; or
(B) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd or approved livestock market from an approved livestock market which received the swine directly from a farm of origin, or
(C) The swine are moved directly to a feedlot, quarantined feedlot, or quarantined herd from an approved livestock market, which received the swine from another approved livestock market, which received the swine directly from a farm of origin.
(c) General movements. Swine not vaccinated for pseudorabies and not known to be infected with or exposed to pseudorabies may be moved interstate only if:
(1) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by a certificate and such certificate is delivered to the consignee; and
(2) The certificate, in addition to the information described in § 85.1, states: (i) The identification required by § 71.19 of this chapter; and (ii) that each animal to be moved: (A) Was subjected to an official pseudorabies serologic test within 30 days prior to the interstate movement and was found negative, the test date and the name of the laboratory conducting the test; or (B) is part of a currently recognized qualified pseudorabies negative herd and the date of the last qualifying test; or, (C) is part of a pseudorabies controlled vaccinated herd and is one of the off-spring that was subjected to the official pseudorabies serologic test to achieve or maintain the status of the herd as a pseudorabies controlled vaccinated herd, and the date of the last test to maintain said status.
Swine from a qualified negative gene-altered vaccinated herd, and not known to be infected with or exposed to pseudorabies, may be moved interstate only in accordance with the following provisions:
(a) Without further restriction under this part if:
(1) The swine are moved directly to a recognized slaughtering establishment, or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment; or
(2) The swine are moved directly to a feedlot, quarantined feedlot, or approved livestock market; or
(3) The swine are moved from an approved livestock market to a feedlot, quarantined feedlot, or other approved livestock market; or
(4) The swine are moved interstate in a swine production system in compliance with § 71.19(g) of this chapter.
(b) For all interstate movements other than those set forth in paragraph (a) of this section, the swine must be accompanied by a certificate, and the certificate must be delivered to the consignee. In addition to the information required by § 85.1 of this part, the certificate must state: (1) That the swine are from a qualified negative gene-altered vaccinated herd; (2) The date of the herd's last qualifying test; (3) The identification for the swine to be moved interstate, in accordance with § 71.19 of this chapter; and (4) If the swine to be moved are official gene-altered pseudorabies vaccinates, the official gene-altered pseudorabies vaccine used in the herd.
The Administrator may, upon request in specific cases, permit the interstate movement of livestock not otherwise provided for in this part under such conditions as he may prescribe to prevent the spread of pseudorabies. The Animal and Plant Health Inspection Service intends that such authority be used only in situations and under circumstances presenting problems that could not have been reasonably anticipated in advance and in unique situations. The Animal and Plant Health Inspection Service does not intend that such authority be used repeatedly to cover the same problem, but that the regulation be amended to conform with needed changes as they come to light.
Swine semen and swine embryos moved interstate for insemination of swine or implantation into swine shall be accompanied by a document issued by an accredited veterinarian stating that the donor swine are not known to be infected with or exposed to pseudorabies, were negative to an official pseudorabies serologic test within 30 days prior to the collection of the semen or embryos or were members of a qualified pseudorabies negative herd, and had not been exposed to pseudorabies within 30 days prior to the collection of the semen or embryos.
(a) Each permit, certificate or owner-shipper statement required under this part to accompany swine interstate shall be delivered with the swine to the consignee by the person delivering the swine.
(b) A copy of each permit or certificate required under this part to accompany swine interstate shall be mailed or delivered to the State animal health official of the State of destination by the person issuing the document within 3 days of the interstate movement of the swine covered by said document.
All means of conveyance used in connection with the interstate movement of pseudorabies infected or exposed livestock shall be cleaned and disinfected in accordance with § 71.7 of this chapter using one of the disinfectants registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135 et seq.) with herpes virucidal claims. These disinfectants shall be used in accordance with directions on their labels accepted in connection with their registration.
Livestock markets and other facilities used in connection with the interstate movement of pseudorabies infected or exposed livestock shall be cleaned and disinfected in compliance with § 71.7 of this chapter using one of the disinfectants registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135 et seq.) with herpes virucidal claims. These disinfectants shall be used in accordance with directions on their labels accepted in connection with their registration.
Animal identification number (AIN). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal. The AIN consists of 15 digits, with the first 3 being the country code (840 for the United States or a unique country code for any U.S. territory that has such a code and elects to use it in place of the 840 code). The alpha characters USA or the numeric code assigned to the manufacturer of the identification device by the International Committee on Animal Recording may be used as an alternative to the 840 or other prefix representing a U.S. territory; however, only the AIN beginning with the 840 or other prefix representing a U.S. territory will be recognized as official for use on AIN tags applied to animals on or after March 11, 2015. The AIN beginning with the 840 prefix may not be applied to animals known to have been born outside the United States.
Approved livestock facility. A stockyard, livestock market, buying station, concentration point, or any other premises under State or Federal veterinary inspection where livestock are assembled and that has been approved under § 71.20 of this chapter.
Approved tagging site. A premises, authorized by APHIS, State, or Tribal animal health officials, where livestock without official identification may be transferred to have official identification applied on behalf of their owner or the person in possession, care, or control of the animals when they are brought to the premises.
Commuter herd. A herd of cattle or bison moved interstate during the course of normal livestock management operations and without change of ownership directly between two premises, as provided in a commuter herd agreement.
Commuter herd agreement. A written agreement between the owner(s) of a herd of cattle or bison and the animal health officials for the States or Tribes of origin and destination specifying the conditions required for the interstate movement from one premises to another in the course of normal livestock management operations and specifying the time period, up to 1 year, that the agreement is effective. A commuter herd agreement may be renewed annually.
Covered livestock. Cattle and bison, horses and other equine species, poultry, sheep and goats, swine, and captive cervids.
Dairy cattle. All cattle, regardless of age or sex or current use, that are of a breed(s) or offspring of a breed used to produce milk or other dairy products for human consumption, including, but not limited to, Ayrshire, Brown Swiss, Holstein, Jersey, Guernsey, Milking Shorthorn, and Red and Whites.
Directly. Moved in a means of conveyance, without stopping to unload while en route, except for stops of less than 24 hours to feed, water, or rest the animals being moved, and with no commingling of animals at such stops.
Flock-based number system. The flock-based number system combines a flock identification number (FIN) with a producer's unique livestock production numbering system to provide a nationally unique identification number for an animal.
Flock identification number (FIN). A nationally unique number assigned by a State, Tribal, or Federal animal health authority to a group of animals that are managed as a unit on one or more premises and are under the same ownership.
Group/lot identification number (GIN). The identification number used to uniquely identify a “unit of animals” of the same species that is managed together as one group throughout the preharvest production chain. When a GIN is used, it is recorded on documents accompanying the animals moving interstate; it is not necessary to have the GIN attached to each animal.
Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, or Tribal government, or an accredited veterinarian, certifying the inspection of animals in preparation for interstate movement.
(1) The ICVI must show:
(i) The species of animals covered by the ICVI;
(ii) The number of animals covered by the ICVI;
(iii) The purpose for which the animals are to be moved;
(iv) The address at which the animals were loaded for interstate movement;
(v) The address to which the animals are destined; and
(vi) The names of the consignor and the consignee and their addresses if different from the address at which the animals were loaded or the address to which the animals are destined.
(vii) Additionally, unless the species-specific requirements for ICVIs provide an exception, the ICVI must list the official identification number of each animal, except as provided in paragraph (2) of this definition, or group of animals moved that is required to be officially identified, or, if an alternative form of identification has been agreed upon by the sending and receiving States, the ICVI must include a record of that identification. If animals moving under a GIN also have individual official identification, only the GIN must be listed on the ICVI. An ICVI may not be issued for any animal that is not officially identified if official identification is required. If the animals are not required by the regulations to be officially identified, the ICVI must state the exemption that applies (e.g., the cattle and bison do not belong to one of the classes of cattle and bison to which the official identification requirements of this part apply). If the animals are required to be officially identified but the identification number does not have to be recorded on the ICVI, the ICVI must state that all animals to be moved under the ICVI are officially identified.
(2) As an alternative to recording individual animal identification on an ICVI, if agreed to by the receiving State or Tribe, another document may be attached to provide this information, but only under the following conditions:
(i) The document must be a State form or APHIS form that requires individual identification of animals, or a printout of official identification numbers generated by computer or other means;
(ii) A legible copy of the document must be attached to the original and each copy of the ICVI;
(iii) Each copy of the document must identify each animal to be moved with the ICVI. The document must not contain any information pertaining to other animals; and
(iv) The following information must be included in the identification column on the original and each copy of the ICVI:
(A) The name of the document; and
(B) Either the unique serial number on the document or both the name of the person who prepared the document and the date the document was signed.
Interstate movement. From one State into or through any other State.
Livestock. All farm-raised animals.
Location-based numbering system. The location-based number system combines a State or Tribal issued location identification (LID) number or a premises identification number (PIN) with a producer's unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal.
Location identification (LID) number. A nationally unique number issued by a State, Tribal, and/or Federal animal health authority to a location as determined by the State or Tribe in which it is issued. The LID number may be used in conjunction with a producer's own unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may also be used as a component of a group/lot identification number (GIN).
Move. To carry, enter, import, mail, ship, or transport; to aid, abet, cause, or induce carrying, entering, importing, mailing, shipping, or transporting; to offer to carry, enter, import, mail, ship, or transport; to receive in order to carry, enter, import, mail, ship, or transport; or to allow any of these activities.
National Uniform Eartagging System (NUES). A numbering system for the official identification of individual animals in the United States that provides a nationally unique identification number for each animal.
Official Animal Identification Device Standards (OAIDS). A document providing further information regarding the official identification device recordkeeping requirements of this part, and technical descriptions, specifications, and details under which APHIS would approve identification devices for official use. Updates or modifications to the Standards document will be announced to the public by means of a notice published in the
Official eartag. An identification tag approved by APHIS that bears an official identification number for individual animals. The design, size, shape, color, and other characteristics of the official eartag will depend on the needs of the users, subject to the approval of the Administrator. The official eartag must be tamper-resistant and have a high retention rate in the animal.
Official eartag shield. The shield-shaped graphic of the U.S. Route Shield with “U.S.” or the State postal abbreviation or Tribal alpha code imprinted within the shield.
Official identification device or method. A means approved by the Administrator of applying an official identification number to an animal of a specific species or associating an official identification number with an animal or group of animals of a specific species or otherwise officially identifying an animal or group of animals.
Official identification number. A nationally unique number that is permanently associated with an animal or group of animals and that adheres to one of the following systems:
(1) National Uniform Eartagging System (NUES).
(2) Animal identification number (AIN).
(3) Location-based number system.
(4) Flock-based number system.
(5) Any other numbering system approved by the Administrator for the official identification of animals.
Officially identified. Identified by means of an official identification device or method approved by the Administrator.
Owner-shipper statement. A statement signed by the owner or shipper of the livestock being moved stating the location from which the animals are moved interstate; the destination of the animals; the number of animals covered by the statement; the species of animal covered; the name and address of the owner at the time of the movement; the name and address of the shipper; and the identification of each animal, as required by the regulations, unless the regulations specifically provide that the identification does not have to be recorded.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other legal entity.
Premises identification number (PIN). A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority a geographically distinct location from other premises. The PIN may be used in conjunction with a producer's own livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may be used as a component of a group/lot identification number (GIN).
Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.), or State meat or poultry inspection acts that is approved in accordance with 9 CFR 71.21.
United States Department of Agriculture (USDA) approved backtag. A backtag issued by APHIS that provides a temporary unique identification for each animal.
(a) The regulations in this part apply only to covered livestock, as defined in § 86.1.
(b) No person may move covered livestock interstate or receive such livestock moved interstate unless the livestock meet all applicable requirements of this part.
(c) The regulations in this part will apply to the movement of covered livestock onto and from Tribal lands only when the movement is an interstate movement; i.e., when the movement is across a State line.
(d) In addition to meeting all applicable requirements of this part, all covered livestock moved interstate must be moved in compliance with all applicable provisions of APHIS program disease regulations (subchapter C of this chapter).
(e) The interstate movement requirements in this part do not apply to the movement of covered livestock if:
(1) The movement occurs entirely within Tribal land that straddles a State line and the Tribe has a separate traceability system from the States in which its lands are located; or
(2) The movement is to a custom slaughter facility in accordance with Federal and State regulations for preparation of meat.
(a) Any State, Tribe, accredited veterinarian, or other person or entity who distributes official identification devices must maintain for 5 years a record of the names and addresses of anyone to whom the devices were distributed. Official identification device distribution records must be entered by the person distributing the devices into the Tribal, State, Federal, or other database acceptable to each government entity. Additional guidance on meeting these recordkeeping requirements is found in the OAIDS.
(b) Records of official identification devices applied by a federally accredited veterinarian to a client animal must be kept in a readily accessible record system.
(c) Approved livestock facilities must keep any ICVIs or alternate documentation that is required by this part for the interstate movement of covered livestock that enter the facility on or after March 11, 2013. For poultry and swine, such documents must be kept for at least 2 years, and for cattle and bison, sheep and goats, cervids, and equids, 5 years.
(d) Records required under paragraphs (a) through (c) of this section must be maintained by the responsible person or entity and must be of sufficient accuracy, quality, and completeness to demonstrate compliance with all conditions and requirements under this part. During normal business hours, APHIS must be allowed access to all records, to include visual inspection and reproduction (e.g., photocopying, digital reproduction). The responsible person or entity must submit to APHIS all reports and notices containing the information specified within 48 hours of receipt of request, or earlier if warranted by an emergency disease response.
(a) Official identification devices and methods. The Administrator has approved the following official identification devices or methods for the species listed. The Administrator may authorize the use of additional devices or methods for a specific species if he or she determines that such additional devices or methods will provide for adequate traceability. Additional guidance on official identification devices, methods, and the approval process is found in the Official Animal Identification Device Standards (OAIDS) document.
(1) Cattle and bison. Cattle and bison that are required to be officially identified for interstate movement under this part must be identified by means of:
(i) For an official eartag, beginning November 5, 2024, all official eartags sold for or applied to cattle and bison must be readable both visually and electronically (EID);
(ii) Brands registered with a recognized brand inspection authority and accompanied by an official brand inspection certificate, when agreed to by the shipping and receiving State or Tribal animal health authorities; or
(iii) Tattoos and other identification methods acceptable to a breed association for registration purposes, accompanied by a breed registration certificate, when agreed to by the shipping and receiving State or/Tribal animal health authorities; or
(iv) Group/lot identification when a group/lot identification number (GIN) may be used.
(2) Horses and other equine species. Horses and other equine species that are required to be officially identified for interstate movement under this part must be identified by one of the following methods:
(i) A description sufficient to identify the individual equid including, but not limited to, name, age, breed, color, gender, distinctive markings, and unique and permanent forms of identification when present (e.g., brands, tattoos, scars, cowlicks, blemishes or biometric measurements). When the identity of the equid is in question at the receiving destination, the State or Tribal animal health official in the State or Tribe of destination or APHIS representative may determine if the description provided is sufficient; or
(ii) Electronic identification that complies with ISO 11784/11785; or
(iii) Non-ISO electronic identification injected into the equid on or before March 11, 2014; or
(iv) Digital photographs sufficient to identify the individual equid; or
(v) For equids being commercially transported to slaughter, a device or method authorized by 88 of this chapter.
(3) Poultry. Poultry that are required to be officially identified for interstate movement under this part must be identified by one of the following methods:
(i) Sealed and numbered leg bands in the manner referenced in the National Poultry Improvement Plan regulations (parts 145 through 147 of this chapter); or
(ii) Group/lot identification when a group/lot identification number (GIN) may be used.
(4) Sheep and goats. Sheep and goats that are required to be officially identified for interstate movement under this part must be identified by a device or method authorized by part 79 of this chapter.
(5) Swine. Swine that are required to be officially identified for interstate movement under this part must be identified by a device or method authorized by § 71.19 of this chapter.
(6) Captive cervids. Captive cervids that are required to be officially identified for interstate movement under this part must be identified by a device or method authorized by part 77 of this chapter.
(b) Official identification requirements for interstate movement—(1) Cattle and bison. (i) All cattle and bison listed in paragraphs (b)(1)(iii)(A) through (b)(1)(iii)(D) of this section must be officially identified prior to the interstate movement, using an official identification device or method listed in paragraph (a)(1) of this section unless:
(A) The cattle and bison are moved as a commuter herd with a copy of the commuter herd agreement or other documents as agreed to by the shipping and receiving States or Tribes. If any of the cattle or bison are shipped to a State or Tribe not included in the commuter herd agreement or other documentation, then these cattle or bison must be officially identified and documented to the original State of origin.
(B) The cattle and bison are moved directly from a location in one State through another State to a second location in the original State.
(C) The cattle and bison are moved interstate directly to an approved tagging site and are officially identified before commingling with cattle and bison from other premises or identified by the use of backtags or other methods that will ensure that the identity of the animal is accurately maintained until tagging so that the official eartag can be correlated to the person responsible for shipping the animal to the approved tagging site.
(D) The cattle and bison are moved between shipping and receiving States or Tribes with another form of identification, as agreed upon by animal health officials in the shipping and receiving States or Tribes.
(ii) Cattle and bison may also be moved interstate without official identification if they are moved directly to a recognized slaughtering establishment or directly to no more than one approved livestock facility and then directly to a recognized slaughtering establishment, where they are harvested within 3 days of arrival; and
(A) They are moved interstate with a USDA-approved backtag; or
(B) A USDA-approved backtag is applied to the cattle or bison at the recognized slaughtering establishment or federally approved livestock facility.
(C) If a determination to hold the cattle or bison for more than 3 days is made after the animals arrive at the slaughter establishment, the animals must be officially identified in accordance with § 86.4(d)(4)(ii).
(D) Cattle and bison leaving a slaughter establishment may only be moved to another recognized slaughter establishment or approved feedlot and can only be sold/re-sold as slaughter cattle, and they must be accompanied by an owner-shipper statement in accordance with § 86.5(c)(1). Information listed on the document must include the name and address of the slaughter establishment from which the animals left, the official identification numbers, as defined in § 86.1, correlated with the USDA backtag number (if available), the name of the destination slaughter establishment, or approved feedlot (as defined in § 77.5 of this subchapter) to which the animals are being shipped.
(iii) Beginning on March 11, 2013, all cattle and bison listed below are subject to the official identification requirements of this section:
(A) All sexually intact cattle and bison 18 months of age or over;
(B) All dairy cattle;
(C) Cattle and bison of any age used for rodeo or recreational events; and
(D) Cattle and bison of any age used for shows or exhibitions.
(2) Sheep and goats. Sheep and goats moved interstate must be officially identified prior to the interstate movement unless they are exempt from official identification requirements under 9 CFR part 79 or are officially identified after the interstate movement, as provided in 9 CFR part 79.
(3) Swine. Swine moving interstate must be officially identified in accordance with § 71.19 of this chapter.
(4) Horses and other equids. Horses and other equids moving interstate must be officially identified prior to the interstate movement, using an official identification device or method listed in paragraph (a)(2) of this section unless:
(i) They are used as the mode of transportation (horseback, horse and buggy) for travel to another location and then return direct to the original location.
(ii) They are moved from the farm or stable for veterinary medical examination or treatment and returned to the same location without change in ownership.
(iii) They are moved directly from a location in one State through another State to a second location in the original State.
(iv) They are moved between shipping and receiving States or Tribes with another form of identification as agreed upon by animal health officials in the shipping and receiving States or Tribes.
(5) Poultry. Poultry moving interstate must be officially identified prior to interstate movement unless:
(i) The shipment of poultry is from a hatchery to a redistributor or poultry grower and the person responsible for receiving the shipment maintains a record of the supplier; or
(ii) The shipment is from a redistributor to a poultry grower and the person responsible for receiving the chicks maintains a record of the supplier of the chicks; or
(iii) The poultry are identified as agreed upon by the States or Tribes involved in the movement.
(6) Captive cervids. Captive cervids moving interstate must be officially identified prior to interstate movement in accordance with part 77 of this chapter.
(c) Use of more than one official eartag. Beginning on March 13, 2013, no more than one official eartag may be applied to an animal, except that:
(1) Another official eartag may be applied providing it bears the same official identification number as an existing one.
(2) In specific cases when the need to maintain the identity of an animal is intensified (e.g., such as for export shipments, quarantined herds, field trials, experiments, or disease surveys), a State or Tribal animal health official or an area veterinarian in charge may approve the application of an additional official eartag to an animal that already has one or more. The person applying the additional official eartag must record the following information about the event and maintain the record for 5 years: The date the additional official eartag is added; the reason for the additional official eartag device; and the official identification numbers of both the new official eartag and the one(s) already attached to the animal.
(3) A visually and electronically readable eartag may be applied to an animal that is already officially identified with one or more non-EID official eartags and/or a non-EID official vaccination eartag used for brucellosis. The person applying the new visually and electronically readable eartag must record the date the eartag is applied to the animal and the official identification numbers of both official eartags and must maintain those records for 5 years.
(d) Removal or loss of official identification devices. (1) Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices, including devices applied to imported animals in their countries of origin and recognized by the Administrator as official, is prohibited except at the time of slaughter, at any other location upon the death of the animal, or as otherwise approved by the State or Tribal animal health official or an area veterinarian in charge when a device needs to be replaced.
(2) All man-made identification devices affixed to covered livestock unloaded at slaughter plants after moving interstate must be removed at the slaughter facility by slaughter-facility personnel with the devices correlated with the animal and its carcass through final inspection or condemnation by means approved by the Food Safety Inspection Service (FSIS). If diagnostic samples are taken, the identification devices must be packaged with the samples and be correlated with the carcasses through final inspection or condemnation by means approved by FSIS. Devices collected at slaughter must be made available to APHIS and FSIS by the slaughter plant.
(3) All official identification devices affixed to covered livestock carcasses moved interstate for rendering must be removed at the rendering facility and made available to APHIS.
(4) If an animal loses an official identification device and needs a new one: (i) A replacement tag with a different official identification number may be applied. The person applying a new official identification device with a different official identification number must record the following information about the event and maintain the record for 5 years: The date the new official identification device was added; the official identification number on the device; and the official identification number on the old device if known.
(ii) Replacement of a temporary identification device with a new official identification device is considered to be a retagging event, and all applicable information must be maintained in accordance with paragraph (d)(4)(i) of this section.
(iii) A duplicate replacement eartag with the official number of the lost tag may be applied in accordance with APHIS' protocol for the administration of such tags.
(e) Replacement of official identification devices for reasons other than loss. (1) Circumstances under which a State or Tribal animal health official or an area veterinarian in charge may authorize replacement of an official identification device include, but are not limited to:
(i) Deterioration of the device such that loss of the device appears likely or the number can no longer be read;
(ii) Infection at the site where the device is attached, necessitating application of a device at another location (e.g., a slightly different location of an eartag in the ear);
(iii) Malfunction of the electronic component of an electronically readable (EID) device; or
(iv) Incompatibility or inoperability of the electronic component of an EID device with the management system or unacceptable functionality of the management system due to use of an EID device.
(2) Any time an official identification device is replaced, as authorized by the State or Tribal animal health official or area veterinarian in charge, the person replacing the device must record the following information about the event and maintain the record for 5 years:
(i) The date on which the device was removed;
(ii) Contact information for the location where the device was removed;
(iii) The official identification number (to the extent possible) on the device removed;
(iv) The type of device removed (e.g., metal eartag, RFID or other EID eartag);
(v) The reason for the removal of the device;
(vi) The new official identification number on the replacement device; and
(vii) The type of replacement device applied.
(f) Sale or transfer of official identification devices. Official identification devices are not to be sold or otherwise transferred from the premises to which they were originally issued to another premises without authorization by the Administrator or a State or Tribal animal health official.
(a) Responsible persons and required documentation. The persons responsible for animals leaving a premises for interstate movement must ensure that the animals are accompanied by an interstate certificate of veterinary inspection (ICVI) or other document required by this part for the interstate movement of animals.
(b) Forwarding of documents. (1) The APHIS representative, State or Tribal representative, or accredited veterinarian issuing an ICVI or other document required for the interstate movement of animals under this part, must forward a copy of the ICVI or other document to the State or Tribal animal health official of the State or Tribe of origin within 7 calendar days from the date on which the ICVI or other document is issued. The State or Tribal animal health official in the State or Tribe of origin must forward a copy of the ICVI or other document to the State or Tribal animal health official in the State or Tribe of destination within 7 calendar days from date on which the ICVI or other document is received.
(2) The animal health official or accredited veterinarian issuing or receiving an ICVI or other interstate movement document in accordance with paragraph (b)(1) of this section must keep a copy of the ICVI or alternate documentation. For poultry and swine, such documents must be kept for at least 2 years, and for cattle and bison, sheep and goats, cervids, and equine species, 5 years.
(c) Cattle and bison. Cattle and bison moved interstate must be accompanied by an ICVI unless:
(1) They are moved directly to a recognized slaughtering establishment, or directly to an approved livestock facility and then directly to a recognized slaughtering establishment, and they are accompanied by an owner-shipper statement.
(2) They are moved directly to an approved livestock facility with an owner-shipper statement and do not move interstate from the facility unless accompanied by an ICVI.
(3) They are moved from the farm of origin for veterinary medical examination or treatment and returned to the farm of origin without change in ownership.
(4) They are moved directly from one State through another State and back to the original State.
(5) They are moved as a commuter herd with a copy of the commuter herd agreement or other document, as agreed to by the States or Tribes involved in the movement.
(6) Additionally, cattle and bison may be moved between shipping and receiving States or Tribes with documentation other than an ICVI, e.g., a brand inspection certificate, as agreed upon by animal health officials in the shipping and receiving States or Tribes.
(7) The official identification number of cattle or bison must be recorded on the ICVI or alternate documentation unless:
(i) The cattle or bison are moved from an approved livestock facility directly to a recognized slaughtering establishment; or
(ii) The cattle and bison are sexually intact cattle or bison under 18 months of age or steers or spayed heifers; except that this paragraph (c)(7)(ii) does not apply to dairy cattle of any age or to cattle or bison used for rodeo, exhibition, or recreational purposes.
(d) Horses and other equine species. Horses and other equine species moved interstate must be accompanied by an ICVI unless:
(1) They are used as the mode of transportation (horseback, horse and buggy) for travel to another location and then return direct to the original location; or
(2) They are moved from the farm or stable for veterinary medical examination or treatment and returned to the same location without change in ownership; or
(3) They are moved directly from a location in one State through another State to a second location in the original State.
(4) Additionally, equids may be moved between shipping and receiving States or Tribes with documentation other than an ICVI, e.g., an equine infectious anemia test chart, as agreed to by the shipping and receiving States or Tribes involved in the movement.
(5) Equids moving commercially to slaughter must be accompanied by documentation in accordance with part 88 of this subchapter. Equine infectious anemia reactors moving interstate must be accompanied by documentation as required by part 75 of this subchapter.
(e) Poultry. Poultry moved interstate must be accompanied by an ICVI unless:
(1) They are from a flock participating in the National Poultry Improvement Plan (NPIP) and are accompanied by the documentation required under the NPIP regulations (parts 145 through 147 of this chapter) for participation in that program; or
(2) They are moved directly to a recognized slaughtering or rendering establishment; or
(3) They are moved from the farm of origin for veterinary medical examination, treatment, or diagnostic purposes and either returned to the farm of origin without change in ownership or euthanized and disposed of at the veterinary facility; or
(4) They are moved directly from one State through another State and back to the original State; or
(5) They are moved between shipping and receiving States or Tribes with a VS Form 9-3 or documentation other than an ICVI, as agreed upon by animal health officials in the shipping and receiving States or Tribes; or
(6) They are moved under permit in accordance with part 82 of this subchapter.
(f) Sheep and goats. Sheep and goats moved interstate must be accompanied by documentation as required by part 79 of this subchapter.
(g) Swine. Swine moved interstate must be accompanied by documentation in accordance with § 71.19 of this subchapter or, if applicable, with part 85 of this subchapter.
(h) Captive cervids. Captive cervids moved interstate must be accompanied by documentation as required by part 77 of this subchapter.
State, Tribal, and local laws and regulations may not specify an official identification device or method that would have to be used if multiple devices or methods may be used under this part for a particular species, nor may the State or Tribe of destination impose requirements that would otherwise cause the State or Tribe from which the shipments originate to have to develop a particular kind of traceability system or change its existing system in order to meet the requirements of the State or Tribe of destination.
The following definitions apply to this part:
APHIS. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Assembly point. Any facility, including auction markets, ranches, feedlots, and stockyards, in which equines are gathered in commerce.
Commercial transportation. Movement for profit via conveyance on any highway or public road.
Conveyance. Trucks, tractors, trailers, or semitrailers, or any combination of these, propelled or drawn by mechanical power.
Equine. Any member of the Equidae family, which includes horses, asses, mules, ponies, and zebras.
Equine for slaughter. Any member of the Equidae family being transferred to a slaughter facility, including an assembly point, feedlot, or stockyard.
Euthanasia. The humane destruction of an animal by the use of an anesthetic agent or other means that causes painless loss of consciousness and subsequent death.
Feedlot. Any facility which consolidates livestock for preconditioning, feeding, fattening, or holding before being sent to slaughter.
Owner/shipper. Any individual, partnership, corporation, or cooperative association that engages in the commercial transportation of more than 20 equines per year to slaughtering facilities, except any individual or other entity who transports equines to slaughtering facilities incidental to his or her principal activity of production agriculture (production of food or fiber).
Owner-shipper certificate. VS Form 10-13,
Secretary. The Secretary of Agriculture.
Slaughtering facility. A commercial establishment that slaughters equines for any purpose.
Stallion. Any uncastrated male equine that is 1 year of age or older.
Stockyard. Any place, establishment, or facility commonly known as stockyards, conducted, operated, or managed for profit or nonprofit as a public market for livestock producers, feeders, market agencies, and buyers, consisting of pens, or other enclosures, and their appurtenances, in which live cattle, sheep, swine, horses, mules, or goats are received, held, or kept for sale or shipment in commerce.
USDA. The U.S. Department of Agriculture.
USDA backtag. A backtag issued by APHIS that conforms to the eight-character alpha-numeric National Backtagging System and that provides unique identification for each animal.
USDA representative. Any employee of the USDA who is authorized by the Deputy Administrator for Veterinary Services of APHIS, USDA, to enforce this part.
(a) State governments may enact and enforce regulations that are consistent with or that are more stringent than the regulations in this part.
(b) To determine whether an individual or other entity found to transport equines for slaughter is subject to the regulations in this part, a USDA representative may request from any individual or other entity who transported the equines information regarding the business of that individual or other entity. When such information is requested, the individual or other entity who transported the equines must provide the information within 30 days and in a format as may be specified by the USDA representative.
(a) The animal cargo space of conveyances used for the commercial transportation of equines for slaughter must:
(1) Be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the equines being transported (e.g., provides adequate ventilation, contains no sharp protrusions, etc.);
(2) Include means of completely segregating each stallion and each aggressive equine on the conveyance so that no stallion or aggressive equine can come into contact with any of the other equines on the conveyance;
(3) Have sufficient interior height to allow each equine on the conveyance to stand with its head extended to the fullest normal postural height; and
(4) Be equipped with doors and ramps of sufficient size and location to provide for safe loading and unloading.
(b) Equines for slaughter must not be transported in any conveyance that has the animal cargo space divided into two or more stacked levels, except that conveyances lacking the capability to convert from two or more stacked levels to one level may be used until December 7, 2006. Conveyances with collapsible floors (also known as “floating decks”) must be configured to transport equines on one level only.
(a) Prior to the commercial transportation of equines for slaughter, the owner/shipper must:
(1) For a period of not less than 6 consecutive hours immediately prior to the equines being loaded on the conveyance, provide each equine appropriate food (i.e., hay, grass, or other food that would allow an equine in transit to maintain well-being), potable water, and the opportunity to rest;
(2) Apply a USDA backtag
(3) Complete and sign an owner-shipper certificate for each equine being transported. The owner-shipper certificate for each equine must accompany the equine throughout transit to slaughter and must include the following information, which must be typed or legibly completed in ink:
(i) The owner/shipper's name, address, and telephone number;
(ii) The receiver's (destination) name, address, and telephone number;
(iii) The name of the auction/market, if applicable;
(iv) A description of the conveyance, including the license plate number;
(v) A description of the equine's physical characteristics, including such information as sex, breed, coloring, distinguishing markings, permanent brands, tattoos, and electronic devices that could be used to identify the equine;
(vi) The number of the USDA backtag applied to the equine in accordance with paragraph (a)(2) of this section;
(vii) A statement of fitness to travel at the time of loading, which will indicate that the equine is able to bear weight on all four limbs, able to walk unassisted, not blind in both eyes, older than 6 months of age, and not likely to give birth during the trip;
(viii) A description of any preexisting injuries or other unusual condition of the equine, such as a wound or blindness in one eye, that may cause the equine to have special handling needs;
(ix) The date, time, and place the equine was loaded on the conveyance; and
(x) A statement that the equine was provided access to food, water, and rest prior to transport in accordance with paragraph (a)(1) of this section; and
(4) Load the equines on the conveyance so that:
(i) Each equine has enough floor space to ensure that no equine is crowded in a way likely to cause injury or discomfort; and
(ii) Each stallion and any aggressive equines are completely segregated so that no stallion or aggressive equine can come into contact with any other equine on the conveyance.
(b) During commercial transportation of equines for slaughter, the owner/shipper must:
(1) Drive in a manner to avoid causing injury to the equines;
(2) Observe the equines as frequently as circumstances allow, but not less than once every 6 hours, to check the physical condition of the equines and ensure that all requirements of this part are being followed. The owner/shipper must obtain veterinary assistance as soon as possible from an equine veterinarian for any equines in obvious physical distress. Equines that become nonambulatory en route must be euthanized by an equine veterinarian. If an equine dies en route, the owner/shipper must contact the nearest APHIS office as soon as possible and allow an APHIS veterinarian to examine the equine. If an APHIS veterinarian is not available, the owner/shipper must contact an equine veterinarian;
(3) Offload from the conveyance any equine that has been on the conveyance for 28 consecutive hours and provide the equine appropriate food, potable water, and the opportunity to rest for at least 6 consecutive hours; and
(4) If offloading is required en route to the slaughtering facility, the owner/shipper must prepare another owner-shipper certificate as required by paragraph (a)(2) of this section and record the date, time, and location where the offloading occurred. In this situation, both owner-shipper certificates would need to accompany the equines for slaughter.
(c) Handling of all equines for slaughter shall be done as expeditiously and carefully as possible in a manner that does not cause unnecessary discomfort, stress, physical harm, or trauma. Electric prods may not be used on equines for slaughter for any purpose, including loading or offloading on the conveyance, except when human safety is threatened.
(d) At any point during the commercial transportation of equines for slaughter, a USDA representative may examine the equines, inspect the conveyance, or review the owner-shipper certificates required by paragraph (a)(3) of this section.
(e) At any time during the commercial transportation of equines for slaughter, a USDA representative may direct the owner/shipper to take appropriate actions to alleviate the suffering of any equine. If deemed necessary by the USDA representative, such actions could include securing the services of an equine veterinarian to treat an equine, including performing euthanasia if necessary.
(f) The individual or other entity who signs the owner-shipper certificate must maintain a copy of the owner-shipper certificate for 1 year following the date of signature.
(a) Upon arrival at a slaughtering facility, the owner/shipper must:
(1) Ensure that each equine has access to appropriate food and potable water after being offloaded;
(2) Present the owner-shipper certificates to a USDA representative;
(3) Allow a USDA representative access to the equines for the purpose of examination; and
(4) Allow a USDA representative access to the animal cargo area of the conveyance for the purpose of inspection.
(b) If the owner/shipper arrives during normal business hours, the owner/shipper must not leave the premises of a slaughtering facility until the equines have been examined by a USDA representative. However, if the owner/shipper arrives outside of normal business hours, the owner/shipper may leave the premises but must return to the premises of the slaughtering facility to meet the USDA representative upon his or her arrival.
(c) Any owner/shipper transporting equines to slaughtering facilities outside of the United States must present the owner-shipper certificates to USDA representatives at the border.
(a) The Secretary is authorized to assess civil penalties of up to $5,000 per violation of any of the regulations in this part.
(b) Each equine transported in violation of the regulations of this part will be considered a separate violation.
(a) Under normal conditions, the amount of feed designated in the following schedule will be considered as sustaining rations for livestock in transit when fed at the intervals required by the Twenty-Eight Hour Law:
| Species and quantity of livestock | At first feeding station | At second and subsequent feeding stations |
|---|---|---|
| Cattle and beef type or range calves (for each car 1) | 200 lbs. of hay 1 2 | 300 lbs. of hay. 1 2 |
| Dairy calves (for each car deck 1) | 100 lbs. of hay 1 2 | 150 lbs. of hay. 1 2 |
| Horses and mules (for each car 1) | 400 lbs. of hay 1 2 | 400 lbs. of hay. 1 2 |
| Sheep and goats (for each car deck 1) | 200 lbs. of hay 1 2 | 300 lbs. of hay. 1 2 |
| Lambs and kids (for each car deck 1) | 100 lbs. of hay 1 2 | 150 lbs. of hay. 1 2 |
| Swine (for each carload lot, in single or double deck car, the amount of shelled corn 2 indicated): | ||
| Lots of not more than 18,000 lbs | 2 bushels | 2 bushels. |
| More than 18,000 lbs. but not more than 21,000 lbs | 2
| 2
|
| More than 21,000 lbs. but not more than 24,000 lbs | 3 bushels | 3 bushels. |
| More than 24,000 lbs. but not more than 27,000 lbs | 3
| 3
|
| More than 27,000 lbs. but not more than 30,000 lbs | 4 bushels | 4 bushels. |
| More than 30,000 lbs.—proportionately larger amounts |
1 The requirements set forth the sustaining rations for a full load of livestock in a railroad car 40 feet in length. The requirements for a full load of livestock in railroad cars of different sizes should be modified proportionately,
2 Or the equivalent in other suitable feed. Dairy calves too young to eat hay or grain, or shipped without their dams, should be given a sufficient amount of prepared calf feed, milk, raw eggs, or other suitable feed. All feed should be of good quality.
(b) When the owner of a consignment of livestock desires that they be fed larger amounts of feed than those designated in paragraph (a) of this section for the particular kind and quantity of livestock, or the carrier believes that they should be fed larger amounts, the amounts to be fed should be agreed upon, if practicable, by the owner and the carrier at the time the animals are offered for shipment.
(c) When emergency conditions arise, such as severe changes in the weather, which increase the rigors of transportation, the livestock should receive amounts of feed, additional to those designated in paragraph (a) of this section, sufficient to sustain them until they arrive at the next feeding station or destination.
(d) When the movement of livestock is delayed en route so that the period of their confinement in the cars materially exceeds that specified by the Twenty-Eight Hour Law, the livestock should receive additional feed in proportion to such excess time.
When livestock are held at a feeding station 12 hours after the last previous feed has been substantially consumed, they should again be fed the ration prescribed by § 89.1(a) for that station: Provided, however, That they may be held without such feeding for a period longer than 12 hours if the time they are so held, added to the time required to reach the next feeding station or destination, whichever is closer, would not ordinarily exceed 40 hours.
(a) Livestock should be unloaded into pens of the character described in § 89.5(a) for feeding, watering, and resting, unless there is ample room in the car for all of the animals to lie down at the same time.
(b) If livestock are watered in the car, adequate facilities should be provided and ample water furnished to insure all the animals an opportunity to drink their fill. In the case of hogs, water should be available for not less than 1 hour.
(c) Livestock unloaded for feed and water and returned to the car for rest should be allowed to remain in the pens not less than 2 hours.
(d) Livestock unloaded for water and returned to the car for feed and rest should be allowed to remain in the pens not less than 1 hour.
(e) When livestock are fed in the car, the feed should be evenly distributed throughout the car.
Livestock should be furnished an ample supply of potable water. Water treated with chemicals for industrial or boiler use, or taken from streams or ponds containing sewage, mud, or other objectionable matter should not be used. Troughs and other receptacles should be clean. In cold weather, the water should be free from ice.
(a) Stock pens and other enclosures for feeding, watering, and resting livestock in transit should have (1) sufficient space for all of the livestock to lie down at the same time, (2) properly designed facilities for feeding and watering the livestock, (3) reasonably well-drained, clean, and safe floors of concrete, cinders, gravel, hard-packed earth, or other suitable material, and (4) suitable protection from weather reasonably to be expected in the region in which the pens are located.
(b) Care should be taken to protect livestock unloaded en route at a point having marked difference in temperature from that at the point from which they were shipped.
As used in this part, the following terms will have the meanings set forth in this section:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal. Any member of the animal kingdom (except a human).
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
APHIS representative. An individual who is authorized by APHIS to perform the function involved.
Date of export. The date animals intended for export are loaded onto an ocean vessel or aircraft or, if moved by land to Canada or Mexico, the date the animals cross the border.
Export health certificate. An official document issued in the United States that certifies that animals or other commodities listed on the certificate meet the export requirements of this part and the importing country.
Export inspection facility. A facility that is affiliated with a port of embarkation and that has been approved by the Administrator as the location where APHIS will conduct health inspections of livestock before they are loaded onto ocean vessels or aircraft for export from the United States.
Export isolation facility. A facility where animals intended for export are isolated from other animals for a period of time immediately before being moved for export.
Horses. Horses, mules, and asses.
Inspector. An individual authorized by APHIS to inspect animals and/or animal products intended for export from the United States.
Livestock. Horses, cattle (including American bison), captive cervids, sheep, swine, and goats, regardless of intended use.
Premises of export. The premises where the animals intended for export are isolated as required by the importing country prior to export or, if the importing country does not require pre-export isolation, the farm or other premises where the animals are assembled for pre-export inspection and/or testing, or the germplasm is collected or stored, before being moved to a port of embarkation or land border port.
Program diseases. Diseases for which there are cooperative State-Federal programs and domestic regulations in subchapter C of this chapter.
Program Handbook. A document that contains guidance and other information related to the regulations in this part. The Program Handbook is available on APHIS' import-export Web site (http://www.aphis.usda.gov/import_export/index.shtml).
State of origin. The State in which the premises of export is located.
You may not export any animal or animal germplasm from the United States except in compliance with this part.
(a) Issuance of export health certificates. (1) Livestock must have an endorsed export health certificate in order to be eligible for export from the United States.
(2) If APHIS knows that an importing country requires an export health certificate endorsed by the competent veterinary authority of the United States for any animal other than livestock or for any animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes intended for export to that country, the animal or other commodity must have an export health certificate endorsed by APHIS in order to be eligible for export from the United States.
(b) Content of export health certificates—(1) Livestock; minimum requirements. Regardless of the requirements of the importing country, at a minimum, the following information must be contained on an export health certificate for livestock:
(i) The species of each animal.
(ii) The breed of each animal.
(iii) The sex of each animal.
(iv) The age of each animal.
(v) The individual identification of the animals as required by § 91.5.
(vi) The importing country.
(vii) The consignor.
(viii) The consignee.
(ix) A certification that an accredited veterinarian inspected the livestock and found them to be fit for export.
(x) A signature and date by an accredited veterinarian.
(xi) An endorsement by the APHIS veterinarian responsible for the State of origin.
(2) Livestock; additional requirements. In addition to the minimum requirements in paragraph (b)(1) of this section, the export health certificate must meet any other information or issuance requirements specified by the importing country.
(3) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. Export health certificates for animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes must meet any information requirements specified by the importing country.
(c) Inspection requirements for livestock. In order to be eligible for export, livestock must be inspected within the timeframe required by the importing country. If the importing country does not specify a timeframe, the livestock must be inspected within 30 days prior to the date of export.
(d) Testing requirements for livestock. All samples for tests of livestock that are required by the importing country must be taken by an APHIS representative or accredited veterinarian. The samples must be taken and tests made within the timeframe allowed by the importing country and, if specified, at the location required by the importing country. If the importing country does not specify a timeframe, the samples must be taken and tests made within 30 days prior to the date of export, except that tuberculin tests may be conducted within 90 days prior to the date of export. All tests for program diseases must be made in laboratories and using methods approved by the Administrator for those diseases. The Program Handbook contains a link to an APHIS Web site that lists laboratories approved to conduct tests for specific diseases. Approved methods are those specified or otherwise incorporated within the domestic regulations in subchapter C of this chapter.
(e) Movement of livestock, animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes with an export health certificate—(1) Livestock. An export health certificate for livestock must be issued and endorsed before the livestock move from the premises of export.
(2) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. When an export health certificate is required by the importing country for any animal other than livestock or for animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes, it must be issued and, if required by the importing country, endorsed by an APHIS representative prior to departure of the animal or other commodity from the port of embarkation or the crossing of the land border port. When presented for endorsement, the health certificate must be accompanied by reports for all laboratory tests specifically identified on the certificate. The laboratory reports must either be the originals prepared by the laboratory that performed the tests or must be annotated by the laboratory that performed the test to indicate how the reports may be verified.
(f) Validity of export health certificate—(1) Livestock. Unless specified by the importing country, the export health certificate is valid for 30 days from the date of issuance, provided that the inspection and test results under paragraphs (c) and (d) of this section are still valid.
(2) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. Unless specified by the importing country, the export health certificate is valid for 30 days from the date of issuance.
No animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes under Federal, State, or local government quarantine or movement restrictions for animal health reasons may be exported from the United States unless the importing country issues an import permit or other written instruction allowing entry of the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes, and APHIS concurs with the export of the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes.
Livestock that are intended for export must be identified in a manner that allows individual animals to be correlated to the animals listed in the export health certificate. If the importing country requires a specific or an additional form of identification, the livestock must also bear that form of identification.
(a) All export health certificates for livestock must be accompanied by a statement issued by an APHIS representative and/or accredited veterinarian that the means of conveyance or container in which the livestock will be transported from the premises of export has been cleaned and disinfected prior to loading the livestock with a disinfectant approved by the Administrator for purposes of this section or by a statement that the means of conveyance or container was not previously used to transport animals.
(b) Livestock moved for export may be unloaded only into a facility which has been cleaned and disinfected prior to such unloading with a disinfectant approved by the Administrator for purposes of this section, and has subsequently been inspected by an APHIS representative or accredited veterinarian. A statement certifying to such action must be attached to the export health certificate by the APHIS representative or accredited veterinarian.
(c) Approved disinfectants. The Administrator will approve a disinfectant for purposes of this section upon determining that the disinfectant is effective against pathogens that may be spread by the animals intended for export and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency. The Program Handbook provides access to a list of disinfectants approved by the Administrator for use as required by this section. Other disinfectants may also be approved by the Administrator in accordance with this paragraph. The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants, if the disinfectant no longer meets the conditions for approval in this section.
(a) All livestock intended for export by air or sea must receive a visual health inspection from an APHIS veterinarian within 48 hours prior to embarkation, unless the importing country specifies otherwise. The purpose of the inspection is to determine whether the livestock are sound, healthy, and fit to travel. The APHIS veterinarian will reject for export any livestock that he or she finds unfit to travel. The owner of the animals or the owner's agent must make arrangements for any livestock found unfit to travel. Livestock that are unfit to travel include, but are not limited to:
(1) Livestock that are sick, injured, weak, disabled, or fatigued;
(2) Livestock that are unable to stand unaided or bear weight on each leg;
(3) Livestock that are blind in both eyes;
(4) Livestock that cannot be moved without causing additional suffering;
(5) Newborn livestock with an unhealed navel;
(6) Livestock that have given birth within the previous 48 hours and are traveling without their offspring;
(7) Pregnant livestock that would be in the final 10 percent of their gestation period at the planned time of unloading in the importing country; and
(8) Livestock with unhealed wounds from recent surgical procedures, such as dehorning.
(b) The APHIS veterinarian must conduct the inspection at the export inspection facility associated with the port of embarkation of the livestock; at an export isolation facility, when authorized by the Administrator in accordance with paragraph (c) of this section; or at an export inspection facility other than the facility associated with the port of embarkation, when authorized by the Administrator in accordance with paragraph (d) of this section. Unless APHIS has authorized otherwise, any sorting, grouping, identification, or other handling of the livestock by the exporter must be done before this inspection. The APHIS veterinarian may also conduct clinical examination, including testing, of any livestock during or after this inspection if he or she deems it necessary in order to determine the animal's health. Any treatment related to this clinical examination performed on the animal must be performed by a licensed veterinarian. Finally, if the facility used to conduct the inspection is a facility other than the export inspection facility associated with the port of embarkation, it must be located within 28 hours driving distance under normal driving conditions from the port of embarkation; livestock must be afforded at least 48 hours rest, with sufficient feed and water during that time period, prior to the pre-export inspection; and the exporter must maintain contact information for a veterinarian licensed in the State of embarkation to perform emergency medical services, as needed, on the animals intended for export.
(c) Conditions for approval of pre-export inspection at an export isolation facility. (1) The Administrator may allow pre-export inspection of livestock to be conducted at an export isolation facility, rather than at an export inspection facility, when the exporter can show to the satisfaction of the Administrator that the livestock would suffer undue hardship if they had to be inspected at the export inspection facility, when the distance from the export isolation facility to the port of embarkation is significantly less than the distance from the export isolation facility to the export inspection facility associated with the port of embarkation, when inspection at the export isolation facility would be a more efficient use of APHIS resources, or for other reasons acceptable to the Administrator.
(2) The Administrator's approval is contingent upon APHIS having personnel available to provide services at that location. Approval is also contingent upon the Administrator determining that the facility has space, lighting, and humane means of handling livestock sufficient for the APHIS personnel to safely conduct required inspections. The Program Handbook contains guidance on ways to meet these requirements. Owners and operators may submit alternative plans for meeting the requirements to APHIS for evaluation and approval. Alternatives must be at least as effective in meeting the requirements as those described in the Program Handbook in order to be approved. Alternate plans must be approved by APHIS before the facility may be used for purposes of this section.
(d) The Administrator may allow pre-export inspection of livestock to be conducted at an export inspection facility other than the export inspection facility associated with the port of embarkation when the exporter can show to the satisfaction of the Administrator that the livestock would suffer undue hardship if they had to be inspected at the export inspection facility associated with the port of embarkation, when inspection at this different export inspection facility would be a more efficient use of APHIS resources, or for other reasons acceptable to the Administrator.
(e) The APHIS veterinarian will maintain an inspection record that includes the date and place of the pre-export inspection, species and number of animals inspected, the number of animals rejected, a description of those animals, and the reasons for rejection.
(f) If requested by the importing country or an exporter, the APHIS veterinarian who inspects the livestock will issue a certificate of inspection for livestock he or she finds to be sound, healthy, and fit to travel.
All livestock that are intended for export by air or sea and that will be inspected for export at an export inspection facility associated with the port of embarkation must be allowed a period of at least 2 hours rest at an export inspection facility prior to being loaded onto an ocean vessel or aircraft for export. Adequate food and water must be available to the livestock during the rest period. An inspector may extend the required rest period up to 5 hours, at his or her discretion and based on a determination that more rest is needed in order to have assurances that the animals are fit to travel prior to loading. Pre-export inspection of the animals must take place at the conclusion of this rest period.
(a) Except as provided in paragraph (b) of this section, livestock exported by air or sea may be exported only through ports designated as ports of embarkation by the Administrator. Any port that has an export inspection facility that meets the requirements of § 91.10 permanently associated with it is designated as a port of embarkation. The Program Handbook contains a list of designated ports of embarkation. A list may also be obtained from a Veterinary Services area office. Information on area offices is available on APHIS' import-export Web site (http://www.aphis.usda.gov/import_export/index.shtml).
(b) The Administrator may approve other ports for the exportation of livestock on a temporary basis with the concurrence of the port director. The Administrator will grant such temporary approvals only for a specific shipment of livestock, and only if pre-export inspection of that shipment has occurred at an export isolation facility or an export inspection facility not associated with the port of embarkation, as provided in § 91.7.
(c) Temporarily approved ports of embarkation will not be added to the list of designated ports of embarkation and are only approved for the time period and shipment conditions specified by APHIS at the time of approval.
(a) Export inspection facilities must be approved by the Administrator before they may be used for any livestock intended for export. The Administrator will approve an export inspection facility upon determining that it meets the requirements in paragraph (b) of this section. This approval remains in effect unless it is revoked in accordance with paragraph (c) of this section, or unless any of the following occur, in which case reapproval must be sought:
(1) The owner of the facility changes.
(2) Significant damage to the facility occurs or significant structural changes are made to the facility.
(b)(1) Export inspection facilities must be constructed, equipped, and managed in a manner that prevents transmission of disease to and from livestock in the facilities, provides for the safe and humane handling and restraint of livestock, and provides sufficient offices, space, and lighting for APHIS veterinarians to safely conduct required health inspections of livestock and related business. The Program Handbook contains guidance on ways to meet these requirements. Owners and operators may submit alternative plans for meeting the requirements to APHIS for evaluation and approval; the address to which to submit such alternatives is contained in the Program Handbook. Alternatives must be at least as effective in meeting the requirements as the methods described in the Program Handbook in order to be approved. Alternatives must be approved by APHIS before being used for purposes of this section.
(2) For the purposes of approval or a subsequent audit, APHIS representatives must have access to all areas of the facility during the facility's business hours to evaluate compliance with the requirements of this section.
(3) The application for approval of an export inspection facility must be accompanied by a certification from the authorities having jurisdiction over environmental affairs in the locality of the facility. The certification must state that the facility complies with any applicable requirements of the State and local governments, and the U.S. Environmental Protection Agency regarding disposal of animal wastes.
(c) The Administrator will deny or revoke approval of an export inspection facility for failure to meet the requirements in paragraph (b) of this section.
(1) APHIS will conduct site inspections of approved export inspection facilities at least once a year for continued compliance with the standards. If a facility fails to pass the inspection, the Administrator may revoke its approval. If the Administrator revokes approval for a facility that serves a designated port of embarkation, the Administrator may also remove that port from the list of designated ports of embarkation.
(2) APHIS will provide written notice of any proposed denial or revocation to the operator of the facility, who will be given an opportunity to present his or her views on the issues before a final decision is made. The notice will list any deficiencies in detail. APHIS will provide notice of pending revocations at least 60 days before the revocation is scheduled to take effect, but may suspend facility operations before that date and before any consideration of objections by the facility operator if the Administrator determines the suspension is necessary to protect animal health or public health, interest, or safety. The operator of any facility whose approval is denied or revoked may request another inspection after remedying the deficiencies.
If an importing country requires export isolation for livestock, such isolation must occur before the animals may be moved to a port of embarkation, and both the manner in which this isolation occurs and the facility at which it occurs must meet the requirements specified by the importing country.
(a) Inspection of the ocean vessel—(1) Certification to carry livestock. Ocean vessels must be certified by APHIS prior to initial use to transport any livestock from the United States. The owner or the operator of the ocean vessel must make arrangements prior to the vessel's arrival at a designated port of embarkation in the United States for an APHIS representative to inspect the vessel while it is at that port of embarkation. Alternatively, at the discretion of the Administrator and upon request of the exporter, transporting company, or their agent, the inspection may be done at a foreign port. If APHIS determines that the ocean vessel meets the requirements of paragraph (d) of this section, APHIS will certify the vessel to transport livestock from the United States. APHIS may certify a vessel that does not meet all of the requirements in paragraph (d), provided that an exemption from the requirements the vessel does not meet has been granted to the vessel pursuant to paragraph (e) of this section. The certification will specify the species of livestock for which the vessel is approved. The certification will be valid for up to 3 years; however, the ocean vessel must be recertified prior to transporting livestock any time significant changes are made to the vessel, including to livestock transport spaces or life support systems; any time a major life support system fails; any time species of livestock not covered by the existing certification are to be transported; and any time the owner or operator of the ocean vessel changes. The owner or operator of the vessel must present the following documentation to APHIS prior to its initial inspection for certification and when requested by APHIS prior to subsequent inspections for recertification:
(i) General information about the vessel, including year built, length and breadth, vessel name history, port of registry, call sign, maximum and average speed, fresh water tank capacity and fresh water generation rate, and feed silo capacity (if the vessel has a silo);
(ii) A notarized statement from an engineer concerning the rate of air exchange in each compartment of the vessel;
(iii) The species of livestock that the vessel would transport;
(iv) Scale drawings that provide details of the design, materials, and methods of construction and arrangement of fittings for the containment and movement of livestock; provisions for the storage and distribution of feed and water; drainage arrangements; primary and secondary sources of power; and lighting;
(v) A photograph of the rails and gates of any pens;
(vi) A description of the flooring surface on the livestock decks; and
(vii) The following measurements: Width of the ramps; the clear height from the ramps to the lowest overhead structures; the incline between the ramps and the horizontal plane; the distance between footlocks on the ramps; the height of side fencing on the ramps; the height of the vessel's side doors through which livestock are loaded; the width of alleyways running fore and aft between livestock pens; and the distance from the floor of the livestock pens to the beams or lowest structures overhead.
(2) Prior to each voyage. Prior to loading any livestock intended for export from the United States, an APHIS representative must inspect the vessel to confirm that the ocean vessel has been adequately cleaned and disinfected as required by paragraph (b) of this section, has sufficient food and water for the voyage as required by paragraph (c) of this section, and continues to meet the requirements of paragraph (d) of this section. APHIS will schedule the inspection after the owner or operator of the ocean vessel provides the following information:
(i) The name of the ocean vessel;
(ii) The port, date, and time the ocean vessel will be available for inspection, and estimated time that loading will begin;
(iii) A description of the livestock to be transported, including the type, number, and estimated average weight of the livestock;
(iv) Stability data for the ocean vessel with livestock on board;
(v) The port of discharge; and
(vi) The route and expected length of the voyage.
(3) The information in paragraphs (a)(2)(i) through (a)(2)(vi) must be provided at least 72 hours before the vessel will be available for inspection.
(b) Cleaning and disinfection. (1) Any ocean vessel intended for use in exporting livestock, and all fittings, utensils, containers, and equipment (unless new) used for loading, stowing, or other handling of livestock aboard the vessel must be thoroughly cleaned and disinfected to the satisfaction of an APHIS representative prior to any livestock being loaded. The disinfectant must be approved by the Administrator. Guidance on cleaning and disinfecting ocean vessels may be found in the Program Handbook.
(2) The Administrator will approve a disinfectant for the purposes of this paragraph upon determining that the disinfectant is effective against pathogens that may be spread by the animals and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency. The Program Handbook provides access to a list of disinfectants approved by the Administrator. Other disinfectants may also be approved by the Administrator in accordance with this paragraph. The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants in the Program Handbook, if the disinfectant no longer meets the conditions for approval in this section.
(3) All ocean vessels, upon docking at a U.S. port to load livestock, must have disinfectant foot baths at entryways where persons board and exit the ocean vessel, and require such baths before allowing any person to disembark.
(c) Feed and water. Sufficient feed and water must be provided to livestock aboard the ocean vessel, taking into consideration the livestock's species, body weight, the expected duration of the voyage, and the likelihood of adverse climatic conditions during transport. Guidance on this requirement may be found in the Program Handbook. Livestock aboard the vessel must be provided feed and water within 28 hours of the time they were last fed and watered within the United States.
(d) Accommodations for the humane transport of livestock; general requirements. Ocean vessels used to transport livestock intended for export must be designed, constructed, and managed to reasonably assure the livestock are protected from injury and remain healthy during loading and transport to the importing country. Except as provided below in paragraph (e) of this section, no livestock may be loaded onto an ocean vessel unless, in the opinion of an APHIS representative, the ocean vessel meets the requirements of this section. The Program Handbook contains guidance on ways to meet the requirements. Owners and operators may submit alternative means and methods for meeting the requirements to APHIS for evaluation and approval. Alternatives must be at least as effective in meeting the requirements as those described in the Program Handbook in order to be approved. Alternatives must be approved by APHIS before being used for purposes of this section.
(1) Pens. All pens, including gates and portable rails used to close access ways, must be designed and constructed of material of sufficient strength to securely contain the livestock. They must be properly formed, closely fitted, and rigidly secured in place. They must have smooth finished surfaces free from sharp protrusions. They must not have worn, decayed, unsound, or otherwise defective parts. Flooring must be strong enough to support the livestock to be transported and provide a satisfactory non-slip foothold. Pens on exposed upper decks must protect the livestock from the weather. Pens next to engine or boiler rooms or similar sources of heat must be fitted to protect the livestock from injury due to transfer of heat to the livestock or livestock transport spaces. Any fittings or protrusions from the vessel's sides that abut pens must be covered to protect the livestock from injury. Pens must be of appropriate size for the species, size, weight, and condition of the livestock being transported and take into consideration the vessel's route. Animals that may be hostile to each other may not be housed in the same pen.
(2) Positioning. Livestock must be positioned during transport so that an animal handler or other responsible person can observe each animal regularly and clearly to ensure the livestock's safety and welfare.
(3) Resources for sick or injured animals. The vessel must have an adequate number of appropriately sized and located pens set aside to segregate livestock that become sick or injured from other animals. It must also have adequate veterinary medical supplies, including medicines, for the species, condition, and number of livestock transported.
(4) Ramps, doors, and passageways. Ramps, doors, and passageways used for livestock must be of sufficient width and height for their use and allow the safe passage of the species transported. They must have secure, smooth fittings free from sharp protrusions and non-slip flooring, and must not have worn, decayed, unsound, or otherwise defective parts. Ramps must not have an incline that is excessive for the species of livestock transported and must be fitted with foot battens to prevent slippage at intervals suitable for the species. The sides of ramps must be of sufficient height and strength to prevent escape of the species of livestock transported.
(5) Feed and water. The feeding and watering system must be designed to permit all livestock in each pen adequate access to feed and water. The system must also be designed to minimize soiling of pens and to prevent animal waste from contaminating feed and water. Similarly, feed must be loaded and stored aboard the vessel in a manner that protects it from weather and sea water and, if kept under animal transport spaces, protects it from spillage from animal watering and feeding and from animal waste. If the normal means of tending, feeding, and watering of livestock on board the ocean vessel is wholly or partially by automatic means, the vessel must have alternative arrangements for the satisfactory tending, feeding, and watering of the animals in the event of a malfunction of the automatic means.
(6) Ventilation. Ventilation during loading, unloading, and transport must provide fresh air and remove excessive heat, humidity, and noxious fumes (such as ammonia and carbon dioxide). Ventilation must be adequate for variations in climate and weather and to meet the needs of the livestock being transported. Ventilation must be effective both when the vessel is stationary and when it is moving and must be turned on when the first animal is loaded. The vessel must have on board a back-up ventilation system (including emergency power supply) in good working order or replacement parts and the means, including qualified personnel, to make the repairs or replacements.
(7) Waste management. The vessel must have a system or arrangements, including a backup system in working order or alternate arrangements, for managing waste to prevent excessive buildup in livestock transport spaces during the voyage.
(8) Lighting. The vessel must have adequate illumination to allow clear observation of livestock during loading, unloading, and transport.
(9) Bedding. Bedding must be loaded and stored aboard the vessel in a manner that protects it from weather and sea water and, if kept under animal transport spaces, protects it from spillage from animal watering and feeding and from animal waste.
(10) Cleaning. The vessel must be designed and constructed to allow thorough cleaning and disinfection and to prevent feces and urine from livestock on upper levels from soiling livestock or their feed or water on lower levels.
(11) Halters and ropes. Halters, ropes, or other equipment provided for the handling and tying of horses or other livestock must be satisfactory to ensure the humane treatment of the livestock.
(12) Personnel. The owner or operator of the ocean vessel must have on board during loading, transport, and unloading at least 3 persons (or at least 1 person if fewer than 800 head of livestock will be transported) with previous experience with ocean vessels that have handled the kind(s) of livestock to be carried, as well as a sufficient number of personnel with the appropriate experience to be able to ensure proper care of the livestock. The APHIS representative assigned to inspect the ocean vessel prior to loading will determine whether the personnel aboard the vessel are sufficient and possess adequate experience, including, if necessary, veterinary experience, to ensure proper care of the livestock.
(13) Vessel stability. The vessel must have adequate stability, taking into consideration the weight and distribution of livestock and fodder, as well as effects of high winds and seas. If requested by APHIS, the owner or operator of the vessel must present stability calculations for the voyage that have been independently verified for accuracy.
(14) Means of humane euthanasia. Ocean vessels must maintain a means of humanely euthanizing sick or injured livestock aboard the vessel. One of the personnel aboard the vessel must be trained in humanely euthanizing livestock by using the means of euthanasia carried by the vessel.
(15) Life support systems. The ocean vessel must maintain replacement parts for major life support systems aboard the vessel, and the means, including qualified personnel, to make the repairs or replacements.
(16) Additional conditions. The vessel must meet any other condition the Administrator determines is necessary for approval, as dictated by specific circumstances and communicated to the owner and operator of the vessel, to protect the livestock and keep them healthy during loading, unloading, and transport to the importing country.
(e) Accommodations for the humane transport of livestock; vessels using shipping containers. An inspector may exempt an ocean vessel that uses shipping containers to transport livestock to an importing country from requirements in paragraph (d) of this section that he or she specifies, if the inspector determines that the containers themselves are designed, constructed, and managed in a manner to reasonably assure the livestock are protected from injury and remain healthy during loading, unloading, and transport to the importing country. During such inspections, particular attention will be paid to the manner in which containers are constructed, the space the containers afford to livestock transported within them, the manner in which the vessel would provide feed and water to the animals in the containers, and the manner in which air and effluent are managed within the containers. The Program Handbook contains exemption guidance.
(f) Operator's report. (1) The owner or operator of any ocean vessel used to export livestock (including vessels that use shipping containers) from the United States must submit a written report to APHIS within 5 business days after completing a voyage. The report must include the name of the ocean vessel; the name and address of all exporters of livestock transported on the vessel; the port of embarkation; dates of the voyage; the port where the livestock were discharged; the number of each species of livestock loaded; the number of each species that died and an explanation for those mortalities; and the number of animals that sustained injuries or sustained illnesses that were significant enough to require medical attention from the personnel entrusted with the care of the animals, as well as the nature of these injuries or illnesses. The report must also document any failure of any major life support system for the livestock, including, but not limited to, systems for providing feed and water, ventilation systems, and livestock waste management systems. Any such failure must be documented, regardless of the duration or whether the failure resulted in any harm to the livestock. The report must include the name, telephone number, and email address of the person who prepared the report and the date of the report. The report must be submitted to APHIS by facsimile or email. Contact numbers and addresses, as well as an optional template for the report, are provided in the Program Handbook.
(2) If an ocean vessel used to export livestock experiences any failure of a major life support system for livestock during the voyage, the owner or operator of the ocean vessel must notify APHIS immediately by telephone, facsimile, or other electronic means. Contact numbers and addresses are provided in the Program Handbook.
(3) Failure to provide timely reports as required by this section may result in APHIS disapproving future livestock shipments by the responsible owner or operator or revoking the vessel's certification under paragraph (a) of this section to carry livestock.
(a) Prior to loading livestock aboard aircraft, the stowage area of the aircraft and any loading ramps, fittings, and equipment to be used in loading the animals must be cleaned and then disinfected with a disinfectant approved by the Administrator, to the satisfaction of an APHIS representative, unless the representative determines that the aircraft has already been cleaned and disinfected to his or her satisfaction.
(1) The Administrator will approve a disinfectant for purposes of this section upon determining that the disinfectant is effective against pathogens that may be spread by the animals and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency.
(2) The Program Handbook provides access to a list of disinfectants approved by the Administrator for use as required by this section. Other disinfectants may also be approved by the Administrator in accordance with paragraph (a)(1) of this section.
(3) The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants in the Program Handbook, if the disinfectant no longer meets the conditions for approval in this section.
(b) The time at which the cleaning and disinfection are to be performed must be approved by the APHIS representative, who will give approval only if he or she determines that the cleaning and disinfection will be effective up to the projected time the livestock will be loaded. If the livestock are not loaded by the projected time, the APHIS representative will determine whether further cleaning and disinfection are necessary.
(c) The cleaning must remove all garbage, soil, manure, plant materials, insects, paper, and other debris from the stowage area. The disinfectant solution must be applied with a device that creates an aerosol or mist that covers 100 percent of the surfaces in the stowage area, except for any loaded cargo and deck surface under it that, in the opinion of the APHIS representative, do not contain material, such as garbage, soil, manure, plant materials, insects, waste paper, or debris, that may harbor animal disease pathogens.
(d) After cleaning and disinfection is performed, the APHIS representative will sign and deliver to the captain of the aircraft or other responsible official of the airline involved a document stating that the aircraft has been properly cleaned and disinfected, and stating further the date, the carrier, the flight number, and the name of the airport and the city and state in which it is located. If an aircraft is cleaned and disinfected at one airport, then flies to a subsequent airport, with or without stops en route, to load animals for export, an APHIS representative at the subsequent airport will determine, based on examination of the cleaning and disinfection documents, whether the previous cleaning and disinfection is adequate or whether to order a new cleaning and disinfection. If the aircraft has loaded any cargo in addition to animals, the APHIS representative at the subsequent airport will determine whether to order a new cleaning and disinfection, based on both examination of the cleaning and disinfection documents and on the inspection of the stowage area for materials, such as garbage, soil, manure, plant materials, insects, waste paper, or debris, that may harbor animal disease pathogens.
(e) Cargo containers used to ship livestock must be designed and constructed of a material of sufficient strength to securely contain the animals and must provide sufficient space for the species being transported given the duration of the trip, as determined by APHIS.
The Administrator may, upon request in specific cases, permit the exportation of livestock not otherwise provided for in this part under such conditions as he or she may prescribe in each specific case to prevent the spread of livestock diseases and to ensure the humane treatment of the animals during transport to the importing country.
Active surveillance. Sample collection using a systematic or statistically designed survey methodology to actively seek out and find cases of animals with a restricted disease agent, or to determine the prevalence of the restricted disease agent in the population.
Adjacent region. Any geographic land area, whether or not identifiable by geological, political or surveyed boundaries, that shares common boundaries with any region.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animals. All species of the animal kingdom, except man, including: Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, poultry, and birds that are susceptible to communicable diseases of livestock and poultry or capable of being carriers of those diseases or their arthropod vectors.
Approved laboratory. A properly equipped institution in the exporting region, approved by the official authority who is responsible for animal health matters in that region, that is staffed by technically competent personnel under the control of a specialist in veterinary diagnostic methods who is responsible for the results.
Bovine. Bos taurus, Bos indicus, and Bison bison.
Communicable disease. Any contagious or infectious disease of animals. It can be transmitted either directly or indirectly to a susceptible animal from an infected animal, vector, inanimate source, or other sources.
Compartment. Any defined animal subpopulation contained in one or more establishments under a common biosecurity management system for which surveillance, control, and biosecurity measures have been applied with respect to a specific disease.
Contagious disease. Any communicable disease transmitted from one animal to another by direct contact or by feed, water, aerosol, or contaminated objects.
Disease agent. A virus, bacterium, or other organism that causes disease in animals.
Exporting region. A region from which shipments are sent to the United States.
European Union. The organization of Member States consisting of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
Import (imported, importation) into the United States. To bring into the territorial limits of the United States.
OIE. The World Organization for Animal Health.
OIE Code. The Terrestrial Animal Health Code of the World Organization for Animal Health.
OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organization for Animal Health.
Passive surveillance. A surveillance system that does not depend on active participation by the responsible agency to seek out and monitor a restricted disease agent. The system relies on mandatory reporting, a pool of trained investigators, diagnostic submission procedures and laboratory support, and periodic public information and continuing education programs on diseases.
Prevalence. The number of cases of a disease in existence at a given time in a designated area.
Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.
Region. Any defined geographic land region identifiable by geological, political or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Region of controlled risk for bovine spongiform encephalopathy (BSE).
(1) Has demonstrated that appropriate mitigations are being taken to manage all identified risks, but may not have been taken for the periods of time necessary to be classified as a region of negligible risk for BSE.
(2) Is a region in which it can be demonstrated through an appropriate control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants.
(3) Has demonstrated that Type A surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met. Type B surveillance in accordance with Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator, is sufficient in place of Type A surveillance or its equivalent once the relevant points target for Type A surveillance or its equivalent has been met.
(4) Meets one of the following conditions:
(i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or
(ii) Has had at least one indigenous case, and all bovines described in either paragraph (4)(ii)(A) or (4)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed:
(A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or
(B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal.
(5) Meets the conditions in one of or both paragraphs (5)(i) or (5)(ii) of this definition:
(i) Has met the following conditions, but not for at least the past 7 years:
(A) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE;
(B) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and
(C) Has carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the surveillance and monitoring described in paragraphs (3) and (5)(i)(A) and (5)(i)(B) of this definition; or
(ii) Has prohibited the feeding to ruminants in the region of meat-and-bone meal and greaves derived from ruminants, but it cannot be demonstrated through an appropriate level of control and audit that the prohibited materials have not been fed to ruminants in the region for at least the past 8 years.
Region of negligible risk for bovine spongiform encephalopathy (BSE).
(1) Has demonstrated that appropriate mitigations to manage all identified risks have been taken for each relevant period of time to meet each identified risk, as set forth in this definition.
(2) Has demonstrated that Type B surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met.
(3) Meets one of the following conditions:
(i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or
(ii) Has had at least one indigenous case, but every indigenous case was born more than 11 years ago, and all bovines described in either paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed:
(A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or
(B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal.
(4) Has, for at least the past 7 years:
(i) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE;
(ii) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and
(iii) Carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the required surveillance and monitoring described in paragraphs (2) and (4)(i) and (4)(ii) of this definition.
(5) Has demonstrated through an appropriate level of control and audit that, for at least the past 8 years, neither meat-and-bone meal nor greaves derived from ruminants have been fed to ruminants in the region.
Region of undetermined risk for bovine spongiform encephalopathy (BSE). Any region that is not classified as either a region of negligible risk for BSE or a region of controlled risk for BSE.
Restricted disease agent. Any communicable disease agent or its vector not known to exist in the United States or that is subject to a Federal or cooperative Federal/State control or eradication program within the United States.
Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.
Surveillance. Systems to find, monitor, and confirm the existence or absence of a restricted disease agent or agents in livestock, poultry and other animals. Surveillance may be passive or active.
United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
Vector-borne disease. A disease transmitted to an animal through an intermediate arthropod vector, including ticks or insects.
(a) The representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS recognize the animal health status of a region or a compartment.
(b) Requests for recognition of the animal health status of a region, other than requests submitted in accordance with paragraph (c) of this section, must include, in English, the information in paragraphs (b)(1) through (8) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737.
(1) Scope of the evaluation being requested.
(2) Veterinary control and oversight.
(3) Disease history and vaccination practices.
(4) Livestock demographics and traceability.
(5) Epidemiological separation from potential sources of infection.
(6) Surveillance.
(7) Diagnostic laboratory capabilities.
(8) Emergency preparedness and response.
(c) Requests for recognition that a region is historically free of a disease based on the amount of time that has elapsed since the disease last occurred in a region, if it has ever occurred, must include, in English, the information in paragraphs (c)(1) through (6) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. For a region to be considered historically free of a disease, the disease must not have been reported in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years.
(1) Scope of the evaluation being requested.
(2) Veterinary control and oversight.
(3) Disease history and vaccination practices.
(4) Disease notification.
(5) Disease detection.
(6) Barriers to disease introduction.
(d) Requests for recognition of the animal health status of a compartment must include, in English, the information in paragraphs (d)(1) through (8) of this section about the compartment. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737.
(1) Scope of the evaluation being requested.
(2) Veterinary control and oversight of the compartment.
(3) Disease history and vaccination practices.
(4) Livestock or poultry commodity movement and traceability.
(5) Epidemiologic separation of the compartment from potential sources of infection.
(6) Surveillance.
(7) Diagnostic laboratory capabilities.
(8) Emergency preparedness and response.
(e) A list of those regions for which an APHIS recognition of their animal health status has been requested, the disease(s) under evaluation, and, if available, the animal(s) or product(s) the region wishes to export, is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.
(f) A list of countries that have requested an APHIS compartmentalization evaluation, and a description of the requested compartment is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.
(g) If, after review and evaluation of the information submitted in accordance with paragraph (b), (c), or (d) of this section, APHIS believes the request can be safely granted, APHIS will indicate its intent and make its evaluation available for public comment through a document published in the
(h) APHIS will provide a period of time during which the public may comment on its evaluation. During the comment period, the public will have access to the information upon which APHIS based its evaluation, as well as the evaluation itself. Once APHIS has reviewed all comments received, it will make a final determination regarding the request and will publish that determination in the
(i) If a region or compartment is granted animal health status under the provisions of this section, the representative of the national government(s) of any country or countries who has the authority to make a regionalization or compartmentalization request may be required to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order for that region or compartment to maintain its animal health status.
Whenever the European Commission (EC) establishes a quarantine for a disease in the European Union in a region the Animal and Plant Health Inspection Service recognizes as one in which the disease is not known to exist and the EC imposes prohibitions or other restrictions on the movement of animals or animal products from the quarantined area in the European Union, such animals and animal products are prohibited importation into the United States.
This section applies to regions or compartments that are designated under this subchapter as free of a specific animal disease and then experience an outbreak of that disease.
(a) Interim designation. If a region or a compartment recognized as free of a specified animal disease in this subchapter experiences an outbreak of that disease, APHIS will take immediate action to prohibit or restrict imports of animals and animal products from the entire region, a portion of that region, or the compartment. APHIS will inform the public as soon as possible of the prohibitions and restrictions by means of a notice in the
(b) Reassessment of the disease situation. (1) Following removal of disease-free status from all or part of a region or a compartment, APHIS may reassess the disease situation in that region or compartment to determine whether it is necessary to continue the interim prohibitions or restrictions. In reassessing disease status, APHIS will take into consideration the standards of the World Organization for Animal Health (OIE) for reinstatement of disease-free status, as well as all relevant information obtained through public comments or collected by or submitted to APHIS through other means.
(2) Prior to taking any action to relieve prohibitions or restrictions, APHIS will make information regarding its reassessment of the region's or compartment's disease status available to the public for comment. APHIS will announce the availability of this information by means of a notice in the
(c) Determination. Based on the reassessment conducted in accordance with paragraph (b) of this section regarding the reassessment information, APHIS will take one of the following actions:
(1) Publish a notice in the
(2) Publish a notice in the
(3) Publish another document in the
All countries of the world are considered by APHIS to be in one of three BSE risk categories—negligible risk, controlled risk, or undetermined risk. These risk categories are defined in § 92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. The listing of those regions classified by APHIS as having either negligible risk or controlled risk can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. The listing can also be obtained by writing to APHIS at National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. APHIS may classify a region for BSE according to either paragraph (a) or paragraph (b) of this section.
(a) BSE risk classification based on OIE classification. If the OIE has classified a country as either BSE negligible risk or BSE controlled risk, APHIS will seek information to support concurrence with the OIE classification. This information could be publicly available information, or APHIS could request that countries supply the same information given to the OIE. APHIS will announce in the
(b) Regions seeking classification as negligible or controlled risk that have not been classified by the OIE. A region that has not received classification by OIE as either negligible risk or controlled risk for BSE and that wishes to be classified by APHIS as negligible risk or controlled risk must submit to the Administrator a request for classification, along with documentation sufficient to allow APHIS to conduct an evaluation of whether the region meets the criteria for classification. A list of the documentation required can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. If, following evaluation of the information submitted, the Administrator determines that the region meets the criteria for classification as negligible risk or controlled risk, APHIS will announce that determination in the
(c) Retention of classification as either negligible risk or controlled risk. (1) As required by the OIE for countries classified as either negligible risk or controlled risk by the OIE, regions evaluated by APHIS and classified as negligible or controlled risk would need to submit updated information to APHIS each year. The required information includes documentation of the following:
(i) Relevant changes in BSE legislation, compared to the previous year;
(ii) The importation into the region during the year of cattle, processed animal protein, and products containing processed animal protein;
(iii) Audit findings in rendering plants and feed mills that process ruminant material or material from mixed species that contains ruminant material, related to the prohibition of the feeding to ruminants of processed animal protein;
(iv) Audit findings in rendering plants and feed mills that process nonruminant material, related to the prohibition of the feeding to ruminants of processed animal protein;
(v) Infractions at the types of facilities listed above;
(vi) If and why, in light of the audit findings, there has been no significant exposure of cattle to the BSE agent through consumption of processed animal protein of bovine origin;
(vii) Surveillance efforts;
(viii) All clinical BSE suspects; and
(ix) Any new cases of BSE.
(2) If APHIS at any time determines that a region no longer meets the criteria for the risk classification it had previously received, APHIS will remove the region from its list of regions so classified. If the OIE determines the region no longer meets the criteria for the risk classification it had previously received, APHIS may concur with the OIE determination or may request updated information from the region and determine whether to concur with the OIE decision APHIS will announce its intent in the
(a) In order for APHIS to determine the eligibility of live bovines for importation from a region classified as BSE negligible risk or BSE controlled risk, APHIS must determine the date from which a ban on the feeding of ruminant material to ruminants has been effectively enforced in the region. APHIS will base its determination of the date of effective enforcement on the information included in the dossier the region submitted when it requested to be classified regarding BSE risk. The information APHIS will consider will include, but not be limited to:
(1) Policies and infrastructure for feed ban enforcement, including an awareness program for producers and farmers;
(2) Livestock husbandry practices;
(3) Disposition of processed animal protein produced from domestic bovines, including the feeding of such material to any animal species;
(4) Measures taken to control cross-contamination and mislabeling of feed; and
(5) Monitoring and enforcement of the ruminant-to-ruminant feed ban, including audit findings in rendering plants and feed mills that process ruminant material.
(b) After conducting its evaluation, APHIS will announce in the
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, USDA must publish notice of change in the
(b) World Organization for Animal Health (OIE), 12, rue de Prony 75017 Paris, France, or email oie@oie.int, http://www.oie.int/eng/normes/Mcode/en_sommaire.htm.
(1) Terrestrial Animal Health Code, Chapter 11.5-Bovine Spongiform Encephalopathy, Article 11.5.22 (Surveillance activities), 22nd Edition, 2013.
(2) [Reserved]
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service.)
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.
Birds. All members of the class aves (including eggs for hatching), other than poultry.
Commercial birds. Birds which are imported for resale, breeding, public display, or any other purpose, except pet birds, zoological birds, research birds, or performing or theatrical birds.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Department. The United States Department of Agriculture (USDA).
Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:
(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Licensed veterinarian. Any person licensed by any region or political subdivision thereof to practice veterinary medicine.
Pen-raised. Cared for in a fenced enclosure, such that the ratites are kept apart from wild ratites, poultry, and other animals; can be readily observed, and be restrained for inspection and treatment. A flock is not considered to be pen-raised if ratites captured in the wild have been added to it after March 8, 1994.
Performing or theatrical birds. Birds, except ratites, which are to be used in shows, theatrical acts or performances only.
Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.
Pet birds. Birds, except ratites, which are imported for the personal pleasure of their individual owners and are not intended for resale.
Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).
Production season. That period of time, usually approximately 9 months each year, from the time ratites in a flock begin laying eggs until the ratites cease laying eggs.
Quarantine facility. A USDA facility, or a private facility approved by APHIS, for the secure housing of imported birds, poultry, or other animals for specified periods.
Ratites. Cassowaries, emus, kiwis, ostriches, and rheas.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Research birds. Birds which are to be used for research purposes only.
Smuggled birds. Any bird which has been brought into the United States contrary to any Federal law or regulation and which has been seized by any official of any Department of the United States Government or which has been abandoned to the United States.
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
Veterinary Services. The Veterinary Services unit of the Department.
Zoological birds. Birds intended for breeding or public display, for recreational or educational purposes, at a zoological park.
Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.
(a) No product or bird subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b)(1) Birds from Canada may be imported in accordance with this section or, except for ratites in accordance with the provisions applicable to importation of poultry from Canada as specified in §§ 93.205, 93.214, and 93.216 of this part.
(2) Ratites and hatching eggs of ratites may be imported into the United States only in accordance with the provisions in this part that apply to commercial and zoological birds, and, where specified, with the provisions that apply to ratites or hatching eggs of ratites.
(3) Except for ratites imported as zoological birds, and ratites and ratite hatching eggs imported from Canada in accordance with § 93.107, ratites and hatching eggs of ratites may not be imported into the United States unless the following conditions are met:
(i) The ratites or hatching eggs are produced by a pen-raised flock, and, in the case of ratites, maintained in a pen-raised flock;
(ii) Each ratite produced in the flock is identified with an identification number by means of a microchip implanted at 1-day of age in the pipping muscle of ostriches and in the upper neck of other ratites, each ratite added from outside the flock is identified in like manner upon arrival in the flock, except that the microchip need not be implanted in the pipping muscle or the upper neck, and each ratite already in the flock as of March 8, 1994 is identified in like manner, prior to the next visit to the flock premises by an APHIS representative under § 93.103(a)(2)(iv), except that the microchip need not be implanted in the pipping muscle or the upper neck;
(iii) On the date it is produced, each hatching egg produced in the flock is marked in indelible ink with the date of the production, and with identification, assigned by the national government of the region of export, of the premises and region from which the ratites or hatching eggs are intended for exportation;
(iv) The owner or manager of the premises from which the ratites or hatching eggs are intended for importation into the United States maintains on a daily basis a register listing the following:
(A) Number of live ratites hatched in the flock or added to the flock, and number of live ratites removed from the flock, and the microchip number for each of these ratites;
(B) Number of eggs produced in the flock and date of production, and number of eggs removed from the flock and date of production; and
(C) Number of eggs in incubator/hatcher and date of production;
(v) The owner or manager of the premises submits a copy of the registers to the National Veterinary Service of the region of export on a quarterly basis. The region of export in turn submits a copy of the registers to the Administrator upon his or her request;
(vi) The region from which the ratites or hatching eggs are exported to the United States maintains a registry of premises that wish to export ratites or hatching eggs of ratites to the United States, that lists each ratite according to the microchip number required under paragraph (b)(3)(iv) of this section, and also maintains a count of hatching eggs of ratites produced on or added to the premises;
(vii) Before a premises is added to the registry, either a veterinary officer of the national government of the region of export, or an employee of that government responsible for the protection of fish and wildlife, visits the premises and determines that all ratites and hatching eggs of ratites are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section.
(viii) The region from which the ratites or hatching eggs of ratites are exported to the United States requires each premises from which ratites or hatching eggs of ratites are exported to the United States to receive approval from the National Veterinary Service of that region before ratites are added to the premises from outside the premises, and also prohibits the addition of ratites to a flock during production seasons;
(ix) The region from which ratites or hatching eggs of ratites are exported to the United States establishes a maximum number of hatching eggs of ratites that may be produced on each premises over a set production season. The ceiling for each premises is calculated jointly by a full-time salaried veterinary officer of the national government of the region of export and the APHIS representative who conducts the site visit required under § 93.103(a)(2)(iv), and is adjusted jointly by an APHIS representative and a full-time salaried veterinary officer of the national government of the region of export according to changes in the number of laying hens in the flock;
(x) The region of export conducts random inspections of each premises intending to export ratites or hatching eggs of ratites to the United States, at least twice during each production season, to ensure that all ratites and hatching eggs of ratites on the premises are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section. These inspections must be conducted by either a veterinary officer of the national government of the region of export or an employee of that government responsible for the protection of fish and wildlife. If any ratites or hatching eggs are not identified as required, the region of export must not issue the export certificate required under § 93.104(a). The region of export must record, on the copy of the report required to be sent to the Administrator under paragraph (b)(3)(v) of this section, whether all ratites and hatching eggs are identified as required;
(xi) The region of export requires each premises on which ratites or hatching eggs of ratites intended for export to the United States are kept to submit to the National Veterinary Service of that region a copy of the certificate required under § 93.104(a);
(xii) The person intending to import ratites into the United States provides the APHIS veterinary inspector at the intended port of entry with a reader capable of reading the microchip implanted in each of the ratites.
(4) Ratites and hatching eggs of ratites may not be imported into the United States in any container that holds hay, straw, grasses, wood chips, sawdust, or other materials likely to harbor ectoparasites. Ratites and hatching eggs of ratites that are imported into the United States in containers holding such materials will be refused entry.
(c)(1) Pet birds offered for entry from Canada and which are not known to be affected with or exposed to any communicable disease of poultry, which are caged (prior to release from the port of entry) and which are personal pets, may be imported by the owner thereof at any port of entry designated in §§ 93.103 or 93.203: Provided, That, such birds are found upon port of entry veterinary inspection under § 93.105 to be free of poultry diseases and at the time of entry the owner signs and furnishes to the Administrator, a statement stating that the bird or birds have been in his or her possession for a minimum of 90 days preceding the date of importation and that during such time such birds have not been in contact with poultry or other birds (for example, association with other avian species at exhibitions or in aviaries.)
(2)(i) Except for pet birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have not been outside the country for more than 60 days may be offered for entry under the provisions of paragraph (c)(1) of this section if:
(A) The pet birds are accompanied by an import permit issued by APHIS: Provided, that an import permit will not be required for pet birds returning from Canada or Mexico through a land border port; and
(B) The birds are also accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(C) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate.
(ii) Except for pet birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have been outside the country for more than 60 days may be imported by their owner if:
(A) The pet birds are accompanied by an import permit issued by APHIS: Provided, that an import permit will not be required for pet birds returning from Canada or Mexico through a land border port; and
(B) The pet birds are found upon port of entry veterinary inspection to be free of poultry diseases; and
(C) The pet birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(D) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate; and
(E) The owner importing the pet birds signs and furnishes to the Administrator the following:
(1) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the bird or birds have not been in contact with poultry or other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and
(2) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:
(i) That the birds will be maintained in confinement in his or her personal possession separate and apart from all poultry and other birds for a minimum of 30 days following importation at the address where the birds are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and
(ii) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the birds or any bird dies during that period. The owner importing such birds must comply with the provisions of the aforementioned agreement before the birds may be released from confinement. Except for pet birds that have been in any region where highly pathogenic avian influenza exists, lots of pet birds of United States origin which do not otherwise meet the requirements of paragraphs (c)(1) or (2) of this section may be offered for entry under the provisions of paragraph (c)(4) of this section.
(3) Any pet birds of United States origin that have been in any region identified in accordance with § 94.6(a)(2) of this subchapter as a region where highly pathogenic avian influenza exists, regardless of the length of time such birds have been outside of the United States, may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The birds meet the requirements of paragraphs (c)(2)(ii)(A) through (D) of this section; and
(ii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a USDA quarantine facility in accordance with § 93.106.
(4) Pet birds which are not known to be affected with or exposed to communicable diseases of poultry may be offered for entry at one of the ports of entry designated in § 93.102(a) under the following conditions:
(i) The pet birds shall be accompanied by a veterinary health certificate issued by a national government veterinary officer of the region of export stating that he or she personally inspected the birds listed on the health certificate and found them to be free of evidence of highly pathogenic avian influenza, Newcastle disease, chlamydiosis, and other communicable diseases of poultry, and that the birds were being exported in compliance with the laws and regulations of the region of export, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so. Certificates in a foreign language must be translated into English at the expense of the importer.
(ii) An advanced reservation fee as required by § 93.103(a)(3) and a request for space which has been confirmed in writing, at a USDA-operated quarantine facility shall be made with the port veterinarian
(iii) During the isolation period, the birds shall be subjected to such tests and procedures as required by the Administrator to determine whether the birds are free from communicable diseases of poultry.
(iv) Following the isolation period, if the birds are found to be free of communicable disease of poultry, the port veterinarian shall issue an agriculture release for entry through U.S. Customs. If the birds are found during port of entry inspection or during quarantine to be infected with or exposed to a communicable disease of poultry, such birds shall be refused entry and handled in accordance with § 93.106(a) of this part.
(v) The owner of the birds is responsible for all costs which result from these procedures and shall reimburse APHIS for governmental expenses in accordance with § 93.210 (b) and (c) of this part.
(d) The provisions in this subpart relating to birds shall not apply to healthy birds, except ratites, not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) Except for birds in transit through Anchorage, Alaska, under § 93.103(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into a bird holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry or birds will be retained aboard such means of conveyance or in an approved holding facility during transhipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of birds in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(e) Commercial birds, zoological birds, research birds, or pet birds may be imported into the United States if they meet the requirements of §§ 93.102(a), 93.103, 93.104, 93.105(a), and 93.106(a) which specifically apply to such birds and the requirements of all other sections in this part that are applicable to poultry generally.
(f) Performing or theatrical birds returning to the United States. (1) Performing or theatrical birds of United States origin that are returning to the United States from Canada or Mexico may be imported if:
(i) The birds are found upon port of entry veterinary inspection to be free of avian diseases; and
(ii) The birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the birds is the same as the one listed on the health certificate.
(2) Except for performing or theatrical birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (f)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:
(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and
(ii) The birds are accompanied by an import permit issued by APHIS; and
(iii) The owner importing the birds signs and furnishes to the Administrator the following:
(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the birds have not been in contact with other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and
(B) An agreement on VS Form 17-8, available electronically or through other authorized method, obtainable from a Federal inspector at the port of entry, stating:
(1) That the birds will be maintained in confinement in his or her personal possession separate and apart from all birds and other birds for a minimum of 30 days following importation at the address where the birds are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and
(2) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the birds or any birds die during that period. The owner importing such poultry must comply with the provisions of the aforementioned agreement before the birds may be released from confinement. Except for performing or theatrical birds that have been in any region where highly pathogenic avian influenza exists, performing or theatrical birds of United States origin which do not otherwise meet the requirements of paragraphs (f)(1) or (2) of this section may be offered for entry under the provisions of § 93.101(c).
(3) Any performing or theatrical birds of United States origin that have been in any region identified in accordance with § 94.6(a)(2) of this subchapter as a region where highly pathogenic avian influenza exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and
(ii) The birds are accompanied by an import permit issued by APHIS; and
(iii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with paragraphs (c)(3)(ii) through (c)(3)(iv) of this section.
(g) Any smuggled bird shall:
(1) Be refused entry into the United States and be removed from the United States,
(2) Be quarantined in a USDA-operated quarantine facility pending negative results to two consecutive tests for highly pathogenic avian influenza and Newcastle disease
(3) Tissue samples from any smuggled bird which has died prior to release from quarantine shall be submitted for highly pathogenic avian influenza and Newcastle disease isolation. Smuggled birds shall also be subject to such other tests and procedures to determine whether the birds are free from communicable diseases of poultry other than highly pathogenic avian influenza and Newcastle disease when the port veterinarian determine that the bird in question has shown physical symptoms of being affected with or exposed to communicable diseases of poultry. A lot of smuggled birds placed into the quarantine facility shall be handled on an “all-in, all-out” basis: Provided, That birds of endangered and threatened species, as determined by the Department of the Interior (16 U.S.C. 1533, as amended) shall be separated for quarantine and testing as separate lots. If highly pathogenic avian influenza or Newcastle disease or any other communicable disease of poultry is diagnosed in any smuggled bird at any point or if it is determined that any smuggled bird has been exposed to highly pathogenic avian influenza or Newcastle disease or any other such communicable disease, such birds shall not be released from quarantine and shall be disposed of in accordance with procedures established by the Administrator to prevent the entry of communicable diseases of livestock or poultry into the United States. However, if endangered or threatened species are determined to be exposed such birds shall be held in permanent quarantine in accordance with such conditions as the Deputy Administrator may prescribe to protect poultry of the United States. At the time any smuggled bird enters the quarantine facility, it shall be identified in a manner approved by the Administrator.
(4) If the laboratory tests for highly pathogenic avian influenza and Newcastle disease are negative and as determined by the port veterinarian the birds are free of clinical evidence of diseases of poultry at the end of the quarantine period, the port veterinarian shall issue an agricultural release for entry of the birds through the United States Customs Service at the termination of the quarantine period. Providing that the sale of the smuggled birds is not contrary to any Federal law or regulation, expenses incurred by the Department for the handling of the smuggled birds under this paragraph shall be reimbursed from funds derived from the sale or disposition of the smuggled birds after their release from quarantine. Any smuggled bird which by law may not be sold, or so disposed, shall be quarantined in accordance with such procedures as the Deputy Administrator may establish to prevent the introduction of communicable diseases of livestock or poultry into the United States, in accordance with the law.
(a) Special ports for pet birds. The following ports are designated as ports of entry for pet birds imported under the provisions of § 93.101(c) and performing or theatrical birds imported under the provisions of § 93.101(f): Los Angeles and San Ysidro, CA; Miami, FL; New York, NY; Baudette, MN; and Hidalgo, TX.
(b) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(c) Notwithstanding any other provisions of this section, all commercial birds, zoological birds, or research birds shall be imported only at a port of entry specified in § 93.105.
(d) Limited ports. The following ports are designated as ports of entry for pet birds imported under the provisions of § 93.101(c)(1) or (2) and performing or theatrical birds imported under the provisions of § 93.101(f): Anchorage and Fairbanks, AK; San Diego, CA; Jacksonville, Port Canaveral, St. Petersburg-Clearwater, and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; New Orleans, LA; Baltimore, MD; Portland, ME; Minneapolis, MN; Great Falls, MT; Covington, KY (Greater Cincinnati International Airport); Portland, OR; San Juan, PR; Galveston and Houston, TX; and Seattle, Spokane, and Tacoma, WA.
(a) Application for permit; reservation required. Before any permit application is submitted, all construction at the quarantine facility must be completed.
(1) For pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, intended for importation into the United States, except as otherwise provided in §§ 93.101(b) and (c), 93.103(c), and 93.107(b), the importer shall first apply for and obtain an import permit. The importer (permit applicant) shall submit a completed VS form 17-128 for ratites or hatching eggs of ratites; or, for other birds, a completed VS form 17-20; or shall submit a document that states that it is an application for a permit to import ratites, hatching eggs of ratites, or birds other than ratites or hatching eggs of ratites. The application
(i) The name, address, and telephone number of the importer;
(ii) The status of the importer, such as individual, partnership, or corporation (if incorporated, include State where incorporated and date of incorporation);
(iii) Name and address of the quarantine facility;
(iv) Date of intended quarantine;
(v) The purpose of the importation;
(vi) The region of origin;
(vii) The name and address of the exporter;
(viii) The port of embarkation in the foreign region;
(ix) The mode of transportation, route of travel, and port of entry in the United States;
(x) The name and location of the quarantine facility in the United States to which delivery will be made from the port of entry, in accordance with § 93.106(c)(5);
(xi) A drawing of the floor plan for the facility showing the location of the bird holding area; equipment storage areas; office areas; clothes storage and change areas; feed storage areas; necropsy areas (showing entry and refrigeration); washing areas for equipment; shower areas; ventilation arrangements; and entries and exits; and, for a facility for hatching eggs of ratites in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from a previously quarantined lot, the incubation/hatcher and bird (chick) holding areas; and
(xii) Date and certification, by signature of the importer (permit applicant), after the following language:
(xiii) In addition, the application for a permit to import ratites or hatching eggs of ratites, except for ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, shall specify the number of ratites or hatching eggs intended for importation, the size of the flock of origin, and the location of the premises where the flock of origin is kept; and shall state that, from the date of application through the date of export, APHIS representatives shall be granted access to the premises where the flock of origin is kept. (For ratites intended for importation as zoological birds, the flock of origin shall be the ratites intended for importation.)
(2)(i) An import permit will be issued only after an APHIS representative has inspected the quarantine facility identified on the permit application, and has determined that it meets the standards set forth in § 93.106(c) of this part.
(ii) An application for a permit to import pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, may be denied or withdrawn because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned countries; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; the lack of APHIS personnel; any outstanding debts to APHIS the permit applicant has not paid when due; or any other circumstances which the Administrator believes require such denial or withdrawal to prevent the dissemination of any communicable disease of livestock or poultry into the United States, such as if:
(A) Any requirement of this subpart is not complied with;
(B) The importer (permit applicant) or any person responsibly connected with the importer's business, any person responsibly connected with the privately owned bird quarantine facility through which the importation is intended, or, in the case of the importation of ratites or ratite hatching eggs, the operator of the flock of origin or a person responsibly connected with the owner of the flock of origin, has been convicted of any crime under any law regarding the import or export of goods, regarding the quarantine of any animal or bird, or the illegal movement of goods within a region, or involving fraud, bribery, extortion, or of any other crime involving lack of the integrity needed for the conduct of operations affecting the importation of birds;
(C) The importer (permit applicant) or any person responsibly connected with the importer's business, any person responsibly connected with the privately owned bird quarantine facility intended for use for the importation, or, in the case of the importation of ratites or ratite hatching eggs, the operator of the flock of origin or a person responsibly connected with the owner of the flock of origin, threatens to forcibly assault or forcibly assaults, intimidates, or interferes with any APHIS representative or employee in or on account of the performance of his or her official duties, unless, promptly upon the incident being brought to the importer's attention by the authorized supervisor of the APHIS representative or employee, and to the satisfaction of that supervisor, the importer justifies the incident, takes effective steps to prevent a recurrence, or provides acceptable assurance that there will not be any recurrences; or
(D) For any violation of the regulations in this subpart.
(iii) In addition, a permit to import ratites or hatching eggs of ratites, except for ratites or hatching eggs of ratites imported from Canada in accordance with § 93.107, will be denied or withdrawn unless APHIS representatives are granted access to the premises where the flock of origin is kept (or, in the case of zoological birds, to the premises where the birds are kept), from the date of the application for the permit through the date of export.
(iv) Except for ratites intended for importation as zoological birds and ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, a permit to import ratites or hatching eggs of ratites will be denied or withdrawn unless an APHIS representative has visited the premises where the flock of origin is kept within the 12-month period before the intended importation and has determined that the flock is pen-raised and contains sufficient breeding pairs to produce the number of ratites or hatching eggs intended for importation.
(v) A permit to import ratites or hatching eggs of ratites will be denied or withdrawn if an inspection of the premises of the flock or origin, carried out by the national government of the region of export under § 93.101(b)(3), indicates that the ratites and hatching eggs are not identified and marked as required under § 93.101(b)(3).
(vi) For the purposes of this section, a person shall be deemed to be responsibly connected with an importer's business, a privately owned bird quarantine facility, or an owner of a flock of origin, if such person has an ownership, mortgage, or lease interest in the physical plant of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or if such person is a partner, officer, director, holder or owner of 10 per centum or more of the voting stock of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or is an employee of the importer's business, the privately owned bird quarantine facility, or the owner of the flock of origin.
(vii) A permit may be denied or withdrawn at any time by the Administrator, for any of the reasons provided in paragraphs (a)(2)(ii), (iii), (iv), or (v) of this section. Before such action is taken, the importer will be informed of the reasons for the proposed action and, upon request in case of a dispute of material facts, shall be afforded an opportunity for a hearing with respect to the merits or validity of such action, in accordance with rules of practice which shall be adopted for the proceeding. However, withdrawal of a permit shall become effective pending final determination in the proceeding, when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the importer. In the event of oral notification, written confirmation shall be given to the importer as promptly as circumstances permit. This withdrawal shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(viii) If APHIS receives more than one application for a permit to import birds through a specified port of entry at approximately the same time, such that APHIS personnel could provide services to only one importer (permit applicant) who requests them, APHIS will issue the permit to the first importer who meets the requirements of this subpart to deposit, with the Administrator, the completed cooperative and trust fund agreement, accompanied by the required deposit.
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of birds to be quarantined in a facility maintained by USDA. For birds the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the birds are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of birds for which the reservation was made: Except that a reservation fee shall not be forfeited if:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry or birds within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine.)
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(4) Permit applications for ratites. (i) If quarantine space for ratites is desired at either the New York Animal Import Center or the Miami Animal Import Center, permit applications must be submitted to the New York Animal Import Center, USDA, APHIS, Veterinary Services, 200 Drury Lane, Rock Tavern, NY, 12575, or to the port veterinarian in charge of the New York Animal Import Center.
(ii) Quarantine space for ratites will be offered in the order that permit applications are or have been received, beginning with those permit applications received on August 12, 1991. Reservations for quarantine space at the Miami Animal Import Center will be limited to a maximum of 100 ratites per permit application. There will be a single waiting list for quarantine space at the Miami Animal Import Center and the New York Animal Import Center. Importers who prefer one of these two facilities over the other may remain on the waiting list until space opens up at the facility of their choice.
(b) Permit. Except as provided in paragraph (c) of this section, when a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. The time prescribed in permits from the importation of pet birds, commercial birds, zoological birds, or research birds, shall not exceed 30 days, and for performing or theatrical birds shall not exceed 90 days. Birds for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the birds offered for entry differ from those described in the permit.
(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of birds other than ratites transiting the port of Anchorage, Alaska, if the following conditions are met:
(1) The importer applies for and obtains an import permit for multiple shipments of birds transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:
(i) The species, breed, and number of birds to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the birds; and
(vii) The name and address of the person to whom the birds or poultry will be delivered.
(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of birds intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:
(i) The species, breed, and number of birds to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the birds; and
(vii) The name and address of the person to whom the birds will be delivered.
(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of birds at the port of Anchorage, Alaska, provides the port veterinarian with a copy of the completed import permit;
(4) A copy of the completed import permit accompanies each separate intransit shipment of birds or poultry to the port of Anchorage, Alaska;
(5) Import permits issued for multiple shipments of birds transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.
(a) General. All pet birds, except as provided for in § 93.101 (b) and (c) of this part; all research birds; and all commercial birds and zoological birds, including ratites and hatching eggs of ratites, offered for importation from any part of the world, shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian authorized or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region.
(b) Birds other than ratites. The certificate for birds other than ratites must state:
(1) That all birds covered by the certificate have been inspected by the veterinarian issuing the certificate;
(2) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found among the birds;
(3) That insofar as has been possible to determine, the birds were not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding their exportation;
(4) That the birds have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza; however, zoological birds that have been vaccinated for avian influenza subtypes H5 or H7 as part of an official program, using vaccine products approved and used under supervision by the veterinary authorities of the exporting country, may be imported under specific conditions as determined by the Administrator and specified in an import permit. Such birds must be exported with permanent individual identification and meet the other requirements for entry under this part, and will be subject to official testing and quarantine on arrival to the United States.
(5) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises from which the birds were to be exported or on adjacent premises during the 90 days immediately preceding the exportation of the birds;
(6) That neither the premises from which the birds were to be exported nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the birds, and that the birds have not originated from or been moved through a region identified in accordance with § 94.6(a) of this subchapter as a region where highly pathogenic avian influenza exists; and
(7) That the birds were placed into new or appropriately sanitized packaging materials at the premises from which the birds were to be exported.
(c) Ratites other than hatching eggs. The certificate for ratites other than hatching eggs must state:
(1) That, except as provided in paragraph (c)(13) of this section, all ratites covered by the certificate, and their flock of origin, have been inspected by the veterinarian issuing the certificate;
(2) That, except when the certificate is for zoological birds or ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised and the ratites covered by the certificate were produced and maintained in that flock;
(3) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;
(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding the exportation;
(5) That none of the ratites intended for shipment to the United States have been vaccinated with Newcastle disease vaccine or with a vaccine for the H5 or H7 subtype of avian influenza;
(6) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation;
(7) That neither the premises where the flock of origin was kept nor any adjacent premises was located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation, and that the ratites have not originated from or been moved through a region identified in accordance with § 94.6(a) of this subchapter as a region where highly pathogenic avian influenza exists;
(8) That, except as provided in § 93.107 for ratites imported from Canada for immediate slaughter, the ratites were treated at least 3 days but not more than 14 days before being loaded for shipment to the United States with a pesticide of a type and concentration sufficient to kill ectoparasites on the ratites;
(9) That the pesticide was applied to all body surfaces of the ratites under the supervision of the veterinarian issuing the certificate;
(10) That the ratites, after being treated for ectoparasites, did not have physical contact with, or share a pen or bedding materials with, any ratite not in the same shipment to the United States; and
(11) That the ratites were placed in new or appropriately sanitized packaging materials for shipment to the United States at the premises where the flock of origin was kept.
(12) The number of ratites contained in the shipment;
(13) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);
(14) That all the ratites and hatching eggs of ratites in the flock from which the ratites come were identified in accordance with § 93.101(b)(3);
(15) Except for ratites imported from Canada in accordance with § 93.107, the number of ratite laying hens in the flock from which the ratites come;
(16) For ratites required to be treated prior to shipment with a pesticide for ectoparasites, the certificate must also state the name, concentration, and date of administration of the pesticide used to treat the ratites;
(17) When ratites intended for importation are zoological birds, only the ratites to be imported must be inspected, and the provisions in paragraphs (c)(3), (c)(4), (c)(5), (c)(6), (c)(7), and (c)(11) that apply to the flock of origin shall apply only to the ratites intended for importation.
(d) Hatching eggs of ratites. The certificate for hatching eggs of ratites must state:
(1) That the flock of origin of the hatching eggs has been inspected by the veterinarian issuing the certificate;
(2) That, except when the certificate is for hatching eggs of ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised, and the hatching eggs covered by the certificate were produced by that flock;
(3) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;
(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding the exportation of the hatching eggs;
(5) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation of the hatching eggs;
(6) That neither the premises where the flock of origin was kept nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the hatching eggs; and
(7) That the hatching eggs were placed into new or appropriately sanitized packaging materials for shipment to the United States at the premises where the flock of origin was kept.
(8) The number of hatching eggs contained in the shipment;
(9) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);
(10) That all the ratites and hatching eggs of ratites in the flock from which the hatching eggs come were identified in accordance with § 93.101(b)(3);
(11) Except for hatching eggs of ratites imported from Canada in accordance with § 93.107, the number of ratite laying hens in the flock from which the hatching eggs come.
(a) All commercial birds, zoological birds, and research birds, including hatching eggs of ratites, but excluding other ratites, imported into the United States, must be inspected by the port veterinarian at the Customs port of entry, which may be any international airport, or any land-border port within 20 miles of an international airport, serviced by Customs, as well as, for Canadian-origin hatching eggs of ratites, ports listed in § 93.107 (c). However, hatching eggs of ratites may be shipped, in bond, from the port of first arrival to the Customs port of entry at which they will be quarantined, for inspection, at that port.
(b) All pet birds imported from any part of the world, except pet birds from Canada and pet birds meeting the provisions of § 93.101(c)(2), shall be subjected to inspection at the Customs port of entry by a veterinary inspector of APHIS and such birds shall be permitted entry only at the ports listed in § 93.102(a). Pet birds of Canadian origin and those birds meeting the provisions of § 93.101(c)(2) shall be subject to veterinary inspection at any of the ports of entry listed in § 93.102 and 93.203.
(c) Ratites, other than hatching eggs of ratites, imported from any part of the world must be inspected at the Customs port of entry by a veterinary inspector of APHIS and, except as provided in § 93.107(b) for ratites imported from Canada, shall be permitted entry only at one of the following ports of entry:
(1) Ostriches:
(i) Up to 36 inches in height (as measured from the top of the head to the base of the feet) or 30 pounds in weight: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.
(ii) Exceeding 36 inches in height or 30 pounds in weight: New York, NY, and Stewart Airport, Newburgh, NY.
(2) Ratites other than ostriches: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.
(a) Birds other than ratites and hatching eggs of ratites. Each lot of pet birds, except as provided for in § 93.101(c) of this part; research birds; and commercial birds and zoological birds, except ratites and hatching eggs of ratites, imported into the United States shall be quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator, in any specific case, on an “all-in, all-out” basis, at a Customs port of entry, at a USDA quarantine facility when arrangements have been made in advance by the importer and approval is granted in the permit described in § 93.103, or in facilities that meet the requirements of paragraph (c) of this section. At a USDA quarantine facility each psittacine bird shall be individually identified by the Department within 7 days of the entry of the bird into the bird quarantine facility with a serially numbered legband which has been coded to the quarantine facility or by other suitable means of identification. The identification device must be approved by the Administrator, before it shall be used to identify birds under this section. Such means of identification shall be supplied by the Department at cost to the importer. The Department shall make an identification record at the time such bird is so identified containing the species of the bird, including the common and scientific name, and the number of the identification device placed on the bird. The daily log and the identification record shall be maintained for 12 months following the date of the release of the bird from quarantine. Prior to use of a privately owned quarantine facility, a Cooperative and Trust Fund Agreement as set forth in paragraph (c)(5) of this section shall be executed by the importer and the Department and appropriate funds shall be deposited with the Administrator pursuant to the Cooperative and Trust Fund Agreement. If the birds are found free of evidence of communicable diseases of poultry during quarantine, then the port veterinarian shall issue an agriculture release for entry through U.S. Customs. If the birds are found during port of entry inspection or during quarantine, to be infected with or exposed to a communicable disease of poultry, such birds shall be refused entry or shall be held for an additional period in quarantine until determined to be free of evidence of any communicable disease, or shall be otherwise disposed of as directed by the Administrator. See also paragraph (c)(3)(ii)(E) of this section.
(b) Ratites and hatching eggs of ratites. (1) Each lot of ratites imported from any part of the world except as provided in § 93.107, shall be quarantined upon arrival for a minimum of 30 days, and for such longer period as may be required by the Administrator to determine the ratites' freedom from ectoparasites and communicable diseases. Quarantine shall be on an “all-in, all-out” basis, as described in paragraph (c)(3)(ii)(A) of this section, at the New York Animal Import Center at Newburgh, NY, when the port of entry is either New York, NY, or Stewart Airport, Newburgh, NY; or at the Miami Animal Import Center, Miami, FL, when the port of entry is Miami, FL. Reservations for space in these quarantine facilities must be made in advance of arrival and in accordance with § 93.103 of this part.
(2) Each lot of hatching eggs of ratites imported from any part of the world except as provided in § 93.107, shall be quarantined upon arrival, incubated for the full incubation period (approximately 42 days), and held in quarantine for a minimum of 30 days following the hatch of the last chick in the lot, and for such longer period as may be required by the Administrator to determine the ratites' freedom from communicable diseases. Quarantine shall be conducted at a facility that meets the requirements of paragraph (c) of this section, and in the manner prescribed by paragraph (c) of this section.
(3) During the quarantine period, the ratites, including chicks hatched in quarantine, shall be tested for viral diseases of poultry, including highly pathogenic avian influenza and Newcastle disease. If any of the ratites exhibit evidence of other communicable diseases, they will be subjected to such additional tests as may be required by the Administrator to determine their freedom from communicable diseases. Ratites other than those imported as hatching eggs also shall be treated for ectoparasites
(4) If the ratites, including chicks hatched during quarantine, are determined to be free of communicable diseases, the port veterinarian shall issue an agricultural release for entry through U.S. Customs. If the port veterinarian finds evidence of communicable disease, or exposure to communicable disease, during port of entry inspection or quarantine of the ratites, the ratites shall be refused entry, or shall be held in quarantine until they are determined to be free of communicable disease, or shall be otherwise disposed of as directed by the Administrator.
(c) Standards for privately owned bird quarantine facilities and handling procedures for importation of birds. Before the Administrator will issue an import permit for a lot of birds, the Administrator must determine that the privately owned bird quarantine facility to be used to quarantine birds imported into the United States (the facility) and its maintenance and operation meet the minimum requirements of paragraphs (c)(1) through (c)(5) of this section, that adequate APHIS personnel are available to provide services required by the facility, and that a Cooperative and Trust Fund Agreement between the importer and the Department has been executed, and the required funds have been deposited, in accordance with that agreement. The cost of the facility and all costs associated with its maintenance and operation must be borne by the importer, in accordance with the provisions of paragraph (e) of this section.
(1) Supervision of the facility. The facility shall be maintained under the supervision of the port veterinarian at the Customs port of entry.
(2) Physical plant requirements. The facility shall comply with the following requirements:
(i) Location. Each privately owned bird quarantine facility shall be located:
(A) Within the immediate metropolitan area of the port of entry to prevent the imported birds, while in transit to the quarantine facility, from introducing or disseminating disease to domestic poultry or livestock.
(B) At least one-half mile from any concentration of avian species, such as, but not limited to, poultry processing plants, poultry or bird farms, pigeon lofts, or other bird quarantine facilities. Factors such as prevailing winds, the efficiency of the air filtration system of the quarantine facility, possible exposure to poultry or birds moving in local traffic, etc., shall be taken into consideration.
(ii) Construction. Each quarantine facility shall consist of a single, self-contained building, which shall:
(A) Be constructed only with material that can withstand continued cleaning and disinfection. All solid walls, floors, and ceilings must be constructed of impervious material. All openings to the outside must be double-screened, with an interior screen of metal or nylon mesh that is impervious to biting insects such as gnats or mosquitos, and an exterior metal screen that is rodent-proof and is made of wire, such as rabbit wire, hardware cloth, or smooth welded wire, with mesh size no larger than 1 inch × 1.5 inches (2.54 cm × 3.81 cm). The interior and exterior screens must be separated by at least 3 inches (7.62 cm);
(B) Have a bird holding area of sufficient size to prevent overcrowding of the birds in quarantine. (All access into this holding area shall be from within the building and each entryway into such area shall be equipped with self-closing, double doors: Provided, That emergency exits to the outside may exist in the bird holding area if required by local fire ordinances. Such emergency exits shall be constructed so as to permit their opening from the inside of the facility only.);
(C) Have a ventilation capacity sufficient to control moisture and odor at levels that are not injurious to the health of the birds in quarantine;
(D) Have a vermin-proof feed storage area;
(E) Have office space for recordkeeping;
(F) Have a separate necropsy room which shall have refrigerated storage space for carcasses retained for laboratory examination and facilities adequate for specimen preparation and carcass disposal;
(G) Have a separate area for washing facility equipment;
(H) Have a shower at the entrance into the area comprised of the bird holding and necropsy rooms and a clothes storage and change area at each end of the shower area;
(I) Have a storage area for equipment necessary for quarantine operations;
(J) Have equipment necessary to maintain the facility in clean and sanitary condition, including insect and pest control equipment;
(K) Have a receptacle for soiled and contaminated clothing in the clothes change area located nearest the entrance to the bird holding area;
(L) All construction must be completed before any permit application is submitted in accordance with § 93.103.
(M) An APHIS representative shall inspect the facility to determine whether the facility complies with the standards set forth in this section before any permit is issued in accordance with § 93.103. Inspections shall take place at least once each year.
(N) In addition, a facility for hatching eggs of ratites, in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from the previously quarantined lot, shall:
(1) Have a wall or a wall with a lockable door separating the incubator/hatcher area from the bird (chick) holding area, and this wall or wall-with-door shall provide an airtight seal between the two areas, shall be impervious to water, and shall be able to withstand continued cleaning and disinfection;
(2) Have a necropsy or sample collection area in both the incubator/hatcher area and the bird (chick) holding area; and
(3) Have separate entrances, showers, toilets, and dressing room facilities for the exclusive use of personnel working in the incubator/hatcher area and the bird (chick) holding area.
(O) The bird (chick) holding area in any facility for hatching eggs of ratites shall be of a size large enough to accommodate 75 percent of the incubator capacity, with a minimum of 10 square feet per egg.
(P) If a facility for hatching eggs of ratites has a sun room, the sun room shall be connected to the chick holding area by a wall with a lockable door. This wall; the other walls, if any; and the flooring, must be impervious to water and able to withstand continued cleaning and disinfection. All walls of the sun room must be at least 8 feet high.
(1) Any of the exterior walls may be replaced by a double-screened wall set in a concrete or concrete-block curb. The double screening shall be of wire mesh or wire mesh and nylon mesh, as provided in paragraph (c)(2)(ii)(A) of this section, with the interior and exterior screens of the sun room wall separated by at least 3 inches (7.62 cm); the concrete or concrete block curb must be at least 12 inches high, impermeable to water, and able to prevent the escape of water, manure, and debris.
(2) The sun room shall have a roof, such as a double-mesh-screened roof or a glass roof, that is both impervious to free-flying birds and biting insects (such as gnats or mosquitoes) and capable of preventing contact between chicks and free-flying birds.
(3) Be attended by personnel working in the bird (chick) holding area whenever chicks are in the sun room.
(iii) Sanitation and security. Arrangements shall exist for:
(A) A supply of water adequate to meet all watering and cleaning needs.
(B) Disposal of wastes by incineration or a public sewer system which meets all applicable environmental quality control standards;
(C) Control of surface drainage onto or from the facility to prevent any disease agent from entering or escaping;
(D) Protective clothing and footwear adequate to insure that workers at the facility have clean clothing and footwear at the start of each workday and at any time such articles become soiled or contaminated;
(E) Power cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment;
(F) Sufficient stocks of a disinfectant authorized in § 71.10(a)(5) of this chapter;
(G) A security system which prevents contact of birds in quarantine with persons not authorized entry to the facility and with other birds and animals. Such a system shall include a daily log to record the entry and exit of all persons entering the facility and controls at all doorways and other openings to the facility to prevent escape or accidental entry of birds.
(3) Operational procedures. The following procedures shall be observed at the facility at all times.
(i) Personnel. Access to the facility shall be granted only to persons working at the facility or to persons specifically granted such access by the port veterinarian.
(A) All personnel granted access to the bird holding area or the incubator/hatcher area shall:
(1) Wear clean protective clothing and footwear upon entering the bird holding area or the incubator/hatcher area;
(2) Change protective clothing and footwear when they become soiled or contaminated;
(3) Shower when entering and leaving any bird holding area, any incubator/hatcher area, and any necropsy area. Showering when moving between the incubator/hatcher area and the bird holding area is not required when the eggs in the hatching area and the chicks in the holding area are part of the same lot;
(4) Work exclusively with one lot of birds until the lot's release from quarantine, and have no contact with other birds or poultry until the release date.
(B) The importer shall handle soiled clothing worn within the quarantine unit in a manner approved by the port veterinarian as adequate to preclude transmission of a poultry disease agent from the facility.
(ii) Handling of the birds in quarantine. The birds shall be kept in the quarantine facility for a minimum of 30 days and while in quarantine shall be handled in compliance with the following requirements:
(A) Each lot of birds to be quarantined shall be placed in the facility on an “all-in, all-out” basis. No birds shall be taken out of the lot while it is in quarantine except for diagnostic purposes and if additional birds are added to a lot, the total quarantine period for that lot shall be extended so that all birds will have completed at least 30 consecutive days of quarantine before release for entry into the commerce of the United States. The quarantine period may be extended as provided in paragraph (a) of this section.
(1) Hatching eggs of ratites comprising a single lot may be added to the facility in stages, provided the entire lot has been placed in the facility no later than 15 days after the arrival of the first shipment.
(2) If hatching eggs of ratites begin to hatch in the incubator/hatcher area while ratite chicks from the previously quarantined lot remain in the bird (chick) holding area, then the separate lots assume the status of a single lot, and will be released from quarantine in accordance with paragraph (c)(3)(ii)(A) of this section.
(B) The birds may be vaccinated during quarantine only with a vaccine that has been approved by the Administrator, and is administered by a licensed veterinarian under the direct supervision of a veterinarian employed by the Animal and Plant Health Inspection Service. The Administrator will approve a vaccine if:
(1) The vaccine is licensed by the Animal and Plant Health Inspection Service in accordance with § 102.5 of this chapter; and
(2) The vaccine is not one that is used to prevent Newcastle disease, avian influenza, or any other hemagglutinating virus of poultry.
(C) Birds of the psittacine family shall receive a balanced, medicated feed ration treatment containing not less than 1% CTC with not more than 0.7% calcium for the entire quarantine period as a precautionary measure against chlamydiosis (psittacosis).
(D) The importer shall immediately collect all birds which die in quarantine and hold them under refrigeration, within the facility, shall account for all birds in the shipment, and shall not dispose of any carcass or parts thereof unless authorized to do so by a Veterinary Medical Officer of APHIS of the Department. Birds that die enroute to the United States or while in quarantine shall be made available at the port of entry for necropsy by a Department poultry disease diagnostician who may submit specimens from such birds for laboratory examination.
(E) During the period of quarantine, the birds shall be subjected to such tests and procedures as are required in specific cases by the port veterinarian, to determine whether the birds are free from communicable diseases of poultry and it shall be the responsibility of the importer to identify individually each psittacine bird within 7 days of the entry of the bird into the quarantine facility with a serially numbered legband which has been coded to the quarantine facility or by other suitable means of identification. Any identification device must be approved by the Administrator, upon written request to him, before it shall be used to identify birds under this section. Such means of identification shall be supplied by the importer, and the importer shall insure that each bird is so identified at the time the bird is released from the facility. If Newcastle disease or highly pathogenic avian influenza is found or detected among any birds in quarantine, all birds in the facility shall be destroyed or refused entry and the entire facility shall be thoroughly cleaned and then disinfected as directed under the supervision of an inspector.
(F) The quarantine facility from which a lot of birds has been released shall be thoroughly cleaned and disinfected with a disinfectant authorized in § 71.10(a)(5) of this chapter, under supervision of an inspector before a new lot is placed in the facility.
(iii) Records. It shall be the responsibility of the importer to maintain a current daily log for each lot of birds, recording such information as the general condition of the birds each day, source of origin of the birds in the lot, total number of birds in the lot when imported, number of dead birds when lot arrived, date lot was placed into the facility, number of deaths each day in the lot during the quarantine period, necropsy results, and laboratory findings on birds that died during the quarantine date of prescribed tests and results, Department import permit numbers of each lot, date lot was removed from the facility, and any other observations pertinent to the general health of the birds in the lot. The importer shall also make an identification record, at the time each psittacine bird is identified, containing the species of the bird, including the common and scientific name and the number of the identification device placed on each psittacine bird. The daily log and the identification record shall be maintained for 12 months following the date of release of the bird from quarantine and shall be made available to APHIS personnel upon request.
(4) Additional requirements as to location, security, physical plant and facilities, sanitation, and other items may be imposed by the Administrator, in each specific case in order to assure that the quarantine of the birds in such facility will be adequate to enable determination of their health status, prevent spread of disease among birds in quarantine, and prevent escape of poultry disease agents from the facility.
(5) Cooperative and Trust Fund Agreement for services required by importer at a privately owned bird quarantine facility.
(i) When the Administrator determines that a privately owned bird quarantine facility meets the requirements set forth in paragraph (c) of this section, the Department and the importer shall execute a Cooperative and Trust Fund Agreement, as specified in paragraph (c)(5)(iii) of this section. In conjunction with the Cooperative and Trust Fund Agreement, the importer shall deposit with the Administrator a money order or cashier's check in an amount determined by the Administrator to cover all costs incurred by the Department in providing services in accordance with the provisions of the Cooperative and Trust Fund Agreement. Any unobligated funds will, upon request, be returned to the importer, after the birds' release from quarantine.
(ii) The Administrator may provide services required by the importer at a privately owned quarantine facility for the importation of birds on a first come, first served basis, if adequate APHIS personnel are available to provide those services, upon determining that the importer has executed a Cooperative and Trust Fund Agreement, and has deposited funds in an amount determined by the Administrator to be sufficient to cover all costs incurred by the Department in providing services in accordance with that agreement, as specified in paragraph (c)(5)(iii) of this section.
(iii) Cooperative and Trust Fund Agreement.
This agreement is made and entered into by and between __________ (name of importer), hereinafter referred to as the Importer, and the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, hereinafter referred to as the Service, with respect to ____________ (quarantine facility and address of facility). Whereas, the Service is authorized pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.) to regulate the introduction of animals into the United States in order to prevent the introduction of animal and poultry diseases into the United States; and
Whereas, the Importer is interested in the importation of certain birds from regions presently under restrictions for such importation; and
Whereas, the Importer is equipped with a bird quarantine facility that meets the requirements of paragraph (c) of this section; and
Whereas, the Importer has requested the Service to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds to insure that they meet the Department's quarantine requirements before release into the United States; and
Whereas, it is the intention of the parties hereto that such cooperation shall be for their mutual benefit and the benefit of the people of the United States;
Now therefore, for and in consideration of the promises and mutual covenants herein contained, the parties hereto do hereby mutually agree with each other as follows:
(A) The Importer Agrees:
(1) To operate the quarantine facility in accordance with all Federal Laws and regulations.
(2) To provide a current list of designated personnel employed by the Importer who will be used to handle and care for birds during the quarantine period. The list will include the legal names, current residential addresses, and social security numbers of the designated personnel. The list will be furnished to the port veterinarian at the time an application for an import permit to import birds into the quarantine facility is submitted to the Service. The list will be updated for any changes in or additions to the designated personnel in advance of such personnel working in the quarantine facility.
(3) To furnish to the Service a signed statement from each of the designated personnel employed by the Importer which provides that such personnel agree that for a period of 3 days from their most recent contact with birds in the quarantine facility, such personnel will refrain from having contact with other birds and poultry. This restriction ceases to apply on the date the birds are released from quarantine.
(4) To not permit any designated personnel which the Service determines to be unfit to be employed at a quarantine facility upon written notice from the Service. Such determination shall be based upon such employee's committing or aiding and abetting in the commission of any violation of title 9, Code of Federal Regulations, part 93. The Importer further agrees to suspend any designated employee from working at a quarantine facility when the Service has reason to believe that such employee has violated any provision of title 9, Code of Federal Regulations, part 93, and the Administrator has determined that the actions of such employee constitute a severe threat to introduce or disseminate a communicable disease of poultry into the United States. Such action shall be made upon receipt of notice from the Service requiring such action by the Importer.
(5) To allow the unannounced entry into the quarantine facility of Service personnel or other persons authorized by the Service for the purpose of inspecting birds in quarantine, the operations at the quarantine facility and to ascertain compliance with the Standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).
(6) To provide permanent restrooms in both the clean and the quarantine areas of the quarantine facility.
(7) To provide a T.V. monitoring system or a window or windows sufficient to provide a full view of the quarantine area excluding the clothes changing area.
(8) To install a communication system between the clean and quarantine areas of the quarantine facility. Such communication system shall not interfere with the maintenance of the biological security of the quarantine area.
(9) To secure all windows and any openings in the quarantine facility in a manner satisfactory to the Department which will insure the biological security of the quarantine facility and prevent the unauthorized removal of birds.
(10) To install tamperproof hasps and to install hinges on doors from which the pins cannot be removed.
(11) To install a hood with a viewing window over the necropsy table.
(12) To bag waste material in leakproof bags. Such material shall be handled in a manner that spoilage is kept to a minimum and control of pests is maintained. Such material shall be disposed of by incineration or by public sewer or other method authorized by the Administrator to prevent the spread of disease. The disposition of such material shall only be under the direction and supervision of the Service.
(13) To feed chlortetracycline to psittacine birds, upon their arrival in the facility as prescribed in § 93.106(c)(3)(ii)(C).
(14) To install an electronic security system which is coordinated through or with the local police so that monitoring of the quarantine facility is maintained whenever Service personnel are not at the facility or, in lieu of such electronic monitoring system to arrange for continuous guarding of the facility with personnel from a bonded, security company. Provided, That, if highly pathogenic avian influenza or Newcastle disease is diagnosed in any of the birds in the quarantine facility, continuous guarding of the facility with personnel from a bonded security company shall be maintained by the Importer. The electronic security system if installed shall be of the “silent type” and shall be triggered to ring at the monitoring site and not at the facility. The electronic system shall be approved by Underwriter's Laboratories.
(15) To not have non-Service personnel in the quarantine area when birds are in the quarantine facility unless Service personnel are present.
(16) To have seals of the Service placed on all entrances and exits of the facility when determined necessary by the Service and to take all necessary steps to ensure that such seals are only broken in the presence of Service personnel.
(17) To decide what the disposition of a lot of birds will be within 48 hours following official notification that such a lot is infected with or exposed to highly pathogenic avian influenza or Newcastle disease. Final disposition of the infected or exposed lot is to be accomplished within 4 working days following official notification. Disposition of the birds will be under the supervision of the Service.
(18) To furnish a telephone number or numbers to the Service at which the Importer can be reached on a daily basis or furnish the same for an agent or representative that can act and make decisions on the Importer's behalf.
(19) To deposit with the Service, upon execution of this agreement, a money order or cashier's check, in an amount determined by the Administrator to be sufficient to defray all costs incurred by the Service in providing services required. If such costs exceed the deposited amount, the importer will pay for additional costs incurred, based on official accounting records, within 14 days of receipt of the bill showing the balance due.
(20) To provide for the maintenance and operation of the quarantine facility in accordance with standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).
(B) The Service agrees:
(1) To furnish the services of technical and/or professional personnel needed to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds being imported to ensure that they meet the Department's quarantine requirements before release into the United States.
(2) To issue permits 3 working days following receipt of the permit application, depending upon the availability of personnel to provide the services required for quarantine and the results of an APHIS representative's inspection of the quarantine facility.
(3) To provide the Importer within 30 days following receipt of a written request from the Importer, with an accounting of funds expended in providing services under paragraph (B)(1) of this agreement. Any unobligated balance upon termination or expiration of this agreement shall be returned to the Importer.
(4) To inform the Importer when a diagnosis of highly pathogenic avian influenza or Newcastle disease has been made in any facility.
(5) To promptly inform the Embassy or Consulate of the foreign region to which lots of birds, refused entry into the United States due to a diagnosis of highly pathogenic avian influenza or Newcastle disease, are to be shipped.
(6) To notify in writing the Importer of any designated employee which the Service believes should be suspended from work at the quarantine facility and the basis for such action. Similar notice shall be afforded to the designated employee. Subsequent to such suspension, the designated employee shall have the right to request an immediate review of such action by the Administrator, including presenting his or her views to the Administrator in an informal conference. If the Administrator makes a final determination that grounds existed to suspend such employee, he or she shall notify the Importer and the suspended employee of his or her decision and such employee shall be discharged by the Importer.
(7) Prior to any final determination being made by the Service concerning the discharge of any designated personnel employed by the Importer, the Service will inform, in writing, the Importer and the designated personnel of the basis for such action. If such person contests such action he or she shall be permitted to present his or her views to the Administrator, provided such request is made within 30 days of the receipt of the aforementioned written notice. If a final determination is made by the Administrator that such personnel should be discharged, he or she shall notify such personnel and the Importer of such determination.
(C) It is mutually understood and agreed:
(1) That a maximum capacity will be established for each quarantine lot. This will be based upon the capacity of the quarantine facility to handle the birds. The number of birds on the permits will not exceed this capacity.
(2) If the seals referred to in paragraph (c)(5)(iii)(A)(16) of this section are broken by other than Service personnel, it will be considered a breach in security and an immediate accounting of all birds in the facility shall be made by the Service. If any birds are determined to be missing from the facility, the quarantine period will be extended for an additional 30-day period.
(3) During the performance of this cooperative work, the Importer agrees to be bound by the equal opportunity and nondiscrimination provisions as set forth in exhibit B and nonsegregation of facilities provisions as set forth in exhibit C,
(4) No member of or delegate to Congress or resident commissioner, shall be admitted to any share or part of this agreement or to any benefit to arise therefrom; but this provision shall not be construed to extend to this agreement if made with a corporation of its general benefit.
(5) This agreement shall become effective upon date of final signature and shall continue until the permitted lot of birds is released from quarantine. This agreement may be amended by agreement of the parties in writing. It may be terminated by either party upon 30 days written notice to the other party.
(d) Charges for services. The charges to be borne by the importer for services provided for quarantine facilities approved in accordance with paragraph (c) of this section shall be:
(1) The appropriate GS hourly rate (including appropriate premium pay in accordance with 5 U.S.C. 5541-5549) of the employee who actually performs the service, including his or her travel time and his or her travel expenses: Provided, however, Such time and travel expense shall not exceed the time and travel expense to and from his or her official duty station;
(2) All applicable user fees, as listed in part 130 of this chapter; and
(3) A surcharge for overhead based on the most current historical data available showing the percentage of APHIS funds expended for administrative support.
(e) Requirements of other Federal laws and regulations, such as the Department's Animal Welfare Regulations in subchapter A of this chapter shall also apply as applicable to the quarantine facilities.
(a) In-bond shipments from Canada. Birds from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.103 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (d) of § 93.101.
(b) Ratites from Canada. Ratites that were hatched and raised in Canada or ratites that were legally imported into Canada and, upon arrival in Canada, were quarantined for a minimum of 28 days at a Canadian quarantine facility and remained in Canada for an additional 60 days following completion of quarantine may be imported into the United States:
(1) Without being quarantined upon arrival in the United States; and
(2) At any of the following ports of entry: Anchorage, AK; Fairbanks, AK; Los Angeles, CA; San Diego, CA; Denver, CO; Miami, FL; Tampa, FL; Atlanta, GA; Eastport, ID; Chicago, IL; New Orleans, LA; Boston, MA; Baltimore, MD; Houlton, ME; Jackman, ME; Detroit, MI; Port Huron, MI; Sault Ste. Marie, MI; Minneapolis, MN; Raymond, MT; Sweetgrass, MT; Buffalo, NY; Champlain, NY; New York, NY; Stewart Airport, Newburgh, NY; Dunseith, ND; Pembina, ND; Portal, ND; Portland, OR; San Juan, PR; Houston, TX; Highgate Springs, VT; Seattle, WA; and Sumas, WA; and
(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and
(4) If consigned directly to slaughter from the port of entry, without being treated for ectoparasites within 3 to 14 days before shipment to the United States, as otherwise required by § 93.104(c)(8); and
(5) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.
(c) Ratite eggs from Canada. Hatching eggs of ratites that were laid in Canada may be imported into the United States:
(1) Without being quarantined upon arrival in the United States; and
(2) At any of the ports of entry listed in paragraph (b)(2) of this section or authorized by § 93.105(a); and
(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and
(4) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching) which are imported for resale, breeding, public display, or any other commercial purpose.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Department. The United States Department of Agriculture (USDA).
Fever tick. Boophilus annulatus, including, but not limited to, the varieties Americana and Australia.
Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:
(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.
Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Operator. For the purpose of § 93.209, any person operating an approved quarantine facility.
Performing or theatrical poultry. Poultry which are to be used in shows, theatrical acts or performances only.
Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).
Quarantine facility. A USDA facility, or a private facility approved by APHIS, for the secure housing of imported birds, poultry, or other animals for specified periods.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Swine. The domestic hog and all varieties of wild hogs.
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
Veterinary services. The Veterinary Services unit of the Department.
(a) No poultry or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) The provisions in this part 93 relating to poultry shall not apply to healthy poultry not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) Except for poultry in transit through Anchorage, Alaska, under § 93.204(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into an animal or bird holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of poultry in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c) Performing or theatrical poultry returning to the United States. (1) Performing or theatrical poultry of United States origin that are returning to the United States from Canada or Mexico may be imported if:
(i) The poultry are found upon port of entry veterinary inspection to be free of poultry diseases; and
(ii) The poultry are accompanied by a United States veterinary health certificate issued prior to the departure of the poultry from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the poultry prior to departure; and
(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the poultry is the same as the one listed on the health certificate.
(2) Except for performing or theatrical poultry that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:
(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and
(ii) The poultry are accompanied by an import permit issued by APHIS; and
(iii) The owner importing the poultry signs and furnishes to the Administrator the following:
(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the poultry have not been in contact with poultry or other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and
(B) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:
(1) That the poultry will be maintained in confinement in his or her personal possession separate and apart from all poultry and other birds for a minimum of 30 days following importation at the address where the poultry are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and
(2) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the poultry or any poultry die during that period. The owner importing such poultry must comply with the provisions of the aforementioned agreement before the poultry may be released from confinement.
(3) Any performing or theatrical poultry of United States origin that have been in any region listed in § 94.6(d) of this subchapter as a region where highly pathogenic avian influenza exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and
(ii) The poultry are accompanied by an import permit issued by APHIS; and
(iii) The poultry are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with §§ 93.209 and 93.210.
(d) The provisions in this part relating to poultry shall not be applicable to performing or theatrical poultry.
(e) Pigeons, doves, and other Columbiform species that have originated from or transited regions where highly pathogenic avian influenza is considered to exist may be imported into the United States under permit and controlled conditions to approved establishments subject to all applicable requirements in this part.
(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.
(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all poultry shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d) and (e) of this section: Los Angeles, California; Miami, Florida; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of poultry from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.
(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of poultry from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, and Columbus, New Mexico.
(d) Limited ports. The following ports are designated as having inspection facilities for the entry of poultry and poultry products such as poultry test specimens, or hatching eggs and day old chicks which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, Port Canaveral, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Galveston and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.
(e) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(a) Application for permit; reservation required. (1) For poultry and poultry test specimens for diagnostic screening purposes, intended for importation from any part of the world, except as otherwise provided for in §§ 93.204(c), 93.214, 93.217, and 93.218, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of poultry or poultry test specimens to be imported; the purpose of the importation; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the poultry or poultry test specimens to be imported; and the name of the person to whom the poultry or poultry test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the poultry are susceptible, as well as vaccinations or other precautionary treatments to which the poultry or poultry test specimens have been subjected. Notice of any such requirement will be given to the applicant in each case.
(2) An application for permit to import poultry may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the poultry; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of poultry to be quarantined in a facility maintained by USDA. For poultry, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the poultry are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of poultry for which the reservation was made: Except that a reservation fee shall not be forfeited if:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b) Permit. Except as provided in paragraph (c) of this section, when a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Poultry and poultry test specimens for diagnostic screening purposes for poultry intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits, except that the time prescribed in permits from the importation of poultry shall not exceed 30 days, and for performing or theatrical poultry shall not exceed 90 days. Poultry and poultry test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the poultry or poultry test specimens offered for entry differ from those described in the permit; or if the poultry or poultry test specimens are not handled as outlined in the application for the permit and as specified in the permit issued.
(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of poultry or pigeons transiting the port of Anchorage, Alaska, if the following conditions are met:
(1) The importer applies for and obtains an import permit for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:
(i) The species, breed, and number of poultry or pigeons to be imported;
(ii) The individual poultry identification;
(iii) The region of origin;
(iv) The name and address of the exporter;
(v) The port of embarkation in the foreign region;
(vi) The mode of transportation and the route of travel;
(vii) The proposed date of arrival of the poultry or pigeons; and
(viii) The name and address of the person to whom the poultry or pigeons will be delivered.
(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of poultry or pigeons intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:
(i) The species, breed, and number of poultry or pigeons to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the poultry or pigeons; and
(vii) The name and address of the person to whom the poultry or pigeons will be delivered.
(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of poultry or pigeons at the port of Anchorage, Alaska, provides the port veterinarian with a copy of the completed import permit;
(4) A copy of the completed import permit accompanies each separate intransit shipment of poultry or pigeons to the port of Anchorage, Alaska;
(5) Import permits issued for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.
(a) Live poultry. (1) All live poultry, except eggs for hatching, offered for importation from any region of the world shall be accompanied by a certificate stating that such poultry and their flock or flocks of origin were inspected on the premises of origin immediately before the date of movement from such region and that they were then found to be free of evidence of communicable diseases of poultry. The certificate shall also state that, as far as it has been possible to determine, during the 90 days prior to movement, the poultry were not exposed to communicable diseases of poultry and the premises were not in any area under quarantine. The certificate shall also state that the poultry have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza. The certificate shall also state that the poultry have been kept in the region from which they are offered for importation since they were hatched, or for at least 90 days immediately preceding the date of movement, that the poultry have not originated from or have been moved through a region referenced in § 94.6(a) of this subchapter as a region where any form of highly pathogenic influenza exists, and that, as far as it has been possible to determine, no case of highly pathogenic avian influenza or Newcastle disease occurred on the premises where such poultry were kept, or on adjoining premises, during that 90-day period. The certificate must also state that the birds were placed into new or appropriately sanitized packaging materials at the premises from which the birds were to be exported.
(2) Live poultry certificates accompanying pigeons, doves, and other Columbiform species that have originated from or been moved through regions where highly pathogenic avian influenza is considered to exist must additionally state that the Columbiform species have been moved and handled under conditions specified on the import permit ensuring that their movement and handling involved no direct or indirect exposure to other animals, birds, and poultry.
(b) Hatching eggs. All eggs for hatching offered for importation from any part of the world shall be accompanied by a certificate stating that the flock or flocks of origin were found upon inspection to be free from evidence of communicable diseases of poultry, the hatching eggs are from poultry that have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza, that during the 90 days prior to movement, the flock or flocks of origin were not exposed to communicable diseases of poultry and the premises were not in any area under quarantine, and that the hatching eggs and the flock or flocks of origin have not originated in or been moved through a region referenced in accordance with § 94.6(a) of this subchapter as a region where any form of highly pathogenic avian influenza exists. The certificate must also state that the hatching eggs were placed into new or appropriately sanitized packaging materials at the premises from which the hatching eggs were to be exported.
(c) Nature of certificate. The certificate required by this section shall be issued by a salaried veterinary officer of the national government of the region of origin, or if the articles are exported from Mexico, may alternatively be issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of poultry at such port, for the use of the veterinary inspector at the port of entry.
(b) For all poultry offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the poultry, the number, breed, species, and purpose of the importation, the name of the person to whom the poultry will be delivered, and the location of the place to which such delivery will be made.
(c) Any declaration, permit, or other document for poultry required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.
Inspection shall be made at the port of entry of all poultry imported from any part of the world except as provided in §§ 93.215 and 93.220. All poultry found to be free from communicable disease and not to have been exposed thereto within 90 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other poultry shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such poultry or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about poultry governed by the regulations this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
(a) Poultry, other than eggs for hatching, imported, except as provided in § 93.216 of this part, shall be quarantined for not less than 30 days, counting from the date of arrival at the port of entry. During their quarantine, such poultry shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry, and their freedom from exposure to such diseases.
(b) Poultry eggs for hatching imported, except from regions designated in § 94.6(a) of this subchapter as free of Newcastle disease and highly pathogenic avian influenza, shall be quarantined from time of arrival at the port of entry until hatched and the poultry from such eggs shall remain quarantined for not less than 30 days following hatch. During their quarantine, such eggs for hatching and poultry from such eggs shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry.
(a) Privately operated quarantine facilities. The importer, or his or her agent, of poultry subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the poultry from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such poultry and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by poultry should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of poultry, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the poultry may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of poultry shall be made by certified check or U.S. money order prior to release of the poultry. If such payment is not made, the poultry may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.
(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of poultry subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the poultry from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of poultry shall be made by certified check or U.S. money order prior to release of the poultry. If such payment is not made, the poultry may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the poultry are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the poultry will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the poultry and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors shall not be admitted to the quarantine enclosure during any time that poultry are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined poultry at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the poultry may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.
No manure shall be removed from the quarantine premises until the release of the poultry producing same.
If any contagious disease appears among poultry during the quarantine period special precautions shall be taken to prevent spread of the infection to other poultry in the quarantine station or to those outside the grounds. The affected poultry shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) For poultry intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204: Provided, That an import permit is not required for poultry if offered for entry at a land border port designated in § 93.203(b).
(b) For all poultry offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(a) In-bond shipments from Canada. (1) Poultry from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.204 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.201. Poultry not accompanied by a permit shall meet the requirements of this part in the same manner as poultry destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable disease of livestock and poultry will be disseminated to the livestock or poultry of the United States.
(2) In-transit shipments through Canada. Poultry originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the poultry for entry into Canada shall be recorded on the United States health certificate, or a document containing the information shall be included with the certificate that accompanies the poultry. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the poultry are the identical poultry covered by said certificate.
(b) Exhibition poultry. Poultry from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That all poultry offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical poultry covered by said certificates or that they otherwise qualified for entry into Canada under the Canadian regulations.
Poultry imported from Canada is not required to meet the requirements of § 93.209 but shall meet all other requirements of this part applicable to poultry or to animals generally.
(a) For poultry intended for importation from regions of Central America or of the West Indies, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204: Provided, That the Administrator, when he or she finds that such action may be taken without endangering the livestock or poultry industry of the United States, may, upon request by any person, authorize the importation by such person, without such application or permit, from the British Virgin Islands into the Virgin Islands of the United States, of poultry consigned for immediate slaughter, and such authorization may be limited to a particular shipment or extend to all shipments under this paragraph by such person during a specified period of time.
(b) For all poultry offered for importation from regions of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(c) All poultry offered for importation from regions of Central America and the West Indies shall also meet the additional requirements in §§ 93.205, 93.207, 93.209, and 93.210 to qualify for entry. All poultry which fail to meet these requirements shall be rejected entry and shall be disposed of as directed by the Administrator in accordance with applicable laws.
(a) For poultry intended for importation from Mexico, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204.
(b) For poultry intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the poultry.
For all poultry offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(a) All poultry offered for entry from Mexico, including such poultry intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such poultry found to be free from communicable disease and fever tick infestation and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Poultry found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.
(b) Poultry covered by paragraph (a) of this section shall be imported through ports designated in § 93.203.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.
Code of practice. A voluntary system of procedures designed to reduce disease spread, that is established by the veterinarians and horse industry in a region and that includes procedures for the following: Testing for and treatment of the diseases, quarantine of horses that are affected with or are suspected of being affected with the disease, certification of whether horses have been affected with or exposed to the disease, and hygiene for personnel conducting treatments and specimen collections.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Department. The United States Department of Agriculture (USDA).
Fever tick. Boophilus annulatus, including, but not limited to, the varieties Americana and Australia.
Horses. Horses, asses, mules, and zebras.
Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Licensed Veterinarian. Any person licensed by any country or political subdivision thereof to practice veterinary medicine.
Lot. A group of horses that, while held on a premises or conveyance, have had opportunity for physical contact with other horses in the group or with their excrement or discharges at any time during their shipment to the United States.
Lot-holding area. That area in a permanent, privately owned quarantine facility in which a single lot of horses is held at one time.
Nonquarantine area. That area in a permanent, privately owned quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to horses, samples taken from horses, and any other objects or substances that have been in the quarantine area during the quarantine of horses.
Operator. A person other than the Federal Government who owns or manages and has responsibility for the services provided by a temporary, privately owned quarantine facility or a permanent, privately owned quarantine facility.
Permanent, privately owned quarantine facility. A facility that offers quarantine services for horses to the general public on a continuing basis and that is owned and operated by an entity other than the Federal Government (also permanent facility).
Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.
Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Quarantine area. That area in a permanent, privately owned quarantine facility that comprises all of the lot-holding areas in the facility, and any other areas in the facility that horses have access to, including loading docks for receiving and releasing horses, and any areas used to conduct examinations of horses and take samples and where samples are processed or examined.
Recognized slaughtering establishment.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.
Temporary, privately owned quarantine facility. A facility that offers quarantine services for horses imported for a specific event and that is owned and operated by an entity other than the Federal Government (also temporary facility).
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.
Veterinary Services. The Veterinary Services unit of the Department.
Weanling or yearling. Any horse, weaned from its dam, that was foaled not more than 731 days prior to its being offered for entry into the United States. A horse will not be considered to be a weanling or yearling if its first permanent incisors have erupted.
(a) General prohibitions. No horse or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) General exceptions. The provisions in this part 93 relating to horses shall not apply to healthy horses in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of horses if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a horse holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the horses will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of horse carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of horses in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c) Specific prohibitions regarding contagious equine metritis; exceptions—(1) Importation prohibited. Except as provided in paragraph (c)(2) of this section, notwithstanding the other provisions of this part concerning the importation of horses into the United States, the importation of all horses from any region that APHIS considers to be affected with contagious equine metritis (CEM) and the importation of all horses that have been in any such region within the 12 months immediately preceding their being offered for entry into the United States is prohibited.
(i) A list of regions that APHIS considers to be affected with CEM is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be available via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable, or upon determining that the region trades horses freely with a region in which CEM exists without testing for CEM. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(2) Exceptions. The provisions of paragraph (c)(1) of this section shall not apply to the following:
(i) Wild (non-domesticated) species of equidae if captured in the wild or imported from a zoo or other facility where it would be unlikely that the animal would come in contact with domesticated horses used for breeding;
(ii) Geldings;
(iii) Weanlings or yearlings that have never been used for breeding, and whose age and breeding status are certified on the import health certificate required under § 93.314(a);
(iv) Horses imported in accordance with conditions prescribed by the Administrator as provided in § 93.301(a);
(v) Spanish Pure Breed horses imported for permanent entry from Spain or thoroughbred horses imported for permanent entry from France, Germany, Great Britain (England, Scotland, and Wales), the Ireland (Republic of), or Northern Ireland if the horses meet the requirements of paragraph (d) of this section;
(vi) Stallions or mares over 731 days of age imported for permanent entry if the horses meet the requirements of paragraph (e) of this section;
(vii) Horses over 731 days of age imported into the United States for no more than 90 days to compete in specified events if the horses meet the requirements of paragraph (f)(1) of this section;
(viii) Horses over 731 days of age imported into the United States for noncompetitive public exhibition and entertainment purposes if the horses meet the requirements of paragraph (f)(2) of this section; and
(ix) Horses temporarily exported from the United States or from another region not known to be affected with CEM to a region listed under paragraph (c)(1) of this section within the 12 months immediately preceding their being offered for entry into the United States if the horses meet the requirements of paragraph (g) of this section.
(d) Spanish Pure Breed horses from Spain and thoroughbred horses from France, Germany, Great Britain (England, Scotland, and Wales), Ireland (Republic of), and Northern Ireland. (1) Spanish Pure Breed horses from Spain and thoroughbred horses from France, Germany, Great Britain (England, Scotland, and Wales), Ireland (Republic of), and Northern Ireland may be imported for permanent entry if the horses meet the following requirements:
(i) Each horse is accompanied at the time of importation by an import permit in accordance with § 93.304;
(ii) Each horse is accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a). In addition to the information required by § 93.314(a), the veterinarian signing and issuing the certificate must certify that:
(A) He or she has examined the daily records of the horse's activities maintained by the trainer and certified to be current, true, and factual by the veterinarian in charge of the training or racing stable;
(B) He or she has examined the records of the horse's activities maintained by a breed association specifically approved by the Department
(1) Identification of the horse by name, sex, age, breed, and all identifying marks;
(2) Identification of all premises where the horse has been since reaching 731 days of age and the dates that the horse was at such premises;
(3) For thoroughbred horses, that none of the premises where the horse has been since reaching 731 days of age are breeding premises; and
(4) For Spanish Pure Breed horses from Spain, that since reaching 731 days of age:
(i) The horse has never been on a premises that is exclusively a breeding premises;
(ii) The horse has never been bred;
(iii) Breeding of the horse has never been attempted; and
(iv) The horse has never been commingled and left unattended with adult horses of the opposite sex;
(C) He or she has compared the records maintained by the approved breed association with the records kept by the trainer and has found the information in those two sets of records to be consistent and current;
(D) For Spanish Pure Breed horses and thoroughbred horses over 731 days of age, cultures negative for CEM were obtained from three sets of specimens collected within a 12-day period from the mucosal surfaces of the clitoral fossa and the clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium, of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both male and female horses, the sets of specimens must be taken within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate; and
(E) All specimens required by paragraph (d)(1)(ii)(D) of this section were received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and were accompanied by a statement indicating the date and time of their collection.
(2) If any specimen collected in accordance with paragraph (d)(1)(ii)(D) of this section is found to be positive for CEM, the horse must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (d)(1)(ii)(D) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.
(3) Spanish Pure Breed horses and thoroughbred horses imported under paragraph (d)(1) of this section may be released upon completion of the Federal quarantine required under § 93.308. Spanish Pure Breed horses and thoroughbred horses found positive for CEM that have been treated and retested as provided in paragraph (d)(2) of this section shall, upon completion of the Federal quarantine required under § 93.308, be consigned to an approved State listed under paragraph (h)(7) or (8) of this section, where they shall be quarantined under State or Federal supervision until the stallions have met the testing and treatment requirements of paragraph (e)(3) of this section and the mares have met the testing and treatment requirements of paragraph (e)(5) of this section.
(e) Stallions and mares over 731 days of age from CEM-affected regions. (1) Stallions or mares over 731 days of age may be imported for permanent entry from a region listed under paragraph (c)(1) of this section if the horses meet the following requirements:
(i) Each horse is accompanied at the time of importation by an import permit issued in accordance with § 93.304. The import permit must indicate that, after completion of the Federal quarantine required in § 93.308, the stallion or mare will be consigned to a State that the Administrator has approved to receive such horses in accordance with paragraph (h) of this section;
(ii) The horses are accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a);
(iii) A set of specimens must be collected from each horse within 30 days prior to the date of export by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate. For stallions, the set of specimens consists of one culture swab from each location shall be taken from the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis; for mares, the specimens must be collected from the mucosal surfaces of the clitoral fossa, clitoral sinuses, and the distal cervix or endometrium in nonpregnant mares. All of the specimens collected must be cultured for CEM with negative results in a laboratory approved to culture for CEM by the national veterinary service of the region of origin;
(iv) The horses described on the certificate must not have been used for natural breeding, for the collection of semen for artificial insemination in the case of stallions, or for artificial insemination in the case of mares, from the time the specimens were collected through the date of export;
(v) All specimens required by paragraph (e)(1)(iii) of this section must be received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and must be accompanied by a statement indicating the date and time of their collection; and
(vi) If any specimen collected in accordance with paragraph (e)(1)(iii) of this section is found to be positive for CEM, the stallion or mare must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (e)(1)(ii) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.
(2) Post-entry. (i) Stallions and mares imported under paragraph (e)(1) of this section must complete the Federal quarantine required under § 93.308. Upon completion of the Federal quarantine, stallions must be sent to an approved State listed under paragraph (h)(7) of this section, and mares must be sent to an approved State listed under paragraph (h)(8) of this section.
(ii) Stallions and mares must be transported to the approved State in a sealed vehicle. The seal may be broken only by an APHIS representative or a State animal health official at the horse's destination. If an APHIS representative or State animal health official is unavailable to break the seal due to extenuating circumstances, the State animal health official may designate the authority to unseal to an accredited veterinarian and will assume the responsibility for oversight and recordkeeping.
(iii) Once in the approved State, the stallions or mares shall be quarantined under State or Federal supervision until the stallions have met the testing and treatment requirements of paragraph (e)(3) of this section and the mares have met the testing and treatment requirements of paragraph (e)(5) of this section.
(iv) All tests and cultures required by paragraphs (e)(3) through (e)(5) of this section shall be conducted at the National Veterinary Services Laboratories, Ames, IA, or at a laboratory approved by the Administrator in accordance with § 71.22 of this chapter to conduct CEM cultures and tests.
(v) To be eligible for CEM culture or testing, all specimens collected in accordance with paragraphs (e)(3) through (e)(5) of this section must be received by the National Veterinary Services Laboratories or the approved laboratory within 48 hours of collection and must be accompanied by a statement indicating the date and time of their collection.
(3) Testing and treatment requirements for stallions. (i) Once the stallion is in the approved State, one specimen each shall be taken from the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of the stallion by an accredited veterinarian and be cultured for CEM. After negative results have been obtained, the stallion must be test bred to two test mares that meet the requirements of paragraph (e)(4) of this section. Upon completion of the test breeding:
(A) The stallion must be treated for 5 consecutive days by thoroughly cleaning and washing (scrubbing) its prepuce, penis, including the fossa glandis, and urethral sinus while the stallion is in full erection with a solution of not less than 2 percent surgical scrub chlorhexidine and then thoroughly coating (packing) the stallion's prepuce, penis, including the fossa glandis, and urethral sinus with an ointment effective against the CEM organism.
(B) Each mare to which the stallion has been test bred shall be cultured for CEM from three sets of specimens from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from either the distal cervix or endometrium, between the third and fourteenth day after breeding (for the purposes of this section, the day after the date of breeding is considered the first day after breeding), with negative results. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. A complement fixation test for CEM must be done with negative results between the twenty-first and twenty-eighth day after the breeding.
(ii) If any culture or test required by this paragraph is positive for CEM, the stallion shall be treated as described in paragraph (e)(3)(i)(A) of this section and retested by being test bred to two mares no less than 21 days after the last day of treatment.
(iii) A stallion may be released from State quarantine only if all cultures and tests of specimens from the mares used for test breeding are negative for CEM and all cultures performed on specimens taken from the stallion are negative for CEM.
(4) Requirements for test mares. (i) Mares to be used to test stallions for CEM shall be permanently identified before the mares are used for such testing with the letter “T” or other permanent identification approved by APHIS on a case-by-case basis. The marking shall be permanently applied by an inspector, a State inspector, or an accredited veterinarian who shall use a hot iron, freezemarking, a lip tattoo, or other APHIS-approved method. If a hot iron or freezemarking is used, the marking shall not be less than 2 inches (5.08 cm) high and shall be applied to the left shoulder or left side of the neck of the mare. If a lip tattoo is used, the marking shall not be less than 1 inch (2.54 cm) high and 0.75 inch (1.9 cm) wide and shall be applied to the inside surface of the upper lip of the test mare.
(ii) The test mares must be qualified prior to breeding as apparently free from CEM and may not be used for breeding from the time specimens are taken to qualify the mares as free from CEM. To qualify, each mare shall be tested with negative results by a complement fixation test for CEM, and specimens taken from each mare shall be cultured negative for CEM. Sets of specimens shall be collected on three separate occasions from the mucosal surfaces of the clitoral fossa and the clitoral sinuses, with one set of specimens including a specimen from either the distal cervix or endometrium, within a 12-day period with no less than 72 hours between each set.
(iii) A test mare that has been used to test stallions for CEM may be released from quarantine only if:
(A) The test mare is found negative for CEM on all cultures and tests required under paragraph (e)(3)(ii) of this section; or
(B) The test mare is subjected to an ovariectomy by an accredited veterinarian under the direct supervision of a State or Federal veterinarian; or
(C) The test mare is treated and handled in accordance with paragraph (e)(5) of this section; or
(D) The test mare is moved directly to slaughter without unloading en route, is euthanized, or dies.
(5) Testing and treatment requirements for mares. (i) Once the mare is in the approved State, a complement fixation test for CEM must be done, and three sets of specimens shall be collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium in nonpregnant mares. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. An accredited veterinarian shall collect specimens and shall submit each set of specimens to the National Veterinary Services Laboratories in Ames, IA, or to a laboratory approved by the Administrator in accordance with § 71.22 of this chapter to conduct CEM cultures and tests.
(ii) After the three sets of specimens required by paragraph (e)(5)(i) of this section have been collected, an accredited veterinarian shall manually remove organic debris from the sinuses of each mare and then flush the sinuses with a cerumalytic agent.
(iii) For 5 consecutive days after the sinuses have been cleaned, an accredited veterinarian shall aseptically clean and wash (scrub) the external genitalia and vaginal vestibule, including the clitoral fossa, with a solution of not less than 2 percent chlorhexidine in a detergent base and then fill the clitoral fossa and sinuses, and coat the external genitalia and vaginal vestibule with an antibiotic ointment effective against the CEM organism.
(iv) A mare may be released from State quarantine only if all cultures performed on specimens taken from the mare are negative for CEM.
(v) If any culture required by this paragraph is positive for CEM, the mare shall be treated as described in paragraphs (e)(5)(ii) and (e)(5)(iii) of this section. No less than 21 days after the last day of treatment, the mare shall be tested again in accordance with paragraph (e)(5)(i) of this section. If all specimens are negative for CEM, the mare may be released from quarantine.
(f) Special provisions for temporary importation for competition or entertainment purposes. (1) Horses over 731 days of age may be imported into the United States for no more than 90 days to compete in specified events provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.
(2) Horses over 731 days of age may be temporarily imported into the United States solely for noncompetitive public exhibition and entertainment purposes provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.
(3) At the time of importation, each horse must be accompanied by an import permit in accordance with § 93.304 and a health certificate issued in accordance with § 93.314. For horses imported in accordance with paragraph (f)(2) of this section, the health certificate must also certify that cultures negative for CEM were obtained from three sets of specimens collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium, of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both female and male horses, the sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate.
(4) Following the horse's arrival in the United States:
(i) A horse imported in accordance with paragraph (f)(1) of this section may remain in the United States for not more than 90 days, except as provided in paragraph (f)(9) of this section.
(ii) A horse imported in accordance with paragraph (f)(2) of this section may remain in the United States indefinitely, except as provided in paragraph (f)(9) of this section, as long as the conditions of paragraphs (f)(3) through (f)(12) of this section are met and the horse's owner or importer applies for and obtains from APHIS an import permit, as provided for in § 93.304, each year prior to the anniversary date of the horse's arrival in the United States.
(5) While the horse is in the United States, the following conditions must be met:
(i) A horse imported in accordance with paragraph (f)(2) of this section:
(A) Must not be entered in competitions.
(B) Must be regularly used in performances or exhibitions, unless sick or injured. A horse that is no longer performing or being exhibited must be exported or made eligible for permanent entry in accordance with paragraph (f)(9) of this section.
(C) Must be kept with the other horses listed on the import permit, unless otherwise approved by an APHIS representative.
(ii) Except as provided in paragraph (f)(5)(viii) of this section, the horse must be moved according to the itinerary and methods of transport specified in the import permit provided for in § 93.304.
(iii) The horse must be monitored by an accredited veterinarian or APHIS representative to ensure that the provisions of paragraphs (f)(5)(ii), (f)(5)(vi), and (f)(5)(vii) of this section are met. If the monitoring is performed by an accredited veterinarian, the Veterinarian in Charge will ensure that the accredited veterinarian is familiar with the requirements of this section and spot checks will be conducted by an APHIS representative to ensure that the requirements of this section are being met. If an APHIS representative finds that requirements are not being met, the Administrator may require that all remaining monitoring be conducted by APHIS representatives to ensure compliance.
(iv) Except when in transit, the horse must be kept on a premises that has been approved by an APHIS representative. For horses imported in accordance with paragraph (f)(1) of this section, such approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit. For horses imported in accordance with paragraph (f)(2) of this section, the approval will be in writing. To receive approval, the premises:
(A) Must not be a breeding premises; and
(B) Must be or contain a building or temporary structure in which the horse can be kept in a stall that is separated from other stalls that contain horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.
(v) While in transit, the horse must be moved in either an aircraft or a sealed van or trailer. If the horse is moved in a sealed van or trailer, the seal may be broken only by an APHIS representative or State animal health official at the horse's destination, except in situations where the horse's life is in danger.
(vi) Except when actually competing, performing, or being exhibited or exercised, the horse must be kept in a pasture approved by APHIS or in a stall that is separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.
(vii) The horse may not be used for breeding purposes (including artificial insemination or semen collection) and may not have any other sexual contact with other horses. The horse may not undergo any genital examinations, except that a horse imported in accordance with paragraph (f)(2) of this section may undergo genital examinations for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.
(viii) The horse may be moved for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.
(ix) After the horse is transported anywhere in the United States, any vehicle in which the horse was transported must be cleaned and disinfected in the presence of an APHIS representative, according to the procedures specified in §§ 71.7 through 71.12 of this chapter, before any other horse is transported in the vehicle.
(x) The cleaning and disinfection specified in paragraph (f)(5)(ix) of this section must be completed before the vehicle is moved from the place where the horse is unloaded. In those cases where the facilities or equipment for cleaning and disinfection are inadequate at the place where the horse is unloaded, the Administrator may allow the vehicle to be moved to another location for cleaning and disinfection when the move will not pose a disease risk to other horses in the United States.
(xi) The owner or importer of the horse must comply with any other provisions of this part applicable to him or her.
(6) Except as provided in paragraph (f)(7) of this section, if the owner or importer wishes to change the horse's itinerary or the methods by which the horse is transported from that which he or she specified in the application for the import permit, the owner or importer must make the request for change in writing to the Administrator. Requests for change must be submitted to APHIS no less than 15 days before the proposed date of the change. Requests may be submitted to APHIS by postal mail, commercial delivery service, fax, or e-mail. The change in itinerary or method of transport may not be made without the written approval of the Administrator, who may grant the request for change when he or she determines that granting the request will not endanger other horses in the United States and that sufficient APHIS personnel are available to provide the services required by the owner or importer.
(7) In response to an emergency or other unforeseen circumstances or events (e.g., weather-related transportation delays, vehicle breakdown, medical emergencies, etc.), the horse's itinerary or methods of transportation may be changed, with the prior approval of an APHIS representative, from that which is specified in the application for an import permit. Requests for such a change may be submitted to APHIS by telephone, postal mail, commercial delivery service, fax, or e-mail. Approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit.
(8) The Administrator may cancel, orally or in writing, the import permit provided for under § 93.304 whenever the Administrator finds that the owner or importer of the horse has not complied with the provisions of paragraphs (f)(3) through (f)(7) of this section or any conditions imposed under those provisions. If the cancellation is oral, the Administrator will confirm the cancellation and the reasons for the cancellation in writing as soon as circumstances permit. Any person whose import permit is canceled may appeal the decision in writing to the Administrator within 10 days after receiving oral or written notification of the cancellation, whichever is earlier. If the appeal is sent by mail, it must be postmarked within 10 days after the owner or importer receives oral or written notification of the cancellation, whichever is earlier. The appeal must include all of the facts and reasons upon which the person relies to show that the import permit was wrongfully canceled. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(9) Except in those cases where an appeal is in process, any person whose import permit is canceled must move the horse identified in the import permit out of the United States within 10 days after receiving oral or written notification of cancellation, whichever is earlier. The horse is not permitted to enter competition, perform, or be exhibited from the date the owner or importer receives the notice of cancellation until the horse is moved out of the United States or until resolution of an appeal in favor of the owner or importer. Except when being exercised, the horse must be kept, at the expense of the owner or importer, in a stall on the premises where the horse is located when the notice of cancellation is received or, if the horse is in transit when the notice of cancellation is received, on the premises where it is next scheduled to compete, perform, or be exhibited according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. In cases where the owners of the above specified premises do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the above specified premises will pose a disease risk to horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator.
(10) Stallions or mares over 731 days of age that are imported in accordance with paragraphs (f)(1) or (f)(2) of this section may be eligible to remain in the United States if the following is completed:
(i) Following completion of the itinerary specified in the import permit provided for in § 93.304, the horse's owner or importer applies for and receives a new import permit that specifies that the stallion or mare will be moved to an approved State listed under paragraph (h)(7) or (8) of this section; and
(ii) The stallion or mare is transported in a sealed vehicle that has been cleaned and disinfected to an approved facility in an approved State where it is quarantined under State or Federal supervision until the stallion or mare has met the testing and treatment requirements of paragraph (e)(3) or (e)(5) of this section.
(11) All costs and charges associated with the supervision and maintenance of a horse imported under paragraphs (f)(1) or (f)(2) of this section will be borne by the horse's owner or importer. The costs associated with the supervision and maintenance of the horse by an APHIS representative at his or her usual places of duty will be reimbursed by the horse's owner or importer through user fees payable under part 130 of this chapter.
(12) In the event that an APHIS representative must be temporarily detailed from his or her usual place of duty in connection with the supervision and maintenance of a horse imported under this paragraph (f), the owner or importer of the horse must execute a trust fund agreement with APHIS to reimburse all expenses (including travel costs, salary, per diem or subsistence, administrative expenses, and incidental expenses) incurred by the Department in connection with the temporary detail. Under the trust fund agreement, the horse's owner or importer must deposit with APHIS an amount equal to the estimated cost, as determined by APHIS, for the APHIS representative to inspect the premises at which the horse will compete, perform, or be exhibited; to conduct the monitoring required by paragraph (f)(5)(iii) of this section; and to supervise the cleaning and disinfection required by paragraph (f)(5)(ix) of this section. The estimated costs will be based on the following factors:
(i) Number of hours needed for an APHIS representative to conduct the required inspection and monitoring;
(ii) For services provided during regular business hours (8 a.m. to 4:30 p.m., Monday through Saturday, except holidays), the average salary, per hour, for an APHIS representative;
(iii) For services provided outside regular business hours, the applicable rate for overtime, night differential, or Sunday or holiday pay, based on the average salary, per hour, for an APHIS representative;
(iv) Number of miles from the premises at which the horse competes, performs, or is exhibited to the APHIS office or facility that is monitoring the activities;
(v) Government rate per mile for automobile travel or, if appropriate, cost of other means of transportation between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility;
(vi) Number of trips between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility that APHIS representatives are required to make in order to conduct the required inspection and monitoring;
(vii) Number of days the APHIS representative conducting the inspection and monitoring must be in “travel status”;
(viii) Applicable Government per diem rate; and
(ix) Cost of related administrative support services.
(13) If a trust fund agreement with APHIS has been executed by the owner or importer of a horse in accordance with paragraph (f)(12) of this section and APHIS determines, during the horse's stay in the United States, that the amount deposited will be insufficient to cover the services APHIS is scheduled to provide during the remainder of the horse's stay, APHIS will issue to the horse's owner or importer a bill to restore the deposited amount to a level sufficient to cover the estimated cost to APHIS for the remainder of the horse's stay in the United States. The horse's owner or importer must pay the amount billed within 14 days after receiving the bill. If the bill is not paid within 14 days after its receipt, APHIS will cease to perform the services provided for in paragraph (f)(5) of this section until the bill is paid. The Administrator will inform the owner or importer of the cessation of services orally or in writing. If the notice of cessation is oral, the Administrator will confirm, in writing, the notice of cessation and the reason for the cessation of services as soon as circumstances permit. In such a case, the horse must be kept, at the expense of the owner or importer and until the bill is paid, in a stall either on the premises at which the horse is located when the notice of cessation of services is received or, if the horse is in transit when the notice of cessation of services is received, on the premises at which it is next scheduled to compete, perform, or be exhibited according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. In cases where the owners of the premises where the horse would be kept following a cessation of services do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the premises will pose a disease risk to other horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator. Until the bill is paid, the horse is not permitted to enter competition, perform, or be exhibited. Any amount deposited in excess of the costs to APHIS to provide the required services will be refunded to the horse's owner or importer.
(g) Special provisions for the importation of horses that have been temporarily exported to a CEM-affected region. If a horse originating from the United States has been temporarily exported for not more than 90 days to a CEM-affected region listed under paragraph (c)(1) of this section and returns to the United States during that time, or if a horse originating from a non-CEM affected region has been temporarily exported for not more than 90 days to a CEM-affected region during the 12 months preceding its proposed importation to the United States, the horse may be eligible for return, or for importation into the United States, without meeting the requirements of paragraphs (d) through (f) of this section, under the following conditions:
(1) The horse must be accompanied by a certificate that meets the requirements of § 93.314(a) of this part issued by each CEM-affected region that the horse has visited during the term of its temporary exportation, and each certificate must contain the following additional declarations:
(i) That the horse was held separate and apart from all other horses except for the time it was actually participating in an event or was being exercised by its trainer;
(ii) That the premises on which the horse was held were not used for any equine breeding purpose;
(iii) That breeding of the horse, either live or artificial, has never been attempted, nor has the horse had any other sexual contact or genital examination while in such region; and
(iv) That all transport while in such region was carried out in cleaned and disinfected vehicles in which no other horses were transported since such cleaning and disinfection;
(2) The horse is accompanied by an import permit issued in accordance with § 93.304 of this part at the time of exportation;
(3) If the horse was temporarily exported from the United States and is being returned to the United States, the horse must be accompanied by a copy of the United States health certificate issued for its exportation from the United States and endorsed in accordance with the export regulations in part 91 of this chapter;
(4) The horse must be examined by an inspector at the U.S. port of entry and found by the inspector to be the identical horse covered by the documents required by paragraphs (g)(1) through (3) of this section and found by the inspector to be free of communicable disease and exposure thereto; and
(5) The horse must be quarantined and tested at the U.S. port of entry as provided in § 93.308 of this part prior to release.
(h) Approval of States. In order for a State to be approved to receive stallions or mares over 731 days of age from a CEM-affected region listed under paragraph (c)(1) of this section that are imported under paragraph (e) of this section, the State must meet the following conditions:
(1) The State must enter into a written agreement with the Administrator, whereby the State agrees to enforce its laws and regulations to control CEM and to abide by the conditions of approval established by the regulations in this part.
(2) The State must agree to quarantine all stallions and mares over 731 days of age imported under the provisions of paragraph (e) of this section until the stallions have been treated in accordance with paragraph (e)(3) of this section and the mares have been treated in accordance with paragraph (e)(5) of this section.
(3) The State must agree to quarantine all mares used to test stallions for CEM until the mares have been released from quarantine in accordance with paragraph (e)(4) of this section.
(4) The State must agree to provide oversight during the test breeding of quarantined stallions.
(5) The State must have laws or regulations requiring that stallions over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(3) of this section, and that mares over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(5) of this section.
(6) Approval of any State to receive stallions or mares imported from regions affected with CEM may be suspended by the Administrator upon his or her determination that any requirements of this section are not being met. After such action is taken, the animal health authorities of the approved State will be informed of the reasons for the action and afforded an opportunity to present their views thereon before such suspension is finalized; however, such suspension of approval shall continue in effect unless otherwise ordered by the Administrator. In those instances where there is a conflict as to the facts, a hearing shall be held to resolve such conflict.
(7) A list of States approved by APHIS to receive stallions over 731 days of age imported under paragraph (e) of this section is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Copies of the list will also be available via postal mail, fax, or email upon request to Live Animal Imports, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737.
(8) A list of States approved by APHIS to receive mares over 731 days of age imported under paragraph (e) of this section is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Copies of the list will also be available via postal mail, fax, or email upon request to Live Animal Imports, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737.
(a) Shipping container requirements. Shipping containers used to transport live equine(s) to the United States must meet the following requirements:
(1) Containers must be new or cleaned and disinfected in a manner that sufficiently reduces the risk of introduction or dissemination of any pests or diseases of livestock into the United States.
(2) Containers must be of sufficient size and construction to reasonably assure that live equine(s) are transported safely.
(3) Stocking density of live equine(s) must not be to an extent that impinges on the animals' safety during transportation.
(4) Guidance on how to meet these requirements may be found in the Live Animals Regulations (LAR), as amended, published by the International Air Transport Association (IATA) or the Terrestrial Animal Health Code published by the World Organization for Animal Health (WOAH). The Administrator may also approve alternative guidance than that described in the LAR or the Terrestrial Animal Health Code.
(b) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.
(c) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(d) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(e) Shipping container. For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all horses shall be entered into the United States through the following station(s), except as provided in paragraphs (b), (c), (d), (e), and (f) of this section, §§ 93.308(a), (b) and (c) and 93.317: Newburgh, New York.
(b) Canadian border ports. Land border ports designated for the entry of horses from Canada may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the
(c) Mexican border ports. Land border ports designated for the entry of horses from Mexico may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the
(d) Limited ports. Certain ports are designated as having inspection facilities for the entry of horses and horse products such as horse test specimens which do not appear to require restraint and holding inspection facilities. These ports may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the
(e) Ports for horses to be quarantined at privately owned quarantine facilities. Horses, except horses from or which have transited any region in which African horsesickness is declared to exist,
(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(a) Application for permit; reservation required. (1)(i) For horses from or transiting regions listed in § 93.301(c)(1) of the regulations, horses intended for quarantine at a Federal quarantine or privately owned quarantine facility, and horse test specimens for diagnostic screening purposes, intended for importation from any part of the world, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of horses or horse test specimens to be imported; the purpose of the importation; individual horse identification which includes a description of the horse, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the horses or horse test specimens to be imported; and the name of the person to whom the horses or horse test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the horses are susceptible, as well as vaccinations or other precautionary treatments to which the horses or horse test specimens have been subjected, or other attestation regarding the health of the animals. Notice of any such requirements will be given to the applicant in each case.
(ii) Horses intended for importation under § 93.301(f)(1) of this part must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f)(1) of this part, the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:
(A) That the application is being made for a horse that will remain in the United States for no more than 90 days;
(B) The names, dates, and locations of the events in which the horse will compete while in the United States;
(C) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises; and
(D) The methods and routes by which the horse will be transported while in the United States.
(iii) Horses intended for importation under § 93.301(f)(2) must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f)(2), the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:
(A) The individual identifying information required in paragraph (a)(1)(i) of this section for all horses to be imported.
(B) The permanent electronic identification of each horse to be imported, if applicable. In the event that a horse has permanent electronic identification, the horse must be accompanied by a compatible reader.
(C) Photographs (head and lateral views) that are sufficient to identify each horse on an electronic medium approved by APHIS.
(D) The proposed total length of stay in the United States.
(E) A description of the shows or events in which the horse will perform while in the United States.
(F) The names, dates, and locations of the venues in which the horse will perform while in the United States.
(G) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises.
(H) The methods and routes by which the horse will be transported while in the United States.
(I) A written plan for handling sick or injured horses that includes:
(1) The name, address, and phone number of each accredited veterinarian who will provide veterinary services in the United States;
(2) The name, address, and phone number of medical facilities to be used to diagnose or treat sick or injured horses while in the United States; and
(3) A plan to return sick or injured horses to performance condition.
(J) An application for a trust fund or escrow account agreement with APHIS in accordance with § 93.301(f)(12).
(iv) Approval of an application for a permit to import a horse under § 93.301(f) of this part is contingent upon a determination by the Administrator that sufficient APHIS personnel are available to provide the services required. If more than one application for an import permit is received, APHIS personnel will be assigned in the order that applications that otherwise meet the requirements of this section are received.
(2) An application for permit to import horses from regions listed in § 93.301(c)(1) or horses intended for quarantine at a privately owned quarantine facility, may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the horses; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of horses to be quarantined in a facility maintained by USDA. For horses, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the horses are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the horse for which the reservation was made: Except that a reservation fee shall not be forfeited if the Administrator determines that services, other than provided by carriers, necessary for the importation of the horses within the required period are unavailable because of unforeseen circumstances as determined by the Administrator (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) If a reservation is canceled, the importer or the importer's agent will be charged a fee according to the following schedule:
| Cancellation date | Fee |
|---|---|
| 30 or more days before the scheduled reservation date | 25 percent of the reservation fee. |
| 15-29 days before the scheduled reservation date | 50 percent of the reservation fee. |
| Less than 15 days before the scheduled reservation date | 100 percent of the reservation fee. |
(vii) If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b) Permit. (1) When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to ensure that the shipper presents the copy of the permit to the carrier and makes the necessary arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs.
(2) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will be received at the port of entry specified on the permit within the time prescribed in the permit, which shall not exceed 14 days from the first day that the permit is effective.
(3) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will not be eligible for entry if:
(i) A permit has not been issued for the importation of the horse or horse test specimen;
(ii) If the horse or horse test specimen is unaccompanied by the permit issued for its importation;
(iii) If the horse or horse test specimen is shipped from any port other than the one designated in the permit;
(iv) If the horse or horse test specimen arrives in the United States at any port other than the one designated in the permit;
(v) If the horse or horse test specimen offered for entry differs from that described in the permit; or
(vi) If the horse or horse test specimen is not handled as outlined in the application for the permit and as specified in the permit issued.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of horses at such port, for the use of the veterinary inspector at the port of entry.
(b) For all horses offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the horses, the number, breed, species, and purpose of the importation, the name of the person to whom the horses will be delivered, and the location of the place to which such delivery will be made.
(c) Any declaration, permit, or other document for horses required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.
Inspection shall be made at the port of entry of all horses imported from any part of the world except as provided in §§ 93.318 and 93.323. All horses found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other horses, to include horses dead upon presentation, and horses arriving in the same shipment as such horses unless the cause of death can be determined to be unrelated to foreign animal disease, shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator of Veterinary Service, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such horses or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about horses governed under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any pests or diseases of livestock, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
(a) Except as provided in this section and in § 93.324, horses intended for importation into the United States from any part of the world shall be shipped directly to a port designated in §§ 93.303 and 92.324 and be quarantined at said port until negative results to port of entry tests are obtained and the horses are certified by the port veterinarian to be free from clinical evidence of disease.
(1) Except as provided in §§ 93.317 (horses from Canada) and 93.324 (horses from Mexico), horses intended for importation from regions that APHIS considers to be affected with Venezuelan equine encephalomyelitis shall be quarantined at a port designated in § 93.303 to be evaluated for signs of Venezuelan equine encephalomyelitis. Each horse must be accompanied at the time of importation by an import permit in accordance with § 93.304.
(i) A list of regions that APHIS considers affected with Venezuelan equine encephalomyelitis is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (WOAH), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(2) Horses intended for importation from regions APHIS considers to be affected with African horse sickness may enter the United States only at the port of New York, and must be quarantined at the New York Animal Import Center in Newburgh, New York, for at least 60 days. This restriction also applies to horses that have stopped in or transited a region considered affected with African horse sickness. Each horse must be accompanied at the time of importation by an import permit in accordance with § 93.304.
(i) A list of regions that APHIS considers affected with African horse sickness is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(3) Horses from regions where APHIS considers screwworm to exist may be imported into the United States only if they meet the requirements in paragraphs (a)(3)(i) through (vii) of this section, obtain an import permit in accordance with § 93.304, and meet all other applicable requirements of this part. A list of regions where screwworm is considered to exist is maintained on the APHIS website at www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list will also be available via postal mail, fax, or email upon request to the Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from WOAH, or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(i) A veterinarian must treat horses with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(ii) Horses must be examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. The official must fully examine the horses, including their external genitalia. If horses are found to be infested with screwworm, they must be treated until free from infestation.
(iii) At the time horses are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(iv) Horses must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the horses, including their external genitalia, have been thoroughly examined and found free of screwworm and that the horses have been treated in accordance with paragraphs (a)(3)(i) and (iii) of this section.
(v) Horses must be quarantined upon arrival in the United States at a port designated in § 93.303 for at least 7 days.
(vi) Horses must be examined for screwworm by a veterinarian within 24 hours after arrival at a port designated in § 93.303. The examining veterinarian must examine horses, including their external genitalia, to determine whether the horse is infested with screwworm.
(vii) Horses must be held at the animal import center for a minimum of 7 days. On day 7, prior to the horses' release, the horses must be examined by a veterinarian at the expense of the owner or broker. For this examination, male horses must be tranquilized or sedated so that the external genitalia of the horses can be thoroughly examined. If screwworm is found during this examination, the horses must be held in quarantine and treated until free of infestation.
(4) To qualify for release from quarantine, all horses, except horses from Iceland, must test negative to official tests for dourine, glanders, equine piroplasmosis, and equine infectious anemia.
(5) Any quarantine period required for a horse shall be counted using the first day after arrival of the horse at the quarantine facility as the first day of quarantine and may be extended for such additional period as the Administrator may require to determine its freedom from disease. Any horse which is positive to any of the port of entry tests named in this paragraph or any other test required by the Administrator, or which is found by the port veterinarian to exhibit evidence of communicable disease during quarantine shall be refused entry into the United States and removed by the importer to a country other than the United States within 10 days of the date that the importer is notified by APHIS that such horse has been refused entry into the United States. Upon request, the Administrator may grant additional time for the removal of a horse from the United States in any case in which he or she determines that delay is unavoidable due to unforeseen circumstances and the additional time for removal of the horse will not present a threat of the spread of communicable disease to other animals in the United States. At the option of the importer, such horse may be disposed of in accordance with such conditions as the Administrator believes necessary to prevent the dissemination of communicable disease into the United States. The importer shall be responsible for all costs of such removal or disposal.
(b) Temporary, privately owned quarantine facilities. Horses presented for entry into the United States as provided in § 93.303(e), except horses originating from regions in which Venezuelan equine encephalomyelitis or screwworm is declared to exist, may be quarantined in temporary, privately owned quarantine facilities that meet the requirements of paragraphs (b)(1) and (b)(2) of this section and that have been approved by the Administrator for a specific importation.
(1) Approval. Requests for approval and plans for proposed temporary facilities must be submitted no less than 15 days before the proposed date of entry of horses into the facility to APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 39, Riverdale, MD 20737-1231. Before facility approval can be granted, a veterinary medical officer of APHIS must inspect the facility to determine whether it complies with the standards set forth in this section: Provided, however, that approval of any temporary facility and use of such facility will be contingent upon a determination made by the Administrator that adequate personnel are available to provide required services at the facility. Approval of any facility may be refused and approval of any quarantine facility may be withdrawn at any time by the Administrator, upon his or her determination that any requirements of this section are not being met. Before such action is taken, the operator of the facility will be informed of the reasons for the proposed action by the Administrator and afforded an opportunity to present his or her views. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. The cost of the facility and all maintenance and operational costs of the facility will be borne by the operator.
(2) Standards and handling procedures. The facility must be maintained and operated in accordance with the following standards:
(i) Inspection. Inspection and quarantine services must be arranged by the operator or his or her agent with the APHIS Veterinarian in Charge for the State in which the approved facility is located
(ii) Physical plant requirements. (A) The facility must be located and constructed to prevent horses from having physical contact with animals outside the facility.
(B) The facility must be constructed only with materials that can withstand repeated cleaning and disinfection. Disinfectants authorized in 9 CFR part 71 must be used. All walls, floors, and ceilings must be constructed of solid material that is impervious to moisture. Doors, windows, and other openings of the facility must be provided with double screens that will prevent insects from entering the facility.
(iii) Sanitation and security. (A) The operator of the facility must arrange for a supply of water adequate to clean and disinfect the facility.
(B) All feed and bedding must originate from an area not under quarantine because of splenetic or tick fever (see part 72 of this chapter) and must be stored within the facility.
(C) Upon the death of any horse, the operator must arrange for the disposal of the horse's carcass by incineration. Disposal of all other waste removed from the facility during the time the horses are in quarantine or from horses that are refused entry into the United States must be either by incineration or in a public sewer system that meets all applicable environmental quality control standards. Following completion of the quarantine period and the release of the horses into the United States, all waste may be removed from the quarantine facility without further restriction.
(D) The facility must be maintained and operated in accordance with any additional requirements the Administrator deems appropriate to prevent the dissemination of any communicable disease.
(E) The facility must comply with all applicable local, State, and Federal requirements for environmental quality.
(iv) Personnel. (A) Access to the facility will be granted only to persons working at the facility or to persons specifically granted such access by an APHIS representative.
(B) The operator must provide attendants for the care and feeding of horses while in the quarantine facility.
(C) Persons working in the quarantine facility may not come in contact with any horses outside the quarantine facility during the quarantine period for any horses in the facility.
(v) Handling of horses in quarantine. Horses offered for importation into the United States that are quarantined in an approved temporary facility must be handled in accordance with paragraph (a) of this section while in quarantine.
(c) Permanent, privately owned quarantine facilities. Horses presented for entry into the United States as provided in § 93.303(e) may be quarantined in permanent, privately owned quarantine facilities approved by the Administrator as meeting the requirements of paragraphs (c)(1) through (c)(6) of this section.
(1) APHIS approval—(i) Approval procedures. Persons seeking APHIS approval of a permanent, privately owned quarantine facility must write to the Administrator, c/o Strategy and Policy, Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231. The application letter must include the full name and mailing address of the applicant; the location and street address of the facility for which approval is sought; blueprints of the facility; a description of the financial resources available for construction, operation, and maintenance of the facility; the anticipated source or origin of horses to be quarantined, as well as the expected size and frequency of shipments; a contingency plan for horses needing emergency veterinary care; and a contingency plan for the disposal of all the horses capable of being housed in the facility.
(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must enter into a service agreement with APHIS wherein the applicant agrees to pay the cost of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for the evaluation of the application and facility at hourly rates listed in part 130 of this chapter. This service agreement applies only to fees accrued during the application process. If the facility is approved by APHIS, facility owners must enter into a compliance agreement in accordance with paragraph (c)(2) of this section.
(B) Requests for approval must be submitted to APHIS at least 120 days prior to the date of application for local building permits. Requests for approval will be evaluated on a first-come, first-served basis.
(ii) Criteria for approval. Before a facility may operate as a permanent, privately owned quarantine facility for horses, it must be approved by APHIS. To be approved:
(A) The facility must meet all of the requirements of this section;
(B) The facility must meet any additional requirements that may be imposed by the Administrator in each specific case, as specified in the compliance agreement required under paragraph (c)(2) of this section, to ensure that the quarantine of horses in the facility will be adequate to determine their health status, as well as to prevent the transmission of diseases into, within, and from the facility; and
(C) The Administrator must determine that sufficient personnel, including one or more APHIS veterinarians and other professional, technical, and support personnel, are available to serve as APHIS representatives at the facility. If the facility is approved, APHIS representatives will be present at all import quarantine operations in order to monitor them and will be present in order to provide other technical services to ensure the biological security of the facility, including, but not limited to, those specified in paragraph (c)(4)(v)(H) of § 93.308. The Administrator's determination will be based on the expected size and frequency of shipments to the facility, as described in the application for approval of a permanent facility, as well as any other pertinent information in the application. APHIS will assign personnel to facilities requesting approval in the order that the facilities are approved. The Administrator has sole discretion on the number of APHIS personnel to be assigned to the facility.
(iii) Maintaining approval. To maintain APHIS approval, the operator must continue to comply with all the requirements of paragraph (c) of this section and the terms of the compliance agreement executed in accordance with paragraph (c)(2) of this section.
(iv) Denial or withdrawal of approval. Approval for a proposed permanent, privately owned quarantine facility may be denied or approval for a facility already in operation may be withdrawn at any time by the Administrator for any of the reasons provided in paragraph (c)(1)(iv)(C) of this section.
(A) Before facility approval is denied or withdrawn, the operator of the facility will be informed of the reasons for the proposed action by the Administrator and afforded an opportunity to present his or her views. If there is a conflict as to any material fact, APHIS will afford the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action.
(B) The Administrator may withdraw approval of an existing facility prior to a final determination in the hearing if the Administrator determines that such action is necessary to protect animal health or the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, APHIS will promptly give written confirmation to the operator of the facility. This withdrawal will continue in effect pending the completion of the hearing and any judicial review, unless otherwise ordered by the Administrator. In addition to withdrawal of approval for the reasons provided in paragraph (c)(1)(iv)(C) of this section, the Administrator will also automatically withdraw approval when the operator of any approved facility notifies the APHIS Veterinarian in Charge for the State in which the facility is located, in writing, that the facility is no longer in operation.
(C) The Administrator may deny or withdraw approval of a permanent, privately owned facility if:
(1) Any requirement of this section or the compliance agreement is not complied with; or
(2) The operator fails to remit any charges for APHIS services rendered; or
(3) The operator or a person responsibly connected with the business of the quarantine facility acts as a paid agent (broker) for the importation or subsequent sale of horses; or
(4) The operator or a person responsibly connected with the business of the quarantine facility is or has been found by a court of competent jurisdiction to have violated any law or regulation pertaining to the importation or quarantine of any animal; or
(5) The operator or a person responsibly connected with the business of the quarantine facility is or has been convicted of any crime involving fraud, bribery, or extortion or any other crime involving a lack of the integrity needed for the conduct of operations affecting the importation of animals; or
(6) The approved quarantine facility has not been in use to quarantine horses for a period of at least 1 year.
(D) For the purposes of this section, a person is deemed to be responsibly connected with the business of the quarantine facility if such person has an ownership, mortgage, or lease interest in the facility's physical plant, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or is an employee in a managerial or executive capacity.
(v) Approval for existing facilities. Any permanent, privately owned quarantine facility operating under APHIS authorization on August 3, 2009 must be approved by APHIS to continue quarantine operations by August 3, 2010 or else must cease horse quarantine operations.
(2) Compliance agreement. (i) All permanent, privately owned quarantine facilities for horses must operate in accordance with a compliance agreement executed by the operator or his or her agent and the Administrator, which must be renewed on an annual basis.
(ii) The compliance agreement must provide that:
(A) The facility must meet all applicable requirements of this section;
(B) The operator agrees to have APHIS representatives present at all import quarantine operations at the facility in order to monitor the import quarantine operations;
(C) The operator agrees to be responsible for the cost of the facility; all costs associated with its maintenance and operation; all costs associated with the hiring of employees and other personnel to attend to the horses as well as to maintain and operate the facility; all costs associated with the care of quarantined horses, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; and all APHIS charges for the services of APHIS representatives in accordance with this section and part 130 of this chapter;
(D) The operator agrees to bar from the facility any employee or other personnel at the facility who fails to comply with paragraph (c) of this section or other provisions of this part, any terms of the compliance agreement, or related instructions from APHIS representatives;
(E) The operator agrees to demonstrate, to the satisfaction of the Administrator, that the routine cleaning and maintenance of the facility, the daily care of animals in quarantine, the disposal of wastes at the facility, the cleaning and disinfection procedures employed by the facility, the handling, washing, and disposal of soiled and contaminated clothing worn within the facility, and the disposal of dead horses, whether onsite or offsite, adhere to the best practices of biological security and animal care;
(F) The operator agrees to random spot audits by APHIS representatives to determine whether employees and other personnel are complying with these practices; and
(G) The operator of the facility allows the Administrator to amend the compliance agreement at any time after approval of the facility in order to incorporate related instructions issued by APHIS representatives while the facility is operational
(3) Physical plant requirements. The facility must meet the following requirements as determined by an APHIS inspection prior to admitting horses into the facility:
(i) Location. The quarantine facility must be located in proximity to a port authorized under § 93.303(e). The site and the specific routes for the movement of horses from the port to the site must be approved by the Administrator based on consideration of whether the site or routes would put the horses in a position that could result in the transmission of communicable diseases to domestic horses.
(ii) Construction. The facility must be of sound construction, in good repair, and properly designed to prevent the escape of quarantined horses. It must have adequate capacity to receive and house shipments of horses as lots on an “all in, all out” basis, whereby separate lots of horses can be received and housed without contact with any other lots being quarantined at the facility. The facility must include the following:
(A) Perimeter fencing. The facility must be surrounded by a security fence of sufficient height and design to prevent the entry of unauthorized people and animals from outside the facility and to prevent the escape of the horses in quarantine.
(B) Entrances and exits. All entryways into the nonquarantine area of the facility must be equipped with a secure and lockable door. While horses are in quarantine, all access to the quarantine area for horses must be from within the building, and each such entryway to the quarantine area must be equipped with a series of solid self-closing double doors. Emergency exits to the outside are permitted in the quarantine area. Such emergency exits must be constructed so as to permit their being opened from the inside of the facility only.
(C) Windows and other openings. The facility must be constructed so that any windows or other openings in the quarantine area are double-screened with screening of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of diseases of horses and to provide ventilation sufficient to ensure the comfort and safety of all horses in the facility. The interior and exterior screens must be separated by at least 3 inches (7.62 cm). All screening of windows or other openings must be easily removable for cleaning, but must otherwise remain locked and secure at all times in a manner satisfactory to APHIS representatives in order to ensure the biological security of the facility.
(D) Lighting. The entire facility, including its stalls and hallways, must have adequate lighting.
(E) Loading docks. The facility must have separate docks for animal receiving and releasing and for general receiving and pickup, unless a single dock used for both purposes is cleaned and disinfected after each use in accordance with paragraph (c)(4)(iv)(F) of this section.
(F) Surfaces. The facility must be constructed so that the floor surfaces with which horses have contact are nonslip and wear-resistant. All floor surfaces with which the horses, their excrement, or discharges have contact must provide for adequate drainage. All floor and wall surfaces with which the horses, their excrement, or discharges have contact must be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Ceilings and wall surfaces with which the horses, their excrement, or discharges do not have contact must be able to withstand cleaning and disinfection between shipments of horses. All floor and wall surfaces must be free of sharp edges that could cause injury to horses.
(G) Horse stalls. The stalls in which horses are kept must be large enough to allow each animal to make normal postural and social adjustments with adequate freedom of movement. Exercise equipment for horses may be kept in the stalls, provided that there will still be sufficient space within the stalls for the horses to move freely once the equipment is installed.
(H) Aisleways. The aisleways through which horses are moved to and from stalls must be wide enough to provide for safe movement of horses, including allowing horses to turn around in the aisleway, preventing horses in facing stalls from coming into contact with horses in the aisleway, and adequately ventilating the stalls.
(I) Means of isolation. Physical barriers must separate different lots of horses in the facility so that horses in one lot cannot have physical contact with horses in another lot or with their excrement or discharges. Stalls must be available that are capable of isolating any horses exhibiting signs of illness.
(J) Showers. A shower must be located at each entrance to the quarantine area. If the facility has a necropsy area, a shower must be located at the entrance to the necropsy area. A clothes-storage and clothes-changing area must be provided with each shower area. There must also be one or more receptacles near each shower so that clothing that has been worn into the quarantine area can be deposited in a receptacle prior to entering the shower.
(K) APHIS space. The facility must have adequate space for APHIS representatives to conduct examinations and testing of the horses in quarantine, prepare and package samples for mailing, and store the necessary equipment and supplies for duplicate samples. The space provided to conduct examinations and testing must include a refrigerator-freezer in which to store samples. The examination space must include equipment to provide for the safe inspection of horses. The facility must also include a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.
(L) Necropsy area. The facility must either include an area for conducting necropsies onsite or must have designated an alternate facility at which a suitable necropsy area is available. If the facility has a necropsy area, it must be of sufficient size to perform necropsies on horses and be equipped with adequate lighting, hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment. If the facility does not have such an area, it must specify an alternate facility at which a suitable necropsy area is available, a route from the quarantine facility to the alternate facility's necropsy area, and the safeguards that will be in place to ensure that communicable diseases of horses are not spread during transit. This alternate facility and transport methodology must be approved by the Administrator under the procedures for requesting variances outlined in paragraph (c)(6) of this section.
(M) Storage. The facility must have sufficient storage space for equipment and supplies used in import quarantine operations. Storage space must include separate, secure storage for pesticides and for medical and other biological supplies, as well as a separate vermin-proof storage area for feed and bedding, if feed and bedding are stored at the facility. If the facility has multiple lot-holding areas, then separate storage space for any reusable supplies and equipment that are not disinfected after each use in accordance with part 71 of this chapter must be provided for each lot-holding area.
(N) Additional space needs. The facility must have an area for washing and drying clothes, linens, and towels and an area for cleaning and disinfecting equipment used in the facility. The facility must also include a work area for the repair of equipment.
(O) Restrooms. The facility must have permanent restrooms in both the quarantine and nonquarantine areas of the facility.
(P) Ventilation and climate control. The facility must be constructed with an air handling system capable of controlling and maintaining the ambient temperature, air quality, humidity, and odor at levels that are not injurious or harmful to the health of horses in quarantine. Air supplied to the quarantine area must not be recirculated or reused for other ventilation needs. Air handling systems for lot-holding areas must be separate from air handling systems for other operational and administrative areas of the facility. In addition, if the facility is equipped to handle more than one lot of horses at a time, the air handling system must be adequate to ensure that there is no cross-contamination of air between separate lot-holding areas.
(Q) Fire protection. The facility, including the lot-holding areas, must have a fire alarm voice communication system.
(R) Communication system. The facility must have a communication system between the nonquarantine and quarantine areas of the facility.
(iii) Sanitation. To ensure that proper animal health and biological security measures are observed, the facility must have the following:
(A) Equipment and supplies necessary to maintain the facility in clean and sanitary condition, including pest control equipment and supplies and cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment.
(B) Any reusable equipment and supplies that are not disinfected after each use in accordance with part 71 of this chapter maintained separately for each lot of horses.
(C) Equipment and supplies used in the quarantine area maintained separately from equipment and supplies used in the nonquarantine area.
(D) A supply of potable water adequate to meet all watering and cleaning needs, with water faucets for hoses located throughout the facility. An emergency supply of water for horses in quarantine must also be maintained.
(E) A stock of disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator that is sufficient to disinfect the entire facility.
(F) The capability to dispose of wastes, including manure, urine, and used bedding, by means of burial, incineration, or public sewer. Other waste material must be handled in such a manner that minimizes spoilage and the attraction of pests and must be disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Disposal of wastes must be carried out in accordance with the terms of the compliance agreement, and is subject to spot audits by APHIS representatives.
(G) The capability to dispose of horse carcasses in a manner approved by the Administrator and under conditions that minimize the risk of disease spread from carcasses.
(H) For incineration to be carried out at the facility, the facility must have incineration equipment that is detached from other facility structures and is capable of burning animal waste and refuse. The incineration site must also include an area sufficient for solid waste holding. Incineration may also take place at a local site away from the facility premises. All incineration activities, whether onsite or offsite, must be carried out in accordance with the terms of the compliance agreement, and are subject to spot audits by APHIS representatives.
(I) The capability to control surface drainage and effluent into, within, and from the facility in a manner that prevents the spread of disease into, within, or from the facility. If the facility is approved to handle more than one lot of horses at the same time, the drainage system must be adequate to ensure that there is no cross-contamination between lot-holding areas.
(iv) Security. Facilities must provide the following security measures:
(A) The facility and premises must be kept locked and secure at all times while horses are in quarantine.
(B) The facility and premises must have signs indicating that the facility is a quarantine area and no visitors are allowed.
(C) The facility and premises must be guarded at all times by one or more representatives of a bonded security company, or, alternatively, the facility must have an electronic security system that indicates the entry of unauthorized persons into the facility. Electronic security systems must be coordinated through or with the local police so that monitoring of the quarantine facility is maintained whenever APHIS representatives are not at the facility. The electronic security system must be of the “silent type” and must be triggered to ring at the monitoring site and not at the facility. The electronic security system must be approved by Underwriter's Laboratories. The operator must provide written instructions to the monitoring agency stating that the police and a representative of APHIS designated by APHIS must be notified by the monitoring agency if the alarm is triggered. The operator must also submit a copy of those instructions to the Administrator. The operator must notify the designated APHIS representative whenever a breach of security occurs or is suspected of having occurred. In the event that disease is diagnosed in quarantined horses, the Administrator may require the operator to have the facility guarded by a bonded security company in a manner that the Administrator deems necessary to ensure the biological security of the facility.
(D) The operator must furnish a telephone number or numbers to APHIS at which the operator or his or her agent can be reached at all times.
(E) APHIS is authorized to place APHIS seals on any or all entrances and exits of the facility when determined necessary by APHIS and to take all necessary steps to ensure that such seals are broken only in the presence of an APHIS representative. If someone other than an APHIS representative breaks such seals, APHIS will consider the act a breach in security and APHIS representatives will make an immediate accounting of all horses in the facility. If a breach in security occurs, APHIS may extend the quarantine period as long as necessary to determine that the horses are free of communicable diseases.
(4) Operating procedures. The following procedures must be observed at the facility at all times:
(i) Oversight by APHIS representatives. (A) Import quarantine operations at a privately owned quarantine facility may only be conducted with the physical presence of and monitoring by APHIS representatives. APHIS representatives are also authorized to perform the services required by this section and by the compliance agreement.
(B) If, as the result of a spot audit, or for any other reason, APHIS determines that the operator has failed to properly care for, feed, or handle quarantined horses as required in this paragraph (c) or in accordance with the terms of the compliance agreement, or has failed to maintain and operate the facility as provided in this paragraph (c) or in accordance with the terms of the compliance agreement, APHIS representatives will furnish such services, will make arrangements for the sale or disposal of quarantined horses at the quarantine facility owner's expense, or will begin the process for withdrawal of approval of the quarantine facility specified in paragraph (c)(1)(iv) of this section.
(ii) Personnel. (A) The operator must provide adequate personnel to maintain the facility and care for the horses in quarantine, including attendants to care for and feed horses, and other personnel as needed to maintain, operate, and administer the facility.
(B) The operator must provide APHIS with an up-to-date list of all personnel who have access to the facility. The list must include the names, current residential addresses, and employee identification numbers of each person. When the operator wishes to grant access to the facility to persons who have not previously had access to it, the operator must update the list prior to such persons having access to the quarantine facility.
(C) The operator must provide APHIS with signed statements from each employee and any other personnel hired by the operator and working at the facility in which the person agrees to comply with paragraph (c) of this section and applicable provisions of this part, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to import quarantine operations, including contact with animals both inside and outside the facility.
(iii) Authorized access. Access to the facility premises as well as inside the quarantine area will be granted only to APHIS representatives, authorized employees, and other personnel of the operator assigned to work at the facility. All other persons are prohibited from the premises unless specifically granted access by an APHIS representative. Any visitors granted access must be accompanied at all times by an APHIS representative while on the premises or in the quarantine area of the facility.
(iv) Sanitary requirements. (A) All persons granted access to the quarantine area must:
(1) Shower when entering and leaving the quarantine area;
(2) Shower when leaving the necropsy area if a necropsy is in the process of being performed or has just been completed, or if all or portions of the examined animal remain exposed;
(3) Wear clean protective work clothing and footwear upon entering the quarantine area;
(4) Wear disposable gloves when handling sick horses and then wash hands after removing gloves; and
(5) Change protective clothing, footwear, and gloves when they become soiled or contaminated.
(B) The operator is responsible for providing a sufficient supply of clothing and footwear to ensure that all persons provided access to the quarantine area at the facility have clean, protective clothing, and footwear when they enter the quarantine area.
(C) The operator is responsible for the handling, washing, and disposal of soiled and contaminated clothing worn within the quarantine facility in accordance with the terms of the compliance agreement. At the end of each workday, work clothing worn into the quarantine area must be collected and kept in a bag until the clothing is washed. Used footwear must either be left in the clothes-changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected in accordance with the terms of the compliance agreement. APHIS representatives may conduct spot audits of all handling, cleaning, and/or disposal of used clothing or used footwear.
(D) All equipment (including tractors) must be cleaned and disinfected prior to being used in the quarantine area of the facility with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. The equipment must remain dedicated to the facility for the entire quarantine period. Any equipment used with quarantined horses (e.g., halters, floats, feed, water buckets, and exercise equipment) must remain dedicated to that particular lot of quarantined horses for the duration of the quarantine period or be cleaned and disinfected before coming in contact with horses from another lot. Prior to its removal from the quarantine premises, any equipment must be cleaned and disinfected in accordance with the terms of the compliance agreement. APHIS representatives may conduct spot audits of all cleaning and disinfection of equipment.
(E) Any vehicle, before entering or leaving the quarantine area of the facility, must be cleaned and disinfected in accordance with the terms of the compliance agreement within a time period authorized by the APHIS representative and with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. APHIS representatives may conduct spot audits of all cleaning and disinfection of vehicles.
(F) If the facility has a single loading dock, the loading dock must be cleaned and disinfected after each use in accordance with the terms of the compliance agreement within a time period authorized by the APHIS representative and with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. APHIS representatives may conduct spot audits of all cleaning and disinfection of the loading dock.
(G) That area of the facility in which a lot of horses has been held or has had access to must be thoroughly cleaned and disinfected, with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator, in accordance with the terms of the compliance agreement, upon release of the horses before a new lot of horses is placed in that area of the facility. APHIS representatives may conduct spot audits of all cleaning and disinfection of lot-holding areas.
(v) Handling of the horses in quarantine. (A) All horses must be handled in accordance with paragraph (a) of this section.
(B) Each lot of horses to be quarantined must be placed in the facility on an “all-in, all out” basis. No horse may be taken out of the lot while it is in quarantine, except for diagnostic purposes or as provided in paragraph (a)(5) of this section, and no horse may be added to the lot while the lot is in quarantine. Once import quarantine operations have been completed on a lot, but while the lot is still at the facility, a horse may be removed from that lot.
(C) The facility must provide sufficient feed and bedding for the horses in quarantine, and it must be free of vermin and not spoiled. Feed and bedding must originate from an area that is not listed in part 72 of this chapter as an area quarantined for splenetic or tick fever.
(D) Breeding of horses or collection of germplasm from horses is prohibited during the quarantine period.
(E) Horses in quarantine will be subjected to such tests and procedures as directed by an APHIS representative to determine whether they are free from communicable diseases of horses.
(F) Any death or suspected illness of horses in quarantine must be reported immediately to APHIS. The affected horses must be disposed of as the Administrator may direct, or depending on the nature of the disease, must be cared for as directed by APHIS to prevent the spread of the disease.
(G) Quarantined horses requiring specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. A second quarantine site must be established to house the horses at the facility of destination (e.g., veterinary teaching hospital). In such cases, APHIS may extend the quarantine period for that horse and for its lot until the results of any outstanding tests or postmortem results are received.
(H) Should a horse be determined to be infected with or exposed to a Federally regulated disease of horses, arrangements for the final disposition of the infected or exposed horse must be accomplished within 10 days of the date that the importer is notified by the overseeing APHIS representative that the horse has been refused entry into the United States. APHIS representatives must be physically present at and directly monitor the subsequent disposition of the horse. The operator must have a preapproved contingency plan for the disposal of all horses housed at the facility prior to issuance of the import permit.
(I) Vaccination of horses in quarantine is prohibited. However, once import quarantine operations have been completed on a lot, but while the lot is still at the facility, horses in that lot may be vaccinated.
(vi) Records. (A) The facility operator must maintain a current daily record to record the entry and exit of all persons entering and leaving the quarantine facility.
(B) The operator must maintain the daily record, along with any records kept by APHIS and deposited with the operator, for at least 2 years following the date of release of the horses from quarantine and must make such records available to APHIS representatives upon request.
(5) Environmental quality. If APHIS determines that a privately operated quarantine facility does not meet applicable local, State, or Federal environmental regulations, APHIS may deny or suspend approval of the facility until appropriate remedial measures have been applied.
(6) Variances. The Administrator may grant variances to existing requirements relating to location, construction, and other design features of the physical facility, as well as to sanitation, security, operating procedures, recordkeeping, and other provisions of paragraph (c) of this section, but only if the Administrator determines that the variance causes no detrimental impact to the overall biological security of the import quarantine operations. The operator must submit a request for a variance from the requirements for the construction of the facility in paragraph (c)(3) of this section to the Administrator in writing prior to the construction of the facility. The operator must submit a request for a variance from the operational requirements in paragraph (c)(4) of this section to the Administrator in writing at least 30 days in advance of the arrival of horses to the facility. Any variance must also be expressly provided for in the compliance agreement.
(a) Privately operated quarantine facilities. The importer, or his or her agent, of horses subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the horses from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such horses and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by horses should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of horses, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the horses may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator, may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of horses shall be made by certified check or U.S. money order prior to release of the horses. If such payment is not made, the horses may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.
(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of horses subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the horses from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of horses shall be made by certified check or U.S. money order prior to release of the horses. If such payment is not made, the horses may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the horses are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the horses will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the horses and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors are not permitted in the quarantine enclosure during any time that the horses are in quarantine unless an APHIS representative specifically grants access under such conditions and restrictions as may be imposed by APHIS. An importer (or his or her agent or accredited veterinarian) may be admitted to the lot-holding area(s) containing his or her quarantined horses at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by an APHIS representative. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the horses may be admitted upon written permission from an APHIS representative. No exhibition or sale shall be allowed within the quarantine grounds.
Milk or cream from horses quarantined under the provisions of this part shall not be used by any person other than those in charge of such horses, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the horses producing same.
If any contagious disease appears among horses during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected horses shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) Horses offered for importation from any part of the world shall be accompanied by an original certificate endorsed by a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall specify the name and address of the importer; the species, breed, number or quantity of horses or horse test specimens to be imported; the purpose of the importation; individual horse identification which requires a description of the horse, name, age, markings and, when present, registration number, tattoo, microchip, eartag, brand, if any; the region and premises of origin; the name and address of the exporter; and the destination address for release into the United States; and shows that:
(1) The horses described in the certificate have been in said region during the 60 days preceding exportation, or, for horses described in § 93.301(g), for the duration of their temporary exportation to each CEM-affected region;
(2) That each horse has been inspected on the premises of origin and found free of evidence of communicable disease and, insofar as can be determined, exposure thereto during the 60 days preceding exportation;
(3) That each horse has not been vaccinated with a live or attenuated or inactivated vaccine during the 14 days preceding exportation: Provided, however, that in specific cases the Administrator may authorize horses that have been vaccinated with an inactivated vaccine to enter the United States when he or she determines that in such cases and under such conditions as he or she may prescribe such importation will not endanger the livestock in the United States, and such horses comply with all other applicable requirements of this part;
(4) The horse, if applicable, has not been gelded during the 14 days preceding exportation;
(5) That, insofar as can be determined, no case of African horse sickness, dourine, glanders, surra, epizootic lymphangitis, ulcerative lymphangitis, equine piroplasmosis, Venezuelan equine encephalomyelitis, vesicular stomatitis, or equine infectious anemia has occurred on the premises of origin or on adjoining premises during the 60 days preceding exportation; and
(6) That, except as provided in § 93.301(g):
(i) The horses, except horses described in § 93.301(d), (e), and (f), have not been in any region listed in accordance with § 93.301(c)(1) on the APHIS website as affected with CEM during the 12 months immediately prior to their importation into the United States;
(ii) The horses have not been on any premises at any time during which time such premises were found by an official of the veterinary services of the national government of the region where such premises are located, to be affected with CEM;
(iii) The horses have not been bred by or bred to any horses from an affected premises; and
(iv) The horses have had no other contact with horses that have been found to be affected with CEM or with horses that were imported from regions affected with CEM.
(b) If a horse is presented for importation from a region where it has been for less than 60 days, the horse must be accompanied by a certificate that meets the requirements of paragraph (a) of this section that has been issued by a salaried veterinary officer of the national government of each region in which the horse has been during the 60 days immediately preceding its shipment to the United States. The dates during which the horse was in each region during the 60 days immediately preceding its exportation to the United States shall be included as a part of the certification.
(c) Following the port-of-entry inspection required by § 93.306 of this part, and before a horse offered for importation from any part of the world is released from the port of entry, an inspector may require the horse and its accompanying equipment to be disinfected as a precautionary measure against the introduction of foot-and-mouth disease or any other disease dangerous to the livestock of the United States.
(d) For purposes of this section, the term “original” means documentation is prepared and issued directly from the national government of the region of origin or annotated by the national government of the region of origin to indicate how the documentation may be verified. Any declaration, permit, or other required document for horses may be issued and presented using a United States Government electronic information exchange system or other method authorized by APHIS.
For all horses offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.
Horses imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. Such horses shall be inspected at the port of entry and otherwise handled in accordance with § 93.306. As used in this section, “directly” means without unloading en route if moved in a means of conveyance, or without stopping if moved in any other manner.
(a) Except as provided in paragraph (d) of this section, horses from Canada shall be inspected as provided in § 93.306 and accompanied by a certificate as required by § 93.314, which shall include evidence of a negative test for equine infectious anemia for which blood samples were drawn during the 180 days preceding exportation to the United States and which test was conducted in a laboratory approved by the Canada Department of Agriculture or the United States Department of Agriculture. Horses accompanying their dams, which were foaled after their dam was so tested negative, need not be so tested and shall otherwise be handled as provided in § 93.314. Certificates required for horses from Canada must be issued or endorsed by a salaried veterinarian of the Canadian Government. USDA veterinary port inspection is not required for horses imported from Canada under temporary Customs authorization for a period of 30 days from the date of issue of the certificate and the certificate issued is valid for an unlimited number of importations into the United States during the 30-day period.
(b) Horses of United States origin that are imported into Canada under an export health certificate valid for a period of 30 days from the date of issue may re-enter the United States an unlimited number of times during the 30-day period, without USDA veterinary port inspection, at any Custom land border port of entry designated for animals from Canada, if accompanied by the original export health certificate under which they were permitted entry into Canada.
(c) Any horse imported into the United States from Canada through air or ocean ports of entry must obtain an import permit under § 93.304 and shall otherwise be handled as provided in §§ 93.305 and 93.314.
(d) Horses for immediate slaughter may be imported from Canada without the certification prescribed in paragraph (a) of this section, but shall be subject to the other applicable provisions of this part, and shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government stating that:
(1) The horses were inspected on the premises where assembled for shipment to the United States within the 30 days immediately prior to the date of export and were found free of evidence of communicable disease, and
(2) As far as can be determined, they have not been exposed to any such disease during the 60 days immediately preceding their exportation.
(a) In-bond shipments from Canada. (1) Horses from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.304 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.301. Horses not accompanied by a permit shall meet the requirements of this part in the same manner as horses destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.
(2) In-transit shipments through Canada. Horses originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the horses for entry into Canada shall be recorded on the United States health certificate, or a paper containing the information shall be attached to the certificate that accompanies the horses. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the horses are the identical horses covered by said certificate.
(b) Exhibition horses. Except as provided in § 93.317(b), horses from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, horse shows, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That in the case of horses for exhibition, including race horses, the certificates shall certify that negative results were obtained from official tests for equine infectious anemia for which blood samples were drawn within 180 days of the date that the horses are offered for return to the United States: And, provided further, That all horses offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical horses covered by said certificates or are the natural increase of such horses born after official test dates certified on the dam's health certificate.
For all horses offered for importation from or transiting through regions of Central America or of the West Indies, the importer or his or her agent shall have obtained an import permit under § 93.304 and shall present two copies of a declaration as provided in § 93.305.
Horses from or transiting through Central America and the West Indies shall be inspected as provided in § 93.306; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.308(a), (b) and (c): Provided, That any such horses that are found to be infested with fever ticks, Boophilus annulatus, shall not be permitted entry until they have been freed therefrom by dipping in a permitted arsenical solution or by other treatment approved by the Administrator.
For horses intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the horses. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the horses may be presented for import inspection. Horses quarantined at a U.S. facility designated in § 93.303 must obtain an import permit under § 93.304.
For all horses offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.
(a) All horses offered for entry from Mexico, including such horses intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at a facility described in § 93.324, and all such horses found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Horses found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.
(b) Horses covered by paragraph (a) of this section shall be imported through facilities described in § 93.324, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.
Horses intended for importation from Mexico shall be quarantined until they qualify for release from such quarantine, either at an APHIS facility designated in § 93.303 (a) or at a facility in Mexico. In order to qualify for such release, all horses while so detained shall test negative to an official test for dourine, glanders, equine piroplasmosis, equine infectious anemia,
Horses offered for entry from Mexico shall be inspected as provided in §§ 93.306 and 93.323; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.324: Provided, That horses offered for importation from tick-infected areas of Mexico shall be chute inspected, unless in the judgment of the inspector a satisfactory inspection can be made otherwise. If upon inspection they are found to be apparently free from fever ticks, before entering the United States they shall be dipped once in a permitted arsenical solution or be otherwise treated in a manner approved by the Administrator.
Horses may be imported from Mexico, subject to the applicable provisions of §§ 93.321, 93.322, and 93.323 for immediate slaughter if accompanied by a certificate of a salaried veterinarian of the Mexican Government, or by a certificate issued by a veterinarian accredited by the Mexican Government and endorsed by a salaried veterinarian of the Mexican Government, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that he or she has inspected such horses on the premises of origin and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the horses are shipped by rail or truck, the certificate shall further specify that the horses were loaded into cleaned and disinfected cars or trucks for transportation directly to the port of entry. Such horses shall be consigned from a facility described in § 93.324 to a recognized slaughtering establishment and there slaughtered within 2 weeks from the date of entry. Such horses shall be moved from the port of entry in conveyances sealed with seals of the United States Government.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Accredited herd for brucellosis. A herd that meets APHIS' standards for accreditation for brucellosis status. Standards for accreditation are specified in import protocols.
Accredited herd for tuberculosis. A herd that meets APHIS' standards for accreditation for bovine tuberculosis status. Standards for accreditation are specified in import protocols.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.
Area veterinarian in charge (AVIC). The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned.
As a group. Collectively, in such a manner that the identity of the animals as a unique group is maintained.
Authorized USDA representative. An APHIS Veterinary Services employee, a USDA Food Safety and Inspection Service inspector, a State representative, an accredited veterinarian, or an employee of an accredited veterinarian, slaughtering establishment, or feedlot who is designated by the accredited veterinarian or management of the slaughtering establishment or feedlot to perform the function involved. In order to designate an employee to break official seals, an accredited veterinarian or the management of a slaughtering establishment or feedlot must first supply in writing the name of the designated individual to the APHIS AVIC in the State where the seals will be broken. Additionally, the management of a slaughtering establishment or feedlot must enter into an agreement with Veterinary Services in which the management of the facility agrees that only designated individuals will break the seals, that the facility will contact an APHIS representative or USDA Food Safety and Inspection Service inspector immediately if the seals are not intact when the means of conveyance arrives or if the animals being transported appear to be sick or injured due to transport conditions, and that the facility will cooperate with APHIS representatives, USDA Food Safety and Inspection Service inspectors, and State representatives in maintaining records of sealed shipments received.
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal risk region. A region listed in § 94.18(a)(3) of this subchapter.
Brucellosis. Infection with or disease caused by Brucella abortus.
Brucellosis certified free herd. A herd in which all eligible cattle in the herd were negative to brucellosis tests under the Canadian requirements and which is officially certified by the Canadian Government as a brucellosis free listed herd.
Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.
Cattle. Animals of the bovine species.
Certified status. A flock that has met requirements equivalent to the Export Certified status of the U.S. Scrapie Flock Certification Program while participating in a program under the supervision of the national veterinary authority of the region of origin, as determined by an evaluation conducted by APHIS of the program.
Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species.
Classical scrapie. Any form of scrapie that the Administrator has determined poses a significant risk of natural transmission.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Country mark. A permanent mark approved by the Administrator for identifying a sheep or goat to its country of origin.
Department. The United States Department of Agriculture (USDA).
Designated feedlot. A feedlot designated by the Administrator as one eligible to receive sheep and goats from regions not free of classical scrapie, and whose owner or legally responsible representative has signed an agreement as specified in § 93.435(c)(11) and is in full compliance with all the provisions of the agreement.
Exporting region. A region from which shipments are sent to the United States.
Federal veterinarian. A veterinarian employed and authorized by the Federal Government to perform the tasks required by this subpart.
Fever tick, Rhipicephalus annulatus, Rhipicephalus microplus, and any other species of tick determined by the Administrator to be a vector of bovine babesiosis and specified on the Internet at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions.
Flock. Any group of one or more sheep or goats maintained on a single premise, or on more than one premises under the same ownership and between which unrestricted movement is allowed; or two or more groups of sheep or goats under common ownership or supervision on two or more premises that are geographically separated, but among which there is an interchange or movement of animals.
Flock of birth. The flock into which a sheep or goat is born.
Flock of residence. The flock:
(1) Within which an individual sheep or goat was born, raised, and resided until exported to the United States; or
(2) In which the sheep or goat resided for breeding purposes for 60 days or more until exported to the United States; or
(3) In which sheep and goats for export were assembled for export to the United States and maintained for at least 60 days immediately prior to export, without any addition of animals or contact with animals other than through birth, on a single premises, or on more than one premises under the same ownership and between which unrestricted movement occurred.
Goat. Any animal of the genus Capra.
Herd. Any group of one or more animals maintained on common ground; or two or more groups of animals under common ownership or supervision on two or more premises that are geographically separated, but among which there is an interchange or movement of animals.
Herd of origin. A herd of one or more sires and dams and their offspring from which animals in a consignment presented for export to the United States originate. The herd of origin may be the birth herd or the herd where the animal has resided for a minimum 4-month period immediately prior to movement, unless otherwise specified in an import criteria. Additional animals can be moved into a herd of origin during or after the 4-month qualifying period only if they:
(1) Originate from an accredited herd; or
(2) Originate from a herd of origin that tested negative to a whole herd test conducted within the last 12 months and the individual animals being moved into the herd also tested negative to any additional individual tests for tuberculosis and brucellosis required by the Administrator.
Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment
Import protocol. A document issued by APHIS and provided to officials of the competent veterinary authority of an exporting region that specifies in detail the mitigation measures that will comply with the regulations in this part regarding the import of certain animals or commodities.
Individual test. A test for brucellosis or tuberculosis that is approved by the Administrator and that is administered individually in accordance with this part to ruminants that are susceptible to brucellosis or tuberculosis.
Inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this subpart.
Killed and completely destroyed. Killed, or maintained under quarantine in a manner preventing disease spread until the animal is no longer living; and the remains have been disposed of in a manner preventing disease spread.
Lot. A group of ruminants that, while held on a conveyance or premises, has opportunity for physical contact with each other or with each other's excrement or discharges at any time between arrival at the quarantine facility and 60 days prior to export to the United States.
Lot-holding area. That area in a privately owned medium or minimum security quarantine facility in which a single lot of ruminants is held at one time.
Moved directly. Moved without unloading and without stopping except for refueling, or for traffic conditions such as traffic lights or stop signs.
Moved directly by land. Moved by rail, truck, or other land vehicle without unloading and without stopping except for refueling, or for traffic conditions such as traffic lights or stop signs.
Non-classical scrapie. Any form of scrapie the Administrator has determined poses a low risk of natural transmission.
Non-negative test results. Any test results for tuberculosis or brucellosis within the suspect, reactor, or positive range parameters of a pathogen assay that has been approved by the Administrator.
Nonquarantine area. That area of a privately owned medium or minimum security quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to ruminants, samples taken from ruminants, and any other objects or substances that have been in the quarantine area during the quarantine of ruminants.
Notifiable disease. A disease for which confirmed or suspected occurrences within a region must be reported to the competent veterinary authority or other competent authority of that region.
Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. For animals intended for importation into the United States, the device or method of identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States.
Officially identified. Individually identified by means of an official identification device or method.
Operator. A person other than the Federal Government who owns or operates, subject to APHIS' approval and oversight, a privately owned medium or minimum security quarantine facility.
Permitted dip. A dip permitted by the Administrator to be used in the official dipping of cattle for fever ticks and for dipping cattle and sheep for scabies.
Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.
Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Positive for a transmissible spongiform encephalopathy. A sheep or goat for which a diagnosis of a transmissible spongiform encephalopathy has been made.
Premises of origin. Except as otherwise used in § 93.423 of this subpart, the premises where the animal was born.
Prevalence. The number of affected herds occurring during the period specified in §§ 93.437 and 93.440. In some instances, the Administrator may allow calculation of prevalence based on affected herd-years to avoid penalizing regions with small herd numbers.
Privately owned medium security quarantine facility (medium security facility). A facility that:
(1) Is owned, operated, and financed by a person other than the Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the requirements for medium security facilities in § 93.412(d); and
(4) Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
Privately owned minimum security quarantine facility (minimum security facility). A facility that:
(1) Is owned, operated, and financed by a person other than the Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the requirements for minimum security facilities in § 93.412(d);
(4) Is used for the quarantine of ruminants that pose no significant risk, as determined by the Administrator, of introducing or transmitting to the U.S. livestock population any livestock disease that is biologically transmissible by vectors; and
(5) Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.
Quarantine area. That area of a privately owned medium or minimum security quarantine facility that comprises all of the lot-holding areas in the facility and any other areas in the facility that ruminants have access to, including loading docks for receiving and releasing ruminants, and any areas used to conduct examinations of ruminants and take samples and any areas where samples are processed or examined.
Recognized slaughtering establishment. Any slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Sheep. Any animal of the genus Ovis.
Spayed heifer. A female bovine that has been neutered in a manner otherwise approved by the Administrator and specified in an import protocol.
State representative. A veterinarian or other person employed in livestock sanitary work by a State or political subdivision of a State who is authorized by such State or political subdivision of a State to perform the function involved under a memorandum of understanding with APHIS.
State veterinarian. A veterinarian employed and authorized by a State or political subdivision of a State to perform the tasks required by this subpart.
Steer. A sexually neutered male bovine.
Swine. The domestic hog and all varieties of wild hogs.
Temporary inspection facility. A temporary facility that is constructed of metal panels that can be erected and broken down alongside the transportation vessel carrying ruminants that are imported into the United States in accordance with § 93.408 of this subpart and that will be quarantined at a minimum or medium security quarantine facilities located more than 1 mile from the port of entry.
Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, typically producing characteristic microscopic changes, including, but not limited to, non-inflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and central nervous systems of affected animals.
TSE-affected sheep or goat. A sheep or goat suspected or known by the national veterinary authority of the region of origin to be infected with a transmissible spongiform encephalopathy prior to the disposal of the animal.
Tuberculosis. Infection with or disease caused by Mycobacterium bovis.
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
Veterinary Services. The Veterinary Services unit of the Department.
Wether. A castrated male sheep or goat.
Whole herd test for brucellosis. A brucellosis test that has been approved by APHIS of all sexually intact bovines in a herd of origin that are 6 months of age or older, and of all sexually intact bovines in the herd of origin that are less than 6 months of age and were not born into the herd of origin, except those sexually intact bovines that are less than 6 months of age and originate directly from a currently accredited herd for brucellosis.
Whole herd test for tuberculosis. A tuberculosis test that has been approved by APHIS of all bovines in a herd of origin that are 6 months of age or older, and of all bovines in the herd of origin that are less than 6 months of age and were not born into the herd of origin, except those bovines that are less than 6 months of age and originate directly from a currently accredited herd for tuberculosis.
World Organization for Animal Health (OIE). The international organization recognized by the World Trade Organization for setting animal health standards, reporting global animal situations and disease status, and presenting guidelines and recommendations on sanitary measures related to animal health.
Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.
(a) General provisions. No ruminant or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) Ruminants in transit. Except for ruminants prohibited entry, the provisions in this part relating to ruminants shall not apply to healthy ruminants in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such ruminants, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a ruminant holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the ruminants will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of ruminant carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of ruminants in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c) Removal and loss of official identification devices. Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices is prohibited except at the time of slaughter. If an official identification device is lost, and it is necessary to retag an animal with a new official number, every effort should be made to correlate the new official number with the previous official number of the animal.
(d) Cleaning and disinfection prior to shipment. A means of conveyance used to transport an animal to the United States in accordance with this subpart must be cleaned and disinfected in a manner specified within an import protocol prior to transport, unless an exemption has been granted by the Administrator.
(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.
(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all ruminants shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d), (e), and (f) of this section; Miami, Florida; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of ruminants from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.
(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of ruminants from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, and Presidio, Texas: Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, Columbus, and Santa Teresa, New Mexico.
(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted, St. Croix, in the United States Virgin Islands, are hereby designated as quarantine stations for the entry of ruminants from the British Virgin Islands into the United States Virgin Islands for immediate slaughter.
(e) Limited ports. The following ports are designated as having inspection facilities for the entry of ruminants and ruminant products such as ruminant test specimens which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii, Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no live animals); El Paso, Galveston, and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.
(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(g) Ports and privately owned quarantine facilities. Ruminants may be imported into the United States at any port specified in paragraph (a) of this section, or at any other port designated as an international port or airport by the Bureau of Customs and Border Protection, and quarantined at an APHIS-approved privately owned quarantine facility, provided the applicable provisions of §§ 93.401, 93.404(a), 93.407, 93.408, and 93.412 are met.
(a) Application for permit; reservation required. (1) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation from any part of the world, except as otherwise provided for in §§ 93.417, 93.422, and 93.424, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of ruminants or ruminant test specimens to be imported; the purpose of the importation; individual ruminant identification, which includes a description of the ruminant, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; for cattle, the address of or other means of identifying the premises of the herd of origin and any other premises where the cattle resided prior to export, including the State or its equivalent, the municipality or nearest city, and the specific location of the premises, or an equivalent method, approved by the Administrator, of identifying the location of the premises; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the name and address of the quarantine facility, if the ruminants are to be quarantined at a privately owned quarantine facility; the proposed date of arrival of the ruminants or ruminant test specimens to be imported; and the name of the person to whom the ruminants or ruminant test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the ruminants are susceptible, as well as vaccinations or other precautionary treatments to which the ruminants or ruminant test specimens have been subjected. Notice of any such requirement will be given to the applicant in each case.
(2) In addition to the requirements in paragraph (a)(1) of this section, the importer must submit the following information along with the application for an import permit:
(i) For sheep or goats imported for immediate slaughter, or for restricted feeding for slaughter:
(A) The slaughter establishment to which the animals will be imported; or
(B) The designated feedlot in which sheep and goats imported for restricted feeding for slaughter will be maintained until moved to slaughter.
(ii) For sheep and goats imported for purposes other than immediate slaughter or restricted feeding for slaughter:
(A) The flock identification number, if imported to a flock, and the premises or location identification number, of the flock or other premises to which the animals are imported as listed in the Scrapie National Database.
(B) For sheep and goats from regions not free from classical scrapie, the importer must provide documentation that the animal has reached and maintained certified status in a scrapie flock certification program determined by the Administrator to provide equivalent risk reduction as the Export Category of the U.S. Scrapie Flock Certification Program. The documentation must specify the address, or other means of identification, of the premises and flock of birth, and any other flock(s) in which the animals have resided.
(3) An application for permit to import will be denied for domestic ruminants from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.
(4) An application for permit to import ruminants may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the ruminants; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(5) In specific cases, a permit may be issued for ruminants that would otherwise be prohibited importation due to TSEs pursuant to this subpart, if the Administrator determines the disease risk posed by the animals can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures. These measures will be specified in the permit. If it is determined prior to or after importation that any pre-entry or post-entry requirements were not met, or the ruminants are affected with or have been exposed to TSEs, the ruminants, their progeny, and any other ruminants that have been housed with or exposed to the ruminants will be disposed of or otherwise handled as directed by the Administrator. Importers seeking a permit pursuant to this paragraph (a)(5) must send their request to the Administrator, c/o Strategy and Policy, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231, or via the APHIS website at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml.
(6) The Administrator may issue permits under paragraph (a)(5) of this section for male sheep determined to be AA at codon 136 and either RR, HR, KR, or QR at codon 171 and for female sheep determined to be AA at codon 136 and RR at codon 171 by the National Veterinary Services Laboratories or another laboratory approved by the Administrator. Such sheep must meet all requirements in this part for import other than the requirement that they originate in a flock or region free of classical scrapie. The permit will provide for post entry confirmation of the animal's scrapie susceptibility genotype and/or genetic testing for identity.
(7)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of ruminants to be quarantined in a facility maintained by USDA. For ruminants, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the ruminants are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of ruminants for which the reservation was made: Except that a reservation fee shall not be forfeited if:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the ruminants within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(7)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(7)(iv)(A) of this section and the provisions of paragraph (a)(7)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Ruminants and ruminant test specimens for diagnostic screening purposes for ruminants intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Ruminants and ruminant test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the ruminants or ruminant test specimens offered for entry differ from those described in the permit; if the ruminants or ruminant test specimens are not handled as outlined in the application for the permit and as specified in the permit issued; or if ruminants or swine other than those covered by import permits are aboard the transporting carrier.
(c) Wild ruminants from regions where foot-and-mouth disease exists. This paragraph (c) applies to the importation of wild ruminants, such as, but not limited to, giraffes, deer and antelopes, from regions designated in part 94 of this subchapter as countries in which foot-and-mouth disease exists.
(1) Permits for the importation of wild ruminants will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:
(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild ruminants; and
(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild ruminants.
(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported ruminants can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead ruminants within the PEQ Zoo; and other reasonable facilities considered necessary to prevent the dissemination of diseases from the PEQ Zoo. The operator of the PEQ Zoo shall have available the services of a full-time or part-time veterinarian, or a veterinarian on a retainer basis, who shall make periodic examinations of all animals maintained at the PEQ Zoo for evidence of disease; who shall make a post-mortem examination of each animal that dies; and who shall make a prompt report of suspected cases of contagious or communicable diseases to an APHIS representative or the State agency responsible for livestock disease control programs.
(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild ruminant enters the zoo. If an APHIS veterinarian determines that an imported ruminant shows no signs of any communicable disease or exposure to any such disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that an imported ruminant does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the ruminant's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.
(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported ruminants are to be consigned, and the importer of the ruminants, if such operator and importer are different parties, shall execute an agreement covering each ruminant or group of ruminants for which the import permit is requested. The agreement shall be in the following form:
________, operator(s) of the zoological park known as ____________________ (Name) located at ____________________ (City and state), and ____________________ (Importer) hereby request a permit for the importation of ________ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.
2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in the United States. If shipment is made by ocean vessel the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.
4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.
6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the receiving zoological park is accredited by the American Zoo and Aquarium Association (AZA), or the receiving zoological park has facilities and procedures in place related to preventing the spread of communicable animal diseases (including but not limited to procedures for animal identification, record keeping, and veterinary care) that are equivalent to those required for AZA accreditation. The Administrator will approve the movement of a carcass, body part, or biological specimen derived from an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the carcass, body part, or biological specimen will be moved only for scientific research or museum display purposes.
Subscribed and sworn to before me this ____ day of ____, ____.
Subscribed and sworn to before me this ____ day of ____,____
(a) Issuance and required information. All ruminants intended for importation from any part of the world, except as provided in §§ 93.423(c) and 93.428(d), shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:
(1) That the ruminants have been kept in that region during the last 60 days immediately preceding the date of shipment to the United States, and that during this time the region has been entirely free from foot-and-mouth disease, contagious pleuropneumonia, and surra; provided, however, that for wild ruminants for exhibition purposes, the certificate need specify only that the district of origin has been free from the listed diseases; and provided further, that for sheep and goats, with respect to contagious pleuropneumonia, the certificate may specify only that the district of origin has been free from this disease;
(2) That the ruminants are not in quarantine in the region of origin; and
(3) If the ruminants are from any region where screwworm is considered to exist, the ruminants may be imported into the United States only if they meet the requirements of paragraphs (a)(3)(i) through (iv) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(i) A veterinarian must treat the ruminants with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(ii) The ruminants must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If ruminants are found to be infested with screwworm, they must be treated until free from infestation.
(iii) At the time ruminants are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(iv) The ruminants must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the ruminants have been thoroughly examined and found free of screwworm and that the ruminants have been treated in accordance with paragraphs (a)(3)(i) and (a)(3)(iii) of this section.
(b) Sheep and goats—(1) Information required. In addition to the statements required by paragraph (a) of this section, the certificate accompanying sheep or goats from any part of the world must also include the name and address of the importer; the number or quantity of sheep or goats to be imported; the purpose of the importation; the official individual sheep or goat identification applied to the animals; and, when required by § 93.435, the permanent country mark and other identification present on the animal, including registration number, if any; a description of each sheep or goat linked to the official identification number, including age, sex, breed, color, and markings, if any; the flock of residence; the address (including street, city, State, and ZIP Code) of the destination where the sheep or goats are to be physically located after importation, including the premises or location identification number assigned in the APHIS National Scrapie Database and when applicable the flock identification number; the name and address of the exporter; the port of embarkation in the region of export; the mode of transportation, route of travel and port of entry in the United States; and, for sheep or goats imported for purposes other than immediate slaughter or restricted feeding for slaughter, the certificate must specify the region of origin and, for regions not free of scrapie, the address or other identification of the premises and flock of birth, and any other flock in which the animals have resided.
(2) Additional statements. The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, and in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also state that:
(i) The sheep or goats originated from a region recognized as free of classical scrapie by APHIS; or the animals have reached and maintained certified status or equivalent status in a scrapie flock certification program or equivalent program approved by APHIS;
(ii) The sheep or goats have not commingled with sheep or goats of a lower health status, or resided on the premises of a flock or herd of lower health status, after leaving the flock of residence and prior to arrival in the United States;
(iii) Any enclosure, container or conveyance in which the sheep or goats had been placed during the export process, and which had previously held sheep or goats, was cleaned and disinfected in accordance with § 54.7(e)(2) of this chapter prior to being used for the sheep or goats;
(iv) None of the female sheep or goats is carrying an implanted embryo from a lower health status flock; or that any implanted embryo meets the requirements for import into the United States when implanted, and documentation as required in part 98 of this subchapter is attached;
(v) The veterinarian issuing the certificate has inspected the sheep or goats, and their flock(s) of residence, within 30 days of consignment for import to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease;
(vi) As far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats in the flock(s) of residence has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States; and
(vii) The animals' movement is not restricted within the country of origin due to animal health reasons.
(3) Test results. The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, or in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also include:
(i) The results of any testing required in the import permit; and
(ii) Any other information required in the import permit.
(4) Sheep or goats imported for immediate slaughter. For sheep or goats imported for immediate slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:
(i) The region where the sheep or goats originated is recognized as free of classical scrapie by APHIS; or
(ii) The region where the sheep or goats originated has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:
(A) TSEs in sheep and goats are compulsorily notifiable to the national veterinary authority of the region;
(B) An effective classical scrapie awareness, surveillance, monitoring, and control system is in place;
(C) TSE-affected sheep and goats are killed and completely destroyed;
(D) The sheep and goats selected for export showed no clinical sign of scrapie on the day of shipment and are fit for travel;
(E) The sheep and goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and
(F) The animals' movement is not restricted within the country of origin due to animal health reasons.
(5) Sheep or goats for restricted feeding for slaughter. For sheep or goats imported for restricted feeding for slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:
(i) The region where the sheep or goats originated is recognized as free of classical scrapie by APHIS; or
(ii) The region where the sheep or goats originated has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:
(A) TSEs in sheep and goats are compulsorily notifiable to the national veterinary authority of the region;
(B) An effective classical scrapie awareness, surveillance, monitoring and control system is in place;
(C) TSE-affected sheep and goats are killed and completely destroyed;
(D) The sheep or goats showed no clinical sign of scrapie or any other infectious disease on the day of shipment and are fit for travel;
(E) The sheep or goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy;
(F) The animals' movement is not restricted within the country of origin due to animal health concerns;
(G) Female sheep and goats are not known to be pregnant, are not visibly pregnant, and female animals have not been exposed:
(1) To a sexually intact male at over 5 months of age; or
(2) To a sexually intact male within 5 months of shipment;
(H) The veterinarian issuing the certificate has inspected the sheep or goats for export, and their flock(s) of residence, within 30 days of consignment for shipment to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease; and
(I) As far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.
(c) Refusal of entry. If ruminants are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if such ruminants are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(a) [Reserved]
(b) Tuberculosis and brucellosis tests of goats. Except as provided in §§ 93.428(b) and 93.435, all goats offered for importation, except for immediate slaughter, shall be accompanied by a satisfactory certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, showing that the goats have been tested for tuberculosis and brucellosis with negative results within 30 days of the date of their exportation. The said certificate shall give the dates and places of testing, method of testing, names of consignor and consignee, and a description of the goats, including breed, ages, markings, and tattoo and eartag numbers.
(c)-(d) [Reserved]
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of ruminants at such port, for the use of the veterinary inspector at the port of entry.
(b) For all ruminants offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the ruminants, the number, breed, species, and purpose of the importation, the name of the person to whom the ruminants will be delivered, and the location of the place to which such delivery will be made.
(c) Any declaration, permit, or other document for ruminants required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.
Inspection shall be made at the port of entry of all ruminants imported from any part of the world except as provided in § 93.421. All ruminants found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other ruminants except as provided in §§ 93.423(c) and 93.427(a) shall be refused entry. Ruminants refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.). Such portions of the transporting vessel, and of its cargo, which have been exposed to any such ruminants or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about ruminants governed by the regulations in this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
Platforms and chutes used for handling imported ruminants shall be cleaned and disinfected under APHIS supervision after being so used. The said ruminants shall not be unnecessarily moved over any highways nor allowed to come in contact with other animals, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of animals or their fresh products. When movement of the aforesaid ruminants upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.
(a) Except for cattle from Central America and the West Indies, and except for ruminants from Canada and Mexico, all ruminants imported into the United States shall be quarantined for not less than 30 days counting from the date of arrival at the port of entry.
(b) Wild ruminants shall be subject, during their quarantine, to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator to determine their freedom from disease.
(a) Privately owned quarantine facilities. The operator of a privately owned medium or minimum security quarantine facility subject to the regulations in this subpart shall arrange for acceptable transportation from the port to the privately owned quarantine facility and for the care, feeding, and handling of the ruminants from the time of unloading at the port to the time of release from the quarantine facility. Such arrangements shall be agreed to in advance by the Administrator. All expenses related to these activities shall be the responsibility of the operator. The privately owned quarantine facility must be suitable for the quarantine of the ruminants and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by the ruminants should be kept clean and sanitary to the satisfaction of the APHIS representatives. If for any cause, the care, feeding, or handling of ruminants, or the sanitation of the facilities is neglected, in the opinion of the overseeing APHIS representative, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section. The operator must request in writing inspection and other services as may be required, and shall waive all claims against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When APHIS finds it necessary to extend the usual minimum quarantine period, APHIS shall advise the operator in writing, and the operator must pay for such additional quarantine and other services required. The operator must pay for all services received in connection with each separate lot of ruminants as specified in the compliance agreement required under paragraph (d)(2) of this section.
(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of ruminants subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the ruminants from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of ruminants shall be made by certified check or U.S. money order prior to release of the ruminants. If such payment is not made, the ruminants may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the ruminants are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the ruminants will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the ruminants and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.
(c) APHIS collection of payments from the importer, or his or her agent, or the operator, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
(d) Standards for privately owned quarantine facilities for ruminants—(1) APHIS approval of facilities—(i) Approval procedures. Persons seeking APHIS approval of a privately owned medium or minimum security quarantine facility for ruminants must make written application to the Administrator, c/o Strategy and Policy, Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231. The application must include the full name and mailing address of the applicant; the location and street address of the facility for which approval is sought; blueprints of the facility; a description of the financial resources available for construction, operation and maintenance of the facility; copies of all approved State permits for construction and operation of the facility (but not local building permits), as well as copies of all approved Federal, State, and local environmental permits; the anticipated source(s) or origin(s) of ruminants to be quarantined, as well as the expected size and frequency of shipments, and a contingency plan for the possible destruction and disposal of all ruminants capable of being held in the facility.
(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in part 130 of this chapter. If the facility is approved by APHIS, the operator must enter into a compliance agreement in accordance with paragraph (d)(2) of this section.
(B) Requests for approval must be submitted at least 120 days prior to the date of application for local building permits. Requests for approval will be evaluated on a first-come, first-served basis.
(ii) Criteria for approval. Before a facility may be built to operate as a privately owned medium or minimum security quarantine facility for ruminants, it must be approved by APHIS. To be approved:
(A) APHIS must find, based on an environmental assessment, and based on any required Federal, State, and local environmental permits or evaluations secured by the operator and copies of which are provided to APHIS, that the operation of the facility will not have significant environmental effects;
(B) The facility must meet all the requirements of paragraph (d) of this section;
(C) The facility must meet any additional requirements that may be imposed by the Administrator in each specific case, as specified in the compliance agreement required under paragraph (d)(2) of this section, to ensure that the quarantine of ruminants in the facility will be adequate to enable determination of their health status, as well as to prevent the transmission of livestock diseases into, within, and from the facility; and
(D) The Administrator must determine whether sufficient personnel, including one or more APHIS veterinarians and other professional, technical, and support personnel, are available to serve as APHIS representatives at the facility and provide continuous oversight and other technical services to ensure the biological security of the facility, if approved. APHIS will assign personnel to facilities requesting approval in the order that the facilities meet all of the criteria for approval. The Administrator has sole discretion on the number of APHIS personnel to be assigned to the facility.
(iii) Maintaining approval. To maintain APHIS approval, the operator must continue to comply with all the requirements of paragraph (d) of this section as well as the terms of the compliance agreement executed in accordance with paragraph (d)(2) of this section.
(iv) Withdrawal or denial of approval. Approval of a proposed privately owned medium or minimum security quarantine facility may be denied or approval of a facility already in operation may be withdrawn at any time by the Administrator for any of the reasons provided in paragraph (d)(1)(iv)(C) of this section.
(A) Before facility approval is denied or withdrawn, APHIS will inform the operator of the proposed or existing facility and include the reasons for the proposed action. If there is a conflict as to any material fact, APHIS will afford the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action in accordance with rules of practice that APHIS adopts for the proceeding.
(B) Withdrawal of approval of an existing facility will become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, APHIS will give written confirmation to the operator of the facility as promptly as circumstances allow. This withdrawal will continue in effect pending the completion of the proceeding and any judicial review, unless otherwise ordered by the Administrator. In addition to withdrawal of approval for the reasons provided in paragraph (d)(1)(iv)(C) of this section, the Administrator will also automatically withdraw approval when the operator of any approved facility notifies the area veterinarian in charge for the State in which the facility is located, in writing, that the facility is no longer in operation.
(C) The Administrator may deny or withdraw the approval of a privately owned medium or minimum security quarantine facility if:
(1) Any requirement of paragraph (d) of this section or the compliance agreement is not met; or
(2) The facility has not been in use to quarantine ruminants for a period of at least 1 year; or
(3) The operator fails to remit any charges for APHIS services rendered; or
(4) The operator or a person responsibly connected with the business of the facility is or has been convicted of any crime under any law regarding the importation or quarantine of any animal; or
(5) The operator or a person responsibly connected with the business of the facility is or has been convicted of a crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity needed for the conduct of operations affecting the importation of animals; or
(6) Any other requirement under the Animal Health Protection Act (7 U.S.C. 8301-8317) or the regulations thereunder are not met.
(D) For the purposes of paragraph (d)(1)(iv) of this section, a person is deemed to be responsibly connected with the business of the facility if such person has an ownership, mortgage, or lease interest in the facility, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or an employee in a managerial or executive capacity.
(2) Compliance agreement. (i) A privately owned medium or minimum security quarantine facility must operate in accordance with a compliance agreement executed by the operator or other designated representative of the facility and by the Administrator. The compliance agreement must be signed by both parties before a facility may commence operations. The compliance agreement must provide that:
(A) The facility must meet all applicable requirements of paragraph (d) of this section;
(B) The facility's quarantine operations are subject to the strict oversight of APHIS representatives;
(C) The operator agrees to be responsible for the cost of building the facility; all costs associated with its maintenance and operation; all costs associated with the hiring of personnel to attend to the ruminants, as well as to maintain and operate the facility; all costs associated with the care of quarantined ruminants, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; all costs associated with the death or destruction and disposition of quarantined ruminants; and all APHIS charges for the services of APHIS representatives in accordance with this section and part 130 of this chapter;
(D) The operator obtained, prior to execution of this agreement, a financial instrument (insurance or surety bond) approved by APHIS that financially guarantees the operator's ability to cover all costs and other financial liabilities and obligations of the facility, including a worst case scenario in which all quarantined ruminants must be destroyed and disposed of because of an animal health emergency, as determined by the Administrator.
(E) The operator will deposit with the Administrator, prior to commencing quarantine operations, a certified check or U.S. money order to cover the estimated costs, as determined by the Administrator, of professional, technical, and support services to be provided by APHIS at the facility over the duration of the quarantine. If actual costs incurred by APHIS over the quarantine period exceed the deposited amount, the operator will pay for any additional costs incurred by APHIS, based on official accounting records. Payment for all services received in connection with each lot of ruminants in quarantine shall be made prior to release of the ruminants. The operator must pay for any other costs incurred by APHIS with respect to the quarantine following the release of the ruminants, based on official records, within 14 days of receipt of the bill showing the balance due. APHIS will return to the operator any unobligated funds deposited with APHIS, after the release of the lot of ruminants from the facility and termination or expiration of the compliance agreement, or, if requested, credit to the operator's account such funds to be applied towards payment of APHIS services at a future date.
(ii) Prior to the entry of each subsequent lot of ruminants into the medium or minimum security facility, a new compliance agreement must be executed, and a certified check or U.S. money order to the Administrator must be deposited to cover the estimated costs, as determined by the Administrator, of professional, technical, and support services to be provided by APHIS at the facility over the duration of the quarantine.
(3) Physical plant requirements. A privately owned medium or minimum security quarantine facility must meet the following requirements as determined by an APHIS inspection before ruminants may be admitted to it.
(i) Location. (A) The medium or minimum security facility must be located at a site approved by the Administrator, and the specific routes for the movement of ruminants from the port must be approved in advance by the Administrator, based on consideration of whether the site or routes would put the animals in a position that could result in their transmitting communicable livestock diseases.
(B) In the case of a medium security facility, the facility must be located at least one-half mile from any premises holding livestock. In the case of a minimum security facility, the Administrator will establish the required minimum distance between the facility and other premises holding livestock on a case-by-case basis.
(C) If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator must make arrangements for the imported ruminants to be held in a temporary inspection facility to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to the animals' movement to the medium or minimum security facility.
(1) The temporary inspection facility must have adequate space for Federal or State veterinarians to conduct examinations and testing of the imported ruminants.
(2) The examination space of the temporary inspection facility must be equipped with appropriate animal restraining devices for the safe inspection of ruminants.
(3) The temporary inspection facility may not hold more than one lot of animals at the same time.
(4) In seeking APHIS approval of the temporary inspection facility, the operator must provide APHIS with the following information: The port of entry; a description of the temporary inspection facility; and the anticipated source(s) of the materials to be used for the facility.
(5) If the ruminants, upon inspection at the temporary inspection facility, are determined to be infected with or exposed to a disease that precludes their entry into the United States, the animals will be refused entry. Ruminants refused entry remain the responsibility of the operator, but subject to further handling or disposition as directed by the Administrator in accordance with § 93.408 of this subpart.
(6) APHIS' approval to build and operate a medium or minimum security facility outside the immediate vicinity of a designated port is contingent upon APHIS' approval of the temporary inspection facility at the port, as well as approval of the routes for the movement of ruminants from the port to the medium or minimum security facility.
(ii) Construction. The medium or minimum security facility must be of sound construction, in good repair, and properly designed to prevent the escape of quarantined ruminants. It must have adequate capacity to receive and hold a shipment of ruminants as a lot on an “all-in, all-out” basis and must include the following:
(A) Loading docks. The facility must include separate docks for animal receiving and releasing and for general receiving and pickup, or, alternatively, a single dock may be used for both purposes if the dock is cleaned and disinfected after each use in accordance with paragraph (d)(4)(iv)(D) of this section.
(B) Perimeter fencing. The facility must be surrounded by double-security perimeter fencing separated by at least 30 feet and of sufficient height and design to prevent the entry of unauthorized persons and animals from outside the facility and to prevent the escape of any ruminants in quarantine.
(C) Means of isolation. The facility must provide pens, chutes, and other animal restraining devices, as appropriate, for inspection and identification of each animal, as well as for segregation, treatment, or both, of any ruminant exhibiting signs of illness. The medium or minimum security facility must also have lot-holding areas of sufficient size to prevent overcrowding. A medium security facility may hold more than one lot of ruminants as long as the lots are separated by physical barriers such that ruminants in one lot do not have physical contact with ruminants in another lot or with their excrement or discharges. A minimum security facility may not hold more than one lot of animals at the same time.
(D) APHIS space. The facility must have adequate space for APHIS representatives to conduct examinations and draw samples for testing of ruminants in quarantine, prepare and package samples for mailing, and store duplicate samples and the necessary equipment and supplies for each lot of ruminants. The examination space must be equipped with appropriate animal restraining devices for the safe inspection of ruminants. The facility must also provide a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.
(E) Storage. The facility must have sufficient storage space for equipment and supplies used in quarantine operations. Storage space must include separate, secure storage for pesticides and for medical and other biological supplies, as well as a separate storage area for feed and bedding, if feed and bedding are stored at the facility.
(F) Other work areas. The facility must include work areas for the repair of equipment and for cleaning and disinfecting equipment used in the facility.
(iii) Additional construction requirements for medium security facilities. For medium security facilities only, the following requirements must also be met:
(A) Self-contained building. The medium security facility must be constructed so that the quarantine area is located in a secure, self-contained building that contains appropriate control measures against the spread of livestock diseases biologically transmissible by vectors. All entryways into the nonquarantine area of the building must be equipped with a secure and lockable door. While ruminants are in quarantine, all access to the quarantine area must be from within the building. Each entryway to the quarantine area must be equipped with a solid self-closing door. Separate access must be provided within the quarantine area to each lot-holding area so that it is not necessary to move through one lot-holding area to gain access to another lot-holding area. Entryways to each lot-holding area within the quarantine area would also have to be equipped with a solid lockable door. Emergency exits to the outside may exist in the quarantine area if required by local fire ordinances. Such emergency exits must be constructed so as to permit their opening from the inside of the facility only.
(B) Windows and other openings. Any windows or other openings in the quarantine area must be double-screened with screening of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of livestock diseases and to provide ventilation sufficient to ensure the comfort and safety of all ruminants in the facility. The interior and exterior screens must be separated by at least 3 inches (7.62 cm). All screening of windows or other openings must be easily removable for cleaning, yet otherwise remain locked and secure at all times in a manner satisfactory to APHIS representatives in order to ensure the biological security of the facility.
(C) Surfaces. The medium security facility must be constructed so that the floor surfaces with which ruminants have contact are nonslip and wear-resistant. All floor surfaces with which the ruminants, their excrement, or discharges have contact must slope gradually to the center, where one or more drains of at least 8 inches in diameter are located for adequate drainage, or, alternatively, must be of slatted or other floor design that allows for adequate drainage. All floor and wall surfaces with which the ruminants, their excrement, or discharges have contact must be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Other ceiling and wall surfaces with which the ruminants, their excrement, or discharges do not have contact must be able to withstand cleaning and disinfection between shipments of ruminants. All floor and wall surfaces must be free of sharp edges that could cause injury to ruminants.
(D) Ventilation and climate control. The medium security facility must be constructed with a heating, ventilation, and air conditioning (HVAC) system capable of controlling and maintaining the ambient temperature, air quality, moisture, and odor at levels that are not injurious or harmful to the health of ruminants in quarantine. Air supplied to lot-holding areas must not be recirculated or reused for other ventilation needs. HVAC systems for lot-holding areas must be separate from air handling systems for other operational and administrative areas of the facility. In addition, if the facility is approved to handle more than one lot of ruminants at a time, each lot-holding area must have its own separate HVAC system that is designed to prevent cross-contamination between the separate lot-holding areas.
(E) Lighting. The medium security facility must have adequate lighting throughout, including in the lot-holding areas and other areas used to examine ruminants and conduct necropsies.
(F) Fire protection. The medium security facility, including the lot-holding areas, must have a fire alarm and voice communication system.
(G) Monitoring system. The medium security facility must have a television monitoring system or other arrangement sufficient to provide a full view of the lot-holding areas.
(H) Communication system. The medium security facility must have a communication system between the nonquarantine and quarantine areas of the facility.
(I) Necropsy area. The medium security facility must have an area that is of sufficient size to perform necropsies on ruminants and that is equipped with adequate lighting, hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment.
(J) Additional storage requirements. Feed storage areas in the medium security facility must be vermin-proof. Also, if the medium security facility has multiple lot-holding areas, then separate storage space for supplies and equipment must be provided for each lot-holding area.
(K) Showers. In a medium security facility, there must be a shower at the entrance to the quarantine area. A shower also must be located at the entrance to the necropsy area. A clothes-storage and clothes-changing area must be provided at each end of each shower area. There also must be one or more receptacles near each shower so that clothing that has been worn in a lot-holding area or elsewhere in the quarantine area can be deposited in the receptacle(s) prior to entering the shower.
(L) Restrooms. The medium security facility must have permanent restrooms in both the nonquarantine and quarantine areas of the facility.
(M) Break room. The medium security facility must have an area within the quarantine area for breaks and meals.
(N) Laundry area. The medium security facility must have an area for washing and drying clothes, linens, and towels.
(iv) Sanitation. To ensure that proper animal health and biological security measures are observed, a privately owned medium or minimum security quarantine facility must provide the following:
(A) Equipment and supplies necessary to maintain the facility in a clean and sanitary condition, including pest control equipment and supplies and cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment.
(B) Separately maintained sanitation and pest control equipment and supplies for each lot-holding area if the facility will hold more than one lot of ruminants at a time (applicable to medium security facilities only).
(C) A supply of potable water adequate to meet all watering and cleaning needs, with water faucets for hoses located throughout the facility. An emergency supply of water for ruminants in quarantine also must be maintained.
(D) A stock of disinfectant authorized in § 71.10(a)(5) of this chapter or otherwise approved by the Administrator that is sufficient to disinfect the entire facility.
(E) The capability to dispose of wastes, including manure, urine, and used bedding, by means of burial, incineration, or public sewer. Other waste material must be handled in such a manner that minimizes spoilage and the attraction of pests and must be disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Disposal of wastes must be carried out under the direct oversight of APHIS representatives.
(F) The capability to dispose of ruminant carcasses in a manner approved by the Administrator and under conditions that prevent the spread of disease from the carcasses.
(G) For incineration to be carried out at the facility, incineration equipment that is detached from other facility structures and is capable of burning wastes or carcasses as required. The incineration site must include an area sufficient for solid waste holding. Incineration may also take place at a local site away from the facility premises. All incineration activities must be carried out under the direct oversight of an APHIS representative.
(H) The capability to control surface drainage and effluent into, within, and from the facility in a manner that prevents the spread of disease into, within, and from the facility. If the facility is approved to handle more than one lot of ruminants at the same time, there must be separate drainage systems for each lot-holding area in order to prevent cross contamination.
(v) Security. (A) A privately owned medium or minimum security quarantine facility must provide the following security measures:
(1) The facility and premises must be kept locked and secure at all times while the ruminants are in quarantine.
(2) The facility and premises must have signs indicating that the facility is a quarantine area and no visitors are allowed.
(3) The operator must furnish a telephone number or numbers to APHIS at which the operator or his or her agent can be reached at all times.
(4) APHIS is authorized to place seals on any or all entrances and exits of the facility, when determined necessary by APHIS to ensure security, and to take all necessary steps to ensure that the seals are broken only in the presence of an APHIS representative. If the seals are broken by someone other than an APHIS representative, it will be considered a breach in security, and an immediate accounting of all ruminants in the facility will be made by an APHIS representative. If a breach in security occurs, APHIS may extend the quarantine period as long as necessary to determine that the ruminants are free of communicable livestock diseases.
(5) In the event that a communicable livestock disease is diagnosed in quarantined ruminants, the Administrator may require that the operator have the facility guarded by a bonded security company, at the expense of the operator of the facility, in a manner that the Administrator deems necessary to ensure the biological security of the facility.
(B) A privately owned medium security facility also must provide the following security measures:
(1) The medium security facility and premises must be guarded at all times by one or more representatives of a bonded security company, or, alternatively, the medium security facility must have an electronic security system that prevents the entry of unauthorized persons into the facility and prevents animals outside the facility from having contact with ruminants in quarantine;
(2) If an electronic security system is used, the electronic security system must be coordinated through or with the local police so that monitoring of the facility is maintained whenever APHIS representatives are not at the facility. The electronic security system must be of the “silent type” and must be triggered to ring at the monitoring site and, if the operator chooses, at the facility. The operator must provide written instructions to the monitoring agency stating that the police and an APHIS representative designated by APHIS must be notified by the monitoring agency if the alarm is triggered. The operator also must submit a copy of those instructions to the Administrator. The operator must notify the designated APHIS representative whenever a break in security occurs or is suspected of occurring.
(4) Operating procedures. The following procedures must be followed at a privately owned medium or minimum security quarantine facility at all times:
(i) APHIS oversight. (A) The quarantine of ruminants at the facility will be subject to the strict oversight of APHIS representatives authorized to perform the services required by this subpart.
(B) If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in paragraph (d) of this section, or in accordance with animal health and husbandry standards provided elsewhere in this chapter, or fails to maintain and operate the facility as provided in paragraph (d) of this section, APHIS representatives are authorized to furnish such neglected services at the operator's expense, as authorized in paragraph (a) of this section.
(ii) Personnel. (A) The operator must provide adequate personnel to maintain the facility and care for the ruminants in quarantine, including attendants to care for and feed ruminants, and other personnel as needed to maintain, operate, and administer the facility.
(B) The operator must provide APHIS with an updated list of all personnel who have access to the facility. The list must include the names, current residential addresses, and identification numbers of each person, and must be updated with any changes or additions in advance of such person having access to the quarantine facility.
(C) The operator must provide APHIS with signed statements from all personnel having access to the facility in which the person agrees to comply with paragraph (d) of this section and applicable provisions of this part, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to quarantine operations, including contact with animals both inside and outside the facility.
(iii) Authorized access. (A) Access to the facility premises as well as inside the quarantine area will be granted only to APHIS representatives and other persons specifically authorized to work at the facility. All other persons are prohibited from the premises unless specifically granted access by an APHIS representative. Any visitors granted access must be accompanied at all times by an APHIS representative while on the premises.
(B) All visitors, except veterinary practitioners who enter the facility to provide emergency care, must sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 5 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.
(iv) Sanitary practices. (A) All persons granted access to the quarantine area must:
(1) Wear clean protective work clothing and footwear upon entering the quarantine area.
(2) Wear disposable gloves when handling sick animals and then wash hands after removing gloves.
(3) Change protective clothing, footwear, and gloves when they become soiled or contaminated.
(4) Be prohibited, if determined necessary by the overseeing APHIS representative, from having contact with any susceptible animals outside the facility for at least 5 days after the last contact with ruminants in quarantine, or for a longer period of time determined necessary by the overseeing APHIS representative to prevent the transmission of livestock diseases.
(B) All equipment (including tractors) must be cleaned and disinfected prior to being used in the quarantine area of the facility with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator. The equipment must remain dedicated to the facility for the entire quarantine period. Any equipment used with quarantined ruminants must remain dedicated to that particular lot of ruminants for the duration of the quarantine period or be cleaned and disinfected before coming in contact with ruminants from another lot. Prior to its use on another lot of ruminants or its removal from the quarantine area, such equipment must be cleaned and disinfected to the satisfaction of an APHIS representative.
(C) Any vehicle, before entering or leaving the quarantine area of the facility, must be immediately cleaned and disinfected under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.
(D) If the facility has a single loading dock, the loading dock must be immediately cleaned and disinfected after each use under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.
(E) That area of the facility in which a lot of ruminants had been held or had access must be thoroughly cleaned and disinfected under the oversight of an APHIS representative upon release of the ruminants, with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator, before a new lot of ruminants is placed in that area of the facility.
(F) For medium security facilities only, the following additional sanitary practices also must be followed:
(1) All persons granted access to the quarantine area, must:
(i) Shower when leaving the quarantine area.
(ii) Shower before entering a lot-holding area if previously exposed from access to another lot-holding area.
(iii) Shower when leaving the necropsy area if a necropsy is in the process of being performed or has just been completed, or if all or portions of the examined animal remain exposed.
(iv) Be prohibited, unless specifically allowed otherwise by the overseeing APHIS representative, from having contact with any ruminants in the facility, other than the lot or lots of ruminants to which the person is assigned or is granted access.
(2) The operator is responsible for providing a sufficient supply of clothing and footwear to ensure that workers and others provided access to the quarantine area of the facility have clean, protective clothing and footwear before entering the facility.
(3) The operator is responsible for the proper handling, washing, and disposal of soiled and contaminated clothing worn in the quarantine area in a manner approved by an APHIS representative as adequate to preclude the transmission of disease within and from the facility. At the end of each workday, work clothing worn into each lot-holding area and elsewhere in the quarantine area must be collected and kept in bags until the clothing is washed. Used footwear must either be left in the clothes changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected as directed by an APHIS representative.
(v) Handling of ruminants in quarantine. (A) Each lot of ruminants to be quarantined must be placed in the facility on an “all-in, all-out” basis. No ruminant may be taken out of a lot while the lot is in quarantine, except for diagnostic purposes, and no ruminant may be added to a lot while in quarantine.
(B) The facility must provide sufficient feed and bedding for the ruminants in quarantine, and it must be free of vermin and not spoiled. Feed and bedding must originate from a region that has been approved by APHIS as a source for feed and bedding.
(C) Breeding of ruminants or collection of germ plasm from ruminants is prohibited during the quarantine period unless necessary for a required import testing procedure.
(D) Ruminants in quarantine will be subjected to such tests and procedures as directed by an APHIS representative to determine whether the ruminants are free of communicable livestock diseases. While in quarantine, ruminants may be vaccinated only with vaccines that have been approved by the APHIS representative and licensed in accordance with § 102.5 of this chapter.
(E) Any death or suspected illness of ruminants in quarantine must be reported immediately to the overseeing APHIS representative. The affected ruminants must be disposed of as the Administrator may direct or, depending on the nature of the disease, must be cared for as directed by APHIS to prevent the spread of disease.
(F) Quarantined ruminants requiring specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. A second quarantine site must be established to house the ruminants at the facility of destination (e.g., veterinary college hospital). In such cases, APHIS may extend the quarantine period until the results of any outstanding tests or postmortems are received.
(G) Should the Administrator determine that an animal health emergency exists at the facility, arrangements for the final disposition of the infected or exposed lot of ruminants must be accomplished within 4 workdays following disease confirmation. Subsequent disposition of the ruminants must occur under the direct oversight of APHIS representatives.
(vi) Recordkeeping. (A) The operator must maintain a current daily log, to record the entry and exit of all persons entering and leaving the facility.
(B) The operator must retain the daily log, along with any logs kept by APHIS and deposited with the operator, for at least 2 years following the date of release of the ruminants from quarantine and must make such logs available to APHIS representatives upon request.
(5) Environmental quality. If APHIS determines that a privately owned medium or minimum security quarantine facility does not meet applicable local, State, or Federal environmental regulations, APHIS may deny or suspend approval of the facility until appropriate remedial measures have been applied.
(6) Other laws. A privately owned medium or minimum security quarantine facility must comply with other applicable Federal laws and regulations, as well as with all applicable State and local codes and regulations.
(7) Variances. The Administrator may grant variances to existing requirements relating to location, construction, and other design features of a privately owned medium security quarantine facility or minimum security quarantine facility as well as to sanitation, security, operating procedures, recordkeeping, and other provisions in paragraph (d) of this section, but only if the Administrator determines that the variance causes no detrimental impact to the health of the ruminants or to the overall biological security of the quarantine operations. The operator must submit a request for a variance to the Administrator in writing at least 30 days in advance of the arrival of the ruminants to the facility. Any variance also must be expressly provided for in the compliance agreement.
Visitors are not permitted in the quarantine enclosures during any time that ruminants are in quarantine unless the APHIS representative or inspector in charge specifically grants access under such conditions and restrictions as may be imposed by the APHIS representative or inspector in charge. An importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined ruminants at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the APHIS representative or the inspector in charge of the quarantine facility or station. On the last day of the quarantine period, owners, officers, or registry societies, and others having official business or whose services may be necessary in the removal of the ruminants may be admitted upon written permission from the APHIS representative or inspector in charge. No exhibition or sale shall be allowed within the quarantine grounds.
Milk or cream from ruminants quarantined under the provisions of this part shall not be used by any person other than those in charge of such ruminants, nor be fed to any animals other than those within the same enclosure, without permission of the APHIS representative or inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the ruminants producing same.
If any contagious disease appears among ruminants during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected ruminants shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) For ruminants intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, That an import permit is not required for ruminants offered for entry at a land border port designated in § 93.403(b) if such ruminant is:
(1) A wether;
(2) A sheep or goat imported for immediate slaughter; or
(3) A ruminant other than a sheep or goat and that ruminant:
(i) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or
(ii) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.
(b) For all ruminants offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a) Health certificates. Cattle intended for importation from Canada must be accompanied by a certificate issued in accordance with § 93.405(a). The certificate must state that the cattle have been inspected and were found to be free from any evidence of communicable disease and that, as far as can be determined, they have not been exposed to any such disease during the preceding 60 days. Cattle found unqualified upon inspection at the port of entry will be refused entry into the United States.
(b)-(c) [Reserved]
(d) Conditions for importation. In addition to meeting the other requirements of this section, bovines may be imported from Canada only under the following conditions:
(1) The bovines are imported for immediate slaughter under § 93.420; or
(2) The bovines are imported for other than immediate slaughter under the following conditions:
(i) The bovines were born after March 1, 1999, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Canada;
(ii) The bovines are imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f);
(iii) The bovines were officially identified prior to arriving at the port of entry in the United States with unique individual identification that is traceable to each bovine's premises of origin. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and
(iv) The bovines are permanently and humanely identified using one of the following additional methods:
(A) A “CΛN” mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be not less than 2 inches nor more than 3 inches high, and must be applied to each animal's right hip, high on the tail-head (over the junction of the sacral and first coccygeal vertebrae); or
(B) A tattoo with the letters “CΛN” applied to the inside of one ear of the animal; or
(C) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from Canada.
(3) The bovines are accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraph (d)(2) of this section, as applicable, have been met.
(a) General requirements. The requirements for the importation of sheep and goats from Canada for immediate slaughter are contained in § 93.435. There are no BSE-related restrictions on the importation of cervids or camelids from Canada. All other ruminants imported from Canada for immediate slaughter, in addition to meeting all other applicable requirements of this part, may be imported only under the following conditions:
(1) The ruminants must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f) and be inspected at the port of entry and otherwise handled in accordance with § 93.408.
(2) The ruminants must be moved directly from the port of entry to a recognized slaughtering establishment in conveyances that are sealed with seals of the U.S. Government at the port of entry. The seals may be broken only at the recognized slaughtering establishment by an authorized USDA representative.
(3) The ruminants must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33, which must include the location of the recognized slaughtering establishment.
(b) Bovines. In addition to meeting the requirements of paragraph (a) of this section, bovines may be imported from Canada for immediate slaughter only under the following conditions:
(1) The bovines must have been born after March 1, 1999, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Canada;
(2) Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from Canada must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and
(3) The bovines must be accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (b)(1) and (b)(2) of this section have been met.
(a) In-bond shipments from Canada. (1) Cattle, sheep, and goats from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.404 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.401. Ruminants not accompanied by a permit shall meet the requirements of this part in the same manner as ruminants destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.
(2) In-transit shipments through Canada. Ruminants originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the ruminants for entry into Canada shall be recorded on the United States health certificate, or a document containing information shall be included with the certificate that accompanies the ruminants. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the ruminants are the identical ruminants covered by said certificate.
(b) Exhibition ruminants. Ruminants from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That all ruminants offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical ruminants covered by said certificates or are the natural increase of such ruminants born after official test dates certified on the dam's health certificate.
(a) For ruminants intended for importation from regions of Central America or of the West Indies, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, That the Administrator, when he or she finds that such action may be taken without endangering the livestock or poultry industry of the United States, may, upon request by any person, authorize the importation by such person, without such application or permit, from the British Virgin Islands into the Virgin Islands of the United States, of ruminants consigned for immediate slaughter, and such authorization may be limited to a particular shipment or extend to all shipments under this paragraph by such person during a specified period of time. The importation of cattle from any area infested with cattle fever ticks is prohibited except as provided in paragraph (c) of § 93.423.
(b) For all ruminants offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a) In addition to all other applicable requirements of the regulations in this part, ruminants intended for importation from Central America and the West Indies, except as provided in paragraph (c) of this section, must be accompanied by a certificate issued in accordance with § 93.405(a) stating that the animals have been in that region at least 60 days immediately preceding the date of shipment to the United States; that he or she has inspected the ruminants on the premises of origin and found them free from evidence of any communicable disease; and that, as far as it has been possible to determine, the ruminants have not been exposed to any communicable disease during the preceding 60 days. If no such veterinary officer is available in the region of origin, ruminants, other than sheep and goats, may be accompanied by an affidavit of the owner or importer stating that such ruminants have been in the region from which they were directly shipped to the United States for a period of at least 60 days immediately preceding the date of shipment therefrom, and that during such period no communicable disease has existed among them or among animals of their kind with which they have come in contact. Ruminants for which such affidavit is presented, unless imported for immediate slaughter, shall be quarantined at the port of entry at least seven days and during that time shall be subjected to such dipping, blood tests or other tests, as may be required by the Administrator to determine their freedom from communicable diseases. If imported for immediate slaughter, such animals shall be handled as provided in § 93.420.
(b) The certificate accompanying sheep and goats intended for importation from Central America and the West Indies must, in addition to the statements required by paragraph (a) of this section, meet all of the requirements of § 93.405.
(c) Cattle, which have been infested with or exposed to fever ticks, may be imported from the British Virgin Islands into the United States Virgin Islands, for immediate slaughter, only, if they are free from fever ticks at the time of such importation; if they are entered through one of the ports designated in § 93.403(d) and are consigned to a recognized slaughtering establishment with facilities approved by the Administrator for holding the animals in isolation until slaughtered, which shall be within 14 days after the date of entry into the United States Virgin Islands; and if they are accompanied by a certificate of a responsible official of the government of the British Virgin Islands certifying that the cattle originated in and are being shipped directly from the British Virgin Islands, that they are free of fever ticks, and that, as far as it has been possible to determine, such cattle are free from evidence of communicable disease and have not been exposed to any such disease common to animals of their kind, other than bovine babesiosis, during the 60 days preceding their movement to the United States Virgin Islands.
(d) If ruminants are unaccompanied by the certificate or affidavit as required by paragraphs (a), (b), or (c) of this section, or if they are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry, except as provided in paragraph (c) of this section. Ruminants refused entry shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(e) In addition to meeting all other applicable requirements of this part, bovines from Central America and the West Indies may be imported only in accordance with § 93.436.
(a) For ruminants intended for importation from Mexico, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, that: An import permit is not required for sheep or goats imported for immediate slaughter if the animal is offered for entry at a land border port designated in § 93.403(c).
(b) For ruminants intended for importation into the United States from Mexico the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutual satisfactory arrangements for the orderly inspection of the animals. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the animals may be presented for import inspection.
For all ruminants offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a) All ruminants offered for entry from Mexico, including such ruminants intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such ruminants found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Ruminants found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry except as provided in § 93.427(b)(2). Ruminants refused entry shall be handled or quarantined or otherwise disposed of as the Administrator may direct.
(b) Ruminants covered by paragraph (a) of this section shall be imported through ports, designated in § 93.403, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.
(a) Cattle and other ruminants from Mexico. Cattle and other ruminants from Mexico, except animals being transported in bond for immediate return to Mexico or animals imported for immediate slaughter, may be detained at the port of entry, and there subjected to such disinfection, blood tests, other tests, and dipping as required in this part to determine their freedom from any communicable disease or infection of such disease. The importer shall be responsible for the care, feed, and handling of the animals during the period of detention. In addition, each steer or spayed heifer imported into the United States from Mexico shall be identified with a distinct, permanent, and legible “M” mark applied with a freeze brand, hot iron, or other method prior to arrival at a port of entry, unless the steer or spayed heifer is being transported in bond for immediate return to Mexico or imported for slaughter in accordance with § 93.429. The “M” mark shall be between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and shall be applied to each animal's right hip, within 4 inches (10 cm) of the midline of the tailhead (that is, the top of the brand should be within 4 inches (10 cm) of the midline of the tailhead, and placed above the hook and pin bones). The brand should also be within 18 inches (45.7 cm) of the anus.
(b)(1) Cattle from regions of Mexico that APHIS has determined to be free from fever ticks. APHIS has evaluated certain regions of Mexico in accordance with § 92.2 of this chapter, and determined that they are free from fever ticks; a list of all such regions is found on the internet at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. Regions may be removed from the list based on a determination by APHIS that fever ticks exist in the region, on the discovery of tick-infested cattle from the region at a port of entry into the United States, or on information provided by a representative of the government of that region that fever ticks exist in the region. Cattle from regions of Mexico that APHIS has determined to be free from fever ticks may be imported into the United States subject to the following conditions:
(i) The cattle are accompanied by a certificate issued in accordance with § 93.405 that states that the cattle originate from a region of Mexico that APHIS has determined to be free from fever ticks.
(ii) If the cattle will transit to the United States through an area of Mexico that APHIS has not determined to be free from fever ticks, they are moved in a sealed means of conveyance, and that seal remains intact throughout such transit.
(iii) The cattle are presented for entry into the United States at a land border port of entry listed in § 93.403(c).
(iv) The cattle are segregated at the U.S. port of entry from cattle from regions of Mexico that APHIS has not determined to be free from fever ticks.
(v) The importer, or his or her agent, executes and delivers to the inspector at the port of entry an application for inspection or supervised dipping. In this application, the importer, or his or her agent, waive all claims against the United States for any loss or damage to the cattle occasioned by or resulting from inspection or dipping or from the fact that the cattle are later found still to be tick infested, and for any loss or damage to any other cattle in the importer's possession or control that come in contact with the dipped cattle.
(vi) The cattle are either inspected by an APHIS inspector at the port of entry for evidence of tick infestation or are treated with a tickicidal dip that is listed in § 72.13 of this chapter under the supervision of an inspector at the port of entry.
(vii) If any cattle are determined to be infested with fever ticks, the lot of cattle is refused entry and may only be imported into the United States subject to the requirements in paragraph (b)(2) of this section.
(2) Cattle from regions of Mexico that APHIS has not determined to be free from fever ticks. Cattle from regions of Mexico that APHIS has not determined to be free from fever ticks may only be imported into the United States subject to the following conditions:
(i) The cattle have been inspected by a veterinarian in Mexico and, in the determination of the veterinarian, are free from fever ticks and all evidence of communicable diseases, and have not been exposed to communicable diseases, other than bovine babesiosis, during the 60 days prior to movement to a port of entry into the United States.
(ii) The cattle have been treated in Mexico with a tickicidal dip that is listed in § 72.13 of this chapter within 7 to 14 days before being offered for entry into the United States.
(iii) The cattle are accompanied by a certificate issued in accordance with § 93.405 that states that this inspection and dipping have occurred.
(iv) The cattle are presented for entry into the United States at the port of entry at Santa Teresa, NM, or a port of entry within Texas that is listed in § 93.403(c).
(v) The importer, or his or her agent, executes and delivers to the inspector at the port of entry an application for inspection and supervised dipping. In this application, the importer, or his or her agent, agrees to waive all claims against the United States for any loss or damage to the cattle occasioned by or resulting from this dipping or from the fact that the cattle are later found to still be infested with ticks, and for any loss or damage to any other cattle in the importer's possession or control that come in contact with the dipped cattle.
(vi) When offered for entry, the cattle receive an inspection by an inspector. If free from fever ticks, the cattle are treated once with a tickicidal dip that is listed in § 72.13 of this chapter 7 to 14 days after the dipping required in paragraph (b)(2)(ii) of this section. If found to be infested with fever ticks, the cattle are refused entry and may not be inspected again at a port of entry until they are again dipped and 7 to 14 days have elapsed.
(vii) The cattle are not imported into an area of Texas that is quarantined in accordance with § 72.5 of this chapter for bovine babesiosis, or for tick infestation.
(c) Importation of Holsteins from Mexico. The importation of Holstein steers, Holstein spayed heifers, Holstein cross steers, and Holstein cross spayed heifers from Mexico is prohibited.
(d) [Reserved]
(e) BSE. In addition to meeting the requirements of this section and all other applicable requirements of this part, bovines may be imported from Mexico only under the following conditions:
(1) The bovines were born after November 30, 2007, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Mexico.
(2) The bovines were officially identified prior to arriving at the port of entry in the United States with unique individual identification that is traceable to each bovine's premises of origin. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter.
(3) The bovines, if sexually intact, are permanently and humanely identified using one of the following additional methods:
(i) An “M” mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and must be applied to the upper right front shoulder of each animal; or
(ii) A tattoo with the letters “MX” applied to the inside of one ear of the animal; or
(iii) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from Mexico.
(4) The bovines are accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (e)(1) through (e)(3) of this section have been met.
(b) * * *
(2) Cattle that have been exposed to splenetic, southern, or tick fever, or that have been infested with or exposed to fever ticks, may be imported from Mexico for admission into the United States, except into areas of Texas quarantined because of said disease or tick infestation as specified in § 72.5 of this chapter, at one of the land border ports in Texas listed in § 93.403(c), the port of Santa Teresa, NM, or the port of San Luis, AZ, provided that the following conditions are strictly observed and complied with:
(a) Sheep, goats, and native wild ruminants intended for import from Mexico must be imported in accordance with § 93.435, and shall be accompanied by a certificate issued in accordance with § 93.405 and stating, if such sheep and goats are shipped by rail or truck, that such animals were loaded into cleaned and disinfected cars or trucks for transportation direct to the port of entry. Notwithstanding such certificate, such sheep and goats shall be detained as provided in § 93.427(a) and shall be dipped at least once in a permitted scabies dip under supervision of an inspector.
(b) The certificate accompanying goats offered for importation from Mexico shall, in addition to the statements required by paragraph (a) of this section, state that such goats have been tested for tuberculosis and brucellosis with negative results within 30 days preceding their being offered for entry, and give the date and method of testing, the name of the consignor and of the consignee, and a description of the animals including breed, ages, markings, and tattoo and eartag numbers. Notwithstanding such certification, such goats shall be detained or quarantined as provided in § 93.427 and retested for brucellosis.
(c) If sheep or goats are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if they are found upon inspection or retesting, as provided for in this part, to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(d) Certificates will not be required for wild ruminants, other than sheep and goats, originating in and shipped direct from Mexico, but such animals are subject to inspection at the port of entry as provided in § 93.426.
Ruminants, other than sheep and goats, may be imported from Mexico, subject to the applicable provisions of §§ 93.424, 93.425, 93.426, and 93.427(b)(2) for immediate slaughter if accompanied by a certificate issued in accordance with § 93.405(a) and stating that the veterinarian who issued the certificate has inspected the animals in the herd from which the ruminants will be imported and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the ruminants are shipped by rail or truck, the certificate shall further specify that the ruminants were loaded into cleaned and disinfected cars or trucks for transportation directly to the port of entry. Such ruminants shall be moved from the port of entry in conveyances sealed with seals of the United States Government. Sheep and goats from any part of Mexico may be imported only in compliance with other applicable sections in this part.
(a) General provisions. (1) Sheep and goats imported from anywhere in the world shall be accompanied by a certificate issued in accordance with § 93.405. If the sheep or goats are not accompanied by the certificate, or if they are found upon inspection at the port of entry to be affected with or exposed to a communicable disease, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of, as the Administrator may direct.
(2) All imported sheep and goats must be officially identified at the time of presentation for entry into the United States with official identification devices or methods and which will allow the animals not imported for immediate slaughter or for feeding for slaughter to be traced at any time to the farm or premises of birth, and for animals imported for immediate slaughter or for feeding for slaughter to the flock of residence. Official identification devices may not be removed or altered at any time after entry into the United States, except by an authorized USDA representative at the time of slaughter. A list of the acceptable types of official identification devices or methods may be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/imports/live-animal-imports.
(3) All imported sheep and goats other than for immediate slaughter or as provided in paragraph (c) of this section for restricted feeding for slaughter must be identified at the time of presentation for entry into the United States with a country mark using a means and in a location on the animal approved by the Administrator for this use. A list of the acceptable country marks may be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/imports/live-animal-imports.
(4) Except as provided in paragraph (b) of this section for sheep or goats imported for immediate slaughter, and in paragraph (c) of this section for sheep or goats for restricted feeding for slaughter, the importer shall maintain records of the sale, death or other disposition of all imported animals including the official identification number(s) and country marks on the animals at the time of import; a record of the replacement of any lost identification devices linking the new official identification number to the lost device number; the date and manner of disposition; and the name and address of the new owner. Such records must be maintained for a period of 5 years after the sale or death of the animal. The records must be available for APHIS to view and copy during normal business hours.
(b) Sheep and goats imported for immediate slaughter from anywhere in the world. (1) Sheep and goats for immediate slaughter may only be imported into the United States from countries or regions determined to be free of classical scrapie by APHIS, or that have scrapie awareness, surveillance, and control programs evaluated and determined by APHIS to be effective.
(2) Sheep and goats imported for immediate slaughter must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f) and be inspected at the port of entry and otherwise handled in accordance with § 93.408.
(3) The ruminants must be moved directly from the port of entry to a recognized slaughtering establishment in conveyances that are sealed with seals of the U.S. Government at the port of entry. The seals may be broken only at the recognized slaughtering establishment by an authorized USDA representative.
(4) The shipment must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33.
(c) Sheep and goats imported for restricted feeding for slaughter. (1) Sheep and goats for restricted feeding for slaughter purposes may only be imported into the United States from countries or regions determined to be free of classical scrapie by APHIS, or that have scrapie awareness, surveillance, and control programs evaluated and determined by APHIS to be effective.
(2) The sheep and goats must be imported only through a port of entry allowed in § 93.403 in a means of conveyance sealed in the region of origin with seals of the national government of the region of origin. The seals may be broken either by an APHIS representative at the port of entry, or at the designated feedlot by an authorized APHIS representative. If the seals are broken by an APHIS representative, the means of conveyance must be resealed with seals of the U.S. Government before being moved to the designated feedlot; and
(3) The sheep and goats shall be inspected by the port veterinarian or other designated representative at the port of entry to determine that the animals are free from evidence of communicable disease and are considered fit for further travel; and
(4) The sheep and goats must be moved directly as a group from the port of entry to a designated feedlot; and
(5) The sheep and goats may not be commingled with any sheep or goats that are not being moved directly to slaughter from the designated feedlot; and
(6) The sheep and goats may be moved from the port of entry only to a feedlot designated in accordance with paragraph (c)(11) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation stipulated in the import permit; and
(7) Upon arrival at the designated feedlot, the official identification for each animal must be reconciled by an APHIS veterinarian, or other official designated by APHIS, with the accompanying documentation; and
(8) The sheep and goats must remain at the designated feedlot until transported to a recognized slaughtering establishment. The sheep and goats must be moved directly to the recognized slaughtering establishment in a means of conveyance sealed by an accredited veterinarian, a State representative, or an APHIS representative with seals of the U.S. Government. The seals must be broken at the recognized slaughtering establishment only by an authorized USDA representative; and
(9) The sheep and goats must be accompanied to the recognized slaughtering establishments by APHIS Form VS 1-27 or other documentation stipulated in the import permits; and
(10) The sheep and goats must be slaughtered within 12 months of importation.
(11) To be eligible as a designated feedlot to receive sheep and goats imported for feeding, a feedlot must be approved by APHIS. To be approved by APHIS, the feedlot operator or his or her agent must enter into a compliance agreement with the Administrator. The compliance agreement must provide that the operator:
(i) Will monitor all imported feeder animals to ensure that they have the required official identification at the time of arrival to the feedlot; and will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records. Any lost official identification will be replaced with eartags provided by APHIS for purposes of this paragraph (c)(11)(i) and will be linked as the new official identification with the lost identification. If more than one animal loses their official identification at the same time, the new official identification will be linked with all possible original identification numbers;
(ii) Will monitor all incoming imported feeder animals to ensure they have the required country mark, or will maintain all imported animals in separate pens from U.S. origin animals, and all sheep and goats that enter the feedlot are moved only for slaughter;
(iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feedlot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For imported animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass;
(iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 or other movement documentation deemed acceptable by the Administrator that have been issued for incoming animals and for animals moved to slaughter and that list the official identification of each animal;
(v) Will allow State and Federal animal health officials access to inspect its premises and animals and to review inventory records and other required files upon request;
(vi) Will keep required records for at least 5 years;
(vii) Will designate either the entire feedlot or pens within the feedlot as terminal for sheep and goats to be moved only directly to slaughter;
(viii) Will prevent fence-line contact with sheep or goats outside the designated feedlot;
(ix) Agrees that if inventory cannot be reconciled or if animals are not moved to slaughter as required, the approval of the feedlot to receive additional animals will be immediately withdrawn and any imported animals remaining in the feedlot will be disposed of as directed by the Administrator;
(x) Agrees that if an imported animal gives birth in the feedlot, the offspring will be humanely euthanized and the birth tissues and soiled bedding disposed of in a sanitary landfill or by another means approved by the Administrator; and
(xi) Agrees to maintain sexually intact animals of different genders over 5 months of age in separate enclosures.
(xii) For a feedlot to be approved to receive sheep or goats imported for feeding under this section, but which do not have a country mark, the compliance agreement must also provide that the feedlot will maintain all imported animals in separate pens from U.S. origin animals and that all sheep and goats that enter the feedlot are moved only for slaughter.
(d) Other importations. Sheep or goats imported other than as provided in paragraph (b) of this section for immediate slaughter or as provided in paragraph (c) of this section for sheep and goats imported for restricted feeding for slaughter must originate from a region recognized as free of classical scrapie by APHIS or from a flock that has certified status or equivalent status in a scrapie flock certification program or equivalent program approved by APHIS, or as provided in § 93.404(a)(5) or (6).
(e) Sheep and goats transiting the United States. Sheep or goats that meet the entry requirements for immediate slaughter in § 93.405 may transit the United States in accordance with § 93.401 regardless of their intended use in the receiving country.
(f) Classical scrapie status of foreign regions. APHIS considers classical scrapie to exist in all regions of the world except those declared free of this disease by APHIS.
(1) A list of regions that APHIS has declared free of classical scrapie is maintained on the APHIS website at https://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. Copies of the list are also available via postal mail, fax, or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
(2) APHIS will add a region to the list in paragraph (f)(1) only after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding classical scrapie is not likely to be present in its sheep or goat populations. In the case of a formerly listed region removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical scrapie upon determining classical scrapie exists there based on reports APHIS receives of outbreaks of the disease in sheep or goats from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), from other sources the Administrator determines to be reliable, or upon determining that the region's animal health infrastructure, regulations, or policy no longer qualifies the region for such status.
The importation of bovines is prohibited, unless the conditions of this section and any other applicable conditions of this part are met. Once the bovines are imported, if they do not meet the conditions of this section, they must be disposed of as the Administrator may direct.
(a) Bovines from a region of negligible risk for BSE in which there has been no indigenous case of BSE. Bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, in which there has been no indigenous case of BSE, may be imported only if the bovines are accompanied by an original certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, and the certificate attests that the exporting region of the bovines is classified by APHIS as a negligible-risk region for BSE in which there has been no indigenous case of BSE.
(b) Bovines from a region of negligible risk for BSE in which there has been an indigenous case of BSE and bovines from a region of controlled risk for BSE. Bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, in which there has been an indigenous case of BSE, and bovines from a region of controlled risk for BSE, as defined in § 92.1 of this subchapter, may be imported only under the following conditions:
(1) Prior to importation into the United States, each bovine is officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter.
(2) The bovines are permanently and humanely identified before arrival at the port of entry with a distinct and legible mark identifying the exporting country. Acceptable means of permanent identification include the following:
(i) A mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be not less than 2 inches nor more than 3 inches high, and must be applied to each animal's right hip, high on the tail-head (over the junction of the sacral and first coccygeal vertebrae);
(ii) A tattoo with letters identifying the exporting country must be applied to the inside of one ear of the animal; or
(iii) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from a region of negligible risk for BSE in which there has been an indigenous case of BSE or from a region of controlled risk for BSE.
(3) The bovines were born after the date from which the ban on the feeding of ruminants meat-and-bone meal or greaves derived from ruminants has been effectively enforced.
(4) The bovines are accompanied by an original certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, and the certificate attests to the BSE risk classification of the exporting region and that the conditions of paragraphs (b)(1) through (b)(3) of this section have been met.
(5) If there has been an indigenous case of BSE in the exporting region, the following restrictions apply:
(i) Bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that an investigation showed consumed the same potentially contaminated feed as the infected animal during that period are not eligible for importation into the United States; and
(ii) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal are not eligible for importation into the United States.
(c) Bovines from a region of undetermined risk for BSE. Importation of bovines from a region of undetermined risk for BSE, as defined in § 92.1 of this subchapter, is prohibited; Except that: The Administrator may allow such imports on a case-by-case basis if the live bovines are imported for specific uses, including, but not limited to, show or exhibition, and under conditions determined by the Administrator to be adequate to prevent the spread of BSE.
(a) Level I regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds of less than 0.001 percent over at least the previous 2 years (24 consecutive months).
(b) Level II regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.001 percent, but less than 0.01 percent, over the previous 2 years (24 consecutive months).
(c) Level III regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.01 percent, but less than 0.1 percent, over the previous year (12 consecutive months).
(d) Level IV regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.1 percent, but less than 0.5 percent, over the previous year (12 consecutive months).
(e) Level V regions. APHIS considers certain regions of the world not to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, to have a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.5 percent, or to be unassessed by APHIS with regard to tuberculosis.
(f) Listing of regions. Lists of all Level I regions, Level II regions, Level III regions, Level IV regions, and Level V regions for tuberculosis are found online, at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to the lists will be made in accordance with § 93.438.
(a) Request for regional classification; requirements. A representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS classify a region for tuberculosis. Requests for classification or reclassification must be submitted to APHIS electronically or through the mail as provided at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to complete a request in a manner that will allow APHIS to review it expeditiously is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by contacting the National Director, Regionalization Evaluation Services, Strategy and Policy Unit, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, in order for APHIS to consider the request complete, it must define the boundaries of the region, specify the prevalence level for tuberculosis within the region, and demonstrate the following:
(1) That there is effective veterinary control and oversight within the region;
(2) That tuberculosis is a notifiable disease within the region; and
(3) That the region has a program in place for tuberculosis that includes, at a minimum:
(i) Epidemiological investigations following the discovery of any infected animals or affected herds, or any animals or herds that have had non-negative test results following a test for tuberculosis, and documentation of these investigations;
(ii) Management of affected herds in a manner designed to eradicate tuberculosis from those herds in a timely manner, and documentation regarding this management;
(iii) Regulatory controls on the movement of livestock into, within, and from the region that correspond to the risk of dissemination of tuberculosis associated with such movement; and
(iv) Access to, oversight of, and quality controls for diagnostic testing for tuberculosis within the region.
(4) That the region has surveillance in place that is equivalent to or exceeds Federal standards for surveillance within the United States.
(b) APHIS evaluation. If, after reviewing and evaluating the request for classification, APHIS believes the region can be accurately classified for tuberculosis, APHIS will publish a notice in the
(c) APHIS determination. (1) If no comments are received on the notice, or if comments are received but do not affect APHIS' proposed classification, APHIS will publish a subsequent notice in the
(2) If comments received on the notice suggest that the region be classified according to a different tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the
(3) If comments received on the notice suggest that insufficient information was supplied on which to base a tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the
(d) Maintaining classification and reclassification initiated by APHIS. If a region is classified under the provisions of this section, that region may be required to submit additional information or allow APHIS to conduct additional information collection activities in order for that region to maintain its classification. Moreover, if APHIS determines that a region's classification for tuberculosis is no longer accurate, APHIS will publish a notice in the
(a) Importation of certain ruminants prohibited. Notwithstanding any other provisions of this section, ruminants that are known to be infected with or exposed to tuberculosis and ruminants that have had a non-negative response to any test for tuberculosis at any time are prohibited importation into the United States.
(b) Identification of bovines imported for any purpose. Unless otherwise specified by the Administrator, bovines imported into the United States for any purpose must be officially identified and accompanied by a certificate, issued in accordance with § 93.405(a), that lists the official identification of the animals presented for import.
(c) Importation of bovines from a Level I region. Unless specified otherwise by the Administrator, bovines may be imported into the United States from a Level I region for tuberculosis in accordance with paragraph (b) of this section.
(d) Importation of bovines from a Level II region. (1) Sexually intact bovines may be imported into the United States from a Level II region for tuberculosis for purposes other than immediate slaughter provided that the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results.
(2) Steers or spayed heifers may be imported into the United States from a Level II region for tuberculosis for purposes other than immediate slaughter in accordance with paragraph (b) of this section.
(e) Importation of bovines from a Level III region. (1) Bovines directly from currently accredited herds for tuberculosis. Bovines may be imported into the United States for purposes other than immediate slaughter directly from a currently accredited herd for tuberculosis in a Level III region for tuberculosis, provided that:
(i) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for tuberculosis; and
(ii) If sexually intact, the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results.
(2) Sexually intact bovines that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level III region for tuberculosis for purposes other than immediate slaughter, provided that:
(i) The bovines originate from a herd that was subjected to a whole herd test for tuberculosis on its premises of origin no more than 1 year prior to the export of the bovines to the United States, with negative results; and
(ii) The bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the animals meet the conditions for importation in paragraph (e)(2)(i) of this section.
(3) Steers or spayed heifers that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level III region for tuberculosis for purposes other than immediate slaughter provided that:
(i) The steers or spayed heifers are subjected to an individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results; and
(ii) The steers or spayed heifers are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the animals meet the conditions for importation in paragraph (e)(3)(i) of this section.
(f) Importation of bovines from a Level IV region. (1) Bovines may be imported into the United States for purposes other than immediate slaughter directly from a currently accredited herd for tuberculosis in a Level IV region for tuberculosis, provided that:
(i) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for tuberculosis and, if steers or spayed heifers, meet the conditions for importation in paragraph (f)(1)(iii) of this section; and
(ii) If sexually intact, the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(iii) If steers and spayed heifers, the bovines are subjected to an individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results.
(2) Sexually intact bovines that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level IV region for tuberculosis for purposes other than immediate slaughter, provided that:
(i) The bovines originate from a herd that was subjected to two whole herd tests for tuberculosis on its premises of origin and conducted no less than 9 months and no more than 15 months apart, with the second whole herd test conducted no less than 60 days and no more than 12 months prior the export of the bovines to the United States, with negative results each time; and
(ii) The bovines are subjected to an additional individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (f)(2)(i) of this section.
(3) Steers or spayed heifers that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level IV region for tuberculosis for purposes other than immediate slaughter provided that:
(i) The bovines originate from a herd that was subjected to a whole herd test for tuberculosis on its premises of origin no more than 1 year prior to the export of the bovines, with negative results; and
(ii) The bovines are subjected to an additional individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results, except that the individual test is not required if the bovines are exported within 60 days of the whole herd test and were included in that test; and
(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in this paragraph (f)(3).
(g) Importation of bovines from a Level V region. At the discretion of the Administrator, bovines may be imported into the United States from a Level V region for tuberculosis for purposes other than immediate slaughter, provided that:
(1) The bovines are subject to a pre-clearance program administered by APHIS and detailed in an import protocol published on the APHIS website; and
(2) The bovines are subjected to an additional individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(3) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that bovines meet the requirements in paragraphs (g)(1) and (2) of this section.
(a) Level I regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, and a prevalence of brucellosis in their domestic bovine herds of less than 0.001 percent over at least the previous 2 years (24 consecutive months).
(b) Level II regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, and a prevalence of brucellosis in their domestic bovine herds equal to or greater than 0.001 percent, but less than 0.01 percent over at least the previous 2 years (24 consecutive months).
(c) Level III regions. APHIS considers certain regions of the world not to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, to have a herd prevalence equal to or greater than 0.01 percent, or to be unassessed by APHIS with regard to brucellosis prevalence.
(d) Listing of regions. Lists of all Level I, Level II, and Level III regions for brucellosis are found online, at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to the lists will be made in accordance with § 93.441.
(a) Request for regional classification; requirements. A representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS classify a region for brucellosis. Requests for classification or reclassification must be submitted to APHIS electronically or through the mail as provided at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to complete a request in a manner that will allow APHIS to review it expeditiously is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by contacting the National Director, Regionalization Evaluation Services, Strategy and Policy Unit, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, in order for APHIS to consider the request complete, it must define the boundaries of the region, specify the prevalence level for brucellosis within the region, and demonstrate the following:
(1) That there is effective veterinary control and oversight within the region;
(2) That brucellosis is a notifiable disease within the region;
(3) That the region has a program for brucellosis in place that includes, at a minimum:
(i) Epidemiological investigations following the discovery of any infected animals or affected herds, or any animals or herds that have had non-negative test results following a test for brucellosis, and documentation of these investigations;
(ii) Management of affected herds in a manner designed to eradicate brucellosis from those herds, and documentation regarding this management;
(iii) Regulatory controls on the movement of livestock into, within, and from the region that correspond to the risk of dissemination of brucellosis associated with such movement; and
(iv) Access to, oversight of, and quality controls on diagnostic testing for brucellosis within the region;
(4) That the region has surveillance in place that is equivalent to or exceeds Federal standards for brucellosis surveillance within the United States; and
(5) That, if the region vaccinates for brucellosis, it is in a manner that has been approved by APHIS.
(b) APHIS evaluation. If, after reviewing and evaluating the request for classification, APHIS believes the region can be accurately classified for brucellosis, APHIS will publish a notice in the
(c) APHIS determination. (1) If no comments are received on the notice, or if comments are received but do not affect APHIS' proposed classification, APHIS will publish a subsequent notice in the
(2) If comments received on the notice suggest that the region be classified according to a different brucellosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the
(3) If comments received on the notice suggest that insufficient information was supplied on which to base a brucellosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the
(d) Maintaining classification and reclassification initiated by APHIS. If a region is classified under the provisions of this section, that region may be required to submit additional information or allow APHIS to conduct additional information collection activities in order for that region to maintain its classification. Moreover, if APHIS determines that a region's classification for brucellosis is no longer accurate, APHIS will publish a notice in the
(a) Importation of certain ruminants prohibited. Notwithstanding any other provisions of this section, ruminants that are known to be infected with or exposed to brucellosis are prohibited importation into the United States.
(b) Identification of bovines imported for any purpose. Unless otherwise specified by the Administrator, bovines imported into the United States for any purpose must be officially identified and accompanied by a certificate, issued in accordance with § 93.405(a), that lists the official identification of the animals presented for import.
(c) Importation of steers and spayed heifers. Unless otherwise specified by the Administrator, steers and spayed heifers may be imported into the United States from a region in accordance with paragraph (b) of this section, without further restrictions under this part.
(d) Importation of sexually intact bovines from Level I regions. Unless specified otherwise by the Administrator, sexually intact bovines may be imported into the United States from a Level I region for brucellosis in accordance with paragraph (b) of this section.
(e) Importation of sexually intact bovines from a Level II region. (1) Sexually intact bovines directly from currently accredited herds for brucellosis. Sexually intact bovines may be imported into the United States for purposes other than immediate slaughter from a currently accredited herd for brucellosis in a Level II region for brucellosis, provided that the bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for brucellosis.
(2) Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis. Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis may be imported into the United States from a Level II region for brucellosis for purposes other than immediate slaughter, provided that:
(i) The bovines originate from a herd that was subjected to a whole herd test for brucellosis on its premises of origin no more than 90 days and no less than 30 days prior to the export of the bovines to the United States, with negative results; and
(ii) The bovines are subjected to an additional individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (d)(2)(i) of this section.
(f) Importation of sexually intact bovines from a Level III region. (1) Sexually intact bovines directly from currently accredited herds for brucellosis. Sexually intact bovines may be imported into the United States for purposes other than immediate slaughter from a currently accredited herd for brucellosis in a Level III region for brucellosis, provided that:
(i) The bovines are subjected to an individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(ii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for brucellosis.
(2) Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis. Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis may be imported into the United States from a Level III region for brucellosis for purposes other than immediate slaughter, provided that:
(i) The bovines originate from a herd that was subjected to two whole herd tests for brucellosis on its premises of origin conducted no less than 9 months and no more than 15 months apart, with the second test taking place no more than 90 days and no less than 30 days prior to the export of the bovines to the United States, with negative results each time; and
(ii) The bovines are subjected to an additional individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and
(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (e)(2)(i) of this section.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.
APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Department. The United States Department of Agriculture (USDA).
Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority.
Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Recognized slaughtering establishment.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Swine. The domestic hog and all varieties of wild hogs.
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
Veterinary Services. The Veterinary Services unit of the Department.
Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.
(a) No swine or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) Except for swine prohibited entry, the provisions in this part 93 relating to swine shall not apply to healthy swine in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such swine, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a swine holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the swine will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of swine carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of swine in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c) Removal and loss of official identification devices. Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices is prohibited except at the time of slaughter. If an official identification device is lost and it is necessary to retag an animal with a new official number, every effort should be made to correlate the new official number with the previous official number of the animal.
(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.
(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all swine shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d), (e), and (f) of this section: Los Angeles, California; Miami, Florida; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of swine from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.
(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of swine from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, and Columbus, New Mexico.
(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted, St. Croix, in the United States Virgin Islands, are hereby designated as quarantine stations for the entry of swine from the British Virgin Islands into the United States Virgin Islands for immediate slaughter.
(e) Limited ports. The following ports are designated as having inspection facilities for the entry of swine and swine products such as swine test specimens which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no live animals); Galveston and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.
(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(a) Application for permit; reservation required. (1) For swine and swine test specimens for diagnostic screening purposes, intended for importation from any part of the world, except as otherwise provided for in §§ 93.516 and 93.520, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of swine or swine test specimens to be imported; the purpose of the importation; individual swine identification which includes a description of the swine, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the swine or swine test specimens to be imported; and the name of the person to whom the swine or swine test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the swine are susceptible, as well as vaccinations or other precautionary treatments to which the swine or swine test specimens have been subjected. Notice of any such requirements will be given to the applicant in each case.
(2) An application for permit to import will be denied for domestic swine from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.
(3) An application for permit to import swine may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the swine; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(4)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of swine to be quarantined in a facility maintained by USDA. For swine the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the swine are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival the lot of swine for which the reservation was made: Except that a reservation fee shall not be forfeited if:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the swine within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantined.)
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(4)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(4)(iv)(A) of this section and the provisions of paragraph (a)(4)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Swine and swine test specimens for diagnostic screening purposes for swine intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Swine and swine test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the swine or swine test specimens offered for entry differ from those described in the permit; if the swine or swine test specimens are not handled as outlined in the application for the permit and as specified in the permit issued; or if ruminants or swine other than those covered by import permits are aboard the transporting carrier.
(c) Wild swine from regions where foot-and-mouth disease exists. This paragraph (c) applies to the importation of wild swine from countries designated in part 94 of this subchapter as regions in which foot-and-mouth disease exists.
(1) Permits for the importation of wild swine will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:
(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild swine; and
(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild swine.
(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported swine can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead swine within the PEQ Zoo; and other reasonable facilities considered necessary to prevent the dissemination of diseases from the PEQ Zoo. The operator of the PEQ Zoo shall have available the services of a full-time or part-time veterinarian, or a veterinarian on a retainer basis, who shall make periodic examinations of all animals maintained at the PEQ Zoo for evidence of disease; who shall make a post-mortem examination of each animal that dies; and who shall make a prompt report of suspected cases of contagious or communicable diseases to appropriate state or federal livestock sanitary officials.
(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild swine enters the zoo. If an APHIS veterinarian determines that an imported swine shows no signs of any communicable disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that the swine does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the swine's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.
(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported swine are to be consigned, and the importer of the swine, if such operator and importer are different parties, shall execute an agreement covering each swine or group of swine for which the import permit is requested. The agreement shall be in the following form:
________, operator(s) of the zoological park known as ____________ (Name) located at ______________ (City and state), and ____________ (Importer) hereby request a permit for the importation of ________ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.
2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in this region. If shipment is made by ocean vessel, the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.
4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.
6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the receiving zoological park is accredited by the American Zoo and Aquarium Association (AZA), or the receiving zoological park has facilities and procedures in place related to preventing the spread of communicable animal diseases (including but not limited to procedures for animal identification, record keeping, and veterinary care) that are equivalent to those required for AZA accreditation. The Administrator will approve the movement of a carcass, body part, or biological specimen derived from an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the carcass, body part, or biological specimen will be moved only for scientific research or museum display purposes.
Subscribed and sworn to before me this ____ day of ____, ____
Subscribed and sworn to before me this ____ day of ____,____
(a) All swine offered for importation from any part of the world except as provided in § 93.517 shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that such swine have been kept in said region at least 60 days immediately preceding the date of movement therefrom and that said region during such period has been entirely free from foot-and-mouth disease, contagious pleuropneumonia, and surra: Provided, however, That certificates for wild swine for exhibition purposes need specify freedom from the said diseases of the district of origin only: And provided further, That in the case of swine the certificate, as far as it relates to contagious pleuropneumonia, may specify freedom from such disease of the district of origin only. For domestic swine, the certificate shall also show that the entire region of origin is free of African swine fever and swine vesicular disease and that, for 60 days immediately preceding the time of movement from the premises of origin, no swine erysipelas or swine plague has existed on such premises or on adjoining premises. Additionally, except for the APHIS-defined European CSF region, as defined in § 94.0 of this subchapter, for which additional certification is required under § 94.31(b)(6), for domestic swine the certificate shall show that the entire region of origin is free of classical swine fever.
(b) Swine from any region where screwworm is considered to exist may only be imported into the United States if they meet the requirements of paragraphs (b)(1) through (4) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(1) A veterinarian must treat the swine with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(2) The swine must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If swine are found to be infested with screwworm, they must be treated until free from infestation.
(3) At the time swine are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(4) The swine must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the swine have been thoroughly examined and found free of screwworm and that the swine have been treated in accordance with paragraphs (b)(1) and (b)(3) of this section.
(c) If swine are unaccompanied by the certificate as required by paragraph (a) of this section, or if such swine are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of swine at such port, for the use of the veterinary inspector at the port of entry.
(b) For all swine offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the swine, the number, breed, species, and purpose of the importation, the name of the person to whom the swine will be delivered, and the location of the place to which such delivery will be made.
(c) Any declaration, permit, or other document for swine required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.
Inspection shall be made at the port of entry of all swine imported from any part of the world except as provided in § 93.519. All swine found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other swine shall be refused entry. Swine refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such swine or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about swine governed by the regulations in this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
Platforms and chutes used for handling imported swine shall be cleaned and disinfected under APHIS supervision after being so used. The said swine shall not be unnecessarily moved over any highways nor allowed to come in contact with other swine, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of swine or their fresh products. When movement of the aforesaid swine upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.
Swine shall be quarantined for not less than 15 days, counting from the date of arrival at the port of entry. During their quarantine, wild swine shall be subject to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator, to determine their freedom from disease and the infection of disease.
(a) Privately operated quarantine facilities. The importer, or his or her agent, of swine subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the swine from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such swine and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by swine should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of swine, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the swine may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator, may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of swine shall be made by certified check or U.S. money order prior to release of the swine. If such payment is not made, the swine may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.
(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of swine subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the swine from the time they arrive at the quarantine facility, and for the care, feed, and handling of the swine from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of swine shall be made by certified check or U.S. money order prior to release of the swine. If such payment is not made, the swine may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the swine are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the swine will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the swine and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors shall not be admitted to the quarantine enclosure during any time that swine are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined swine at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the swine may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.
Milk or cream from swine quarantined under the provisions of this part shall not be used by any person other than those in charge of such swine, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the swine producing same.
If any contagious disease appears among swine during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected swine shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) For swine intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.504: Provided, That an import permit is not required for swine offered for entry at a land border port designated in § 93.503(b) if such swine:
(1) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or
(2) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.
(b) For all swine offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
(a) For purposes other than immediate slaughter. Swine offered for importation from Canada for purposes other than immediate slaughter shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government showing that said swine have been inspected on the premises of origin immediately before the date of movement therefrom and found to be free of evidence of communicable disease and that, as far as it has been possible to determine, they were not exposed to any such disease during the preceding 60 days; in addition, the certificate shall show that no classical swine fever or swine plague has existed on the premises of origin or on adjoining premises for such 60 days.
(b) For immediate slaughter. Swine for immediate slaughter may be imported from Canada without certification as prescribed in paragraph (a) of this section but shall be subject to the provisions of §§ 93.507, 93.516, and 93.518.
Swine imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. As used in this section, “directly” means without unloading en route if moved in a means of conveyance, or without stopping if moved in any other manner.
(a) In-bond shipments from Canada. (1) Swine from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.504 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.501. Swine not accompanied by a permit shall meet the requirements of this part in the same manner as swine destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.
(2) In-transit shipments through Canada. Swine originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the swine for entry into Canada shall be recorded on the United States health certificate, or a document containing the information shall be included with the certificate that accompanies the swine. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the swine are the identical swine covered by said certificate.
(b) Exhibition swine. Swine from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in Part 91 of this chapter for entry into Canada: Provided, That all swine offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical swine covered by said certificates or are the natural increase of such swine born after official test dates certified on the dam's health certificate.
For all swine offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
For all swine offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
(a) All dogs. Dogs from any region of the world where screwworm is considered to exist may only be imported into the United States if they meet the requirements of paragraphs (a)(1) and (2) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(1) Dogs must be accompanied by a certificate signed by a full-time salaried veterinary official of the region of origin stating that the dog has been inspected for screwworm within 5 days preceding its shipment to the United States.
(2) The certificate must state that the dog is either free from screwworm or was found to be infested with screwworm and was held in quarantine and treated until free from screwworm prior to leaving the region of origin.
(b) Dogs for handling livestock. Collie, Shepherd, and other dogs that are imported from any part of the world except Canada, Mexico, and regions of Central America and the West Indies and that are to be used in the handling of sheep or other livestock must be inspected and quarantined at the port of entry for a sufficient time to determine their freedom from tapeworm (Taenia spp.). If found to be infested with tapeworm, dogs must be treated under the supervision of an inspector at the port of entry until they are free from infestation.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
Brushtail possum. Vulpine phalangers (Trichosurus vulpecula) of the family Phalangeridae.
Delivery. The transfer of goods or interest in goods from one person to another.
Enter (entry). To introduce into the commerce of the United States after release from government detention.
Hedgehog. All members of the family Erinaceidae.
Import (imported, importation). To bring into the territorial limits of the United States.
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Tenrec. All members of the family Tenrecidae.
United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
(a) No person may import a hedgehog or tenrec into the United States from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.
(b) No person may import a brushtail possum or hedgehog into the United States from New Zealand.
(c) No person may import leopard tortoise (Geochelone pardalis), African spurred tortoise (Geochelone sulcata), or Bell's hingeback tortoise (Kinixys belliana) into the United States.
Hedgehogs and tenrecs not specifically prohibited from being imported under § 93.701 may be imported into the United States only in accordance with the regulations in this subpart.
(a) Any person importing a hedgehog or tenrec into the United States may import it, except as provided in paragraph (b) of this section, only through the following ports:
(1) Air and ocean ports. Anchorage and Fairbanks, AK; San Diego and Los Angeles, CA; Denver, CO; Jacksonville, Miami, St. Petersburg-Clearwater, and Tampa, FL; Atlanta, GA; Chicago, IL; New Orleans, LA; Portland, ME; Baltimore, MD; Boston, MA; Minneapolis, MN; Great Falls, MT; Newburgh, NY; Portland, OR; San Juan, PR; Galveston and Houston, TX; and Seattle, Spokane, and Tacoma, WA.
(2) Canadian border ports. Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, and Sault Ste. Marie, MI; Opheim, Raymond, and Sweetgrass, MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, VT; Oroville and Sumas, WA.
(3) Mexican border ports. Douglas, Naco, Nogales, Sasabe, and San Luis, AZ; Calexico and San Ysidro, CA; Antelope Wells, and Columbus, NM; and Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, TX.
(b) The Secretary of the Treasury has approved the designation, as inspection stations, of the ports specified in paragraph (a) of this section. In special cases, the Administrator may designate other ports as inspection stations in accordance with this section, with the concurrence of the Secretary of the Treasury.
(a) General requirements. No person may import a hedgehog or tenrec into the United States unless it is accompanied by an import permit issued by APHIS and is imported into the United States within 30 days after the proposed date of arrival stated in the import permit. The importer or his or her agent must notify the inspector at the port of first arrival of the date of arrival at least 72 hours before the hedgehog or tenrec arrives in the United States.
(b) Import permit required. Any person who desires to import a hedgehog or tenrec must submit an application (VS Form 17-129) for an import permit. Applications are available from, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737; or by visiting https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits. A separate application must be prepared for each shipment.
(c) Application for an import permit. The importer must complete, sign, and date the application for an import permit, which must include the following information:
(1) The name and address of the shipper in the region of origin of the hedgehog or tenrec intended for importation into the United States.
(2) The name, address, and telephone number of the importer.
(3) The port of embarkation.
(4) The region from which the hedgehog or tenrec will be shipped to the United States.
(5) The mode of transportation.
(6) The number, breed, species, and descriptions of the hedgehogs or tenrecs to be imported.
(7) The purpose of the importation.
(8) The route of travel, including all carrier stops en route.
(9) The proposed shipping and arrival dates.
(10) The port of first arrival in the United States.
(11) The name, mailing address, and telephone number of the person to whom the hedgehog or tenrec will be delivered in the United States.
(12) The location of the place where delivery will be made in the United States.
(13) Any remarks regarding the shipment.
(d) Issuance of an import permit. Upon receipt of the application, APHIS will review the application. If the hedgehog or tenrec appears to be eligible to be imported into the United States, APHIS will issue an import permit indicating the applicable requirements under this subpart for the importation of the hedgehog or tenrec. Even though an import permit has been issued for the importation of a hedgehog or tenrec, the animal may enter the United States only if all other applicable requirements of this subpart have been met.
(a) No person may import a hedgehog or tenrec into the United States unless it is accompanied by a health certificate either issued by a full-time salaried veterinary officer of the national government of the exporting region or issued by a veterinarian authorized or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region. The health certificate must contain the names and street addresses of the consignor and consignee and must state:
(1) That the hedgehog or tenrec originated in a region that has been recognized as free of foot-and-mouth disease by the USDA;
(2) That the hedgehog or tenrec has never been in a region where foot-and-mouth disease exists;
(3) That the hedgehog or tenrec has not been commingled with any other hedgehog or tenrec that originated in or has ever been in a region where foot-and-mouth disease exists;
(4) That the hedgehog or tenrec was inspected by the individual issuing the health certificate and was found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States;
(5) That all body surfaces of the hedgehog or tenrec were treated for ectoparasites under the supervision of the veterinarian issuing the health certificate at least 3 days but not more than 14 days before being loaded on the means of conveyance that transported the animal to the United States;
(6) That the pesticide and the concentration used would kill the types of ectoparasites that may infest the animal to be imported;
(7) That the hedgehog or tenrec, after being treated for ectoparasites in accordance with paragraphs (a)(5) and (a)(6) of this section, had physical contact only with, or shared a pen or bedding materials only with, treated hedgehogs or tenrecs in the same shipment to the United States; and
(8) The name and concentration of the pesticide used to treat the hedgehog or tenrec.
(b) [Reserved]
Upon the arrival of a hedgehog or tenrec at the port of first arrival in the United States, the importer or his or her agent must present the import permits and health certificates required by this subpart to the collector of customs for the use of the inspector at that port.
(a) A hedgehog or tenrec from any part of the world must be inspected by an APHIS inspector at the port of first arrival. Subject to the other provisions in this subpart, a shipment of hedgehogs or tenrecs may enter the United States only if each hedgehog or tenrec in the shipment is found free of ectoparasites and any clinical signs of communicable diseases.
(b) If any hedgehog or tenrec in a shipment is found to be infested with ectoparasites or demonstrates any clinical signs of communicable diseases, then the entire shipment will be refused entry. The importer will be given the following options:
(1) Remove the shipment from the United States; or
(2) Release the shipment to the U.S. Department of Agriculture. The Administrator will destroy or otherwise dispose of the shipment as necessary to prevent the possible introduction into the United States of communicable animal diseases.
The following terms, when used in this part, shall be construed as defined. Those terms used in the singular form in this part shall be construed as the plural form and vice versa, as the case may demand.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of this chapter, and subchapters B, C, and D of this chapter; and to perform functions required by cooperative State-Federal disease control and eradication programs.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
APHIS representative. A veterinarian or other person employed by APHIS in animal health activities, who is authorized to perform the function involved.
Enter (entered, entry) into the United States. To introduce into the commerce of the United States after release from government detention.
Import (imported, importation) into the United States. To bring into the territorial limits of the United States.
Incinerate (incinerated). To reduce to ash by burning.
Inspector. An employee of APHIS who is authorized to perform the function involved.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other legal entity.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
United States. All of the several States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
United States health certificate. An official document issued by an APHIS representative or an accredited veterinarian at the point of origin of a movement of animals. It must show the identification tag, tattoo, or registration number of each animal to be moved; the age and sex of each animal to be moved; the number of animals covered by the document; the points of origin and destination; the consignor; and the consignee.
Veterinary Services. The Veterinary Services unit of the Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Elephants, hippopotami, rhinoceroses, or tapirs shall not be imported or entered into the United States unless in accordance with this part.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 30 days after the proposed date of arrival stated in the import permit. The port veterinarian must be notified of the date of arrival at least 72 hours before the animal arrives in the United States.
(b) An application for an import permit may be obtained from Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737; or by visiting https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits. A separate application must be prepared for each shipment.
(c) The completed application shall include the following information:
(1) The name and address of the person intending to export an elephant, hippopotamus, rhinoceros, or tapir to the United States;
(2) The name and address of the person intending to import an elephant, hippopotamus, rhinoceros, or tapir into the United States;
(3) The species, breed, and number of elephants, hippopotami, rhinoceroses, or tapirs to be imported;
(4) The purpose of the importation;
(5) The port of embarkation;
(6) The name and concentration of the pesticide intended to be used to treat the elephant, hippopotamus, rhinoceros, or tapir for ectoparasites prior to the animal being transported to the United States;
(7) The mode of transportation;
(8) The route of travel;
(9) The port of entry in the United States and, if applicable, the address of the facility to be provided by the importer for inspection, treatment, and incineration pursuant to § 93.6 of this part;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered in the United States.
(d) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this part for importation into the United States shall be issued for the importation of the elephant, hippopotamus, rhinoceros, or tapir described in the application if such animal appears to be eligible to be imported. Even though an import permit has been issued for the importation of an elephant, hippopotamus, rhinoceros, or tapir, the animal may be imported only if all applicable requirements of this part are met.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by a health certificate either signed by a salaried veterinarian of the national veterinary services of the region where the inspection and treatment required by this section occurred or signed by a veterinarian authorized by the national veterinary services of such region and endorsed by a salaried veterinarian of the national veterinary services of such region (the endorsement representing that the veterinarian signing the health certificate was authorized to do so), certifying:
(1) That the elephant, hippopotamus, rhinoceros, or tapir was inspected by the individual signing the health certificate and found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States; and
(2) That the elephant, hippopotamus, rhinoceros, or tapir was treated for ectoparasites at least 3 days but not more than 14 days before being loaded on the means of conveyance which transported the animal to the United States. The animal shall have been treated, under the supervision of the individual signing the health certificate, by being thoroughly wetted with a pesticide applied with either a sprayer with a hand-held nozzle, a spray-dip machine, or a dip vat; and
(3) That the elephant, hippopotamus, rhinoceros, or tapir, after being treated for ectoparasites in accordance with paragraph (a)(2) of this section, did not have physical contact with or share a pen or bedding materials with any elephant, hippopotamus, rhinoceros, or tapir not in the same shipment to the United States; and
(4) The name and concentration of the pesticide used to treat the animal (such pesticide and the concentration used must be adequate to kill the types of ectoparasites likely to infest the animal to be imported; a list of recommended pesticides and concentrations may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231; and
(5) The name and address of the consignor and consignee.
(b) [Reserved]
Upon arrival of an elephant, hippopotamus, rhinoceros, or tapir at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a completed VS Form 17-29, “Declaration of Importation for Animals, Animal Semen, Birds, Poultry, and Eggs for Hatching.” (This form is available from Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737 or by visiting https://www.aphis.usda.gov/aphis/resources/forms/ct_vs_forms.) Forms may be provided to the inspector using a U.S. Government electronic information exchange system or other authorized method. The completed form must state:
(a) The port of entry;
(b) The date of arrival;
(c) The import permit number;
(d) The name of the carrier and identification of the means of conveyance;
(e) The name and address of the importer;
(f) The name and address of the broker;
(g) The region from which the elephant, hippopotamus, rhinoceros, or tapir was shipped;
(h) The number, species, and purpose of importation of the elephant, hippopotamus, rhinoceros, or tapir; and
(i) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall be imported into the United States only:
(1) At Los Angeles, California; Miami, Florida; and Newburgh, New York; or
(2) On a case-by-case basis, at another port of entry if:
(i) The animals will be inspected and treated at a facility provided by the importer;
(ii) The Administrator has determined that the importer's facility is adequate for inspection, treatment, and incineration required under this section;
(iii) The Administrator has determined that an inspector is available to perform at the importer's facility the services that are required under this section; and
(iv) The Administrator has determined that an inspector is available to perform at the port of entry the services that are required under this section if the animals will be inspected and treated at a facility provided by the importer.
(b) An elephant, hippopotamus, rhinoceros, or tapir shall be entered into the United States only under the following conditions:
(1) Any documents accompanying the animal shall be subject to inspection by an inspector at the port of entry;
(2) If the animal is to be moved from the port of entry to a facility provided by the importer:
(i) At the port of entry the animal shall be subject to as much inspection by an inspector as is feasible and shall be sprayed or dipped, as feasible, under the supervision of an inspector and with a permitted dip listed in § 72.13(b) of this chapter;
(ii) At the port of entry, as much hay, straw, feed, bedding, and other material as can feasibly be removed from the shipping crate or vehicle containing the animal shall be removed, sealed in plastic bags, and incinerated by the importer under the supervision of an inspector;
(iii) At the port of entry, the shipping crate or the vehicle containing the animal shall be sealed by an inspector with an official seal of the United States Department of Agriculture:
(iv) If the animal is moved from the port of entry in a shipping crate, plastic must be fastened around the shipping crate so that all animal waste, hay, straw, feed, bedding, and other material accompanying the animal are retained inside the crate, but not so as to interfere with ventilation, feeding, and watering of the animal;
(v) After the arrival of the animal at the facility provided by the importer, the seal shall be broken by an inspector;
(3) The animal shall be inspected by an inspector within 24 hours of being unloaded at the port of entry or at a facility provided by the importer, and shall be treated under the supervision of an inspector, as follows:
(i) The animal shall be removed from its shipping crate or cargo hold, placed on a concrete or other nonporous surface, and physically inspected for ectoparasites by an inspector. If inspection and treatment are not performed upon unloading, the animal must be isolated from all other animals, except those in the same shipment, and kept in a facility with a nonporous floor and where any ectoparasites that may drop off the animal can be contained and destroyed, until the animal has been inspected and treated;
(ii) If the inspector finds no ectoparasites, the animal shall be sprayed or dipped one time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter; or
(iii) If the inspector finds ectoparasites, the animal shall be sprayed or dipped in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter for as many times as necessary until the inspector finds no ectoparasites; and thereafter the animal shall be sprayed or dipped one additional time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter;
(4) All hay, straw, feed, bedding, and other material that has been placed with the animal at any time prior to the final treatment referred to in paragraph (b)(3) of this section, and any plastic sheet used to wrap any shipping crate, shall be sealed in plastic bags and incinerated under the supervision of an inspector;
(5) Any shipping crate shall be, under the supervision of an inspector, either cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter or incinerated; and if the shipping crate is cleaned and disinfected, it shall then be treated under the supervision of an inspector with a permitted dip listed in § 72.13(b) of this chapter;
(6) Any means of conveyance used to transport an animal not in a shipping crate shall be, under the supervision of an inspector, cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter and then treated with a permitted dip listed in § 72.13(b) of this chapter.
Any elephant, hippopotamus, rhinoceros, or tapir refused entry into the United States for noncompliance with the requirements of this part shall be removed from the United States within a time period specified by the Administrator or shall be considered abandoned by the importer, and pending removal or abandonment, the animal shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction of ectoparasites into the United States. If such animal is not removed from the United States within such time period or is abandoned, it may be seized, destroyed, or otherwise disposed of as the Administrator determines necessary to prevent the possible introduction of ectoparasites into the United States.
(a) Elephants, hippopotami, rhinoceroses, and tapirs are exempt from the regulations in this part under the following circumstances:
(1) They are imported from Canada and are accompanied by a document signed by a salaried veterinarian of the Canadian Government that states:
(i) They were not imported into Canada during the year preceding their importation into the United States; and
(ii) They did not, during the year preceding their importation into the United States, have physical contact with or share a pen or bedding materials with any elephant, hippopotamus, rhinoceros, or tapir imported into Canada during that year; or
(2) They were exported into Canada from the United States and then imported back into the United States accompanied by a United States health certificate.
(b) Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry of elephants, hippopotami, rhinoceroses, or tapirs into the United States other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction of ectoparasites into the United States.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.
Certifying official. An individual authorized by the competent authority of a country to sign health certificates for aquatic animals.
Competent authority. The national veterinary services or other authority of a country, having the responsibility and competence for ensuring or supervising the implementation of aquatic animal health measures.
Container. A transport receptacle that is specially constructed to facilitate transportation of aquatic animals or aquatic animal products by one or several means of transport.
Department. The United States Department of Agriculture (USDA).
Fertilized egg. A viable fertilized ovum of an aquatic animal.
Gamete. The sperm or unfertilized egg of aquatic animals that is held or transported separately.
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Person. Any individual, corporation, company, association, firm, partnership, society or joint stock company.
Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this subpart at a port of entry.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Spring viremia of carp (SVC). A disease caused by infection with spring viremia of carp virus, a rhabodivrus capable of infecting several carp species, in addition to some other cyprinid and ictalurid fish species.
SVC-susceptible species. Common carp (Cyprinus carpio), grass carp (Ctenopharyngodon idellus), silver carp (Hypophthalmichthys molitrix), bighead carp (Aristichthys nobilis), Crucian carp (Carassius carassius), goldfish (Carassius auratus), tench (Tinca tinca), and sheatfish (Silurus glanis).
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
(a) No live fish, fertilized eggs, or gametes of SVC-susceptible species may be imported into the United States except in accordance with this subpart,
(b) Other provisions of this subpart relating to the importation of live fish, fertilized eggs, and gametes shall not apply to shipments of SVC-susceptible species of live fish, fertilized eggs, or gametes in transit through the United States if an import permit has been obtained under § 93.903 and all conditions of the permit are observed; and if the live fish, fertilized eggs, and gametes are handled as follows:
(1) They are maintained under continuous confinement while in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(2) They are unloaded, in the course of such transit, into a holding facility
(3) They are moved in accordance with any additional conditions prescribed in the permit and determined by the Administrator to be necessary to ensure that the live fish, fertilized eggs, or gametes through the United States do not introduce SVC into the United States.
(4) For a holding facility to be approved by the Administrator:
(i) The holding facility must be sufficiently isolated to prevent direct or indirect contact of the live fish, fertilized eggs, or gametes it contains with any other SVC-susceptible species in the United States;
(ii) The holding facility must be constructed to provide adequate protection against environmental conditions and so that it can be adequately cleaned, washed and disinfected;
(iii) Provision must be made for disposal of fish carcasses, shipping water, waste and any associated shipping materials in a manner that will prevent dissemination of disease;
(iv) Provision must be made for adequate sources of feed and water and for attendants for the care and feeding of live fish, fertilized eggs, or gametes in the facility;
(v) The holding facility must comply with all applicable local, State and Federal requirements for environmental quality.
(vi) The holding facility must comply with any additional requirements that may be imposed by the Administrator for a particular shipment if necessary to prevent the dissemination of disease.
(a) The following ports are designated as ports of entry for live fish, fertilized eggs, and gametes of SVC-susceptible species imported under this subpart:
(1) Air and ocean ports. Los Angeles and San Francisco, CA; Miami and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, MA; Newark, NJ; New York, NY; Portland, OR; Dallas-Ft. Worth, TX; and San Juan, PR.
(2) Canadian border ports. Detroit, MI; Buffalo-Niagara, NY; and Blaine and Seattle, WA.
(3) Mexican border ports. Otay Mesa, CA.
(b) Designation of other ports. Other ports may be designated by the Administrator in specific cases with the concurrence of the Secretary of the Department of Homeland Security.
(a) Live fish, fertilized eggs, or gametes of SVC-susceptible species imported into the United States must be accompanied by an import permit issued by APHIS and must be imported within 30 days after the proposed date of arrival stated in the import permit.
(b) An application for an import permit must be submitted for each shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species to Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, MD 20737-1231. Application forms for import permits may be obtained from this address.
(c) A completed application shall include the following information:
(1) The name and address of the person intending to export live fish, fertilized eggs, or gametes of SVC-susceptible species to the United States;
(2) The proposed date of shipment to the United States;
(3) The name and address of the person intending to import live fish, fertilized eggs, or gametes of SVC-susceptible species into the United States;
(4) The species and number of live fish, fertilized eggs, or gametes of SVC-susceptible species to be imported into the United States;
(5) The purpose of the importation;
(6) The port of embarkation;
(7) The mode of transportation;
(8) The route of travel, including all carrier stops en route;
(9) The port of entry in the United States;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the live fish, fertilized eggs, or gametes of SVC-susceptible species will be delivered in the United States.
(d) If APHIS determines that the live fish, fertilized eggs, or gametes are eligible for importation, APHIS will issue an import permit indicating the applicable conditions for importation. An import permit does not guarantee that any live fish, fertilized eggs, or gametes will be allowed entry into the United States; the fish, fertilized eggs, or gametes will be allowed to enter the United States only if they meet all applicable requirements of the permit and regulations.
(a) General. All live fish, fertilized eggs, and gametes of SVC-susceptible species that are imported from any region of the world must be accompanied by a health certificate issued by a full-time salaried veterinarian of the national government of the exporting region, or issued by a certifying official and endorsed by the competent authority of that country. The health certificate must be written in English or contain an English translation. The health certificate will be valid for 30 days from the date of issuance. The health certificate for the live fish, fertilized eggs, or gametes must state that:
(1) The live fish, fertilized eggs, or gametes were inspected by the veterinarian or certifying official who issued the certificate within 72 hours prior to shipment, and were found to be free of any clinical signs of disease consistent with SVC; and
(2) The live fish, fertilized eggs, or gametes covered by the health certificate meet the requirements of this section.
(b) Surveillance. The live fish, fertilized eggs, or gametes must meet the following conditions to be eligible for importation into the United States:
(1) The live fish, fertilized eggs, or gametes must originate in a region or establishment which conducts a surveillance program for SVC under the supervision of the competent authority.
(2) The region or establishment must demonstrate freedom from SVC through a minimum of 2-years' continuous health history, supported by laboratory testing by a pathogen detection facility approved for SVC viral assays by the competent authority.
(3) SVC-susceptible fish populations in the region or establishment must be tested at least twice annually, with at least 3 months between the tests and at times or under environmental conditions that would facilitate the detection of SVCV if it were present. Sampling procedures must utilize an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent. Samples must be collected and submitted by a certifying official or veterinarian recognized by the competent authority. The standard screening method for SVC must include isolation of SVCV in cell culture, using either the epithelioma papulosum cyprini (EPC) or fathead minnow (FHM) cell lines. However, the Administrator may authorize other assays for SVCV detection in lieu of virus isolation through cell culture, if the Administrator determines that such assays provide equivalent assurance of the SVC status of an exporting region or establishment. All viral testing results must be negative.
(c) Shipping containers. All live fish, fertilized eggs, and gametes must be shipped to the United States in new containers or in used containers that have been cleaned and disinfected in accordance with this section.
(1) Cleaning and disinfection of shipping containers must take place under the supervision of the veterinarian or certifying official who issues the health certificate.
(2) Cleaning and disinfection must be sufficient to neutralize any SVC virus to which shipping containers may have been exposed. Acceptable disinfection procedures include individual or combination treatments with: Solutions having a pH of 12 or higher or 3 or lower with a contact time of at least 10 minutes; heat at or above 56 °C for at least 15 minutes; chlorine solutions having a concentration of at least 500 ppm with a contact time of at least 10 minutes; iodine solutions having a concentration of at least 100 ppm with a contact time of at least 10 minutes; ultraviolet exposure (254 nm; min exposure of 10,000 microwatt seconds/cm
(3) Cleaning and disinfection protocols must be referenced in the health certificate or in a separate cleaning and disinfection certificate accompanying the shipment to the U.S. port of entry.
(a) For all live fish, fertilized eggs, and gametes offered for importation under this subpart, the importer or his or her agent must submit the following documents to the collector of customs for use by the port veterinarian:
(1) All permits, certificates, or other documentation required by this subpart; and
(2) Two copies of a declaration that lists the port of entry, the name and address of the importer, the name and address of the broker, the origin of the live fish, fertilized eggs, or gametes, the number, species, and the purpose of the importation, the name of the person to whom the fish will be delivered, and the location of the place to which such delivery will be made.
(b) Any declaration, permit, or other document for live fish, fertilized eggs, and gametes required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.
(a) All live fish, fertilized eggs, and gametes of SVC-susceptible species imported from any part of the world must be presented for inspection at a port of entry designated under § 93.902. The APHIS port veterinarian must be notified at least 72 hours in advance of the arrival in the United States of a shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species. Any shipment of live SVC-susceptible fish species that the port veterinarian determines to exhibit clinical signs consistent with SVCV infection or disease, or any shipments of live fish, fertilized eggs, and gametes of SVC-susceptible species that otherwise do not meet the requirements of this subpart, shall be refused entry.
(b) Shipments refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling, shall be disposed of as the Administrator may direct.
As used in this part, the following terms shall have the meanings set forth in this section.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service, of the United States Department of Agriculture (APHIS.)
APHIS-defined European CSF region. A single region of Europe recognized by APHIS as low risk for classical swine fever.
(1) A list of areas included in the region is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list are also available via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(2) APHIS will add an area to the region after it conducts an evaluation of the area to be added in accordance with § 92.2 of this subchapter and finds that the risk profile for the area is equivalent with respect to classical swine fever to the risk profile for the region it is joining.
APHIS-defined European Poultry Trade Region. A single region consisting of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain (England, Scotland, and Wales), Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Northern Ireland, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
APHIS representative. An individual employed by Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the function involved.
Approved establishment means an establishment authorized by Veterinary Services for the receipt and handling of restricted imported animal carcasses, products, and byproducts.
Authorized inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.
Birds. All members of the class Aves (other than poultry or game birds).
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal-risk region. A region that:
(1) Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE in an indigenous ruminant, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:
(i) Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;
(ii) Surveillance for BSE at levels that meet or exceed recommendations of the World Organization for Animal Health (Office International des Epizooties) for surveillance for BSE; and
(iii) A ruminant-to-ruminant feed ban that is in place and is effectively enforced.
(2) In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.
(3) In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.
Cold spot. The area in a flexible plastic cooking tube or other type of container loaded with meat product, or the areas at various points along the belt in an oven chamber, slowest to reach the required temperature during the cooking process. The cold spot(s) for each container is experimentally determined before the cooking process begins, and once identified, remains constant.
Commercial birds. Birds that are imported for resale, breeding, public display, or any other purpose, except pet birds, zoological birds, research birds, or performing or theatrical birds.
Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching) which are imported for resale, breeding, public display, or any other commercial purpose.
Contact. Known or potential commingling of products during processing or storage, or while being transported from any point to any other point. Contact includes the simultaneous processing in the same room, locker, or container, but not necessarily the same storage facility or conveyance, as long as adequate security measures are taken to prevent commingling, as determined by an authorized APHIS representative.
Container. For the purposes of § 94.1(c) and § 94.16(c), this term means a receptacle, sometimes refrigerated, which is designed to be filled with cargo, sealed, and then moved, without unsealing or unloading, aboard a variety of different transporting carriers.
Department. The United States Department of Agriculture (USDA, Department).
Direct transloading. The transfer of cargo directly from one means of conveyance to another.
Exporting region. A region from which shipments are sent to the United States.
Farm equipment. Equipment used in the production of livestock or crops, including, but not limited to, mowers, harvesters, loaders, slaughter machinery, agricultural tractors, farm engines, farm trailers, farm carts, and farm wagons, but excluding automobiles and trucks.
Flock of origin. The flock in which the eggs were produced.
Food Safety and Inspection Service. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.
FSIS inspector. An individual authorized by the Administrator, Food Safety and Inspection Service, United States Department of Agriculture, to perform the function involved.
Game birds. Migratory birds, including certain ducks, geese, pigeons, and doves (“migratory” refers to seasonal flight to and from the United States); free-flying quail, wild grouse, wild pheasants (as opposed to those that are commercial, domestic, or pen-raised).
Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:
(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.
House. A structure, enclosed by walls and a roof, in which poultry are raised.
Immediate export. The period of time determined by APHIS, based on shipping routes and timetables, to be the shortest practicable interval of time between the arrival in the United States of an incoming carrier and the departure from the United States of an outgoing carrier, to transport a consignment of products.
Import (imported, importation) into the United States. To bring into the territorial limits of the United States.
Indicator piece. A cube or slice of meat to be used for the pink juice test, required to meet minimum size specifications.
Mechanically separated meat. A finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of bovine carcasses that meets the FSIS specifications contained in 9 CFR 319.5.
Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residues between residues 113 and 116. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.
Operator. The operator responsible for the day-to-day operations of a facility.
Personal use. Only for personal consumption or display and not distributed further or sold.
Pink juice test. Determination of whether meat has been thoroughly cooked by observation of whether the flesh and juices have lost all red and pink color.
Port of arrival. Any place in the United States at which a product or article arrives, unless the product or article remains on the means of conveyance on which it arrived within the territorial limits of the United States.
Positive for a transmissible spongiform encephalopathy. A sheep or goat for which a diagnosis of a transmissible spongiform encephalopathy has been made.
Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea fowl; nonmigratory ducks, geese, pigeons, and doves; commercial, domestic, or pen-raised grouse, pheasants, and quail.
Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.
Premises of origin. The premises where the flock of origin is kept.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Region of origin. For meat and meat products, the region in which the animal from which the meat or meat products were derived was born, raised and slaughtered; and for eggs, the region in which the eggs were laid.
Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited.
Ruminants. All animals that chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Sentinel bird. A chicken that has been raised in an environment free of pathogens that cause communicable diseases of poultry and that has not been infected with, exposed to, or immunized with any strain of virus that causes Newcastle disease.
Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.
State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
Suspect for a transmissible spongiform encephalopathy. (1) A sheep or goat that has tested positive for a transmissible spongiform encephalopathy or for the proteinase resistant protein associated with a transmissible spongiform encephalopathy, unless the animal is designated as positive for a transmissible spongiform encephalopathy; or
(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
Temperature indicator device (TID). A precalibrated temperature-measuring instrument containing a chemical compound activated at a specific temperature (the melting point of the chemical compound) identical to the processing temperature that must be reached by the meat being cooked. The Administrator will approve a TID for use after determining that the chemical compound in the device is activated at the specific temperature required.
Thoroughly cooked. Heated sufficiently to inactivate any pathogen that may be present, as indicated by the required TID or pink juice test.
United States. All of the States.
Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State or area concerned.
Wild swine. Any swine which are allowed to roam outside an enclosure.
(a) APHIS considers foot-and-mouth disease to exist in all regions of the world except those declared free of the disease by APHIS.
(1) A list of regions that APHIS has declared free of foot-and-mouth disease is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(2) APHIS will add a region to the list of those it has declared free of foot-and-mouth disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of foot-and-mouth disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.
(b) The importation of any ruminant or swine or any fresh (chilled or frozen) meat of any ruminant or swine
(1) Except as provided in part 93 of this chapter for wild ruminants and wild swine;
(2) Except as provided in paragraph (d) of this section for fresh (chilled or frozen) meat of ruminants or swine that is otherwise eligible for importation under this part but that enters a port or otherwise transits a region where foot-and-mouth disease exists; and
(3) Except as provided in § 94.4 of this part for cooked or cured meat from regions where foot-and-mouth disease exists.
(4) Except as provided in § 94.29 for fresh (chilled or frozen) beef and ovine meat.
(c) The importation of any used farm equipment that originates in any region where foot-and-mouth disease exists, as designated in paragraph (a) of this section, is prohibited, unless the equipment is accompanied by an original certificate signed by an authorized official of the national animal health service of the exporting region that states that the equipment, after its last use and prior to export, was steam-cleaned free of all exposed dirt and other particulate matter. Such farm equipment is subject to APHIS inspection at the port of arrival. If it is found during such inspection to contain any exposed dirt or other particulate matter, it will be denied entry into the United States, unless, in the judgment of the APHIS inspector, the amount of exposed soil is minimal enough to allow cleaning at the port of arrival, and there are adequate facilities and personnel at the port to conduct such cleaning without risk of disease contamination.
(d) Except as otherwise provided in this part, fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of foot-and-mouth disease, as designated in paragraph (a) of this section, and fresh (chilled or frozen) beef and ovine meat exported in accordance with § 94.29, which during shipment to the United States enters a port or otherwise transits a region where foot-and-mouth disease exists, may be imported provided that all of the following conditions are met:
(1) The meat is accompanied by the foreign meat inspection certificate required by § 327.4 of this title and, upon arrival of the meat in the United States, the foreign meat inspection certificate is presented to an authorized inspector at the port of arrival;
(2) The meat is placed in the transporting carrier in a hold, compartment, or, if the meat is containerized, in a container that which was sealed in the region of origin by an official of such region with serially numbered seals approved by APHIS, so as to prevent contact of the meat with any other cargo, handling of the meat after the hold, compartment, or container is sealed, and the loading of any cargo into and the removal of any cargo from the sealed hold, compartment, or container en route to the United States;
(3) If any foreign official breaks a seal applied in the region of origin in order to inspect the meat, he or she then reseals the hold, compartment, or container with a new serially numbered seal; and, if any member of a ship's crew breaks a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal are recorded in the ship's log.
(4) The serial numbers of the seals used to seal the hold, compartment, or container are recorded on the foreign meat inspection certificate which accompanies the meat;
(5) Upon arrival of the carrier in the United States port of arrival, the seals are found by an APHIS representative to be intact, and the representative finds that there is no evidence indicating that any seal has been tampered with; Provided that, if the representative finds that any seal has been broken or has a different number than is recorded on the foreign meat inspection certificate, then the meat may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the packages of meat, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of that government) that demonstrates to the satisfaction of the Administrator that the meat was not contaminated or exposed to contamination during movement from the region of origin to the United States; and
(6) The meat is found by an authorized inspector to be as represented on the foreign meat inspection certificate.
(a) The importation of fresh (chilled or frozen) products (other than meat and milk and milk products) derived from ruminants or swine, originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.3 and parts 95 and 96 of this chapter.
(b) The importation of milk and milk products of ruminants and swine originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.16.
The importation of fresh (chilled or frozen) organs, glands, extracts, or secretions derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, except for pharmaceutical or biological purposes under conditions prescribed by the Administrator in each instance, is prohibited.
(a) The importation of cured meats derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited unless the following conditions have been fulfilled:
(1) All bones shall have been completely removed in the region of origin.
(2) The meat shall have been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived.
(3)(i) The meat shall have been thoroughly cured and fully dried in such manner that it may be stored and handled without refrigeration, as in the case of salami and other summer sausages, tasajo, xarque, or jerked beef, bouillon cubes, dried beef, and Westphalia, Italian and similar type hams. The term “fully dried” as used in this paragraph means dried to the extent that the water-protein ratio in the wettest portion of the product does not exceed 2.25 to 1.
(ii) Laboratory analysis of samples to determine the water-protein ratios will not be made in the case of all shipments of cured and dried meats. However, in any case in which the inspector is uncertain whether the meat complies with the requirements of paragraph (a)(3)(i) of this section, he will send a sample of the meat representative of the wettest portion to the Meat Inspection Division for analysis of the water-protein ratio. Pending such analysis the meat shall not be released or removed from the port of arrival.
(4) The cured meat shall be accompanied by a certificate issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that such meat has been prepared in accordance with paragraphs (a)(1), (a)(2) and (a)(3)(i) of this section. Upon arrival of the cured meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(b) The importation of cooked meats from ruminants or swine originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited, except as provided in this section.
(1) The cooked meat must be boneless and must be thoroughly cooked.
(2) The cooked meat must have been prepared in an establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in 9 CFR 327.2; must meet all other applicable requirements of the Federal Meat Inspection Act and regulations thereunder (9 CFR Chapter III); and must have been approved by the Administrator in accordance with paragraph (c) of this section.
(3) Canned product (canned meat), as defined in part 431 of this title, is exempt from the requirements in this section.
(4) Ground meat cooked in an oven. Ground meat must be shaped into patties no larger than 5 inches in diameter and 1-inch thick. Each patty must weigh no more than 115 grams, with fat content no greater than 30 percent. These patties must be broiled at 210 °C for at least 133 seconds, then cooked in moist heat (steam heat) in a continuous, belt-fed oven for not less than 20 minutes, to yield an internal exit temperature of at least 99.7 °C, as measured by temperature indicator devices (TID's) placed in temperature monitor patties positioned, before the belt starts moving through the oven, on each of the predetermined cold spots along the oven belt. TID's must be used at the beginning of each processing run.
(5) Meat cooked in tubes. Ground meat (which must not include cardiac muscle), cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) weighing no more than 5 kg (11.05 lbs) must be loaded into a flexible or semiflexible cooking tube constructed of plastic or other material approved by the U.S. Food and Drug Administration. The meat must then be cooked in either boiling water or in a steam-fed oven, in either a batch cooker or a continuous cooker, to reach a minimum internal temperature of 79.4 °C (175 °F) at the cold spot after cooking for at least 1.75 hours. Thoroughness of cooking must be determined by a TID registering the target temperature at the cold spot, or by the pink juice test as follows:
(i) Cubes of meat and ground meat. For cubes of meat, at least 50 percent of meat pieces per tube must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of the cubes of meat pieces per tube are smaller than 3.8 cm (1.5 in) in any dimension after cooking, or if the meat is ground meat, an indicator piece consisting of a single piece of meat of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must have been placed at the cold spot of the tube.
(ii) Slices of meat. At least 50 percent of the slices of meat must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of meat pieces are smaller than 3.8 cm (1.5 in) in any dimension after cooking, an indicator piece of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must be placed at the cold spot of the tube.
(iii) Anatomical cuts of meat. An indicator piece removed from an anatomical cut of meat after cooking must be removed from the center of the cut, farthest from all exterior points and be 3.8 cm (1.5 in) or larger in each dimension for performance of the pink juice test.
(6) Further processing of meat cooked in tubes. Cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) cooked in tubes in accordance with paragraph (b)(5) of this section may be processed further after cooking if the following provisions are met:
(i) For meat that is cooked and is intended for further processing, up to two tubes from each batch per cooker must be randomly selected by the official of the National Government of the region of origin who is authorized to issue the meat inspection certificate required by § 327.4 of this title. If a TID is not used, a cylindrical or square piece of at least 3.8 cm (1.5 in) in each dimension must be cut from the cold spot of each tube. The cylindrical or square piece will be the indicator piece for the pink juice test. The indicator piece or piece containing the TID must be sealed in plastic or other material approved by the U.S. Food and Drug Administration, and be accompanied by a certificate issued by the official who selected the tube. The certificate must provide the date the tube was cooked and the cooker and batch number, and the date the tube was selected for sampling. Each batch per cooker must have at least one but no more than two indicator pieces or pieces containing TID's. All indicator pieces and pieces containing TID's must be individually sealed, properly labeled, and enclosed together in one sealed box that accompanies the shipment. Any indicator pieces or pieces containing TID's that are not used to accompany a shipment to the United States must be destroyed following loading of the batch into a container; and
(ii) After removing the indicator piece or piece containing a TID, all remaining meat from the same batch may be cut into smaller cubes and sealed in plastic or other material approved by the U.S. Food and Drug Administration. After being processed into smaller cubes once, the meat may not be further processed before shipment to the United States. The cubes of meat and the indicator piece or piece containing a TID must be accompanied to the United States by a certificate as provided in paragraph (b)(8) of this section.
(7) Any TID used in accordance with paragraph (b)(4) or (b)(5) of this section must remain in the meat, as originally inserted, and must accompany the cooked meat whose temperature it has gauged when that meat is shipped to the United States.
(8) Pork rind pellets (pork skins). Pork rind pellets (pork skins) must be cooked in one of the following ways:
(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.
(ii) Two-step process. The pork skins must be dry-cooked at 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at 104 °C for an additional 150 minutes.
(9) Certificate. (i) The cooked meat must be accompanied by a certificate issued by an official of the National Government of the region of origin who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating: “This cooked meat produced for export to the United States meets the requirements of title 9, Code of Federal Regulations, § 94.4(b).” Upon arrival of the cooked meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(ii) For cooked meat that is further processed in accordance with paragraph (b)(6) of this section, the certificate must include the following statement, in addition to the certification required under paragraph (b)(9)(i) of this section: “No more than two tubes were randomly selected per batch per cooker for cutting an indicator piece or obtaining a piece containing a TID. The indicator piece or piece containing a TID represents a shipment of (describe form of processed product—e.g., diced cubes of a particular size). A piece containing a TID or a piece 3.8 cm (1.5 in) or larger in each dimension was cut from the cold spot of the tube, and was sealed and marked with the following cooking date, cooker, and batch: __________ and the following date of selection of the tube__________. The total number of indicator pieces or pieces containing TID's enclosed in a sealed box is__________.”
(10) The meat is inspected by an FSIS inspector at a port of arrival in a defrost facility approved by the Administrator
(i) Request for approval of any defrost facility must be made to the Administrator. The Administrator will approve a defrost facility only under the following conditions:
(A) The defrost facility has equipment and procedures that permit FSIS inspectors to determine whether meat is thoroughly cooked;
(B) The defrost facility is located at a port of arrival; and
(C) The defrost facility is approved by the Food Safety and Inspection Service, United States Department of Agriculture.
(ii) The Administrator may deny approval of any defrost facility if the Administrator determines that the defrost facility does not meet the conditions for approval. If approval is denied, the operator of the defrost facility will be informed of the reasons for denial and be given an opportunity to respond. The operator will be afforded an opportunity for a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding.
(iii) The Administrator may withdraw approval of any defrost facility as follows: (A) When the operator of the defrost facility notifies the Administrator in writing that the defrost facility no longer performs the required services; or (B) when the Administrator determines that the defrost facility does not meet the conditions for approval. Before the Administrator withdraws approval from any defrost facility, the operator of the defrost facility will be informed of the reasons for the proposed withdrawal and given an opportunity to respond. The operator will be afforded a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding. If approval of a defrost facility is withdrawn, the Administrator will remove its name from the list of approved defrost facilities.
(c) Meat processing establishment; standards. (1) Before the Administrator will approve a meat processing establishment for export shipment of cooked meat to the United States, the Administrator must determine:
(i) That the meat processing establishment has furnished APHIS with a description of the process used to inactivate FMD virus that may be present in meat intended for export to the United States, and with blueprints of the facilities where this meat is cooked and packaged;
(ii) That an APHIS representative has inspected the establishment and found that it meets the standards set forth in paragraph (c)(2) of this section;
(iii) That the operator of the establishment has signed a cooperative service agreement with APHIS, stating:
(A) That all cooked meat processed for importation into the United States will be processed in accordance with the requirements of this part;
(B) that a full-time, salaried meat inspection official of the National Government of the exporting region will supervise the processing (including certification of the cold spot) and examination of the product, and certify that it has been processed in accordance with this section; and
(C) that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records; and
(iv) That the operator of the establishment has entered into a trust fund agreement with APHIS and is current in paying all costs for an APHIS representative to inspect the establishment for initial evaluation, and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the trust fund agreement, before the APHIS representative's site inspection, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued, to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.
(2) Establishment. An APHIS representative will conduct an on-site evaluation, and subsequent inspections, as provided in § 94.4(c)(1), to determine whether the following conditions are met:
(i) The facilities used for processing cooked meat in the meat processing establishment are separate from the facilities used for processing raw meat (precooking, boning, preparation, and curing), with only the through-the-wall cooking system through which the meat product is delivered at the end of the cooking cycle connecting them; and there is at all times a positive air flow from the cooked to the raw product side;
(ii) The cooking equipment has the capacity to cook all meat pieces in accordance with § 94.4(b)(4) or (b)(5);
(iii) Workers who process cooked meat are at all times kept separate from workers who process raw meat, and have, for their exclusive use: A separate entrance, dining area, toilets, lavatories with cold and hot water, soap, disinfectants, paper towels, clothes hampers and waste baskets for disposal, and changing rooms stocked with the clean clothing and rubber boots into which all persons must change upon entering the establishment. Workers and all other persons entering the establishment must wash their hands and change into the clean clothing and boots provided in the changing rooms before entering the cooking facilities, and must leave this clothing for laundering and disinfecting before exiting from the establishment, regardless of the amount of time spent inside or away from the establishment;
(iv) Original records identifying the slaughtering facility from which the meat was obtained and the date the meat entered the meat processing establishment, and original certification (including temperature recording charts and graphs), must be kept for all cooked meat by the full-time salaried meat inspection official of the National Government of the exporting region assigned to the establishment, and must be retained for 2 years.
(a) General restrictions—(1) Interstate movements of garbage from Hawaii and U.S. territories and possessions to the continental United States. Hawaii, Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana Islands, the Federated States of Micronesia, Guam, the U.S. Virgin Islands, Republic of the Marshall Islands, and the Republic of Palau are hereby quarantined, and the movement of garbage therefrom to any other State is hereby prohibited except as provided in this section in order to prevent the introduction and spread of exotic plant pests and diseases.
(2) Imports of garbage. In order to protect against the introduction of exotic animal and plant pests, the importation of garbage from all foreign countries except Canada is prohibited except as provided in paragraph (c)(2) of this section.
(b) Definitions—Agricultural waste. Byproducts generated by the rearing of animals and the production and harvest of crops or trees. Animal waste, a large component of agricultural waste, includes waste (e.g., feed waste, bedding and litter, and feedlot and paddock runoff) from livestock, dairy, and other animal-related agricultural and farming practices.
Approved facility. A facility approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that it has equipment and uses procedures that are adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that it is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.
Approved sewage system. A sewage system approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that the system is designed and operated in such a way as to preclude the discharge of sewage effluents onto land surfaces or into lagoons or other stationary waters, and otherwise is adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.
Carrier. The principal operator of a means of conveyance.
Continental United States. The 49 States located on the continent of North America and the District of Columbia.
Garbage. All waste material that is derived in whole or in part from fruits, vegetables, meats, or other plant or animal (including poultry) material, and other refuse of any character whatsoever that has been associated with any such material.
Incineration. To reduce garbage to ash by burning.
Inspector. A properly identified employee of the U.S. Department of Agriculture or other person authorized by the Department to enforce the provisions of applicable statutes, quarantines, and regulations.
Interstate. From one State into or through any other State.
Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company.
Shelf-stable. The condition achieved in a product, by application of heat, alone or in combination with other ingredients and/or other treatments, of being rendered free of microorganisms capable of growing in the product under nonrefrigerated conditions (over 50 °F or 10 °C).
Sterilization. Cooking garbage at an internal temperature of 212 °F for 30 minutes.
Stores. The food, supplies, and other provisions carried for the day-to-day operation of a conveyance and the care and feeding of its operators.
Yard waste. Solid waste composed predominantly of grass clippings, leaves, twigs, branches, and other garden refuse.
(c) Garbage generated onboard a conveyance—(1) Applicability. This section applies to garbage generated onboard any means of conveyance during international or interstate movements as provided in this section and includes food scraps, table refuse, galley refuse, food wrappers or packaging materials, and other waste material from stores, food preparation areas, passengers' or crews' quarters, dining rooms, or any other areas on the means of conveyance. This section also applies to meals and other food that were available for consumption by passengers and crew on an aircraft but were not consumed.
(i) Not all garbage generated onboard a means of conveyance is regulated for the purposes of this section. Garbage regulated for the purposes of this section is defined as “regulated garbage” in paragraphs (c)(2) and (c)(3) of this section.
(ii) Garbage that is commingled with regulated garbage is also regulated garbage.
(2) Garbage regulated because of movements outside the United States or Canada. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if, when the garbage is on or removed from the means of conveyance, the means of conveyance has been in any port outside the United States and Canada within the previous 2-year period. There are, however, two exceptions to this provision. These exceptions are as follows:
(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the aircraft:
(A) The aircraft had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After the garbage and stores referred to in paragraph (c)(2)(i)(A) of this section were removed, the aircraft has not been in a non-Canadian foreign port.
(ii) Exception 2: Other conveyances. Garbage on or removed in the United States from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the means of conveyance:
(A) The means of conveyance is accompanied by a certificate from an inspector stating the following:
(1) That the means of conveyance had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(2) That the means of conveyance had then been cleaned and disinfected in the presence of the inspector; and
(B) Since being cleaned and disinfected, the means of conveyance has not been in a non-Canadian foreign port.
(3) Garbage regulated because of certain movements to or from Hawaii, territories, or possessions. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if at the time the garbage is on or removed from the means of conveyance, the means of conveyance has moved during the previous 1-year period, either directly or indirectly, to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession. There are, however, two exceptions to this provision. These exceptions are as follows:
(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the aircraft:
(A) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After the garbage and stores referred to in paragraph (c)(3)(i)(A) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession.
(ii) Exception 2: Other conveyances. Garbage on or removed from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the means of conveyance:
(A) The means of conveyance is accompanied by a certificate from an inspector stating that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After being cleared of the garbage and stores referred to in paragraph (c)(3)(ii)(A) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.
(4) Restrictions on regulated garbage. (i) Regulated garbage may not be disposed of, placed on, or removed from a means of conveyance except in accordance with this section.
(ii) Regulated garbage is subject to general surveillance for compliance with this section by inspectors and to disposal measures authorized by the Plant Protection Act and the Animal Health Protection Act to prevent the introduction and dissemination of pests and diseases of plants and livestock.
(iii) All regulated garbage must be contained in tight, covered, leak-proof receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, covered, leak-proof receptacles under the direction of an inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under direct supervision by such an inspector, or such regulated garbage is removed for other handling in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as adequate to prevent the introduction and dissemination of plant pests and animal diseases and sufficient to ensure compliance with applicable laws for environmental protection. Provided that, a cruise ship may dispose of regulated garbage in landfills at Alaskan ports only, if and only if the cruise ship does not have prohibited or restricted meat or animal products on board at the time it enters Alaskan waters for the cruise season, and only if the cruise ship, except for incidental travel through international waters necessary to navigate safely between ports, remains in Canadian and U.S. waters off the west coast of North America, and calls only at continental U.S. and Canadian ports during the entire cruise season.
(A) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application must be endorsed by the operator of the facility or sewage system.
(B) Approval will be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefore and an opportunity to show cause why the approval should be reinstated.
(iv) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the U.S. Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.
(d) Garbage generated in Hawaii—(1) Applicability. This section applies to garbage generated in households, commercial establishments, institutions, and businesses prior to interstate movement from Hawaii, and includes used paper, discarded cans and bottles, and food scraps. Such garbage includes, and is commonly known as, municipal solid waste.
(i) Industrial process wastes, mining wastes, sewage sludge, incinerator ash, or other wastes from Hawaii that the Administrator determines do not pose risks of introducing animal or plant pests or diseases into the continental United States are not regulated under this section.
(ii) The interstate movement from Hawaii to the continental United States of agricultural wastes and yard waste (other than incidental amounts (less than 3 percent) that may be present in municipal solid waste despite reasonable efforts to maintain source separation) is prohibited.
(iii) Garbage generated onboard any means of conveyance during interstate movement from Hawaii is regulated under paragraph (c) of this section.
(2) Restrictions on interstate movement of garbage. The interstate movement of garbage generated in Hawaii to the continental United States is regulated as provided in this section.
(i) The garbage must be processed, packaged, safeguarded, and disposed of using a methodology that the Administrator has determined is adequate to prevent the introduction and dissemination of plant pests into noninfested areas of the United States.
(ii) The garbage must be moved under a compliance agreement in accordance with paragraph (e) of this section. APHIS will only enter into a compliance agreement when the Administrator is satisfied that the Agency has first satisfied all its obligations under the National Environmental Policy Act and all applicable Federal and State statutes to fully assess the impacts associated with the movement of garbage under the compliance agreement.
(iii) All such garbage moved interstate from Hawaii to any of the continental United States must be moved in compliance with all applicable laws for environmental protection.
(e) Compliance agreement and cancellation—(1) Any person engaged in the business of handling or disposing of garbage in accordance with this section must first enter into a compliance agreement with the Animal and Plant Health Inspection Service (APHIS). Compliance agreement forms (PPQ Form 519) are available without charge from local USDA/APHIS/Plant Protection and Quarantine offices, which are listed in telephone directories.
(2) A person who enters into a compliance agreement, and employees or agents of that person, must comply with the following conditions and any supplemental conditions which are listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the introduction and dissemination into or within the United States of plant pests and livestock or poultry diseases:
(i) Comply with all applicable provisions of this section;
(ii) Allow inspectors access to all records maintained by the person regarding handling or disposal of garbage, and to all areas where handling or disposal of garbage occurs;
(iii)(A) If the garbage is regulated under paragraph (c) of this section, remove garbage from a means of conveyance only in tight, covered, leak-proof receptacles;
(B) If the garbage is regulated under paragraph (d) of this section, transport garbage interstate in sealed, leak-proof packaging approved by the Administrator;
(iv) Move the garbage only to a facility approved by the Administrator; and
(v) At the approved facility, dispose of the garbage in a manner approved by the Administrator and described in the compliance agreement.
(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the applicant has not met or is unable to meet the requirements set forth in this section. Prior to denying any application for a compliance agreement, APHIS will provide notice to the applicant thereof, and will provide the applicant with an opportunity to demonstrate or achieve compliance with requirements.
(4) Any compliance agreement may be canceled, either orally or in writing, by an inspector whenever the inspector finds that the person who has entered into the compliance agreement has failed to comply with this section. If the cancellation is oral, the cancellation and the reasons for the cancellation will be confirmed in writing as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agreement.
(5) Where a compliance agreement is denied or canceled, the person who entered into or applied for the compliance agreement may be prohibited, at the discretion of the Administrator, from handling or disposing of regulated garbage.
(a) Disease status of regions for Newcastle disease and highly pathogenic avian influenza (HPAI)—(1) Regions in which Newcastle disease is not considered to exist. (i) A list of free regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(ii) APHIS will remove a region from the list referenced in paragraph (a)(1)(i) of this section upon determining that Newcastle disease exists there based on reports APHIS receives of outbreaks of the disease in commercial birds or poultry from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will add a region to this list after it conducts an evaluation of the region and finds that Newcastle disease is not likely to be present in its commercial bird or poultry populations. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(2) Regions in which HPAI is considered to exist. (i) A list of affected regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(ii) APHIS will consider a region to have HPAI and add it to this list referenced in paragraph (a)(2)(i) of this section upon determining that HPAI exists in commercial birds or poultry in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the OIE, or from other sources the Administrator determines to be reliable. APHIS will remove a region from this list only after it conducts an evaluation of the region and finds that HPAI is not likely to be present in its commercial bird or poultry populations.
(b) Carcasses, and parts or products of carcasses, including meat, from regions where Newcastle disease or HPAI is considered to exist. This paragraph applies to carcasses, and parts or products of carcasses,
(1) Carcasses of game birds, if eviscerated with heads and feet removed, may be imported from regions where Newcastle disease is considered to exist. Carcasses of game birds may not be imported from regions where any subtype of HPAI is considered to exist. Viscera, heads, and feet removed from game birds in any of these regions are ineligible for entry into the United States.
(2) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds from regions where Newcastle disease or HPAI are considered to exist may be imported for consignment to any museum, educational institution or other establishment which has provided the Administrator with evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the introduction or dissemination of Newcastle disease or HPAI into the United States, and which is approved by the Administrator.
(3) Carcasses, or parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if packed in hermetically sealed containers and if cooked by a commercial method after such packing to produce articles that are shelf stable without refrigeration.
(4) Carcasses and parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if they are accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region and that specifies that the articles were cooked throughout to reach a minimum internal temperature of 74 °C (165 °F).
(5) Carcasses, and parts or products of carcasses, including meat, of poultry, game birds, or other birds, that originated in a region considered to be free of Newcastle disease and any subtype of HPAI, and that are processed (cut, packaged, or other processing) in a region where Newcastle disease or HPAI is considered to exist, may be imported under the following conditions:
(i) Shipment to processing establishments. All poultry, game bird, or other bird products from such regions shall be shipped from the Newcastle disease and HPAI-free region where they originated to a processing establishment
(A) The poultry, game bird, or other bird carcasses or parts or products may be removed from containers at the processing establishment in the region where Newcastle disease or HPAI is considered to exist only after an official of the national government has determined that the seals are intact and free of any evidence of tampering. The official must attest to this fact by signing the certificate accompanying the shipment.
(B) [Reserved]
(ii) Handling of poultry, game bird, or other bird carcasses or parts or products. Establishments in regions where Newcastle disease or HPAI is considered to exist that process poultry, game bird, or other bird carcasses or parts or products for export to the United States:
(A) May not receive or handle any live poultry or birds.
(B) Must keep any records required by this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections.
(C) May process carcasses or parts or products that originate in any region, provided that:
(1) All areas, utensils, and equipment likely to contact the carcasses or parts or products to be processed, including skinning, deboning, cutting, and packing areas, are cleaned and disinfected between processing carcasses or parts or products from regions where Newcastle disease or HPAI is considered to exist and processing those from Newcastle disease and HPAI-free regions.
(2) Carcasses or parts or products intended for export to the United States are not handled, cut, or otherwise processed at the same time as any carcasses or parts or products not eligible for export to the United States.
(3) Carcasses or parts or products intended for export to the United States are packed in clean new packaging that is clearly distinguishable from that containing any carcasses or parts or products not eligible for export to the United States.
(4) Carcasses or parts or products are stored in a manner that ensures that no cross-contamination occurs.
(iii) Cooperative service agreement. Operators of processing establishments must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS in inspecting the establishment. APHIS anticipates that such inspections will occur once a year. The cooperative service account must always contain a balance that is at least equal to the cost of one inspection. APHIS will charge the cooperative service account for travel, salary, and subsistence of APHIS employees, as well as administrative overhead and other incidental expenses (including excess baggage charges up to 150 pounds).
(iv) Shipment to the United States. Poultry, game bird, or other bird carcasses or parts or products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where articles were processed that lists the numbers of the seals applied and states that all of the conditions of this section have been met. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.
(6) Poultry, game bird, or other bird carcasses or parts or products that do not otherwise qualify for importation under paragraphs (b)(1) through (5) of this section may be imported only if the importer applies to, and is granted a permit by, the Administrator, authorizing such importation. A permit will be given only when the Administrator determines that such importation will not constitute a risk of introduction or dissemination of Newcastle disease or HPAI into the United States. Application for a permit may be made in accordance with paragraph (d) of this section.
(c) Eggs (other than hatching eggs) from regions where Newcastle disease or HPAI is considered to exist. Eggs (other than hatching eggs
(1) With a certificate. The eggs may be imported if they are accompanied by a certificate signed by a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, and:
(i) The eggs are imported in cases marked with the identity of the flock of origin and sealed with the seal of the national government of the region of origin.
(ii) The certificate accompanying the eggs is presented to an authorized inspector when the eggs reach the port of arrival in the United States.
(iii) The certificate identifies the flock of origin and shows the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs, and cases of eggs, shipped with the certificate, and the date the certificate was signed.
(iv) The certificate states that the eggs qualify for importation in accordance with this section.
(v) The certificate states that no more than 90 days before the certificate was signed, a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, by a veterinarian accredited by the national government of Mexico, inspected the flock of origin and found no evidence of communicable diseases of poultry.
(vi) The eggs were washed, to remove foreign material from the surface of the shells, and sanitized on the premises of origin with a hypochlorite solution of from 100 ppm to 200 ppm available chlorine.
(vii) The eggs were packed on the premises of origin in previously unused cases.
(viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian of the national government of the region of origin who signed the certificate or, if exported from Mexico, by the veterinarian accredited by the national government of Mexico who signed the certificate.
(ix) In addition, if the eggs were laid in any region where Newcastle disease or HPAI is considered to exist (see paragraph (a) of this section), the certificate must also state:
(A) No Newcastle disease or HPAI occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed.
(B) There is no evidence that the flock of origin was exposed to Newcastle disease or HPAI during the 90 days before the certificate was signed.
(C) The eggs are from a region free of HPAI, or from a flock of origin found free of Newcastle disease as follows: On the seventh and fourteenth days of the 21-day period before the certificate is signed, at least 1 cull bird (a sick or dead bird, not a healthy bird that was killed) for each 10,000 live birds occupying each poultry house certified for exporting table eggs was tested for Newcastle disease virus using embryonated egg inoculation technique. The weekly cull rate of birds of every exporting poultry house within the exporting farm does not exceed 0.1 percent. The tests present no clinical or immunological evidence of Newcastle disease by embryonated egg inoculation technique from tissues of birds that were culled and have been collected by a salaried veterinary officer of the national government of the region of origin or by a veterinarian accredited by the national government of Mexico. All examinations and embryonated egg inoculation tests were conducted in a laboratory located in the region of origin, and the laboratory was approved to conduct the examinations and tests by the veterinary services organization of the national government of that region. All results were negative for Newcastle disease.
(D) Egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in the flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate.
(2) To an approved establishment for breaking and pasteurization. The eggs may be imported if they are moved from the port of arrival in the United States, under seal of the United States Department of Agriculture, to an approved establishment for breaking and pasteurization. Establishments will be approved when the Administrator determines that pasteurization and sanitation procedures for handling the eggs, and for disposing of egg shells, cases, and packing materials, are adequate to prevent the introduction of Newcastle disease and HPAI into the United States.
(3) For scientific, educational, or research purposes. The eggs may be imported if they are imported for scientific, educational, or research purposes and the Administrator has determined that the importation can be made under conditions that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.
(4) Other. The eggs may be imported when the Administrator determines that the eggs have been cooked or processed or will be handled in a manner that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.
(d) To apply for a permit, contact Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737, or visit https://efile.aphis.usda.gov/s/vs-permitting-assistant.
(a) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by ocean vessel and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 48 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(b) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States aboard an airplane or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 24 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(c) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means other than ocean vessel, airplane, or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 8 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(d) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means but are not offered for entry into this country, and other animals, meats, and other articles prohibited importation under other sections of this part, which come into the United States by any means, whether they are offered for entry into this country or not, shall be immediately destroyed or otherwise disposed of as the Administrator may direct at any time.
(a) African swine fever exists or the Administrator has reason to believe that African swine fever exists in the regions listed under paragraph (a)(2) of this section.
(1) The Administrator bases the reason to believe African swine fever exists in a region on the following factors:
(i) When a region allows the importation of host animals, pork or pork products, or vectors of African swine fever from a region in which African swine fever exists under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for importing host animals, pork or pork products, or vectors of African swine fever into the United States from a region in which African swine fever exists; or
(ii) When a region allows the importation or use of African swine fever virus or cultures under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for the importation or use of African swine fever virus or cultures into or within the United States; or
(iii) When a region has a contiguous border with, or is subject to commercial exchange or natural spread of African swine fever host animals, host materials, or vectors with, another region with known outbreaks of African swine fever; or
(iv) A region's lack of a disease detection, control, or reporting system capable of detecting or controlling African swine fever and reporting it to the United States in time to allow the United States to take appropriate action to prevent the introduction of African swine fever into the United States; or
(v) Any other fact or circumstance found to exist which constitutes a risk of introduction of African swine fever into the United States.
(2) A list of regions where African swine fever exists or the Administrator has reason to believe that African swine fever exists is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(3) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable, or upon determining that there is reason to believe the disease exists in the region. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present and that there is no reason to believe the disease is present. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.
(b) No pork or pork products may be imported into the United States from any region listed in this section unless:
(1) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully-sterilized product which is shelf-stable without refrigeration; or
(2) Such pork or pork product is not otherwise prohibited importation under this part and is consigned directly from the port of arrival in the United States to a meat processing establishment operating under Federal meat inspection, approved by the Administrator, for further processing of such pork or pork product by heat.
(3) Such pork or pork product:
(i) Was processed in a single establishment that meets the requirements in paragraph (b)(5) of this section.
(ii) Was heated by other than a flash-heating method to an internal temperature of at least 69 °C. (156 °F.) throughout after the bones had been removed.
(iii) Is accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 of chapter III of this title. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(4) The pork product is pork rind pellets (pork skins) that were cooked in one of the following ways in an establishment that meets the requirements in paragraph (b)(5) of this section:
(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.
(ii) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.
(5) The processing establishment
(i) All areas, utensils, and equipment likely to contact the pork or pork products to be processed, including skinning, deboning, cutting, and packing areas, and related utensils and equipment, must be cleaned and disinfected after processing pork or pork products not eligible for export to the United States and before processing any pork or pork products eligible for export to the United States.
(ii) Pork or pork products eligible for export to the United States may not be handled, cut, or otherwise processed at the same time as any pork or pork products not eligible for export to the United States.
(iii) Pork or pork products eligible for export to the United States must be packed in clean new packaging that is clearly distinguishable from that containing any pork or pork products not eligible for export to the United States.
(c) Pork or pork products consigned from the port of arrival to an approved establishment under the provisions of paragraph (b)(2) of this section shall be moved from the port of arrival to the approved establishment under Customs seals or seals of the Administrator, and shall be otherwise handled as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of African swine fever. Seals applied under this section shall not be broken except by persons authorized to do so by the Administrator.
(d) Pork or pork products imported into the United States from a region listed in this section which do not meet the requirements specified in this section shall be seized, quarantined, and disposed of as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of the disease.
(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.
(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.
(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.
(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no fresh pork or pork product may be imported into the United States from any region where classical swine fever is known to exist unless it complies with the following requirements:
(1) Such pork or pork product has been treated in accordance with one of the following procedures:
(i) Such pork and pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration;
(ii) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product was heated by other than a flash-heating method to an internal temperature of 69 °C. (156 °F.) throughout;
(iii) Such pork or pork product is in compliance with the following requirements:
(A) All bones have been completely removed in the region of origin, and
(B) The meat has been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived, and
(C) The meat has been thoroughly cured and fully dried for a period of not less than 90 days so that the product is shelf stable without refrigeration: Provided, That the period of curing and drying shall be 45 days if the pork or pork product is accompanied to the processing establishment by a certificate of an official of the national government of a classical swine fever free region which specifies that:
(1) The pork involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a) of this section as free of classical swine fever), in a closed container sealed by the national veterinary authorities of the classical swine fever free region by seals of a serially numbered type; and
(2) The numbers of the seals used were entered on the meat inspection certificate of the classical swine fever free region which accompanied the shipment from such free region: And, provided further, That the certificate required by paragraph (c)(3) of this section also states that: The container seals specified in paragraph (c)(1)(iii)(C)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment by a national veterinary inspector; and the processing establishment from which the pork or pork product is shipped to the United States does not receive or process any live swine, and uses only pork or pork product which originates in regions listed under paragraph (a) of this section as free of classical swine fever and processes all such pork or pork products in accordance with paragraph (c)(1)(i), (ii), or (iii) of this section; or
(iv) Pork rind pellets (pork skins) originating in regions where classical swine fever is known to exist may be imported into the United States provided they have been cooked in one of the following ways:
(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.
(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.
(2) Articles under paragraph (c)(1)(ii), (iii), or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and § 327.2 of this title; and,
(3) In addition to the foreign meat inspection certificate required by § 327.4 of this title, pork and pork products prepared under paragraph (c)(1)(ii), (iii), or (iv) of this section shall be accompanied by a certificate that states that the provisions of paragraph (c)(1)(ii), (iii), or (iv) of this section have been met. This certificate shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title.
(4) Small amounts of pork or pork product, subject to the restrictions in this section, may in specific cases be imported for purposes of examination, testing, or analysis if the importer applies for and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.
(d) Thoroughly cured and fully dried pork and pork products from regions where both classical swine fever and swine vesicular disease are known or considered to exist need not comply with paragraph (c)(1)(iii) of this section if they are in compliance with the provisions of § 94.12(b)(1)(iii) of this part.
(e) Uncooked pork or pork products that originated in a region considered to be free of classical swine fever (CSF) and are processed in a region where CSF exists may be imported into the United States under the following conditions:
(1) Shipment to approved establishments. (i) The uncooked pork or pork products must be shipped from the CSF-free region of origin in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by an official of that region's national government and that specifies the product's region of origin, the name and number of the establishment of origin, and the processing establishment to which the uncooked pork or pork products are consigned, and the numbers of the seals applied to the shipping containers.
(ii) The uncooked pork or pork products may be removed from containers at the processing establishment in the region where CSF is considered to exist only after an official of that region's national government has determined that the seals are intact and free of any evidence of tampering.
(2) Handling of uncooked pork and pork products. Establishments
(i) May not receive or handle any live swine;
(ii) May not receive, handle, or process uncooked pork or pork products that originate in regions affected with CSF;
(iii) Must keep the certificate required by paragraph (e)(1)(i) of this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections; and
(iv) Must be evaluated and approved by APHIS through a site inspection.
(3) Compliance agreement. The operators of the processing establishment must sign a compliance agreement with APHIS, stating that:
(i) All meat processed for importation to the United States will be processed in accordance with the requirements of this part; and
(ii) A full-time, salaried meat inspection official of the national government of the region in which the processing facility is located will supervise the processing and examination of the product, and certify that it has been processed in accordance with this section; and
(iii) APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.
(4) Cooperative service agreement. The processing establishment, or a party on its behalf, must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS for the initial evaluation of the processing establishment and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. In accordance with the terms of the cooperative service agreement, before the APHIS representative's site inspection, the operator of the processing establishment or the party acting on their behalf must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.
(5) Shipment to the United States. Uncooked pork or pork products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where the pork or pork products were processed that lists the numbers of the seals applied and states that all of the conditions of this paragraph (e) have been met. The certificate shall also state that the container seals specified in paragraph (e)(1)(i) and (ii) of this section were found by an official of the region's national government to be intact and free of any evidence of tampering on arrival at the processing establishment in the CSF-affected region. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.
(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.
(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.
(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.
(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no swine that are moved from or transit any region where classical swine fever is known to exist may be imported into the United States, except for wild swine imported into the United States in accordance with paragraph (d) of this section.
(d) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.
(a) The meat of ruminants or swine, and other animal products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in any region listed as provided in paragraph (a)(2) of this section may not be imported into the United States unless the requirements in this section, in addition to other applicable requirements of chapter III of this title, are met. However, meat and meat products that meet the requirements of § 94.4 do not have to comply with the requirements of this section. As used in this section, the term “other animal product” means all parts of the carcass of any ruminant or swine, other than meat and articles regulated under part 95 or part 96 of this chapter.
(1) The regions listed under paragraph (a)(2) of this section have been declared free of foot-and-mouth disease by APHIS as provided in § 94.1(a) but supplement their national meat supply by the importation of fresh (chilled or frozen) meat of ruminants or swine from regions that APHIS considers to be affected with foot-and-mouth disease as provided in § 94.1(a); or have a common land border with regions considered to be affected with foot-and-mouth disease; or import ruminants or swine from regions considered to be affected with foot-and-mouth disease under conditions less restrictive than would be acceptable for importation into the United States. Thus, the meat may be commingled with the fresh (chilled or frozen) meat of animals from an affected region, resulting in an undue risk of introducing foot-and-mouth disease into the United States.
(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that foot-and-mouth disease exists in the region.
(b) All meat or other animal product from such regions, whether in personal-use amounts or commercial lots (except that which has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration) shall have been prepared only in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2, chapter III of this title, issued thereunder, and shall be accompanied by a Department-approved meat inspection certificate prescribed in § 327.4 in chapter III of this title, or similar certificate approved by the Administrator, as adequate to effectuate the purposes of this section, regardless of the purpose or amount of product in the shipment.
(c) Additional certification. Meat of ruminants or swine or other animal products from any region listed under paragraph (a)(2) of this section must be accompanied by additional certification by a full-time salaried veterinary official of the agency in the national government that is responsible for the health of the animals within that region. Upon arrival of the meat of ruminants or swine or other animal product in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must give the name and official establishment number of the establishment where the animals were slaughtered, and shall state that:
(1) The slaughtering establishment is not permitted to receive animals that originated in, or have ever been in, or that have been aboard a means of conveyance at the time such means of conveyance called at or landed at a port in, a region designated under § 94.1(a) as a region where foot-and-mouth disease exists;
(2) The slaughtering establishment is not permitted to receive meat or other animal products derived from ruminants or swine which originated in such a foot-and-mouth disease affected region, or meat or other animal products from a foot-and-mouth disease free region transported through a foot-and-mouth disease affected region except in containers sealed with serially numbered seals of the National Government of the noninfected region of origin;
(3) The meat or other animal product covered by the certificate was derived from animals born and raised in a region listed under § 94.1(a) as free of foot-and-mouth disease and the meat or other animal product has never been in any region in which foot-and-mouth disease existed;
(4) The meat or other animal product has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner to preclude its being commingled or otherwise in contact with meat or other animal products that do not comply with the conditions contained in this certificate.
(a) APHIS considers swine vesicular disease to exist in all regions of the world except those declared free of the disease by APHIS.
(1) A list of regions that APHIS has declared free of swine vesicular disease is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(2) APHIS will add a region to the list of those it has declared free of swine vesicular disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of swine vesicular disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.
(b) No pork or pork product may be imported into the United States from any region where swine vesicular disease is known to exist unless it complies with the following requirements and it is not otherwise prohibited importation into the United States under this part:
(1) Such pork or pork product has been treated in accordance with one of the following procedures:
(i) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling, but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration.
(ii) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received heat treatment in a commercially accepted manner used for perishable canned pork products so that it reached an internal temperature of 69 °C. (156 °F.) throughout.
(iii) Such pork or pork product if cured and dried is in compliance with the following requirements:
(A) All bones have been completely removed in the region of origin, and
(B) Such pork or pork products shall be consigned directly from the port of entry in the United States to a meat processing establishment operating under Federal meat inspection and approved by the Administrator,
(iv) Such pork or pork product, if it originated in a swine vesicular disease free region, has been cured and dried and is in compliance with the following requirements:
(A) All bones have been completely removed, either in the region of origin or in the region where the pork or pork products are processed; and
(B)(1) Such pork or pork product is accompanied from the swine vesicular disease free region of origin to the processing establishment in the swine vesicular disease affected region by a certificate signed by an official of the National Government of the swine vesicular disease free region of origin specifying that the pork or pork product involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a)(1) of this section as free of swine vesicular disease), in a closed container sealed by the national veterinary authorities of the swine vesicular disease free region of origin by seals of a serially numbered type. The numbers of these seals shall be entered on this certificate; and
(2) The certificate required by paragraph (b)(3) of this section shall also state that:
(i) The container seals specified in paragraph (b)(1)(iv)(B)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment in the swine vesicular disease affected region by a national veterinary inspector of that region,
(ii) The processing establishment from which the pork or pork product was shipped to the United States does not receive or process any live swine, and uses only pork or pork products which originate in regions listed under paragraph (a)(1) of this section as free of swine vesicular disease; and
(iii) That such establishment processes all such pork or pork products in accordance with paragraph (b)(1)(i), (ii), (iii) or (iv) of this section.
(v) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received continual heat treatment in an oven for a minimum of 10 hours so that it reached an internal temperature of 65 °C. (149 °F.) throughout. The oven temperature started at a minimum of 62 °C. (143.6 °F.) and reached at least 85 °C. (185 °F.).
(vi) Pork rind pellets (pork skins) must be cooked in one of the following ways:
(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.
(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.
(2) Articles under paragraph (b)(1)(ii), (iii) or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and the regulations in § 327.2 in chapter III of this title.
(3) In addition to the foreign meat inspection certificate required in § 327.4 of this title, pork or pork products prepared under paragraph (b)(1)(ii), (iii) or (iv) of this section shall be accompanied by certification that paragraph (b)(1)(ii), (b)(1)(iii)(A), or (b)(1)(iv)(B)(2) of this section has been met. The certification shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title.
(4) Small amounts of pork or pork product subject to the restrictions of this section, may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies for and receives written approval for such importation from the Administrator, authorizing such importation. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.
(c) Requirements for pork-filled pasta products from regions affected with swine vesicular disease. (1) Pork-filled pasta products processed for export to the United States may only be filled with pork or pork products that are otherwise eligible to be exported to the United States and that meet the requirements of paragraph (b)(1)(i), (ii), or (v) of this section or of § 94.17.
(2) The operator of the pork-filled pasta processing facility must have signed a cooperative service agreement with APHIS prior to receipt of the pork intended to be used in pork-filled pasta products, stating that all such pork will be processed only in accordance with § 94.12 or § 94.17. Pursuant to the cooperative service agreement, the establishment must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the facilities, operations, and records of the establishment. The establishment must be current in paying all costs for such inspections (it is anticipated that such inspections will occur up to four times per year). These costs include travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate costs for APHIS to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and, as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level must be paid within 14 days of receipt of such bills.
(3) At the pasta processing establishment, pork intended to be used for pork-filled pasta products for export to the United States must be stored apart from any meat or meat products not eligible for export to the United States, either in a separate storage room or facility or in a separate area of the same storage room. Any storage room area reserved for pork or pork products eligible for export to the United States must be separated by at least 1 meter from any storage room area where meat or meat products ineligible for export to the United States are stored and must be marked by signs and by having its borders outlined on the floor.
(4) Prior to handling pork used for pork-filled pasta products intended for export to the United States, workers at the processing facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States.
(5) All equipment and machinery that will come in contact with the pork or other ingredients of pork-filled pasta products intended for export to the United States must be cleaned and disinfected before each use.
(6) Processing lines working with pork-filled pasta products for export to the United States must be totally dedicated to the production of such products for the time needed to complete a given lot. When any processing line in a facility is working with pork-filled pasta products intended for export to the United States, no other processing lines in the same facility may work on products using meat that is not eligible for export to the United States.
(7) Processing facilities that are completely dedicated to producing only pork-filled pasta products for export to the United States and do not receive, handle, or process any animal product not intended for export to the United States are exempt from the requirements of paragraphs (c)(3) through (c)(6) of this section.
(8) During processing, the pork-filled pasta must be steam-heated to a minimum internal temperature of 90 °C, then dried, cooled, and packed to make the product shelf stable without refrigeration.
(9) The processing facility must maintain under lock and key, for a minimum of 2 years, an original record of each lot of pork or pork products used for pork-filled pasta products for export to the United States. Each record must include the following:
(i) The date that the cooked or dry-cured pork product was received in the processing facility;
(ii) The number of packages, the number of hams or cooked pork products per package, and the weight of each package;
(iii) A lot number or other identification marks;
(iv) The health certificate that accompanied the cooked or dry-cured pork product from the slaughter/processing facility to the meat-filled pasta product processing facility; and
(v) The date that the pork or pork product used in the pasta started dry curing (if the product used is a dry-cured ham) or the date that the product was cooked (if the product used is a cooked pork product).
(10) The pork-filled pasta must be accompanied by a certificate issued by an official of the National Government of the region in which the pasta product is processed who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating that the pork-filled pasta product has been processed in accordance with the requirements of this section.
Upon arrival of the pork-filled pasta in the United States, the certificate must be presented to an inspector at the port of arrival.
(a) Pork or pork products and ship's stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, produced in any region listed under paragraph (a)(2) of this section may not be imported into the United States unless the requirements of this section, in addition to other applicable requirements of part 327 of this title, are met.
(1) The regions listed under paragraph (a)(2) of this section have been declared free of swine vesicular disease as provided in § 94.12(a) but supplement their national pork supply by the importation of fresh (chilled or frozen) meat of animals from regions where swine vesicular disease is considered to exist, or have a common border with such regions, or have trade practices that are less restrictive than are acceptable to the United States. Thus, the pork or pork products may be commingled with fresh (chilled or frozen) meat of animals from a region where swine vesicular disease is considered to exist, resulting in an undue risk of swine vesicular disease introduction into the United States.
(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances listed in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that swine vesicular disease exists in the region.
(b) All such pork or pork products, except those treated in accordance with § 94.12(b)(1)(i) of this part, shall have been prepared only in inspected establishments that are eligible to have their products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and under § 327.2 of this title and shall be accompanied by the foreign meat inspection certificate required by § 327.4 of this title. Upon arrival of the pork or pork products in the United States, the foreign meat inspection certificate must be presented to an authorized inspector at the port of arrival.
(c) Unless such pork or pork products are treated according to one of the procedures described in § 94.12(b) of this part, the pork or pork products must be accompanied by an additional certificate issued by a full-time salaried veterinary official of the agency in the national government responsible for the health of the animals within that region. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival. The certificate shall state the name and official establishment number of the establishment where the swine involved were slaughtered and the pork was processed. The certificate shall also state that:
(1) The slaughtering establishment is not permitted to receive animals that originated in a region considered to have swine vesicular disease or that have ever been in a region in which swine vesicular disease existed.
(2) The slaughtering establishment is not permitted to receive pork derived from swine which originated in such a region or pork from swine from a swine vesicular disease free region which has been transported through a region where swine vesicular disease is considered to exist except pork which was transported in containers sealed with serially numbered seals of the National Government of a region of origin listed under § 94.12(a) as a region considered free of the disease.
(3) The pork has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner that precludes its being commingled or otherwise coming in contact with pork or pork products that have not been handled in accordance with the requirements of this section.
(a) Swine vesicular disease is known to exist in all regions of the world except those listed under § 94.12(a) of this part. No swine which are moved from or transit any region in which swine vesicular disease is known to exist may be imported into the United States except wild swine imported in accordance with paragraph (b) of this section.
(b) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.
(a) Any meat or other animal product or material (excluding materials that are required to be consigned to USDA-approved establishments for further processing) eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit the United States by air and ocean ports and overland transportation if the articles are accompanied by the required documentation specified in this part and in part 95.
(b) Any meat or other animal product or material not eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit air and ocean ports only, with no overland movement outside the airport terminal area or dock area of the maritime port, in the United States for immediate export if the conditions of paragraphs (b)(1) through (4) of this section are met.
(1) The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain under either Customs seal or foreign government seal during the entire time that it is in the United States.
(2) Before transit, the person moving the articles must notify, in writing, the authorized Customs inspector at both the place in the United States where the articles will arrive and the port of export. The notification must include the:
(i) Times and dates of arrival in the United States;
(ii) Times and dates of exportation from the United States;
(iii) Mode of transportation; and
(iv) Serial numbers of the sealed containers.
(3) The articles must transit the United States under Customs bond.
(4) The shipment is exported from the United States within 7 days of its entry.
(c) Pork and pork products from Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, and Yucatan, Mexico, that are not eligible for entry into the United States in accordance with this part may transit the United States via land border ports for immediate export if the following conditions of paragraphs (c)(1) through (4) of this section are met:
(1) The person moving the pork and pork products must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).
(2) The pork or pork products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, or Yucatan, Mexico, in leakproof containers and sealed with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit across Mexico and the United States.
(3) The person moving the pork and pork products through the United States notifies, in writing, the authorized Customs inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the pork and pork products:
(i) Permit number;
(ii) Times and dates of arrival in the United States;
(iii) Time schedule and route to be followed through the United States; and
(iv) Serial numbers of the seals on the containers.
(4) The pork and pork products must transit the United States under Customs bond and must be exported from the United States within the time limit specified on the permit. Any pork or pork products that have not been exported within the time limit specified on the permit or that have not been transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).
(d) Poultry carcasses, parts, or products (except eggs and egg products) from Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, that are not eligible for entry into the United States in accordance with the regulations in this part may transit the United States via land ports for immediate export if the following conditions of paragraphs (d)(1) through (4) of this section are met:
(1) The person moving the poultry carcasses, parts, or products through the United States must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).
(2) The poultry carcasses, parts, or products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, in leakproof containers with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit through Mexico and the United States.
(3) The person moving the poultry carcasses, parts, or products through the United States must notify, in writing, the authorized U.S. Customs and Border Protection (CBP) inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the poultry to transit the United States:
(i) Permit number;
(ii) Times and dates of arrival in the United States;
(iii) Time schedule and route to be followed through the United States; and
(iv) Serial numbers of the seals on the containers.
(4) The poultry carcasses, parts, or products must transit the United States under U.S. Customs bond and must be exported from the United States within the time limit specified on the permit. Any poultry carcasses, parts, or products that have not been exported within the time limit specified on the permit or that have not transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).
(e) Meat and other products of ruminants or swine from regions listed in § 94.11(a) and pork and pork products from regions listed in § 94.13 that do not meet the requirements of § 94.11(b) or § 94.13(a) may transit through the United States for immediate export, provided the provisions of paragraph (b) of this section are met, and provided all other applicable provisions of this part are met.
(a) The following milk products are exempt from the provisions of this part:
(1) Cheese, but not including cheese with liquid and not including cheese containing any item that is regulated by other sections of this part, unless such item is independently eligible for importation into the United States under this part;
(2) Butter; and
(3) Butteroil.
(b) Milk and milk products originating in, or shipped from, any region where foot-and-mouth disease is considered to exist under § 94.1(a) may be imported into the United States if they meet the requirements of paragraphs (b)(1), (2), or (3) of this section:
(1) They are in a concentrated liquid form and have been processed by heat by a commercial method in a container hermetically sealed promptly after filling but before such heating, so as to be shelf stable without refrigeration.
(2) They are dry milk or dry milk products, including dry whole milk, nonfat dry milk, dried whey, dried buttermilk, and formulations which contain any such dry milk products, and are consigned directly to an approved establishment
(3) Milk and milk products not exempted under paragraph (a) and not of classes included within the provisions of paragraphs (b)(1) or (2) of this section may be imported if the importer first applies to and receives written permission from the Administrator, authorizing such importation. Permission will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States. Products subject to this provision include but are not limited to condensed milk, long-life milks such as sterilized milk, casein and caseinates, lactose, and lactalbumin.
(4) Small amounts of milk and milk products subject to the restrictions of this part may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies to and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States.
(c) Milk and milk products originating in and shipped from regions listed under § 94.1(a) as free of foot-and-mouth disease but which have entered a port or otherwise transited a region where APHIS considers the disease to exist may not be imported into the United States unless:
(1) The product was transported under serially numbered official seals applied at the point of origin of the shipment by an authorized representative of the region of such origin; except that, if any seal applied at the point of origin was broken by any foreign official to inspect the shipment, an authorized representative of that region applied a new serially numbered official seal to the hold, compartment, or container in which the milk or milk products were transported; and if any member of a ship's crew broke a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal were recorded in the ship's log.
(2) The numbers of such seals are listed on, or are on a list attached to, the bill of lading or similar document accompanying the shipment.
(3) Upon arrival of the carrier at the United States port, an inspector of the Animal and Plant Health Inspection Service determines that the seals are intact and that their numbers are in agreement with the numbers appearing on the accompanying document; Provided, That, if the representative finds that any seal has been broken or has a different number than is recorded on the accompanying document, then the milk or milk products may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the cartons or other containers of milk or milk products, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of the government) that demonstrates to the satisfaction of the Administrator that the milk or milk products were not contaminated or exposed to contamination during movement from the region of origin to the United States.
(d) Except for milk and milk products imported from Canada, and except as provided in this paragraph, milk or milk products imported from a region listed under § 94.1(a) as free of foot-and-mouth disease must be accompanied by a certificate endorsed by a full-time, salaried veterinarian employed by the region of export. The certificate must state that the milk was produced and processed in a region listed under § 94.1(a) as free of foot-and-mouth disease, or that the milk product was processed in one such region from milk produced in another such region. The certificate must name the region in which the milk was produced and the region in which the milk or milk product was processed. Further, the certificate must state that, except for movement under seal as described in § 94.16(c), the milk or milk product has never been in a region in which foot-and-mouth disease exists. Milk or milk products from a region listed under § 94.1(a) as free of foot-and-mouth disease and that were processed in whole or in part from milk or milk products from a region not listed under § 94.1(a) as free of foot-and-mouth disease may be imported into the United States only in accordance with paragraph (b)(3) of this section.
Notwithstanding any other provisions in this part, dry-cured ham, pork shoulder, or pork loin, whether whole or sliced and packaged, shall not be prohibited from being imported into the United States if it meets the following conditions:
(a) Except for Italian-type hams, Serrano hams, Iberian hams, Iberian pork shoulders, and Iberian pork loins that have been processed in accordance with paragraph (i) of this section, the dry-cured ham, pork shoulder, or pork loin came from a swine that was never out of the region in which the dry-cured ham, pork shoulder, or pork loin was processed;
(b) The ham, pork shoulder, or pork loin came from a region determined by the Administrator, to have and to enforce laws requiring the immediate reporting to the national veterinary services in that region any premises found to have any animal infected with foot-and-mouth disease, African Swine fever, classical swine fever, or swine vesicular disease;
(c) The ham, pork shoulder, or pork loin came from a swine that was not on any premises where foot-and-mouth disease, African swine fever, classical swine fever, or swine vesicular disease exists or had existed within 60 days prior to slaughter;
(d) The whole ham, pork shoulder, or pork loin was accompanied from the slaughtering facility to the processing establishment by a numbered certificate issued by a person authorized by the government of the region of origin stating that the provisions of paragraphs (a) and (c) of this section have been met;
(e) The ham, pork shoulder, or pork loin was processed whole as set forth in paragraph (i) of this section in only one processing establishment;
(f) The ham, pork shoulder, or pork loin was processed whole in a processing establishment that prior to the processing of any hams, pork shoulders, or pork loins in accordance with this section, was inspected by a veterinarian of APHIS and determined by the Administrator, to be capable of meeting the provisions of this section for processing hams, pork shoulders, or pork loins for importation into the United States;
(g) The ham, pork shoulder, or pork loin was processed whole in a processing establishment for which the operator of the establishment has signed an agreement with APHIS prior to receipt of the hams, pork shoulders, or pork loins for processing, stating that all hams, pork shoulders, or pork loins processed for importation into the United States will be processed only in accordance with the provisions of this part;
(h) Workers who handle fresh pork in the processing establishment where the dry-cured ham, pork shoulder, or pork loin was processed whole are required to shower and put on a full set of clean clothes, or to wait 24 hours after handling fresh pork, before handling hams, pork shoulders, or pork loins that have progressed in the aging/curing process as follows:
(1) In the case of Italian-type hams processed in accordance with paragraph (i)(1) of this section, those that have progressed beyond the final wash stage;
(2) In the case of Serrano hams or Iberian hams or pork shoulders processed in accordance with paragraphs (i)(2), (i)(3), or (i)(4) of this section, those that have progressed beyond salting; and
(3) In the case of Iberian pork loins processed in accordance with paragraph (i)(5) of this section, those that have progressed beyond being placed in a casing.
(i) The dry-cured ham, pork shoulder, or pork loin was processed whole in accordance with this paragraph. Except for pork fat treated to at least 76 °C (168.8 °F), which may have been placed over the meat during curing, the dry-cured pork product must have had no contact with any other meat or animal product during processing.
(1) Italian-type hams. The ham was processed for a period of not less than 400 days in accordance with the following conditions: after slaughter the ham was held at a temperature of 0-3 °C. (32-34.7 °F) for a minimum of 72 hours during which time the “aitch” bone and the foot was removed and the blood vessels at the end of the femur were massaged to remove any remaining blood; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 5-7 days on racks in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F) and at a relative humidity of 70-85 percent; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 21 days in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F.) and at a relative humidity of 70-85 percent; thereafter the salt was brushed off the ham; thereafter the ham was placed in a chamber maintained at a temperature of 1-6 °C. (33.8-42.8 °F.) and at a relative humidity of 65-80 percent for between 52 and 72 days; thereafter the ham was brushed and rinsed with water; thereafter the ham was placed in a chamber for 5-7 days at a temperature of 15-23 °C. (59-73.4 °F.) and a relative humidity of 55-85 percent; thereafter the ham was placed for curing in a chamber maintained for a minimum of 314 days at a temperature of 15-20 °C. (59-68 °F.) and at a relative humidity of 65-80 percent at the beginning and increased by 5 percent every 2
(2) Serrano hams. Serrano hams were processed as follows (190-day minimum curing process):
(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 12 °C to 13 °C (53.6 °F to 55.4 °F) for the first 24 hours, then at 13 °C to 14 °C (55.4 °F to 57.2 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham.
(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with a relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days;
(v) The ham was placed for curing in a chamber with a relative humidity of 60 to 80 percent and a temperature gradually raised in 3 phases, as follows:
(A) A temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F), maintained for a minimum of 45 days;
(B) A temperature of 16 °C to 24 °C (60.8 °F to 75.2 °F), maintained for a minimum of 35 days;
(C) A temperature of 24 °C to 34 °C (75.2 °F to 93.2 °F), maintained for a minimum of 30 days;
(vi) Finally, with the relative humidity unchanged at 60 to 80 percent, the temperature was lowered to 12 °C to 20 °C (53.6 °F to 68 °F) and maintained at that level for a minimum of 35 days, until at least 190 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 370 days, until at least 560 days after the start of the curing process.
(3) Iberian hams. Iberian hams were processed as follows (365-day minimum curing process):
(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 5.5 °C to 6.5 °C (41.9 °F to 43.7 °F) for the first 24 hours, then at 9.5 °C to 10.5 °C (49.1 °F to 50.9 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, and kept in the chamber for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham;
(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days.
(v) The ham was placed for curing in a chamber with a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and relative humidity of 60 to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity reduced to 55 to 85 percent, for a minimum of 90 days.
(vii) Finally, with the relative humidity raised to 60 to 90 percent, the temperature was lowered to 12 °C to 22 °C (53.6 °F to 71.6 °F) and maintained at that level for a minimum of 115 days, until at least 365 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 195 days, until at least 560 days after the start of the curing process.
(4) Iberian pork shoulders. Iberian pork shoulders were processed as follows (240-day minimum curing process):
(i) If the pork shoulder is received frozen, it was thawed at a room temperature of 12 °C to 13 °C (53.6 °F to 55.4 °F), with the relative humidity between 75 and 85 percent, for approximately 24 hours, until the internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels in the scapular region were massaged to remove any remaining blood.
(ii) The pork shoulder was covered in salt and placed in a chamber maintained at a temperature of 0 °C to 4 °C (32 °F to 39.2 °F) with the relative humidity between 75 and 95 percent, for a period of no less than 0.65 days per kg and no more than 2 days per kg of the weight of the pork shoulder.
(iii) The pork shoulder was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The pork shoulder was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F) and a relative humidity of 70 to 95 percent for not less than 40 days and not more than 60 days.
(v) The pork shoulder was placed for curing in a chamber at a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and a relative humidity of 60 to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity was changed to 55 to 85 percent, and those levels were maintained for a minimum of 90 days.
(vii) Finally, the temperature was reduced to 12 °C to 22 °C (53.6 °F to 71.6 °F) and the relative humidity was raised to 60 to 90 percent for a minimum of 45 days, until at least 240 days after the start of the curing process.
(5) Iberian pork loins. Iberian pork loins were processed as follows (130-day minimum curing process):
(i) If the pork loin is received frozen, it was thawed at a room temperature maintained at 11 °C to 12 °C (51.8 °F to 53.6 °F), with the relative humidity between 70 and 80 per cent for the first 24 hours, then between 75 and 85 percent, until the loin's internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the external fat, aponeurosis, and tendons were cleaned from the loin.
(ii) The pork loin was covered in a pickle preparation (25-30 grams of salt for each kilogram of pork loin) and placed in a chamber where it was maintained at a relative humidity of 75 to 95 percent and a temperature of 3 °C to 4 °C (37.4 °F to 39.2 °F) for 72 hours.
(iii) The pork loin was removed from the pickle preparation (25-30 grams of salt for each kilogram of pork loin), externally cleaned (brushed or rinsed), placed in an artificial casing, and fastened shut with a metal clip.
(iv) The pork loin was placed for curing in a chamber with a relative humidity of 60 to 90 percent and a temperature gradually raised in 3 phases, as follows:
(A) A temperature of 2 °C to 6 °C (35.6 °F to 42.8 °F), maintained for a minimum of 20 days;
(B) A temperature of 6 °C to 15 °C (42.8 °F to 59.0 °F), maintained for a minimum of 20 days;
(C) A temperature of 15 °C to 25 °C (59.0 °F to 77.0 °F), maintained for a minimum of 40 days;
(v) Finally, with the relative humidity unchanged at 60 to 80 percent and the temperature lowered to 0 °C to 5 °C (32.0 °F to 41.0 °F), the pork loin was vacuum-packed and maintained under those conditions for a minimum of 15 days, until at least 130 days after the start of the curing process.
(j)(1) The whole ham, if it is Italian-type ham processed in accordance with paragraph (i)(1) of this section, bears a hot iron brand or an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, bears a button seal (approved by the Administrator, as being tamper-proof) on the hock that states the month and year the ham entered the processing establishment and a hot iron brand (with the identifying number of the processing establishment and the date salting began) which were placed thereon at the processing establishment immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin;
(2) The whole dry-cured ham, if it is processed in accordance with paragraphs (i)(2) or (i)(3) of this section, or the whole dry-cured pork shoulder, if it is processed in accordance with paragraph (i)(4) of this section, bears an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and an ink seal (with the identifying number of the processing establishment and the date the salting began) which was placed thereon at the processing establishment, immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin; or
(3) The whole dry-cured pork loin, if it is processed in accordance with paragraph (i)(5) of this section, is packaged with material that bears a seal of the government of the region of origin which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and bears a tamper-proof plastic tag, securely attached to the pork loin itself, that states the identifying number of the slaughtering establishment and the date the pork loin was placed in the pickle preparation under the supervision of a person authorized to supervise such activity by the veterinary service of the national government of the region of origin.
(k) The whole dry-cured ham, pork shoulder, or pork loin came from an establishment where a person authorized by the veterinary services of the national government of the region of origin to conduct activities under this paragraph, maintained original records (which shall be kept for a minimum of two years) identifying the dry-cured ham, pork shoulder, or pork loin by the date it entered the processing establishment, by the slaughtering facility from which it came, and by the number of the certificate which accompanied the dry-cured ham, pork shoulder, or pork loin from the slaughtering facility to the processing establishment, and where such original records are maintained under lock and key by such person, with access to such original records restricted to officials of the government of the region of origin, officials of the United States Government, and such person maintaining the records;
(l) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment which allows the unannounced entry into the establishment of APHIS personnel, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment;
(m) The dry-cured ham, pork shoulder, or pork loin was processed in accordance with one of the following criteria:
(1) The ham, if it is an Italian-type ham processed in accordance with paragraph (i)(1) of this section, was processed in a region which has submitted, through its veterinary services, to the Administrator, a written statement stating that it conducts a program to authorize persons to supervise activities specified under this section;
(2) The Serrano ham, processed in accordance with paragraph (i)(2) of this section, and came from any breed of large, white swine, including but not limited to Landrace, Pietrain, Duroc, Jersey, Hampshire, and Yorkshire breeds, and crosses of such breeds;
(3) The Iberian ham, processed in accordance with paragraph (i)(3) of this section, and came from a swine of the Iberico breed of pigs;
(4) The Iberian pork shoulder, processed in accordance with paragraph (i)(4) of this section, and came from a swine of the Iberico breed of pigs;
(5) The Iberian pork loin, if processed in accordance with paragraph (i)(5) of this section, and came from a swine of the Iberico breed of pigs.
(n) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment that has entered into a cooperative service agreement executed by the operator of the establishment or a representative of the establishment and APHIS, and that pursuant to the cooperative service agreement is current in paying all costs for a veterinarian of APHIS to inspect the establishment (it is anticipated that such inspections will occur up to four times per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment shall deposit with the Administrator, an amount equal to the approximate costs for a veterinarian to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level shall be paid within 14 days of receipt of such bills.
(o) The dry-cured ham, pork shoulder, or pork loin is accompanied at the time of importation into the United States by a certificate issued by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin, stating:
(1) That all the provisions of this section have been complied with, including paragraphs (i) and (m) of this section;
(2) The paragraph of this section under which the dry-cured ham, pork shoulder, or pork loin was processed; and stating further that, if the product covered by the certificate:
(i) Is an Italian-type ham processed under paragraph (i)(1) of this section, it was processed for a minimum of 400 days;
(ii) Is a Serrano ham processed under paragraph (i)(2) of this section, it was:
(A) Processed for a minimum of 190 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,
(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;
(iii) Is an Iberian ham processed under paragraph (i)(3) of this section, it was:
(A) Processed for a minimum of 365 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,
(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;
(iv) Is a dry-cured pork shoulder, it was processed in accordance with paragraph (i)(4) of this section for a minimum of 240 days; or
(v) Is a dry-cured pork loin, it was processed in accordance with paragraph (i)(5) of this section for a minimum of 130 days.
(p) Whole hams, pork shoulders, and pork loins that have been dry-cured in accordance with paragraph (i) of this section may be transported to a facility in the same region for slicing and packaging in accordance with this paragraph.
(1) The slicing/packaging facility. (i) The slicing/packaging facility
(ii) The slicing/packaging facility must be either in a separate, physically detached building, or in a separate room in the facility where the whole ham, pork shoulder, or pork loin was dry-cured in accordance with paragraph (i) of this section. If the slicing/packaging facility is in a separate room, the room must have no direct access to areas in the facility where pork is cured and dried and it must be capable of being closed off from the rest of the facility so unauthorized individuals cannot enter.
(iii) The slicing/packaging facility, including all equipment used to handle pork and pork products, such as containers, work surfaces, slicing machines, and packaging equipment, must be cleaned and disinfected after sliced and packaged pork products that are not eligible for export to the United States leave the facility, and before whole dry-cured hams, pork shoulders, or pork intended for importation into the United States enter the facility for slicing and packaging. Cleaning and disinfecting must be adequate to ensure that disease agents of concern are killed or inactivated and that pork products intended for importation into the United States are not contaminated.
(iv) The slicing/packaging facility must maintain under lock and key for a minimum of 2 years, original records on each lot of whole dry-cured hams, pork shoulders, and pork loins entering the facility for slicing and packaging under this section, including:
(A) The approval number of the facility where the whole ham, shoulder, or loin was dry-cured in accordance with paragraph (i) of this section;
(B) The date the whole ham, shoulder, or loin started dry-curing;
(C) The date the whole ham, shoulder, or loin completed dry-curing;
(D) The date the whole ham, shoulder, or loin was sliced and packaged; and
(E) A copy of all certifications required under paragraph (p) of this section.
(v) Access to records required to be maintained under paragraph (p) of this section must be restricted to officials of the national government of the region of origin, representatives of the United States Government, and persons maintaining the records.
(vi) The operator of the slicing/packaging facility must have signed a cooperative service agreement with APHIS prior to receipt of the whole dry-cured hams, pork shoulders, or pork loins for slicing and packaging, stating that all hams, pork shoulders, or pork loins sliced and packaged at the facility for importation into the United States will be sliced and packaged only in accordance with this section.
(vii) The operator of the slicing/packaging facility must be current, in accordance with the terms of the cooperative service agreement signed with APHIS, in paying all costs for an APHIS representative to inspect the establishment, including travel, salary, subsistence, administrative overhead, and other incidental expenses.
(viii) The slicing/packaging facility must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment.
(ix) Workers at the slicing/packaging facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States, before handling dry-cured hams, pork shoulders, or pork loins in the slicing/packaging facility that are intended for importation into the United States.
(x) Pork products intended for importation into the United States may not be in the slicing/packaging facility at the same time as pork products not intended for exportation to the United States.
(2) Slicing and packaging and labeling procedures. (i) A full-time salaried veterinarian employed by the national government of the region of origin must inspect each lot of whole dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility, before slicing is begun, and must certify in English that it is eligible for importation into the United States in accordance with this section; and
(ii) Either a full-time salaried veterinarian employed by the national government of the region of origin, or, if the national government of the region of origin recognizes a local consortium as responsible for product quality, a representative of that local consortium, must certify in English that he or she personally supervised the entire process of slicing and packaging each lot of dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility; that each lot of dry-cured hams, pork shoulders, and pork loins was sliced and packaged in accordance with the requirements of this paragraph; and that the sliced and packaged pork ham, shoulder, or loin is the same dry-cured ham, pork shoulder, or pork loin certified under paragraph (p)(2)(i).
(iii) The sliced and packaged dry-cured pork ham, pork shoulder, or pork loin must be labeled with the date that processing of the meat under paragraph (i) of this section began, and with the date the meat was sliced and packaged.
(a) The importation of meat, meat products, and other edible products derived from bovines is prohibited with regard to BSE, except as provided in this section and in §§ 94.19, 94.20, 94.21, 94.22, and 94.23.
(b) The following commodities derived from bovines may be imported into the United States without restriction regarding BSE, provided that all other applicable requirements of this part are met:
(1) Milk and milk products;
(2) Boneless skeletal muscle meat (excluding mechanically separated meat) that:
(i) Is derived from bovines that were not, prior to slaughter, subjected to a pithing process or to stunning with a device injecting compressed air or gas into the cranial cavity, and that passed ante-mortem and post-mortem inspection;
(ii) Has been prepared in a manner to prevent contamination with SRMs; and
(iii) Is accompanied to the United States by an original certificate stating that the conditions of paragraphs (b)(2)(i) and (b)(2)(ii) of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.
Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:
(a) The commodities were exported from a region of negligible risk for BSE.
(b) If BSE has been diagnosed in one or more indigenous bovines in the region of negligible risk, the commodities were derived from bovines subject to a ban on the feeding to ruminants of meat-and-bone meal or greaves derived from ruminants.
(c) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.
(d) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of negligible risk for BSE and that the conditions of paragraphs (a) through (c) of this section, as applicable, have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.
To be eligible to export meat, meat byproducts, and meat food products under the conditions of this section for human consumption, a region must also be one that has demonstrated to FSIS in accordance with 9 CFR 310.22 that its BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as does prohibiting specified risk materials for use as human food in the United States.
Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2—except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of controlled risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:
(a) The commodities were exported from a region of controlled risk for BSE.
(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.
(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.
(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with either of the following:
(1) SRMs from regions of controlled risk for BSE; or
(2) Mechanically separated meat from the skull and vertebral column from bovines 30 months of age or older.
(e) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of controlled risk for BSE, and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.
Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from regions of undetermined risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:
(a) The commodities were derived from bovines that have never been fed meat-and-bone meal or greaves derived from ruminants.
(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.
(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.
(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with any of the following:
(1) SRMs from regions of undetermined risk for BSE; or
(2) Mechanically separated meat from the skull and vertebral column from bovines over 12 months of age.
(e) The commodities are accompanied by an original certificate stating that the exporting region is a region of undetermined risk for BSE and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.
The meat or dressed carcass (eviscerated and the head is removed) is derived from a wild bovine that has been legally harvested in the wild, as verified by proof such as a hunting license, tag, or the equivalent that the hunter must show to the authorized inspector.
(a) The importation of gelatin derived from bovines is prohibited because of BSE, unless:
(1) The gelatin meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or
(2) The gelatin is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part.
(b) The gelatin is derived from hides and skins, provided the gelatin has not been commingled with materials ineligible for entry into the United States.
(c) The gelatin is derived from the bones of bovines and originates in a region of negligible risk for BSE.
(d) The gelatin is derived from the bones of bovines, originates in a region of controlled risk or undetermined risk for BSE, and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:
(1) The bones from which the gelatin was derived were derived from bovines that passed ante-mortem and post-mortem inspection.
(2) The bones from which the gelatin was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older.
(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:
(i) Degreasing;
(ii) Acid demineralization;
(iii) Acid or alkaline treatment;
(iv) Filtration; and
(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and
(4) The gelatin has not been commingled with materials ineligible for entry into the United States.
(e) The gelatin is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for gelatin other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.
(f) The Administrator determines that the gelatin will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the gelatin has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant). The application for such a permit must state the intended use of the gelatin and name and address of the consignee in the United States.
Gelatin derived from horses, swine, or non-bovine ruminants must be accompanied at the time of importation into the United States by an official certificate issued by a veterinarian employed by the national government of the region of origin. The official certificate must state the species of animal from which the gelatin is derived.
(a) Poultry meat and products. In addition to meeting all other applicable provisions of this part, poultry meat and poultry products, including eggs and egg products (other than hatching eggs) imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:
(1) The poultry meat and products must not have been derived from birds and poultry that were in any of the following regions or zones, unless the birds and poultry were slaughtered after the periods described, or unless the poultry meat and products are accompanied by a certificate specifying that the articles were cooked and processed in accordance with the regulations in § 94.6(b)(3) or (b)(4):
(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;
(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, or wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.
(2) The poultry meat and products must not have been commingled with poultry meat and products derived from other birds and poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section. Additionally, the poultry meat and products must not have been derived from poultry that were commingled with other poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section.
(3) No equipment or materials used in transporting the birds or poultry from which the poultry meat and products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting live birds or poultry that do not meet the requirements of § 94.28(b), unless the equipment and materials have first been cleaned and disinfected.
(4) The poultry meat and products, including eggs and egg products (other than hatching eggs) must be accompanied by a certificate issued by an official of the competent veterinary authority of the APHIS-defined European Poultry Trade Region country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (a)(1) through (a)(3) of this section have been met. The certification for poultry meat and products may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.
(b) Live birds and poultry. In addition to meeting all other applicable provisions of this title, live birds and poultry, except hatching eggs, imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:
(1) The birds and poultry must not have been in any of the following regions or zones, unless the birds and poultry are exported to the United States after the periods described.
(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;
(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, and wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.
(2) The birds and poultry must not have been commingled with other birds or poultry that have at any time been in any of the regions or zones described in paragraphs (b)(1)(i) through (b)(1)(iii) of this section.
(3) No equipment or materials used in transporting the birds and poultry may have been used previously for transporting birds or poultry that do not meet the requirements of this paragraph, unless the equipment and materials have first been cleaned and disinfected.
(4) The birds and poultry must be accompanied by a certificate issued by an official of the competent veterinary authority of the country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (b)(1) through (b)(3) of this section have been met. The certification may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.
(c) Hatching eggs. Hatching eggs intended for import from the APHIS-defined European Poultry Trade Region are subject to all applicable provisions of paragraph (b) of this section, except that such hatching eggs may be moved through zones established because of detection of HPAI within the APHIS-defined European Poultry Trade Region provided that the hatching eggs are transported under official seal and accompanied by a certificate as indicated in paragraph (b)(4) of this section stating that the applicable provisions of paragraph (b) have been met. The import permit will require the seal number to be listed on the health certificate that accompanies the shipment and the veterinarian who places the seal will be required to sign his or her name under the seal number. Seals must not be broken until the shipment reaches its U.S. port of entry. Hatching egg shipment with seals that are not intact will be rejected upon inspection at the U.S. port of entry.
(d) Presentation of certificates. The certificates required by paragraphs (a)(4), (b)(4), and (c) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the birds, poultry, hatching eggs, or poultry meat and products at the port.
Notwithstanding any other provisions of this part, fresh (chilled or frozen) beef from a region in Argentina located north of Patagonia South and Patagonia North B, referred to as Northern Argentina (the region sometimes referred to as Patagonia North A is included in Northern Argentina); fresh (chilled or frozen) beef from a region in Brazil composed of the States of Bahia, Distrito Federal, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio Grande do Sul, Rio de Janeiro, Rondônia, São Paulo, Sergipe, and Tocantins; fresh (chilled or frozen) beef from Paraguay; and fresh (chilled or frozen) beef and ovine meat from Uruguay may be exported to the United States under the following conditions:
(a) The meat is:
(1) Beef from animals that have been born, raised, and slaughtered in the exporting regions of Argentina or Brazil or in Paraguay; or
(2) Beef or ovine meat from Uruguay derived from animals that have been born, raised, and slaughtered in Uruguay.
(b) Foot-and-mouth disease has not been diagnosed in the exporting region of Argentina (for beef from Argentina), the exporting region of Brazil (for beef from Brazil), in Paraguay (for beef from Paraguay), or in Uruguay (for beef or ovine meat from Uruguay) within the previous 12 months.
(c) The meat comes from bovines or sheep that originated from premises where foot-and-mouth disease has not been present during the lifetime of any bovines and sheep slaughtered for the export of beef and ovine meat to the United States.
(d) The meat comes from bovines or sheep that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.
(e) The meat comes from bovines or sheep that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.
(f) The meat consists only of bovine parts or ovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter and before removal of any bone, blood clots, or lymphoid tissue. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.
(g) All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat; except that bone-in ovine meat from Uruguay may be exported to the United States under the following conditions:
(1) The meat must be derived from select lambs that have never been vaccinated for FMD;
(2) The select lambs must be maintained in a program approved by the Administrator. Lambs in the program must:
(i) Be segregated from other FMD-susceptible livestock at a select lamb facility operated under the authority of the national veterinary authority of Uruguay;
(ii) Be subjected to an FMD testing scheme approved by the Administrator; and
(iii) Be individually identified with official unique identification that is part of a national traceability system sufficient to ensure that only the products of select lambs meeting all required criteria are exempt from the deboning requirement.
(3) Select lambs and their products must not be commingled with other animals and their products within the slaughter facility.
(h) The meat has not been in contact with meat from regions other than those listed in § 94.1(a).
(i) The meat came from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States.
(j) An authorized veterinary official of the government of the exporting region certifies on the foreign meat inspection certificate that the above conditions have been met.
(k) The establishment in which the bovines and sheep are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.
Notwithstanding any other provisions of this part, poultry meat and other poultry products from the States of Sinaloa and Sonora, Mexico, may be imported into the United States under the following conditions:
(a) The poultry meat or other poultry products are derived from poultry born and raised in Sinaloa or Sonora and slaughtered in Sinaloa or Sonora at a federally inspected slaughter plant under the direct supervision of a full-time salaried veterinarian of the Government of Mexico, and the slaughter plant must be approved to export poultry meat and other poultry products to the United States in accordance with 9 CFR 381.196.
(b) If processed, the poultry meat or other poultry products were processed in either Sinaloa or Sonora, Mexico, in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico.
(c) The poultry meat or other poultry products have not been in contact with poultry from any State in Mexico other than Sinaloa or Sonora or with poultry from any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist.
(d) The foreign meat inspection certificate accompanying the poultry meat or other poultry products (required by 9 CFR 381.197) includes statements certifying that the requirements in paragraphs (a), (b), and (c) of this section have been met and, if applicable, listing the numbers of the seals required by paragraph (e)(1) of this section.
(e) The shipment of poultry meat or other poultry products has not been in any State in Mexico other than Sinaloa or Sonora or in any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist, unless:
(1) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing intact, serially numbered seals that were applied at the federally inspected slaughter plant by a full-time salaried veterinarian of the Government of Mexico, and the seal numbers correspond with the seal numbers listed on the foreign meat inspection certificate; or
(2) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing seals that have different numbers than the seal numbers on the foreign meat inspection certificate, but, upon inspection of the hold, compartment, or container and all accompanying documentation, an APHIS representative is satisfied that the poultry containers were opened and resealed en route by an appropriate official of the Government of Mexico and the poultry meat or other poultry products were not contaminated or exposed to contamination during movement from Sinaloa or Sonora to the United States.
(a) Pork and pork products. In addition to meeting all other applicable provisions of this part, fresh pork and pork products imported from the APHIS-defined European CSF region must meet the following conditions:
(1) The pork or pork products must not have been derived from swine that were in any of the following regions or zones, unless the swine were slaughtered after the periods described:
(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;
(ii) A restricted zone in the APHIS-defined European CSF region established because of detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.
(2) The pork and pork products must not have been commingled with pork or pork products derived from other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the other swine were slaughtered after the periods described. Additionally, the pork and pork products must not have been derived from swine that were commingled with other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine from which the pork or pork products were derived were slaughtered after the periods described.
(3) The swine from which the pork or pork products were derived must not have transited any region or zone described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine were slaughtered after the periods described.
(4) No equipment or materials used in transporting the swine from which the pork or pork products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.
(5) The pork and pork products must be accompanied by a certificate issued by an official of the competent veterinary authority who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that the applicable provisions of paragraphs (a)(1) through (a)(4) of this section have been met.
(b) Live swine. In addition to meeting all other applicable provisions of this title, live swine imported from the APHIS-defined European CSF region must meet the following conditions:
(1) The swine must be breeding swine.
(2) The swine must not have been in any of the following regions or zones, unless the swine are exported to the United States after the periods described:
(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;
(ii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.
(3) The swine must not have been commingled with other swine that have at any time been in any of the regions or zones described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine are exported after the periods described.
(4) The swine must not have transited any region or zone described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine are exported after the periods described;
(5) No equipment or materials used in transporting the swine may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.
(6) The swine must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority, stating that the conditions of paragraphs (b)(1) through (b)(5) of this section have been met.
(c) The certificates required by paragraphs (a)(5) and (b)(6) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the swine, pork, or pork products at the port.
(a) Live swine, pork, or pork products and ship stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, may not be imported into the United States from a region listed under paragraph (a)(2) of this section unless the requirements in this section, in addition to other applicable requirements of part 93 of this chapter and part 327 of this title, are met.
(1) The regions listed under paragraph (a)(2) of this section have been declared free of classical swine fever (CSF) by APHIS in accordance with §§ 94.9(a) and 94.10(a) but either supplement their pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplement their pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of this part, or share a common land border with CSF-affected regions, or import live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. Thus, the live swine, pork, or pork products from those regions may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States.
(2) A list of regions whose live swine, pork, and pork products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.
(3) APHIS will add a region to the list of those whose live swine, pork, and pork products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that classical swine fever exists in the region.
(b) Live swine. The swine must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the swine in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the swine were in the region and must state that:
(1) The swine have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;
(2) The swine have never been commingled with swine that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;
(3) The swine have not transited a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(4) The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of § 93.502 of this chapter.
(c) Pork or pork products. The pork or pork products must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the pork or pork products in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin of the pork or pork products as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the pork or pork products were in the region and must state that:
(1) The pork or pork products were derived from swine that were born and raised in a region listed under §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2 of this title;
(2) The pork or pork products were derived from swine that have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;
(3) The pork or pork products have never been commingled with pork or pork products that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;
(4) The pork or pork products have not transited through a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(5) If processed, the pork or pork products were processed in a region listed under §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the national government of that region.
Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan, which are declared in § 94.6(a)(1) to be free of Newcastle disease, supplement their meat supply by the importation of fresh (chilled or frozen) poultry meat from regions designated in § 94.6(a) as regions where Newcastle disease is considered to exist, have a common land border with regions where Newcastle disease is considered to exist, or import live poultry from regions where Newcastle disease is considered to exist under conditions less restrictive than would be acceptable for importation into the United States. Thus, even though the Department has declared such regions to be free of Newcastle disease, live poultry originating in such free regions may be commingled with live poultry originating in an Newcastle disease-affected region and the meat and other animal products produced in such free regions may be commingled with the fresh (chilled or frozen) meat of animals from an Newcastle disease-affected region, resulting in an undue risk of introducing Newcastle disease into the United States. Therefore, live poultry, poultry meat and other poultry products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in the free regions listed in this section may not be imported into the United States unless the following requirements, in addition to all other applicable requirements of part 93 of this chapter and of chapter III of this title, are met:
(a) Additional certification. Live poultry, poultry meat, and other poultry products from any region designated in this section must be accompanied by an additional certification by a full-time salaried veterinary officer of the national Government of the exporting region. Upon arrival of the live poultry, poultry meat, or other poultry product in the United States, the certification must be presented to an authorized inspector at the port of arrival.
(b) Live poultry. The certification accompanying live poultry must identify the exporting region of the poultry as a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at the time the poultry were in the region and must state that:
(1) The poultry have not been in contact with poultry or poultry products from any region where Newcastle disease is considered to exist;
(2) The poultry have not lived in a region where Newcastle disease is considered to exist; and
(3) The poultry have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination.
(c) Poultry meat or other poultry products. The certification accompanying poultry meat or other poultry products must state that:
(1) The poultry meat or other poultry products are derived from poultry that meet all requirements of this section and that have been slaughtered in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region and that is approved to export poultry meat and other poultry products to the United States in accordance with § 381.196 of this title;
(2) The poultry meat or other poultry products have not been in contact with poultry meat or other poultry products from any region where Newcastle disease is considered to exist;
(3) The poultry meat or other poultry products have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(4) If processed, the poultry meat or other poultry products were processed in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region.
Whenever in the regulations in this part the following words, names, or terms are used they shall be construed, respectively, to mean:
Administrator means the Administrator, Animal and Plant Health Inspection Service, or any individual authorized to act for the Administrator.
Animal and Plant Health Inspection Service (APHIS) means the Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal byproducts means hides, skins, hair, wool, glue stock, bones, hoofs, horns, bone meal, hoof meal, horn meal, blood meal, meat meal, tankage, glands, organs, or other parts or products of ruminants and swine unsuitable for human consumption.
Approved chlorinating equipment means equipment approved by Veterinary Services as efficient for the disinfection of effluents against the contagion of foot-and-mouth disease.
Approved establishment means an establishment approved by Veterinary Services for the receipt and handling of restricted import animal byproducts.
Approved sewerage system means a drainage system equipped and operated so as to carry and dispose of sewage without endangering livestock through the contamination of streams or fields and approved by the Veterinary Services.
Approved warehouse means a warehouse having facilities approved by Veterinary Services for the handling and storage, apart from other merchandise, of restricted import products.
Bird trophy. A carcass or part of a carcass of a wild bird taken as game during a hunting expedition for the purpose of processing into taxidermy mounts for personal exhibition.
Blood meal means dried blood of animals.
Bone meal means ground animal bones and hoof meal and horn meal.
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal-risk region. A region listed in § 94.18(a)(3) of this subchapter.
Department means the United States Department of Agriculture.
Deputy Administrator of Veterinary Services means the Deputy Administrator of Veterinary Services.
Direct transloading. The transfer of cargo directly from one means of conveyance to another.
Exporting region. A region from which shipments are sent to the United States.
Glue stock means fleshings, hide cuttings and parings, tendons, or other collagenous parts of animal carcasses.
Hay and straw means dried grasses, clovers, legumes, and similar materials or stalks or stems of various grains, such as barley, oats, rice, rye, and wheat.
Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:
(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.
Inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.
Meat meal or tankage means the rendered and dried carcasses or parts of the carcasses of animals.
Offal. The inedible parts of a butchered animal.
Processed animal protein means meat meal, bone meal, meat and bone meal, blood meal, dried plasma and other blood products, hydrolyzed proteins, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.
Tallow derivative. Any chemical obtained through initial hydrolysis, saponification, or transesterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or transesterification may be applied to obtain the desired product.
United States means the several States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
Veterinary Services means the Veterinary Services unit of the Animal and Plant Health Inspection Service, United States Department of Agriculture.
No products or materials specified in the regulations in this part shall be imported unless there be shown upon the commercial invoice, or in some other manner satisfactory to the Deputy Administrator, Veterinary Services, the name of the region of origin of such product or material: Provided, That the region of origin shall be construed to mean (a) in the case of an animal byproduct, the region in which such product was taken from an animal or animals, and (b) in the case of other materials, the region in which such materials were produced.
The importation of any animal byproduct taken or removed from an animal affected with anthrax, foot-and-mouth disease, highly pathogenic avian influenza, or Newcastle disease is prohibited.
(a) Except as provided in this section, or in § 94.15, any of the materials listed in paragraph (b) in this section derived from animals, or products containing such materials, are prohibited importation into the United States.
(b) The restricted materials are as follows:
(1) Processed animal protein, tankage, offal, tallow, and tallow derivatives, unless in the opinion of the Administrator, the tallow cannot be used in feed;
(2) Glands, unprocessed fat tissue, and blood and blood products;
(3) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal; or
(4) Derivatives of glands and blood and blood products.
(c) The import prohibition in paragraph (a) of this section does not apply if the following conditions are met prior to importation:
(1) The material is derived from one of the following:
(i) A nonruminant species and the material is not ineligible for importation under § 95.13 or § 95.14;
(ii) Cervids or camelids, and the material is not ineligible for importation under the conditions of § 95.5;
(iii) Bovines, and the material is not ineligible for importation under the conditions of § 95.5, § 95.6, § 95.7, § 95.8, § 95.9, § 95.10, or § 95.12; or
(iv) Ovines or caprines, and the material is not ineligible for importation under the conditions of § 95.5.
(2) The facility demonstrates to APHIS that the materials intended for exportation to the United States were transported to and from the facility in a manner that would prevent cross-contamination by or commingling with prohibited materials.
(3) If the facility processes or handles any processed animal protein, inspection of the facility for compliance with the provisions of this section is conducted at least annually by a representative of the government agency responsible for animal health in the region, unless the region chooses to have such inspection conducted by APHIS. If APHIS conducts the inspections required by this section, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.
(4) The facility allows periodic APHIS inspection of its facilities, records, and operations.
(5) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the exporting region certifying that the conditions of paragraphs (c)(1) through (3) of this section have been met.
(6) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3, which may be obtained from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.
(d) Insulin otherwise prohibited under paragraphs (a) and (b) of this section may be imported if the insulin is for the personal medical use of the person importing it and if the person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the insulin and the name and address of the consignee in the United States.
Insulin that is not prohibited from importation under this paragraph may be prohibited from importation under other Federal laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq.
The importation of ruminant-derived processed animal protein, or any commodities containing such products, is prohibited unless the conditions of this section are met:
(a) The exporting region is a region of negligible risk for BSE; and
(1) The product has not been commingled or contaminated with ruminant meat-and-bone meal or greaves from a region of controlled or undetermined risk for BSE; and
(2) The product must be derived from ruminants that were subject to a ban on the feeding of ruminants with meat-and-bone meal or greaves derived from ruminants if it is either:
(i) Exported from a region of negligible risk for BSE in which there has been at least one indigenous case of BSE; or
(ii) Derived from ruminants that were in a region of negligible risk for BSE in which there has been at least one indigenous case of BSE.
(b) The exporting region is a region of controlled or undetermined risk, the product is ruminant-derived processed animal protein other than ruminant meat-and-bone meal or greaves, and it has been demonstrated that the product has not been commingled or contaminated with ruminant meat-and-bone meal or greaves from a controlled or undetermined risk region.
(c) Each shipment to the United States is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state the exporting region and that the requirements of this section, as applicable, have been met.
(d) The person importing the processed animal protein obtains a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the processed animal protein and name and address of the consignee in the United States.
Offal derived from bovines is prohibited importation into the United States unless it meets the requirements for the importation of meat, meat products, and meat byproducts in either § 94.19, § 94.20, or § 94.21, with the exception of the requirements in §§ 94.19(c), 94.20(b), and 94.21(b), respectively. The person importing the offal must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the offal and name and address of the consignee in the United States.
(a) The importation of collagen derived from bovines is prohibited because of BSE unless:
(1) The collagen meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or
(2) The collagen is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part:
(b) The collagen is derived from hides and skins, provided the collagen has not been commingled with materials ineligible for entry into the United States.
(c) The collagen is derived from the bones of bovines that originated from a region of negligible risk for BSE.
(d) The collagen is derived from the bones of bovines that originated from a region of controlled or undetermined risk for BSE and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:
(1) The bones from which the collagen was derived were derived from bovines that passed ante-mortem and post-mortem inspection;
(2) The bones from which the collagen was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older;
(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:
(i) Degreasing;
(ii) Acid demineralization;
(iii) Acid or alkaline treatment;
(iv) Filtration; and
(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and
(4) The collagen has not been commingled with materials ineligible for entry into the United States.
(e) The collagen is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for collagen other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.
(f) The Administrator determines that the collagen will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the collagen has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the collagen and the name and address of the consignee in the United States.
(a) The importation of bovine-derived tallow is prohibited unless:
(1) The requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section are met; or
(2) The requirements of paragraph (f) of this section are met.
(b) The tallow is composed of a maximum level of insoluble impurities of 0.15 percent in weight; or
(c) The tallow originates from a region of negligible risk for BSE; or
(d) The tallow originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and has not been prepared using SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.
(e) The tallow is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for tallow other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.
(f) The Administrator determines that the tallow will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the tallow has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the tallow and the name and address of the consignee in the United States.
(a) The importation of derivatives of tallow from bovines is prohibited unless the commodity meets the conditions of either paragraph (b), (c), (d), or (e) of this section as well as paragraph (f) of this section, or, alternatively, meets the conditions of paragraph (g) of this section.
(b) The commodity meets the definition of tallow derivative in § 95.1.
(c) The derivative is from tallow composed of a maximum level of insoluble impurities of 0.15 percent in weight.
(d) The derivative is from tallow that originates from a region of negligible risk for BSE.
(e) The derivative is from tallow that originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and does not contain SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.
(f) The tallow derivative is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), (d), or (e) of this section, as applicable, have been met and, for tallow derivatives other than those described in paragraph (b) or (c) of this section, must indicate the BSE risk classification of the exporting region.
(g) The Administrator determines that the tallow derivative will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the tallow derivative has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the tallow derivative and the name and address of the consignee in the United States.
(a) The importation of dicalcium phosphate derived from bovines is prohibited unless:
(1) The requirements of either paragraph (b), (c), or (d) and the requirements of paragraph (e) of this section are met; or
(2) The requirements of paragraph (f) of this section are met.
(b) The dicalcium phosphate contains no trace of protein or fat; or
(c) The dicalcium phosphate originates from a region of negligible risk for BSE; or
(d) The dicalcium phosphate originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and does not contain SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.
(e) The dicalcium phosphate is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must indicate the BSE risk classification of the exporting region and state that the requirements of paragraph (b) (c), or (d) of this section, as applicable, have been met.
(f) The Administrator determines that the dicalcium phosphate will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the dicalcium phosphate has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the dicalcium phosphate and the name and address of the consignee in the United States.
Notwithstanding any other provisions of this part, the importation of specified risk materials from controlled-risk regions or undetermined-risk regions for BSE, and any commodities containing such materials, is prohibited, unless the Administrator determines that the materials or other commodities will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the materials or other commodities has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the materials and other commodities and the name and address of the consignee in the United States.
The importation of bovine blood and products derived from bovine blood is prohibited unless the following conditions and the conditions of all other applicable parts of this chapter are met:
(a) For blood collected at slaughter and for products derived from blood collected at slaughter:
(1) The blood was collected in a hygienic manner, as determined by the Administrator, that prevents contamination of the blood with SRMs; and
(2) The slaughtered animal passed ante-mortem inspection and was not subjected to a pithing process or to a stunning process with a device injecting compressed air or gas into the cranial cavity.
(b) For blood collected from live donor bovines and for products derived from blood collected from live donor bovines:
(1) The blood was collected in a hygienic manner, as determined by the Administrator, that prevents contamination of the blood with SRMs; and
(2) The donor animal was free of clinical signs of disease.
(c) The blood and blood products are accompanied to the United States by an original certificate that states that the conditions of this section have been met. The certificate must be issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so.
The importation from regions of negligible risk for BSE of processed animal protein derived from animals other than ruminants is prohibited importation into the United States unless the following conditions are met:
(a) The processed animal protein is not prohibited importation under § 95.4;
(b) The processed animal protein imported into the United States in accordance with this section is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, that indicates that the material is derived from animals other than ruminants.
(c) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.
The importation from regions of controlled risk or undetermined risk for BSE of processed animal protein derived from animals other than ruminants is prohibited importation into the United States unless the following conditions are met:
(a) The processed animal protein is not prohibited importation under § 95.4;
(b) Except as provided in paragraph (c) of this section, the processed animal protein does not contain and was not commingled with material derived from ruminants originating in a BSE controlled- or undetermined-risk region;
(c) For blood meal, blood plasma, and other blood products, the material does not contain and was not commingled with ruminant blood or blood products prohibited importation into the United States under this part.
(d) Inspection of the facility for compliance with the provisions of this section is conducted at least annually by a competent authority of the government agency responsible for animal health in the region, unless the region chooses to have such inspections conducted by APHIS. The inspections must verify either that:
(1) All steps of processing and storing the material are carried out in a facility that has not been used for the processing or storage of materials derived from ruminants originating in a BSE controlled- or undetermined-risk region; or
(2) The material is produced in a manner that prevents contamination of the processed animal protein with materials prohibited importation into the United States.
(e) If APHIS conducts the inspections required by paragraph (d) of this section, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.
(f) The facility allows periodic APHIS inspection of its facilities, records, and operations.
(g) The processed animal protein imported into the United States in accordance with this section is accompanied by an original certificate signed by a full-time, salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time, salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, that states that the processed animal protein is not of ruminant origin and that conditions of this section have been met.
(h) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.
Untanned hides and skins and bird trophies
(a) Untanned hides and skins. (1) Except for ruminant hides or skins from Mexico, any untanned hides or skins of ruminants from regions free of foot-and-mouth disease and any untanned hides or skins of swine from regions free of foot-and-mouth disease and African swine fever may be imported without further restriction.
(2) Untanned ruminant hides or skins may be imported from any region without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they are hard dried hides or skins.
(3) Except for ruminant hides or skins from Mexico, untanned abattoir hides or skins of ruminants may be imported from any region without other restriction if the following requirements are met:
(i) The ruminants from which the hides or skins were taken have been slaughtered under national government inspection in a region
(ii) The hides or skins are accompanied by a certificate bearing the seal of the proper department of that national government and signed by an official veterinary inspector of the region in which the ruminants were slaughtered. The certificate must state that the hides or skins were taken from ruminants slaughtered in an abattoir that meets the requirements of paragraph (a)(3)(i) of this section and that the hides or skins are free from anthrax and foot-and-mouth disease.
(4) Untanned ruminant hides or skins from any region may be imported without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they have been pickled in a solution of salt containing mineral acid and packed in barrels, casks, or tight cases while still wet with such solution. The solution must be determined by the inspector to have a pH of less than or equal to 5.
(5) Untanned ruminant hides or skins from any region may be imported without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they have been treated with lime in such manner and for such period as to have obviously been processed, to have become dehaired, and to have reached the stage of preparation for immediate manufacture into products ordinarily made from rawhide.
(b) Ruminant hides and skins from Mexico. Ruminant hides and skins from Mexico may enter the United States without other restriction if:
(1) They are free of ticks and have been subjected to any one of the treatments specified in paragraphs (a)(2), (a)(4), or (a)(5) of this section; or
(2) They are inspected and found to have been frozen solid for 24 hours by an inspector and are accompanied by a certificate attesting to that fact issued by the shipper or importer that is reviewed by the inspector, and are free from ticks; or
(3) They are free from ticks and are accompanied by a certificate issued by a full-time salaried veterinary officer of the Government of Mexico stating that they have been treated with an acaricide; or
(4) They are bovine hides taken from cattle that were subjected to a tickicidal dip in one of the permitted dips listed in § 72.13(b) of this chapter at a Mexican facility 7 to 12 days prior to slaughter, and are free from ticks.
(c) Bird trophies. Bird trophies from regions designated in § 94.6 of this subchapter as free of Newcastle disease and free of HPAI may be imported without further restriction if accompanied by a certificate of origin issued by the national government of the region of export.
Except for ruminant hides or skins from Mexico, hides or skins or bird trophies offered for importation which do not meet the conditions or requirements of § 95.16 shall be handled and treated in the following manner after arrival at the port of entry:
(a) They shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services such hides or skins or bird trophies may be stored for a temporary period in approved warehouses under bond, and under the supervision of an inspector: And provided further, That I. T. or inbound shipments of hides or skins or bird trophies may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port in the United States for consumption entry subject to the other provisions of this section.
(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bound shipments, from the interior port to the approved establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to the inspector in charge at the port of entry.
(c) They shall be handled at the approved establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease, African swine fever, highly pathogenic avian influenza, and Newcastle disease. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said hides and skins or bird trophies from the port of arrival to the said establishment.
Wool, hair, or bristles derived from ruminants and/or swine which do not meet the conditions or requirements specified in any one of paragraphs (a) to (d) of this section shall not be imported except subject to handling and treatment in accordance with § 95.19 after their arrival at the port of entry: Provided, however, That no bloodstained wool, hair, or bristles shall be imported under any condition:
(a) Such wool, hair, or bristles may be imported without other restriction if originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.
(b) Wool or hair clipped from live animals or pulled wool or hair may be imported without other restriction if the said wool or hair is reasonably free from animal manure in the form of dung locks or otherwise.
(c) Wool, hair, or bristles taken from sheep, goats, cattle, or swine, when such animals have been slaughtered under national government inspection in a region
(d) Wool, hair, or bristles which have been scoured, thoroughly washed, or dyed may be imported without other restriction.
Wool, hair, or bristles offered for importation which do not meet the conditions or requirements of § 95.18 shall be handled and treated in the following manner after arrival at the port of entry:
(a) Such wool, hair, or bristles shall be consigned from the coast or border port of arrival to an approved establishment: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services such wool, hair, or bristles may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. on in-bond shipments of wool, hair, or bristles may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port for consumption entry, subject to the other provisions of this section.
(b) Such wool, hair, or bristles shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases acceptable to an inspector.
(c) Such wool, hair, or bristles shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease. Such products shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said wool, hair, or bristles from the port of arrival to the said establishment.
Glue stock which does not meet the conditions or requirements specified in any one of paragraphs (a) to (c) of this section shall not be imported except subject to handling and treatment in accordance with § 95.21 after arrival at the port of entry:
(a) Glue stock originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease may be imported without other restriction.
(b) Glue stock may be imported without other restriction if found upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to have been properly treated by acidulation or by soaking in milk of lime or a lime paste; or to have been dried so as to render each piece of the hardness of a sun-dried hide.
(c) Glue stock taken from cattle, sheep, goats, or swine slaughtered under national government inspection in a region
Glue stock offered for importation which does not meet the conditions or requirements of § 95.20 shall be handled and treated in the following manner after arrival at the port of entry:
(a) It shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services glue stock may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. or in-bond shipments of glue stock may go forward under customs seals from a coast or border port of arrival with the approval of an inspector at said port to another port for consumption entry, subject, after arrival at the latter port, to the other provisions of this section.
(b) It shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at port of entry.
(c) It shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease. It shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said glue stock from the port of arrival to the said establishment.
(a) Clean, dry bones, horns, and hoofs, that are free from undried pieces of hide, flesh, and sinew and are offered for entry as trophies or for consignment to museums may be imported without other restrictions.
(b) Clean, dry hoofs disinfected in the region of origin may be imported without other restrictions if the following conditions are met:
(1) The hoofs have been disinfected using one of the following methods:
(i) Dry heat at 180 °F (82.2 °C) for 30 minutes;
(ii) Soaking in boiling water for 20 minutes;
(iii) Soaking in a 0.1 percent chlorine bleach solution for 2 hours;
(iv) Soaking in a 5 percent acetic acid solution for 2 hours; or
(v) Soaking in a 5 percent hydrogen peroxide solution for 2 hours.
(2) The hoofs are accompanied by a certificate issued by the national government of the region of origin and signed by an official veterinary inspector of that region stating that the hoofs have been disinfected and describing the manner in which the disinfection was accomplished.
Bones, horns, and hoofs offered for importation which do not meet the conditions or requirements of § 95.22 shall be handled and treated in the following manner after arrival at the port of entry:
(a) They shall be consigned from the coast or border port of arrival to an approved establishment having facilities for their disinfection or their conversion into products customarily made from bones, horns, or hoofs: Provided, however, That I. T. or in-bond shipments of bones, horns, or hoofs may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port for consumption entry subject to the other provisions of this section.
(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at the port of entry.
(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of anthrax, foot-and-mouth disease, highly pathogenic avian influenza, and Newcastle disease, and the bags, burlap, or other containers thereof, before leaving the establishment, shall be disinfected by heat or otherwise, as directed by the Deputy Administrator, Veterinary Services or burned at the establishment. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said bones, horns, and hoofs.
Steamed or degelatinized or special steamed bone meal, which, in the normal process of manufacture, has been prepared by heating bone under a minimum of 20 pounds steam pressure for at least one hour at a temperature of not less than 250 °Fahrenheit (121 °Centigrade), may be imported without further restrictions for use as fertilizer or as feed for domestic animals if such products are free from pieces of bone, hide, flesh, and sinew and contain no more than traces of hair and wool. Bone meal for use as fertilizer or as feed for domestic animals which does not meet these requirements will not be eligible for entry.
Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and similar products, for use as fertilizer or as feed for domestic animals, shall not be imported except subject to handling and treatment in accordance with paragraphs (a), (b), and (c) of § 95.27, unless:
(a) Such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease; or
(b) The inspector at the port of entry finds that such products have been fully processed by tanking under live steam or by dry rendering.
Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts shall not be imported except subject to handling and treatment in accordance with § 95.27, unless such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.
Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts, which do not meet the conditions or requirements of § 95.26 shall be handled and treated in the following manner after arrival at the port of entry.
(a) They shall be consigned from the coast or border port of arrival to an approved establishment: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services they may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. or in-bond shipments of such products may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port of consumption entry, subject after arrival at the latter port to the other provisions of this section.
(b) They shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by Veterinary Services inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at the port of entry.
(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of foot-and-mouth disease. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said products from the port of arrival to the said establishment.
Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, intended for use in the manufacture of pharmaceutical products shall not be imported except subject to handling and treatment in accordance with § 95.29, unless such glands, organs, or materials originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.
Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, which do not meet the requirements of § 95.28 may be imported for pharmaceutical purposes if in tight containers and consigned to an approved establishment: Provided, however, That upon special permission of the Deputy Administrator, Veterinary Services they may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector. They shall be handled and processed at the said establishment in a manner approved by the Deputy Administrator, Veterinary Services and the containers shall be destroyed or disinfected as prescribed by him. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said glands, organs, ox gall, and like materials from the port of arrival to the said establishment.
Stomachs or portions of the stomachs of ruminants or swine, other than those imported for food purposes under the meat-inspection regulations of the Department, shall not be imported without permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as the Deputy Administrator, Veterinary Services may deem necessary in each instance.
Manure of horses, cattle, sheep, other ruminants, and swine shall not be imported except upon permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as he may deem necessary in each instance: Provided, however, That manure produced by animals while in transit to the United States shall be subject only to the requirements of the Department regulations governing the importation of domestic livestock and other animals.
Except as provided in § 95.39, hay or straw shall not be imported except subject to handling and treatment in accordance with § 95.33 after arrival at the port of entry, unless such hay or straw originated in and was shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.
Except as provided in § 95.39, hay or straw which does not meet the conditions or requirements of § 95.32 shall be handled and treated in the following manner upon arrival at the port of entry:
(a) Hay or straw packing materials shall be burned or disinfected at the expense of the importer or consignee in the manner and at the time directed by the Deputy Administrator, Veterinary Services.
(b) Hay or straw for use as feeding material, bedding, or similar purposes shall be stored and held in quarantine for a period of not less than 90 days in an approved warehouse at the port of entry and shall be otherwise handled as directed by the Deputy Administrator, Veterinary Services.
Cloth or burlap which has been used to cover fresh or frozen meats originating in any region designated in § 94.1 of this subchapter as a region in which foot-and-mouth disease exists, shall not be imported except under the following conditions:
(a) The cloth or burlap shall be consigned from the coast or border port of arrival to an establishment specifically approved for the purpose by the Deputy Administrator, Veterinary Services.
(b) The cloth or burlap shall be immediately moved from the coast or border port of arrival, or in case of I. T. or in-bond shipments from the interior port, to the establishment, in railroad cars or trucks, or in vessel compartments, with no other material contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services, such cloth or burlap may be stored for a temporary period in approved warehouses at the port of arrival under bond and under the supervision of an inspector.
(c) The material shall be disinfected and otherwise handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease, and the material shall not be removed therefrom, except upon special permission of the Deputy Administrator, Veterinary Services, until all of the conditions and requirements of this section have been complied with.
Hides, skins, and other materials required by the regulations in this part to be disinfected shall be subjected to disinfection by methods found satisfactory and approved from time to time by the Deputy Administrator, Veterinary Services.
(a) Transportation companies or other operators of cars, trucks or other vehicles carrying import products or materials moving under restriction, other than those in tight cases or casks, shall affix to and maintain on both sides of all such vehicles durable placards not less than 5
(b) If it is necessary to unload enroute any of the materials or products transported in a placarded car, truck or other vehicle as provided in this section, the car, truck or other vehicle from which the transfer is made and any part of the premises in or upon which the product or material may have been placed in the course of unloading or reloading shall be cleaned and disinfected by the carrier, in accordance with the provisions of § 95.37, and the said carrier shall immediately report the matter, by telegraph, to the Deputy Administrator, Veterinary Services, Washington, DC 20251. Such report shall include the following information: Nature of emergency; place where product or material was unloaded; original points of shipment and destination; number and materials of the original car or truck; and number and initials of the car, truck or other vehicle into which the product or material is reloaded in case the original car or truck is not used.
Railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises which have been used in the transportation, handling, or storing of restricted import products or materials, other than those contained in leak proof cases or casks, shall be cleaned and disinfected with a disinfectant approved for use in this part under the supervision of the division at the time and in the manner provided in this section. Except as provided in paragraph (a) of this section, such railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, shall not be moved in interstate or foreign commerce until they have been so treated.
(a) Cars to be cleaned and disinfected by final carrier at destination. Cars required by this part to be cleaned and disinfected shall be so treated by the final carrier at destination as soon as possible after unloading and before the same are moved from such final destination for any purpose: Provided, however, That when the products or materials are destined to points at which an inspector or other duly authorized representative of Veterinary Services is not maintained or where proper facilities cannot be provided, the transportation company shall seal, bill, and forward the cars in which the products or materials were transported to a point to be agreed upon between the transportation company and Veterinary Services, and the transportation company shall there clean and disinfect the said cars under the supervision of Veterinary Services.
(b) Methods of cleaning and disinfecting. (1) Railroad cars, trucks, aircraft and means of conveyance other than boats, equipment or containers, required by this part to be cleaned and disinfected shall be treated in the following manner: Collect all litter and other refuse therefrom and destroy by burning or other approved method, clean the exterior and interior of the cars or trucks, and the areas of the aircraft or other means of conveyance, equipment or containers that may have been contaminated, and saturate the entire surface with a permitted disinfectant approved for use in this part.
(2) Boats required by this part to be cleaned and disinfected shall be treated in the following manner: Collect all litter and other refuse from the decks, compartments, and all other parts of the boat used for the transportation of the products or materials covered by this part, and from the portable chutes or other appliances, fixtures or areas used in loading and unloading same, and destroy the litter and other refuse by burning or by other approved methods, and saturate the entire surface of the said decks, compartments, and other parts of the boat with a permitted disinfectant approved for use in this part.
(3) Buildings, sheds, and premises required by this part to be disinfected shall be treated in the following manner: Collect all litter and other refuse therefrom and destroy the same by burning or other approved methods, and saturate the entire surface of the fencing, chutes, floors, walls, and other parts with a permitted disinfectant approved for use in this part.
(c) Permitted disinfectants. The disinfectants permitted for use in disinfecting railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises against infection of foot-and-mouth disease are freshly prepared solutions of:
(1) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 gallons of water.
(2) Sodium carbonate (4 percent) plus sodium silicate (0.1 percent) in the proportion of 1 pound of sodium carbonate plus sodium silicate to 3 gallons of water.
(3) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(d) Permitted disinfectants against ticks. The disinfectants permitted for use against tick infestation are liquefied phenol (U. S. P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to one gallon of water; or chlorinated lime (U. S. P. strength 30 percent available chlorine) in the proportion of one pound to three gallons of water; or any one of the cresylic disinfectants permitted by the Animal and Plant Health Inspection Service in the proportion of at least four fluid ounces to one gallon of water; or through application of boiling water if the treatment is against foot-and-mouth disease and tick infestation; or other disinfectants or treatments approved by the Deputy Administrator, Veterinary Services.
The regulations in this part shall be applicable to all the products and materials specified in this part which are offered for entry into the United States from any place under the jurisdiction of the United States to which the animal-quarantine laws of this country do not apply.
Hay or straw, grass, or similar material from tick-infested pastures, ranges, or premises may disseminate the contagion of splenetic, Southern or Texas fever when imported for animal feed or bedding; therefore, such hay or straw, grass, or similar materials shall not be imported unless such material is first disinfected with a disinfectant specified in § 95.26(d).
Administrator. The Administrator, Animal and Plant Health Inspector Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).
Animal casings. Intestines, stomachs, esophagi, and urinary bladders from cattle, sheep, swine, or goats that are used to encase processed meats in foods such as sausage.
APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.
Authorized inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this subpart.
Department. The United States Department of Agriculture.
Food and Drug Administration. The Food and Drug Administration of the United States Department of Health and Human Services.
Food Safety and Inspection Service. The Food Safety and Inspection Service of the United States Department of Agriculture.
Import (imported, importation) into the United States. To bring into the territorial limits of the United States.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, American Samoa, and the territories and possessions of the United States.
(a) Swine casings. The importation of swine casings that originated in or were processed in a region where African swine fever exists, as listed under § 94.8(a) of this subchapter, is prohibited, with the following exception: Swine casings that are processed in a region where African swine fever exists may be imported into the United States under the following conditions:
(1) Origin of casings. The swine casings were derived from swine raised and slaughtered in a region not listed under § 94.8(a) of this subchapter.
(2) Shipping requirements. The casings were shipped from the region of origin to a processing establishment in a region listed under § 94.8(a) of this subchapter in a closed container sealed with serially numbered seals applied by an official of the national government of the region of origin.
(3) Origin certificate. The casings were accompanied from the region of origin to the processing establishment by a certificate written in English and signed by an official of the national government of the region of origin specifying the region of origin, the processing establishment to which the swine casings were consigned, and the numbers of the seals applied.
(4) Integrity of seals. The casings were taken out of the container at the processing establishment only after an official of the national government of the region where the processing establishment is located determined that the seals were intact and free of any evidence of tampering and had so stated on the certificate referred to in paragraph (a)(3) of this section.
(5) The processing establishment. The casings were processed at a single processing establishment
(6) Compliance agreement. The processing establishment is operated by persons who have entered into a valid written compliance agreement with APHIS to maintain on file at the processing establishment for at least 2 years copies of the certificates referred to in paragraph (a)(4) of this section, to allow APHIS personnel to make unannounced inspections as necessary to monitor compliance with the provisions of this section, and to otherwise comply with the provisions of this section.
(7) Cooperative service agreement. The processing establishment is operated by persons who have entered into a cooperative service agreement with APHIS. The establishment is current in paying for APHIS personnel to inspect the establishment (it is anticipated that such inspections will occur once per year). In addition, the processing establishment has on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds).
(8) Compliance agreement cancellation. Any compliance agreement may be canceled orally or in writing by the inspector who is supervising its enforcement whenever the authorized inspector finds that such person has failed to comply with the provisions of this section or any conditions imposed by this section. If the cancellation is oral, the decision and the reasons will be confirmed in writing, as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision to the Administrator, in writing, within 10 days after receiving written notification of the cancellation. The appeal should state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. The Administrator will grant or deny the appeal, in writing, stating the reasons for such decision, as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing will be held to resolve such conflict. Rules of Practice governing such a hearing will be adopted by the Administrator.
(9) Export certification. The casings are accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 in chapter III of this title. Upon arrival of the swine casings in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(b) Casings from ovines or caprines. The importation of casings, except stomachs, derived from ovines or caprines that originated in or were processed in any region listed in § 95.4(a)(4) are prohibited, unless the following conditions are met:
(1) The casings are accompanied by an original certificate that meets the requirements of § 96.3 and:
(i) States that the casings meet the conditions of this section;
(ii) Is written in English;
(iii) Is signed by an individual eligible to issue the certificate required under § 96.3; and
(iv) Is presented to an authorized inspector at the port of entry.
(2) [Reserved]
(c) Casings from bovines. The importation of casings derived from bovines is prohibited, unless the following conditions are met:
(1) If the casings are derived from bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, the certificate required under § 96.3 indicates the APHIS BSE risk classification of the region in which the bovines were slaughtered and the casings were collected.
(2) If the casings are derived from bovines from a region of controlled risk for BSE or a region of undetermined risk for BSE, as defined in § 92.1 of this subchapter, the casings are not derived from the small intestine or, if the casings are derived from the small intestine, the casings are derived from that part of the small intestine that is eligible for use as human food in accordance with the requirements established by the Food Safety and Inspection Service at 9 CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
(3) The casings are accompanied by an original certificate that meets the requirements of § 96.3 and paragraph (b)(1) of this section.
(a) No animal casings shall be imported into the United States from any foreign region unless they are accompanied by a certificate signed by either (1) a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected, and who is authorized by the national government to conduct casings inspections and issue certificates, and who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings; or (2) a non-government veterinarian authorized to issue the certificate by the national government of the region in which the animals were slaughtered and the casings were collected, who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings. A certificate issued by a non-government veterinarian is valid only if the certificate is endorsed by a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected.
(b) All signatures on the certificate shall be original.
(c) The certificate shall bear the insignia of the national government of the region in which the animals were slaughtered and the casings were collected, and shall be in the following form:
I hereby certify that the animal casings herein described were derived from healthy animals (cattle, sheep, swine, or goats), which received, ante mortem and post mortem veterinary inspections at the time of slaughter, are clean and sound, and were prepared and handled only in a sanitary manner and were not subjected to contagion prior to exportation.
(d) In addition to meeting the requirements of this section, the certificate accompanying sheep casings from Canada must state that the casings meet the requirements of § 96.2(b) and the certificate accompanying bovine casings must state that the casings meet the requirements of either § 96.2(c)(1) or (c)(2) as applicable.
Animal casings which are unaccompanied by the required certificate, those shipped in sheepskins or other skins as containers, and those found upon inspection to be unclean or unsound when offered for importation into the United States shall be kept in customs custody until exported or destroyed, or until disinfected and denaturated as prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) in §§ 96.5 through 96.16.
(a) Animal casings are not classed as meat product, therefore the certificate required for foreign meat product is not acceptable for animal casings offered for importation.
(b) Casings offered for importation into the United States shall remain in customs custody at the port until released by an APHIS inspector for admission into the United States or otherwise disposed of as required by this part.
(c) The provision that under certain conditions casings which have been offered for importation shall be exported, shall be construed to mean the removal of the casings from the United States or its possessions.
(1) The provision that under certain conditions casings be destroyed shall be construed to mean the treatment or handling of the casings in a manner to take away completely the usefulness of them as by tanking or incineration.
(2) The provision that under certain conditions casings shall be disinfected and denatured shall be construed to mean such treatment and handling as will be prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) to free them from pathogenic substances or organisms, or to render such substances and organisms inert; and that the nature of the casings be changed to make them unfit for eating without destroying other useful properties. For instance, each casing may be split throughout its length and after disinfection, as above indicated, be released for industrial use.
(d) Dried intestines offered for importation into the United States for use as gut strings or similar purpose are not regarded as animal casings within the meaning of this part. Such dried intestines are classed with tendons, sinews, and similar articles and are subject to the provisions of part 95.
(a) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where an APHIS inspector is stationed shall be released for entry by the inspector at the seaboard or border port.
(b) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where an APHIS inspector is stationed, shall be shipped in United States Customs custody to destination for release.
(c) Properly certified foreign animal casing arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where no APHIS inspector is stationed, shall be transported in United States Customs custody to the nearest point where an APHIS inspector is stationed for release at that point.
(d) Properly certified foreign animal casings forming a part of a foreign meat consignment routed through a border port to an interior point in the United States shall be transported to destination as though the entire consignment consisted of meat. In such cases the APHIS inspector who inspects the meat at destination shall supervise the release of the casings.
Dried animal bladders, dried weasands, and all other dried animal casings offered for importation into the United States as food containers unaccompanied by foreign certification which have been retained in the dry state continuously for not less than 90 days from the date of shipment shown on the consular invoice, may be released for entry as food containers without disinfection.
Uncertified foreign animal casings arriving at a seaboard port may be imported into the United States for use as food containers after they have been disinfected under the direct supervision of an APHIS inspector at the seaboard port.
Foreign animal casings offered for importation into the United States which are admitted upon disinfection shall be handled as follows:
(a) The containers of such casings shall be sealed on the steamship pier or other place of first arrival. Four seals shall be affixed to both ends of each tierce, barrel, and similar container in the space where the ends of the container enter the staves, by means of red sealing wax imprinted with the No. 3 Veterinary Services brass brand from which “
(b) Uncertified animal casings sealed as above indicated shall be transferred from the steamship pier or other place of first arrival to the premises of the importer or other designated place, where they shall be disinfected by the importer under the supervision of an APHIS inspector before they are offered for sale. The object of this ruling is to place full responsibility for disinfection of casings on the original importer and to prevent the sale of casings subject to disinfection by the purchaser.
(a) Foreign animal casings imported into the United States without certification may be forwarded in customs custody to a USDA-approved facility for disinfection under APHIS supervision and release by the United States Customs authorities, provided that, before being transported over land in the United States, each and every container of such casings shall be disinfected by the application of a solution of sodium hydroxide prepared as follows:
(1) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(2) This solution shall be thoroughly applied to all exterior surfaces of the containers and be allowed to remain for at least thirty minutes to accomplish disinfection. The containers should then be washed with water to remove the caustic soda which otherwise might cause injury to the handlers of the packages.
(b) When uncertified foreign casings are removed from the original shipping containers these containers shall be destroyed by burning or promptly and thoroughly disinfected both inside and out with the solution and in the manner above prescribed. If these containers are to be re-used it is important that they be thoroughly washed both inside and out with water after disinfection has been completed, and in order to insure against the injurious effect of caustic soda remaining in the wood it is advisable to allow the containers to stand for not less than six hours filled with water.
(c) The salt removed from all original shipping containers of uncertified foreign animal casings shall be immediately dissolved in water and heated to boiling, or disposed of as provided in paragraph (c)(1) or (2) of this section as follows:
(1) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 2
(2) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 20 pounds of 95 percent to 98 percent sodium hydroxide (commercial “76 percent caustic soda”) and stir until solution is complete; and allow it to stand for at least 30 minutes. (This solution may be utilized in the disinfection of casing containers as prescribed in paragraphs (a)(2) and (b) of this section.
(3) It is best to employ flaked caustic soda and not the variety which is very finely powdered. The fine powder is irritating and injurious to workers if it becomes suspended in the air. Containers of caustic soda should be kept tightly closed as the product deteriorates from contact with the air.
Uncertified foreign animal casings shall be disinfected only at a plant whose sanitation and disinfecting equipment have been approved by an APHIS inspector.
Foreign animal casings offered for importation without certification shall be disinfected as prescribed in § 96.13 within a period of 30 days after arrival in the United States, subject to the ability of Division inspectors to cover their respective districts. Otherwise such casings shall be exported or destroyed.
Foreign animal casings offered for importation into the United States without certification may be disinfected, as prescribed in this section, under the supervision of an APHIS inspector for use as food containers, as an alternative for foreign certification.
(a) Disinfect the casings in a solution made as follows: Dissolve 90 pounds common salt in 100 gallons water and mix. Add 2
(b) Containers of the disinfectant solution may be either of wood or of metal, but the interior surfaces must be protected by means of an acid resistant coating.
(c) Not more than 175 pounds casings shall be treated with each 100 gallons of the solution. After the treatment of 175 pounds of casings, or at the end of the day if less than 175 pounds of casings are disinfected in any one day, the solution shall be discarded unless means are provided for accurately determining the loss of strength. In event means for accurately determining loss of strength are provided it will be permissible to restore the strength of the solution with fresh acid and use it repeatedly.
(d) Shake as much of the adherent salt as possible from the casings and weigh them. Bundles must be separated but individual hanks need not be untied. Place the casings in the disinfecting solution a few hanks at a time with vigorous agitation to insure the fullest possible contact of the solution with them. Then keep the casings completely submerged in the solution for not less than three-fourths of an hour.
(e) Remove the casings from the solution, rinse them with water, and place them in a solution containing 8
Foreign animal casings offered for importation into the United States upon disinfection, may either be disinfected with hydrochloric acid as at present or if preferred may be submerged in a saturated brine solution at a temperature not less than 127 °F. for at least 15 minutes. The time held as well as the temperature of such brine solution must be recorded on a one-hour dial of a recording thermometer and filed in the local APHIS office for official inspection at any time. In order that this required temperature may be more readily maintained, such casings must first be submerged in a brine solution at approximately 127 °F. for about five minutes immediately before the 15-minute recorded submersion period begins. This may be done either in the testing vat or a preliminary vat. By following this procedure the temperature will not vary unduly and thus cause unsatisfactory results. After removing the casings from the testing vat, it will be found advantageous to submerge them in another vat containing cold brine solution or cold water in order to remove the extra heat from the casings as promptly as possible, but of course this is optional with the importer. In order to obtain the most satisfactory results, the hanks, rings, and similar units must be separated as much as possible without untying, but “dolls” will not be permitted to be disinfected by this heating method. In order to keep the temperature of the brine in the testing vat of a uniform degree, it is necessary to agitate the solution occasionally by moving the casings. The tip of the recording thermometer should be located at a point which would be approximately at the bottom of the volume of casings being disinfected.
(a) Any person, firm, or corporation having ownership, custody, or control of animals, animal byproducts, or other commodities or articles subject to inspection, laboratory testing, certification, or quarantine under this subchapter and subchapter G of this chapter, and who requires the services of an employee of the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection on a Sunday or holiday, or at any other time outside the regular tour of duty of the employee, shall sufficiently in advance of the period of Sunday, holiday, or overtime service request the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector in charge to furnish the service and shall pay the Government at the rate listed in the following table, except as provided in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section:
Overtime for Inspection, Laboratory Testing, Certification, or Quarantine of Plant, Plant Products, Animals, Animal Products or Other Regulated Commodities
| Outside the employee's normal tour of duty | Overtime rates (per hour) | ||
|---|---|---|---|
| Nov. 2, 2015-Sept. 30, 2016 | Oct. 1, 2016-Sept. 30, 2017 | Beginning
Oct. 1, 2017 | |
| Monday through Saturday and holidays | $75 | $75 | $75 |
| Sundays | 99 | 99 | 100 |
(1) For any services performed on a Sunday or holiday, or at any time after 5 p.m. or before 8 a.m. on a weekday, in connection with the arrival in or departure from the United States of a private aircraft or private vessel, the total amount payable shall not exceed $25 for all inspection services performed by the U.S. Customs and Border Protection , Public Health Service, and the Department of Agriculture;
(2) Owners and operators of aircraft will be provided service without reimbursement during regularly established hours of service on a Sunday or holiday; and
(3) The overtime rate to be charged owners or operators of aircraft at airports of entry or other places of inspection as a consequence of the operation of the aircraft, for work performed outside of the regularly established hours of service is listed in the following table:
Overtime for Commercial Airline Inspection Services 1
| Outside the employee's normal tour of duty | Overtime rates (per hour) | ||
|---|---|---|---|
| Nov. 2, 2015-Sept. 30, 2016 | Oct. 1, 2016-Sept. 30, 2017 | Beginning
Oct. 1, 2017 | |
| Monday through Saturday and holidays | $64 | $65 | $65 |
| Sundays | 85 | 86 | 86 |
1 These charges exclude administrative overhead costs.
(4) The overtime rate and all other charges, including minimum and commute compensation charges, to be billed for services provided by an employee of U.S. Customs and Border Protection shall be charged according to the provisions of this section, 5 CFR part 551, or 19 CFR 24.16.
(b) A minimum charge of 2 hours shall be made for any Sunday or holiday or unscheduled overtime duty performed by an employee on a day when no work was scheduled for him or her, or which is performed by an employee on his or her regular workday beginning either at least 1 hour before his or her scheduled tour of duty or which is not in direct continuation of the employee's regular tour of duty. In addition, each such period of Sunday or holiday or unscheduled overtime work to which the 2-hour minimum charge applies may include a commuted traveltime period (CTT) the amount of which shall be prescribed in administrative instructions to be issued by the Administrator, Animal and Plant Health Inspection Service or U.S. Customs and Border Protection for the areas in which the Sunday or holiday or overtime work is performed and such period shall be established as nearly as may be practicable to cover the time necessarily spent in reporting to and returning from the place at which the employee performs such Sunday, holiday or overtime duty. With respect to places of duty within the metropolitan area of the employee's headquarters, such CTT period shall not exceed 3 hours. It shall be administratively determined from time to time which days constitute holidays. The circumstances under which such CTT periods shall be charged and the percentage applicable in each circumstance are as reflected in the following table:
| Actual time 1 charge—no minimum | 2-hour guarantee charge | Commuted 2 traveltime (CTT) charge | |
|---|---|---|---|
| Work beginning before daily tour begins: | |||
| 8 to 59 minutes | Yes | No | None. |
| 60 to 119 minutes | Yes |
| |
| 120 minutes or more | Yes | Full CTT. | |
| Work beginning after daily tour ends: | |||
| Direct continuation | Yes | No | None. |
| Break-in-service of: | |||
| 2-29 minutes | Yes | None. | |
| 30-60 minutes | Yes |
| |
| 61 minutes or more | Yes | Full CTT. | |
| Work beginning before daily tour begins: | |||
| 8 to 59 minutes | Yes | No |
|
| 60 minutes or more | Yes | Full CTT. | |
| Work beginning after daily tour ends: | |||
| Direct continuations | Yes | No |
|
| 2-59 minutes | No | Yes |
|
| 60 minutes or more | No | Yes | Full CTT. |
| Work beginning at any time | No | Yes | Full CTT. |
1 Actual time charged when work is contiguous with the daily tour will be in quarter hour multiples, with service time of 8 minutes or more rounded up to the next quarter hour and any time of less than 8 minutes will be disregarded.
2 The full CTT allowance will be the amount of commuted traveltime prescribed for the place at which the inspections are performed. See part 97.2. One-half CTT is
(c) As used in this section—
(1) The term private aircraft means any civilian aircraft not being used to transport persons or property for compensation or hire, and
(2) The term private vessel means any civilian vessel not being used (i) to transport persons or property for compensation or hire, or (ii) in fishing operations or in processing of fish or fish products.
(d)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity acting as an agent or broker by requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector on behalf of any other person, firm, partnership, corporation, or other legal entity (principal), and who has not previously requested such service from an Animal and Plant Health Inspection Service inspector, must pay the inspector before service is provided.
(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.
(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection determines that the agent, broker, or principal has established an acceptable credit history.
(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service inspector or U.S. Customs and Border Protection.
(e)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service inspector, and who has a debt to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection more than 60 days delinquent, must pay the inspector before service is provided.
(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.
(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the debtor pays the delinquent debt.
(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector.
(f) Reimbursable Sunday, holiday, or overtime services will be denied to any principal, or any person, firm, partnership, corporation, or other legal entity who has a debt to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection more than 90 days delinquent. Services will be denied until the delinquent debt is paid.
Each period of overtime and holiday duty as prescribed in § 97.1 shall in addition include a commuted traveltime period for the respective ports, stations, and areas in which employees are located. The prescribed computed traveltime periods are as follows:
Commuted Traveltime Allowances
[In hours]
| Location covered | Served from | Metropolitan Area | |
|---|---|---|---|
| Within | Outside | ||
| Alaska: | |||
| Anchorage | 1 | ||
| Do | Palmer | 3 | |
| Arizona: | |||
| Douglas | 1 | ||
| Do | Nogales | 6 | |
| Do | Phoenix | 6 | |
| Do | Sierra Vista | 3 | |
| Naco | Douglas | 2 | |
| Do | Nogales | 4 | |
| Do | Phoenix | 6 | |
| Do | Sierra Vista | 2 | |
| Nogales | 1 | ||
| Do | Douglas | 6 | |
| Do | Phoenix | 6 | |
| Do | Sierra Vista | 3 | |
| San Luis | Phoenix | 6 | |
| Do | Yuma | 2 | |
| Sasabe | Douglas | 6 | |
| Do | Nogales | 4 | |
| Do | Phoenix | 6 | |
| Do | Sierra Vista | 6 | |
| Do | Tuscon | 3 | |
| California: | |||
| Calexico | San Ysidro | 6 | |
| Edwards Air Force Base | Los Angeles | 4 | |
| Los Angeles and Los Angeles International Airport | San Bernardino | 5 | |
| Do | Los Angeles | 2 | |
| Los Angeles Harbor, San Pedro, including Long Beach, Wilmington, and Terminal Island | Los Angeles | 2 | |
| March Field | ......do | 5 | |
| Mexicali | Calexico | 1 | |
| Newport Beach | ......do | 4 | |
| Ontario | ......do | 3 | |
| Ramona | San Ysidro | 2 | |
| Sacramento | ...... | 1 | |
| Do | San Francisco | 5 | |
| San Diego | ....... | 1 | |
| Do | San Ysidro | 2 | |
| San Francisco including, Alameda, Richmond, Pittsburg, and other ports in San Francisco and San Pablo Bay areas | 2 | ||
| San Louis Obispo | San Pedro | 6 | |
| San Ysidro | ....... | 1 | |
| Stockton | San Francisco | 4 | |
| Colorado: | |||
| Stapleton International Airport, Denver | Arvada | 1 | |
| Do | Aurora | 2 | |
| Connecticut: | |||
| Bradley International Airport | Westerly, RI | 5 | |
| Do | Willington | 1 | |
| Bradley International Airport, Windsor Locks | Ashford | 1 | |
| Do | Hartford | 2 | |
| Do | N. Stonington, CT | 4 | |
| Do | Waterbury, CT | 3 | |
| Delaware: | |||
| Wilmington | Dover | 3 | |
| Florida: | |||
| Jacksonville | 2 | ||
| Miami | 2 | ||
| Port Everglades | Miami | 2 | |
| St. Petersburg | Tampa | 2 | |
| Do | Miami | 6 | |
| Tampa | 2 | ||
| Do | Miami | 6 | |
| Georgia: | |||
| Atlanta International Airport | Acworth | 3 | |
| Do | Carrollton | 3 | |
| Do | Covington | 3 | |
| Do | Forsyth | 3 | |
| Port of Brunswick | Savannah | 4 | |
| Port of Savannah | ......do | 2 | |
| Port of St. Mary's | ......do | 6 | |
| Hawaii: | |||
| Kawaihae | Waimea | 1 | |
| Hilo | ......do | 3 | |
| Honolulu, including Aiea, Barber's Point Naval Air Station, Honolulu International Airport, West Loch, Middle Loch, East Loch, Pearl City and Waipahu | 2 | ||
| Idaho: | |||
| Boise | Caldwell or Middleton | 2 | |
| Eastport | Bonners Ferry | 2 | |
| Do | Spokane, WA | 6 | |
| Illinois: | |||
| Chicago | 3 | ||
| Do | Geneseo | 6 | |
| Do | Kirkland | 4 | |
| Springfield | 2 | ||
| Indiana: | |||
| Indianapolis | 1 | ||
| Do | Anderson | 2 | |
| Do | West Lafayette | 3 | |
| Iowa: | |||
| Ames | 1 | ||
| Kentucky: | |||
| Standiford Field | Frankfort | 3 | |
| Do | Louisville | 1 | |
| Louisiana: | |||
| Acadian Regional Airport, New Iberia | Abbeville | 2 | |
| Any point below Chalmette and on the East Bank, Belle Chasse, LA, and points to and including Port Sulphur on the west bank | Baton Rouge | 4 | |
| Any point on the Mississippi River above the St. Charles-Jefferson Parish boundary to and including Gramercy | ......do | 2 | |
| Morgan City | ......do | 5 | |
| New Orleans including Orleans Parish and all points on the east bank of the Mississippi River from the St. Charles-Jefferson Parish boundary to and including Chalmette, LA, and all points on the west bank from the St. Charles-Jefferson Parish boundary to but excluding Belle Chasse, LA | ......do | 4 | |
| Undesignated ports | ......do | 3 | |
| Maine: | |||
| Bangor | Augusta | 3 | |
| Do | Newport | 1 | |
| Houlton | 1 | ||
| Jackman | Augusta | 6 | |
| Do | Bangor | 5 | |
| Do | Newport | 5 | |
| Port of Portland | Augusta | 3 | |
| Do | Bangor | 6 | |
| Do | Concord, NH | 4 | |
| Maryland: | |||
| Baltimore: | 3 | ||
| Largo | Bowie | 2 | |
| Do | Owings Mills | 3 | |
| Do | Easton | 4 | |
| Laurel | Bowie | 2 | |
| Do | Owings Mills | 3 | |
| Do | Easton | 4 | |
| Massachusetts: | |||
| Boston | 3 | ||
| Do | Grafton | 4 | |
| Do | Loudon, NH | 5 | |
| Do | N. Attleboro | 4 | |
| Do | Westerly, RI | 4 | |
| Mexico: | |||
| Ciudad Acuna | Del Rio, TX | 1
| |
| Do | Eagle Pass, TX | 3 | |
| Do | Laredo, TX | 6 | |
| Do | Pleasanton, TX | 6 | |
| Juarez | El Paso, TX | 1 | |
| Nuevo Laredo | Del Rio, TX | 4 | |
| Do | Eagle Pass, TX | 5 | |
| Do | Laredo, TX | 1
| |
| Do | Pharr, TX | 6 | |
| Do | Pleasanton, TX | 5 | |
| Ojinaga | El Paso, TX | 6 | |
| Do | Presidio, TX | 1 | |
| Piedras Negras | Eagle Pass, TX | 1 | |
| Do | Laredo, TX | 5 | |
| Do | Pharr, TX | 10 | |
| Do | Pleasanton, TX | 5 | |
| Reynosa (Pharr International Bridge) | Eagle Pass, TX | 12 | |
| Do | Hidalgo, TX | 1 | |
| Do | Laredo, TX | 5 | |
| Do | Mission, TX | 1 | |
| Do | Pharr, TX | 1 | |
| San Jeronimo | El Paso, TX | 2 | |
| Do | Presidio, TX | 6 | |
| Do | Santa Theresa, NM | 1 | |
| Michigan: | |||
| Detroit | 3 | ||
| Do | Beaverton | 6 | |
| Do | Chelsea | 3 | |
| Do | Clara | 6 | |
| Do | Kalamazoo | 5 | |
| Do | Lansing | 4 | |
| Do | Port Huran | 4 | |
| Port Huron | 1 | ||
| Do | Beaverton | 6 | |
| Do | Chelsea | 6 | |
| Do | Clara | 6 | |
| Do | Detroit | 3 | |
| Do | Lansing | 5 | |
| Do | Kalamazoo | 6 | |
| Minnesota: | |||
| Minneapolis/St. Paul International Airport | 2 | ||
| Do | Rochester | 3 | |
| Do | Princeton | 3 | |
| Noyes | Pembina | 1 | |
| Missouri: | |||
| Kansas City International Airport | Jefferson | 6 | |
| St. Louis Airport | Beaufort | 3 | |
| St. Louis Zoological Park | ......do | 3 | |
| Montana: | |||
| Bozeman | 1 | ||
| Bozeman Laboratory | Bozeman | 1 | |
| Great Falls Airport | Great Falls | 1 | |
| Do | Helena | 5 | |
| Helena | 1 | ||
| Port of Opheim | Plentywood | 5 | |
| Do | Opheim | 1 | |
| Port of Raymond | Plentywood | 1 | |
| Do | Raymond | 1 | |
| Port of Sweetgrass | Great Falls | 5 | |
| Do | Shelby | 2 | |
| Do | Sunburst/Sweetgrass | 1 | |
| Sweetgrass | 1 | ||
| Nebraska: | |||
| Lincoln Airport | 1 | ||
| New Jersey: | |||
| Newark International Airport | Hightstown | 2 | |
| Do | Mount Holly | 3 | |
| Do | Princeton | 2 | |
| Port of Salem | Hightstown | 3
| |
| Do | Mount Holly | 3 | |
| Do | Princeton | 4 | |
| New Mexico: | |||
| Columbus | 1 | ||
| Do | Las Cruces | 4 | |
| Port of Columbus | Deming | 2 | |
| New York: | |||
| Alexandria Bay | 1 | ||
| Buffalo | 2 | ||
| Do | Akron | 2 | |
| Champlain | 1 | ||
| Do | Highgate Springs, VT | 2 | |
| Do | Milton, VT | 3 | |
| Do | Calais, VT | 5 | |
| Malone | Champlain | 3 | |
| Newburgh | 1 | ||
| Do | New York, NY | 4 | |
| New York | 3 | ||
| Niagara Falls | Akron | 2 | |
| Odgensburg | 1 | ||
| Port of Albany | 1 | ||
| Rochester | Buffalo | 4 | |
| Rooseveltown | Odgensburg | 2 | |
| Rouses Point | Champlain | 1 | |
| Stewart Airport, Newburgh | Albany | 4 | |
| North Carolina: | |||
| Iredell | Franklin | 6 | |
| Do | Lumberton | 6 | |
| Do | Raleigh | 6 | |
| North Dakota: | |||
| Dunseith | Minot | 4 | |
| Do | Pembina | 6 | |
| Minot | 1 | ||
| Peace Gardens | Bottineau | 1 | |
| Pembina | 1 | ||
| Do | Fargo | 6 | |
| Do | Valley City | 6 | |
| Portal | 1 | ||
| Do | Bismarck | 6 | |
| Do | Dickinson | 6 | |
| Do | Minot | 4 | |
| Ohio: | |||
| Vandalia Dayton International Airport | Greenville | 2 | |
| Do | Pickerington | 3 | |
| Wilmington | Greenville | 4 | |
| Do | Pickerington | 3 | |
| Oregon: | |||
| Hermiston | Troutdale | 6 | |
| Portland | Salem | 3 | |
| Do | Sunny Valley | 6 | |
| Do | Tigard | 2 | |
| Do | Troutdale | 2 | |
| Pennsylvania: | |||
| Harrisburg | Camp Hill | 1 | |
| Do | Morgantown | 3 | |
| Do | Northumberland | 2 | |
| Do | Shippensburg | 3 | |
| Philadelphia | 3 | ||
| Puerto Rico: | |||
| Aquadilla | Aquadilla | 2 | |
| Salinas | San Juan | 4 | |
| San Juan | 2 | ||
| Tennessee: | |||
| Fort Campbell, Clarkesville | Nashville | 2 | |
| Memphis | 2 | ||
| Memphis | Gadsden | 4 | |
| Memphis | Jackson | 4 | |
| Nashville | 2 | ||
| Texas: | |||
| Brownsville | 1 | ||
| Do | Laredo or San Antonio | 6 | |
| Brownsville and Brownsville International Airport | Harlingen and San Benito | 1 | |
| Do | McAllen or Edinburg | 3 | |
| Do | Weslaco | 2 | |
| Dallas-Fort Worth International Airport | Decatur | 2 | |
| Do | Ft. Worth or Dallas | 2 | |
| Del Rio | 1 | ||
| Do | Eagle Pass | 3 | |
| Do | Edinburg, McAllen or Mission | 6 | |
| Do | Laredo or San Antonio | 5 | |
| Eagle Pass | 1 | ||
| Do | Del Rio | 3 | |
| Do | Edinburgh, McAllen or Mission | 6 | |
| Do | Laredo or San Antonio | 5 | |
| El Paso | 1 | ||
| Do | Hatchita or Deming, NM | 6 | |
| Do | Las Cruces, NM | 3 | |
| Forney | Corsicana | 3 | |
| Do | Ft. Worth | 3 | |
| Do | Tyler | 3 | |
| Harlingen | Edinburg, McAllen or Mission | 2 | |
| Do | Weslaco | 1 | |
| Hidalgo | Brownsville | 3 | |
| Do | Edinburg, Mission and McAllen | 1 | |
| Do | Harlingen | 2 | |
| Do | Lyford | 2 | |
| Do | Rio Grande City | 2 | |
| Houston (including Houston Intercontinental Airport) | 2 | ||
| Do | Bellville, TX | 4 | |
| Do | Bryan, TX | 4 | |
| Do | Georgetown, TX | 8 | |
| Do | Pleasanton, TX | 8 | |
| Laredo | 1 | ||
| Do | Brownsville or San Antonio | 6 | |
| Do | Eagle Pass | 5 | |
| Do | McAllen, Edinburg or Mission | 6 | |
| Presidio | 1 | ||
| Do | El Paso | 6 | |
| Utah: | |||
| Salt Lake City | Murray and Ogden | 2 | |
| Vermont: | |||
| Burlington International Airport | Burlington | 1 | |
| Do | Milton | 1 | |
| Do | Calais | 3 | |
| Derby Line | Milton | 4 | |
| Do | Calais | 4 | |
| Highgate | 1 | ||
| Do | Milton | 2 | |
| Do | Calais | 4 | |
| Highgate Springs | ......do | 1 | |
| Virginia: | |||
| Dulles International Airport | Annapolis, MD | 3 | |
| Do | Richmond | 5 | |
| Do | Warrenton | 3 | |
| Port of Richmond | 2 | ||
| Washington: | |||
| Blaine | 1 | ||
| Do | Seattle | 6 | |
| Lynden | Blaine | 2 | |
| Do | Seattle | 6 | |
| Moses Lake | Oroville, WA | 6 | |
| Do | Spokane | 5 | |
| Do | Wenatchee | 3 | |
| Do | Yakima | 4 | |
| Oroville | 1 | ||
| Sea-Tac Airport | Olympia | 3 | |
| Seattle | 2 | ||
| Sumas | Blaine | 2 | |
| Do | Olympia | 6 | |
| Do | Seattle | 6 | |
| Tacoma | ......do | 3 | |
| Yelm | Olympia | 2 | |
| Do | Seattle | 3 | |
| Wisconsin: | |||
| Barron | Ripon | 6 | |
| Madison | 1 | ||
| Monroe | Madison | 3 | |
An embryo shall not be imported or entered into the United States unless in accordance with the provisions of this part.
The following terms, when used in this subpart, shall be construed as defined. Those terms used in the singular form in this subpart shall be construed as the plural form and vice versa, as the case may demand.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal. Any cattle, sheep, goats, other ruminants, swine, horses, or asses.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
Approved artificial insemination center. A facility approved or licensed by the national government of the region in which the facility is located to collect and process semen under the general supervision of such government.
Approved embryo transfer unit. A facility approved or licensed by the national government of the region in which the facility is located for the artificial insemination of donor dams or for conception as a result of artificial breeding by a donor sire and for collecting and processing embryos for export under the general supervision of such government.
Department. The United States Department of Agriculture.
Embryo. The initial stage of an animal's development after collection from the natural mother, while it is capable of being transferred to a recipient dam, but not including an embryo that has been transferred to a recipient dam.
Enter (entered, entry) into the United States. To introduce into the commerce of the United States after release from governmental detention at the port of entry.
Flock. A herd.
Herd. All animals maintained on any single premises; and all animals under common ownership or supervision on two or more premises which are geographically separated, but among which there is an interchange or movement of animals.
Import (imported, importation) into the United States. To bring into the territorial limits of the United States.
Inspector. An employee of APHIS who is authorized to perform the function involved.
Oocyte. The first and second maturation stages of a female reproductive cell prior to fertilization.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other legal entity.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, typically producing characteristic microscopic changes, including, but not limited to, noninflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and nervous systems of affected animals.
United States. All of the several States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States and all other territories and possessions of the United States.
Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is from a region listed under § 94.1(a) of this chapter as being free of foot-and-mouth disease, and:
(a) The embryo is exported to the United States from the region in which it was conceived;
(b) The embryo was conceived as a result of artificial insemination with semen collected from a donor sire at an approved artificial insemination center, or the embryo as conceived as a result of natural breeding by a donor sire at an approved embryo transfer unit;
(c) If artificially inseminated, the donor dam conceived the embryo after being inseminated in an approved embryo transfer unit with semen collected at an approved artificial insemination center;
(d) At the time of collection of the semen used to conceive the embryo or at the time of natural breeding, the donor sire met all requirements the donor sire would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor sire must meet the scrapie requirements in § 98.35 instead of the requirements in § 93.435 of this chapter;
(e) At the time of collection of the embryo from the donor dam, the donor dam met all requirements the donor dam would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor dam must meet the requirements for embryo donors in § 98.10(a) instead of the requirements in § 93.435 of this chapter;
(f) There is no basis for denying an import permit for the donor sire or donor dam under § 93.304(a)(2) for horses, § 93.404(a)(3) or (4) for ruminants, and § 93.504(a)(2) or (3) for swine of this chapter;
(g) The embryo is collected and maintained under conditions determined by the Administrator to be adequate to protect against contamination of the embryo with infectious animal disease organisms; and
(h) The embryo was determined, based on microscopic examination, to have an intact zona pellucida at the time the embryo was placed into its immediate container (straw or ampule) for shipping.
(i) The embryo is contained in a shipping container which at the time of offer for entry is sealed with an official seal which was affixed to the shipping container by a full-time salaried veterinarian of the national animal health service of the region of origin or by a veterinarian authorized to do so by the national animal health service of the region of origin.
(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 14 days after the proposed date of arrival stated in the import permit.
(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. An application form for an import permit may be obtained from this staff.
(c) The completed application shall include the following information:
(1) The name and address of the person intending to export an embryo from the region of origin,
(2) The name and address of the person intending to import an embryo,
(3) The species, breed, and number of embryos to be imported,
(4) The purpose of the importation,
(5) The region in which the embryo is conceived,
(6) The port of embarkation,
(7) The mode of transportation,
(8) The route of travel,
(9) The port of entry in the United States,
(10) The proposed date of arrival in the United States,
(11) The name and address of the person to whom the embryo will be delivered in the United States, and
(12) The measures to be taken to ensure that the embryo is collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.
(d) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.
(e) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this subpart for importation into the United States shall be issued for the importation of embryos described in the application if such embryos appear to be eligible to be imported. Even though an import permit has been issued for the importation of an embryo, the embryo may be imported only if all applicable requirements of this subpart are met.
(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:
(1) The dates, places, types, and results of all examinations and tests performed on the donor sire and donor dam as a condition for importation of the embryo, and the names and addresses of persons or laboratories conducting the examinations or tests, and a statement that any other requirements established by § 98.3 have been complied with,
(2) The name and address of the consignor and consignee,
(3) The name and address of the approved artificial insemination center where the semen for the embryo was collected, if applicable,
(4) The name and address of the approved embryo transfer unit where the donor dam was inseminated or bred and the embryo was collected, and
(5) The measures taken to ensure that the embryo was collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.
(b) [Reserved]
An embryo shall not be imported into the United States unless at a port of entry listed in § 93.303 for horses, § 93.403 for ruminants, or § 93.503 for swine of this chapter.
Upon arrival of an embryo at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a document stating:
(a) The port of entry,
(b) The date of arrival,
(c) Import permit number,
(d) Carrier, and identification of the means of conveyance,
(e) The name and address of the importer,
(f) The name and address of the broker,
(g) The region of origin of the embryo,
(h) The number, species, and purpose of importation of the embryo, and
(i) The name and address of the person to whom the embryo will be delivered.
Any embryo offered for entry into the United States in accordance with this subpart and documents accompanying the embryo shall be subject to inspection by an inspector at the time the embryo is offered for entry in order to determine whether the embryo is eligible for entry. The import permit and the health certificate shall be given to the inspector.
Any embryo refused entry into the United States for noncompliance with the requirements of this subpart shall be removed from the United States within a time period specified by the Administrator or abandoned by the importer for destruction, and pending such action shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases. If such embryo is not removed from the United States within such time period, or abandoned for destruction, it may be seized, destroyed, or otherwise disposed of as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases.
Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry into the United States of embryos other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction into the United States of infectious animal diseases.
(a) Sheep and goat embryos or oocytes collected from donors located in, or originating from, regions recognized by APHIS as free of classical scrapie, or from a flock or herd having certified status in a scrapie flock certification program recognized by APHIS as acceptable, may be imported in accordance with §§ 98.3 through 98.8. In addition to the requirements of § 98.5, the health certificate must indicate that the embryos or oocytes were collected, processed, and stored in conformity with the requirements in § 98.3(g).
(b) In vivo-derived sheep and goat embryos or oocytes collected from donors located in, or originating from, regions or flocks not recognized by APHIS as free of classical scrapie, may be imported in accordance with §§ 98.3 through 98.8 and the following conditions:
(1) The embryos or oocytes must be accompanied by a health certificate meeting the requirements listed in § 98.5, and with the following additional certifications:
(i) The embryos or oocytes were collected, processed and stored in conformity with the requirements in § 98.3(g).
(ii) For in vivo-derived sheep embryos only: The embryo is of the genotype AAQR or AARR based on official testing of the parents or the embryo.
(iii) Certificates for sheep embryos not of the genotype AAQR or AARR, and for all goat embryos, must contain the following additional certifications:
(A) In the country or zone:
(1) TSEs of sheep and goats are compulsorily notifiable to the national veterinary authority of the region;
(2) A scrapie awareness, surveillance, monitoring, and control system is in place;
(3) TSE-affected sheep and goats are killed and completely destroyed; and
(4) The feeding to sheep and goats of meat-and-bone meal of ruminant origin has been banned and the ban is effectively enforced in the whole country.
(B) The donor animals:
(1) Have been kept since birth in flocks or herds where no case of scrapie had been confirmed during their residency; and
(2) Are permanently identified to enable a traceback to their flock or herd of origin, and this identification is recorded on the certificate accompanying the embryo(s) and linked to the embryo container identification; and
(3) Showed no clinical sign of scrapie at the time of embryo/oocyte collection; and
(4) Have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and
(5) Are not under movement restrictions within the country or region of origin as a result of exposure to a transmissible spongiform encephalopathy.
(2) [Reserved]
(c) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the embryo or embryo parents, and/or on scrapie testing of the embryo donor, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the embryo(s).
(d) Sheep and goat embryos or oocytes may only be imported for transfer to recipient females in the United States if the flock or herd where the recipients reside is listed in the National Scrapie Database; except APHIS may permit importation of sheep and goat embryos or oocytes to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported embryos or oocytes. Imported sheep or goat embryos or oocytes not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd, or from an embryo storage facility to a listed flock or herd, with written notification to the responsible APHIS Veterinary Services Service Center.
(e) The importer, the owner of a recipient flock or herd where delivery of the embryos or oocytes is made, or the owner of an APHIS-approved embryo or oocyte storage facility must maintain records of the disposition (including destruction) of imported or stored embryos or oocytes for 5 years after the embryo or oocyte is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.
(f) For in vitro-derived and manipulated sheep or goat embryos and oocytes, APHIS will make a case-by-case determination or establish conditions in an import permit that includes any additional mitigations deemed necessary to prevent the introduction of disease as provided in § 98.10.
(g) The owner of all sheep or goats resulting from embryos or oocytes imported under this section shall:
(1) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;
(2) Maintain a record linking the official identification number to the imported embryo or oocyte including a record of the replacement of lost tags;
(3) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and
(4) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.
Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species.
Collection of embryos. Embryos removed from a single donor dam in one operation.
Embryo. The initial stages of development of an animal, after collection from the natural mother and while it is capable of being transferred to a recipient dam, but not after it has been transferred to a recipient dam.
Embryo collection unit. Area or areas where the donor dam will be bred to produce embryos for importation into the United States, and where the embryos will be collected, processed, and stored pending shipment to the United States.
Foreign Animal Disease Diagnostic Laboratory. The Foreign Animal Disease Diagnostic Laboratory of the Animal and Plant Health Inspection Service.
Herd of origin. The herd in which the donor dam is kept during the 60 days before the donor dam is required to be housed in an embryo collection unit, in accordance with § 98.17(a) of this subpart.
Import. To bring into the territorial limits of the United States.
Inspector. An employee of the Animal and Plant Health Inspection Service who is authorized to perform the function involved.
Official veterinarian. A full-time salaried veterinarian of the national government of the country of origin or a veterinarian employed by the Animal and Plant Health Inspection Service (APHIS), and designated by APHIS to supervise or conduct procedures required by this subpart, and to certify that requirements of this subpart have been met.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Region of origin. The region in which the embryo is conceived and collected and from which the embryo is imported into the United States.
Ruminant. All animals which chew the cud, including cattle, buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep, goats, and giraffes.
Swine. The domestic hog and all varieties of wild hogs.
United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
(a) Ruminant and swine embryos may not be imported from regions where foot-and-mouth disease exists except in accordance with this subpart.
(b) Ruminant and swine embryos may not be imported into the United States from any region other than the region in which they were conceived and collected.
(a) Ruminant and swine embryos and all test samples required by this subpart may be imported into the United States from regions where foot-and-mouth disease exists only if accompanied by import permits issued by the Animal and Plant Health Inspection Service (APHIS).
(b) An application for the import permits must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Application forms also may be obtained at this same address. The application for a permit to import embryos will also serve as the application for a permit to import test samples for those embryos; separate applications are not required. The application must include the following information:
(1) The name and address of the exporter;
(2) The name and address of the importer;
(3) The name and address of the place where the donor dam will be bred and where the embryo(s) will be collected;
(4) The species, breed, and number of embryos to be imported;
(5) The purpose of the importation;
(6) The port of embarkation;
(7) The mode of transportation;
(8) The route of travel;
(9) The port of entry in the United States;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the embryos will be delivered in the United States.
(c) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.
(a) Ruminant and swine embryos shall not be imported into the United States unless they are accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.
(b) The health certificate must state:
(1) The name and address of the place where the embryos were collected;
(2) The name and address of the veterinarian who collected the embryos;
(3) The date of embryo collection;
(4) The identification and breed of the donor dam and donor sire;
(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;
(6) The dates, types, and results of all examinations and tests performed on the donor dam and donor sire as a condition for importing the embryos;
(7) The dates and results of all tests performed on unfertilized eggs, nontransferrable embryos, and embryo collection and wash fluids;
(8) The names and addresses of the consignor and consignee;
(9) That the embryos are being imported into the United States in accordance with subpart B of 9 CFR part 98.
(c) If any of the information required by paragraph (b) of this section is provided in code, deciphering information must be attached to the health certificate.
(d) The health certificate accompanying sheep or goat embryos intended for importation from any part of the world shall, in addition to the statements required by paragraph (b) of this section, state that:
(1) The embryos' sire and dam have not been in any flock or herd nor had contact with sheep or goats which have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years prior to the date of collection of the embryos;
(2) The embryos' sire and dam showed no evidence of scrapie at the time the embryos were collected;
(3) Scrapie has not been suspected nor confirmed in any progeny of the embryos' donor dam; and
(4) The parents of the embryos' sire and dam are not, nor were not, affected with scrapie.
(e) There must be a separate health certificate for each collection of embryos.
Ruminant and swine embryos may be imported from a region where foot-and-mouth disease exists only if all of the following conditions are met:
(a) The donor dam is determined to be free of communicable diseases based on tests, examinations, and other requirements, as follows:
(1) During the year before embryo collection, no case of the following diseases occurred in the embryo collection unit or in any herd in which the donor dam was present:
(i) Ruminant: Contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or
(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.
(2) During the year before embryo collection, no case of the following diseases occurred within 5 kilometers of the embryo collection unit or in any herd in which the donor dam was present:
(i) Ruminant: Contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or
(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.
(3) During the 60 days before embryo collection, the donor dam did not receive a vaccination for foot-and-mouth disease.
(4) During the 60 days before the donor dam was required to be in the embryo collection unit, in accordance with § 98.17(a) of this subpart, the donor dam remained in the same herd, and no ruminants or swine were added to that herd.
(5)(i) On the day of embryo collection, and again not less than 30 days nor more than 120 days afterward, one sample of at least 10 ml of serum was collected from the donor dam, frozen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing.
(ii) The donor dam was determined to be free of foot-and-mouth disease based upon tests of the pair of serum samples. In addition, if any of the following diseases exist in the region of origin, the donor dam was determined to be free of these diseases based upon additional tests of the serum samples:
(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, or vesicular stomatitis; or
(B) Swine: African swine fever, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.
(iii) If the donor dam was in any herd during the year before embryo collection that was not certified free of brucellosis by the national government of the region of origin, the donor dam was determined to be free of brucellosis based on tests of the serum samples.
(iv) The only official test results will be those provided by the Foreign Animal Disease Diagnostic Laboratory.
(6) If the donor dam was in any herd during the year before embryo collection that was not certified free of tuberculosis by the national government of the region of origin, the donor dam was determined to be free of tuberculosis by an official veterinarian based on an intradermal tuberculin test. The test must have been administered to the donor dam by an official veterinarian not less than 30 days nor more than 120 days after embryo collection, and not less than 60 days after any previously administered intradermal test for tuberculosis.
(7)(i) Not less than 30 days nor more than 120 days after embryo collection, the donor dam was examined by an official veterinarian and found free of clinical evidence of the following diseases:
(A) Ruminant: Brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or
(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.
(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.
(8)(i) Between the time the embryos were collected and all examinations and tests required by this subpart were completed, no animals in the embryo collection unit with the donor dam, or in the donor dam's herd of origin, exhibited any clinical evidence of:
(A) Ruminant: Brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or
(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.
(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.
(b) The donor dam or donor sire is determined to be free of communicable diseases based on other testing or certifications if required by the Administrator. The Administrator may require additional testing or certifications if he or she determines that they are necessary to determine either the donor dam's or the donor sire's freedom from communicable diseases. Circumstances that may result in additional testing or certifications include, but are not limited to:
(1) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin;
(2) A high prevalence or an increase in the incidence of a communicable disease in the region of origin;
(3) The use of natural breeding, rather than artificial insemination to conceive the embryos;
(4) The use of fresh, rather than frozen semen, for artificial insemination; and
(5) The use of semen collected at a site other than an artificial insemination center approved by the national government of the region of origin.
(c) Embryos produced by any donor dam or sire that dies before being examined and tested as required under this subpart will not be eligible for importation into the United States.
Ruminant and swine embryos may be imported into the United States from a region where foot-and-mouth disease exists only if they were conceived, collected, processed, and stored prior to importation at an embryo collection unit. The embryo collection unit may be located on the premises where the donor dam's herd of origin is kept, or at any other location, provided that the embryo collection unit has been inspected and approved by an APHIS veterinarian and that the following requirements are met:
(a) Animal holding and breeding area(s). The embryo collection unit must have an area or areas for holding the donor dams and for breeding them (either natural breeding or artificial insemination).
(b) Embryo collection area. The embryo collection must have a room or outdoor area for collection of embryos that contains a device or devices for restraining embryo donors during embryo collection. If a room, the floor, walls, and ceiling must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. If an outdoor area, the area must have a floor that is impervious to moisture and is constructed of materials that can withstand repeated cleaning and disinfection. If the outdoor area also has walls or a roof, the walls or roof also must be impervious to moisture and be constructed of materials that can withstand repeated cleaning and disinfection.
(c) Embryo processing area. The embryo collection unit must have an enclosed room, which may be mobile, that is used only for processing embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. The room must contain a work surface for handling the embryos, such as a table or countertop that is impervious to moisture. The room also must contain a microscope with a minimum of 50x magnification, and equipment for freezing the embryos.
(d) Embryo storage area. The embryo collection unit must have one lockable area that is used only for storing frozen embryos intended for importation into the United States.
(e) Area for cleaning and disinfecting or sterilizing equipment. The embryo collection unit must have an enclosed room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection.
(a) Housing of the donor dam. (1) Beginning at least 24 hours before a donor dam is bred to produce embryos for importation to the United States, the donor dam must be housed at an embryo collection unit.
(2) The donor dam must remain at the embryo collection unit until the embryos for importation into the United States have been collected.
(3) After collection of embryos, the donor dam must either remain at the embryo collection unit or be returned to the herd of origin and remain there until all examinations and tests required by this subpart have been completed.
(4) During the time the donor dam is in the embryo collection unit, in accordance with paragraphs (a)(1) through (a)(3) of this section, no animals may be in the embryo collection unit with the donor dam unless:
(i) They meet the requirements of § 98.15 of this subpart that are applicable to the donor dam at that time;
(ii) They are part of the donor dam's herd of origin; or
(iii) They are serving as donor sires for the production of embryos to be imported into the United States.
(b) Oversight and supervision. (1) All procedures associated with the production of embryos for importation into the United States, including artificial insemination, natural breeding, and cleaning and disinfection, must be performed under the oversight of an APHIS veterinarian. Collecting test samples, and collecting, processing, and storing embryos, must be supervised in person by an APHIS veterinarian.
(2) Officials from the Animal and Plant Health Inspection Service must be given access to all areas of the embryo collection unit and the donor dam's herd of origin during the time the donor dam is housed there, in accordance with paragraphs (a)(1) through (a)(3) of this section.
(c) Personnel. All personnel must put on clean outer garments, including disinfected boots, and must scrub their hands with soap and water each time they enter the embryo collection unit and before entering any room or area listed in § 98.16 of this subpart.
(d) Cleaning, disinfection, and sterilization. (1) All equipment that comes in contact with embryos or with media used for their collection or processing must be sterile. Equipment used for embryos from one donor dam, or with associated media, may not be used for embryos or associated media from any other donor dam until it has been resterilized.
(2) All equipment that comes in contact with a donor dam's secretions or excretions must be sterile and may not be used with any other donor dam until it has been resterilized.
(3) Containers used for storing embryos or for shipping embryos to the United States must be examined and found free of any organic matter and then disinfected before the ampules or straws are placed inside.
(4) The floor, ceiling, and walls of any room or outdoor area used for embryo collection, and the restraining device(s) used for this procedure, must be cleaned with soap and water and disinfected before the room or area is used to collect embryos intended for importation to the United States, and at least daily while in use for this purpose.
(5) The room and work surface used for processing embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before the room is used for embryos intended for importation to the United States, and the work surface must be cleaned and disinfected at least daily while in use for this purpose.
(6) The area of the embryo collection unit used to store embryos intended for importation to the United States must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to store the embryos.
(7) The room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to prepare equipment for donors of embryos intended for importation into the United States, and at least daily while in use for this purpose.
(e) Media; cryogenic agent. (1) All media containing products of animal origin and used for embryo collection and processing must be from sources in the United States or Canada.
(2) The liquid nitrogen used to freeze embryos may not have been used previously for any other products of animal origin.
(f) Collection and processing of embryos. (1) If embryos are collected in an outdoor area, they must be collected by using a closed collection system so that the embryos are not exposed to open air until they are inside the embryo processing room.
(2) Embryos from donors that do not meet the requirements of § 98.15 of this subpart that are applicable at the time of embryo collection may not be in the processing room at the same time as embryos intended for importation into the United States.
(3) Each embryo must be washed at least 10 times. Each wash must be accomplished by transferring the embryo into an aliquot of fresh medium that is 100 times the volume of the embryo plus any fluid transferred from the previous wash. No more than 10 embryos from the same flush may be washed together. A sterile micropipette must be used for each transfer, and the embryos must be well agitated throughout the entire volume of the wash before the next transfer. Embryos from different donors may not be washed together.
(4) After the last wash, each embryo must be microscopically examined over its entire surface at not less than 50 × magnification. An embryo may not be imported into the United States unless its zona pellucida is found to be intact and free from any adherent material.
(5) After washing and examination of the zona pellucida, embryos must be individually packaged in sterile ampules or straws and frozen in liquid nitrogen. The donor dam's and sire's identifications and breed, the date of embryo collection, the name and address of the place where the embryos were collected, and an identification number for the straw or ampule must be recorded with indelible markings on each ampule or straw. If any of this information is provided in code, deciphering information must be attached to the health certificate for the embryos.
(6) The Administrator may require additional measures to be taken in processing embryos after collection (for example, adding trypsin to the washes) if he or she determines that such measures are necessary to ensure the embryos freedom from infectious agents that may cause communicable diseases. Circumstances that may result in such additional measures being required include, but are not limited to:
(i) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin; and
(ii) A high prevalence or an increase in the incidence of a communicable disease in the region of origin.
(g) Preparation of test samples; tests. (1) All nontransferrable embryos and unfertilized eggs from each collection of embryos intended for importation into the United States must be pooled, frozen in liquid nitrogen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. The collection and last two wash fluids from the collection of embryos must be frozen and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. Samples from different collections may not be mixed.
(2) All samples collected in accordance with paragraph (g)(1) of this section must be tested and found negative for viral contamination. The wash fluids also must be found negative for bacterial contamination. The only official results for these tests will be those provided by the Foreign Animal Disease Diagnostic Laboratory.
(h) Storage of embryos. (1) Frozen embryos to be imported into the United States must be stored in a locked area or must remain in the custody of an official veterinarian until they are sealed in accordance with paragraph (h)(2) of this section and released for shipment to the United States in accordance with § 98.18(a) of this subpart; except that, the embryos may be moved to a U.S. Department of Agriculture-operated animal import center in either New York, Hawaii, or Florida, under seal and in the custody of that individual, and remain in quarantine there until all tests and examinations required by this subpart have been completed and all test results have been provided by the Foreign Animal Disease Diagnostic Laboratory.
(2) Containers in which embryos will be imported into the United States must be sealed by an official veterinarian with the official seal of the region of origin or, if the official veterinarian is an employee of the Animal and Plant Health Inspection Service, with an official seal of the United States Department of Agriculture. The seal number must be recorded on the health certificate that accompanies the embryos to the United States.
(a) Release from the embryo collection unit. Except as provided in § 98.17(h)(1) of this subpart, embryos may not be moved from the embryo collection unit until all tests and examinations required by this subpart have been completed and the Import-Export Animals Staff, Veterinary Services, APHIS, has received written notification of all test results from the Foreign Animal Disease Diagnostic Laboratory.
(b) Route. The sealed shipping containers must be routed directly to the U.S. port of entry designated on the import permit.
(c) Ports of entry. The embryos may be imported into the United States only through a port of entry listed in § 93.203(a) of this chapter.
(d) Date of arrival in the United States. Embryos that arrive at the port of entry more than 14 days after the proposed date of arrival stated in the import permit will not be eligible for importation into the United States.
(a) Upon arrival at the port of entry, the importer or the importer's agent must present an inspector at the port with the original health certificate and the original import permit for the embryos.
(b) The shipping container and all straws or ampules containing embryos must be made available to an inspector at the port of entry for inspection, and may not be removed from the port of entry until an inspector determines that the embryos are eligible for entry in accordance with this subpart and releases them.
If any embryos are determined to be ineligible for importation into the United States upon arrival at the port of entry, the importer must remove the embryos from the United States within 30 days, or the embryos will be destroyed.
Except for embryos from sheep in Australia, Canada, or New Zealand, embryos from sheep may only be imported into the United States if they comply with all applicable provisions of this subpart and with § 98.10a.
Whenever in this subpart of the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service.)
Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, zebras, and poultry.
Cattle. Animals of the bovine species.
Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.
Department. The United States Department of Agriculture (USDA).
Establishment. The premises in which animals are kept.
Flock. A herd.
Herd. All animals maintained on any single premises; and all animals under common ownership or supervision on two or more premises which are geographically separated, but among which there is an interchange or movement of animals.
Horses. Horses, asses, mules, and zebras.
Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.
Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).
Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited.
Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Swine. The domestic hog and all varieties of wild hogs.
United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.
(a) No product subject to the provisions of this subpart shall be brought into the United States except in accordance with the regulations in this subpart and part 94 of this subchapter; nor shall any such product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, except as prohibited by section 306 of the Act of June 17, 1930, as amended (19 U.S.C. 1306), the Administrator may upon request in specific cases permit products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States.
(b) Animal semen may not be imported into the United States from any region other than the region in which it was collected.
(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.
(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a) Air and ocean ports. The following air and ocean ports are designated as having inspection facilities for the entry of animal semen: Los Angeles, California; Miami, Florida; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.
(c) Mexican border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Mexico: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; Calexico and San Ysidro, California; Antelope Wells, Columbus, and Santa Teresa, New Mexico; Brownsville, Del Rio, Eagle Pass, El Paso, Hidalgo, Laredo, and Presidio, Texas.
(d) Limited ports. The following limited ports are designated as having inspection facilities for the entry of animal semen: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; International Falls and Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee; Galveston and Houston, Texas; Seattle, Spokane, and Tacoma, Washington.
(e) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.
(a) Application for permit; reservation required. (1) For poultry semen and animal semen, intended for importation from any part of the world, except as otherwise provided for in § 98.36, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, quantity of animal semen to be imported; the purpose of the importation; individual animal identification (except poultry) which includes a description of the animal, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the animal semen to be imported; and the name of the person to whom the animal semen will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the animals are susceptible, as well as vaccinations or other precautionary treatments to which the animals or animal semen have been subjected. Notice of any such requirements will be given to the applicant in each case.
(2) An application for permit to import will be denied for semen from ruminants or swine from any region where it has been declared, under section 306 of the Act of June 17, 1930, that foot-and-mouth disease has been determined to exist, except as provided in paragraph (c) of this section.
(3) An application for permit to import poultry semen or animal semen may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals or animal semen; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Animal semen intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Poultry semen and animal semen for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the animal semen offered for entry differs from that described in the permit; or if the animal semen is not handled as outlined in the application for the permit and as specified in the permit issued.
(c) Animal semen from regions where foot-and-mouth disease exists. Importation of semen of ruminants or swine, originating in any region designated in paragraph (a) of § 94.1 of this subchapter as a region where foot-and-mouth disease is determined to exist, is prohibited, except that semen from ruminants or swine originating in such a region may be offered for entry into the United States at the port of New York and later released from such port provided the following conditions have been fulfilled:
(1) The importer has applied for and obtained an import permit for the semen in accordance with the provisions of this section and related requirements concerning application therefor, which permit is in effect at the time of importation, and has deposited with the Department prior to the issuance of the permit sufficient funds so as to be available for defraying estimated expenses to be incurred in connection with the proposed semen importation and following the issuance of the permit has deposited such other amounts as may be required from time to time to defray unanticipated costs or increased expenses. Such an import permit may be denied for the reasons specified in paragraph (a)(3) of this section. Furthermore, an import permit will be revoked unless the following conditions have been complied with:
(i) The donor animal shall have been inspected on the farm of origin or on another premises (the inspection may be on another premises only if a veterinarian of the Department has traced the donor animal back to its farm of origin) by a veterinarian of the United States Department of Agriculture who, in cooperation with the veterinary service of the region of origin of the donor animal, shall have determined, insofar as possible, that the donor animal was never infected with foot-and-mouth disease; that the donor animal was never on a farm or other premises where foot-and-mouth disease then existed; that the donor animal has not been on a premises that had an animal that was susceptible to the virus of foot-and-mouth disease and that was exposed to the disease during the 12 months immediately prior to the date of inspection of the donor animal; that the donor animal, if a swine, has never been vaccinated against foot-and-mouth disease; and that the donor animal was free from evidence of other communicable disease;
(ii) The donor animal shall have been permanently identified in a manner satisfactory to a veterinarian of this Department; a blood sample and an oesophageal-pharyngeal tissue sample (O-P sample) from such a donor ruminant and a blood sample from such a donor swine for tests as specified in paragraph (c)(1)(iv) of this section or other tests shall have been collected by a veterinarian of the United States Department of Agriculture and transported by air to the New York Port Veterinarian for delivery to the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, in containers approved by a veterinarian of this Department, sealed in the region of origin by a veterinarian of this Department; and pending the results of the tests, the donor animal shall have been kept in isolation on the farm of origin or other acceptable location under the supervision of a veterinarian of this Department, and during such isolation period no animal susceptible to foot-and-mouth disease shall have been permitted to enter such farm or location and no other source of exposure to foot-and-mouth disease shall have been present;
(iii) The blood samples from the donor animal shall have been negative to the tests specified in paragraph (c)(1)(iv) of this section made at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and to any other test for foot-and-mouth disease or other communicable disease prescribed by the Administrator.
(iv) In the case of a ruminant, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and each O-P sample collected pursuant to paragraph (c)(1)(ii) or (iv) of this section shall have been tested for foot-and-mouth disease using the virus isolation test. In the case of a swine, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and the virus neutralization test.”
(v) Following isolation, preliminary veterinary inspection, and testing while the donor animal was on the farm of origin or other acceptable location, the donor animal shall have been transported, under such conditions as the Department veterinarian prescribed to prevent exposure of the animal to the virus of foot-and-mouth disease, to an isolation facility properly equipped for the necessary care and maintenance of the donor animal and for the proper collection and handling of semen, approved by a veterinarian of this Department and under the direct supervision of such veterinarian;
(vi) The semen of the donor animal shall have been collected at the approved isolation facility under the direct supervision of a veterinarian of this Department (any number of collections may be made); such veterinarian shall take a 0.5 ml sample of semen from each semen collection; and all handling procedures, such as examination, dilution, refrigeration, and preparation of the semen for shipment, shall have been under the direct supervision of a veterinarian of this Department. In the case of a ruminant, a blood sample and an O-P sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of these samples another blood sample shall have been taken from the donor animal by a veterinarian of the Department. In the case of a swine, a blood sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of the sample, another blood sample shall have been taken from the donor animal by a veterinarian of the Department.
(2) The semen collected at the approved isolation facility shall have been at all times, except during air transportation to New York, in the custody of a veterinarian of this Department.
(3) The semen for which an import permit has been issued shall have been transported by air to the port of New York in liquid nitrogen containers approved by a veterinarian of this Department; sealed in the region of origin by a veterinarian of this Department; and accompanied by a statement by such veterinarian showing the identification of the donor animal and the dates the semen was collected, along with a certificate regarding the health status of the donor animal as of the date of shipment of the semen to the port of New York. All semen received at the port of New York shall be held under quarantine in liquid nitrogen storage at such port in the custody of APHIS until released or otherwise disposed of as provided in this section.
(4) The donor animal shall have been retained at the approved isolation facility in the region where the semen was collected until all of the applicable samples referred to in paragraph (c)(1)(vi) of this section have been collected by a veterinarian of the Department for tests as specified in paragraph (c)(1)(iv) of this section at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and any other tests as required by the Administrator.
(5) The semen sample from each collection shall have consisted of unprocessed semen without any added substances, and shall have been tested at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York. Such tests shall have been performed by injecting the semen samples into test animals which are susceptible to foot-and-mouth disease. The semen collected at the approved isolation facility, other than the semen samples, may be held in the region of origin or at the port of New York, at the option of the importer, until all of the testing required to be conducted under this section is completed.
(6) If it is determined that the requirements set forth in this paragraph have been complied with and there are no indications that the donor animal or the semen from the donor animal harbors the virus of foot-and-mouth disease or any other communicable disease and if the donor animal, blood samples from the donor animal, O-P samples (if applicable) from the donor animal, and semen samples from the donor animal are negative to all other tests required, the semen shall be released for shipment to the consignee listed by the importer; otherwise the semen shall be destroyed or disposed of as the Administrator, may direct.
(7) Porcine semen from the People's Republic of China. In addition to the other requirements of this part, porcine semen may be imported into the United States from the People's Republic of China (PRC) only after the official veterinary organization (OVO) of the PRC has certified that the PRC is free of African swine fever, and Teschen's disease, and after the following conditions have been fulfilled:
(i) The donor boars must pass a 60-day isolation/collection period in a facility jointly approved by the OVO of the PRC and the USDA as adequate to prevent exposure of the donor boars to infectious diseases. Any other swine at the isolation facility, such as teaser animals, must also meet the requirements of this paragraph. No animals may be added to the group after the start of the 60-day isolation/collection period. The Department will permit collection of semen to be initiated at the beginning of the isolation/collection period. The facility shall be cleaned and disinfected with a 4 percent sodium carbonate solution used in accordance with applicable label instructions in the presence of OVO quarantine personnel prior to the start of the isolation. During the isolation/collection period, personnel handling the animals shall not have contact with other domestic farm livestock (this term does not include pets such as dogs and cats). Raw animal food wastes (garbage) shall not be fed to the donor boars while in isolation. At the start of the isolation/collection period, and again after 14 days of isolation, all animals offered for collection of semen must be given an intramuscular injection of dihydrostreptomycin at a rate of 25 mg/kg dosage as a precautionary treatment for leptospirosis. Feed and bedding used during the isolation/collection period shall not originate from areas infected with epizootic diseases and must meet veterinary hygienic requirements established by the OVO of the PRC concerning freedom of the feed and bedding from contamination that could transmit diseases. During the isolation/collection period the swine at the collection center shall not have direct contact with, or exposure to, any other animals not included in the group at the isolation facility. Exposure consists of contact with yards, pens, or other facilities or vehicles that have been in contact with animals and have not been cleaned and disinfected.
(ii) Donor boars shall be selected from premises which are solely swine breeding operations. These premises must be located at the center of an area with a 16 km radius that was free of foot-and-mouth disease (FMD), swine vesicular disease (SVD), and classical swine fever for three years prior to semen collection. Donor boars shall not have been vaccinated against these diseases. There shall have been no cases of these diseases on these premises for five years prior to the collection of semen. There shall have been no animal introduced into these premises from farms affected with these diseases for three years prior to the collection of semen. There shall have been no evidence of brucellosis, tuberculosis, or pseudorabies on these premises or on premises adjacent to these premises for one year prior to the collection of semen.
(iii) During the 60-day isolation/collection period, the boars offered for collection of semen shall be subjected to the following tests,
(A) Foot-and-mouth disease:
(1) Microtiter virus neutralization (VN) test for types, A, O, C, and Asia. (The PRC will test for types A and O, and the United States will test for types C and Asia at the USDA Foreign Animal Disease Diagnostic Laboratory (FADDL)).
(2) Agar gel immunodiffusion (AGID) test using virus infection associated antigen (VIAA) in serum. (Animals having responses to the AGID test or reacting to the VN test at 1:10 dilution or greater shall be eliminated as semen donors, and all other swine in contact with them shall be retested within 30 days. If the whole group does not have the above responses and there is no clinical evidence of FMD, the group shall be eligible for collection of semen with respect to FMD. Otherwise, none of the group shall qualify as donors of semen for export.)
(B) Brucellosis: Standard tube test (STT) at less than 30 IU/ml, and card test (antigen and protocol to be supplied by USDA).
(C) Swine vesicular disease: Virus neutralization test at 1:40 dilution (serums to be tested at FADDL).
(D) Classical swine fever: Fluorescent antibody neutralization (FAN) test at 1:16 dilution.
(E) Japanese B encephalitis: Hemagglutination inhibition (HI) test, negative according to PRC standards.
(F) Pseudorabies: Virus neutralization at 1:4 dilution.
(G) Tuberculosis: Intradermal test using bovine PPD tuberculin (Positive animals will be necropsied. If there are lesions of TB in the test positive pigs, the whole group will be ineligible as semen donors. If no lesions are found, the rest of the pigs will be eligible as semen donors with respect to tuberculosis.
(iv) The semen will not be eligible for release in the United States until all tests in paragraph (c)(7)(iii) of this section have been completed with negative results.
(v) Each semen straw or ampule for export must be identified with the name or identification number of the donor boar and with the date of collection. A USDA veterinarian shall certify that he or she has supervised the collection and processing of the semen and its storage until the time it is shipped to the United States. Each shipment will be accompanied by a USDA veterinarian unless the semen is shipped directly to the port of New York, with no stops en route. Shipment to the United States will be in accordance with the terms of a USDA import permit. Semen imported in accordance with this section shall be released by USDA to the importer only after all requirements of this section have been met.
(d) Sheep and goat semen from regions where scrapie exists. Importation of semen of sheep and goats is subject to the requirements in § 98.35(e). Applications for a permit to import sheep and goat semen must include statements that:
(1) All first generation (F1) progeny resulting from imported semen will be identified with a permanent official identification consistent with the provisions of § 79.2 of this chapter; and
(2) Records of any sale of F1 progeny, including the name and address of the buyer, will be kept for a period of 5 years. APHIS may view and copy these records during normal business hours.
(a) The certificates, declarations, and affidavits required by the regulations in this subpart shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of animal semen at such port, for the use of the veterinary inspector at the port of entry.
(b) For all animal semen offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the animal semen, the number, breed, species, and purpose of the importation, the name of the person to whom the animal semen will be delivered, and the location of the place to which such delivery will be made.
(c) All animal semen intended for importation into the United States shall be accompanied by a health certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.
(d) The health certificate must state:
(1) The name and address of the place where the semen was collected;
(2) The name and address of the veterinarian who supervised the collection of the semen;
(3) The date of semen collection;
(4) The identification and breed of the donor animal;
(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;
(6) The dates, types, and results of all examinations and tests performed on the donor animal as a condition for importing the semen;
(7) The seal number on the shipping container;
(8) The names and addresses of the consignor and consignee; and
(9) That the semen is being imported into the United States in accordance with subpart C of 9 CFR part 98.
(e) The certificates accompanying sheep semen collected from rams that are not of the genotypes AARR or AAQR, and for all goat semen shall, in addition to the statements required by paragraph (d) of this section, state that:
(1) The donor animals:
(i) Are permanently identified, to enable traceback to their establishment of origin; and
(ii) Neither showed clinical signs of scrapie at the time of semen collection nor developed scrapie between the time of semen collection and the export of semen to the United States; and
(iii) The donor animal is not, nor was not, restricted in the country of origin, or destroyed, due to exposure to a TSE.
(iv) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the semen donor, and/or on scrapie testing of the donor or semen, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the semen.
(2) In the region where the semen originates:
(i) Scrapie is a compulsorily notifiable disease; and
(ii) An effective surveillance and monitoring system for scrapie is in place; and
(iii) Affected sheep and goats are slaughtered and completely destroyed; and
(iv) The feeding of sheep and goats with meat-and-bone meal or greaves derived from ruminants has been banned and the ban effectively enforced in the whole region.
(3) Sheep and goat semen may only be imported for transfer to recipient females in the United States if the flock or herd in which recipients reside is listed in the National Scrapie Database; except that APHIS may permit importation of sheep and goat semen to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported semen. Imported sheep or goat semen not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd or from an approved semen storage facility to a listed flock or herd or another approved semen storage facility with written notification to the responsible APHIS Veterinary Services Service Center.
(4) The importer, the owner of a recipient flock or herd to which delivery of the semen is made, or the owner of an APHIS-approved semen storage facility must maintain records of the disposition (including destruction) of imported or stored semen for 5 years after the semen is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.
(5) The owner of all sheep or goats resulting from semen imported under this section shall:
(i) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;
(ii) Maintain a record linking the official identification number to the imported semen, including a record of the replacement of lost tags;
(iii) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and
(iv) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.
(f) All shipping containers carrying animal semen for importation into the United States must be sealed with an official seal of the national veterinary service of the region of origin. The health certificate must show the seal number on the shipping container. The semen must remain in the sealed container until arrival in the United States and, at the U.S. port of entry, an inspector determines that either:
(1) The seal numbers on the health certificate and shipping container match; or
(2) The seal numbers on the health certificate and shipping container do not match, but an APHIS representative at the port of entry is satisfied that the shipping container contains the semen described on the health certificate, import permit, declaration, and any other accompanying documents.
(a) General importation requirements for animal semen from Canada.
| If the product is . . . | Then . . . |
|---|---|
| (1) Equine semen | There are no importation requirements under this part. |
| (2) Sheep or goat semen | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present:
(i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate. |
| (3) Animal semen other than equine, sheep, or goat semen | See paragraph (b) of this section. |
(b) Importation requirements for animal semen other than equine, sheep, or goat semen from Canada.
| If the product is offered for entry at a . . . | And . . . | Or . . . | Then . . . |
|---|---|---|---|
| (1) Canadian land border port listed in § 98.33(b) of this part | The donor animal was born in Canada or the United States and has never been in a region other than Canada or the United States | The donor animal was legally imported into Canada, released to move freely in Canada, and has been released in Canada for no less than 60 days | The importer or his agent, in accordance with § 98.35 of this part, must present:
(i) Two copies of a declaration; and (ii) A health certificate. |
| (2) Canadian land border port listed in § 98.33(b) of this part | The donor animal does not meet the special conditions listed above in paragraph (b)(1) of this table | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present:
(i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate. | |
| (3) Port not listed in § 98.33(b) of this part | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present:
(i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate. |
In addition to meeting all other applicable provisions of this part, swine semen imported from the APHIS-defined European CSF region, as defined in § 94.0 of this subchapter, must meet the following conditions:
(a) The semen must come from a semen collection center approved for export by the competent veterinary authority.
(b) The semen must not have been collected from a donor boar that was in any of the following regions or zones, unless the semen was collected after the periods described:
(1) Any region when the region was classified under §§ 94.9(a) and 94.10(a) of this chapter as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;
(2) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(3) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.
(c) The semen must not have been collected from a donor boar that was commingled with swine that at any time were in any of the regions or zones described in paragraphs (b)(1) through (b)(3) of this section, unless the semen was collected after the periods described.
(d) The semen must not have been collected from a donor boar that transited any region or zone described in paragraphs (b)(1) through (b)(3) of this section during the periods described, unless the donor boar was moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the semen was collected after the periods described;
(e) The donor boar must be held in isolation for at least 30 days prior to entering the semen collection center.
(f) No more than 30 days prior to being held in isolation as required by paragraph (e) of this section, the donor boar must be tested with negative results with a classical swine fever test approved by the World Organization for Animal Health.
(g) No equipment or materials used in transporting the donor boar from the farm of origin to the semen collection center may have been used previously for transporting swine that do not meet the requirements of this section, unless such equipment or materials have first been cleaned and disinfected.
(h) The semen must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority, stating that the provisions of paragraphs (a) through (g) of this section have been met.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 99.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
When used in parts 101 through 117 of this subchapter, the meaning of the words and phrases listed shall be as defined in this part.
The following administrative words and phrases shall mean:
Adjacent herd. Adjacent herds are herds physically contiguous to the herd of origin; there are no herds between an adjacent herd and the herd of origin.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Adverse event. Any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis.
Adverse event report. Direct communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes the following information:
(1) An identifiable reporter;
(2) An identifiable animal;
(3) An identifiable biologic product; and
(4) One or more adverse events.
Animal and Plant Health Inspection Service. The agency in the Department of Agriculture responsible for administering the Virus-Serum-Toxin Act.
Biological products. The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.
(1) A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance.
(2) The term analogous products shall include:
(i) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or
(ii) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or
(iii) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.
(3) The term treatment shall mean the prevention, diagnosis, management, or cure of diseases of animals.
Department. The U.S. Department of Agriculture.
Distributor. A person who sells, distributes, or otherwise places in channels of trade, one or more biological products he does not produce or import.
Division. A marketing unit established by the licensee which may be named on labels, advertisements and promotional material in addition to the name and address of the producer.
Domestic animals. All animals, other than man, including poultry.
Establishment. One or more premises designated on the establishment license.
Guidelines. Guidelines establish principles or practices related to test procedures, manufacturing practices, product standards, scientific protocols, labeling, and other technical or policy considerations. Guidelines contain procedures or standards of general applicability that are usually not regulatory in nature, but that are related to matters that fall under the Virus-Serum-Toxin Act. Guidelines issued by the agency include Veterinary Biologics Licensing Considerations, Memoranda, Notices, and Supplemental Assay Methods.
Herd. Any group of animals, including birds, fish, and reptiles, maintained at a common location (e.g. lot, farm or ranch) for any purpose. The herd (or flock) includes all animals subsequently housed at the common location. If the principal animals of a group are moved to a different location, the group is still considered the same herd.
Herd of origin. The herd from which the microorganism used as seed for production of an autogenous biologic is isolated. Offspring and excess breeding stock (not the principal animals) moved or sold from one group of animals to another have changed herds and are no longer considered part of the herd they originated from. Groups of animals under the same ownership but at different locations are separate herds.
Inspection. An examination made by an inspector to determine the fitness of animals, establishments, facilities, and procedures used in connection with the preparation, testing, and distribution of biological products and the examination or testing of biological products.
Inspector. Any officer or employee of Animal and Plant Health Inspection Service who is authorized by the Administrator to do inspection work.
Licensed establishment. An establishment operated by a person holding an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License.
Licensee. A person to whom an establishment license and at least one product license has been issued.
Microorganisms. Microscopic or submicroscopic organisms, which are sometimes referred to as organisms, which may introduce or disseminate disease of animals.
Nonadjacent herd. Nonadjacent herds are all herds other than the herd of origin and other than herds adjacent to the herd of origin. Herds adjacent to the herd of origin but in a different State from the herd of origin are also considered nonadjacent herds.
Permittee. A person who resides in the United States or operates a business establishment within the United States, to whom a permit to import biological products has been issued.
Person. Any individual, firm, partnership, corporation, company, association, educational institution, State or local governmental agency, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.
Premises. All buildings, appurtenances, and equipment used to produce and store biological products located within a particular land area shown on building plans or drawings furnished by the applicant or the licensee and designated by an address adequate for identification.
Prepare or preparation. Sometimes referred to as manufacture or produce, means the steps and procedures used in the processing, testing, packaging, labeling, and storing of a biological product.
Regulations. The provisions in parts 101 through 118 of this subchapter.
Research investigator or research sponsor. A person who has requested authorization to ship an experimental biological product for the purpose of evaluating such product, or has been granted such authorization.
Secretary. The Secretary of Agriculture of the United States or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
Subsidiary. A corporation in which a corporate licensee owns in excess of 50 percent of the voting stock.
Veterinary Services. Veterinary Services unit of Animal and Plant Health Inspection Service of the Department.
Virus-Serum-Toxin Act. The Act of March 4, 1913, 37 Stat. 832-833; as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; and as further amended September 28, 1988, Public Law 100-449, 102 Stat. 1868; 21 U.S.C. 151-159.
U.S. Veterinary Biological Product License. A document, sometimes referred to as a product license, which is issued pursuant to part 102 of this subchapter to the holder of an establishment license, as a part of and ancillary to the establishment license, and which authorizes production of a specified biological product in the designated licensed establishment.
U.S. Veterinary Biological Product Permit. A document, sometimes referred to as a permit, issued to a person authorizing the importation of specified biological products subject to restrictions and controls as provided in the regulations.
U.S. Veterinary Biologics Establishment License. A document referred to as an establishment license, which is issued pursuant to part 102 of this subchapter, authorizing the use of designated premises for production of biological products specified in one or more unexpired, unsuspended, and unrevoked product license(s).
When used in conjunction with or in reference to a biological product, the following terms shall mean:
(a) Licensed biological product. A biological product prepared within a licensed establishment by a person holding an unexpired, unsuspended, and unrevoked product license for such product.
(b) Experimental biological product. A biological product which is being evaluated to substantiate an application for a product license or permit.
(c) Completed product. A biological product in bulk or final container produced in compliance with the regulations to final form and composition.
(d) Finished product. A completed product which has been bottled, sealed, packaged, and labeled as required by the regulations.
(e) Released product. A finished product released for marketing after all requirements have been satisfactorily complied with.
(f) Fraction. A specific antigen, its antibodies, or its antitoxin which constitutes a component of a biological product.
(g) Diluent. A liquid used to rehydrate a desiccated product or a liquid used to dilute another substance.
(h) Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number: Provided, That, when all or part of a serial of liquid biological product is packaged as diluent for all or part of a serial of desiccated product, the resulting combination packages shall be considered a serial of the multiple fraction product.
(i) Subserial. Each of two or more properly identified portions of a serial which are further processed at different times or under different conditions such as, but not limited to, being desiccated in different size final containers and/or at different times.
(j) Outline of production. A detailed protocol of methods of manufacture to be followed in the preparation of a biological product and which may sometimes be referred to as an outline.
(k) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of licensed biological product.
(l) Harvest date. Unless otherwise specified in a filed Outline of Production, the harvest date shall be the date blood or tissues are collected for production or the date cultures of living microorganisms are removed from production incubators.
(m) Bacterin. An inactivated bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products, which has been inactivated as demonstrated by acceptable tests written into the filed Outline of Production for the product.
(n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from which the bacterial cells have been removed, which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, and which is nontoxic as demonstrated by acceptable tests written into the filed Outline of Production.
(o) Bacterin-toxoid. An inactivated bacterial product which is either:
(1) A suspension of organisms, representing a whole culture or a concentrate thereof, with the toxic growth products from the culture which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, the inactivation of organisms and toxins being demonstrated by acceptable tests written into the filed Outline of Production: Provided, That it shall contain cellular antigens and shall stimulate the development of antitoxin; or
(2) A combination product in which one or more toxoids or bacterin-toxoids is combined with one or more bacterins or one or more bacterin-toxoids.
(p) Bacterial extract. An inactivated bacterial product which consists of the sterile, nontoxic, antigenic derivatives extracted from bacterial organisms or from culture medium in which bacterial organisms have grown.
(q) Combination package. Biological product consisting of two or more licensed biological products. Each completed product in final container is packaged together and mixed prior to administration. A combination package is issued a separate U.S. Veterinary Biological Product License and assigned a product code number to distinguish it from its component products, which also may be marketed individually unless otherwise restricted.
Terms pertaining to identification and packaging of biological products shall mean:
(a) Label. All written, graphic, or printed matter:
(1) Upon or attached to a final container of a biological product;
(2) Appearing upon any immediate carton or box used to package such final container; and
(3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found.
(b) Labeling. All labels and other written, printed, or graphic matter accompanying the final container.
(c) Final container. The unit, bottle, vial, ampule, tube, or other receptacle into which any biological product is filled for distribution and sale.
(d) True name. The name entered on the product license or permit at the time of issuance to differentiate the biological product from others: Provided, That, the principal part of such name shall be emphasized on such license or permit by being more prominently lettered than descriptive terms which may be necessary to complete the differentiation.
(e) Serial number. Numbers or numbers and letters used to identify and distinguish one serial from others.
(f) Expiration date. A date designating the end of the period during which a biological product, when properly stored and handled, can be expected with reasonable certainty, to be efficacious.
(g) Label number. A number assigned by Animal and Plant Health Inspection Service to each label or sketch submitted for review.
(h) Master label. The finished carton, container, or enclosure label for the smallest size final container that is authorized for a biological product, that serves as the Master template label applicable to all other size containers or cartons of the same product that is marketed by a licensee, subsidiary, division, or distributor.
Terms used when evaluating biological products shall mean:
(a) Standard Requirement. Test methods, procedures, and criteria established by Animal and Plant Health Inspection Service for evaluating biological products to be pure, safe, potent, and efficacious, and not to be worthless, contaminated, dangerous, or harmful under the Act.
(b) Log. Logarithm computed to the base 10.
(c) Pure or purity. Quality of a biological product prepared to a final form relatively free of extraneous micro-organisms and extraneous material (organic or inorganic) as determined by test methods or procedures established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product, but free of extraneous microorganisms or material which in the opinion of the Administrator adversely affects the safety, potency, or efficacy of such product.
(d) Safe or safety. Freedom from properties causing undue local or systemic reactions when used as recommended or suggested by the manufacturer.
(e) Sterile or sterility. Freedom from viable contaminating microorganisms as demonstrated by procedures prescribed in part 113 of this subchapter, Standard Requirements, and approved Outlines of Production.
(f) Potent or potency. Relative strength of a biological product as determined by test methods or procedures as established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product.
(g) Efficacious or efficacy. Specific ability or capacity of the biological product to effect the result for which it is offered when used under the conditions recommended by the manufacturer.
(h) Dose. The amount of a biological product recommended on the label to be given to one animal at one time.
(i) Vaccinate. An animal which has been inoculated, injected, or otherwise administered a biological product being evaluated.
(j) Control animal. An animal, which may be referred to as a control, used in a test procedure for purposes of comparison or to add validity to the results.
(k) Day. Time elapsing between any regular working hour of one day and any regular working hour of the following day.
(l) Test results. Terms used to designate testing results are as follows:
(1) No Test. Designation used when a deficiency in the test system has rendered a test unsuitable for drawing a valid conclusion.
(2) Satisfactory. Designation is a final conclusion given to a valid test with results that meet the release criteria stated in the filed Outline of Production or Standard Requirement.
(3) Unsatisfactory. Designation is a final conclusion given to a valid test with results that do not meet the release criteria stated in the filed Outline of Production or Standard Requirement.
(4) Inconclusive. Designation used for an initial test when a sequential test design established in the filed Outline of Production or Standard Requirement allows further testing if a valid initial test is not satisfactory.
(m) Healthy. Apparently normal in all vital functions and free of signs of disease.
(n) Unfavorable reactions. Overt adverse changes which occur in healthy test animals subsequent to initiation of a test and manifested during the observation period prescribed in the test protocol which are attributable either to the biological product being tested or to factors unrelated to such product as determined by the responsible individual conducting the test.
(o) Master reference. A Master Reference is a reference whose potency is correlated, directly or indirectly, to host animal immunogenicity. The Master Reference may be used as the working reference in in vitro tests for relative potency. The Master Reference may also be used to establish the relative potency of a serial of product used in requalification studies and to establish the relative potency of working references. The preparation of a Master Reference as described in a filed Outline of Production may be:
(1) A completed serial of vaccine or bacterin prepared in accordance with a filed Outline of Production;
(2) A purified preparation of a protective immunogen or antigen; or
(3) A nonadjuvanted harvested culture of microorganisms.
(p) Working reference. A Working Reference is the reference preparation that is used in the in vitro test for the release of serials of product. Working References may be:
(1) Master References; or
(2) Serials of product that have been prepared and qualified, in a manner acceptable to Animal and Plant Health Inspection Service for use as reference preparations.
(q) Qualifying serial. (1) A serial of biological product used to test for immunogenicity when the Master or Working Reference is a purified antigen or nonadjuvanted harvest material. Qualifying serials shall be produced in accordance with the filed Outline of Production, tested for immunogenicity in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service, and have a geometric mean relative potency, when compared to the Master Reference, of not greater than 1.0 as established by: independent parallel line assays with five or more replicates; or other valid assay methods for determining relative antigen content which demonstrate linearity, specificity, and reproducibility at least equivalent to the parallel line assay and are acceptable to the Animal and Plant Health Inspection Service.
(2) Qualifying serials used to requalify or extend the dating period of a Master Reference shall be determined to be immunogenic in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service as provided in paragraph (a)(1) of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance with the production method described in the currently filed Outline of Production.
(r) Immunogenicity. The ability of a biological product to elicit an immune response in animals as determined by test methods or procedures acceptable to the Animal and Plant Health Inspection Service.
(s) Stability-indicating assay. A stability-indicating assay is a validated quantitative analytical procedure that can detect changes over time in a pertinent property of the product.
When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:
(a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture.
(b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin.
(c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications.
(d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate.
When used in conjunction with or in reference to seed organisms, the following shall mean:
(a) Master Seed. An organism at a specific passage level which has been selected and permanently stored by the producer from which all other seed passages are derived within permitted levels.
(b) Working Seed. An organism at a passage level between Master Seed and Production Seed.
(c) Production Seed. An organism at a specified passage level which is used without further propagation for initiating preparation of a fraction.
Each establishment qualified to prepare biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License for each product prepared in such establishment unless the product is subject to the provisions of 9 CFR parts 103 or 106 of this subchapter.
(a) Every person who prepares biological products subject to the Virus-Serum-Toxin Act shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product.
(b) An applicant who applies for an establishment license must also apply for at least one product license. An establishment license will not be issued without a license authorizing the production of a biological product in the establishment.
(a) U.S. Veterinary Biologics Establishment License. (1) The operator of each establishment of the kind specified in § 102.2 shall make written application to the Administrator for a license. Blank forms of application will be furnished upon request to Animal and Plant Health Inspection Service.
(2) When a person conducts more than one establishment, a separate application shall be made for each establishment.
(3) Whenever subsidiaries are to operate in an establishment for which license application is made, the applicant shall apply for permission for such subsidiaries to operate in the establishment and furnish therewith a complete statement regarding the relationship between the applicant and the subsidiaries.
(4) Facilities documents, prepared as prescribed in part 108 of this subchapter, shall accompany the application for license unless previously filed with Animal and Plant Health Inspection Service.
(5) Each application for a U.S. Veterinary Biologics Establishment License shall be accompanied by an application for one or more U.S. Veterinary Biological Product Licenses and the supporting documents required by paragraph (b)(2) of this section.
(6) A new application shall be made when a change of ownership, operation, or location of an establishment occurs; or prior to the expiration of a U.S. Veterinary Biologics Establishment License issued for an interim period of time.
(b) U.S. Veterinary Biological Product License. (1) The licensee of each establishment or applicant for an establishment license shall make written application to the Administrator for a U.S. Veterinary Biological Product License for each biological product to be prepared in the licensed establishment.
(2) Each application for a U.S. Veterinary Biological Product License shall be supported by:
(i) At least two copies of an Outline of Production prepared in accordance with §§ 114.8 and 114.9 of this subchapter; and
(ii) At least three copies of test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product; and
(iii) Legends prepared as prescribed in § 108.5 of this subchapter designating which facilities are to be used in the preparation of each fraction; and
(iv) Labels in finished form or sketches prepared as prescribed in § 112.5 of this subchapter, together with information regarding all claims to be made on labels and in advertising matter to be used in connection with or related to the biological product.
(a) Before a U.S. Veterinary Biologics Establishment License will be issued by the Administrator for any establishment, an inspection shall be made to determine whether the condition, equipment, facilities, and the like, of the establishment, and the methods used to prepare biological products are in conformity with the requirements in the regulations.
(b) A license shall not be issued unless:
(1) In the opinion of the Administrator, the condition of the establishment, including its facilities, and the methods of preparation of biological products are such as reasonably to assure that the products shall accomplish the purpose for which they are intended; and
(2) The Administrator is satisfied on the basis of information before him that:
(i) The establishment shall be operated in compliance with the Act and applicable regulations and be under the supervision of person(s) competent in the preparation of biological products; and
(ii) The applicant, or the person having the responsibility for producing biological products in the establishment, or both, is qualified by education and experience, and has demonstrated fitness to produce such products in compliance with the Act and regulations issued pursuant thereto; Provided, That, previous violations of the Act, or such regulations or both shall be relevant to the Administrator's determination of fitness.
(3) Written assurance is filed with Animal and Plant Health Inspection Service that the biological products which are licensed to be prepared therein shall not be so advertised as to mislead or deceive the purchasers and that the packages or containers in which the same are to be marketed shall not bear any statement, design, or device which is false or misleading in any particular.
(c) U.S. Veterinary Biologics Establishment Licenses shall be numbered.
(d) Two or more licenses may bear the same number when they are issued for establishments under the same ownership or control, provided a serial letter is added to one or more to identify each license and the product produced thereunder.
(e) When a U.S. Veterinary Biologics Establishment License is issued for an establishment, it shall not apply to more than one person at the same location, except that subsidiaries of the licensee, when named in the license, may operate thereunder at the establishment named. The licensee with its subsidiaries will be held responsible for all operations conducted in the licensed establishment.
(f) When a licensee no longer holds at least one unexpired, unsuspended, or unrevoked product license authorizing the preparation of a biological product, or is in the process of obtaining a product license, the establishment license shall no longer be valid and shall be returned to the Administrator. In the case where an establishment license expires or is suspended or revoked, any product license authorizing preparation of a product at such establishment shall be invalid indefinitely or for as long as the suspension is in effect.
(g) Any license issued under this part to establishments in which biological products are prepared shall be issued on condition that the licensee permit the inspection of such establishments, products, product preparation, and all relevant records as provided in part 115 of this subchapter. Failure to permit inspection may result in the license being suspended or revoked.
(h) The provisions of paragraph (b) of this section shall also be applicable to, and be considered by, the Administrator in connection with each application for an additional product license.
(a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the Administrator, and supplementary to the U.S. Veterinary Biologics Establishment License named therein.
(b) The following shall appear on the U.S. Veterinary Biological Product License:
(1) The U.S. Veterinary Biologics Establishment License Number for the establishment from which the product is released for marketing.
(2) The true name of the product.
(3) The product code number for the product.
(4) The date of issuance.
(5) Any restrictions designated by the Administrator under paragraph (e) of this section.
(6) When necessary to comply with § 102.6 of this part, a termination date and a brief description of requirements to be met for reissuance.
(c) The following provisions shall apply to all licensed biological products:
(1) Licensed biological products shall be prepared as required by the regulations and in accordance with a filed Outline of Production as prescribed in §§ 114.8 and 114.9 of this subchapter. No change shall be made in the preparation of a biological product without prior approval of the Administrator.
(2) In addition to restrictions imposed by the Administrator pursuant to paragraph (e) of this section, biological products may be subject to restrictions which are imposed by any State or other jurisdiction pertaining to the distribution and use of such products, based on local disease conditions.
(3) When requested by the Administrator, a licensee shall submit a list of licensed biological products prepared in the licensed establishment.
(d) Where the Administrator determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a product, the product shall be subject to such additional restrictions as are prescribed on the license. Such restrictions may include, but are not limited to, limits on distribution of the product or provisions that the biological product is restricted to use by veterinarians, or under the supervision of veterinarians, or both.
(e) Any person may request that the distribution and use of a veterinary biological product be restricted if the restriction pertains to the protection of domestic animals or the public health, interest, or safety, or both. All requests must be sent, in writing, to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010. Requests must specify the restriction(s) being requested and must explain why the restrictions are needed. Copies of any supporting documents, such as scientific literature, published or unpublished articles, or data from tests, should be attached to the request. When a decision is reached regarding the request, the person submitting the request will be sent written notification of such decision.
In order to meet an emergency condition, limited market, local situation, or other special circumstance, including production solely for intrastate use under a State-operated program, the Administrator may, in response to an application submitted as specified in § 102.3(b) of this part, issue a conditional U.S. Veterinary Biological Product License to an establishment under an expedited procedure which assures purity and safety, and a reasonable expectation of efficacy. Preparation of products under a conditional license shall be in compliance with all applicable regulations and standards and may be restricted as follows:
(a) The preparation may be limited to a predetermined time period which shall be established at the time of issuance and specified on the license. Prior to termination of the license, the licensee may request reissuance. Such requests shall be substantiated with data and information obtained since the license was issued. After considering all data and information available, the Administrator shall either reissue the U.S. Veterinary Biological Product License or allow it to terminate.
(b) Distribution may be limited to the extent necessary to assure that the product will meet the basic criteria for issuance of the conditional license.
(c) Labeling for the product may be required to contain information on the conditional status of the license.
Except as otherwise provided in this section, experimental biological products which are neither composed of nor prepared with organisms or antigens used in biologicals already licensed, shall not be prepared in the production facilities of a licensed establishment. Upon application therefor, the Administrator may authorize the preparation of experimental products on the premises of a licensed establishment if he determines that such preparation will not result in contamination of the licensed products. Each request for permission to prepare an experimental biological product on licensed premises shall indicate the nature of the unlicensed product, designate facilities to be used, and specify precautions which will be taken to prevent contamination of licensed products. Such requests shall be submitted to the Administrator. Research facilities that are entirely separate and apart from facilities used for the preparation of licensed biological products will not be considered a part of the licensed premises for purposes of this section.
Safeguards as herein provided shall be established by the research investigator or research sponsor to control disposition of all animals administered experimental biological products or live organisms.
(a) Surviving test animals (including challenged control animals) shall not be removed from the premises on which the tests are conducted for at least 14 days after administration of an experimental biological product or live organisms: Provided, however, That this holding period may be increased or decreased as permitted or requested by the Administrator following review of all relevant information or data available.
(b) All animals administered experimental biological products which are to be slaughtered at establishments subject to the Federal Meat Inspection Act, as amended and extended (21 U.S.C. 601 et. seq.) are subject to the applicable requirements of § 309.16 of this title (Meat Inspection Regulations).
(c) Except as otherwise provided in this paragraph, the research investigator or research sponsor shall maintain adequate records relative to the disposition of each animal administered experimental biological products. These records shall be maintained for a minimum period of two years from the date that an experimental product was administered to such animal, and shall show the name and address of the owner; number, species, class and location of the animals; and if sold, the name and address of the consignee, buyer, commission, firm or abattoir: Provided, however, That a research investigator or research sponsor may be exempted from these recordkeeping requirements by the Administrator on the basis of acceptable data demonstrating that use of the experimental biological product will not result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.
Except as provided in this section, no person shall ship or deliver for shipment in or from the United States, the District of Columbia, or any Territory of the United States any unlicensed biological product for experimental use in animals. For the benefit of license applicants and to permit and encourage research, a person may be authorized by the Administrator to ship unlicensed biological products for the purpose of evaluating such experimental products by treating limited numbers of animals, Provided, that, the Administrator determines that the conditions under which the experiment is to be conducted are adequate to prevent the spread of disease and approves the procedures set forth in the request for such authorization. Special restrictions or tests may be imposed, especially in the case of products containing live organisms, when they are deemed necessary or advisable by the Administrator. A request for authorization to ship an unlicensed biological product for experimental study and evaluation shall be accompanied by the following:
(a) One copy of a permit or letter of permission from the proper State or foreign animal health authorities of each State or foreign country involved.
(b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. In the event of subsequent changes, additional information shall be furnished when such facts are known;
(c) Two copies of a description of the product, recommendations for use, and results of preliminary research work;
(d) A copy of the labels or label sketches which show the name or identification of the product and bear the statement “Notice! For experimental use only-Not For Sale” or equivalent. Such statement shall appear on final container labels, except that it may appear on the carton in the case of very small final container labels and labeling for diagnostic test kits. The U.S. Veterinary License legend shall not appear on such labels; and
(e) Two copies of a proposed general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities of experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and submitted to the Animal and Plant Health Inspection Service.
(f) Data acceptable to the Administrator demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.
(g) A statement from the research investigator or research sponsor agreeing to furnish, upon the Administrator's request, additional information concerning each group of meat animals involved prior to movement of these animals from the premises where the test is to be conducted. Such information shall include the owner's name and address; number, species, class and location of animals involved; date shipment is anticipated; along with name and address of consignee, buyer, commission firm or abattoir.
(h) Any information the Administrator may require in order to assess the product's impact on the environment.
Unless otherwise authorized or directed by the Administrator, each permit to import a biological product into the United States shall be issued in accordance with the regulations in this part.
(a) No biological product shall be brought into the United States unless a permit has been issued for such product. A separate U.S. Veterinary Biological Product Permit shall be required for each shipment of biological product to be imported: Provided, That, a permit shall also be required for each transit shipment of biological products moved through the United States.
(b) Each person importing biological products shall hold an unexpired, unsuspended, and unrevoked permit issued by Animal and Plant Health Inspection Service. Such person shall reside within the United States, or operate a business establishment within the United States, or both.
(a) Animal and Plant Health Inspection Service is authorized to issue three types of permits for importing biological products. They shall be:
(1) U.S. Veterinary Biological Product Permit for Research and Evaluation;
(2) U.S. Veterinary Biological Product Permit for Distribution and Sale; or
(3) U.S. Veterinary Biological Product Permit for Transit Shipment Only.
(b) A permit shall not be issued for a biological product from countries known to have exotic diseases, including but not limited to foot-and-mouth disease, highly pathogenic avian influenza, swine vesicular disease, Newcastle disease, and African swine fever, if in the opinion of the Administrator, such products may endanger the livestock or poultry of this country.
(c) A permit shall not be issued until an inspector has determined the condition of the equipment and facilities of the producer, of the applicant, or of both if such a determination is considered necessary by the Administrator.
(d) A permit shall not be issued for a biological product prepared in the United States, exported, and presented for reentry except as provided in § 104.4(d).
(a) Each person desiring to import a biological product shall make written application to Animal and Plant Health Inspection Service for a permit. Application forms are available on the Internet at (http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml) and application for a permit to import a veterinary biologic for research and evaluation or transit shipment may be made on the Internet at (http://www.aphis.usda.gov/animal_health/permits/vet_bio_permits.shtml).
(b) The application shall specify the type of permit required, the port of entry at which the product shall be cleared through Customs, the estimated quantity involved, and the anticipated date on which the importation shall be made.
(a) An application for a U.S. Veterinary Biological Product Permit to import a biological product for research and evaluation shall be accompanied by a brief description of such product, methods of propagating antigens including composition of medium, species of animals or cell cultures involved, degree of inactivation or attenuation, recommendations for use, and the proposed plan of evaluation. The applicant shall also provide any information the Administrator may require in order to assess the product's impact on the environment.
(b)(1) A permit to import a biological product for research and evaluation shall not be issued unless the scientific capabilities of the investigator are determined to be adequate to safeguard domestic animals and protect public health, interest, or safety from any deleterious effects which might result from use of such product. Special restrictions or tests may be specified as part of the permit when they are deemed necessary or advisable by the Administrator.
(2) No person shall ship a product imported under this section for research and evaluation anywhere in or from the United States unless authorized by the Administrator in accordance with the provisions of § 103.3 of this subchapter.
(c) A biological product shall not be imported for Research and Evaluation which is not packaged and labeled in accordance with § 112.9 of this subchapter.
(d) When a licensed product has been exported from the United States, a permit may be issued to the producer for a small quantity of such product for in vitro Research and Evaluation tests: Provided, That, the importation of such product will not endanger the livestock or poultry of this country.
An application for a U.S. Veterinary Biological Product Permit to import a biological product for Distribution and Sale shall be accompanied by supporting material necessary to satisfy the requirements provided in this section.
(a) A permit shall not be issued unless the conditions under which the biological product is to be prepared or the methods to be used are such as to reasonably insure that the product is pure, safe, potent, and efficacious.
(1) Two copies of blueprints of the producing foreign establishment shall be submitted with the application unless satisfactory plans are on file with Animal and Plant Health Inspection Service from a previous application. The production facilities to be used for each product prepared at the establishment shall be designated.
(2) The manufacturer shall submit written authorization for properly accredited inspectors to inspect without previous notification, and at such times as may be demanded by the aforesaid inspectors, all parts of the establishment in which biological products shall be prepared, all processes of preparation, and all records relative to such preparation.
(3) The manufacturer shall furnish written assurance that a biological product to be imported for Distribution and Sale shall be prepared under the supervision of a person competent by education and experience to handle all matters pertaining to the preparation of such product and that each biological product shall be prepared in accordance with the regulations applicable to the product or in a manner acceptable to the Administrator so as to carry out the purposes of the Act.
(4) The methods to be used in the preparation of each biological product shall be written into an approved Outline of Production prepared in accordance with the applicable provisions of part 114 of this subchapter. Two copies of such Outlines of Production shall be submitted to Animal and Plant Health Inspection Service and be approved before the permit is issued.
(5) Data shall be furnished by the applicant which establishes that the product involved complies with the provisions of the Act and the regulations issued pursuant thereto. When deemed necessary to obtain required information, Animal and Plant Health Inspection Service may require that the product be tested under field conditions within or outside the United States as the occasion demands.
(b) The permittee shall furnish the following:
(1) Adequate facilities for storing all imported biological products. An inspection of such facilities shall be made by inspectors before a permit is issued and additional inspections shall be made at any time subsequent to the importation of the biological products if deemed necessary by the Administrator;
(2) Information regarding all claims to be made on labels and advertising matter used in connection with or related to the biological product to be imported;
(3) Mounted copies of final container labels, carton labels, and enclosures to be used with the imported product as provided in part 112 of this subchapter; and
(4) Samples of each serial from each shipment of biological products imported or offered for importation. Such samples shall be collected, examined, and tested in a manner specified by the Administrator. The biological products being sampled shall not be further distributed by the permittee until released by Animal and Plant Health Inspection Service.
An application for a permit for Transit Shipment Only shall be required when a biological product is being shipped from one foreign country to another foreign country by way of the United States. The shipment shall move under a permit subject to the following restrictions:
(a) The shipment shall be confined to the carrier at all times when such shipment is to transit the United States on the same carrier on which it arrived. If the shipment is to be transferred to a carrier other than the one on which it shall arrive into the United States, a schedule of arrival and departure of each shipment shall be furnished by the permittee to Animal and Plant Health Inspection Service prior to arrival in the United States.
(b) The permittee shall be responsible to Animal and Plant Health Inspection Service for handling, storing, and forwarding of the biological product. Animal and Plant Health Inspection Service shall be notified of all shipments received and forwarded by the permittee and an accurate accounting shall be made.
(a) A permit shall be numbered and dated.
(b) The purpose for which the product is imported shall be specified on the permit as for Research and Evaluation, Distribution and Sale, or Transit Shipment Only.
(c) A permit shall not be used after the date specified.
(a) Biological products which are presented for importation without a permit having been issued shall be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel.
(b) Biological products for Distribution and Sale presented for importation under a permit and found to be worthless, contaminated, dangerous, or harmful shall, within a period of 30 days after such finding, be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel: Provided, That such product shall not be returned to the country of origin while bearing a U.S. permit number on the label.
(a) An establishment license, product license, or permit issued under the Virus-Serum-Toxin Act may be formally suspended or revoked after opportunity for hearing has been accorded the licensee or permittee as provided in part 123 of this subchapter if the Secretary is satisfied that the license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation contrary to said Act of any worthless, contaminated, dangerous, or harmful biological product. Such use may be found to exist if:
(1) The construction of the establishment in which the biological product is prepared is defective, or the establishment is not conducted as required by the regulations in parts 101 through 118 of this subchapter;
(2) The methods of preparation of the product are faulty, or the product contains impurities or lacks potency;
(3) The product is so labeled or advertised as to mislead or deceive the purchaser in any particular;
(4) The licensee, permittee, or the foreign manufacturer has failed to maintain and make available for inspection records in connection with the development and preparation of product, has failed to provide complete and accurate information when requested, or has failed to provide complete and accurate information in the Outline of Production or in reports and records;
(5) The licensee or permittee has violated or failed to comply with any provision of the Virus-Serum-Toxin Act or the regulations in this subchapter;
(6) The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation, contrary to the Virus-Serum-Toxin Act, of any worthless, contaminated, dangerous, or harmful biological product.
(b) In case of willfulness or where the public health, interest, or safety so required the Secretary may, without hearing, informally suspend such establishment license, product license, or permit upon the grounds set forth in paragraph (a) of this section pending determination of formal proceedings under part 123 of this subchapter for suspension or revocation of the license or permit.
If an infraction of a requirement of a product license is brought to the attention of the licensee by written notification thereof by Animal and Plant Health Inspection Service, a subsequent violation of similar nature occurring with the same licensed biological product within 6 months of the said written notification shall be primafacie evidence of willful violation and the license for the product shall be subject to suspension or revocation under the provisions of § 105.1(b).
(a) If at any time it appears that the preparation, sale, barter, exchange, shipment, or importation, as provided in the Virus-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in the treatment of domestic animals, the Secretary may without hearing notify the licensee or permittee, and pending determination of formal proceedings instituted under part 123 of this subchapter for suspension or revocation of the license or permit insofar as it authorizes the manufacture or importation of the particular product, no person so notified shall thereafter so prepare, sell, barter, exchange, ship, deliver for shipment, or import such product.
(b) If a serial of biological product is found to be unsatisfactory according to applicable Standard Requirements, the Administrator may notify the licensee to stop distribution and sale of the serial.
(c) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange, shipment, or importation of the affected serial(s) or subserial(s) of any veterinary biological product pending further instructions from APHIS.
(2) Immediately, but no later than 2 days, send stop distribution and sale notifications to any wholesalers, jobbers, dealers, foreign consignees, or other persons known to have any such veterinary biological product in their possession, which instruct them to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any such veterinary biological product. All notifications shall be documented in writing by the licensee or permittee.
(3) Account for the remaining quantity of each serial(s) or subserial(s) of any such veterinary biological product at each location in the distribution channel known to the manufacturer (licensee) or importer (permittee).
(4) When required by the Administrator, submit complete and accurate reports of all notifications concerning stop distribution and sale actions to the Animal and Plant Health Inspection Service pursuant to § 116.5 of this subchapter.
(a) If a biological product has not been prepared by a licensee, or imported by a permittee for a period of 5 years or more, the Administrator may require the licensee to show intent to resume production, or the permittee to show intent to resume importation, within 6 months of notification. If the licensee does not resume preparation, or the permittee does not resume importation, within 6 months of notification, or within a mutually agreeable period, the product license, or permit, may be terminated by the Administrator.
(b) When a license or permit is terminated, the licensee or permittee shall continue to be subject to the applicable records provisions of § 116.8.
The Administrator may exempt any biological product from one or more of the requirements of this subchapter if he determines that such product will be used by the Department or under the supervision or control of the Department in the prevention, control or eradication of animal diseases in connection with (a) an official USDA program; or (b) an emergency animal disease situation, or (c) a USDA experimental use of the product.
Products prepared as provided in paragraphs (a) and (b) of this section and facilities in which such products are prepared, shall be exempt from preparation pursuant to unsuspended and unrevoked establishment and product licenses. Persons exempt from licensure under this part shipping products which contain live organisms shall provide any information the Administrator may require prior to shipment, or at any other time deemed necessary, in order to assess the products' safety and effect on the environment. The shipment or delivery for shipment anywhere in or from the United States of any exempted product which is worthless, contaminated, dangerous, or harmful is prohibited, and any person shipping such product, or delivering such product for shipment, shall be subject to sanctions under the Act.
(a)(1) Products prepared by a veterinary practitioner (veterinarian) solely for administration to animals in the course of a State licensed professional practice of veterinary medicine by such veterinarian under a veterinarian-client-patient relationship and facilities in which such products are prepared shall be exempt from licensing under the Act and regulations. Such a relationship is considered to exist when:
(i) The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to follow the instructions of the veterinarian; and when
(ii) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept; and when
(iii) The practicing veterinarian is readily available for followup in case of adverse reactions or failure of the regimen.
(2) All steps in the preparation of product being prepared under the exemption in paragraph (a)(1) of this section must be performed at the facilities that the veterinarian utilizes for the day-to-day activities associated with the treatment of animals in the course of his/her State-licensed professional practice of veterinary medicine. A veterinary assistant employed by the veterinary practitioner and working at the veterinary practice's facility under the veterinarian's direct supervision may perform the steps in the preparation of product. Such preparation may not be consigned to any other party or sub-contracted to a commercial laboratory/manufacturing facility.
(3) Veterinarians preparing products subject to the exemption for products under this section shall maintain and make available for inspection by Animal and Plant Health Inspection Service representatives or other Federal employees designated by the Secretary such records as are necessary to establish that a valid veterinarian-client-patient relationship exists and that there is a valid basis for the exemption under this section.
(b) Products prepared by a person solely for administration to animals owned by that person shall be exempt from the requirement that preparation be pursuant to an unsuspended and unrevoked license.
(a) The Administrator shall exempt from the requirement of preparation pursuant to an unsuspended and unrevoked USDA establishment and product license, any biological product prepared solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Administrator to be consistent with the intent of the Act to prohibit the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful biological products.
(b) A request for exemption under this section must be made by the appropriate State authority and shall include information demonstrating that:
(1) The State has the authority to license viruses, serums, toxins, and analogous products and establishments that produce such products; and
(2) The State has the authority to review the purity, safety, potency, and efficacy of such products prior to release to the market; and
(3) The State has the authority to review product test results to assure compliance with applicable standards of purity, safety, and potency prior to release to the market; and
(4) The State has the authority to deal effectively with violations of State law regulating viruses, serums, toxins, and analogous products; and
(5) The State effectively exercises the authority specified in paragraphs (b)(1) through (4) of this section consistent with the intent of the Act prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful viruses, serums, toxins, or analogous products.
(c) Each product to be exempted and each establishment preparing such product shall be identified by the State and the State shall give written notification to the Administrator of each such product and establishment. The State shall also give written notice to the Administrator of each new license issued and of each license terminated.
(d) In order to determine whether a State exercises its authority with respect to biological products and establishments and whether its laws and regulations are being achieved, the Administrator, in cooperation with proper State authorities, may conduct an on-site evaluation of the State's program which may include inspection of establishments and/or products to be included under the exemptions in this section.
Unless otherwise authorized by the Administrator, all buildings, appurtenances, and equipment used in the preparation of biological products shall be in compliance with the regulations in this part. Each land area on which such buildings and appurtenances are located shall be identified by an address which shall appear on the establishment license.
Each applicant for an establishment license shall prepare a plot plan showing all buildings for each particular land area, blueprints for each building used in the preparation of biological products and legends containing a brief description of all activities in each room or area.
Plot plans shall show all of the buildings on a particular land area, whether or not they are all used for the preparation and initial shipping of biological products: Provided, That, when a great number of buildings are on the same premises, only those surrounding the buildings used for preparation and initial shipping of biological products shall be shown. The presence of the remainder of the buildings may be accounted for by a single statement denoting the total number of such buildings not used for the preparation or shipping of biological products.
(a) Reduce the entire premises to any standard scale on one sheet of paper which meets any of the American standard trimmed sizes. Indicate the scale used.
(b) Clearly mark the boundaries of the licensed premises and indicate what marking denotes the boundaries. Such boundaries shall coincide with some readily apparent perimeter line. Identify all fences, walls, or streets.
(c) Show buildings as reduced dimensional drawings in the proper scale distance relationship with each other.
(d) Number, letter, or otherwise identify all buildings so that they may be correlated with the respective blueprints and legends.
(e) Describe on the plot plan the use of immediate adjacent properties such as, residential area, pasture, box factory, or the like.
(f) Show compass points.
(g) Show date of preparation.
(h) Apply signature of responsible official of the firm.
(a) Blueprints, drawn to any suitable scale, on regular blueprint paper or a good grade of white paper of any one of the American standard trimmed sizes shall be acceptable: Provided, That the same scale shall be used for future revisions unless the entire blueprint is revised. Indicate the scale used.
(b) Use a single sheet of paper for each floor of all buildings in which biological products are prepared. Illustrate in detail the areas in each building utilized for such preparation.
(c) If only a portion of a floor is used in the preparation of a biological product, the blueprint shall illustrate the entire floor in essentially the same detail throughout. All functions or activities performed in the remainder of the floor shall be indicated.
(d) Identify the floors if the drawing is not for all floors in a multiple-story building and identify activities on each floor.
(e) Identify all rooms by letters or numbers.
(f) Show the location of important stationary equipment by a suitable code which will be further identified on legends.
(g) Explain on the blueprint or on the legend, by a statement or listing, which rooms are equipped with water outlets, drains, and lighting. Show the location of doors and windows.
(h) Show compass points.
(i) Show building number.
(j) Show date of preparation.
(k) Apply signature of responsible official of firm.
A brief description of the activities performed in each room or area shall be prepared as provided in this section and shall be referred to as a legend. Legends shall be provided for each plot plan and each blueprint or drawing. All pages of the legends shall be numbered, identified with corresponding plot plan or blueprint, and submitted in booklet form either stapled together or clipped into a suitable folder.
(a) Plot plan legends shall show the following:
(1) Number of each building and the functions performed in each: Provided, That if it is a multiple-story building in which biological products are prepared or handled, briefly describe functions performed on each floor.
(2) A practical and nontechnical description of construction materials used throughout those buildings used entirely or partially for production and handling of biological products.
(b) Blueprint legends shall show the following:
(1) A listing of all rooms by identifying letters or numbers and the fractions prepared in each. Exceptions may be listed for general purpose areas or rooms. Functions performed in each area and room shall be described, whether the licensed or unlicensed products. In rooms where products are exposed to the surroundings, a description of decontamination procedures and other precautions against cross contamination shall be included.
(2) A listing of the coded stationary equipment.
(3) A general listing of other essential biological equipment such as mills, centrifuges, mixing tanks, bottling and sealing equipment, and the like, which are not regarded as stationary but are maintained in certain rooms.
Preliminary drawings may be submitted to Animal and Plant Health Inspection Service for comment prior to construction of new facilities or when remodeling is anticipated, old facilities are to be torn down, or other changes affecting the workflow are to be made. The licensee shall:
(a) Prepare revised plot plans, blueprints, or legends and submit to Animal and Plant Health Inspection Service for review and filing when changes have been completed. Also prepare a statement to accompany each revision to identify, by date of the superseded item, what is being superseded.
(b) Prepare a drawing of the revised rooms, unit, or section to the same scale as the blueprint on file which shall be stamped and applied to the existing blueprint. If changes are numerous, prepare a new blueprint.
(c) Drawings of new buildings may be added to existing plot plans. Indicate the distance from surrounding buildings and boundary lines.
(d) Any change prescribed in this section shall necessitate a change in one or more pages of the respective legends. The revised pages shall carry the same numbers as superseded pages.
Two copies of all plot plans, blueprints, and legends, including revisions, shall be submitted to Animal and Plant Health Inspection Service for review and filing. When the reviewer takes exception to a submitted item, such item shall be returned with appropriate comments for correction and resubmission. Acceptable submissions shall be stamped as filed and the date noted. One stamped copy shall be returned and two copies retained for Animal and Plant Health Inspection Service files.
(a) The floors, walls, ceilings, partitions, posts, doors, and all other parts of all structures, rooms, or facilities used for the preparation of biological products or ingredients of biological products at licensed establishments shall be of such material, construction, and finish as may be readily and thoroughly cleaned.
(b) All rooms used in connection with the preparation of biological products shall be so constructed and arranged as to prevent cross-contamination of such biological products. Halls or walkways shall be provided for the movement of personnel or materials to each biological products preparation area without going through another such area.
(c) Rooms or compartments separate from the remainder of the establishment shall be provided at licensed establishments for preparing, handling, and storing virulent or dangerous microorganisms and products.
(d) All rooms and compartments at licensed establishments shall have an adequate air handling system to supply proper ventilation sufficient to insure sanitary and hygienic conditions for the protection of the products and personnel.
(e) The supply of hot and cold water at licensed establishments shall be ample and clean. Adequate facilities shall be provided for the distribution of water in each establishment and for the washing of all containers, machinery, instruments, other equipment, and animals used in the preparation of a biological product.
(f) There shall be an efficient drainage and plumbing system for each licensed establishment and premises thereof, and all drains and gutters shall be properly installed with approved traps and vents.
Each licensed establishment shall have dressing rooms, toilet facilities, and lavatory accommodations, including hot and cold running water, soap, towels, and the like. They shall be in sufficient number, ample in size, conveniently located, properly ventilated, and meeting all requirements as to sanitary construction and equipment.
(a) These rooms and facilities shall be separate from rooms or compartments in which biological products are prepared, handled, or stored.
(b) These rooms and facilities shall be so located in the establishment as to be readily accessible to all persons without having to enter or pass through biological products preparation areas.
(a) The outer premises of licensed establishments, embracing docks, driveways, approaches, yards, pens, chutes, and alleys shall be drained properly and kept in a clean and orderly condition. No nuisance shall be allowed in any licensed establishment or on its premises.
(b) Stables or other premises for animals used in the production or testing of biological products at licensed establishments shall be properly ventilated and lighted, appropriately drained and guttered, and kept in sanitary condition.
(c) Every practical precaution shall be taken to keep licensed establishments free of flies, rats, mice, and other vermin. The accumulation, on the premises of an establishment, of any material in which flies or other vermin may breed is forbidden. Suitable arrangements, in keeping with the local health practices, shall be made for the disposal of all refuse.
A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control standards, pursuant to section 401 of the Federal Water Pollution Control Act, as amended (86 Stat. 877; 33 U.S.C. 1341), shall be filed with Animal and Plant Health Inspection Service for each licensed establishment.
(a) All containers, instruments, and other apparatus and equipment, before being used in preparing, handling, or storing biological products, at a licensed establishment, except as otherwise prescribed herein, shall be thoroughly sterilized by live steam at a temperature of at least 120 °C. for not less than one-half hour, or by dry heat at a temperature of at least 160 °C. for not less than one hour. If for any reason such methods of sterilization are impracticable, then a process known to be equally efficacious in destroying microorganisms and their spores may be substituted after approval by the Administrator.
(b) Instruments which are found to be damaged by exposure to the degree of heat prescribed in this section, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes.
Steam and dry-heat sterilizers used in connection with the processing of biological products at licensed establishments shall be equipped with automatic temperature recording gauges: Provided, That other record keeping systems may be used when approved by the Administrator. When gauges are used, they shall be periodically standardized to assure accuracy. Charts and other temperature records made during production shall be available at all times charts and records shall be kept in accordance with part 116 of this chapter.
All pasteurizing equipment shall meet the requirements in paragraphs (a), (b), and (c) of this section and be acceptable to Animal and Plant Health Inspection Service.
(a) Metal serum containers shall be used in licensed establishments. During the heating process, each container shall be surrounded by a separate water jacket or equivalent so that the entire container, including its lid, is heated to the required temperature. Each serum container shall be equipped with a motor-driven agitator and a separate automatic recording thermometer.
(b) Each water bath shall have an automatic temperature control to limit the temperature of the water to a maximum of 62 °C., an automatic recording thermometer, an indicating thermometer set in a fixed position, and circulating mechanism adequate to insure equal temperatures throughout the bath. The heating unit for the bath shall be separated from the serum container and the water jacket.
(c) Accurate thermometers at licensed establishments shall be used at frequent intervals to check temperatures of the serum as registered by recording thermometers.
(a) Unless otherwise authorized or directed by the Administrator, each biological product prepared at a licensed establishment, or imported, shall be packaged and labeled as prescribed in this part before it is removed from the licensed establishment or presented for importation: Provided, That biological products to be imported for research and evaluation shall be subject to packaging and labeling requirements in § 112.9. Provided further, That, unless otherwise exempted, all preparation, including packaging and labeling, of biological products shall only be performed in a licensed establishment under an approved Outline of Production.
(b) No person shall apply or affix to or include with, or cause to be applied or affixed to or included with, any carton or final container of a biological product, any label, stamp, mark or statement that is false or misleading in any particular, is not in compliance with the regulations, or is not approved by APHIS.
(c) No person shall alter, mark or remove any approved labeling affixed to or included with any biological product prior to selling or otherwise distributing such product. In addition, no person shall mark any carton, other container, or final container of a biological product so as to falsify the labeling, make it misleading, or cause it to be illegible.
(d) Labels that are stamped, printed or glued directly on cartons, other containers, or final containers shall be legible throughout the dating period. Biological products bearing labels, which have been altered, mutilated, destroyed, obliterated or removed, shall be withheld from the market.
(a) Unless otherwise provided, final container labels, carton labels, and enclosures (inserts, circulars, or leaflets) shall include the information specified in this section.
(1) The complete true name of the biological product which name shall be identical with that shown in the product license under which such product is prepared or the permit under which it is imported, shall be prominently lettered and placed giving equal emphasis to each word composing it. Descriptive terms used in the true name on the product license or permit shall also appear. Abbreviations of the descriptive terms may be used on the final container label if complete descriptive terms appear on the carton label and enclosure. The following exceptions are applicable to small final containers, and containers of interchangeable reagents included in diagnostic test kits:
(i) For small final containers, an abbreviated true name of the biological product, which shall be identical with that shown in the product license under which the product is prepared or the permit under which it is imported, may be used: Provided, That the complete true name of the product must appear on the carton label and enclosures;
(ii) In addition to the true name of the kit, the functional and/or chemical name of the reagent must appear on labeling for small final containers of reagents included in diagnostic kits: Provided, That the true name is not required on labeling for small final containers of interchangeable (non-critical) components of diagnostic kits.
(2) For biological product prepared in the United States or in a foreign country, the name and address of the producer (licensee, or subsidiary) or permittee and of the foreign producer, and an appropriate consumer contact telephone number: Provided, That in the case of a biological product exported from the United States in labeled final containers, a consumer contact telephone number is not required; however, small single dose containers marketed in the United States must include contact telephone information on carton and enclosures.
(3) The United States Veterinary Biologics Establishment License Number (VLN) or the United States Veterinary Biological Product Permit Number (VPN), and the Product Code Number (PCN) assigned by the Department, which shall be shown only as “VLN/PCN” and “VPN/PCN,” respectively, except that:
(i) Only the VLN or VPN is required on container labels of interchangeable (non-critical) components of diagnostic kits and container labels for individual products packaged together for co-administration.
(ii) The PCN may be used in lieu of the true name of the kit on small container labels for critical components of diagnostic kits.
(iii) Container labels for individually licensed biological products, when marketed as components of combination packages, must include a statement referring the consumer to the carton or enclosure for the PCN of the combination package.
(4) Storage temperature recommendation for the biological product stated as 2 to 8 °C or 35 to 46 °F, or both.
(5) Full instructions for the proper use of the product, including indications for use, target species, minimum age of administration, route of administration, vaccination schedule, product license restriction(s) that bear on product use, warnings, cautions, and any other vital information for the product's use; except that in the case of limited space on final container labels, a statement as to where such information is to be found, such as “See enclosure for complete directions,” “Full directions on carton,” or comparable statement.
(6) In the case of a multiple-dose final container, a warning to use entire contents when first opened: Provided, That a diagnostic or a desensitizing antigen packaged in a multiple-dose final container is exempt.
(7) The following warning statements, or equivalent statements, shall appear on the labeling as applicable:
(i) Products other than diagnostic kits: “Do not mix with other products, except as specified on this label.”
(ii) Injectable products and other products containing hazardous components: “In case of human exposure, contact a physician.”
(iii) Products containing viable organisms: “Inactivate unused contents before disposal.”
(8) In the case of a biological product recommended for use in domestic animals, the edible portion of which may be used for food purposes, a withholding statement of not less than 21 days to read: “Do not vaccinate within (insert number) days before slaughter” or “Do not vaccinate food-producing animals within (insert number) days before slaughter”: Provided, That longer periods shall be stated when deemed necessary by the Administrator. Very small final container labels are exempted from this requirement.
(9) The following information shall appear on the final container label and carton label, if any, but need not appear on the enclosure:
(i) A permitted expiration date;
(ii) The number of doses where applicable;
(iii) The recoverable quantity of the content of each final container stated in cubic centimeters (cc.) or milliliters (ml.) or units.
(iv) A serial number by which the product can be identified with the manufacturer's records of preparation: Provided, That when a liquid antigenic fraction is to be used instead of a water diluent for one or more desiccated antigenic fractions in a combination package, a hyphenated serial number composed of a serial number for the desiccated fraction and the serial number for the liquid fraction shall be used on the carton.
(v) A statement similar to “For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.
(10) In the case of a product that contains a preservative that is added during the production process and is not reduced to undetectable levels in the completed product through the production process, the statement “Contains [name of preservative] as a preservative” or an equivalent statement must appear on cartons and enclosures, if used. If cartons are not used, such information must appear on the final container label.
(11) The number of final containers of biological product and the number of doses in each final container shall be stated on each carton label for all cartons containing more than one final container of biological product. The number of final containers of diluent, if any, and the quantity in each shall also be stated on each carton label.
(12) An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) ____ weeks of age or older against ____.” Provided, That in the case of very small final container labels or carton, a statement as to where such information is to be found, such as “See enclosure for complete directions,” “Full directions on carton,” or comparable statement.
(b) Labels may also include any other statement which is not false or misleading and may include factual statements regarding variable response of different animals when vaccinated as directed but may not include disclaimers of merchantability, fitness for the purpose offered, or responsibility for the product.
(c) Labels of biological products prepared at licensed establishments or imported shall not include any statement, design, or device, which overshadows the true name of the product as licensed or which is false or misleading in any particular or which may otherwise deceive the purchaser.
(d) Carton labels and enclosures shall be subject to paragraph (d)(1), (d)(2), and (d)(3) of this section.
(1) The statement, “Restricted to use by or under the direction of a veterinarian” or “Restricted to use by a veterinarian,” shall be used on all carton labels and enclosures when such restriction is prescribed on the product license.
(2) If the licensee states on the carton labels and enclosures of a product that its sales are restricted to veterinarians, then the entire production of that particular product in the licensed establishment shall be so restricted by the licensee.
(3) The statement “For use in animals only” may appear on the labeling as appropriate for a product to indicate that the product is recommended specifically for animals and not for humans.
(e) When label requirements of a foreign country differ from the requirements as prescribed in this part, special labels may be approved by APHIS for use on biological products to be exported to such country upon receipt of written authorization, acceptable to APHIS, from regulatory officials of the importing country, provided that:
(1) If the labeling contains claims or indications for use not supported by data on file with APHIS, the special labels for export shall not bear the VLN.
(2) All other labels for export shall bear the VLN unless the importing country provides documentation that the VLN is specifically prohibited. When laws, regulations, or other requirements of foreign countries require exporters of biological products prepared in a licensed establishment to furnish official certification that such products have been prepared in accordance with the Virus-Serum-Toxin Act and regulations issued pursuant to the Act, such certification may be made by APHIS.
(f) Multiple-dose final containers of liquid biological product and carton tray covers showing required labeling information are subject to the requirements in this paragraphs.
(1) If a carton label or an enclosure is required to complete the labeling for a multiple-dose final container of liquid biological product, only one final container, with a container of diluent if applicable, shall be packaged in each carton: Provided, That if the multiple-dose final container is fully labeled without a carton label or enclosure, two or more final containers, and a corresponding number of diluent containers, may be packaged in a single carton which shall be considered a shipping box. Labels or stickers for shipping boxes shall not contain false or misleading information, but need not be submitted to APHIS for approval.
(2) When required labeling information is shown on a carton tray cover, it must be printed on the outside face of such tray cover where it may be read without opening the carton. The inside face of the tray cover may contain information suitable for an enclosure.
Each final container of diluent, other than a liquid biological product, packaged with desiccated biological products shall bear a label that includes the following:
(a) The name—Sterile Diluent.
(b) True name of the biological product with which the diluent is packaged, except that when the firm packages all desiccated biological products with the same diluent, or two or more types of diluent are used, and the licensees' methods of identification and storage insure that all products are packaged with the correct type of diluent, labels affixed to the containers of diluent are exempt from this provision.
(c) The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).
(d) A serial number by which the diluent can be identified with the manufacturer's records of preparation;
(e) Name and address of the licensee or the permittee;
(f) In the case of a diluent with which a desiccated biological product is to come in contact while the diluent is in its original container; and,
(1) Is in a multiple-dose container, a positive warning that all of the biological product shall be used at the time the container is first opened; and/or
(2) The biological product is composed of viable or dangerous organisms or viruses, the notice, “Inactivate unused contents before disposal.”
(g) The establishment license number or the permit number, as the case may be, in one of the forms provided in § 112.2(a)(3).
Labels used by subsidiaries, divisions, distributors, and permittees shall be affixed by the licensee in a licensed establishment where the product is produced. Such labels shall comply with requirements for their review, approval, and filing as provided in the regulations.
(a) Subsidiaries. Labels to be used on a licensed biological product prepared by a subsidiary operating in a licensed establishment shall be submitted in accordance with § 112.5. Only labels approved for use on such product shall be used by the subsidiary.
(b) Divisions. Labels to be used on a licensed biological product prepared in a licensed establishment for distribution by a division or marketing unit of the licensee shall be submitted in accordance with § 112.5. The name, address, and license number of the licensee shall be prominently placed on such labels. The relationship of the division or marketing unit to the licensee shall appear prominently on the label by use of the term “division of” or equivalent.
(c) Distributors. The name and address of the distributor or any statement, design, or device shall not be placed on the labels or containers of a licensed biological product in a manner which could be false or misleading or which could indicate that the distributor is the manufacturer of such product or operating under the license number shown on the label. The manufacturer shall be identified by name, address, and license number with the term “manufactured by,” “produced by,” or an equivalent term prominently placed in connection therewith. The name and address of the distributor may be placed on labels or containers if the term “distributor,” or “distributed by,” or an equivalent term is prominently placed in connection therewith.
(d) Permittees. The name and address of the permittee and any statement, design, or device shall not be placed on the labels or containers of a biological product imported for sale and distribution in accordance with § 104.5 in a manner which could be false or misleading or which could falsely indicate that the permittee is the manufacturer of such product. The manufacturer shall be identified by name and address with the term “manufactured by,” “produced by,” or an equivalent term prominently placed in connection therewith. Reference to the permittee shall be made by name, address, and permit number with the term “imported by,” “produced for,” or an equivalent term prominently placed in connection therewith.
Labels used with biological products prepared at licensed establishments or imported for general distribution and sale must be submitted to the Animal and Plant Health Inspection Service for review for compliance with the regulations and approval in writing prior to use, except as provided in paragraph (d) of this section and under the master label system provided in paragraph (e) of this section.
(a) Transmittal forms, available on the APHIS Web page at http://www.aphis.usda.gov/animalhealth/cvb/forms, shall be used with each submission of sketches (including proofs) and labels. Separate forms shall be used for each biological product but only one copy of the form shall be used for all sketches and labels submitted at the same time for the same biological product.
(b) A data summary, available on the Internet at productdata.aphis.usda.gov, shall be used with each submission of efficacy and safety data in support of a label claim. Manufacturers will submit the efficacy and safety data information with either the efficacy and safety studies or at the time of label submission. This information will be posted at productdata.aphis.usda.gov to allow public disclosure of product performance.
(c) Sketches may be submitted for comment to Animal and Plant Health Inspection Service by the licensee or permittee before preparing the finished label. Such sketches shall be returned to the licensee or permittee with comments, if any. Failure of the reviewer to take exception to a sketch shall not constitute approval of a finished label subsequently prepared.
(d)(1) Labels must be submitted to the Animal and Plant Health Inspection Service for review and written approval. Only labels which are approved as provided in paragraph (e) of this section may be used. When changes are made in approved labels, the new labels shall be subject to review and approval before use: Provided, That certain minor changes may be made in labels for products with approved labels or master labels, and the revised labels may be used prior to review by APHIS, with the provision that a new label or master label bearing these changes is submitted to APHIS for review and written approval within 60 days of label use, and that such minor changes do not render the product mislabeled or the label false and misleading in any particular.
(2) Minor label changes that may be made under the provision for products with approved labels or master labels are:
(i) Changes in the physical dimensions of the label provided that such change does not affect the legibility of the label;
(ii) Changes in the color of label print or background, provided that such changes do not affect the legibility of the label;
(iii) The addition or deletion of a Trade Mark (TM) or Registered (R) symbol;
(iv) The correction of typographical errors;
(v) Adding, changing, deleting, or repositioning label control numbers, universal product codes, or other inventory control numbers;
(vi) Revising or updating logos;
(vii) Changing the telephone contact number;
(viii) Adding, changing, or deleting an email and/or Web site address;
(ix) Changing the establishment license or permit number assigned by APHIS, and/or changing the name and/or address of the manufacturer or permittee, provided that such changes are identical to information on the current establishment license or permit; and
(x) Adding or changing the name and/or address of a distributor.
(e) Labels and sketches submitted shall be prepared in the number and manner prescribed in this paragraph.
(1) Copies required:
(i) For label sketches, submit two copies of each sketch of a final container label, carton label, and enclosure. Sketches must be legible, and must include all information specified in § 112.2. One copy of each sketch will be returned with applicable comments, and one copy will be held on file by APHIS for no more than one year after processing, until replaced by a finished label: Provided, That sketches submitted in support of an application for a license or permit shall be held as long as the application is considered active.
(ii) For master label sketches, submit for each product two copies of each sketch of an enclosure, label for the smallest size final container, and carton label; Provided, That labels for larger size containers and/or cartons that are identical, except for physical dimensions, need not be submitted. One copy of each master label sketch will be returned with applicable comments, and one copy will be held on file by APHIS for one year after processing, until replaced by a finished master label that is submitted according to paragraph (e)(1)(iii) of this section: Provided, That master label sketches submitted in support of an application for license or permit shall be held as long as the application is considered active.
(iii) For finished labels, submit two copies of each finished final container label, carton label, and enclosure: Provided, That when an enclosure is to be used with more than one product, one extra copy shall be submitted for each additional product. One copy of each finished label will be retained by APHIS. One copy will be stamped and returned to the licensee or permittee. Labels to which exceptions are taken shall be marked as sketches and handled under paragraph (e)(1)(i) of this section.
(iv) For finished master labels, submit for each product two copies each of the enclosure and the labels for the smallest size final container and carton. Labels for larger sizes of containers or cartons of the same product that are identical, except for physical dimensions, need not be submitted. Such labels become eligible for use concurrent with the approval of the appropriate finished master label, provided that the marketing of larger size final containers is approved in the filed Outline of Production, and the appropriate larger sizes of containers or cartons are identified on the label mounting sheet. When a master label enclosure is to be used with more than one product, one extra copy for each additional product shall be submitted. One copy of each finished master label will be retained by APHIS. One copy will be stamped and returned to the licensee or permittee. Master labels to which exception are taken will be marked as sketches and handled under paragraph (e)(1)(ii) of this section.
(2) Mounting:
(i) Each label or sketch shall be securely fastened to a separate sheet of heavy bond paper (8
(ii) Two-or three-part cartons, including “sleeves,” shall be considered as one label. All parts shall be submitted together.
(iii)(A) When two final containers are packaged together in a combination package, the labels for each shall be mounted on the same sheet of paper and shall be treated as one label. For diagnostic test kits, the labels for use on the individual reagent containers to be included in the kit shall be mounted together on a single sheet of paper, if possible; if necessary, a second sheet of paper may be used. The carton label and enclosure shall be mounted on separate individual sheets.
(B) If either final container label is also used alone or in another combination package, sets of separate labels for each biological product with which it is used shall be submitted for review.
(iv) When the same final container label is applied by different methods such as paper or screen printing, one of each shall be mounted on the same sheet of paper as one submission.
(3) To appear on the top of each page:
(i)(A) Name and product code number of the biological product as it appears on the product license or permit.
(B) Extra copies of enclosures to be used with another product shall bear the name and code number of the product affected.
(ii)(A) Designation of the specimen as a label or master label: sketch, final container label, carton label, or enclosure.
(B) If two final container labels or multiple parts are on one sheet, each shall be named, and the label or part being revised shall be designated.
(iii) Size of package (dose, ml., cc., or units) for which the labels or enclosures are to be used.
(4) To appear on the bottom of each page in the lower left hand corner, if applicable:
(i) The dose size(s) to which the master label applies.
(ii) The APHIS assigned number for the label or sketch to be replaced.
(iii) The APHIS assigned number for the label to be used as a reference for reviewing the submitted label.
(f) Special requirements for foreign language labels:
(1) An accurate English translation must accompany each foreign language label submitted for approval. A statement affirming the accuracy of the translation must also be included.
(2) Foreign language portion of a bilingual label shall be a true translation of the English portion. Reference to additional information on the enclosure shall not be made unless that enclosure is also bilingual.
(g) When a request is received from Animal and Plant Health Inspection Service, the licensee or permittee shall submit a list of all approved labels currently being used. Each label listed shall be identified as to:
(1) Name and product code number as it appears on the product license or permit for the product; and
(2) Where applicable, the size of the package (doses, ml., cc., or units) on which the label shall be used; and
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the producer.
(h) At the time of an inspection, or when requested by APHIS, licensees or permittees shall make all labels and master labels, including labels approved for use but exempted from filing under the master label system, available for review by authorized inspectors. Such labels shall be identical to the approved label or master label except for physical dimensions, reference to recoverable volume or doses and/or certain minor differences permitted in accordance with paragraph (d) of this section.
(a) Multiple-dose final containers of a biological product with final container labeling including all information required under the regulations may be packaged one or more per carton with a container(s) of the proper volume of diluent, if required, for that dose as specified in the filed Outline of Production: Provided, That cartons containing more than one final container of product must comply with the conditions set forth in paragraphs (c)(1) through (4) of this section. Multiple-dose final containers of a product that require a carton or enclosure in order to provide all information required under the regulations shall be packaged one container per carton with the proper volume of diluent, if required, for that dose as specified in the filed Outline of Production.
(b) Single-dose final containers of a product need not be packaged one per carton. For single-dose products which require a diluent for administration, the number of containers of the proper amount of diluent specified in the filed Outline of Production for the number of doses contained in the carton shall be included in each carton.
(c) Poultry products for mass administration (including but not limited to administration through drinking water and spray) and products used in automatic vaccinating systems (including but not limited to pneumatic beak injectors and automated needle injectors) may be packaged in multiple-dose final containers as specified in the filed Outline of Production. Poultry products for manual administration to individual birds shall not exceed 1,000 doses in each final container. Diluent need not be packaged with the final container(s) of the product, but the licensee shall provide the required number of containers of diluent as specified in the filed Outline of Production. The following requirements apply to cartons containing more than one final container of poultry product:
(1) They shall be sealed prior to leaving the licensed establishment.
(2) The contents may not be repackaged.
(3) The contents of such cartons may not be sold in fractional units.
(4) The following statement must appear in a prominent place on the carton label: “Federal regulations prohibit the repackaging or sale of the contents of this carton in fractional units. Do not accept if seal is broken.”
(d) Diluent for the following products need not be packaged with the final container(s) of the product, but the licensee shall provide the consumer with the required number of containers of the proper amount of diluent as specified in the filed Outline of Production:
(1) Marek's Disease Vaccine.
(2) Poultry vaccines administered to individual birds using automatic vaccinating equipment.
(e) Final containers of biological product prepared at a licensed establishment, or imported, in cartons or other containers shall not be removed from such cartons or containers for sale or distribution, unless each final container bears, or is packaged in a carton with, complete and approved labeling which is affixed to or included with each container by the licensed establishment producing the product or by the producer in the case of imported product: Provided, That this paragraph is not intended to apply to licensed veterinary practitioners administering or dispensing biological products in the course of their practice under a veterinary-client-patient-relationship as that term is used in § 107.1.
(f) Labels which are affixed to or included with a biological product shall not be removed or altered in any manner.
The label requirements in this section are additional to those prescribed elsewhere in this part.
(a) In the case of biological products containing live Newcastle Disease virus, a caution statement indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to the user to avoid infecting his eyes shall be included on the enclosure.
(b) In the case of a biological product containing infectious bronchitis virus, all labels shall show the infectious bronchitis virus type or types used in the product. Abbreviation is permitted.
(c) In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, and all but very small final container labels shall include a warning against freezing and the recommendations provided in this paragraph.
(1) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(2) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.209, paragraph (b) or (c), or both.
(d) In the case of a biological product containing modified live rabies virus, the carton labels, enclosures, and all but very small final container labels shall include the recommendations provided in this paragraph.
(1) For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs Only! Not For Use in Any Other Animal!”
(2) For other vaccines containing modified live rabies virus, the statement “For Use In (designate animal(s)) Only! Not For Use In Any Other Animal!”
(3) Intramuscular injection at one site in the thigh shall be recommended.
(4) The statement “In event of accidental exposure to the vaccine virus, the possible hazard to human health should be considered and State Public Health Officials should be consulted for specific recommendations” shall be prominently placed on all carton labels and on enclosures, if used.
(5) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(6) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.312, paragraph (b) or (c), or both.
(e) Labeling for all products for use in mammals must bear an appropriate statement concerning use in pregnant animals.
(1) For bovine rhinotracheitis vaccine or bovine virus diarrhea vaccine containing modified live virus, all labeling except small final container labels shall bear the following statement: “Do not use in pregnant cows or in calves nursing pregnant cows.”: Provided, That such vaccines which have been shown to be safe for use in pregnant cows may be excepted from this label requirement by the Administrator.
(2) For other modified live and inactivated vaccine, labeling shall bear a statement appropriate to the level of safety that has been demonstrated in pregnant animals.
(i) Products known to be unsafe in pregnant animals shall include statements such as “Do not use in pregnant animals,” or “Unsafe for use in pregnant animals,” or an equivalent statement acceptable to APHIS.
(ii) Products without safety documentation acceptable to APHIS, but not known to be unsafe, labeling shall include the statement “This product has not been tested in pregnant animals” or an equivalent statement acceptable to APHIS.
(3) For modified live vaccines containing agents with potential reproductive effects but having acceptable pregnant animal safety data on file with APHIS, labeling still must bear the following statement concerning residual risk: “Fetal health risks associated with the vaccination of pregnant animals with this vaccine cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with vaccine use in pregnant animals should be discussed with a veterinarian.”
(f) For biological products recommending annual booster vaccinations, such recommendations must be supported by data acceptable to APHIS. In the absence of data that establish the need for booster vaccination, labeling must bear the following statement: “The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended.”
(g) In the case of a liquid product authorized in a filed Outline of Production to be used as a diluent in a combination package, the carton labels and enclosures used for serials which are either not tested for bactericidal or viricidal activity or have been found unsatisfactory by such test shall contain the statement: “CAUTION: DO NOT USE AS DILUENT FOR LIVE VACCINES.”
(h) In the case of wart vaccine, recommendations shall be limited to use in cattle. Indications for use shall be for prophylactic use only, as an aid in the control of viral papillomas (warts). All labels shall include a dosage recommendation of at least 10 ml to be given subcutaneously and the dose repeated in 3 to 5 weeks.
(i) All but very small final container labels for feline panleukopenia vaccines shall contain the following recommendations for use:
(1) Killed virus vaccines. Vaccinate healthy cats with one dose, except that if the animal is less than 12 weeks of age, a second dose should be given no earlier than 16 weeks of age.
(2) Modified live virus vaccines. Vaccinate healthy cats with one dose, except that if the animal is less than 12 weeks of age, a second dose should be given no earlier than16 weeks of age.
(j) In the case of normal serum, antiserum, or antiserum derivatives, the type of preservative used shall be indicated on all labels.
(k) Unless acceptable data has been filed with Animal and Plant Health Inspection Service, to show that development of corneal opacity is not associated with the product, carton labels and enclosures used with biological products containing modified live canine hepatitis virus or modified live canine adenovirus Type 2 shall bear the following statement: “Occasionally, transient corneal opacity may occur following the administration of this product.”
(l) All labels for autogenous biologics must specify the name of the microorganism(s) or antigen(s) that they contain, and shall bear the following statement: “Potency and efficacy of autogenous biologics have not been established. This product is prepared for use only by or under the direction of a veterinarian or approved specialist.”
(m) In the case of biological products containing Marek's disease virus, all labels shall specify the Marek's disease virus serotype(s) used in the product.
(n) All labels for conditionally licensed products shall bear the following statement: “This product license is conditional; efficacy and potency have not been fully demonstrated.”
The applicable regulations for packaging and labeling a biological product produced in the United States shall apply to such biological product if exported from the United States except as otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.
(a) Biological products which have been packaged and labeled for export or which have been exported, shall be subject to the applicable provisions in this paragraph.
(1) After leaving the licensed establishment, a biological product shall not be bottled, repackaged, relabeled, or otherwise altered in any way while in the United States; and
(2) An exported biological product shall not be returned to the United States: Provided, That, in the case of a biological product exported in labeled final containers, the Administrator may authorize by permit the importation of a limited number for research and evaluation by the producing licensee; and
(3) An exported biological product which is bottled, rebottled, or altered in any way in a foreign country shall not bear a label which indicates by establishment license number that it has been prepared in the United States.
(b) Desiccated and frozen liquid products, packaged and labeled as for domestic use, may be exported without the diluent required for rehydration or dilution, as the case may be, if the labeling includes adequate instructions for preparing the product for use and the words “For Export Only”.
(c) Final containers of products, labeled or unlabeled, may be exported in sealed shipping boxes, adequately identified as to contents with an approved label, and plainly marked “For Export Only”: Provided, That such products shall not be diverted to domestic use.
(d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.
(e) Concentrated inactivated liquid product, completed except for dilution to the proper strength for use, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.
A biological product imported for research and evaluation under a permit issued in accordance with § 104.4, with the exception of products imported under § 104.4(d), shall be labeled as provided in this section.
(a) The label shall identify the product and the name and address of the manufacturer and shall provide instructions for proper use of the product, including all warnings and cautions needed by the permittee to safely use the product.
(b) Labels on each product to be further distributed in accordance with § 103.3 shall bear the statement “Notice! For Experimental Use Only—Not for Sale!”
(c) The labeling shall contain any other information deemed necessary by the Administrator and specified on the permit.
A biological product, which requires special packaging and/or labeling not provided for in this part, shall be packaged and/or labeled in accordance with requirements written into the approved outline for such product.
The regulations in this part apply to each serial or subserial of a licensed biological product manufactured in a licensed establishment and to each serial or subserial of a biological product in each shipment imported for distribution and sale.
To better ensure consistent and reproducible test results when Standard Requirement tests prescribed in the regulations are conducted, National Veterinary Services Laboratories, U.S. Department of Agriculture, may provide testing aids, when available, to licensees, permittees, and applicants for licenses and permits. Such aids shall be as follows:
(a) Supplemental Assay Method (SAM) is a technical bulletin containing detailed instructions for conducting a test. Such instructions shall be in accordance with the procedures currently being followed at National Veterinary Services Laboratories and as improved, proven procedures are developed, shall be revised and reissued prior to application.
(b) Standard Reference Preparation is a serum, virus, bacterial culture, or antigen to be used in test systems for direct comparison with serials of biological products under test.
(c) Standard Test Reagent is a serum, antitoxin, fluorescent antibody conjugate, toxin, virus, bacterial cultural, or antigen to be used in test systems but not for direct comparison with serials of biological products under test.
(d) Seed cultures are small quantities of standard organisms to be propagated by the recipient to establish a supply for use.
(e) Test Code Number is a number assigned by Animal and Plant Health Inspection Service to each test procedure specified in the Standard Requirements and in each filed Outline of Production where such test is conducted to support a request for release of a serial or subserial.
Each licensee and permittee shall furnish representative samples of each serial or subserial of a biological product manufactured in the United States or imported into the United States as prescribed in this section. Additional samples may be purchased in the open market by a Animal and Plant Health Inspection Service representative.
(a) Either an employee of the Department of Agriculture, of the licensee, or of the permittee, as designated by the Administrator shall select prerelease samples of biological product in the number prescribed in paragraph (b) of this section. Each sample shall be marked for identification by the person making the selection after which they shall be packaged by the licensee or permittee, as the case may be, and forwarded to National Veterinary Services Laboratories; except that an employee of the Department may forward or deliver the samples to National Veterinary Services Laboratories if such action deemed advisable by the Administrator.
(1) Selection shall be made as follows:
(i) Nonviable liquid biological products—either bulk or final container samples of completed product shall be selected for purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi.
(ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the end of the filling operation. Bulk containers of completed product may be sampled when authorized by the Administrator.
(iii) Desiccated biological products; samples shall be in final containers and shall be randomly selected if desiccated in the final container. Biological products desiccated in bulk shall be sampled at the end of the filling operation.
(iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected.
(2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for similar tests.
(3) When bulk samples of completed product in liquid form are to be tested as prescribed in paragraph (a)(1) of this section, the number of such samples from each serial and the minimum quantity of product to be provided in each sample shall be stated in the filed Outline of Production.
(b) Unless otherwise prescribed by the Administrator, the number of final container samples to be selected from each serial and subserial shall be:
(1) Vaccines:
(i) Six multiple-dose samples of Brucella Abortus Vaccine;
(ii) Twelve samples of all other live bacterial vaccines;
(iii) Two samples of Coccidiosis Vaccine;
(iv) Eighteen samples of Rabies Vaccine, Modified Live Virus;
(v) Sixteen samples of all other vaccines consisting of live microorganisms;
(vi) Thirty single-dose or 14 multiple-dose samples of Equine Encephalomyelitis Vaccine, Killed Virus;
(vii) Twenty-two single-dose or 14 multiple-dose samples of Rabies Vaccine, Killed Virus;
(viii) Sixteen single-dose or 12 multiple-dose samples of all other vaccines consisting of killed microorganisms.
(2) Bacterins and bacterin-toxoids:
(i) Twelve samples of single-fraction products;
(ii) Thirteen samples of two-fraction products;
(iii) Fourteen samples of products consisting of 3 or more fractions.
(3) Antiserums: Twelve samples of antiserum recommended for large animals or 14 samples of antiserum recommended for small animals or the number of reagent serum samples prescribed in the filed Outline of Production for the product.
(4) Antitoxins:
(i) Fourteen single-dose or 12 multiple dose samples of Tetanus Antitoxin;
(ii) Twelve samples of all other antitoxins.
(5) Toxoids:
(i) Eighteen single-dose or 12 multiple dose samples of all toxoids.
(6) Antigens: Twelve samples of poultry antigens or 20 samples of tuberculin or four samples of all other diagnostic antigens.
(7) Diagnostic test kits: Two samples of diagnostic test kits. The licensee or permittee will hold one of these selected samples at the storage temperature recommended on the label while awaiting a request by the animal and Plant Health Inspection Service to submit the additional sample. If submission is not requested by the Animal and Plant Health Inspection Service, the additional sample may be returned to the serial inventory after the serial is released. In the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, the licensee or permittee may submit a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production and retain a similar amount as a second sample for submission upon request. When the initial sample is not representative of final packaging by the licensee of permittee, e.g., does not consist of all the microtiter test plates or strips, the second sample is not eligible to be returned to serial inventory after the serial is released.
(8) Autogenous biologics: With the exception of the first serial or subserial, 10 samples must be selected and submitted to the Animal and Plant Health Inspection Service from each serial or subserial of an autogenous biologic eligible to be shipped that consists of more than 50 containers. For first serials or subserials eligible for shipment consisting of more than 50 containers, 10 samples from each serial or subserial must be selected and held for submission to the Animal and Plant Health Inspection Service upon request in accordance with paragraph (e)(4) of this section. For serials or subserials of autogenous biologic with 50 or fewer containers, no samples, other than those required by paragraph (e) of this section, are required.
(9) Miscellaneous: The number of samples from products not in the categories provided for in paragraphs (b)(1) through (b)(8) of this section shall be prescribed in the filed Outline of Production for the product.
(c) Prelicensing and Outline of Production changes: Samples needed to support a license application or a change in the Outline of Production for a licensed product shall be submitted only upon request from the animal and Plant Health Inspection Service. Except for miscellaneous products specified in paragraph (b)(9) of this section, the number of such samples shall be at least one and one-half times the number prescribed for such product in paragraph (b) of this section. Samples of Master Seeds and Master Cell Stocks with a minimum individual volume of 1 ml shall be submitted as follows:
(1) Ten samples of Bacterial Master Seeds.
(2) Thirteen samples of viral Master Seeds or nonviral Master Seeds requiring cell culture propagation. For Master Seeds isolated or passed in a cell line different from the species of intended use, an additional 2 samples are required for each additional species. For Master Seeds grown in cell culture and intended for use in more than one species, an additional 2 samples are required for each additional species.
(3) Thirty-six samples of at least 1 ml each or six samples of at least 1 ml each, one sample of at least 20 ml, and one sample of at least 10 ml of Master Cell Stocks. In the case of Master Cell Stocks which are persistently infected with a virus, an additional four samples of at least 1 ml each are required. If these persistently infected cell stocks are intended for use in more than one species, an additional two samples of at least 1 ml each are required for each additional species.
(4) Four samples of the Master Cell Stock + n (highest passage) cells.
(d) Sterile diluent: A sample of Sterile Diluent shall accompany each sample of product, other than Marek's Disease Vaccine, if such diluent is required to rehydrate or dilute the product before use. The volume of diluent shall be an appropriate amount to rehydrate or dilute the product. Samples of Sterile Diluent prepared for use with Marek's Disease Vaccine shall be submitted upon request from the Animal and Plant Health Inspection Service.
(e) Reserve samples shall be selected from each serial and subserial of biological product. Such samples shall be selected at random from final containers of completed product by an employee of the Department, of the licensee, or of the permittee, as designated by the administrator. Each sample shall:
(1) Consist of 5 single-dose packages, 2 multiple-dose packages, or 2 diagnostic test kits, except that, in the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, a sample may consist of a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production;
(2) Be adequate in quantity for appropriate examination and testing;
(3) Be truly representative and in final containers;
(4) Be held in a special compartment set aside by the licensee or permittee for holding these samples under refrigeration at the storage temperature recommended on the labels for 6 months after the expiration date stated on the labels. The samples that are stored in this manner shall be delivered to the Animal and Plant Health Inspection Service upon request.
(a) The test methods and procedures contained in all applicable Standard Requirements shall be complied with unless otherwise exempted by the Administrator and provided that such exemption is noted in the filed Outline of Production for the product.
(b) Test methods and procedures by which the biological products shall be evaluated shall be designated in the Outline of Production for such products.
(a) No biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production or Standard Requirements for the product to establish the product to be pure, safe, potent, and efficacious.
(b) Tests of biological products shall be observed by a competent employee of the manufacturer during all critical periods. A critical period shall be the time when certain specified reactions must occur in required tests to properly evaluate the results.
(c) Records of all tests shall be kept in accordance with part 116 of this chapter. Results of all required tests prescribed in the filed Outline of Production or the Standard Requirements for the product shall be submitted to Animal and Plant Health Inspection Service. Blank forms shall be furnished upon request to Animal and Plant Health Inspection Service.
(d) When the initial or any subsequent test is declared a No Test, the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated. When a test is declared satisfactory, the test designation is considered to be a final conclusion. When a test is declared unsatisfactory, the test designation is considered to be a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons shall be reported in the test records, the result shall not be considered as final, and the test may be repeated as established in the filed Outline of Production or Standard Requirement. If a test is designated inconclusive or No Test and the biological product is not further tested, the test designation of unsatisfactory is the final conclusion.
(e) When new test methods are developed and approved by Animal and Plant Health Inspection Service, biological products tested thereafter shall be evaluated by such methods, and if not found to be satisfactory when so tested shall not be released.
A biological product shall with reasonable certainty yield the results intended when used as recommended or suggested in its labeling or proposed labeling prior to the expiration date.
(a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy; in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.
(b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market.
(a) When a biological product contains more than one immunogenic fraction, the completed product shall be evaluated by tests applicable to each fraction.
(b) When similar potency tests are required for more than one fraction of a combination biological product, different animals must be used to evaluate each fraction except when written Standard Requirements or outlines of production make provisions and set forth conditions for use of the same animals for testing different fractions.
(c) When the same safety test is required for more than one fraction, requirements are fulfilled by satisfactory results from one test of the completed product.
(d) When an inactivated fraction(s) is used as a diluent for a live virus fraction(s), the inactivated fraction(s) may be tested separately and the live virus fraction(s) may be tested separately: Provided, That, the viricidal test requirements prescribed in § 113.100 are complied with.
(e) Virus titrations for a multivirus product shall be conducted by methods which will quantitate each virus.
(a) Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seed for production as specified in the Standard Requirements or in the filed Outline of Production. The Administrator may exempt a product from a required animal potency test for release when an evaluation can, with reasonable certainty, be made by:
(1) Subjecting the master seed to the applicable requirements prescribed in §§ 113.64, 113.100, 113.200, and 113.300;
(2) Testing the Master Seed for immunogenicity in a manner acceptable to the Animal and Plant Health Inspection Service (APHIS);
(3) Establishing satisfactory potency for the product in accordance with the following provisions:
(i) Potency for live products may be determined by log
(ii) Potency for inactivated products may be determined using tests for relative antigen content by comparing the antigen content of the test serial to a reference preparation using a parallel line immunoassay or equivalent method which measures linearity, specificity, and reproducibility in a manner acceptable to APHIS.
(b) In the case of live products, each serial and subserial of desiccated product derived from an approved Master Seed and bulk or final container samples of each serial of completed liquid product derived from an approved Master Seed shall be evaluated by a test procedure acceptable to APHIS. On the basis of the results of the test, as compared with the required minimum potency, each serial and subserial shall either be released to the firm for marketing or withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:
(1) If the initial test shows the count or titer to equal or exceed the required minimum, the serial or subserial is satisfactory without additional testing.
(2) If the initial test shows the count or titer to be lower than the required minimum, the serial or subserial may be retested, using double the number of samples. The average counts or titers obtained in the retests shall be determined. If the average is less than the required minimum, the serial or subserial is unsatisfactory without further consideration.
(3) If the average is equal to or greater than the required minimum, the following shall apply to live virus vaccines:
(i) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is 10
(ii) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is less than 10
(4) If the average is equal to or greater than the required minimum, the following shall apply to bacterial vaccines:
(i) If the average count obtained in the retests is at least three times the count obtained in the initial test, the initial count may be considered a result of test system error and the serial or subserial considered satisfactory for bacterial count.
(ii) If the average count obtained in the retests is less than three times the count obtained in the initial test, a new average shall be determined using the counts obtained in all tests. If the new average count is below the required minimum, the serial or subserial is unsatisfactory.
(5) Exceptions. When a product is evaluated in terms other than log
(c) In the case of inactivated products, bulk or final container samples of completed product from each serial derived from an approved Master Seed, shall be evaluated for relative antigen content (potency) as compared with an unexpired reference by a parallel line immunoassay or other procedure acceptable to APHIS. Firms currently using immunoassays which do not satisfy this requirement shall have 2 years from the effective date of the final rule to update their filed Outlines of Production to be in compliance with this requirement unless granted an extension by the Administrator based on a showing by the firm seeking the extension that they have made a good faith effort with due diligence to achieve compliance. On the basis of the results of such test procedures, each serial that meets the required minimum potency shall be released to the firm for marketing; each serial not meeting the required minimum potency shall be withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:
(1) A test that results in no valid lines is considered a “no test” and may be repeated.
(2) An initial test (test 1) that results in valid lines that are not parallel is considered a valid equivocal test. Release of the serial may not be based on such test since the result cannot be termed “satisfactory” or “unsatisfactory.”
(3) If the initial test (test 1) shows that potency equals or exceeds the required minimum potency, the serial is satisfactory without additional testing.
(4) If the initial test (test 1) is an equivocal test due to lack of parallelism, the serial may be retested up to three times (tests 2, 3, and 4) with disposition to be as specified in paragraphs (c)(4)(i) and (ii) of this section; Provided, That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.
(i) If: The first retest (test 2) following an initial equivocal test; the second retest (test 3) following two consecutive equivocal tests (tests 1 and 2); or the third retest (test 4) following three consecutive equivocal tests (tests 1, 2, and 3) shows that the potency equals or exceeds the required minimum potency, the serial is satisfactory.
(ii) If the first retest (test 2) following an initial equivocal test shows that potency is less than the required minimum potency, disposition of the serial will be based on the outcome of retests 2 and 3 (tests 3 and 4) as follows: if either retest (test 3 or 4) shows that potency is less than the required minimum potency, the serial is unsatisfactory. If either retest 2 or retest 3 (tests 3 or 4) is an equivocal test, or in the event that each retest (tests 2, 3, and 4) following an initial equivocal test is also an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld. In which case, the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (i) and (ii) and confirmatory testing by APHIS.
(5) If the initial test (test 1) shows that potency is less than the required minimum potency, the serial may be retested a minimum of two times (tests 2 and 3) but not more than three times (tests 2, 3, and 4) with disposition as specified in paragraphs (c)(5) (i) and (ii) of this section; Provided, That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.
(i) If two consecutive retests (tests 2 and 3) show that potency of the serial equals or exceeds the required minimum potency, the serial is satisfactory. If one of the two retests (test 2 or 3) shows that the potency is less than the required minimum potency, the serial is unsatisfactory.
(ii) If one of the retests (tests 2 or 3) shows that the potency equals or exceeds the required minimum potency and the other retest (test 2 or 3) is an equivocal test, a third retest (test 4) may be performed. If the third retest (test 4) shows that the potency of the serial equals or exceeds the required minimum potency, the serial is deemed satisfactory. If both retests (tests 2 and 3) or if the third retest (test 4) is an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld, in which case the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (c)(4) (i) and (ii) and (c)(5) (i) and (ii) of this section, and confirmatory testing by APHIS.
(d) Extending the dating of a reference. All determinations of relative antigen content using parallel line immunoassays or equivalent methods shall be conducted with an unexpired reference. The lot of reference used to determine antigenic content shall have an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating of up to 5 years, Provided, That the request for dating of the frozen references beyond the dating of the product is supported by preliminary data acceptable to APHIS and includes provisions for monitoring the stability of the reference to determine when the potency starts to decline and for taking the appropriate steps to requalify a reference with declining potency either by testing a Qualifying Serial in host animals or by providing other evidence of immunogenicity, e.g., antibody titers or laboratory animal test data previously correlated to host animal protection in a manner acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating, Provided, That its immunogenicity has been confirmed using a Qualifying Serial of product in a manner acceptable to APHIS. The dating period of the Master Reference and Working Reference may be extended by data acceptable to APHIS if the minimum potency of the Master Reference is determined to be adequately above the minimum level needed to provide protection in the host animal. If a new Master Reference is established, it shall be allowed an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating period of 5 years, or as supported by data acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating by confirming its immunogenicity using a Qualifying Serial of product.
(e) Final container samples of completed product derived from Master Seed found immunogenic in accordance with paragraph (a) of this section and found satisfactory in accordance with paragraphs (b) and (c) of this section may also be subjected to an animal potency test by Animal and Plant Health Inspection Service as provided in this paragraph. Products shall be used according to label directions including dose(s) and route of administration.
(1) A one stage test using 20 vaccinates and 5 controls or a two stage test using 10 vaccinates and 5 controls for each stage shall be used. The criteria used for judging the specific response in the controls and vaccinates shall be in accordance with the test protocol used in the Master Seed immunogenicity test.
(2) If at least 80 percent of the controls do not show specific responses to challenge, the test is inconclusive and may be repeated. If a vaccinate shows the specific responses to challenge expected in the controls, the vaccinate shall be listed as a failure.
(3) The results of the testing shall be evaluated according to the following table:
Cumulative totals
| Stage | Number of animals | Failures for satisfactory serials | Failures for unsatisfactory serials |
|---|---|---|---|
| 1 | 10 | 1 or less | 3 or more. |
| 2 (or 1) | 20 | 4 or less | 5 or more. |
(4) When a serial has been found unsatisfactory for potency by the test provided in paragraphs (e)(1), (2), and (3) of this section, the serial shall be withheld from the market and the following actions taken:
(i) The Administrator shall require that at least two additional serials prepared with the same Master Seed be subjected to similar animal potency tests by Animal and Plant Health Inspection Service or the licensee or both.
(ii) If another serial is found unsatisfactory for potency, the product shall be removed from the market while a reevaluation of the product is made and the problem is resolved.
A potency test written into the filed Outline of Production for a product shall be considered confidential information by Animal and Plant Health Inspection Service until at least two additional product licenses are issued for the product or unless use of the test is authorized by the licensee, in which case, such potency test may be published as part of the Standard Requirement for the product.
(a) Until a potency test is published as part of the Standard Requirement for the product, reference to such a test shall be made in the filed Outline of Production and the test shall be conducted.
(b) When a potency test has been published as part of the Standard Requirement, such test shall be conducted unless the product is specifically exempted as provided in § 113.4.
When a product is prepared in a licensed establishment for export in large multiple-dose containers as provided in § 112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in § 114.3(d) of this subchapter, samples of the bulk material shall be subjected to all required tests prescribed in the filed Outline of Production or Standard Requirements for the product. Samples of concentrated liquid product shall be diluted to a volume equal to the contents of the sample times the concentration factor prior to initiating potency tests.
(a) Ingredients for which standards are prescribed in the United States Pharmacopeia, or elsewhere in this part, shall conform to such standards. In lieu of preparing the media from the individual ingredients, they may be made from dehydrated mixtures which, when rehydrated with purified water, have the same or equivalent composition as such media and have growth-promoting buffering, and oxygen tension-controlling properties equal to or better than such media. The formulas for the composition of the culture media prescribed in §§ 113.26 and 113.27 are set forth in the United States Pharmacopeia, 19th Edition.
(b) The licensee shall test each quantity of medium prepared at one time from individual ingredients and the first quantity prepared from each lot of commercial dehydrated medium for growth-promoting qualities. If any portion of a lot of commercial dehydrated medium is held for 90 days or longer after being so tested, it shall be retested before use. Two or more strains of micro-organisms that are exacting in their nutritive requirements shall be used. More than one dilution shall be used to demonstrate the adequacy of the medium to support the growth of a minimum number of micro-organisms.
(c) The sterility of the medium shall be confirmed by incubating an adequate number of test vessels and examining each for growth. Additional control may be used by incubation of representative uninoculated test vessels for the required incubation period during each test.
(d) A determination shall be made by the licensee for each biological product of the ratio of inoculum to medium which shall result in sufficient dilution of such product to prevent bacteriostatic and fungistatic activity. The determination may be made by tests on a representative biological product for each group of comparable products containing identical preservatives at equal or lower concentrations. Inhibitors or neutralizers of preservatives, approved by the Administrator, may be considered in determining the proper ratio.
Each serial and subserial of biological product except live vaccines shall be tested as prescribed in this section unless otherwise specified by the Administrator. When cell lines, primary cells, or ingredients of animal origin used in the preparation of a biological product are required to be free of viable bacteria and fungi, they shall also be tested as prescribed in this section.
(a) The media to be used shall be as follows:
(1) Fluid Thioglycollate Medium with 0.5 percent beef extract shall be used to test for bacteria in biological products containing clostridial toxoids, bacterins, and bacterin-toxoids.
(2) Fluid Thioglycollate Medium with or without 0.5 percent beef extract shall be used to test for bacteria in biological products other than clostridial toxoids, bacterins, and bacterin-toxoids.
(3) Soybean-Casein Digest Medium shall be used to test biological products for fungi; provided, that Fluid Thioglycollate Medium without beef extract shall be substituted when testing biological products containing mercurial preservatives.
(b) Test procedure:
(1) Ten test vessels shall be used for each of two media selected in accordance with paragraph (a)(1), (a)(2), or (a)(3) of this section. Each test vessel shall contain sufficient medium to negate the bacteriostatic or fungistatic activity in the inoculum as determined in § 113.25(d).
(2) Inoculum:
(i) When completed product is tested, 10 final container samples from each serial and each subserial shall be tested. One ml from each sample shall be inoculated into a corresponding individual test vessel of culture medium: Provided, That, if each final container sample contains less than 2 ml, one-half of the contents shall be used as inoculum for each test vessel.
(ii) When cell lines, primary cells, or ingredients of animal origin are tested, at least a 20 ml test sample from each lot shall be tested. One ml shall be inoculated into each test vessel of medium.
(3) Incubation shall be for an observation period of 14 days at 30 °to 35 °C. to test for bacteria and 14 days at 20 °to 25 °C. to test for fungi.
(4) If the inoculum renders the medium turbid so that the absence of growth cannot be determined by visual examination, subcultures shall be made on the seventh to eleventh day from biological products prepared from clostridial toxoids, bacterins, and bacterin-toxoids and the third to seventh day for other biological products. Portions of the turbid medium in amounts of not less than 1.0 ml. shall be transferred to 20 to 25 ml. of fresh medium, and incubated the balance of the 14-day period.
(c) Examine the contents of all test vessels for macroscopic microbial growth during the incubation period. When demonstrated by adequate controls to be invalid, the test may be repeated. For each set of test vessels representing a serial or subserial in a valid test, the following rules shall apply:
(1) If no growth is found in any test vessel, the serial or subserial meets the requirements of the test.
(2) If growth is found in any test vessel, one retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(3) If growth is found in any test vessel of the final test, the serial, subserial, or ingredients to be used in the preparation of a biological product, as the case may be, is unsatisfactory.
Unless otherwise specified by the Administrator or elsewhere exempted in this part, each serial and subserial of live vaccine and each lot of Master Seed Virus and Master Seed Bacteria shall be tested for extraneous viable bacteria and fungi as prescribed in this section. A Master Seed found unsatisfactory shall not be used in vaccine production and a serial found unsatisfactory shall not be released.
(a) Live viral vaccines. Each serial and subserial of live viral vaccine shall be tested for purity as prescribed in this paragraph. However, products of chicken embryo origin recommended for administration other than by parenteral injection may be tested as provided in paragraph (e) of this section.
(1) Soybean Casein Digest Medium shall be used.
(2) Ten final container samples from each serial and subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water.
(4) To test for bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 120 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.
(5) To test for fungi, place 0.2 ml of vaccine from each final container sample into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.
(6) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(ii) If no growth is found in 9 or 10 of the test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.
(iii) If growth is found in four or more test vessels in the initial test, or two or more in a retest, the serial or subserial is unsatisfactory.
(b) Live bacterial vaccines. Each serial or subserial of live bacterial vaccine shall be tested for purity as prescribed in this paragraph.
(1) Soybean Casein Digest Medium and Fluid Thioglycollate Medium shall be used.
(2) Ten final container samples from each serial and subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.
(4) To test for extraneous bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Fluid Thioglycollate Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.
(5) To test for extraneous fungi, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.
(6) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subculturing, microscopic examination, or both.
(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If extraneous growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(ii) If no extraneous growth is found in 9 or 10 test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.
(iii) If extraneous growth is found in 4 or more test vessels in the initial test, or 2 or more in a retest, the serial or subserial is unsatisfactory.
(c) Master Seed Virus. Not less than 4 ml of each lot of Master Seed Virus shall be tested. Frozen liquid Master Seed Virus shall be thawed, and desiccated Master Seed Virus shall be rehydrated with Soybean Casein Digest Medium immediately prior to starting the test.
(1) To test for bacteria, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 120 ml of Soybean Casein Digest Medium. Incubation shall be at 30 °to 35 °C for 14 days.
(2) To test for fungi, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.
(3) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(4) For each set of test vessels representing a lot of Master Seed Virus tested according to these procedures, the following rules shall apply:
(i) If growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Virus.
(ii) If growth is found in any test vessel of the final test, the lot of Master Seed Virus is unsatisfactory.
(d) Master Seed Bacteria. Not less than 4 ml of each lot of Master Seed Bacteria shall be tested. Frozen liquid Master Seed Bacteria shall be thawed, and desiccated Master Seed Bacteria shall be rehydrated with sterile purified water immediately prior to starting the test.
(1) To test for extraneous bacteria, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Fluid Thioglycollate Medium. Incubation shall be at 30 °to 35 °C for 14 days.
(2) To test for extraneous fungi, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.
(3) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(4) For each set of test vessels representing a lot of Master Seed Bacteria tested according to these procedures, the following rules shall apply:
(i) If extraneous growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Bacteria.
(ii) If extraneous growth is found in any test vessel of the final test, the lot of Master Seed Bacteria is unsatisfactory.
(e) Live viral vaccines of chicken embryo origin recommended for administration other than by parenteral injection, which were not tested or have not been found free of bacteria and fungi by the procedures prescribed in paragraph (a) of this section, may be tested according to the procedures prescribed in this paragraph.
(1) Brain Heart Infusion Agar shall be used with 500 Kinetic (Kersey) units of penicillinase per ml of medium added just prior to pouring the plates.
(2) Ten final containers from each serial and each subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the quantity recommended on the label using the accompanying sterile diluent or sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.
(4) From each container sample, each of 2 plates shall be inoculated with vaccine equal to 10 doses if the vaccine is recommended for poultry or 1 dose if the vaccine is recommended for other animals. Twenty ml of medium shall be added to each plate. One plate shall be incubated at 30 °to 35 °for 7 days and the other plate shall be incubated at 20 °to 25 °C for 14 days.
(5) Colony counts shall be made for each plate at the end of the incubation period. An average colony count for the 10 samples representing the serial or subserial shall be made for each incubation condition.
(6) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If the average count at either incubation condition exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals in the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final containers.
(ii) If the average count at either incubation condition of the final test for a serial or subserial exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals, the serial or subserial is unsatisfactory.
The heart infusion test, using heart infusion broth and heart infusion agar, provided in this section shall be conducted when a test for mycoplasma contamination is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Media additives provided in this paragraph shall be prepared as follows:
(1) DPN-Cysteine Solution:
(i) Use Nicotinamide adenine dinucleotide (oxidized) and L-Cysteine hydrochloride.
(ii) Prepare 1 gram/100 milliliters (ml) purified water (1 percent solution) of each. Mix the solutions together; the cysteine reduces the DPN. Filter sterilize, dispense in appropriate amounts and store frozen at −20 degrees centigrade.
(2) Inactivated horse serum—horse serum which has been inactivated at 56 °C for 30 minutes.
(b) Heart infusion broth shall be prepared as provided in this paragraph.
(1) Dissolve in 970 ml of purified water, 25 grams of heart infusion broth, 10 grams of proteose peptone No. 3, and either 5 grams of yeast autolysate or 5 ml of fresh yeast extract.
(2) Add the following:
| 1 percent tetrazolium chloride (ml) | 5.5 |
| 1 percent thallium acetate (ml) | 25 |
| Penicillin (units) | 500,000 |
| Inactivated horse serum (ml) | 100 |
(3) Adjust pH to 7.9 with NaOH, filter sterilize, and dispense 100 ml aliquots into 125 ml flasks and store until needed.
(4) Add 2 ml of DPN-Cysteine solution to each 100 ml of broth on day of use.
(c) Heart Infusion Agar shall be prepared as provided in this paragraph.
(1) Dissolve in 900 ml of purified water by boiling the following:
| Heart infusion agar (g) | 25 |
| Heart-infusion broth (g) | 10 |
| Proteose peptone No. 3 (g) | 10 |
| 1 pct thallium acetate (ml) | 25 |
(2) Cool the medium and adjust pH to 7.9 with NaOH.
(3) Autoclave the medium.
(4) Cool the medium 30 minutes in a 56 °C waterbath.
(5) Dissolve 5 grams of yeast autolysate in 100 ml of distilled water, filter sterilize, and add to the medium.
(6) Add to the medium:
(d) The test procedure provided in this paragraph shall be followed when conducting the mycoplasma detection test.
(1) Preparation of inoculum. Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the volume recommended on the label with mycoplasma medium. In the case of a lyophilized biological product, e.g., 1,000 dose vial of poultry vaccine to be administered via the drinking water, the vaccine shall be rehydrated to 30 ml with mycoplasma medium. In the case of a cell line or a sample of primary cells, the inoculum shall consist of the resuspended cells. Control tests shall be established as provided in paragraph (d)(4) of this section.
(2) Inoculation of plate. Plate 0.1 ml of inoculum on an agar plate and make a short, continuous streak across the plate with a pipet. Tilt the plate to allow the inoculum to flow over the surface.
(3) Inoculation of flask of medium. Transfer 1 ml of the inoculum into a flask containing 100 ml mycoplasma medium and mix thoroughly. Incubate the flask at 33 to 37 °C for 14 days during which time, one of four agar plates shall be streaked with 0.1 ml of material from the incubating flask of inoculated medium on the 3d day, one on the 7th day, one on the 10th day, and one on the 14th day post-inoculation.
(4) Control tests shall be conducted simultaneously with the detection test using techniques provided in paragraphs (d)(2) and (3) of this section, except the inoculum for the positive control test shall be selected mycoplasma cultures and the negative control test shall be uninoculated medium from the same lot used in the detection test.
(5) All plates shall be incubated in a high humidity, 4-6 percent CO
(e) Interpretation of test results.
(1) If growth appears on at least one of the plates in the positive control test and does not appear on any of the plates in the negative control test, the test is valid.
(2) If mycoplasma colonies are found on any of the plates inoculated with material being tested, the results are positive for mycoplasma contamination.
Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product. Firms currently using methods other than those provided in this section for determining the moisture content in desiccated biological products have until November 5, 2004 to update their Outlines of Production to be in compliance with this requirement.
(a) Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows:
(1) Cylindrical weighing bottles with airtight glass stoppers.
(2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve.
(3) Balance, accurate to 0.1 mg (rated precision ±0.01mg).
(4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent.
(5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use.
(b) Test procedure:
(1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa.
(i) Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature.
(ii) After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as “A.”
(iii) Return weighing bottles to the desiccator.
(2) Remove the sample container seal.
(i) Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle.
(ii) Insert the stopper and weigh and record the weights of the weighing bottles as “B.”
(3) Place the weighing bottle with the stopper at an angle in the vacuum oven. Set the vacuum to <2.5 kPa and the temperature to 60 ±3 °C.
(4) After a minimum of 3 hours of drying time, turn off the vacuum pump and allow dry air to bleed into the oven until the pressure inside the oven is equalized with the prevailing atmospheric pressure.
(5) While the bottle is still warm, replace the stopper in its normal position and transfer the weighing bottle to the desiccator.
(i) Allow a minimum of 2 hours for the weighing bottle to cool to room temperature or for its weight to reach equilibrium.
(ii) Weigh, and record the weight as “C.”
(6) Calculate the percentage of moisture in the original sample as follows:
(7) The results are considered satisfactory if the percentage of residual moisture is less than or equal to the manufacturer's specification.
The test for detection of Salmonella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Samples shall be collected from the bulk suspension before bacteriostatic or bactericidal agents have been added. When tissue culture products are to be tested, 1 ml of tissue extract used as the source of cells or 1 ml of the minced tissue per se shall be tested.
(b) Five ml of the liquid vaccine suspension shall be used to inoculate each 100 ml of liquid broth medium (tryptose and either selenite F or tetrathionate). The inoculated media shall be incubated 18-24 hours at 35-37 °C.
(c) Transfers shall be made to either MacConkey agar or Salmonella-Shigella agar, incubated for 18-24 hours and examined.
(d) If no growth typical of Salmonella is noted, the plates shall be incubated an additional 18-24 hours and again examined.
(e) If suspicious colonies are observed, further subculture on suitable media shall be made for positive identification. If Salmonella is found, the bulk suspension is unsatisfactory.
The complement-fixation test for detection of avian lymphoid leukosis provided in this section shall be conducted on all biological products containing virus which has been propagated in substrates of chicken origin: Provided, An inactivated viral product shall be exempt from this requirement if the licensee can demonstrate to Animal and Plant Health Inspection Service that the agent used to inactivate the vaccine virus would also inactivate lymphoid leukosis virus.
(a) Propagation of contaminating lymphoid leukosis viruses, if present, shall be done in chick embryo cell cultures.
(1) Each vaccine virus, cytopathic to chick embryo fibroblast cells, shall be effectively neutralized, inactivated, or separated so that minimal amounts of lymphoid leukosis virus can be propagated on cell culture during the 21-day growth period. If a vaccine virus cannot be effectively neutralized, inactivated, or separated, a sample of another vaccine prepared the same week from material harvested from each source flock (or other sampling procedure acceptable to Animal and Plant Health Inspection Service) used for the preparation of the questionable vaccine virus that cannot be neutralized, inactivated, or separated shall be tested each week during the preparation of such questionable vaccine.
(2) When cell cultures are tested, 5 ml of the final cell suspension as prepared for seeding of production cell cultures shall be used as inoculum. When vaccines are tested, the equivalent of 200 doses of Newcastle disease vaccine or 500 doses of other vaccines for use in poultry, or one dose of vaccine for use in other animals shall be used as inoculum. Control cultures shall be prepared from the same cell suspension as the cultures for testing the vaccine.
(3) Uninoculated chick embryo fibroblast cell cultures shall act as negative controls. One set of chick fibroblast cultures inoculated with subgroup A virus and another set inoculated with subgroup B virus shall act as positive controls, A and B respectively.
(4) The cell cultures shall be propagated at 35-37 °C for at least 21 days. They shall be passed when necessary to maintain viability and samples harvested from each passage shall be tested for group specific antigen.
(b) The microtiter complement-fixation test shall be performed using either the 50 percent or the 100 percent hemolytic end point technique to determine complement unitage. Five 50 percent hemolytic units or two 100 percent hemolytic units of complement shall be used for each test.
(1) All test materials, including positive and negative controls, shall be stored at −60 °C or colder until used in the test. Before use, each sample shall be thawed and frozen three times to disrupt intact cells and release the group specific antigen.
(2) The antiserum used in the microtiter complement-fixation test shall be a standard reagent supplied or approved by the Animal and Plant Health Inspection Service. Four units of antiserum shall be used for each test.
(3) Presence of complement-fixing activity in the harvested samples (from passages) at the 1:4 or higher dilution, in the absence of anticomplementary activity, shall be considered a positive test unless the activity can definitely be established to be caused by something other than lymphoid leukosis virus, subgroups A and/or B. Activity at the 1:2 dilution shall be considered suspicious and the sample further subcultured to determine presence or absence of the group specific antigen.
(4) Biological products or primary cells which are found contaminated with lymphoid leukosis viruses are unsatisfactory. Source flocks from which contaminated material was obtained are also unsatisfactory.
The test for detection of Brucella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production for the product.
(a) One ml of the minced tissue used as the source of cells or 1 ml of the extract of the tissue prior to the addition of antibiotics, diluent and stabilizer, shall be inoculated onto each of three tryptose agar plates and incubated in a 10 percent CO
(b) If colonies are identified as Brucella, the biological product is unsatisfactory.
(c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either
(1) The biological product shall be regarded as unsatisfactory and destroyed; or
(2) Further subculture or other procedures shall be carried out until a positive identification can be made.
One of the mouse safety tests provided in this section shall be conducted when such test is prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for animals other than poultry: Provided, That if the inherent nature of one or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for the animals for which it is recommended, the licensee shall demonstrate the safety of such product by an acceptable test written into such Outline of Production.
(a) Final container samples of completed product from live virus vaccines shall be tested for safety using young adult mice in accordance with the test provided in this paragraph.
(1) Vaccine prepared for use as recommended on the label shall be tested by inoculating eight mice intraperitoneally or subcutaneously with 0.5 mL (the inoculation volume may be divided among more than one injection site), and the animals observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
(b) Bulk or final container samples of completed product from liquid products, such as but not limited to antiserums and bacterins, shall be tested for safety in accordance with the test provided in this paragraph.
(1) Unless otherwise prescribed in the Standard Requirement or approved in a filed Outline of Production for the product, a 0.5 ml dose shall be injected intraperitoneally or subcutaneously into eight mice and the animals observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
The test for detection of hemagglutinating viruses provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Final container samples of completed product rehydrated as recommended on the label shall be used as inoculum: Provided, That poultry vaccines distributed without diluent shall be rehydrated with 30 ml of sterile distilled water per 1,000 doses and used as inoculum. When one or more fractions are to be used in combination with Newcastle Disease Vaccine, test samples shall be collected from bulk suspensions of each prior to mixing with the Newcastle Disease Vaccine.
(b) Each of ten 9- to 10-day-old embryonating eggs from Newcastle disease susceptible flocks shall be inoculated into the allantoic cavity with 0.2 ml of the undiluted inoculum.
(1) Test five uninoculated embryos of the same age and from the same flock as those used for the test as negative controls.
(2) Test an allantoic fluid sample of Newcastle disease virus as a positive control.
(c) Three to five days post-inoculation, a sample of allantoic fluid from each egg shall be tested separately by a rapid plate test for hemagglutinating activity using a 0.5 percent suspension of fresh chicken red blood cells.
(d) If the results are inconclusive, one or two blind passages shall be made using fluids from each of the original test eggs. Fluids from dead and live embryos may be pooled separately for inoculum in these passages.
(e) If hemagglutinating activity attributable to the product is observed, the serial is unsatisfactory.
The test for detection of viricidal activity provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in the filed Outline of Production for each inactivated liquid biological product used as diluent for a desiccated live virus vaccine in a combination package.
(a) Bulk or final container samples of completed product from each serial shall be tested.
(b) The product shall be tested with each virus fraction for which it is to be used as a diluent. If the vaccine to be rehydrated contains more than one virus fraction, the test shall be conducted with each fraction after neutralization of the other fraction(s), and/or dilution of the vaccine beyond the titer range of the other fraction(s), or the test shall be conducted using representative single-fraction desiccated vaccines which are prepared by the licensee and which are licensed. Provided, That the Administrator may authorize licensees to prepare and use unlicensed single-fraction vaccines for this purpose.
(c) Test procedure: (1) Rehydrate at least two vials of the vaccine with the liquid product under test according to label recommendations and pool the contents.
(2) Rehydrate at least two vials of the vaccine with the same volume of sterile purified water and pool the contents.
(3) Neutralize to remove other fractions, if necessary.
(4) Hold the two pools of vaccine at room temperature (20 °to 25 °C) for 2 hours. The holding period shall begin when rehydration is completed.
(5) Titrate the virus(es) in each pool of vaccine as provided in the filed Outline of Production or an applicable standard requirement.
(6) Compare respective titers.
(d) If the titer of the vaccine virus(es) rehydrated with the product under test is more than 0.7 log
(e) If the product is unsatisfactory in the first test, one retest to rule out faulty techniques may be conducted using four vials of the vaccine for each pool and the acceptability of the product judged by the results of the second test.
(f) Liquid products found to be unsatisfactory for use as diluent by this test are not prohibited from release as separate licensed products if labeled as prescribed in § 112.7(g).
The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.
(b) At least 25 healthy susceptible young chickens, properly identified and obtained from the same source and hatch, shall be immunized at least 14 days prior to being put on test. The immunizing agent shall be the same as the product to be tested but from a serial previously tested and found satisfactory.
(c) At least 20 of the previously immunized birds shall be inoculated with 10 label doses of the vaccine being tested by each of the following routes: Subcutaneous, intratracheal, eye-drop, and comb scarification (1 cm
(d) At least five birds shall be isolated as control birds.
(e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions.
(f) If the controls remain healthy and unfavorable reactions attributable to the product occur in the vaccinates, the serial or subserial tested is unsatisfactory. If the controls do not remain healthy or if unfavorable reactions not attributable to the product occur in the vaccinates, or both, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial of subserial tested shall be considered unsatisfactory.
The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.
(b) One volume of the prepared vaccine shall be mixed with up to nine volumes of sterile heat-inactivated specific antiserum to neutralize the vaccine virus in the product. Each lot of antiserum shall be demonstrated by virus neutralization tests not to inhibit other viruses known to be possible contaminants.
(c) After neutralization, 0.2 ml of the vaccine-serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos.
(1) Twenty embryos, 9 to 11 days old, shall be inoculated on the chorio-allantoic membrane (CAM) with 0.1 ml, and in the allantoic sac with 0.1 ml.
(2) Eggs shall be candled daily for 7 days. Deaths occurring during the first 24 hours shall be disregarded but at least 18 viable embryos shall survive 24 hours post-inoculation for a valid test. Examine all embryos and CAM's from embryos which die after the first day. When necessary, embryo subcultures shall be made to determine the cause of a death. The test shall be concluded on the seventh day post-inoculation and the surviving embryos (including CAM's) examined.
(d) If death and/or abnormality attributable to the inoculum occur, the serial is unsatisfactory: Provided, That, if there is a vaccine virus override, the test may be repeated, using a higher titered antiserum.
The guinea pig safety test provided in this section shall be conducted when prescribed in a Standard Requirement or approved Outline of Production for a biological product. When desiccated products are tested, final container samples of completed product prepared for administration in the manner recommended on the label shall be used. When liquid products are tested, either bulk or final container samples of completed product shall be used.
(a) Unless otherwise specified in the Standard Requirement or approved Outline of Production for the product, a 2 ml dose shall be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals observed for 7 days.
(b) If unfavorable reactions attributable to the product occur in either of the guinea pigs during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
The safety tests provided in this section shall be conducted when prescribed in a standard requirement or in the filed Outline of Production for a biological product recommended for use in cats.
(a) The cat safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.
(1) The test animals shall be determined to be susceptible to the virus under test as follows:
(i) Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of the virus. Blood samples shall also be drawn and individual serum samples tested for antibody to the virus.
(ii) The cats shall be considered susceptible if swabs are negative for virus isolation and the serums are free of virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other serum-neutralization test of equal sensitivity.
(iii) When determining susceptibility to a virus which does not lend itself to the methods in paragraphs (a)(1)(i) and (ii) of this section, a method acceptable to Animal and Plant Health Inspection Service shall be used.
(2) Each of at least 10 susceptible cats shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one cat dose of the vaccine, by the method to be recommended on the label, and the cats observed each day for 14 days.
(3) If unfavorable reactions attributable to the virus occur in any of the cats during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the Master Seed Virus shall be unsatisfactory.
(b) The cat safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.
(1) Each of two healthy cats shall be administered 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.
(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the serial shall be unsatisfactory.
The safety tests provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the procedures in this section may not be released for shipment.
(a) The dog safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.
(1) The test animals shall be determined to be susceptible to the virus under test by a method acceptable to the Animal and Plant Health Inspection Service.
(2) Each of at least 10 susceptible dogs shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose of the vaccine, by the method recommended on the label, and the dog shall be observed each day for 14 days.
(3) If unfavorable reactions attributable to the virus occur in any of the dogs during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and may be repeated: Provided: That, if the test is not repeated, the Master Seed Virus shall be considered unsatisfactory.
(b) The dog safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.
(1) Each of two healthy dogs shall be administered 10 dog doses by the method recommended on the label and the dogs shall be observed each day for 14 days.
(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the biological product, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be considered unsatisfactory.
The calf safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a) Test procedure. Each of two calves shall be injected with the equivalent of 10 doses of vaccine administered in the manner recommended on the label and observed each day for 21 days.
(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the calves during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
The test for detection of lymphocytic choriomeningitis (LCM) virus provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production. Vaccine virus may be neutralized with specific antiserum when necessary.
(a) Each of at least 10 mice obtained from a source free of LCM shall be injected in the footpad of a hindfoot with 0.02 ml of the material being tested and observed each day for 21 days.
(b) If any of the mice show swelling in the injected footpad or if more than one becomes systemically abnormal, the material being tested is unsatisfactory.
The test for chlamydial agents provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in a filed Outline of Production.
(a) The yolk sac of 6-day-old chicken embryos shall be injected. Three groups of 10 embryos shall be used sequentially.
(1) The inoculum for each embryo in the first group shall consist of 0.5 ml of a mixture of equal parts of the seed virus with phosphate buffered saline that may contain Streptomycin, Vancomycin, Kanamycin, or a combination thereof. Not more than 2 mg/ml of each antibiotic shall be used.
(2) On the 10th day postinoculation, the yolk sac of viable embryos shall be harvested, pooled, homogenized as a 20 percent suspension in phosphate buffered saline antibiotic diluent, and 0.5 ml of the mixture injected into the second group of chicken embryos. This process shall be repeated for the injection of the third group of embryos using the yolk sacs of viable embryos from the second group.
(3) For each of the three passages, embryo deaths occurring within 48 hours of injection shall be disregarded, except that if more than three such deaths occur at any passage, that passage shall be repeated.
(b) If one or more embryo deaths occur at any passage after 48 hours postinjection, the yolk sacs from each of the dead embryos shall be subcultured into 10 additional embryos. If one or more embryo deaths again occur due to chlamydial agents, the Master Seed Virus is unsatisfactory for use to produce vaccine.
The swine safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a) Test procedure. (1) Inject each of two swine of the minimum age for which the product is recommended with the equivalent of two doses of bacterial vaccine or 10 doses of viral vaccine.
(2) Administer vaccine in the manner recommended on the label.
(3) Observe swine each day for 21 days.
(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the swine during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated; Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
The sheep safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a) Test procedure. (1) Inject each of two sheep of the minimum age for which the product is recommended with the equivalent of two doses of bacterial vaccine or 10 doses of viral vaccine.
(2) Administer vaccine in the manner recommended on the label.
(3) Observe sheep each day for 21 days.
(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the sheep during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated; Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
The tests for detection of cytopathogenic and/or hemadsorbing agents provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in the filed Outline of Production for a product.
(a) Test for cytopathogenic agents. One or more monolayers that are at least 6 cm
(1) Stain each monolayer with a suitable cytological stain.
(2) Examine the entire area of each stained monolayer for evidence of inclusion bodies, abnormal number of giant cells, or other cytopathology indicative of cell abnormalities attributable to an extraneous agent.
(b) Test for hemadsorbing agents. One or more monolayers that are at least 6 cm
(1) Wash the monolayer with several changes of phosphate buffered saline.
(2) Add an appropriate volume of a 0.2 percent red blood cell suspension to uniformly cover the surface of the monolayer of cultured cells. Suspensions of washed guinea pig and chicken red blood cells shall be used. These suspensions may be mixed before addition to the monolayer or they may be added separately to individual monolayers.
(3) Incubate the monolayer at 4 °C for 30 minutes, wash with phosphate buffered saline, and examine for hemadsorption.
(4) If no hemadsorption is apparent, repeat step (b)(2) of this section and incubate the monolayers at 20-25 °C for 30 minutes, wash with phosphate buffered saline, and examine again for hemadsorption. If desired, separate monolayers may be used for each incubation temperature.
(c) If specific cytopathology or hemadsorption attributable to an extraneous agent is found, the material under test is unsatisfactory and shall not be used to prepare biological products. If an extraneous agent is suspected because of cytopathology or hemadsorption and cannot be eliminated as a possibility by additional testing, the material under test is unsatisfactory.
The test for detection of extraneous viruses by the fluorescent antibody technique provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in a filed Outline of Production for a product.
(a) Monolayer cultures of cells (monolayers), at least 7 days after the last subculturing, shall be processed and stained with the appropriate antiviral fluorochrome-conjugated antibody as specified in paragraph (b) of this section.
(1) Three groups of one or more monolayers shall be required for each specific virus prescribed in paragraph (b) of this section.
(i) At the time of the last subculturing, one group of test monolayers shall be inoculated with approximately 100-300 FAID
(ii) One group of monolayers shall be the “material under test.”
(iii) One group of monolayers, that are of the same type of cells as the test monolayers and that have been tested as prescribed in §§ 113.51 or 113.52 (whichever is applicable), shall be prepared as negative controls.
(2) Each group of monolayers shall have a total area of at least 6 cm
(3) Positive control monolayers may be fixed (processed so as to arrest growth and assure attachment of the monolayer to the surface of the vessel in which they are grown) before 7 days after subculturing if fluorescence is enhanced by doing so, Provided, That a monolayer of the material under test is also fixed at the same time as the positive control and a monolayer of the material under test is also fixed at least seven days after subculturing. Monolayers that are fixed before 7 days after subculturing shall be stained at the same time as the test monolayers and negative controls fixed at least 7 days after subculturing.
(b) The antiviral fluorochrome-conjugated antibodies to be used shall depend on the type of cells required to be tested for extraneous viruses as specified in an applicable Standard Requirement or in a filed Outline of Production. Antiviral fluorochrome-conjugated antibodies specific for the extraneous viruses shall be applied to each respective type of cell in accordance with the following list. Under certain circumstances, additional tests may need to be conducted, as determined by the Administrator. When a specific antiviral fluorochrome-conjugated antibody is used in testing for the listed extraneous viruses specified in more than one cell type, it need only be applied to the most susceptible cell type.
(1) All cells shall be tested for:
(i) Bovine virus diarrhea virus;
(ii) Reovirus; and
(iii) Rabies virus.
(2) Bovine, caprine, and ovine cells shall, in addition, be tested for:
(i) Bluetongue virus;
(ii) Bovine adenoviruses;
(iii) Bovine parvovirus; and
(iv) Bovine respiratory syncytial virus.
(3) Canine cells shall, in addition, be tested for:
(i) Canine coronavirus;
(ii) Canine distemper virus; and
(iii) Canine parvovirus.
(4) Equine cells shall, in addition, be tested for:
(i) Equine herpesvirus; and
(ii) Equine viral arteritis virus.
(5) Feline cells shall, in addition, be tested for:
(i) Feline infectious peritonitis virus; and
(ii) Feline panleukopenia virus.
(6) Porcine cells shall, in addition, be tested for:
(i) Porcine adenovirus;
(ii) Porcine parvovirus;
(iii) transmissible gastroenteritis virus; and
(iv) Porcine hemagglutinating encephalitis virus.
(7) Firms that do not have rabies virus on premises either for research or production purposes are exempt from having to produce positive rabies virus control monolayers. Fixed positive rabies virus control monolayers will be provided by the National Veterinary Services Laboratories.
(c) After staining, each group of monolayers shall be examined for the presence of specific fluorescence attributable to the presence of extraneous viruses.
(1) If the material under test shows any evidence of specific viral fluorescence, it is unsatisfactory and may not be used; Provided, That, if specific fluorescence attributable to the virus being tested for is absent in the positive control monolayers, the test is a No Test and may be repeated.
(2) If the fluorescence of the monolayers inoculated with the specific virus as positive controls is equivocal, or if the negative monolayers show equivocal fluorescence indicating possible viral contamination, or both, the test shall be declared a No Test, and may be repeated; Provided, That, if the test is not repeated, the material under test shall be regarded as unsatisfactory for use in the production of biologics.
All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.
Primary cells used to prepare biological products shall be derived from normal tissue of healthy animals. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, each batch of primary cells used to prepare a biological product shall be tested as prescribed in this section. A batch of primary cells found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from primary cells that are found unsatisfactory by any prescribed test.
(a) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm
(b) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable).
(c) A monolayer at least 75 cm
(1) The test monolayer shall be maintained using the medium (with additives) and under conditions similar to those used to prepare biological products.
(i) Monolayers of avian origin shall be maintained for at least 14 days and shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm
(ii) Monolayers not of avian origin shall be maintained for at least 28 days and shall be subcultured at least twice during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm
(2) Monolayers shall be examined regularly throughout the required maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the batch of primary cells is unsatisfactory.
(3) At the conclusion of the required maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
When prescribed in an applicable Standard Requirement or in a filed Outline of Production each cell line used to prepare a biological product shall be tested as prescribed in this section. A cell line found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a cell line that is found unsatisfactory by any prescribed test.
(a) General requirements. (1) A complete record of the cell line shall be kept, such as, but not limited to, the source, passage history, and medium used for propagation.
(2) A Master Cell Stock (MCS) shall be established at a specified passage level for each cell line. The passage level and identity of the MCS and the highest passage level (MCS + n) intended for use in the preparation of a biological product shall be specified in the Outline of Production for the product.
(3) Sufficient 1.0 ml or larger aliquots of MCS and MCS + n shall be prepared, kept in a frozen state, and made available to Animal and Plant Health Inspection Service (APHIS) upon request for performing the tests prescribed in this section.
(4) Each lot of cells shall be monitored for the characteristics determined to be normal for the cell line, such as, but not limited to, microscopic appearance, growth rate, acid production, or other observable features.
(b) The MCS shall be shown to be of the same species of origin as that reported in paragraph (a)(1) of this section by the following method:
(1) At least four monolayers with a total area of at least 6 cm
(2) The monolayers shall be removed from their media, processed, stained, and examined.
(i) At least two monolayers shall be stained with an antispecies fluorchrome-conjugated antibody unrelated to the species of origin of the MCS.
(ii) At least two monolayers shall be stained with an antispecies fluorochrome-conjugated antibody specific to the species of origin of the MCS.
(iii) All monolayers shall be examined for evidence of specific fluorescence.
(3) If specific fluorescence is not found in the monolayers stained with the conjugate specific to the species of origin of the MCS, the cell line is unsatisfactory and shall not be used for vaccine production.
(4) If nonspecific fluorescence is found in the monolayers stained with conjugate from an unrelated species of origin or other results make the test results equivocal, the procedure shall be repeated until either specific fluorescence is found only in the monolayers stained with conjugate specific to the species of origin of the MCS and not in the control monolayers or specific fluorescence cannot be identified and the MCS is declared unsatisfactory.
(5) Alternate tests to determine the species of origin of the MCS may be used if approved by APHIS.
(c) The MCS and either each subculture of cells used to prepare a biological product or the final pool of harvested material (with or without the stabilizer) or final container samples of completed product for each serial of such product shall be shown to be free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm
(d) The MCS and either each subculture used to prepare a biological product or the final pool of harvested material for each serial of such product or final container samples of completed product for each serial of such product shall be tested for bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable). If bacteria or fungi are found in the MCS, the MCS shall not be used. If bacteria or fungi are found in a subculture, the subculture shall not be used.
(e) A monolayer at least 75 cm
(1) The test monolayer shall be maintained for at least 21 days using the medium (with additives) intended for growth and maintenance and under conditions similar to those used to prepare biological products.
(2) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm
(3) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.
(4) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.
(f) At the conclusion of the 21-day maintenance period provided in paragraph (e) of this section, at least one monolayer of at least 75 cm
(1) Alternately freeze and thaw the monolayer(s) three times. Centrifuge the disrupted cells at no greater than 2,000 × g for no more than 15 minutes to remove cellular debris. Divide the supernatant into equal aliquots and dispense 1.0 ml onto each of at least one monolayer (at least 75 cm
(i) Vero (African green monkey kidney) cell line;
(ii) Embryonic cells, neonatal cells, or a cell line of the same species of origin as the MCS if different than provided in paragraph (f)(1)(i) of this section;
(iii) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended if different than provided in paragraph (f)(1)(ii) of this section; and
(iv) Embryonic cells, neonatal cells, or a cell line of bovine origin if not specified in paragraphs (f)(1)(ii), and (iii) of this section.
(2) The monolayers of cells specified in paragraphs (f)(1)(i), (ii), (iii), and (iv) of this section shall be maintained for at least 14 days after inoculation with the aliquot of disrupted MCS. Monolayers shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm
(3) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.
(4) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
(g) The karyology of cells lines used in the production of biologics shall be examined as follows. A minimum of 50 mitotic cells shall be examined at both the MCS and MCS + n. The modal number in the MCS + n shall not exceed plus or minus 15 percent of the modal number of the MCS. Any marker chromosomes present in the MCS shall persist at the MCS + n. If the modal number exceeds the limits and/or the marker chromosomes do not persist (through the MCS + n passage level), the cell line shall not be used for vaccine production.
(h) If direct or indirect evidence exists that a cell line which is intended for use in the preparation of a vaccine may induce malignancies in the species for which the product is intended, that cell line shall be tested for tumorigenicity/oncogenicity by a method acceptable to APHIS.
Each lot of ingredient of animal origin which is not subjected to heat sterilization or other sterilization methods acceptable to Animal and Plant Health Inspection Service (APHIS), such as, but not limited to serum and albumin, used to prepare a biological product shall be tested as prescribed in this section by the licensee or a laboratory acceptable to VS. Results of all tests shall be recorded by the testing laboratory and made a part of the licensee's records. A lot of ingredient found unsatisfactory by any prescribed test shall not be used to prepare a biological product. A serial of biological product shall not be released if produced using an ingredient that is found unsatisfactory by any prescribed test.
(a) Samples of each lot of ingredient of animal origin which is not subjected to heat sterilization, used to prepare a biological product shall be shown free of mycoplasma by the method prescribed in § 113.28.
(b) Samples of each lot of ingredient or animal origin which is not subjected to heat sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26.
(c) Samples of each lot of ingredient of animal origin, except porcine trypsin, which is not subjected to heat sterilization or other viricidal procedure acceptable to APHIS used in the preparation of biological products shall be tested as prescribed in this paragraph;
(1) Monolayers at least 75 cm
(2) At least 3.75 ml or 15 percent of the ingredient shall be used in the growth medium for the preparation of at least 75 cm
(3) The test monolayers shall be maintained for at least 21 days.
(4) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm
(5) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the ingredient is unsatisfactory.
(6) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
(d) Each lot of porcine trypsin which has not been treated to inactivate porcine parvovirus (PPV) in a manner acceptable to VS shall be tested for PPV as prescribed in this paragraph.
(1) Not less than 5.0 grams of trypsin shall be dissolved in a volume of suitable diluent sufficient to fill a centrifuge angle head. After centrifuging for 1 hour at 80,000 × g, the pellet material shall be reconstituted in distilled water and inoculated into a flask containing 75 cm
(2) The test and control monolayers shall be maintained for at least 14 days and subcultured at least once during the maintenance period.
(3) At the end of the 14-day maintenance period, and 4 to 7 days after the last subculturing, monolayers shall be tested for the presence of porcine parvovirus by the fluorescent antibody technique as prescribed in § 113.47(c).
(e) A sample of serum from each donor horse used to produce a lot of equine serum used in the preparation of biological products recommended for use in horses shall be tested at a laboratory approved by Animal and Plant Health Inspection Service using the Coggins test for equine infectious anemia antibodies. If antibodies to equine infectious anemia are found, the lot of serum is unsatisfactory.
Sterile Diluent shall be supplied in a final container by the licensee when such diluent is required for rehydration or dilution of the vaccine.
(a) Sterile Diluent may be distilled or deionized water or it may be a special liquid solution formulated in accordance with an acceptable outline on file with Animal and Plant Health Inspection Service.
(b) Each quantity prepared at one time in a single container and bottled into final containers shall be designated as a serial. Each serial shall be given a number which shall be used in records, test reports, and on the final container label.
(c) Final container samples from each serial shall be tested for bacteria and fungi in accordance with the test provided in § 113.26. Any serial found to be unsatisfactory shall not be released.
Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, each Master Seed Virus (MSV) shall be tested as prescribed in this section. A MSV found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a MSV that is found unsatisfactory by any prescribed test.
(a) At least a 1.0 ml aliquot per cell culture of MSV shall be dispensed onto monolayers (at least 75 cm
(1) Vero (African green monkey kidney) cell line;
(2) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended; and
(3) Embryonic cells, neonatal cells, or a cell line of the species of cells in which the MSV is presently being propagated if different than prescribed in paragraphs (a)(1) and (a)(2) of this section. Cell lines used shall have been found satisfactory when tested as prescribed in § 113.52 and primary cells used shall have been found satisfactory when tested as prescribed in § 113.51. If the MSV is cytopathic for or causes hemadsorption in the cells in which it is to be tested, the MSV shall be neutralized with monospecific antiserum supplied or approved by Animal and Plant Health Inspection Service (APHIS) or counteracted by a method approved by APHIS.
(b) At least one monolayer of each cell type used in the test shall be maintained as an uninoculated control.
(c) Each monolayer shall be maintained at least 14 days.
(d) Cells shall be subcultured at least once during the maintenance period. All but the last subculture shall result in at least one new monolayer at least 75 cm
(e) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MSV is unsatisfactory.
(f) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:
(1) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;
(2) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live bacterial vaccine shall meet the requirements in this section.
(a) Purity test. Final container samples of completed product from each serial and subserial, and samples of each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(b).
(b) Safety tests. (1) Samples of completed product from each serial or first subserial and samples of each lot of Master Seed Bacteria shall be tested for safety in young adult mice in accordance with the test provided in § 113.33(b) unless:
(i) The bacteria or agents in the vaccine are inherently lethal for mice.
(ii) The vaccine is recommended for poultry.
(2) Samples of completed product from each serial or first subserial of live bacterial vaccine shall be tested for safety in one of the species for which the product is recommended as follows:
(i) Live bacterial vaccine recommended for use in dogs shall be tested as provided in § 113.40, except that dogs shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.
(ii) Live bacterial vaccine recommended for use in cattle shall be tested as provided in § 113.41, except that calves shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.
(iii) Live bacterial vaccine recommended for use in sheep shall be tested as provided in § 113.45.
(iv) Live bacterial vaccine recommended for use in swine shall be tested as provided in § 113.44.
(c) Identity test. At least one of the identity tests provided in this paragraph shall be conducted for the Master Seed Bacteria and final container samples from each serial or first subserial of completed biological product. A known positive control (reference) provided or approved by Animal and Plant Health Inspection Service shall be included in such tests.
(1) Fluorescent antibody test. The direct fluorescent antibody staining technique shall be conducted using suitable smears of the vaccine bacteria. Fluorescence typical for the bacteria concerned shall be demonstrated. Fluorescence shall not occur in control smears treated with specific antiserum.
(2) Tube agglutination test. A tube agglutination test shall be conducted with a suitable suspension of the vaccine bacteria using the constant antigen decreasing serum method with specific antiserum. Agglutination typical for the bacteria shall be demonstrated. Agglutination shall not occur with negative serum used as a control in this test.
(3) Slide agglutination test. The rapid plate (slide) agglutination test shall be conducted with suitable suspensions of the vaccine bacteria using the hanging drop, slide or plate method, with specific antiserum. Agglutination typical for the bacteria shall be demonstrated by microscopic or macroscopic observation. Agglutination shall not occur with negative serum used as a control in this test.
(4) Characterization tests. Applicable biochemical and cultural characteristics shall be demonstrated as specified in the filed Outline of Production.
(d) Ingredient requirements. Ingredients used for the growth and preparation of Master Seed Bacteria and of live bacterial vaccine shall meet the requirements provided in § 113.50. Ingredients of animal origin shall meet the applicable requirements provided in § 113.53.
(e) Moisture content. The maximum percent moisture in desiccated vaccines shall be stated in the filed Outline of Production and shall be established by the licensee as follows:
(1) Prelicensing. Data obtained by conducting accelerated stability tests and bacterial counts shall be acceptable on a temporary basis.
(2) Licensed products. Data shall be obtained by determining the percent moisture and bacterial count at release and expiration on a minimum of 10 consecutive released serials.
(3) Final container samples of completed product from each serial and subserial must be tested for moisture content in accordance with the test provided in § 113.29.
Brucella Abortus Vaccine shall be prepared as a desiccated live culture bacterial vaccine from smooth colonial forms of the Brucella abortus organism, identified as Strain 19. Each serial and subserial shall be tested for purity, potency, and moisture content. A serial or subserial found unsatisfactory by a prescribed test shall not be released.
(a) Purity tests. Each serial and subserial shall be tested for purity as provided in this paragraph.
(1) Macroscopic and microscopic examination shall be made on bulk samples from production containers. If organisms not typical of Brucella abortus organisms are evident, the serial or subserial is unsatisfactory.
(2) Two final container vials of completed product shall be tested by inoculating one tube of Dextrose Andrades broth with gas tube and one tube of thioglycollate broth from each vial. The inoculated media shall be incubated at 35 to 37 °C for 96 hours. If growth not typical of Brucella abortus organisms is evident, the serial or subserial is unsatisfactory.
(3) Bacterial dissociation test. Final container samples of completed product from each serial and subserial shall be tested for bacterial dissociation. Smooth colonies are the desired form. Rough colonies are undesirable terminal dissociation forms. Intermediate and intermediate-to-rough are also undesirable.
(i) The sample container shall be rehydrated and streaked on one potato agar plate in such a manner as to produce confluent colonies. Artificial reflected light shall be used so that the rays pass through the plate at a 45 °angle.
(ii) If the vaccine contains more than 5 percent rough colonies or more than 15 percent total undesirable colonies, the serial or subserial is unsatisfactory. If organisms or growth not characteristic of Brucella abortus are found, the serial or subserial is unsatisfactory. The test may be repeated one time using double the number of samples: Provided, That, if the test is not repeated, the serial or subserial is unsatisfactory.
(b) Bacterial count requirements for reduced dose vaccine. Each serial and each subserial shall be tested for potency.
(1) Two final container vials of completed product shall be tested for the number of viable organisms per dose of rehydrated vaccine. A bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 °C for 96 hours.
(2) If the average count of the two final container samples of freshly prepared vaccine contains less than 3.0 or more than 10.0 billion organisms per dose, the serial or subserial is unsatisfactory.
(3) If the average count on the initial test is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial may be retested one time using four additional final container vials. The average count of the retest is determined. If the average count of the four vials retested is less than the required minimum or greater than the required maximum, the serial or subserial is unsatisfactory. If the average count of the four vials retested is within the required limits described in paragraph (b)(2) of this section, the following shall apply:
(i) If the average count obtained in the initial test is less than one-third or more than three times the average count obtained on the retest, the average count of the initial test shall be considered the result of test system error and the serial or subserial is satisfactory.
(ii) If the average count obtained in the initial test is one-third or more than the average retest count or three times or less than the average retest count, a new average count shall be determined from the counts of all six vials. If the new average is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial is unsatisfactory.
(4) If tested at any time within the expiration period, each dose of rehydrated vaccine must contain at least 3.0 billion viable organisms per dose.
(c) Bacterial count requirements for standard vaccine. Each serial and subserial shall be tested for potency.
(1) Two final container samples shall be tested for the number of viable organisms per milliliter of rehydrated vaccine. One bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 °C for 96 hours.
(2) If the average count of the two final container samples of freshly prepared vaccine does not contain at least 10 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.
(3) If the initial bacterial count is less than 10 billion organisms per milliliter, the serial or subserial may be retested one time using four samples. If the average count of the four vials retested is less than the required minimum, the serial or subserial is unsatisfactory.
(4) If tested at any time within the expiration period, each milliliter of rehydrated vaccine does not contain at least 5 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.
Anthrax Spore Vaccine—Nonencapsulated shall be a live spore suspension prepared from nonencapsulated variants of Bacillus anthracis. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity as follows:
(1) Forty-two susceptible guinea pigs from the same source each weighing 400 to 500 grams, shall be used as test animals (30 vaccinates and 12 controls).
(2) An arithmetic mean spore count of vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The guinea pigs used as vaccinates shall be injected as recommended on the label with a predetermined number of vaccine spores. To confirm the dosage, five replicate spore counts shall be conducted on a sample of the vaccine dilution used.
(3) Fourteen to fifteen days postvaccination the vaccinates and controls shall each be challenged with not less than 4,500 guinea pig LD
(4) If at least 10 of the 12 controls do not die from Bacillus anthracis within the 10-day postchallenge observation period the test is invalid and may be repeated.
(5) If at least 27 of 30 of the vaccinates do not survive the 10-day postchallenge observation period, the Master Seed is unsatisfactory.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c) Test Requirements for Release. Each serial and subserial shall meet the applicable general requirements prescribed in 9 CFR 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in sheep or goats by the methods described in 9 CFR 113.45(a).
(2) Spore Count Requirements. Final container samples of completed product shall be tested for spore count. Samples shall be diluted in tenfold steps. Each dilution expected to yield 30 to 300 colonies per plate shall be plated in triplicate on tryptose agar, inverted, and incubated at 35 to 70 °C for 24 hours to 28 hours. Each plate having uniformly distributed colonies shall be counted and an average count determined. To be eligible for release, each serial and each subserial shall have a spore count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that when tested at any time within the expiration period, each serial and subserial shall have a spore count of at least twice that used in the immunogenicity test but not less than 2,000,000 spores per dose.
Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of Erysipelothrix rhusiopathiae. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production.
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Thirty Erysipelothrix rhusiopathiae susceptible swine shall be used as test animals (20 vaccinates and 10 controls) for each route of administration recommended on the label.
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 swine to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control swine shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine dilution used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days postvaccination, the vaccinates and controls shall be challenged with a virulent Erysipelothrix rhusiopathiae culture and observed for 7 days. The challenge culture and instructions for preparation and use shall be obtained from Animal and Plant Health Inspection Service.
(4) A satisfactory challenge shall be evidenced in the controls by a high body temperature or clinical signs including, but not limited to acute illness with hyperemia of the abdomen and ears, possibly terminating in sudden death; moribundity, with or without metastatic skin lesions; depression with anorexia, stiffness, and/or joint involvement; or any combination of these symptoms and lesions.
(5) If at least 80 percent of the controls do not show characteristic signs during the observation period including, but not limited to a body temperature of 105.6 °F or higher on at least 2 consecutive days, the test shall be considered a No Test: Provided, That control pigs which meet the criteria requirements for susceptibility except for high body temperature shall be considered susceptible if sacrificed and organisms identified as Erysipelothrix rhusiopathiae can be isolated from the blood, spleen, or other organs.
(6) To demonstrate immunity after challenge, the vaccinates shall remain free of clinical signs and the body temperature shall not exceed 104.6 °F on 2 or more consecutive days. If at least 90 percent of the vaccinates do not remain free from clinical signs and high body temperature throughout the observation period, the Master Seed is unsatisfactory.
(7) An Outline of Production change shall be made before authority for use of a new Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable requirements in § 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in young adult mice as prescribed in § 113.33(b) and in swine as prescribed in § 113.44.
(2) Bacterial count requirements. Final container samples of completed product from each serial and each subserial shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each sample. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count two times greater than that used in such immunogenicity test.
Pasteurella Haemolytica Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of Pasteurella haemolytica, identified as serotype 1. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Fifteen Pasteurella haemolytica susceptible calves shall be used as test animals (10 vaccinates and 5 controls) for each route of administration recommended on the label.
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The five control calves shall be held separately from the vaccinates. To confirm the dosage calculation, five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered a valid test.
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing Pasteurella haemolytica culture and observed for 4 to 7 days. The challenge culture and instructions for preparation for use shall be furnished or approved by the Animal and Plant Health Inspection Service.
(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to lacrimation, mucoid nasal exudates, expiratory dyspnea, tachypnea, pulmonary rales, and cough possibly terminating in death; moribundity, depression with anorexia, diarrhea with substantial weight loss; or any combination of these symptoms.
(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 7 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(6) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b) except, that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.
(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.
Pasteurella Multocida Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of Pasteurella multocida, of bovine origin. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Fifteen Pasteurella multocida susceptible calves shall be used as test animals (10 vaccinates and 5 controls) for each route of administration recommended on the label.
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The five control calves shall be held separately from the vaccinates. To confirm the dosage calculation, arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered a valid test.
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing Pasteurella multocida culture and observed for 4 to 10 days. The challenge culture and instructions for preparation for use shall be furnished or approved by the Animal and Plant Health Inspection Service.
(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to acute illness with higher body temperature and respiration rate, lacrimation, mucoid nasal exudate, expiratory dyspnea, tachypnea, pulmonary rales, and cough, possibly terminating in death; moribundity, depression with anorexia; diarrhea with substantial weight loss; or any combination of these symptoms.
(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 10 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(6) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety Test. Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b), except that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.
(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test count per dose established to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.
Pasteurella Multocida Vaccine, Avian Isolate, shall be prepared as a desiccated live culture of an avirulent or modified strain of Pasteurella multocida. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity in each species and for each serotype for which the Master Seed is claimed to give protection.
(1) Thirty Pasteurella multocida susceptible birds shall be used as test animals (20 vaccinates and 10 controls) for each bird species, route of administration, and serotype for which protection is claimed on the label.
(2) An arithmetic mean count of colony forming units from vaccine produced from the highest passage of Master Seed shall be established before the immunogenicity test is conducted. The 20 birds to be used as vaccinates shall be inoculated, as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control birds shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.
(3) Not less than 14 days after vaccination, each of 20 vaccinates and each of 10 unvaccinated controls shall be challenged intramuscularly or by other methods acceptable to the Animal and Plant Health Inspection Service with a virulent Pasteurella multocida strain, for which protection is claimed, and observed daily for a 14 day post-challenge period.
(4) Eight or more of the unvaccinated controls must die for the test to be valid. If at least 16 of 20 of the vaccinates do not survive the 14-day postchallenge period, the Master Seed is unsatisfactory at the selected bacterial count.
(c) Test requirements for release. Each serial and subserial shall meet the applicable requirements in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety.
(i) Ten birds of a species for which the vaccine is recommended shall be given the equivalent of 10 doses each of the vaccine and observed for 10 days. If the vaccine is recommended for more than one species, only one species needs to be tested.
(ii) If unfavorable reactions attributable to the vaccine occur during the observation period in two or more of the test birds, the serial is unsatisfactory.
(iii) If unfavorable reactions occur which are not attributable to the test vaccine, the test is a No Test and may be repeated. If the results of the next test are not satisfactory, or if the test is not repeated, the serial shall be considered unsatisfactory.
(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test count per dose established to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.
Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia, shall be prepared from chlamydia-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.300 and the requirements in this section. Master Seed propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory by any prescribed test, the Master Seed shall not be used.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected dose from the lot of Master Seed shall be established as follows:
(1) Thirty feline pneumonitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all serums are negative for pneumonitis antibody in a complement fixation test or other test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate titrations shall be conducted on a sample of the vaccine dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 10,000 yolk sac LD50 of virulent feline pneumonitis furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 28 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs noted and recorded each day.
(i) If less than 8 of 10 controls show clinical signs of feline pneumonitis infection other than fever, the test is a No Test and may be repeated.
(ii) If a significant difference in clinical signs other than fever or chlamydia shedding cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(4) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c) Test requirements for release: Except for § 113.300(a)(3)(ii), each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.
(2) Chlamydia titer requirements. Final container samples of completed product shall be tested for chlamydia titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and each subserial shall have a titer sufficiently greater than the titer of vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a titer 0.7 greater than that used in such immunogenicity test but not less than 2.5 ID50 per dose.
Unless otherwise prescribed in an applicable Standard Requirement or in the filed Outline of Production, an inactivated bacterial product shall meet the applicable requirements in this section.
(a) Purity tests. (1) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(d).
(b) Safety tests. Bulk or final container samples of completed product from each serial shall be tested for safety in young adult mice in accordance with the test provided in § 113.33(b) unless:
(1) The product contains material which is inherently lethal for mice. In such instances, the guinea pig safety test provided in § 113.38 shall be conducted in place of the mouse safety test.
(2) The product is recommended for poultry. In such instances, the product shall be safety tested in poultry as defined in the specific Standard Requirement or Outline of Production for the product.
(3) The product is recommended for fish, other aquatic species, or reptiles. In such instances, the product shall be safety tested in fish, other aquatic species, or reptiles as required by specific Standard Requirement or Outline of Production for the product.
(c) Identity test. Methods of identification of Master Seed Bacteria to the genus and species level by laboratory tests shall be sufficient to distinguish the bacteria from other similar bacteria according to criteria described in the most recent edition of “Bergey's Manual of Systematic Bacteriology” or the American Society for Microbiology “Manual of Clinical Microbiology”. If Master Seed Bacteria are referred to by serotype, serovar, subtype, pilus type, strain or other taxonomic subdivision below the species level, adequate testing must be used to identify the bacteria to that level. Tests which may be used to identify Master Seed Bacteria include, but are not limited to:
(1) Cultural characteristics,
(2) Staining reaction,
(3) Biochemical reactivity,
(4) Fluorescent antibody tests,
(5) Serologic tests,
(6) Toxin typing,
(7) Somatic or flagellar antigen characterization, and
(8) Restriction endonuclease analysis.
(d) Ingredient requirements. Ingredients used for the growth and preparation of Master Seed Bacteria and of final product shall meet the requirements provided in § 113.50. Ingredients of animal origin shall meet the applicable requirements provided in § 113.53.
(e) Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as diluent for desiccated fractions in combination packages.
(f) If formaldehyde is used as the inactivating agent, and the serial has not been found satisfactory by the viricidal activity test, bulk or final container samples of completed product from each serial must be tested for residual free formaldehyde content using the ferric chloride test.
(1) The residual free formaldehyde content of biological products containing clostridial antigens must not exceed 1.85 grams per liter (g/L).
(2) The residual free formaldehyde content of bacterins, bacterin-toxoids, and toxoids, other than those containing clostridial antigens, must not exceed 0.74 grams per liter (g/L).
Leptospira Pomona Bacterin shall be produced from a culture of Leptospira pomona which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira pomona fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/800th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.
(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.
(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.
(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira pomona organisms, using a dose of 10-10,000 hamster LD
(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die of leptospirosis, the test is valid and the results shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial |
|---|---|---|---|---|
| 1 | 10 | 10 | 2 or less | 5 or more. |
| 2 | 10 | 20 | 5 or less | 6 or more. |
(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Icterohaemorrhagiae Bacterin shall be produced from a culture of Leptospira icterohaemorrhagiae which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira icterohaemorrhagiae fraction shall meet the applicable requirements in § 113.100 and be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/80th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.
(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.
(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.
(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira icterohaemorrhagiae organisms, using a dose of 10-10,000 hamster LD
(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die from leptospirosis, the test is valid and the results shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial |
|---|---|---|---|---|
| 1 | 10 | 10 | 2 or less | 5 or more. |
| 2 | 10 | 20 | 5 or less | 6 or more. |
(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Canicola Bacterin shall be produced from a culture of Leptospira canicola which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira canicola fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Serials found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/80th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.
(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.
(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.
(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira canicola organisms, using a dose of 10-10,000 hamster LD
(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die from leptospirosis, test is valid and the results shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial |
|---|---|---|---|---|
| 1 | 10 | 10 | 2 or less | 5 or more. |
| 2 | 10 | 20 | 5 or less | 6 or more. |
(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Grippotyphosa Bacterin shall be produced from a culture of Leptospira grippotyphosa which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira grippotyphosa fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/800th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.
(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.
(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.
(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira grippotyphosa organisms, using a dose of 10-10,000 hamster LD
(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die of leptospirosis, the test is valid and the results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Number of vaccinates | Dead hamsters for acceptance | Dead hamsters for rejection |
|---|---|---|---|
| 1 | 10 | 2 or less | 5 or more. |
| 2 | 20 | 5 or less | 6 or more. |
(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.
Clostridium Chauvoei Bacterin shall be produced from a culture of Clostridium chauvoei which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium chauvoei fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Serials found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage test provided in this paragraph.
(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.
(2) Clostridium chauvoei challenge material, available upon request from Animal and Plant Health Inspection Service, shall be used for challenge 14 to 15 days following the last injection of the product. Each of eight vaccinates and each of five additional nonvaccinated guinea pigs for controls shall be injected intramuscularly with approximately 100 LD
(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of deaths for a satisfactory test | Cumulative total number of deaths for an unsatisfactory test |
|---|---|---|---|---|
| 1 | 8 | 8 | 1 or less | 3 or more. |
| 2 | 8 | 16 | 4 or less | 5 or more. |
Clostridium Haemolyticum Bacterin shall be produced from a culture of Clostridium haemolyticum which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium haemolyticum fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage test provided in this paragraph.
(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.
(2) Clostridium haemolyticum challenge material, available upon request from Animal and Plant Health Inspection Service, shall be used for challenge 14 to 15 days following the last injection of the product. Each of eight vaccinates and each of five additional nonvaccinated guinea pigs for controls shall be injected intramuscularly with approximately 100 LD
(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of deaths for a satisfactory test | Cumulative total number of deaths for an unsatisfactory test |
|---|---|---|---|---|
| 1 | 8 | 8 | 1 or less | 3 or more. |
| 2 | 8 | 16 | 4 or less | 5 or more. |
Clostridium Novyi Bacterin-Toxoid shall be produced from a culture of Clostridium novyi which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium novyi fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Alpha toxin-neutralization test provided in this paragraph.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of Alpha Antitoxin which reacts with Lo and L + doses of Standard Toxin according to their definitions.
(ii) Lo dose. The largest quantity of toxin which can be mixed with one unit of Standard Antitoxin and not cause sickness or death in injected mice.
(iii) L + dose. The smallest quantity of toxin which can be mixed with one unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.
(iv) Standard antitoxin. The Alpha Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium novyi Alpha Antitoxin Standard and which is either supplied by or acceptable to the Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The Alpha toxin preparation which is supplied by or is acceptable to the Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 121 °C for 25 minutes; and storing at 4 °C until used.
(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose. Provided, That, if the product is recommended only for sheep, half of the recommended sheep dose shall be used. A second dose shall be given not less than 20 days nor more than 23 days after the first dose.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is invalid and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:
(i) Make a dilution of Standard Antitoxin to contain 0.1 International Unit of antitoxin per ml.
(ii) Make a dilution of Standard Toxin in which 0.1 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 0.1 L + dose is contained in a volume of 1 ml or less.
(iii) Combine 0.1 International Unit of Standard Antitoxin with 0.1 Lo dose of diluted Standard Toxin and combine 0.1 International Unit of Standard Antitoxin with 0.1 L + dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.
(iv) Combine 0.1 Lo dose of diluted Standard Toxin with a 0.2 ml volume of undiluted serum. The mixture is adjusted to a final volume of 2.0 ml with diluent.
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 Lo doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(ii) If less than 80 percent of the mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 L + doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(iii) If any mice inoculated with the mixture of 0.2 ml undiluted serum with 0.1 Lo dose of Standard Toxin die, the serum is considered to contain less than 0.50 International Units per ml.
(iv) If the single pooled serum from seven or more rabbits contains less than 0.5 International Unit per ml, the serial is unsatisfactory.
Clostridium Sordellii Bacterin-Toxoid shall be produced from a culture of Clostridium sordellii which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium sordellii fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the toxin-neutralization test provided in this paragraph.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of antitoxin which reacts with Lo and L + doses of Standard Toxin according to their definitions.
(ii) Lo dose. The largest quantity of toxin which can be mixed with one unit of Standard Antitoxin and not cause sickness or death in injected mice.
(iii) L + dose. The smallest quantity of toxin which can be mixed with one unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.
(iv) Standard antitoxin. The antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium sordellii Antitoxin Standard and which is either supplied by or acceptable to the Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The toxin preparation which is supplied by or is acceptable to the Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 121 °C for 25 minutes; and storing at 4 °C until used.
(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose: Provided, That, if the product is recommended only for sheep, half of the recommended sheep dose shall be used. A second dose shall be given not less than 20 days nor more than 23 days after the first dose.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:
(i) Make a dilution of Standard Antitoxin to contain 1.0 international unit of antitoxin per ml.
(ii) Make a dilution of Standard Toxin in which 1.0 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 1.0 L + dose is contained in a volume of 1 ml or less.
(iii) Combine 1.0 International Unit Standard Antitoxin with 1.0 Lo dose of diluted Standard Toxin and combine 1.0 International Unit of Standard Antitoxin with 1.0 L + dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.
(iv) Combine 1.0 Lo dose of diluted Standard Toxin with a 1.0 ml volume of undiluted serum. This mixture is adjusted to a final volume of 2.0 ml with diluent.
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 Lo doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(ii) If less than 80 percent of the mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 L + doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(iii) If any mice inoculated with the mixture of 1.0 ml undiluted serum with 1.0 Lo dose of Standard Toxin die, the serum is considered to contain less than 1.0 International Units per ml.
(iv) If the single pooled serum from seven or more rabbits contains less than 1.0 International Unit per ml, the serial is unsatisfactory.
Clostridium Botulinum Type C Bacterin-Toxoid shall be produced from a culture of Clostridium botulinum Type C which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium botulinum Type C fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency, using susceptible mink as test animals. At least five vaccinates and three unvaccinated controls of the same source and approximately the same age shall be used.
(1) Each of the vaccinates shall be injected subcutaneously with the dose recommended on the label for mink. Twenty-one to twenty-eight days post-injection, the vaccinates and the controls shall be challenged intraperitoneally with botulinum Type C toxin which has been titrated in mice to provide for a 10
(2) The vaccinates and controls shall be observed for 7 days post-challenge and signs of botulism and deaths noted. For a valid test, the controls shall die of botulism. If the test is valid and 80 percent of the vaccinates do not remain free of botulism, the serial is unsatisfactory.
Clostridium Perfringens Type C Toxoid and Clostridium Perfringens Type C Bacterin-Toxoid shall be produced from a culture of Clostridium perfringens Type C which has been inactivated and is nontoxic. Each serial shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Beta toxin-neutralization test provided in this paragraph.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of Beta Antitoxin which reacts with L
(ii) L
(iii) L
(iv) Standard antitoxin. The Beta Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Beta Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The Beta toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 grams of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F for 25 minutes; and storing at 4 °C until used.
(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first does.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(4) The antitoxin content of the rabbit serums shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Combine 10 International Units of Standard Antitoxin with 10 L
(iv) Combine 1 ml of undiluted serum with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 10 International Units of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of serum with 10 L
Clostridium Perfringens Type D Toxoid and Clostridium Perfringens Type D Bacterin-Toxoid shall be produced from a culture of Clostridium perfringens Type D which has been inactivated and is nontoxic. Each serial shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Epsilon toxin-neutralization test provided in this paragraph.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of Epsilon Antitoxin which reacts with L
(ii) L
(iii) L
(iv) Standard antitoxin. The Epsilon Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Epsilon Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The Epsilon toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F for 25 minutes; and storing at 4 °C until used.
(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first dose.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(4) The antitoxin content of the rabbit serums shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 1 International Unit of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Combine 1 International Unit of Standard Antitoxin with 10 L
(iv) Dilute 1 ml of serum with 1 ml of diluent (1:2) and combine 1 ml of this solution with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 1 International Unit of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 1 International Unit of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of serum with 10 L
Autogenous biologics shall be prepared from cultures of microorganisms which have been inactivated and are nontoxic. Such products shall be prepared only for use by or under the direction of a veterinarian under a veterinarian-client-patient relationship, Provided, That, such products may be prepared for use under the direction of a person of appropriate expertise in specialized situations such as aquaculture, if approved by the Administrator.
Each serial of an autogenous biologic shall meet the requirements in this section, and if found unsatisfactory by any prescribed test shall not be used.
(a) Seed requirements. The microorganisms used as seed to prepare autogenous biologics shall be microorganisms which are isolated from sick or dead animals in the herd of origin and which there is reason to believe are the causative agent(s) of the current disease affecting such animals.
(1) More than one microorganism isolated from the same herd may be used as seed.
(2) Under normal circumstances, microorganisms from one herd must not be used to prepare an autogenous biologic for another herd. The Administrator, however, may authorize preparation of an autogenous biologic for use in herds adjacent to the herd of origin, when adjacent herds are considered to be at risk. To request authorization to prepare a product for use in herds adjacent to the herd of origin, the establishment seeking authorization must submit to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) the following information. (If any of the data are unavailable, the applicant for authorization should indicate that such data are unavailable and why.)
(i) Name, address, and phone number of the owner of the herd of origin.
(ii) Attending veterinarian's name, address, and phone number.
(iii) Animal species and number in herd of origin.
(iv) Identification of microorganism(s), at least to genus.
(v) Diagnosis or clinical signs of the disease observed.
(vi) Name and address of the person who isolated the microorganism(s) and the date of isolation.
(vii) Number of doses of autogenous biologic requested and vaccination schedule.
(viii) Each adjacent herd owner's name, address, and phone number.
(ix) Number of animals and species in each adjacent herd.
(x) The attending veterinarian's or approved specialist's assessment of the involvement of the adjacent herd(s) with the disease observed.
(3) The Administrator may authorize preparation of an autogenous biologic for use in herds which are not adjacent to the herd of origin, but which he or she considers to be at risk of infection with the same microorganism(s). Except as provided below, the same information which is required for preparation of such product for use in herds adjacent to the herd of origin must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) for authorization to prepare a product for use in herds not adjacent to the herd of origin. Because the recipient herd involved may not be known when autogenous biologics are to be used in other geographic areas, the following data may be used in place of the data required in paragraphs (a)(2)(viii) and (a)(2)(ix) of this section.
(i) Names and addresses of practitioners in the area in place of the name, address, and phone number of the adjacent herd owner.
(ii) The geographic designations of the area involved.
(iii) A summary of the epidemiology of the disease situation that links the designated geographic areas with the herd of origin.
(4) Under normal circumstances, microorganism(s) used for the production of autogenous biologics may not be older than 15 months from the date of isolation, or 12 months from the date of harvest of the first serial of product produced from the microorganism(s), whichever comes first. The Administrator, however, may authorize production of additional serials from microorganism(s) older than the above stated time periods, Provided, That, the person requesting such authorization submits the following supporting information to the address listed in paragraph (a)(3):
(i) The attending veterinarian's or approved specialist's current assessment of the continued involvement of a herd with the originally isolated microorganism(s), including a summary of the diagnostic work that has been done to support this assessment.
(ii) Evidence of satisfactory protection from the previous use of the autogenous biologic produced from the microorganisms involved.
(iii) Any other information the Administrator may require in order to determine the need to use the microorganism to make additional serials.
(b) Restrictions. Unless otherwise authorized by the Administrator, each serial of an autogenous biologic shall be subject to the following restrictions:
(1) Microorganisms used to prepare autogenous biologics shall not be maintained in the licensed establishment beyond the time authorized for use in production.
(2) The expiration date of the autogenous biologic shall not exceed 18 months from the date of harvest.
(c) Testing requirements for autogenous biologics. (1) Final container samples of completed product from the first serial or subserial of an autogenous biologic produced from an isolate shall be tested for purity as prescribed in § 113.26, and for safety as prescribed in § 113.33(b) or § 113.38 except that:
(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.
(ii) Serials which are satisfactory after the third day of observation of purity test cultures and of safety test animals may be released for shipment to the customer and the tests continued throughout the required period; and
(iii) Serials released on the basis of satisfactory results of third day observations shall be immediately recalled if evidence of contamination occurs in test cultures or if any of the test animals used to demonstrate product safety, sicken, or die during the observation period.
(iv) Test summaries must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) on a quarterly basis by the 21st day of January, April, July, and October or more often as required by the Administrator.
(2) Each serial or subserial of autogenous bacterial product other than the first serial or subserial produced from an isolate shall meet the applicable general requirements prescribed in § 113.100 and the special requirements prescribed in this section. Each serial or subserial of autogenous viral product other than the first serial or subserial produced from an isolate shall meet the applicable general requirements prescribed in § 113.200 and the special requirements prescribed in this section. A serial or subserial found unsatisfactory by any prescribed test shall not be released.
(i) Purity test. Final container samples of completed product from each serial and subserial shall be tested for viable bacteria and fungi as provided in § 113.26. When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.
(ii) Safety test. Bulk of final container samples of completed product from each serial shall be tested for safety as provided in § 113.33 (b) or § 113.38.
(iii) Identification. All microorganisms used for the production of autogenous biologics shall be identified as follows: Bacteria, fungi, and mycoplasma shall be identified at least to genus and species. Viruses shall be identified at least to family. After 15 months from the date of isolation, or 12 months from the harvest date of the first serial of autogenous product produced from a microorganism, whichever comes first, characterization and identification shall be completed to strain and/or serotype before such microorganism may be used for production.
(iv) Antigenicity, or immunogenicity, and potency. Persons seeking authorization to prepare additional serials of autogenous biologics from microorganisms that are older than 24 months from the date of isolation, shall be required to conduct the following additional tests:
(A) Completed product shall be tested for antigenicity or immunogenicity in the species for which the product is recommended or in another animal species whose immunological response has been shown in the scientific literature to correlate with the response of the species for which the product is recommended. Such tests shall be conducted in accordance with a protocol developed by the licensee and approved by the Administrator and the results submitted to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010 for review. Microorganisms not shown to be antigenic (that is, not shown to induce a significant serological response) or immunogenic by such approved tests shall not be used for the preparation of such product.
(B) Bulk or final container samples of completed product from each serial of such autogenous biologics containing fractions for which standard requirement potency test procedures have been established shall be tested for potency in accordance with applicable standard requirement potency tests provided in 9 CFR part 113. If the culture of microorganisms used to produce such fractions is shown to be of a different strain or serotype than the reagent or challenge microorganisms used in the standard requirement potency test, reagents or challenges of the same strain or serotype as the microorganism used for production may be used.
(C) If no standard requirement potency test procedures have been established for a fraction(s) in the autogenous biologic, such fraction(s) of each serial of product shall be tested for potency using a developmental potency test described in the filed outline of production or shall at least be standardized to contain an antigenic mass for such fraction(s) that has been shown to be antigenic or immunogenic in accordance with paragraph (c)(2)(iv)(A) of this section.
Tetanus Toxoid shall be produced from a culture of Clostridium tetani which has been inactivated and is nontoxic. The toxoid may be either absorbed, precipitated, or purified and concentrated. Each serial of biological product containing tetanus toxoid fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial or subserial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency. A group of 10 guinea pigs consisting of an equal number of males and females weighing 450 to 550 grams shall each be injected subcutaneously with 0.4 of the largest dose recommended on the product labels.
(1) Six weeks after injection, all surviving guinea pigs shall be bled and equal portions of serum, but not less than 0.5 ml from each, shall be pooled. For a valid test, the pool shall contain the serum from at least eight animals.
(2) The antitoxin titer of the pooled serum shall be determined in antitoxin units (A.U.) per ml using an enzyme-linked immunosorbent assay method acceptable to the Animal and Plant Health Inspection Service.
(3) If the antitoxin titer of the serum pool is at least 2.0 A.U. per ml, the serial is satisfactory. If the antitoxin titer of the serum pool is less than 2.0 A.U. per ml, the serial may be retested by the following procedure: Provided, That, if the serial is not retested, it shall be declared unsatisfactory.
(4) For serials in which the serum pool contains less than 2.0 A.U. per ml, the individual serum that constituted the pool may be tested by the enzyme-linked immunosorbent assay. If at least 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial is satisfactory. If less than 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial may be retested in 10 guinea pigs using the procedure described in (c)(1) and (2) above. The antitoxin titer of the pooled serum from the guinea pigs used in the retest shall be averaged with the antitoxin level of the pooled serum from the initial test. If the average of the two pools is at least 2.0 A.U. per ml, the serial is satisfactory. If the average of the two pools is less than 2.0 A.U. per ml, the serial is unsatisfactory and shall not be retested further.
Staphylococcus Aureus Bacterin-Toxoid shall be prepared from toxoided broth cultures of selected toxogenic strains of Staphylococcus aureus which has been inactivated and is nontoxic. Each serial of biological product containing Staphylococcus Aureus Bacterin-Toxoid shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product shall be tested for safety as provided in § 113.33(b). Also, the rabbits used in the potency test provided in paragraph (c) of this section shall constitute an additional safety test. If unfavorable reactions attributable to the product occur in any of the rabbits during the observation period, the serial is unsatisfactory.
(c) Potency test. Rabbits, each weighing 2000-3000 grams, shall be used as test animals. Either a five rabbit individual serum test or an eight rabbit pooled serum test shall be conducted. At the start of the test, individual serums from the five rabbits or pooled serums from the eight rabbits shall contain less than 0.2 alpha antitoxin units per ml.
(1) Each rabbit shall be given a series of not more than three intramuscular injections at 7 day intervals (1.0 ml, 2.0 ml, 3.0 ml) and observed from 7-14 days following the third injection. At the end of the observation period, a blood sample shall be taken from each rabbit.
(2) The sample of serum from each rabbit, if the five rabbit individual test is conducted or a pooled sample of equal quantities of serum from the rabbits if the eight rabbit pooled serum test is conducted, shall be tested to determine the staphylococcus alpha antitoxin units per ml as provided in paragraphs (c)(3), (4), (5), (6), (7), and (8) of this section.
(3) Inactivate rabbit serum 56 °C for 30 minutes.
(4) Make serial twofold dilutions of the serum samples and conduct the test, using 1 ml of the serial dilutions. Appropriate controls should be included for accurate interpretations.
(5) Add 1 ml of the standardized toxin containing the established “Lh” dose. The “Lh” dose is the amount of toxin which when mixed with one unit of standard antitoxin produces a 50 percent hemolysis of rabbit red blood cells.
(6) Incubate toxin-antitoxin mixture at room temperature for 30 minutes and add 1 ml of a 1.5 percent suspension of washed freshly drawn rabbit red blood cells suspended in normal saline to each tube. Mix and incubate the combined product in a 37 °C water bath for 1 hour. Refrigerate at 5 °C overnight.
(7) Read the hemolysis produced and establish the 50 percent end point. The 50 percent end point of hemolysis should be established by determining the size of the button produced by the unlysed red blood cells.
(8) Determine the units of antitoxin per 1 ml of serum.
(9) If the individual samples from four of the five rabbits in the individual serum test or the pooled samples from the eight rabbits in the pooled serum test do not contain three alpha antitoxin units per ml, the serial is unsatisfactory.
Pasteurella Multocida Bacterin, Avian Isolate, Type 4 shall be prepared from cultures of Pasteurella multocida, avian isolate, Type 4 (Little and Lyons classification), which have been inactivated, and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 4, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency, as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.
(b) Safety test. Observation of the vaccinated turkeys during the prechallenge period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one turkey, test results shall be determined by observing the remaining 20 turkeys. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more turkeys, but the serial is unsatisfactory if the test is not repeated.
(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 4 strain, using the two-stage test provided in this paragraph. Turkeys at least 6 weeks old obtained from the same source and hatch shall be properly identified and used as provided in this paragraph.
(1) Vaccinates. Each of not more than 21 turkeys shall be vaccinated with the dose and by the route recommended on the label. A second dose shall be given after 3 weeks and the turkeys observed for an additional 2-week prechallenge period.
(2) Unvaccinated controls. Each of not more than 11 turkeys shall be held as controls.
(3) Challenge. Not less than 14 days after the second dose, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with virulent Pasteurella multocida, Strain P-1662, Type 4 (Little and Lyons classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.
(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If this requirement is met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirement is not met, but the serial is unsatisfactory if the test is not repeated.
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______ | |
|---|---|---|---|---|
| Satisfactory serial | Unsatisfactory serial | |||
| 1 | 20 | 20 | 6 or less | 9 or more. |
| 2 | 20 | 40 | 15 or less | 16 or more. |
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Pasteurella Multocida Bacterin, Avian Isolate, Type 1, shall be prepared from cultures of Pasteurella multocida, avian isolate, Type 1 (Little and Lyons classification), which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 1, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Observation of the vaccinated chickens during the prechallenged period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one chicken, test results shall be determined by observing the remaining 20 chickens. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more chickens, but the serial is unsatisfactory if the test is not repeated.
(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 1 strain, using the two-stage test provided in this paragraph. Chickens, at least 12 weeks of age, obtained from the same source and hatch, shall be properly identified and used as provided in this paragraph.
(1) Vaccinates. Each of not more than 21 chickens shall be injected with the dose and by the route recommended on the label. A second dose shall be injected after 3 weeks and the chickens observed for an additional 2 week prechallenge period.
(2) Unvaccinated controls. Each of not more than 11 chickens shall be held as controls.
(3) Challenge. Not less than 14 days after the second injection, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with a minimum of 250 colony-forming units of virulent Pasteurella multocida, Strain X-73, Type 1 (Little and Lyons classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.
(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If these requirement are met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirements are not met, but the serial is unsatisfactory if the test is not repeated.
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______ | |
|---|---|---|---|---|
| Satisfactory serial | Unsatisfactory serial | |||
| 1 | 20 | 20 | 6 or less | 9 or more. |
| 2 | 20 | 40 | 15 or less | 16 or more. |
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Pasteurella Multocida Bacterin, Avian Isolate, Type 3, shall be prepared from culture of Pasteurella multocida, avian isolate, Type 3 (Little and Lyons classification), which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 3, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency, as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Observation of the vaccinated turkeys during the prechallenge period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one turkey, test results shall be determined by observing the remaining 20 turkeys. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more turkeys, but the serial is unsatisfactory if the test is not repeated.
(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 3 strain, using the two-stage test provided in this paragraph. Turkeys, at least 6 weeks of age, obtained from the same source and hatch, shall be properly identified and used as provided in this paragraph.
(1) Vaccinates. Each of not more than 21 turkeys shall be injected with the dose and by the route recommended on the label. A second dose shall be injected after 3 weeks and the turkeys observed for an additional 2 week prechallenge period.
(2) Unvaccinated controls. Each of not more than 11 turkeys shall be held as controls.
(3) Challenge. Not less than 14 days after the second injection, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with a minimum of 150 colony-forming units of virulent Pasteurella multocida, Strain P-1059, Type 3 (Little and Lyons Classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.
(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If these requirements are met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirements are not met, but the serial is unsatisfactory if the test is not repeated.
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______ | |
|---|---|---|---|---|
| Satisfactory serial | Unsatisfactory serial | |||
| 1 | 20 | 20 | 6 or less | 9 or more. |
| 2 | 20 | 40 | 15 or less | 16 or more. |
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Erysipelothrix Rhusiopathiae Bacterin shall be produced from a culture of Erysipelothrix rhusiopathiae which has been inactivated and is nontoxic. Each serial of biological product containing Erysipelothrix rhusiopathiae shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse protection test provided in this paragraph. A mouse dose shall be
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three threefold dilutions shall be made with the Standard and the same threefold dilutions shall be made for each Unknown. Dilutions shall be made with physiological saline solution.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in each group shall be injected subcutaneously with one mouse dose of the appropriate dilution.
(4) Each of 20 injected mice from each group shall be challenged subcutaneously 14 to 21 days after being injected. A dose containing at least 100 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the standard by the following formula:
(7) If the RP of the Unknown is less than 0.6, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test: Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial is unsatisfactory.
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than 0.6, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than 0.6, the serial is unsatisfactory without further testing. If the average RP obtained in the retests is equal to or greater than 0.6, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory for potency.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than 0.6, the serial is unsatisfactory.
Salmonella Typhimurium Bacterin shall be prepared from a culture of Salmonella typhimurium which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella typhimurium fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7-10 days after the second vaccination with a 0.25 ml dose containing 100-10,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
Pasteurella Multocida Bacterin shall be prepared from a culture of Pasteurella multocida strains other than avian which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella multocida fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). The subcutaneous route is to be used.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilutions shall be made for each Unknown. The dilutions will be made in Phosphate Buffered Saline.
(3) For each dilution of the Standard and each dilution of each Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 injected mice per group shall be challenged intraperitoneally 10-12 days after the second vaccination with a 0.2 ml dose containing 100-10,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test: Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
Salmonella Choleraesuis Bacterin shall be prepared from a culture of Salmonella choleraesuis which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella choleraesuis fraction shall meet the applicable requirements in 9 CFR 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in 9 CFR 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.
(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilution shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 10-1,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
Salmonella Dublin Bacterin shall be prepared from a culture of Salmonella dublin which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella dublin fraction shall meet the applicable requirements in 9 CFR 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in 9 CFR 113.33(b).
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.
(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 1,000-100,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a killed virus vaccine shall meet the applicable requirements in this section.
(a) Killing agent. The vaccine virus shall be killed (inactivated) by an appropriate agent. The procedure involved may be referred to as inactivation. Suitable tests to assure complete inactivation shall be written into the filed Outline of Production.
(b) Cell culture requirements. If cell cultures are used in the preparation of the vaccine, primary cells shall meet the requirements in § 113.51 and cell lines shall meet the requirements in § 113.52.
(c) Purity tests—(1) Bacteria and fungi. Final container samples of completed product from each serial shall be tested as prescribed in § 113.26.
(2) Avian origin vaccine. Bulk pooled material or final container samples from each serial shall also be tested for:
(i) Salmonella contamination as prescribed in § 113.30; and
(ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and
(iii) Hemagglutinating viruses as prescribed in § 113.34.
(3) Mycoplasma. If the licensee cannot demonstrate that the agent used to kill the vaccine virus would also kill mycoplasma, each serial of the vaccine shall be tested for mycoplasma as prescribed in § 113.28, prior to adding the killing agent. Material found to contain mycoplasma is unsatisfactory for use.
(4) Extraneous viruses. Each lot of Master Seed Virus used to prepare killed virus vaccine recommended for animals other than poultry shall meet the requirements for extraneous viruses as prescribed in § 113.55.
(d) Safety tests. Final container samples of completed product from each serial shall be tested for safety in guinea pigs as prescribed in § 113.38 and for safety in mice as prescribed in § 113.33: Provided, That, vaccines recommended for use only in poultry are exempt from this requirement.
(e) Viricidal activity test. Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as diluent for desiccated fractions in combination packages.
(f) Formaldehyde content. If formaldehyde is used as the killing agent, the residual free formaldehyde content must not exceed 0.74 grams per liter (g/L) as determined using the ferric chloride test.
Mink Enteritis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or tissues obtained from mink that have developed mink enteritis following inoculation with virulent mink enteritis virus. Each serial shall meet the applicable requirements prescribed in § 113.200 and special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Safety test. Vaccinates used in the potency test in paragraph (b) of this section shall be observed each day prior to challenge. If unfavorable reactions attributable to the vaccine occur, the serial is unsatisfactory. If unfavorable reactions not attributable to the vaccine occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial is unsatisfactory.
(b) Potency test. Bulk or final container samples of completed product shall be tested for potency using 10 mink enteritis susceptible mink (five vaccinates and five controls) as follows:
(1) Vaccination. Each of the five vaccinates shall be injected with one dose of vaccine as recommended on the label and observed each day for 14 days.
(2) Challenge. At least 2 weeks after the last inoculation, the five vaccinates and the five controls shall be challenged with virulent mink enteritis virus and observed each day for 12 days. Fecal material shall be collected on one day between days 4-8 (inclusive) postchallenge from each test animal that remains free of enteric signs and tested for the presence of mink enteritis virus by cell culture with fluorescent antibody examination.
(3) Interpretation. A serial is satisfactory if at least 80 percent of the vaccinates remain free of enteric signs and do not shed virus in the feces, while at least 80 percent of the controls develop clinical signs of mink enteritis or shed virus in the feces. If at least 80 percent of the vaccinates remain free of enteric signs and do not shed virus in the feces, while less than 80 percent of the controls develop clinical signs of mink enteritis or shed virus in the feces, the test is considered a No Test and may be repeated: Provided, That, if at least 80 percent of the vaccinates do not remain well and free of detectable virus in the feces, the serial is unsatisfactory.
Newcastle Disease Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs or cell cultures. With the exception of § 113.200(c)(2)(iii), each serial shall meet the applicable general requirements prescribed in § 113.200 and special requirements prescribed in this section. A serial found unsatisfactory by a prescribed test shall not be released.
(a) Safety test. The prechallenge part of the potency test in paragraph (b) of this section shall constitute a safety test. If unfavorable reactions attributable to the product occur in any of the vaccinates, the serial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(b) Potency test. A vaccination-challenge test shall be conducted using susceptible chickens 2 to 6 weeks of age at time of vaccination, properly identified and obtained from the same source and hatch.
(1) Ten or more chickens shall be vaccinated as recommended on the label and kept isolated under observation for at least 14 days.
(2) After at least 14 days post-vaccination, the vaccinates and at least 10 unvaccinated chickens that have been kept isolated as controls shall be challenged with a virulent strain of Newcastle disease virus supplied by or approved by Veterinary Services and the vaccinates observed each day for 14 days.
(3) If at least 90 percent of the controls do not show typical signs of Newcastle disease or die, the test is a No Test and may be repeated. If at least 90 percent of the vaccinates do not remain normal, the serial is unsatisfactory.
Wart Vaccine, Killed Virus, shall be prepared from virus-bearing epidermal tumors (warts) obtained from a bovine. Each serial shall meet the requirements prescribed in this section and any serial found unsatisfactory by a prescribed test shall not be released.
(a) Purity. Final container samples of completed product shall meet the requirements for purity as prescribed in § 113.200 (c)(1) and (3).
(b) Safety. Bulk or final container samples of completed product shall meet the requirements for safety as prescribed in §§ 113.33(b) and 113.38.
(c) Formaldehyde content. Bulk or final container samples of completed product shall meet the requirements for formaldehyde content as prescribed in § 113.200(f).
(d) Potency and efficacy. The efficacy of wart vaccine has been demonstrated to the satisfaction of Veterinary Services as being a valuable biological product. The inherent nature of the product precludes the possible development of serial to serial potency tests and none is required: Provided, That,
(1) The vaccine shall be a tissue extract representing at least 10 percent weight to volume suspension of wart tissue; and
(2) The vaccine shall be limited to use in the prevention of warts in cattle. Labeling recommendations shall be in accordance with § 112.7(h).
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Each serial or subserial shall meet the requirements prescribed in this section and the general requirements prescribed in § 113.200, except those in § 113.200(d). Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(a) Safety test. Bulk samples of completed product from each serial shall be tested for encephalomyelitis virus inactivation.
(1) Each of at least ten 6 to 12 hour old chickens shall be injected subcutaneously with 0.5 ml of the product and the chickens observed each day for 10 days.
(2) If unfavorable reactions attributable to the product occur in the chickens during the observation period, the serial is unsatisfactory. If unfavorable reactions not attributable to the product occur, the test is a No Test and may be repeated: Provided, That, if the test is not repeated, the serial is unsatisfactory.
(b) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency in accordance with the two-stage test provided in this paragraph. For each fraction contained in the product—Eastern type, Western type, or Venezuelan type—the serological interpretations required in this test shall be made independently. A serial or subserial found unsatisfactory for any of the fractions shall not be released.
(1) For this test, a guinea pig dose shall be one-half the amount recommended on the label for a horse and shall be administered as recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) shall be injected with two guinea pig doses with an interval of 14 to 21 days between doses. Two additional guinea pigs from the same source shall be held as controls.
(2) Fourteen to 21 days after the second injection, serum samples from each vaccinate and each control shall be tested by a plaque reduction, serum neutralization test using Vero 76 cells.
(3) If the control serum samples show a titer of 1:4 or greater for any fraction, the test is a No Test for that fraction and may be repeated: Provided, That, if four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory without further testing.
(4) If two or three of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the second stage of the test may be used for the relevant fraction(s): Provided, That, if a fraction is found acceptable by the first stage of the test, the second stage need not be conducted for that fraction.
(5) If the second stage is used and four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction or the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory.
(6) The results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Vaccinates | Failures for acceptance | Failures for rejection |
|---|---|---|---|
| 1 | 10 | 1 or less | 4 or more. |
| 2 | 20 | 3 or less | Do. |
Avian Encephalomyelitis Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs. Each serial shall meet the general requirements prescribed in § 113.200 and the requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Safety tests. (1) The prechallenge part of the potency test prescribed in paragraph (b) of this section shall constitute a safety test. If any of the vaccinates develop clinical signs of disease or die due to causes attributable to the product, the serial is unsatisfactory.
(2) An inactivation test for viable avian encephalomyelitis (AE) virus shall be conducted on each serial. The test shall be conducted using susceptible chicken embryos: Provided, That, if a non-embryo adapted virus is used for vaccine production, the test shall be conducted in susceptible chickens.
(i) Chicken Embryo Test. Each of 15 or more AE susceptible 5 or 6 day old embryos shall be injected in the yolk sac with 0.2 ml of the vaccine. For a valid test, at least 80 percent of the embryos shall survive for 48 hours post-inoculation (PI). Eleven to 13 days PI, all embryos surviving the 48 hour PI period shall be examined for gross lesions of AE; all these embryos shall be normal or the serial is unsatisfactory. Concurrently, five additional embryos from the same source shall be injected with live AE virus of the production strain to serve as positive controls. At least 4 of the 5 embryos shall show evidence of AE virus infection during the 11 to 13 day PI period or the test shall be considered a No Test and repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.
(ii) Chicken test. Each of 10 or more AE susceptible 7 day old chickens shall be injected intracerebrally with 0.1 ml vaccine each. The chickens shall be observed each day for 28 days. If any chickens show clinical signs of AE, the serial is unsatisfactory. Concurrently, 5 additional chickens from the same source shall be injected intracerebrally with live AE virus of the production strain to serve as positive controls. At least 4 of the 5 controls shall show evidence of AE virus infection during the observation period or the test shall be a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be unsatisfactory.
(b) Potency test. Bulk or final container samples of completed product from each serial or one subserial shall be tested. Ten or more AE-susceptible chickens (vaccinates), 4 weeks or older, properly identified and obtained from the same source and hatch, shall be injected as recommended on the label. At least 10 additional AE-susceptible chickens, properly identified and obtained from the same source and hatch shall be kept in isolation as controls.
(1) At least 28 days post-injection, the vaccinates and the controls shall be challenged intramuscularly with a virulent AE virus and the chickens observed each day for 21 days.
(2) If at least 80 percent of the controls do not show clinical signs of or die from AE infection, the test is a No Test and may be repeated.
(3) If at least 80 percent of the vaccinates do not remain normal, the serial is unsatisfactory.
Rabies Vaccine (Killed Virus) shall be prepared from virus-bearing cell cultures or nerve tissues obtained from animals that have developed rabies infection following injection with rabies virus. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.200 and the requirements prescribed in this section.
(1) Each lot of Master Seed Virus propagated in tissue or cells of avian origin shall also be tested for extraneous pathogens by procedures prescribed in § 113.37.
(2) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.
(b) The immunogenicity of vaccine prepared with virus at the highest passage from the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product to be tested shall include all fractions to be tested.
(1) The preinactivation virus titer must be established as soon as possible after harvest by at least five separate virus titrations. A mean relative potency value of the vaccine to be used in the host animal potency test must be established by at least five replicate potency tests conducted in accordance with the standard NIH test for potency in chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), edited by F.X. Meslin, M.M. Kaplan, and H. Koprowski, World Health Organization, Geneva, Switzerland (ISBN 92 4 154479 1). The provisions of chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), are the minimum standards for achieving compliance with this section and are incorporated by reference. These provisions state that the challenge virus standard to be used as the challenge in the NIH test and the reference vaccine for the test are available from the national control authority. In the United States, that authority is the Animal and Plant Health Inspection Service's Center for Veterinary Biologics Laboratory, located at 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100; fax (515) 337-6120. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the World Health Organization Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies may be inspected at the Animal and Plant Health Inspection Service, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount which, on the basis of The NIH Test For Potency, has been diluted to the proposed minimum acceptable potency value.
(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.
(i) Twenty-five or more animals shall be used as vaccinates. Each shall be administered a dose of vaccine at the proposed minimum potency level and by the method specified in the Outline of Production.
(ii) Ten or more additional animals shall be held as controls.
(iii) On or about 30, 90, 180, 270, and 365 days postvaccination, all test animals shall be bled and individual serum samples tested for neutralizing antibodies to rabies virus.
(iv) All surviving test animals shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccinations, except as provided in (b)(4) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenges shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.
(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of the controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.
(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be titrated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccines, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.
(5) An Outline of Production change shall be made before authority for use a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.
(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.200 and special requirements in this paragraph.
(1) Purity test. Primary cell cultures of hamster origin or brain tissues of mouse origin used in vaccine production shall be tested for LCM virus as prescribed in § 113.42. Hamster origin cells shall be disrupted and undiluted cell fluids from each lot shall be tested. Where mouse brains are used in production, at least five mice which have not been injected with rabies virus shall be sacrificed and a 10 percent suspension of brain material shall be prepared and tested.
(2) Safety tests. Bulk samples from each serial shall be tested for virus inactivation and safety as follows:
(i) At the end of the inactivation period, each of 20 12 to 16 gram mice shall be injected intracerebrally with 0.03 ml and two rabbits shall be injected into each cerebral hemisphere with 0.25 ml and observed each day for 21 days. The brains of animals dying between the fourth and 21st day post-injection shall be checked for rabies virus. Material from each brain recovered shall be injected into each of five mice and the mice observed each day for 14 days. The fluorescent antibody test or serum neutralization test shall be used to confirm the presence or absence or live rabies virus. If live rabies virus is confirmed, the serial is unsatisfactory unless reprocessed in accordance with § 114.18.
(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall in injected intramuscularly with one recommended dose of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.
(3) Potency test. Bulk or final container samples of completed product from each serial must be tested for potency by tests conducted in accordance with the standard NIH test for potency in Chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), which is incorporated by reference at paragraph (b)(1) of this section. The relative potency of each serial must be at least equal to that used in an approved host animal immunogenicity test.
Feline Calicivirus Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.
(b) The Master Seed shall be tested for chlamydial agents as prescribed in § 113.43.
(c) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.
(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety. Vaccinates used in the potency test in paragraph (d)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, including oral lesions, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is inconclusive and may be repeated. If the test is not repeated, the serial is unsatisfactory.
(2) Potency. Bulk or final container samples of completed product shall be treated for potency as follows:
(i) Eight feline calicivirus susceptible cats (five vaccinates and three controls) shall be used as test animals. Throat and nasal swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested for neutralizing antibody. The cats shall be considered suitable for use if all swabs are negative for virus isolation and all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other test of equal sensitivity.
(ii) The five cats used as vaccinates shall be administered one dose of vaccine by the method recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label.
(iii) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with virulent feline calicivirus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs, particularly lesions on the oral mucosa, noted and recorded each day.
(iv) If three of three controls do not show clinical signs of feline calicivirus infection other than fever, the test is inconclusive and may be repeated.
(v) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the serial is unsatisfactory.
Bursal Disease Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.200.
(b) Each lot of Master Seed shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production. The test shall establish that the vaccine, when used as recommended on the label, is capable of inducing an immune response in dams of sufficient magnitude to provide significant protection to offspring.
(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety. Vaccinates used in the potency test in paragraph (d)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions attributable to the vaccine occur, the serial is unsatisfactory. If unfavorable reactions which are not attributable to the vaccine occur, the test is a No Test and may be repeated. If the test is not repeated, the serial is unsatisfactory.
(2) Potency. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage potency test provided in this paragraph.
(i) Vaccinates. Inject each of 21 susceptible chickens 14 to 28 days of age, properly identified and obtained from the same source and hatch, with one dose of vaccine by the route recommended on the label and observe for at least 21 days.
(ii) Controls. Retain at least 10 additional chickens from the same source and hatch as unvaccinated controls.
(iii) Challenge. Twenty-one to 28 days postvaccination, challenge 20 vaccinates and 10 controls by eyedrop with a virulent infectious bursal disease virus furnished or approved by Animal and Plant Health Inspection Service.
(iv) Postchallenge period. Four days postchallenge, necropsy all chickens and examine each for gross lesions of bursal disease. For purposes of this test, gross lesions shall include peribursal edema and/or edema and/or macroscopic hemorrhage in the bursal tissue. Vaccinated chickens showing gross lesions shall be counted as failures. If at least 80 percent of the controls do not have gross lesions of bursal disease in a stage of the test, that stage is considered inconclusive and may be repeated. In a valid test, the results shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of failures for— | |
|---|---|---|---|---|
| Satisfactory serial | Unsatisfactory serial | |||
| 1 | 20 | 20 | 3 or less | 6 or more. |
| 2 | 20 | 40 | 8 or less | 9 or more. |
(v) If four or five vaccinates show lesions of bursal disease in the first stage, the second stage may be conducted in a manner identical to the first stage. If the second stage is not conducted, the serial is unsatisfactory.
(vi) If the second stage is used, each serial shall be evaluated according to the second part of the table on the basis of cumulative results.
Bovine Virus Diarrhea Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.
(b) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety. Vaccinates used in the potency test in paragraph (c)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, including respiratory signs, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated one time. If results of the second test are not satisfactory, or if the test is not repeated, the serial is unsatisfactory.
(2) Potency. Bulk or final container samples of completed product shall be tested for potency using the method described in this paragraph.
(i) Eight bovine virus diarrhea susceptible calves (five vaccinates and three controls) shall be used as test animals. Individual serum samples shall be collected, inactivated, and individually tested for neutralizing antibody.
(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity approved by the Animal and Plant Health Inspection Service may be used.
(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.
(iv) Fourteen days or more after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for bovine virus diarrhea virus neutralizing antibody by the same method used to determine susceptibility.
(v) Test interpretation. If the controls have not remained seronegative at 1:2, the test is a No Test (NT) and may be repeated. If at least four of the five vaccinates in a valid test have not developed 50 percent endpoint titers of 1:8 or greater, the serial is unsatisfactory, except as provided in paragraph (c)(2)(vi) of this section.
(vi) Virus Challenge Test. If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and controls may be challenged with virulent bovine virus diarrhea virus furnished or approved by the Animal and Plant Health Inspection Service. The animals shall be observed for 14 days post-challenge. If two of the three control calves do not show a temperature rise to 104.5 °F and develop respiratory or clinical signs of bovine virus diarrhea, the test is a No Test and may be repeated one time. If two or more vaccinates show a temperature of 104.0 °F for 2 or more days and develop respiratory or clinical or other signs, the serial is unsatisfactory.
(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for confirmatory testing.
Infectious Bovine Rhinotracheitis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.
(b) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.
(c) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety. Vaccinates used in the potency test in paragraph (c)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated one time. If the results of the second test are not satisfactory, or if the test is not repeated, the serial is unsatisfactory.
(2) Potency. Bulk or final container samples of completed product shall be tested for potency using the method described in this paragraph.
(i) Eight infectious bovine rhinotracheitis susceptible calves (five vaccinates, three controls) shall be used as test animals. Individual serum samples shall be collected, inactivated, and individually tested for neutralizing antibody.
(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity acceptable to the Animal and Plant Health Inspection Service may be used.
(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.
(iv) Fourteen or more days after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for infectious bovine rhinotracheitis virus neutralizing antibody by the same method used to determine susceptibility.
(v) Test interpretation. If the three controls have not remained seronegative at 1:2, the test is a No Test (NT) and may be repeated. If at least four of the five vaccinates in a valid test have not developed 50 percent endpoint titers of 1:8, the serial is unsatisfactory, except as provided in paragraph (c)(2)(vi) of this section.
(vi) Virus Challenge Test. If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and controls may be challenged with virulent infectious bovine rhinotracheitis virus furnished or approved by the Animal and Plant Health Inspection Service. The animals shall be observed each day for 14 days post-challenge. If two of the three control calves do not show a temperature rise to 104.5 °F and develop respiratory or other clinical signs of infectious bovine rhinotracheitis, the test is a No Test (NT) and may be repeated one time. If more than one of the vaccinates shows a temperature of 104.0 °F for 2 or more days or if more than one of the vaccinates develops respiratory or clinical or other signs, the serial is unsatisfactory.
(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for testing by the Animal and Plant Health Inspection Service.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the applicable requirements in this section.
(a) Purity tests—(1) Bacteria and fungi. Final container samples of completed product and comparable samples of each lot of Master Seed Virus shall be tested for bacteria and fungi in accordance with the test provided in § 113.27.
(2) Mycoplasma. Final container samples of completed product and comparable samples of each lot of Master Seed Virus shall be tested for mycoplasma in accordance with the test provided in § 113.28.
(3) Avian Origin Vaccine. Samples of each lot of Master Seed Virus and bulk pooled material or final container samples from each serial shall also be tested for:
(i) Salmonella contamination as prescribed in § 113.30; and
(ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and
(iii) Hemagglutinating viruses as prescribed in § 113.34.
(4) Extraneous viruses. Each lot of Master Seed Virus used to prepare live virus vaccine recommended for animals other than poultry shall meet the requirements for extraneous viruses as prescribed in § 113.55
(b) Safety tests. Samples of each lot of Master Seed Virus and final container samples of completed product from each serial or first subserial of live virus vaccine recommended for animals other than poultry shall be tested for safety in at least one species for which the vaccine is intended using methods prescribed in §§ 113.39, 113.40, 113.41, 113.44, and 113.45 or in a filed Outline of Production. The mouse safety test prescribed in § 113.33(a) shall also be conducted unless the virus or agent in the vaccine is inherently lethal for mice.
(c) Virus identity test. At least one of the virus identity tests provided in this paragraph or a suitable identity test prescribed in the filed Outline of Production shall be conducted on the Master Seed Virus and final container samples from each serial or first subserial of biological product.
(1) Fluorescent antibody test. The fluorescent antibody test shall be conducted using virus inoculated cells and uninoculated control cells. Cells shall be stained with fluorochrome conjugated specific antiserum. Fluorescence typical of the virus concerned shall be demonstrated in the inoculated cells. The control cells shall remain free of such fluorescence.
(2) Serum neutralization test. The serum neutralization test shall be conducted using the constant serum-decreasing virus method with specific antiserum. For positive identification, at least 100 ID
(d) Cell Culture Requirements. If cell cultures are used in the preparation of Master Seed Virus or of the vaccine, primary cells shall meet the requirements prescribed in § 113.51, cell lines shall meet the requirements prescribed in § 113.52, and ingredients of animal origin shall meet the applicable requirements in § 113.53.
(e) Moisture content. (1) The maximum moisture content in desiccated vaccines must be stated in the filed Outline of Production.
(2) Final container samples of completed product from each serial or subserial must be tested for moisture content in accordance with the test prescribed in § 113.29.
Ovine Ecthyma Vaccine shall be prepared from tissue culture fluids or virus-bearing tissues obtained from sheep that have developed ovine ecthyma following inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements prescribed in §§ 113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture requirements in § 113.300(e) and the special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Safety tests. (1) Bulk or final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.
(2) The prechallenge period of the potency test shall constitute a safety test. If unfavorable reactions attributable to the vaccine occur in either of the vaccinates during the observation period, the serial is unsatisfactory.
(b) Potency test. Final container samples of completed product from each serial and each subserial shall be tested for potency using susceptible lambs. The vaccine shall be prepared as recommended for use on the label.
(1) Each of two lambs (vaccinates) shall be vaccinated by application of the vaccine to a scarified area on the medial surface of the thigh and observed each day for 14 days.
(2) The immunity of the two vaccinates and one or more unvaccinated lambs (controls) shall be challenged in the same manner as for vaccination, using the opposite thigh.
(3) If typical signs of ovine ecthyma, such as hyperemia, vesicles, and pustules do not develop on the controls during the first 2 weeks following challenge and persist for approximately 30 days, the test is a No Test and may be repeated.
(4) If the vaccinates do not show a typical immune reaction, the serial is unsatisfactory: Provided, That, an initial active reaction with hyperemia which resolves progressively and disappears within 2 weeks, may be characterized as a typical immune reaction.
Distemper Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) The lot of Master Seed Virus shall be tested for extraneous viruses as follows:
(1) To detect virulent canine distemper virus, each of two distemper susceptible mink or ferrets shall be inoculated with 1 ml of the Master Seed Virus and observed each day for 21 days. If undesirable reactions occur in either test animal, the lot of Master Seed Virus is unsatisfactory.
(2) Master Seed Virus propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37 except lesions typical of distemper virus may be disregarded. If found unsatisfactory, the Master Seed Virus shall not be used.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) At least 25 distemper susceptible mink shall be used as test animals. Blood samples shall be drawn from these animals and individual serum samples tested. The mink shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. At least 20 mink shall be vaccinated with a predetermined quantity of vaccine virus and at least 5 additional mink shall be held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least twenty-one days post-injection, the immunity of each of the vaccinates and the controls shall be challenged with the same size dose of virulent distemper virus and observed each day for 21 days.
(i) If at least 80 percent of the controls do not die or show severe signs of distemper, the test is a No Test and may be repeated.
(ii) If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates do not survive without showing clinical signs of distemper during the observation period, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be authorized by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Mink safety test. Each of 2 mink shall be vaccinated with the equivalent of 10 doses of vaccine rehydrated with sterile diluent and administered in the manner recommended on the label. The mink shall be observed each day for 21 days. If unfavorable reactions attributable to the product occur in either of the mink during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
(2) Potency Test. An in vitro potency test shall be conducted. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer 10
Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing the seeds for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for transmissibility and reversion to virulence in sheep using a method acceptable to Animal and Plant Health Inspection Service. If reversion to virulence is demonstrated, the Master Seed is unsatisfactory.
(c) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:
(1) Twenty-five lambs, susceptible to the bluetongue virus serotype contained in the vaccine, shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serums tested. A lamb shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus varying serum neutralization test with 60 to 300 TCID
(2) A geometric mean titer of the vaccine produced from the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 lambs to be used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the virus dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine used.
(3) At least once during the period of 14 to 18 days postvaccination, individual serum samples shall be collected from each of the vaccinates and tested for virus neutralizing antibody using the 60 to 300 TCID
(4) Twenty-one to twenty-eight days postvaccination the vaccinates and the controls shall each be challenged with virulent bluetongue virus and observed for 14 days. The rectal temperature of each animal shall be taken and recorded for 17 consecutive days beginning 3 days prechallenge. The presence or absence of lesions or other clinical signs of bluetongue noted and recorded on each of 14 consecutive days postchallenge.
(i) If at least four of the five controls do not show clinical signs of bluetongue and a temperature rise of 3 °F or higher over the prechallenge mean temperature, the test shall be considered a No Test and may be repeated.
(ii) If at least 19 of the 20 vaccinates tested as prescribed in paragraph (c)(3) of this section do not have bluetongue neutralizing antibody titers of 1:4 final serum dilution or higher, or if more than one of the vaccinates shows a temperature rise of 3 °F or higher than its prechallenge mean temperature for 2 or more days, or if more than one of the vaccinates exhibits clinical signs of bluetongue, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the lamb safety test prescribed in § 113.45 shall be conducted.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Feline Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) The lot of Master Seed Virus shall be tested for other agents as follows:
(1) To detect virulent feline panleukopenia virus or virulent mink enteritis virus, each of two feline panleukopenia susceptible cats, as determined by the criteria prescribed in paragraph (c)(1) of this section, shall be injected subcutaneously with the equivalent of one cat dose each and the cats observed each day for 21 days. If either or both cats show signs of disease or reduced white blood cell counts below 50 percent of the normal level established by an average of three or more counts taken prior to injection, the Master Seed Virus is unsatisfactory.
(2) To detect chlamydial agents, the Master Seed Virus shall be tested as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five feline panleukopenia susceptible cats shall be used as test animals (20 vaccinates and 5 controls). Blood samples drawn from each cat shall be individually tested for neutralizing antibody against feline panleukopenia virus to determine susceptibility.
(i) A constant virus-carrying serum neutralization test in tissue culture using 100 to 300 TCID
(ii) Cats shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five cats held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) Fourteen days post-injection, the vaccinates and the controls shall be challenged with virulent feline panleukopenia virus furnished by Animal and Plant Health Inspection Service and the cats observed each day for 14 days.
(i) If at least 80 percent of the controls do not show clinical signs of feline panleukopenia during the observation period, the test is a No Test and may be repeated. Clinical signs of feline panleukopenia shall include a pronounced leukopenia wherein the white cell count drops to 4,000 or less per cubic mm, or the white cell count drops to less than 25 percent of the normal level established by an average of three or more counts taken prior to challenge.
(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing clinical signs of feline panleukopenia as described in paragraph (c)(3)(i) of this section, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39 shall be conducted.
(i) Each of two healthy cats shall be injected with 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.
(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the serial shall be unsatisfactory.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Canine Hepatitis Vaccine and Canine Adenovirus Type 2 Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used in preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except that the dog safety test prescribed in § 113.40(a) shall be conducted by the intravenous route.
(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity by one or both of the following methods:
(1) Immunogenicity for canine hepatitis. Twenty-five canine hepatitis susceptible dogs shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID
(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(ii) Not less than 14 days postinjection, the vaccinates and the controls shall each be challenged intravenously with virulent infectious canine hepatitis virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days.
(A) If at least four of the five controls do not show severe clinical signs of canine hepatitis, the test is a No Test and may be repeated.
(B) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of infectious canine hepatitis during the observation period, the Master Seed Virus is unsatisfactory.
(2) Immunogenicity for canine adenovirus Type 2. Thirty canine adenovirus type 2 susceptible dogs shall be used as test animals (20 vaccinates and 10 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID
(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining 10 dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(ii) Not less than 14 days postinjection, the vaccinates and the controls shall be challenged by exposure to a nebulized aerosol of virulent canine adenovirus type 2 furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of canine adenovirus type 2 noted and recorded each day.
(A) If at least 6 of 10 controls do not show clinical signs of canine adenovirus type 2 infection other than fever, the test is a No Test and may be repeated.
(B) If a significant difference in clinical signs in a valid test cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed Virus is unsatisfactory.
(iii) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(1)(i) and/or (b)(2)(i) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test(s) prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
(2) [Reserved]
Canine Distemper Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) Master Seed Virus. The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(1) To detect ferret virulent canine distemper virus, each of five canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions are observed during the observation period, the lot of Master Seed is unsatisfactory.
(2) Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory, the Master Seed Virus shall not be used.
(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five canine distemper susceptible dogs shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least 14 days post-injection, the vaccinates and the controls shall each be challenged intracerebrally with virulent canine distemper virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 21 days.
(i) If at least four of the five controls do not die and the survivor, if any, does not show clinical signs of canine distemper the test is a No Test and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of canine distemper during the observation period, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.
(c) Test requirements for release. Except for § 113.300(a)(3)(ii), each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Encephalomyelitis Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 except (b), and the requirements prescribed in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:
(1) Tests conducted by the Department have established that horses having Venezuelan equine encephalomyelitis antibody titers of 1:20 by the hemagglutination-inhibition (HI) method or 1:40 by the serum neutralization (SN) method were immune to challenge with virulent virus. The immunogenicity test is based on the demonstration of a serological response of at least that magnitude following vaccination of serologically negative horses.
(2) At least 22 horses (20 vaccinates and 2 controls), susceptible to Venezuelan equine encephalomyelitis, shall be used as test animals. Blood samples shall be taken from each horse and the serums individually tested for neutralizing antibody. Horses shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 60 to 300 TCID
(3) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed shall be established using a method acceptable to Veterinary Services before the immunogenicity test is conducted. The 20 horses used as vaccinates shall be injected with a predetermined quantity of vaccine virus by the method to be recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(4) Twenty-one to twenty-eight days postvaccination, blood samples shall be drawn from all test animals. For a valid test, the controls shall remain seronegative at 1:2 final serum dilution. In a valid test, if at least 19 of 20 vaccinates do not have antibody titers of at least 1:20 in a hemagglutination-inhibition test or at least 1:40 in a serum neutralization test, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and special requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. The mouse safety test prescribed in § 113.33(b) shall be conducted.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the method in paragraph (b)(3) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of the vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Bovine Parainfluenza
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five bovine parainfluenza, susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. Also, nasal specimens shall be collected for virus isolation attempts. The calves shall be considered susceptible if:
(i) The results are negative at a 1:2 final serum dilution in a varying serum constant virus neutralization test with less than 500 TCID
(ii) Shall be negative to bovine parainfluenza
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculation, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) The vaccinates and controls shall be examined for clinical signs of respiratory disease and the body temperature taken and recorded on each of the first 14 consecutive days post-injection. The vaccinates shall be bled on day 6 ±2 days post-injection.
(4) Three to four weeks post-vaccination, all calves shall be bled for serum antibodies and nasal specimens shall be collected for PI
(5) Each animal shall be examined for clinical signs of respiratory disease and the body temperature recorded on each of the 14 consecutive days of the post-challenge observation period. Each day for at least the first 10 days post-challenge, nasal specimens for virus isolation attempts shall be taken. All animals shall be bled on day 6 ±2 days post-challenge, and all animals shall be bled at least once 14 to 28 days post-challenge for serum antibody studies.
(6) Satisfactory Test Criteria:
(i) All virus isolations attempts shall be by culture and at least one subculture in PI
(ii) Two to four weeks post-vaccination, at least 19 of the 20 vaccinates shall have PI
(iii) Satisfactory resistance to challenge by vaccinates shall be determined by a significant difference between virus isolation rates from vaccinates and controls. The virus neutralization titers of post-challenge serums and respiratory symptoms and temperatures from all animals shall be considered in the evaluation of the test validity.
(7) Designated animal alternates for test animals showing anamnestic antibody responses (titers 1:32 or greater) on day 6 serums may be included in the study under the following provisions:
(i) No more than five alternates shall be allowed for the vaccinates and no more than two for the controls.
(ii) Alternates shall be subject to all requirements outlined for the animals for which they are alternates.
(iii) Antibody values from alternate animals may be used only to replace values from up to and including five vaccinates which develop antibody of 1:32 or greater by day 6 ±2 days post-vaccination or up to and including two controls which develop antibody titers of 1:32 or greater by day 6 ±2 days post-challenge.
(8) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(9) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.
(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Bovine Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five infectious bovine rhinotracheitis susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. The calves shall be considered susceptible if the results are negative at a 1:2 final serum dilution by the virus plaque reduction method.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least once during a period of 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be 100 to 500 TCID
(4) The vaccinates and the controls shall each be challenged with virulent infectious bovine rhinotracheitis virus and observed for 14 days. The rectal temperature of each animal shall be taken and the presence or absence of respiratory or other clinical signs of bovine rhinotracheitis noted and recorded on each of the 14 consecutive days.
(5) If at least four of the five controls do not show clinical signs of infectious bovine rhinotracheitis and a marked temperature rise to 104.5 °F. or higher post-challenge, the test shall be considered a No Test and may be repeated.
(6) If less than 19 of the post-injection serum samples tested as prescribed in paragraph (c)(3) of this section show neutralization in all tubes of the 1:2 final serum dilution, or if more than one of the vaccinates show a temperature of 103.5 °F. or higher for 2 or more days, or if more than one of the vaccinates exhibit respiratory or other clinical signs of infectious bovine rhinotracheitis, or both, the Master Seed Virus is unsatisfactory.
(7) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(8) An outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.
(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Bovine Virus Diarrhea Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five bovine virus diarrhea susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individuals serum samples tested. The calves shall be considered susceptible to bovine virus diarrhea virus infection if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 TCID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least once during a period 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be less than 500 TCID
(4) The vaccinates and the controls shall each be challenged with virulent bovine virus diarrhea virus and observed for 14 consecutive days. The white cell count shall be determined daily on each animal from the second through the eighth day post-challenge. If leukopenia does not develop in at least four of the five controls as compared with the vaccinates, the test shall be considered a No Test and may be repeated.
(5) If less than 19 of the post-injection serum samples, tested as prescribed in paragraph (c)(3) of this section, show neutralization in all tubes of the 1:8 dilution; or if more than one of the vaccinates exhibits respiratory or other clinical signs of bovine virus diarrhea post-challenge; or both, the Master Seed Virus is unsatisfactory.
(6) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.
(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have virus titer of 10
Rabies Vaccine shall be prepared from virus-bearing cell cultures or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(1) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(2) Each lot of Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by procedures prescribed in § 113.37.
(3) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be studied in each species of carnivore or domesticated wild animal for which the vaccine is specifically recommended to attempt to determine the fate of the vaccine virus. Results shall be considered in evaluating safety of vaccine virus.
(i) Obtain at least 10 unvaccinated animals, negative at 1:2 final serum dilution, of each species in which tests will be conducted. Divide each species into two groups of five animals.
(ii) For each species of animal, inject one group of five animals intramuscularly. Infiltrate a major nerve and the surrounding tissue in each of the five animals in the other group. Use 1.0 ml of high titer virus for each method of administration.
(iii) Observe all animals for signs of rabies until scheduled time to sacrifice. If animals show definite symptoms, sacrifice and check regional lymph nodes, brain, salivary glands, and kidney for rabies virus by injection of suckling mice (not more than 7 days of age). Tissues may be held frozen at −70 °C. until suckling mice are available. Inject each mouse in one litter intracerebrally with 0.02 ml of a ground tissue suspension from each organ. Observe mice each day for 21 days. If any mice die, determine if the deaths were due to rabies virus in the brain by a fluorescent antibody test.
(iv) Sacrifice animals that do not show signs of rabies according to the following schedule and check regional lymph nodes, brain, salivary glands, and kidney in suckling mice.
| Route of injection | Days after injection | Number of animals |
|---|---|---|
| Intramuscularly | 15, 20, 25, 30, 35 | 1 each day. |
| Intraneurally | 3, 6, 9, 15, 30 | 1 each day. |
(5) Each lot of Master Seed Virus shall be tested for safety in at least 10 unvaccinated serologically negative animals of each domestic species for which the vaccine is recommended.
(i) Each group of 10 animals shall be divided into 2 groups of 5 animals. For each species, inject one group intramuscularly with 10 doses of high titer virus.
(ii) Infiltrate a major nerve of each of the animals in the other group of 5 with 10 doses of the same high titer virus. For all species except dogs and cats, multiple injections along the cervical spine in the proximity to the nerve trunks emerging from the spinal cord may be used: Provided, That a 1-dose volume shall be injected into each of four or more sites bilaterally.
(iii) Observe all animals each day for 90 days.
(iv) If any animals show clinical signs of rabies, sacrifice the animal and check appropriate brain tissue for rabies virus by the fluorescent antibody test and by mouse injection.
(v) If rabies is confirmed, the lot of Master Seed Virus is unsatisfactory.
(b) The immunogenicity of vaccine prepared with virus at the highest passage of the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product tested shall include all fractions to be recommended.
(1) A geometric mean virus titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount of rehydrated vaccine which, on the basis of previous titrations, has been diluted to the proposed minimum acceptable virus titer.
(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.
(i) Twenty-five or more animals shall be used as vaccinates. Each shall be injected intramuscularly at one site in the thigh with a dose of vaccine at the proposed minimum virus titer as specified in the filed Outline of Production.
(ii) Ten or more additional animals shall be held as controls.
(iii) On or about days 30, 90, 180, 270, and 365 postvaccination, all animals shall be bled and individual serums tested for neutralizing antibodies to rabies virus.
(iv) All surviving test animals of each species shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccination, except as provided in paragraphs (b)(4), (b)(5), and (b)(6) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenge shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.
(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.
(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be iterated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccinates, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.
(5) An outline of Production change shall be made before authority for use of a new lot of Master Virus shall be granted by Animal and Plant Health Inspection Service.
(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.
(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.300 and special requirements in this paragraph.
(1) Purity and safety tests. Final container samples of completed product from each serial or one subserial shall be tested.
(i) The test for pathogens, prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin. If necessary, neutralize the rabies virus with specific rabies antiserum.
(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall be injected intramuscularly with 10 recommended doses of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.
(iii) If primary cell cultures of hamster origin or of mouse origin are used vaccine production, they shall be tested for LCM virus as prescribed in § 113.42. The cells shall be disrupted and undiluted cell fluids from each lot shall be tested.
(2) Virus titrations. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(1) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently higher than the titer of the vaccine virus used in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer equal to or greater than that used in the immunogenicity test.
(3) Young adult mice, each weighing 14 to 16 grams, shall be used as test animals when the virus in vaccine prepared with a low egg passage Flury Strain or high cell passage Street Alabama Dufferin Strain (HCP SAD) of rabies virus is titrated. At least 10 mice for each dilution shall be used.
(i) At least 10 mice shall be used for each dilution. Each shall be injected intracerebrally with 0.03 ml.
(ii) The injected young adult mice shall be observed each day for 14 days except when testing vaccines made with HCP SAD strain of rabies virus, in which case, the mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD
(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available: Provided, That, the lowest titer permitted at expiration date when determined by this test shall be 10
(4) Suckling mice, 6 days of age or younger, shall be used as test animals when virus in vaccine prepared with a high egg passage Flury Strain of rabies virus is titrated.
(i) Six to twelve mice shall be used for each dilution. Each shall be injected intracerebrally with 0.02 ml.
(ii) The injected suckling mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD
(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available: Provided, That, the lowest titer permitted at expiration date when determined by this test shall be 10
Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300. Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(b) To detect virulent canine distemper virus, each of two canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions occur in either ferret, the lot of Master Seed Virus is unsatisfactory.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five dogs, less than 12 weeks of age and free of measles antibody, shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Twenty dogs shall be vaccinated with a predetermined quantity of vaccine virus and the remaining five dogs held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) On the day of challenge, serum samples shall be obtained from each vaccinate and individually tested for antibody against canine distemper virus. For a valid test, each vaccinate shall be negative at a 1:4 final serum dilution in varying serum-constant virus neutralization test using less than 500 ID
(4) At least 21 days postinoculation, the immunity of the vaccinates and controls shall be challenged by exposure to a uniform dose of aerosolized virulent canine distemper virus. All test dogs shall be observed daily for 21 days postchallenge.
(i) If at least 4 of the 5 controls do not die or show signs of distemper, including a temperature of 104.0 °F. or higher and at least 15 percent weight loss, the test is a No Test and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive without showing a temperature of 104.0 °F. or higher and a weight loss exceeding 15 percent after day 8 postchallenge, the Master Seed Virus is unsatisfactory.
(5) When approved in advance by Animal and Plant Health Inspection Service, a sequential test procedure may be used in lieu of the 20 dog requirement. A beta value of 0.05 and a tolerance level of 0.78 shall be required.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety tests. The dog safety test prescribed in § 113.40 and the mouse safety test prescribed in § 113.33(a) shall be conducted.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of the vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Feline Calicivirus Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Thirty feline calicivirus susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID
(i) If less than 8 of 10 controls show clinical signs of feline calicivirus infection other than fever, the test is a No Test and may be repeated.
(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39(b) shall be conducted.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Feline Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Thirty feline rhinotracheitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline rhinotracheitis virus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for feline rhinotracheitis virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID
(i) If less than 8 of 10 controls show clinical signs of feline rhinotracheitis infection other than fever, the test is a No Test and may be repeated.
(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Veterinary Services and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39(b) shall be conducted.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Canine Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five canine parainfluenza susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Nasal swabs shall be collected from each dog on the day the first dose of vaccine is administered and individually tested on susceptible cell cultures for the presence of canine parainfluenza virus. Blood samples shall also be drawn and individual serum samples tested for neutralizing antibody. Dogs shall be considered susceptible if all swabs are negative for virus isolation and if all serums are negative for canine parainfluenza antibody at a 1:2 final dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID
(2) A geometric mean titer of vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used to confirm the dosage administered. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Three to 4 weeks after the final dose of vaccine, all dogs shall be bled for serum antibodies and nasal swabs shall be collected for canine parainfluenza virus isolation. On the same day, all vaccinates and controls shall be challenged with canine parainfluenza virus furnished or approved by Animal and Plant Health Inspection Service.
(4) The rectal temperature of each dog shall be taken and the presence of respiratory or other clinical signs of canine parainfluenza virus infection noted and recorded each day for 14 consecutive days postchallenge. Nasal swabs shall be collected from each dog each day for at least 10 consecutive days postchallenge. Individual swabs shall be tested for virus isolation by culture in canine parainfluenza virus susceptible cells for at least 7 days. Results shall be evaluated according to the following criteria:
(i) If five of five controls have not remained seronegative at a final serum dilution of 1:2 during the prechallenge period, the test is a No Test and may be repeated.
(ii) If more than one vaccinate shows febrile response, respiratory or other clinical signs of canine parainfluenza virus infection; or, if less than 19 of 20 vaccinates show serum neutralization titers of 1:4 or greater; or, if there is not a significant reduction in virus isolation rate in vaccinates when compared with controls, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer at least 10
(2) [Reserved]
Parvovirus Vaccine recommended for use in dogs shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) The Master Seed shall be tested for reversion to virulence in dogs using a method acceptable to Animal and Plant Health Inspection Service. If a significant increase in virulence is seen within five backpassages, the Master Seed is unsatisfactory.
(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five canine parvovirus susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Blood samples drawn from each dog shall be individually tested for neutralizing antibody against canine parvovirus to determine susceptibility. Dogs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Fourteen days or more after the final dose of vaccine the vaccinates and the controls shall be challenged with virulent canine parvovirus furnished or approved by Animal and Plant Health Inspection Service and the dogs observed each day for 14 days. Rectal temperature, blood lymphocyte count, and feces for viral detection shall be taken from each dog each day for at least 10 days postchallenge and the presence or absence of clinical signs noted and recorded each day.
(i) The immunogenicity of the Master Seed shall be evaluated on the following criteria of infection: temperature ≥103.4 °F; lymphopenia of ≥50 percent of prechallenge normal; clinical signs such as diarrhea, mucus in feces, or blood in feces; and viral hemagglutinins at a level of ≥1:64 in a 1:5 dilution of feces or a test of equal sensitivity. If at least 80 percent of the controls do not show at least three of the four criteria of infection during the observation period, the test is a No Test and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing more than one criterion of infection described in paragraph (c)(3)(i), of this section, the Master Seed is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine used in the immunogenicity test in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five pseudorabies susceptible pigs (20 vaccinates and 5 controls) of the youngest age for which the vaccine is recommended, shall be used as test animals. Blood samples shall be taken from each pig and the serums inactivated and individually tested for neutralizing antibody against pseudorabies virus. Pigs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 pigs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) Fourteen to 28 days postvaccination, the vaccinates and controls shall be challenged with virulent pseudorabies virus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days.
(i) If at least four of the five controls do not develop severe central nervous system signs or die, the test is a No Test and may be repeated.
(ii) If at least 19 of the 20 vaccinates in a valid test do not remain free of signs of pseudorabies, the Master Seed is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph.
(2) Virus titer requirements. Final container samples of completed product shall be titrated by the method used in paragraph (b)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of the vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer at least 10.
Avian Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Avian encephalomyelitis susceptible chickens, all of the same age (eight weeks or older) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:
(i) For each dilution, inoculate at least 10 embryos, 5 or 6 days old, in the yolk sac with 0.2 ml each. Twenty similar embryos obtained from the same source shall be kept as uninoculated negative controls. Disregard all deaths during the first 48 hours post-inoculation.
(ii) Eggs for each dilution shall be kept in separate containers and allowed to hatch. Sufficient precaution shall be taken to assure that chickens from each dilution remain separated. To be a valid test, at least 75 percent of the uninoculated eggs shall hatch.
(iii) On the third day after normal hatching time, count all unhatched eggs and all dead, paralyzed and ataxic chickens as positive evidence of viral infection.
(iv) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(v) Calculate the EID
(3) At least 21 days post-vaccination, the vaccinates and the controls shall be challenged intracerebrally with a virulent avian encephalomyelitis virus and observed each day for 21 days.
(4) If at least 80 percent of the controls do not show signs of avian encephalomyelitis or die, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of avian encephalomyelitis during the observation period, the Master Seed Virus is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2) Safety test. Final container samples of completed product shall be tested for safety as follows:
(i) At least 25 AE susceptible birds (6 to 10 weeks of age) shall be vaccinated with the equivalent of 10 doses by each of all routes recommended on the label and be observed each day for 21 days.
(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Fowl Pox Vaccine and Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except paragraph (c) of this section and shall meet the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken inoculation test prescribed in § 113.36.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Fowl pox susceptible birds all of the same age and from the same source, shall be used as test birds. Twenty or more birds shall be used as vaccinates for each method of administration recommended on the label. Ten additional birds of the same age and from the same source as the vaccinates shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each bird used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:
(i) For each dilution, inoculate at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with at least 0.2 ml each. Disregard all deaths during the first 24 hours post-inoculation. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-inoculation.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Fourteen to twenty-one days post-vaccination, all vaccinates and controls shall be challenged by the wing web method and observed each day for 10 days. If the wing web method was used for vaccination, the opposite wing shall be used for challenge. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.
(4) If at least 90 percent of the controls do not develop fowl pox during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of fowl pox during the observation period, the Master Seed Virus is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the requirements in § 113.36, in § 113.300 except paragraph (c), and in this paragraph.
(1) Safety test. Final container samples of completed product from each serial shall be tested. Vaccines recommended for use in birds 10 days of age or younger shall be tested in accordance with paragraphs (d)(1)(i), (ii), and (iii) of this section.
(i) Each of 25 susceptible birds 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. Severe clinical signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.
(ii) The results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Number of birds | Failures for satisfactory serials | Failures for unsatisfactory serials |
|---|---|---|---|
| 1 | 25 | 2 or less | 4 or more. |
| 2 | 50 | 5 or less | 6 or more. |
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated or, in lieu thereof, the serial declared unsatisfactory.
(iv) Vaccines not recommended for use in birds 10 days of age or younger shall be tested for safety as follows: Each of twenty-five 3- to 5-week-old, fowl-pox susceptible birds shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated or, in lieu thereof, the serial declared unsatisfactory.
(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Bronchitis susceptible chickens, all of the same age and from the same source, shall be used in the virus-recovery test. For each method of administration recommended on the label for each serotype against which protection is claimed, twenty or more chickens shall be used as vaccinates. Ten additional chickens for each serotype against which protection is claimed shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity tests are conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in such tests. At least three approved (not to exceed tenfold) dilutions shall be used and the test conducted as follows;
(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with 0.1 ml each. Deaths occurring during the first 24 hours shall be disregarded, but at least four viable embryos in each dilution shall survive beyond 24 hours of a valid test. After 5 to 8 days incubation, examine the surviving embryos for evidence of infection.
(ii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iii) Calculate the EID
(3) Twenty-one to twenty-eight days post-vaccination, all vaccinates and controls shall be challenged by eye-drop with virulent bronchitis virus. A separate set of vaccinates and controls shall be used for each serotype against which protection is claimed. Each challenge virus shall be approved or provided by Animal and Plant Health Inspection Service and shall titer at least 10
(i) Tracheal swabs shall be taken once, 5 days post-challenge, from each control and vaccinate. Each swab shall be placed in a test tube containing 3 ml of tryptose phosphate broth and antibiotics. The tube and swab shall be swirled thoroughly and if they are to be stored, be immediately frozen and be stored at below −40 °C. pending egg evaluation. For each chicken swab, at least five chicken embryos 9 to 11 days old shall be inoculated in the allantoic cavity with 0.2 ml each of broth from each tube.
(ii) All embryos surviving the third day post-inoculation shall be used in the evaluation, except that, if a swab is not represented by at least four embryos, the test of that swab is invalid and the results a No Test. A tracheal swab shall be positive for virus recovery when any of the embryos in a valid test show typical infectious bronchitis virus lesions, such as but not limited to, stunting, curling, kidney urates, clubbed down, or death during the 4 to 7 day post-inoculation period. If less than 20 percent of the embryos which survive the third day post-inoculation die during the 4 to 7 day post-inoculation period and show no gross lesions typical of infectious bronchitis, they may be disregarded.
(iii) If less than 90 percent of the controls are positive for virus recovery, the test is a No Test and may be repeated.
(iv) If less than 90 percent of the vaccinates are negative for virus recovery, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph, except that, if the vaccine contains more than one virus type, bulk samples taken from each type prior to mixing shall be used in the virus identity tests prescribed in § 113.300(c). The additional requirements in this paragraph shall also be met.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2) Safety test. Final container samples of completed product shall be tested to determine safety for use in bronchitis susceptible young chickens.
(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye-drop method with the equivalent of 10 doses of vaccine and observed each day for 21 days post-vaccination. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.
(ii) The results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials |
|---|---|---|---|
| 1 | 25 | 2 or less | 4 or more. |
| 2 | 50 | 5 or less | 6 or more. |
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the procedure prescribed in paragraph (c)(2) of this section and in this paragraph.
(i) The Newcastle disease virus fraction of combined Newcastle-Bronchitis Vaccines shall be neutralized prior to titration of the bronchitis virus fraction. Equal parts of heat-inactivated Newcastle disease antiserum shall be mixed with each appropriate serial ten-fold dilution of the vaccine. After inactivation, embryos shall be injected with 0.2 ml each and results calculated as a 0.1 ml dose to allow for serum dilution of the vaccine. The allantoic fluids, tested as prescribed in § 113.34 shall not show hemagglutinating activity in the lowest dilution used in the titration.
(ii) Each bronchitis virus type shall be harvested separately and a sample of bulk harvested material shall be collected prior to mixing with the other virus type(s). Each sample shall contain not less than the minimum virus titer stated in the filed Outline of Production.
(iii) To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Fowl Laryngotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot shall also be tested for safety as follows:
(1) Each of at least ten 3 to 4 week old susceptible chickens obtained from the same source and hatch as those used in the immunogenicity test prescribed in paragraph (c) of this section shall be injected intratracheally with 0.2 ml of the virus as used in the vaccine and the chickens observed each day for 14 days.
(2) If more than 20 percent of the chickens die during the observation period, the virus is unsatisfactory.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Fowl laryngotracheitis susceptible chickens all of the same age and from the same source shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used for vaccine of chicken embryo origin and the test conducted as follows:
(i) For each dilution, inject at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with 0.2 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 8 days post-injection.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Tissue culture origin vaccine may be titrated by a tissue culture method approved by Animal and Plant Health Inspection Service and written into the filed Outline of Productions.
(4) Ten to fourteen days post-vaccination, all vaccinates and controls shall be challenged intratracheally or in the orbital sinus with infectious fowl laryngotracheitis virus and observed each day for 10 days. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.
(5) If at least 80 percent of the controls do not die or show clinical signs of fowl laryngotracheitis during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free of clinical signs of fowl laryngotracheitis during the observation period, the Master Seed Virus is unsatisfactory.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2) Safety test. Final container samples of completed product from each serial of modified live virus vaccine shall be tested for safety as provided in this paragraph. Live virus vaccine not prepared with modified live virus shall be tested for safety as provided in the filed Outline of Production.
(i) Twenty-five 3 to 4 week old laryngotracheitis susceptible chickens shall be injected intratracheally with 0.2 ml of vaccine rehydrated at the rate of 30 ml for 1,000 doses. Chickens shall be observed each day for 14 days. Deaths shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has five, six, or seven failures.
(ii) The results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials |
|---|---|---|---|
| 1 | 25 | 4 or less | 8 or more. |
| 2 | 50 | 10 or less | 11 or more. |
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated or in lieu thereof, the serial declared unsatisfactory.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method provided in paragraphs (c)(2) or (3) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Newcastle Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, except § 113.34, and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Newcastle Disease susceptible chickens, all of the same age and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:
(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with at least 0.1 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-injection.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Twenty to twenty-eight days postvaccination, all vaccinates and controls shall be challenged intramuscularly with at least 10
(4) If at least 90 percent of the controls do not develop clinical signs of Newcastle disease during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of Newcastle disease during the observation period, the Master Seed Virus is unsatisfactory.
(5) A strain identity test acceptable to Animal and Plant Health Inspection Service shall be conducted.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300, except § 113.34, and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2) Safety test: Final container samples of completed product from each serial shall be tested to determine whether the vaccine is safe for use in susceptible young chickens. Vaccines recommended for use in chickens 10 days of age or younger shall be tested in accordance with paragraphs (d)(2)(i), (ii), and (iii) of this section.
(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye drop method with the equivalent of 10 doses of vaccine and the chickens observed each day for 21 days. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has 3 failures.
(ii) The results shall be evaluated according to the following table:
Cumulative Totals
| Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials |
|---|---|---|---|
| 1 | 25 | 2 or less | 4 or more. |
| 2 | 50 | 5 or less | 6 or more. |
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated.
(iv) Vaccines not recommended for use in chickens 10 days of age or younger shall be tested for safety as follows:
Each of twenty-five 3 to 5 week old Newcastle disease susceptible chickens shall be vaccinated as recommended on the label with the equivalent of ten doses and observed each day for 21 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Marek's disease vaccine shall be prepared from virus-bearing tissue culture cells. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, and the requirements prescribed in this section. The identity test required in § 113.300(c) shall be conducted in a serotype-specific manner by a method acceptable to APHIS. Each lot of Master Seed Virus shall also be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(b) Safety test. The Master Seed Virus shall be nonpathogenic for chickens as determined by the following procedure:
(1) Specific pathogen free chickens or embryos, negative for Marek's disease virus antibodies, and from the same source, shall be isolated into the following groups:
(i) Group 1. At least 50 test subjects shall be inoculated with 10 times as much viable virus as will be contained in one dose of vaccine, by the route recommended for vaccination.
(ii) Group 2. At least 50 test subjects shall be injected with a very virulent Marek's disease virus provided or approved by APHIS, at a dosage level that will cause gross lesions of Marek's disease in at least 80 per cent of the chickens within 50 days.
(iii) Group 3. Fifty uninoculated controls. For in ovo studies, this group should receive a sham inoculation of diluent.
(iv) Group 4. For studies evaluating Serotype 1 Master Seed Viruses, a group of 50 uninoculated control chickens shall be housed in contact with the group 1 vaccinated chickens.
(2) At least 40 chickens in each group shall survive to 5 days of age. All chickens that die shall be necropsied and examined for lesions of Marek's disease and cause of death. The test shall be judged according to the following criteria:
(i) At 50 days of age, the remaining chickens in group 2 shall be killed and examined for gross lesions of Marek's disease. If at least 80 percent of this group do not develop Marek's disease, the test is a No Test and may be repeated.
(ii) At 120 days of age, the remaining chickens in groups 1, 3, and 4 shall be weighed, killed, and necropsied. If less than 30 of the chickens in group 3 survive the 120 day period, or if any of the chickens in group 3 have gross lesions of Marek's disease at necropsy, the test is declared a No Test. If less than 30 chickens in groups 1 and 4 survive the 120 day period; or if any of the chickens in groups 1 and 4 have gross lesions of Marek's disease at necropsy; or if the average body weight of the chickens in groups 1 or 4 is significantly (statistically) different from the average in group 3 at the end of the 120 days, the lot of Master Seed Virus is unsatisfactory.
(3) For tests involving in ovo inoculation, hatchability results shall also be reported for each group.
(c) Immunogenicity. Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity at the highest passage level allowed for the product, and the virus dose to be used shall be established as follows:
(1) Specific pathogen free chickens or embryos, negative for Marek's disease antibodies, and from the same source, shall be isolated into the following groups:
(i) Group 1. A minimum of 35 test subjects shall be inoculated with the vaccine, using the recommended route, at 1 day of age for chicks or 18 days of embryonation for embryos. The dose used shall be established by 5 replicate virus titrations conducted by a cell culture system or other titration method acceptable to APHIS.
(ii) Group 2. A minimum of 35 nonvaccinated test subjects shall be held as challenge controls.
(iii) Group 3. A minimum of 25 nonvaccinated test subjects shall be held as nonchallenge controls.
(iv) Group 4. Except for studies evaluating vaccines which contain only a Serotype 3 virus as the Marek's disease fraction, a minimum of 35 chicks shall be vaccinated at 1 day of age with a licensed Serotype 3 vaccine, in order to document the severity of the very virulent challenge.
(2) At least 30 chickens in groups 1, 2, and 4, and at least 20 chickens in group 3, shall survive to 5 days of age. All chickens in groups 1, 2, and 4 shall be challenged at 5 days of age in the following manner:
(i) For studies evaluating vaccines which contain only a Serotype 3 virus as the Marek's disease fraction, groups 1 and 2 shall be inoculated with a standard virulent challenge virus provided or approved by APHIS.
(ii) For all other Marek's disease vaccines, groups 1, 2, and 4 shall be inoculated with a very virulent challenge virus provided or approved by APHIS.
(3) All chickens shall be observed until 7 weeks of age, necropsied, and examined for grossly observable lesions consistent with Marek's disease. All chickens dying before the end of the 7 week observation period shall be necropsied and evaluated for gross lesions of Marek's disease. Any chickens not so examined shall be scored as positive for Marek's disease.
(4) For a valid test, at least 80 percent of the chickens in group 2 must develop grossly observable lesions, none of the chickens in group 3 shall develop grossly observable lesions, and (when included) greater than 20 percent of the chickens in group 4 must develop grossly observable lesions.
(5) For a valid test to be considered satisfactory, at least 80 percent of the chickens in group 1 must remain free of grossly observable lesions. The appropriate product claim resulting from a satisfactory test would be to aid in the prevention of Marek's disease, for vaccines containing only a Serotype 3 virus as the Marek's disease fraction, or to aid in the prevention of very virulent Marek's disease, for all other vaccines.
(d) Test requirements for release. Each serial and subserial shall meet the applicable requirements prescribed in § 113.300. The identity test required in § 113.300(c) shall be conducted in a serotype-specific manner by a method acceptable to APHIS. Final container samples of completed product shall also meet the requirements in paragraphs (d) (1), (2), and (3) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1) Purity test. The chicken embryo inoculation test prescribed in § 113.37 shall be conducted, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(2) Safety test. At least 25 one-day-old, specific pathogen free chickens shall be injected, by the subcutaneous route, with the equivalent of 10 chicken doses of virus (vaccine concentrated 10X). The chickens shall be observed each day for 21 days. Chickens dying during the period shall be examined, cause of death determined, and the results recorded.
(i) If at least 20 chickens do not survive the observation period, the test is a No Test.
(ii) If lesions of any disease or cause of death are directly attributable to the vaccine, the serial is unsatisfactory.
(iii) If less than 20 chicks survive the observation period and there are no deaths or lesions attributable to the vaccine, the test may be repeated one time, Provided, that if the test is not repeated, the serial shall be declared unsatisfactory.
(3) Potency test. The samples shall be titrated using a cell culture system or other titration method acceptable to APHIS. For vaccines composed of more than one Marek's disease virus serotype, each fraction shall be titrated in a serotype-specific manner.
(i) Samples of desiccated vaccine shall be incubated at 37 °C for 3 days before preparation for use in the potency test. Samples of desiccated or frozen vaccine shall be reconstituted in diluent according to the label recommendations, and held in an ice bath at 0 °C to 4 °C for 2 hours prior to use in the potency test.
(ii) For a serial or subserial to be eligible for release, each serotype contained in the vaccine shall have a virus titer per dose which is at least 3 times greater than the number of plaque forming units (pfu) used in the immunogenicity test prescribed in paragraph (c) of this section, but not less than 1000 pfu per dose.
(iii) When tested (without the pretest incubation of desiccated products) at any time within the expiration period, each serotype contained in the vaccine shall have a virus titer per dose which is at least 2 times the number of pfu used in the immunogenicity test, but not less than 750 pfu per dose.
Bursal Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot of Master Seed Virus used in the preparation of modified live virus vaccines shall also be nonpathogenic to chickens as determined by the following procedures:
(1) Each of twenty-five 1-day-old bursal disease susceptible chickens (vaccinates) shall be injected subcutaneously with 10 times the recommended dose of vaccine virus and observed for 21 days. Fifteen chickens of the same source and hatch shall be kept isolated as controls.
(i) Seventeen days postvaccination, each of five controls shall be administered at least 10
(ii) If the vaccinates do not remain free of clinical signs of bursal disease, the Master Seed Virus is unsatisfactory. If unfavorable reactions which are not attributable to the Master Seed Virus occur in more than two of the vaccinates, the test shall be declared a No Test and may be repeated.
(iii) Twenty-one days postvaccination, the vaccinates and the controls shall be necropsied and examined for gross lesions of bursal disease. If more than two of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than four of the positive controls have such lesions, the test is a No Test and may be repeated. For purposes of this test, gross lesions shall include obvious pathological processes and/or obvious reduction in size of the bursa from normal.
(2) Each of thirty-five 3- to 4-week-old bursal disease susceptible chickens (vaccinates) shall be vaccinated with approximately one minimum protective dose of vaccine virus as determined in paragraph (c) of this section. Each of 10 chickens of the same source and hatch shall be administered at least 10
(i) Three or four days postvaccination, 10 of the vaccinates, the 10 positive controls, and 10 of the negative controls shall be necropsied and examined for gross lesions of bursal disease. If any of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than 8 of the positive controls have such lesions, the test is a No Test and may be repeated. For purposes of this test, gross lesions shall include peri-bursal edema and/or edema and/or macroscopic hemorrhage in the bursal tissue.
(ii) Fourteen days post-vaccination, the remaining vaccinates and negative controls shall be necropsied and examined for obvious bursal atrophy. If any of the vaccinates have such atrophy, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls have such atrophy, the test is a No Test and may be repeated.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Bursal Disease susceptible chickens, all of the same age (3 weeks or younger) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used to conduct the titrations by a method acceptable to Animal and Plant Health Inspection Service.
(3) When the test chickens are 28 to 35 days of age but not less than 14 days postvaccination, each vaccinate and each control shall be challenged by eye-drop with a virulent bursal disease virus provided or approved by Animal and Plant Health Inspection Service.
(i) Three to five days postchallenge, all vaccinates and controls shall be necropsied and examined for gross lesions of bursal disease as described in paragraph (b)(2)(i) of this section.
(ii) If at least 19 of 20, or 27 of 30, or 36 of 40 vaccinates in each group are not free from such lesions, the Master Seed Virus is unsatisfactory, except that, if less than 90 percent of the controls have such lesions, the test is a No Test and may be repeated.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1) Tests for pathogens. Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the serial judged accordingly.
(2) Safety tests. (i) Final container samples of completed product from each serial shall be tested to determine whether the vaccine is safe as follows:
(A) For vaccines intended for parenteral administration, each of twenty-five 1-day-old bursal disease susceptible chickens shall be vaccinated with the equivalent of 10 doses by subcutaneous injection.
(B) For vaccines intended for drinking water administration, each of twenty-five 4- to 5-week-old bursal disease susceptible chickens shall be vaccinated orally with the equivalent of 10 doses.
(C) Ten chickens of the same source and hatch shall be maintained in isolation as negative controls. The vaccinates and controls shall be observed each day for 21 days.
(ii) If unfavorable reactions which are attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur in more than one of the controls or if unfavorable reactions which are not attributable to the biological product occur in more than two of the vaccinates, the test shall be declared a No Test and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.
(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs.
Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300, except (a)(3)(ii) and (c), and the special requirements in this section.
(b) Each lot of Master Seed shall be tested for:
(1) Pathogens by the chicken inoculation test prescribed in § 113.36.
(2) Lymphoid leukosis virus contamination as follows:
(i) Each of at least 10 3-week-old or older lymphoid leukosis free chickens from the same source and hatch shall be injected intra-muscularly with an amount of Master Seed equal to 100 label doses of vaccine. At least 15 chickens of the same source and hatch shall be used as controls; 5 or more shall be unvaccinated and serve as negative controls; 5 or more shall be injected with subgroup A lymphoid leukosis virus; and 5 or more with subgroup B lymphoid leukosis virus. Each group of control chickens shall be held isolated from each other and from the vaccinates.
(ii) Twenty-one to 28 days postinoculation, blood samples shall be taken from each chicken and the serum separated using a technique conducive to virus preservation. These serums shall be used as inocula in the complement fixation for avian lymphoid leukosis (COFAL) test prescribed in § 113.31.
(iii) Serums from the vaccinates shall be tested separately, but serums within each control group may be pooled. A valid test shall have positive COFAL reactions from each virus inoculated group and negative reactions from the uninoculated controls. If any of the chickens injected with the Master Seed have positive COFAL test reactions in a valid test, the Master Seed is unsatisfactory.
(3) Identity using the following agar gel immunodiffusion test. The undiluted Master Seed may be used as test antigen or the Master Seed may be inoculated onto the chorioallantoic membrane (CAM) of fully susceptible chicken embryos and the infected CAMs ground and used as antigen. A known tenosynovitis antiserum and a known tenosynovitis antigen shall be used in the test. A precipitin line shall form between the test antigen and the known antiserum in the center well which shows identity with the line formed between the antiserum and the known antigen, or the Master Seed is unsatisfactory.
(4) Safety using the following chicken test:
(i) For vaccines intended for use in chickens less than 14 days of age, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 1-day-old tenosynovitis susceptible chickens.
(ii) For vaccines intended for use only in chickens 14 days of age or older, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 4-week-old or older tenosynovitis susceptible chickens.
(iii) The vaccinates shall be observed each day for 21 days. If unfavorable reactions occur which are attributable to the vaccine, the Master Seed is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated.
(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Tenosynovitis susceptible chickens, of the same age and from the same source shall be used as test birds. Vaccines intended for use in very young chickens shall be administered to chickens of the youngest age for which the vaccine is recommended. Vaccines intended for use in older chickens shall be administered to 4-week-old or older chickens. Twenty or more vaccinates shall be used for each method of administration recommended on the label. Ten or more chickens shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established using a method acceptable to Animal and Plant Health Inspection Service before the immunogenicity test is conducted. A predetermined quantity of vaccine virus shall be administered to each vaccinate. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the dose.
(3) Twenty-one to 28 days postvaccination, each vaccinate and control shall be challenged by injecting virulent virus furnished or approved by Animal and Plant Health Inspection Service into one foot pad. The vaccinates and controls shall be observed each day for 14 days. If at least 90 percent of the controls do not develop swelling and discoloration in the phalangeal joint area of the injected foot pad typical of infection with tenosynovitis virus, the test is a No Test and may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 vaccinates do not remain free from these signs, disregarding transient swelling which subsides within 5 days postchallenge, the Master Seed is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300, except (c), and the requirements in this paragraph.
(1) Purity. Final container samples of completed product from each serial shall be tested for pathogens by the chicken inoculation test prescribed in § 113.36.
(2) Safety. (i) Final container samples of completed product from each serial shall be safety tested as follows:
(A) For vaccines intended for use in very young chickens, each of 25 1-day-old tenosynovitis susceptible chickens shall be vaccinated with the equivalent of 10 doses by one method recommended on the label.
(B) For vaccines intended for use in older chickens, each of 25 4-week-old or older tenosynovitis susceptible chickens shall be vaccinated with the equivalent of 10 doses by one method recommended on the label.
(ii) The vaccinates shall be observed each day for 21 days. If unfavorable reactions occur which are attributable to the product, the serial is unsatisfactory. If unfavorable reactions occur in more than two vaccinates which are not attributable to the product, the test is a No Test and may be repeated. If the test is not repeated, the serial is unsatisfactory.
(3) Virus titer requirements. Final container samples of completed product shall be titrated by the method used in paragraph (c)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of the vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer 10
(4) Identity. Bulk or final container samples of completed product from each serial shall be tested for identity as prescribed in paragraph (b)(3) of this section and shall meet the criteria stated therein.
Tuberculin, Intradermic, is a filtrate produced from cultures of Pn, C, and Dt strains of Mycobacterium tuberculosis (supplied by Animal and Plant Health Inspection Service) which has been inactivated and is non-toxic. Each serial shall be tested for purity, safety, potency, and special chemical tests in accordance with the conditions prescribed for each test. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Each serial shall be tested for purity as provided in this paragraph.
(1) Final container samples of completed product shall be tested for viable bacteria and fungi as prescribed in § 113.26.
(2) A 20 ml sample shall be centrifuged and the sediment examined microscopically for the presence of acidfast (Ziehl-Nielsen stain) or other microorganisms (Gram stain). A serial which contains microorganisms is unsatisfactory for release.
(b) Safety test. Final container samples of completed product from each serial shall be tested for safety. Two mature guinea pigs shall be injected subcutaneously with 1 ml and observed for 10 days. If unfavorable reactions attributable to the product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That if the test is not repeated, the serial shall be declared unsatisfactory.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be subjected to a comparison test using a Reference Tuberculin supplied by Animal and Plant Health Inspection Service. Test animals shall be 10 sensitized white female guinea pigs from one source which weigh 500-700 grams at the beginning of the test and which have not been used in a previous test. The comparison test shall be conducted in accordance with the procedures prescribed in paragraphs (c)(1), (2), (3), (4), (5), (6), (7), and (8) of this section.
(1) The guinea pigs shall be sensitized with a sterile heat-killed suspension of equal amounts of strains Pn, C, and Dt of Mycobacterium tuberculosis. The heat-killed sensitizing agent shall be injected in a volume of 0.5 ml per guinea pig. The guinea pigs shall be considered sensitized for testing not less than 30 days nor more than 120 days post-injection.
(2) The guinea pigs shall be prepared for sensitivity testing at least 4 hours prior to the injection of tuberculin. The entire abdominal and flank areas shall be clipped, a depilatory agent applied for 5-10 minutes, the area rinsed with warm water, and dried.
(3) Dilutions of 1:100, 1:200, and 1:400 shall be prepared with the Reference Tuberculin and the unknown tuberculin. Three test sites on each side of and equidistant from the abdominal midline shall be chosen on each guinea pig. Using a tuberculin syringe and needle, 0.05 ml of each dilution shall be injected intradermally at one of the test sites which has been randomly selected for the dilution.
(4) The sensitivity of the tuberculins shall be determined 24 hours after injected by measuring the area of erythema. Measurements in millimeters shall be made anterior of the greatest diameter and perpendicular to the first measurement. The square millimeter shall be calculated by multiplying the two measurements.
(5) The total area of response for each tuberculin tested shall be determined by adding the areas of erythema for each dilution of each of the test animals in a group. The sums of the areas of erythema for all three dilutions of each tuberculin shall be added to give the total area of tuberculin response.
(6) The total tuberculin response area of the serial being tested shall be expressed as a percentage of the total tuberculin response area of the Reference Tuberculin. (The total response area of the serial divided by the total response area of the Reference Tuberculin times 100.)
(7) If the total tuberculin response area of the serial being tested does not fall between 75 percent and 125 percent of the total tuberculin response area of the Reference Tuberculin, the serial is unsatisfactory.
(8) Two unsensitized guinea pigs are given 0.05 ml intradermal injections of 1:4 and 1:10 dilutions of both the serial being tested and the Reference Tuberculin as a control for nonspecific positive reactions. If positive reactions are observed with the Reference Tuberculin, the test is considered a “No Test” and repeated. If positive reactions are observed with the serial being tested only, the serial is unsatisfactory.
(d) Special chemical tests and requirements. Final container samples of completed product from each serial shall be tested as follows:
(1) Hydrogen ion concentration. The hydrogen ion concentration shall be determined with a pH meter which has been standardized with a pH 7.0 buffer just prior to use. The pH of the product shall be 7.0 ±0.3.
(2) Total nitrogen determination. The nitrogen content shall be determined by the Kjeldahl method on duplicate 15 ml samples consisting of 5 ml from each of three vials. The total nitrogen content of the product shall be 0.18 percent ±0.06 percent.
(3) Trichloroacetic acid precipitable nitrogen. The determination of precipitable nitrogen by a final concentration of 4 percent trichloroacetic acid shall be made by the Kjeldahl method on duplicate 15 ml samples, consisting of 5 ml from each of three vials. The trichloroacetic acid precipitable nitrogen content shall be 0.047 percent ±0.01 percent.
(4) Phenol determination. The phenol content shall be determined by direct titration with a standardized bromide-bromate solution. (A correction factor of 0.04 should be subtracted from the final value in the determination of phenol in tuberculin.) The phenol content shall be 0.54 percent ±0.04 percent.
(5) Clarity. The product shall be optically clear and free from any extraneous particles.
Pullorum Antigen shall be produced from a culture of representative strains of Salmonella pullorum which are of known antigenic composition, high agglutinability, but are not sensitive to negative and nonspecific serum. Each serial shall be tested for purity, density, preservative content, sensitivity, homogeneity, and hydrogen ion concentration. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as prescribed in § 113.26. In addition, each serial shall be free from extraneous organisms as determined by Gram staining and microscopic examination.
(b) Nephelometric determination of bacterial density. The bacterial density shall be 80 ±15 times McFarland No. 1 standard for stained antigen K's and 50 ±10 times McFarland No. 1 standard for tube antigen.
(c) Preservative requirements. (1) The formalin content of Pullorum Stained Antigen K shall be 1.0 ±0.2 percent as determined by a colorimetric method.
(2) The phenol content for Pullorum Tube Antigen shall be 0.55 ±0.05 percent as determined by direct titration with a standardized bromide-bromate solution.
(d) Sensitivity requirements. (1) Each serial of antigen shall be compared with a reference antigen of known sensitivity using positive and negative chicken serum. The manufacturers' recommendations for use on the accompanying label or package insert shall be followed. The recommended time limit specified for each antigen shall be carefully observed in the test.
(2) A total of at least 12 serums shall be used. This shall include at least three definitely positive, at least three weakly positive, and at least six negative serums. At least three positive chicken serums diluted with negative chicken serum shall be used to further assay comparative sensitivity between test and reference plate antigens. All test antigens shall agree closely with the reference antigen. Tests in which variation of readings between the reference and test antigen would result in a different National Poultry Improvement Plan classification shall be regarded as unsatisfactory. No unsatisfactory tests among the six or more negative serums and not more than one unsatisfactory test among the six or more positive serums shall be permitted. All tests performed shall be included for evaluation of the sensitivity assay. In the event of an unsatisfactory test using positive serums, at least three additional definitely positive and three additional weakly positive serums shall be tested. If not more than one unsatisfactory test is obtained with the additional serums, the antigen shall be acceptable.
(e) Homogeneity requirement. Antigens shall show no evidence of autoagglutination or unusual appearance such as the presence of flakes, specks, or a preponderance of filament forms. Microscopic examination shall be made in this determination.
(f) Hydrogen ion concentration. The hydrogen ion concentration shall be determined with a pH meter which has been standardized with a pH 4.0 buffer just prior to use. The pH of Pullorum Stained Antigen K shall be 4.6 ±0.4. No pH level is specified for Pullorum Tube Antigen but after dilution as recommended for use, it shall have a pH of 8.2 to 8.5.
Mycoplasma antigens shall be prepared from organisms, grown in broth cultures, that are inactivated and standardized. Plate antigens shall be stained with a dye acceptable to Animal and Plant Health Inspection Service (APHIS). Final container samples of completed product from each serial shall be tested for density, preservative content, homogeneity, hydrogen ion concentration, purity, sensitivity, and specificity in accordance with the conditions prescribed for each test. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Density requirements. A 2.5 ml sample of completed antigen shall be diluted with 2.5 ml of buffer solution formulated in the same manner as the vehicle of the antigen being tested in a modified Hopkins tube and then sedimented at 1,000 × g in a refrigerated centrifuge at 20 °C for 90 minutes. If the packed cell volume of the completed antigen is not 1.2 percent (±0.4 percent), the serial is unsatisfactory.
(b) Preservative requirements. Preservatives shall be as specified in the Outline of Production filed with APHIS in accordance with 9 CFR 114.8. If phenol is used, a direct titration with a standardized bromide-bromate solution shall be made. If the final concentration of phenol is not 0.25 percent (±0.05 percent), the serial is unsatisfactory.
(c) Homogeneity requirements. (1) Plate antigen shall be checked on a plate for homogeneity and autoagglutination. If plate antigen is not homogeneous and free of large visible particles (strands or clumps) or if it autoagglutinates, the serial is unsatisfactory.
(2) Stereo-microscopic examination shall be used when necessary to evaluate a granular appearing antigen.
(d) Hydrogen ion concentration. The hydrogen ion concentration shall be determined with a pH meter which has been standardized with a pH buffer just prior to use. The pH of Mycoplasma Gallisepticum Antigen shall be 6.0±0.2. The pH of Mycoplasma Synoviae Antigen and Mycoplasma Meleagridis Antigen shall be 7.0±0.2.
(e) Purity requirements. The antigen shall be tested for viable bacteria and fungi as prescribed in § 113.26.
(f) Sensitivity requirements. The reactivity of each antigen shall be tested by comparing the agglutination reactions of each serial of antigen with the agglutination reactions of a standard reference antigen which is supplied by or acceptable to APHIS. A set consisting of five known positive and five known negative serums shall be used. The negative serums shall be tested against the antigens undiluted and the positive serums shall be tested against the antigens diluted 1:4 in buffer solution formulated in the same manner as the vehicle of the antigen being tested. If negative serums do not have negative reactions in this test, the serial is unsatisfactory. If the test antigen and the reference antigen do not have the same agglutination reactions with at least four of the five positive serums used, the serial is unsatisfactory.
(1) The sensitivity of Mycoplasma Gallisepticum Antigen shall be tested using a set of chicken and a set of turkey serums (the positive serums shall have varying degrees of reactivity from weakly positive to strongly positive).
(2) The sensitivity of Mycoplasma Synoviae Antigen shall be tested using chicken serums.
(3) The sensitivity of Mycoplasma Meleagridis Antigen shall be tested using turkey serums.
(g) Specificity requirements. Mycoplasma Synoviae Antigen shall be examined for cross-agglutination with five Mycoplasma gallisepticum antiserums (chicken origin); Mycoplasma Meleagridis Antigen shall be examined for cross-agglutination with five Mycoplasma gallisepticum antiserums (turkey origin) and five Mycoplasma synoviae antiserums (turkey origin). Tests shall be conducted with undiluted antigen. If cross-agglutination occurs, the serial is unsatisfactory.
Tuberculin—PPD Bovis, Intradermic is a purified protein derivative produced from cultures of Mycobacterium bovis Strain AN-5 (supplied by Animal and Plant Health Inspection Service), which has been inactivated and is nontoxic. Each serial shall be tested for purity, safety, potency, and special chemical characteristics in accordance with the conditions prescribed for each test. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Each serial shall be tested for viable bacteria and fungi as prescribed in § 113.26.
(b) Safety test. Final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be subjected to a comparison specificity test using a Reference PPD Tuberculin supplied by Animal and Plant Health Inspection Service.
(1) Test animals. White female guinea pigs from one source, which weigh 500 to 700 grams at the beginning of the test, and which have not been used in a previous test, shall be used in the specificity test. Twenty-three guinea pigs (10 sensitized with M. bovis, 10 sensitized with M. avium and three unsensitized) shall be required for each serial being tested, and 20 guinea pigs (10 sensitized with M. bovis and 10 sensitized with M. avium) shall be required for the Reference PPD Tuberculin. Allowance should be made for deaths during the sensitization period.
(2) Sensitization of guinea pigs. (i) Sensitize one group of guinea pigs to M. bovis. Inject each animal intramuscularly with 0.5 ml of a sterile heat-killed suspension of M. bovis Strain AN-5 supplied by Animal and Plant Health Inspection Service.
(ii) Sensitize one group of guinea pigs to M. avium. Inject each animal intramuscularly with 0.5 ml of a sterile heat-killed suspension of M. avium Strain D-4 supplied by Animal and Plant Health Inspection Service.
(iii) Maintain an unsensitized group as control animals.
(3) Thirty-five days post-injection, the guinea pigs shall be used for tuberculin testing.
(4) The sensitized animals and controls shall be prepared at least 4 hours prior to injection of PPD tuberculin by clipping the hair from the entire abdominal and flank areas, applying a depilatory agent for 5 to 10 minutes, then rinsing with warm water and drying.
(i) Select four sites on each guinea pig for injection of PPD tuberculin. Two sites shall be on each side of the midline and spaced a sufficient distance from each other to avoid overlapping of skin reactions.
(ii) Prepare four dilutions of the Reference PPD Tuberculin and each serial of PPD tuberculin being tested so as to contain 0.6, 1.2, 2.4, and 4.8 micrograms of protein per 0.1 ml dose. Each of the four dilutions of the same tuberculin shall be randomly assigned a site on a guinea pig.
(iii) Inject one dose of each dilution at the assigned site using a tuberculin syringe.
(5) Measurement of skin reactions. Measure the area of erythema produced at each site on each guinea pig 24 hours following injection of PPD tuberculin. Measurements in millimeters shall be made anterior to posterior across the greatest diameter and perpendicular to the first measurement. Calculate the area of erythema in square millimeters at each site by multiplying the two measurements.
(6) Calculation of average response per guinea pig. Obtain the total area of erythema for each guinea pig by adding the areas of the four test sites. Add these composite areas of erythema from all guinea pigs with the same sensitization and the same PPD tuberculin injection, then divide by the number of animals in the group. The number obtained is the average response per guinea pig to the PPD tuberculin for the given type of sensitization.
(7) Determination of specificity index. The specificity index of a PPD tuberculin is determined by subtracting the average response obtained on M. avium sensitized guinea pigs from the average response obtained on M. bovis sensitized guinea pigs.
(8) Validity of bioassay. The bioassay test results obtained on serials tested concurrently in a single test series are valid if the specificity index of the reference PPD tuberculin is at least 400 square millimeters. If the results are not valid, the bioassay test series must be repeated with a different set of sensitized guinea pigs.
(9) Reactions in unsensitized guinea pigs. If a positive reaction (erythema) is observed in one or more of the 3 unsensitized guinea pigs, the serial is unsatisfactory.
(10) Interpretation of specificity index. When a bioassay is valid and reactions are not observed in unsensitized guinea pigs, the following interpretation of the specificity index will be used for classifying each serial of PPD tuberculin:
| Specificity index | Classification |
|---|---|
| 440 mm 2 or greater | Satisfactory. |
| Between 360 mm 2 and 440 mm 2 | Inconclusive. |
| Less than 360 mm 2 | Unsatisfactory. |
(11) Second stage test. If a serial is classified as inconclusive, it can be declared unsatisfactory or undergo a second stage test. The second stage shall be conducted in a manner identical to the first stage, except that unsensitized guinea pig controls are not necessary. The results are evaluated by combining the results obtained on all guinea pigs tested in stages one and two. Calculate the average response on the 20 M. bovis sensitized animals and on the 20 M. avium sensitized animals and determine the specificity index. An inconclusive serial is satisfactory after the second stage test, if its specificity index is 400 square millimeters or more, and unsatisfactory if its specificity index is less than 400 square millimeters.
(d) Special chemical tests and requirements. Final container samples of completed product from each serial shall be tested as follows:
(1) Protein concentration. The final product shall contain a protein concentration of 1.0 ±0.1 mg/ml. The Microkjeldahl Test for Nitrogen shall be used.
(2) Phenol content. Phenol content of the final product shall be 0.50 percent plus or minus 0.04 percent. A direct titration with a standardized bromide-bromate solution shall be conducted.
Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, all antibody products shall meet the applicable requirements of this section.
(a) Terminology. The following terms in the regulations and standards concerning antibody products shall mean:
Antibody. An immunoglobulin molecule, having a precise glycoprotein structure, produced by certain cells of the B lymphocyte lineage in response to antigenic stimulation, and functioning to specifically bind and influence the antigens that induced its synthesis.
IgG (Immunoglobulin G). One of the several recognized classes of structurally related glycoproteins whose representatives include all known antibodies.
Monoclonal. Produced by, or derived from, the offspring of a single common progenitor cell.
Failure of passive transfer. A condition of neonates characterized by an abnormally low concentration of circulating maternal IgG.
(b) Nomenclature. Antibody products shall be named as follows:
(1) Virus-specific products. The true name of a virus-specific product shall: include the term “antibody,” specify the disease for which the product is intended, and indicate the type of animal that supplied the component antibodies. If the antibodies are monoclonal, the term “monoclonal” shall be used. Example: “Duck Virus Hepatitis Antibody, Duck Origin.”
(2) Bacterium-specific products. The true name of a bacterium-specific product shall: include the term “antibody” if the component antibodies are directed against a nontoxin antigen or the term “antitoxin” if the component antibodies are directed against toxin, specify the organism against which the product is intended, and indicate the type of animal that supplied the component antibodies. If the antibodies are monoclonal, the term “monoclonal” shall be used. Example: “Escherichia Coli Monoclonal Antibody, Murine Origin.”
(3) Failure of passive transfer products. The true name of a product for treatment of failure of passive transfer shall include the term “IgG” and indicate the type of animal that supplied the component IgG. Example: “Bovine IgG.”
(4) Combination products. The true name of a product for treatment of failure of passive transfer as well as for the prevention and/or alleviation of a specific viral or bacterial disease shall be named according to the nomenclature prescribed above for virus-specific or bacterium-specific products.
(c) Animals. All animals used in the production of antibody products shall be healthy. Their health status shall be determined by physical examination by, or under the direct supervision of, a licensed veterinarian and by tests for infectious diseases. Such animals shall be maintained at licensed establishments: Provided, That cows maintained at Grade A dairies (or the equivalent) that are not injected with antigens for the purpose of stimulating the production of specific antibodies and that are used only for the purpose of supplying lacteal secretions are exempt from being maintained at a licensed establishment.
(1) No animal shall be used while showing clinical signs of disease. The presence of minor localized injuries or lesions (contusions, lacerations, burns, etc.) without body temperature elevation and without significant pain and distress shall not be construed as clinical evidence of disease.
(2) Before first use and on a regular basis, all animals used in the manufacture of antibody products shall be individually subjected to applicable tests for infectious diseases. Records of all test results shall be maintained. An animal which tests positive for an infectious disease shall not be used in the manufacture of antibody products. Retests shall be conducted as deemed necessary by the Administrator.
(i) Before first use, horses shall be tested as follows for:
(A) Equine infectious anemia (EIA) at a laboratory approved by APHIS.
(B) Piroplasmosis, dourine, and glanders at the National Veterinary Services Laboratories.
(C) Brucellosis at a laboratory approved by APHIS. Horses with standard agglutination titers of 1:50 or less can be used for production. Horses with standard agglutination titers equal to or greater than 1:100 may be tested by the Rivanol or card tests. Reactors to these supplemental tests shall not be used for production. Nonreactors to the supplemental tests shall be retested after 30 days. If the supplemental tests are negative and the agglutination titer has not increased, the animal may be used for production. Otherwise, the animal is unsatisfactory for this purpose.
(ii) Horses shall be retested annually for EIA and, if housed or pastured with any other species, shall be retested annually for brucellosis.
(iii) Before first use, cattle shall be tested as follows for:
(A) Tuberculosis by an accredited veterinarian: Provided, That cattle at Grade A dairies supplying only lacteal secretions need only be tested for tuberculosis in accordance with applicable Milk Ordinances or similar laws or regulations.
(B) Brucellosis at a laboratory approved by APHIS. Cattle with standard agglutination titers of 1:50 or less can be used for production. Cattle with standard agglutination titers equal to or greater than 1:100 may be tested by the Rivanol or card tests. Reactors to these supplemental tests shall not be used for production. Nonreactors to the supplemental tests shall be retested after 30 days. If the supplemental tests are negative and the agglutination titer has not increased, the animal may be used for production; otherwise, the animal is unsatisfactory for this purpose. Cattle at Grade A dairies supplying only lacteal secretions need not be tested individually for brucellosis if a portion of their secretions contribute to the herd milk pool tested as required by the brucellosis ring test. An animal of a herd testing positive by this test shall not be used in production.
(iv) Cattle shall be retested annually for both tuberculosis and brucellosis. Cattle at Grade A dairies supplying only lacteal secretions need only be tested for tuberculosis in accordance with applicable Milk Ordinances or similar laws or regulations. Cattle at Grade A dairies supplying only lacteal secretions need not be tested individually for brucellosis if a portion of their secretions contribute to the herd milk pool tested as required by the brucellosis ring test. An animal of a herd testing positive by this test shall not be used in production.
(v) For other species, appropriate tests and the frequency with which they are applied shall be specified in the filed Outline of Production for the product.
(vi) If a positive result is obtained on any prescribed test, the positive animal(s) shall be removed from the herd and the remaining animals retested. Production shall not be renewed until a negative herd test is obtained not less than 28 days following removal of the positive animal(s).
(vii) Negative animals shall be maintained separate and apart from untested or positive animals of any species. Production animals shall not be used for any other purpose, such as testing, work, or recreation.
(d) Collection procedures. Blood, lacteal secretions, and egg material shall be collected as described in the filed Outline of Production for the product.
(e) Ingredient handling and processing. Blood derivatives (serum, plasma, etc.), lacteal secretions, and egg material used in the production of antibody products shall be subjected to an appropriate procedure for the inactivation of potential contaminating microorganisms. The procedure shall be one of those described below and specified in the filed Outline of Production for the product: Provided, That another procedure may be substituted if demonstrated to be at least as effective by data acceptable to APHIS and specified in the filed Outline of Production for the product. These data are expected to come from a study comparing the effectiveness of the established and substitute procedures against a satisfactory battery of potential contaminating microorganisms.
(1) Blood derivatives of equine origin shall be heated at 58.0-59.0 °C for 60 minutes, and blood derivatives of bovine, porcine, or other origin shall be heated at 58.0-59.0 °C for 30 minutes. In lieu of heat treatment, blood derivatives of any origin may be treated with at least 2.5 megarads of ionizing radiation, with a maximum radiation dosage specified in the filed Outline of Production for the product.
(2) Lacteal secretions shall be heated as described in paragraph (e)(1) of this section, or shall be pasteurized at either 72 °C for 15 seconds or 89 °C for 1 second using appropriate equipment. In lieu of the heat treatment regimens prescribed, lacteal secretions may be treated with at least 2.5 megarads of ionizing radiation, with a maximum radiation dosage specified in the Outline of Production for the product.
(3) Egg material shall be heated at 58.0-59.0 °C for 30 minutes, or treated with at least 2.5 megarads of ionizing radiation, with a maximum radiation dosage specified in the filed Outline of Production for the product.
(4) Blood derivatives, lacteal secretions, and egg material shall not contain preservatives at the time of heat treatment, and immediately after heat treatment shall be cooled to 7 °C or lower.
(5) Licensees shall keep detailed records as to each batch treated and each serial of product prepared for marketing. Recording charts shall bear full information concerning the material treated and tests made of the equipment used for treatment.
(f) Preservatives. Liquid antibody products, except those immediately frozen following preparation and maintained in a frozen state until time of use, shall contain at least one preservative from the following list, within the range of concentration set forth:
(1) Phenol 0.25 to 0.55 percent, or
(2) Cresol 0.10 to 0.30 percent, and/or
(3) Thimerosal 0.01 to 0.03 percent, or
(4) Other preservative(s) specified in the filed Outline of Production for the product.
(g) Antigens for hyperimmunization. If animals are hyperimmunized to generate antibodies for a product for the prevention and/or alleviation of a specific infectious disease, and a USDA-licensed veterinary biological product is not employed for this purpose, the following shall apply:
(1) For each antigen, a Master Seed shall be established.
(i) Bacterial Master Seeds shall be tested for purity and identity as prescribed for live bacterial vaccines in § 113.64.
(ii) Viral Master Seeds shall be tested for purity and identity as prescribed for live virus vaccines in § 113.300.
(2) The maximum allowable passage level of the hyperimmunizing antigen shall be the passage level of the antigen used to generate product shown to be efficacious and shall not exceed 10 passages from the Master Seed.
(h) Purity tests. Final container samples of each serial and each subserial shall be tested for viable bacteria and fungi as follows:
(1) Dried products for parenteral administration and liquid products shall be tested as prescribed in § 113.26.
(2) For dried products for oral administration, 10 final container samples shall be reconstituted with sterile water at the volume recommended on the label and tested for the following contaminants:
(i) Coliforms. One milliliter of each rehydrated sample shall be pipetted into a 100 × 15 mm petri dish and 10-15 ml of violet red bile agar at 45-50 °C added. The plate shall be manipulated to coat its entirety with the agar-sample mixture and allowed to stand until the mixture solidifies. The plate shall then be incubated at 35 °C for 24 hours. A positive control plate and a negative control plate shall be prepared at the same time and in the same manner as the plates containing samples of the serial. All plates shall be examined at the end of the incubation period. If characteristic growth is observed on the negative control plate, or no characteristic growth is observed on the positive control plate, the test shall be considered a No Test and may be repeated. If characteristic growth is observed on any of the 10 plates containing samples of the serial, one retest to rule out faulty technique may be conducted on samples from 20 final containers. If characteristic growth is observed on any of the retest plates, or if a retest is not initiated within 21 days of the completion of the original test, the serial or subserial is unsatisfactory.
(ii) Salmonellae. One milliliter of each rehydrated sample shall be pipetted into a 100 × 15 mm petri dish and 10-15 ml of brilliant green agar at 45-50 °C added. The dish shall be manipulated to coat its entirety with the agar-sample mixture and allowed to stand until the mixture solidifies. The plate shall then be incubated at 35 °C for 24 hours. A positive control plate and a negative control plate shall be prepared at the same time and in the same manner as the plates containing samples of the serial. All plates shall be examined at the end of the incubation period. If characteristic growth is observed on the negative control plate, or no characteristic growth is observed on the positive control plate, the test shall be considered a No Test and may be repeated. If characteristic growth is observed on any of the 10 plates containing samples of the serial, one retest to rule out faulty technique may be conducted on samples from 20 final containers. If characteristic growth is observed on any of the retest plates, or if a retest is not initiated within 21 days of the completion of the original test, the serial or subserial is unsatisfactory.
(iii) Fungi. One milliliter of each rehydrated sample shall be pipetted into a 100 × 15 mm petri dish and 10-15 ml of appropriately acidified potato dextrose agar at 45-50 °C added. The plate shall be manipulated to coat its entirety with the agar-sample mixture and allowed to stand until the mixture solidifies. The plate shall then be incubated at 20-25 °C for 5 days. A positive control plate and a negative control plate shall be prepared at the same time and in the same manner as the plates containing samples of the serial. All plates shall be examined at the end of the incubation period. If growth is observed on the negative control plate, or no growth is observed on the positive control plate, the test shall be considered a No Test and may be repeated. If growth is observed on any of the 10 plates containing samples of the serial, one retest to rule out faulty technique may be conducted on samples from 20 final containers. If growth is observed on any of the retest plates, or if a retest is not initiated within 21 days of the completion of the original test, the serial or subserial is unsatisfactory.
(iv) Total bacterial count. One milliliter of each rehydrated sample, undiluted or diluted as prescribed in the Outline of Production, shall be pipetted into a 100 × 15 mm petri dish and 10-15 ml of tryptone glucose extract agar at 45-50 °C added. The plate shall be manipulated to coat its entirety with the agar-sample mixture and allowed to stand until the mixture solidifies. The plate shall then be incubated at 35 °C for 48 hours. A positive control plate and a negative control plate shall be prepared at the same time and in the same manner as the plates containing samples of the serial. All plates shall be examined at the end of the incubation period. If growth is observed on the negative control plate, or no growth is observed on the positive control plate, the test shall be considered a No Test and may be repeated. If the average number of bacterial colonies on the 10 plates containing samples of the serial exceeds that specified in the filed Outline of Production for the product, one retest to rule out faulty technique may be conducted on samples from 20 final containers. If the average number of bacterial colonies on the retest plates exceeds that specified in the filed Outline of Production for the product, or if a retest is not initiated within 21 days of the completion of the original test, the serial or subserial is unsatisfactory.
(i) Safety tests. Bulk or final container samples of each serial shall be tested as prescribed in § 113.33(b). Dried product shall be reconstituted as indicated on the label and 0.5 ml injected per mouse.
Tetanus Antitoxin is a specific antibody product containing antibodies directed against the toxin of Clostridium tetani. Each serial shall meet the applicable general requirements provided in § 113.450 and paragraph (a) of this section, and be tested for potency as provided in paragraph (b) of this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) General requirements. The amount of antitoxin in a final container shall be the amount which is delivered from such container when opened and inverted until the flow stops. A graduated volumetric cylinder which conforms to the National Institute of Standards and Technology requirements shall be used. The reading shall be made at the bottom of the meniscus. Volumes of 10 ml or less shall be recorded to the nearest 0.1 and volumes over 10 ml shall be recorded to the nearest ml.
(1) All final containers of Tetanus Antitoxin shall yield not less than the labeled unitage of antitoxin throughout the dating period. The minimum package size permitted for marketing in the United States shall be a 1,500 unit vial.
(2) The expiration date of Tetanus Antitoxin shall be not more than 3 years after the date of a potency test which demonstrates that the recoverable antitoxin from the final container provides at least 20 percent excess over the number of units claimed on the label or not more than 1 year after the date of a potency test which demonstrates that the recoverable antitoxin from the final container provides 10 to 19 percent excess over the number of units claimed on the label.
(b) Potency test. Bulk or final container samples of completed product from each serial shall be assayed to calculate the units of Tetanus Antitoxin in each final container. A comparative toxin-antitoxin neutralization test shall be conducted using a standard antitoxin and a standard toxin. All dilutions shall be made in M/15 phosphate buffered (pH) 7.4 physiological saline with 0.2 percent gelatin.
(1) One ml of the Standard Antitoxin shall be diluted before use so the final volume contains 0.1 unit per ml. The dilution shall be held at 20° to 25 °C for 30 minutes prior to combination with a test does of toxin.
(2) The Standard Toxin test dose is that amount which when mixed with 0.1 unit of Standard Antitoxin, incubated at 20° to 25 °C for 1 hour, and injected subcutaneously into a 340 to 380 gram guinea pig, results in death of that guinea pig within 60 to 120 hours with clinical signs of tetanus. The toxin shall be diluted so the test dose shall be in 2.0 ml.
(3) A mixture of diluted Standard Toxin and diluted Standard Antitoxin shall be made so that 0.1 unit of antitoxin in 1 ml is combined with a test dose of toxin. This Standard Toxin-Antitoxin mixture shall be held at 20° to 25 °C for 1 hour before injections of guinea pigs are made.
(4) A sample from each serial of antitoxin shall be prepared as was the Standard Toxin-Antitoxin mixture; except the amount of antitoxin shall be based on an estimation of the expected potency. When testing is done on bulk material, the final container fill shall reflect the endpoint value plus 10 percent overage for 1 year dating and 20 percent overage for 3 year dating.
(5) Normal guinea pigs weighing within a range of 340 to 380 grams shall be used. Pregnant guinea pigs must not be used.
(i) Each of two guinea pigs (controls) shall be injected subcutaneously with a 3 ml dose of the Standard Toxin-Antitoxin mixture. Injections shall be made in the same order that toxin is added to the dilutions of antitoxins. These shall be observed parallel with the titration of one or more unknown antitoxins.
(ii) Two guinea pigs shall be used as test animals for each dilution of the unknown antitoxin. A 3.0 ml dose shall be injected subcutaneously into each animal.
(6) Controls shall be observed until they are down and are unable to rise or stand under their own power. At this time they are euthanized and the time of death is recorded in hours. For a satisfactory test, the controls must reach this point with clinical signs of tetanus within 24 hours of each other and within an overall time of 60 to 120 hours. The clinical signs to be observed are increased muscle tonus, curvature of the spine, asymmetry of the body outline when the resting animal is viewed from above, generalized spastic paralysis, particularly of the extensor muscles, inability to rise from a smooth surface when the animal is placed on its side, or any combination of these signs. If the control guinea pigs do not respond in this manner, the entire test shall be repeated.
(7) Potency of an unknown antitoxin is determined by finding the mixture which will protect the test animal the same as the Standard Toxin-Antitoxin mixture. Test animals dying sooner than the controls indicate the unit value selected in that dilution was not present, whereas those living longer indicate a greater unit value.
Erysipelothrix Rhusiopathiae Antibody is a specific antibody product containing antibodies directed against one or more somatic antigens of Erysipelothrix rhusiopathiae. Each serial shall be tested as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b) Potency test. Bulk or final container samples of completed product from each serial shall be tested using the two-stage test provided in this section.
(1) In the first stage, each of 40 Swiss mice, each weighing 16 to 20 grams, shall be injected subcutaneously with 0.1 ml of product (dried product shall be rehydrated according to label directions). Twenty-four hours postinjection, the injected mice and 10 additional mice designated controls shall be challenged subcutaneously with the same culture of Erysipelothrix rhusiopathiae.
(2) If less than eight of the 10 controls die from erysipelas within 7 days post-challenge, the test is invalid. All dead mice shall be examined to determine if the cause of death was Erysipelothrix rhusiopathiae infection.
(3) The mice injected with product shall be observed for 10 days postchallenge and all deaths recorded. The second stage shall be required when 7-10 of the mice injected with product die in the first stage. The second stage shall be conducted in a manner identical to the first stage.
(4) The results of the test shall be evaluated according to the following table:
| Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of deaths for a satisfactory test | Cumulative total number of deaths for an unsatisfactory test |
|---|---|---|---|---|
| 1 | 40 | 40 | 6 or less | 11 or more. |
| 2 | 40 | 80 | 12 or less | 13 or more. |
Clostridium Perfringens Type C Antitoxin is a specific antibody product containing antibodies directed against the toxin of Clostridium perfringens Type C. Each serial shall be tested as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b) Potency test. Bulk or final container samples of completed product from each serial shall be tested using the toxin-neutralization test for Beta Antitoxin provided in this section. Dried products shall be rehydrated according to label directions.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of Beta Antitoxin which reacts with L
(ii) L
(iii) L
(iv) Standard antitoxin. The Beta Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Beta Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The Beta toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solution shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F. for 25 minutes; and storing at 4 °C. until used.
(2) The antitoxin content of the test sample shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Dilute 1 ml of the test sample with 49 ml of diluent and combine 1 ml of this dilution with 1 ml of the Standard Toxin diluted to contain 10 L
(iv) Combine 10 International Units of Standard Antitoxin with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(3) Test Interpretation. (i) If any mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of Clostridium Perfringens Type C Antitoxin diluted 1:50 and 10 L
Clostridium Perfringens Type D Antitoxin is a specific antibody product containing antibodies directed against the toxin of Clostridium perfringens Type D. Each serial shall be tested as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b) Potency test. Bulk or final container samples of completed product from each serial shall be tested using the toxin-neutralization test for Epsilon Antitoxin provided in this section. Dried products shall be rehydrated according to label directions.
(1) When used in this test, the following words and terms shall mean:
(i) International antitoxin unit. (I.U.) That quantity of Epsilon Antitoxin which reacts with L
(ii) L
(iii) L
(iv) Standard antitoxin. The Epsilon Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Epsilon Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.
(v) Standard toxin. The Epsilon toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.
(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solution shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F. for 25 minutes; and storing at 4 °C. until used.
(2) The antitoxin content of the test sample shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 1 International Unit of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Dilute 1 ml of the test sample with 33 ml of diluent and combine 1 ml of this dilution with 1 ml of the Standard Toxin diluted to contain 10 L
(iv) Combine 1 International Unit of Standard Antitoxin with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour, and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(3) Test Interpretation. (i) If any mice inoculated with the mixture of 1 International Unit of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 1 International Unit of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of Clostridium Perfringens Type D Antitoxin diluted 1:34 and 10 L
A product for the treatment of failure of passive transfer (FPT) shall contain a specified minimum quantity of IgG per dose and shall be recommended for use only in neonates of the same species as that of antibody origin. A product for oral administration shall not be recommended for use in animals more than 24 hours of age, while one for parenteral administration shall only be recommended for use in neonatal animals. Each serial shall meet the applicable general requirements provided in § 113.450 and be tested for potency as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Qualification of an IgG Reference Product. An IgG Reference Product (reference) shall be a serial of product that is manufactured according to the filed Outline of Production, properly qualified, and used to assess the potency of subsequent product serials, as described in paragraph (c) below. The reference shall be qualified as follows:
(1) At least 20 newborn, colostrum-deprived animals of the species for which the product is recommended shall be randomly selected.
(2) Blood samples shall be taken from each animal.
(3) Each animal shall be administered one dose of reference by the recommended route and shall be observed for 24 hours.
(i) Any adverse reactions shall be recorded.
(ii) The dosage of reference administered to each animal shall be in accordance with label directions. Label directions may indicate a single dosage regardless of weight, in which case the animals in the study shall be at or near the maximum weight for neonates of the species.
(4) After 24 hours, blood samples shall be taken from each animal.
(5) Pretreatment and post treatment serum IgG concentrations shall be concurrently determined for each animal using a radial immunodiffusion (RID) method acceptable to APHIS and described in the filed Outline of Production for the product.
(6) Concurrently, using the same method, five IgG measurements shall be made on an IgG Species Standard supplied or approved by APHIS. The IgG Species Standard shall be a preparation that contains IgG specific for the species in question at a concentration acceptable to APHIS.
(7) For an IgG Reference Product to be satisfactory, all animals used to qualify the reference must remain free of unfavorable product-related reactions and at least 90 percent of the paired serum samples must reflect an increase in IgG concentration (posttreatment minus pretreatment concentration) equal to or greater than the IgG concentration of the IgG Species Standard.
(b) Antibody functionality. Prior to licensure, the prospective licensee shall perform a neutralization study, or another type of study acceptable to APHIS, to demonstrate functionality of product antibody.
(c) Potency. Bulk or final container samples of completed product from each serial shall be tested for IgG content as provided in this paragraph. Samples of the test serial and of an IgG Reference Product established in accordance with paragraph (a) of this section shall be concurrently tested for IgG content by the RID method referred to in paragraph (a)(5) of this section. Five IgG measurements shall be made on each. If the IgG level per dose of the test serial does not meet or exceed that of the reference, one complete retest, involving five IgG measurements on both the reference and two samples of the test serial, may be conducted. If, upon retest, the average IgG level per dose of the two samples of the test serial does not meet or exceed that of the reference, or if a retest is not conducted, the serial is unsatisfactory.
Unless exempted by regulation or otherwise authorized by the Administrator, all biological products prepared, sold, bartered or exchanged, shipped or delivered for shipment in or from the United States, the District of Columbia, any Territory of the United States, or any place under the jurisdiction of the United States shall be prepared in accordance with the regulations in this part. The licensee or permittee shall adopt and enforce all necessary measures and shall comply with all directions the Administrator prescribes for carrying out such regulations.
(a) When an establishment license is issued, if biological products which were not prepared in compliance with the regulations are in the establishment, such products shall not be shipped or delivered for shipment or otherwise dealt with as having been prepared under such regulations.
(b) Except as provided in 9 CFR part 103, a biological product shall not be prepared in a licensed establishment unless the person to whom the establishment license is issued holds an unexpired, unsuspended, and unrevoked product license issued by the Administrator to prepare such biological product, or unless the products prepared are subject to the provisions of § 107.2 of this subchapter.
(c) A biological product produced in a USDA-licensed establishment shall be produced under a U.S. Veterinary Biological Product License or a license granted by a State under § 107.2 (referred to as a State biological product license and the products prepared pursuant thereto as State-licensed biological products, including autogenous biologics), but not under both a U.S. Veterinary Biological Product License and a State biological product license. Before a U.S. Veterinary Biological Product License (including a conditional license) is issued, the licensee shall relinquish its State license for that product: Provided, That autogenous biologics shall not be subject to this provision when they are prepared in accordance with the provisions of paragraph (c)(5) of this section.
(1) State-licensed biological products (including autogenous biologics) shall only be distributed or shipped intrastate, must not bear a U.S. Veterinary Biologics Establishment License Number, and must not otherwise be represented in any manner as having met the requirements for a U.S. Veterinary Biological Product license. Labeling of State- and USDA-licensed biological products produced in the same establishment must be distinctly different in color and design.
(2) All biological products in USDA-licensed establishments, whether licensed by USDA or by the State, shall be prepared only in locations indicated in legends filed in accordance with 9 CFR part 108. A description of each State-licensed product must be filed with the Animal and Plant Health Inspection Service as part of the blueprint legends and must be sufficient for Animal and Plant Health Inspection Service to determine any risk to the production of other products in the licensed establishment and to determine that adequate procedures are followed to prevent contamination during production.
(3) Records in such establishments must be maintained in accordance with §§ 116.1 and 116.2 of this subchapter and shall include all products licensed by the State or USDA.
(4) Reports prescribed in § 116.5 of this subchapter for USDA-licensed establishments shall be submitted for all veterinary biological products in the establishment.
(5) Under the following conditions, an autogenous biologic may be produced in a USDA-licensed establishment under either a State or U.S. Veterinary Biological Product License:
(i) When a culture of microorganisms, isolated from a herd in a State, is received at a USDA-licensed establishment that is in the same State but that holds both a State and a U.S. Veterinary Biological Products License for autogenous biologics, the isolate shall be designated by the licensee for use in the production of an autogenous biological product under either the State product license, or the U.S. Veterinary Biological Product License: Provided, That the isolate meets the requirements of the respective regulatory authority for an autogenous biologic. If, after producing the product pursuant to one license, the licensee elects to produce an autogenous biologic from the same isolate under provisions of the other license, the licensee may do so only with the approval of the other licensing authority.
(ii) The true name of a State-licensed autogenous biologic shall specify the State of licensure: e.g.
(a) Each licensed establishment shall be separate and distinct from any other establishment in which a biological product is prepared.
(b) No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by another licensed establishment except as provided in paragraphs (c) and (d) of this section.
(c) When a partially prepared biological product cannot be completed at a licensed establishment due to failure of essential equipment, the Administrator may authorize the use of similar equipment at another licensed establishment: Provided, That, such authorization shall be limited to the duration of the emergency and to the phase of production affected by the equipment failure.
(d) Partially prepared products or serials of completed products for further manufacture may be moved from one licensed establishment to another licensed establishment, imported under the provisions of § 104.5, or moved from a licensed establishment for purpose of being exported under conditions prescribed in an Outline of Production filed with Animal and Plant Health Inspection Service. Licensed products or products imported for distribution and sale may be prepared and recommended for final use, for further manufacturing purposes, or both. All serials shall be subject to the requirements for testing and release specified in § 113.5 or § 113.10 and to the requirements for identification specified in § 114.4.
Suitable tags or labels of a distinct design shall be used for identifying all ingredients used in the preparation of biological products, all component parts to be combined to form a biological product, all biological products while in the course of preparation and all completed biological products held in storage at licensed establishments: Provided, That, if such ingredients, components, or biological products are not so identified, they shall be disposed of as provided in § 114.15.
Micro-organisms used in the preparation of biological products at licensed establishments shall be free from the causative agents of other diseases or conditions. A complete record of such micro-organisms shall be kept currently correct and a list submitted to Animal and Plant Health Inspection Service upon request of the Administrator.
Each biological product, when in liquid form, shall be mixed thoroughly in a single container. During bottling operations, the product shall be constantly mixed sufficient to maintain physical uniformity of the entire fill. A serial number, with any other markings that may be necessary for ready identification of the serial, shall be applied to identify it with the records of preparation and labeling.
(a) Each licensee shall designate a person(s) to make all official contacts with Animal and Plant Health Inspection Service on matters pertaining to the preparation of biological products under the Virus-Serum-Toxin Act. The licensee shall file three copies of biographical summary with Animal and Plant Health Inspection Service for such designated person and for each person responsible for any phase of preparation of a biological product.
(b) All personnel employed in the preparation of biological products at a licensed establishment shall be competent in good laboratory techniques through education or training, or both, so as to consistently prepare high quality products.
(c) All biological products prepared at licensed establishments shall be prepared and handled with due sanitary precautions. Good sanitary measures shall be practiced at all times by all personnel involved in such preparation and handling of biological products.
(1) The clothing worn by persons while preparing biological products shall be clean. All persons, immediately before entering laboratory rooms of a licensed establishment, shall change their outer clothing or effectively cover the same with gowns or other satisfactory clean garments.
(2) Unsanitary practices such as, but not limited to, eating, smoking, or expectorating on the floors or otherwise creating a nuisance in any room, compartment, or place in which biological products are prepared, handled, or stored at licensed establishments are prohibited.
An Outline of Production shall be on file with Animal and Plant Health Inspection Service for each licensed biological product or for each biological product authorized to be imported into the United States for Distribution and Sale. Preparation of a biological product in a licensed establishment shall be in accordance with the Outline of Production for such product filed with Animal and Plant Health Inspection Service as provided in this section, but subject to changes as may be required under § 114.8(f).
(a) The Outline of Production shall be prepared as prescribed in § 114.9 and submitted to Animal and Plant Health Inspection Service for filing. When objectionable features, if any, are corrected and no further exceptions are taken by Animal and Plant Health Inspection Service to an Outline of Production for a biological product, such Outline of Production shall be approved for filing.
(b) Each page shall be stamped as filed on the date such action was taken in the bottom right hand corner. Although the filed outline may be referred to as an approved outline, approval for filing constitutes no endorsement by Animal and Plant Health Inspection Service of such biological product or the methods and procedures used to prepare such biological product.
(c) One copy of the Outline of Production shall be retained by the Animal and Plant Health Inspection Service and one copy returned to the licensee or permittee.
(d) Each licensee shall review each Outline of Production for accuracy and sufficiency not less frequently than once a year. Revisions necessary to bring an Outline of Production into compliance with the regulations shall be submitted to Animal and Plant Health Inspection Service.
(e) When a list of licensed products to be continued in production at a licensed establishment is requested by the Administrator in accordance with § 102.5(d) of this subchapter, the licensee shall supplement the list with information for each product as follows:
(1) The Outline of Production currently being used shall be identified as to the date when last revised and filed with Animal and Plant Health Inspection Service and the date of the last review made by the licensee.
(2) The Outline of Production to be kept in the active file shall be designated. If more than one has been filed for a product, only the Outline of Production currently being used shall be included.
(f) The Administrator may, upon the basis of information not available to him at the time the current Outline of Production for a biological product was filed, object to the methods or procedures being used in the preparation of such biological product and notify the licensee to modify the filed Outline of Production to eliminate such objections. If the licensee does not comply with the notice, the Administrator may, after affording opportunity for a hearing to the licensee, suspend the product license for the biological product involved; in which case, the licensee shall not prepare such product until subsequent notice of withdrawal of the suspension is given to the licensee.
Each Outline of Production shall be prepared in accordance with the applicable directions provided in this section.
(a) General requirements. (1) All copies of each Outline of Production or special outline or revised pages of either shall be prepared on heavy paper (8.5″ × 11″) of a type receptive to permanent stamp ink.
(2) The name of the biological product (or component), the establishment license number, and the date prepared shall appear on a front cover page and each page of the Outline of Production or special outline. The name of the licensee (or foreign manufacturer) shall appear on the front cover page.
(3) The pages shall be numbered in the upper center. At least 1
(4) Amended pages shall be numbered the same as those being superseded. They shall bear the date prepared and refer to the date on the pages being superseded. If one replacement page supersedes more than one page, the new page shall indicate same, but if several replacement pages are added to supersede one page, the page number followed by letters shall be used.
(5) The last page of both copies of either a new or a completely rewritten Outline of Production and each page revised separately shall be signed in the lower left corner by the authorized representative of the licensee (or foreign producer). Stamped or facsimile signatures are not acceptable.
(6) A summary of changes shall appear on an attached page and refer to each page, paragraph, or subparagraph being changed.
(7) Transmittal forms shall be used for the original and subsequent revisions. Transmittal forms are available on the Internet at (http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml).
(b) Special outline. An outline describing the preparation of a component of a biological product or an operation performed in the preparation of a biological product may be required if such special outline could be referred to in Outlines of Production to eliminate repetition. Each special outline shall be identified by number and shall not be used until accepted and filed by Animal and Plant Health Inspection Service.
(c) Outline of Production for anti-serum, antitoxin, and normal serum shall be written according to the following:
I. Serum animals. A. Species, conditions, age, and general health.
B. Examination, preparation, care, quarantine, tests, and treatment of animals before injections are started.
C. Holding, handling, exercising, and monitoring the condition of animals after injections are started.
II. Antigens. A. Composition and character of the antigen.
1. Micro-organisms.
2. Source and date of accession of each micro-organism.
3. Strains.
4. Proportions of each micro-organism and strain.
B. Identification methods used for each micro-organism and frequency with which these methods are applied.
C. Virulence and purity of cultures or antigen and the determination and maintenance thereof. Range of subcultures or passages to be used in production.
D. Attenuation, if any, before use for production purposes.
E. Character, size, and shape of containers used for growing micro-organisms.
F. Media used for stock, seed, and antigen cultures (composition and reaction of). May refer to a special outline by number.
G. Preparation of the antigen or toxin and toxoid. Complete and full description of each step and its manner of accomplishment and number these steps in sequence. Include all tests for each antigen, and the specifications for character, identity, virulence, concentration, and standardization.
III. Immunization of animals. A. Outline fully with special attention given to the following:
1. Character and dose of the antigen.
2. Method and frequency of injections.
3. Time required for immunization or hyperimmunization.
4. Preliminary bleedings and tests, if any, to ascertain quality of serum.
5. All other similar matters, including treatments between bleedings.
B. Period of time elapsing between last injection and first bleeding; and between bleedings.
C. Technique of bleeding operations; volume of blood collected at each bleeding; and period of rest.
IV. Preparation of the biological product. A. Describe fully and show each step of preparation from the first bleeding to the completion of the preserved product in bulk containers prior to filling of final containers.
B. Composition of the preservative and proportions used. Indicate at which step of production, and the method used in adding the preservative.
C. Agglutination and complement-fixation titers and the methods of their determinations.
D. Disposition of unsatisfactory biological products and infective materials not used in production.
E. Assembly of units to make a serial; volume of the average serial; and the volume of the maximum serial.
V. Testing. Indicate the stages in the preparation of the biological product at which samples are collected. Refer to all applicable Standard Requirements. Outline all additional tests in detail and state minimum requirements for each satisfactory test.
A. Purity.
B. Safety.
C. Potency.
D. Other tests.
VI. Post preparatory steps.
A. Form and size of final containers in which the product is to be distributed.
B. Methods and techniques of filling final containers. Volume of fill for each size final container.
C. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
D. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test.
E. Use, dosage, and route of administration for each animal species for which it is recommended.
F. Include any additional pertinent information.
(d) Outline of Production for vaccines, bacterins, antigens, and toxoids shall be written according to the following:
I. Composition, etc., of the product. A. Micro-organisms used. Give the isolation and passage history.
B. Source and date of accession of each micro-organism.
C. Strains.
D. Proportions of each strain.
II. Cultures. A. Brief description of methods of identifying each micro-organism and the frequency with which these methods are applied.
B. Virulence and purity of cultures and the determination and maintenance thereof. Range of subcultures or passages to be used in production.
C. Composition and reaction of media used for seed and production cultures. Include the source of eggs, tissue, or cell cultures, and the tests to determine that eggs, tissues, and cells are free of contamination.
D. Character, size, and shape of containers used for growing cultures.
E. Storage conditions of seed cultures.
F. Methods of preparing suspensions for seeding or inoculation.
G. Technique of inoculating (1) seed media; (2) production media. Titer or concentration of inoculum, and the volume of medium for each size and type of culture container.
H. Period of time and conditions for incubation and degree of temperature used for each micro-organism or group of micro-organisms.
I. Character and amount of growth; observation as to contamination of growth.
J. Method of attenuation, if any, before used for production purposes.
III. Harvest. A. Handling and preparation of cultures and media (including eggs) before removal of micro-organisms or tissues for production purposes.
B. Minimum and maximum period of time elapsing from time of inoculation until harvest.
C. Technique of harvesting micro-organisms or tissues (specify) for production purposes.
D. Specifications for acceptable harvest material.
E. Handling of discarded material not used in production.
F. Include any additional pertinent information.
IV. Preparation of the product. Describe fully and show each step of preparation from harvest of antigen containing tissues or production cultures to the completion of the finished product in final containers. In describing the preparation of the product, emphasize the following:
A. Method of inactivation, attenuation, or detoxification.
B. Composition of preservative, adjuvant or stabilizer, and proportions used stated in such a manner that the concentration can be calculated; stage and method of addition.
C. Method and degree of concentration.
D. If product is standardized to give concentration of antigen, show procedures and calculations.
E. 1. Assembly of units to make a serial (illustrate by example).
2. Volume of average serial.
3. Volume of maximum serial.
4. Any other pertinent information.
F. Volume of fill for each size vial. Type of vial if unusual.
G. Method and technique of filling and sealing of final containers.
H. Desiccation, including moisture control. Give maximum percent moisture.
I. Amount of antigenic material per dose or doses in final container.
V. Testing. Indicate the stages in the preparation of the biological product at which the samples are collected. Refer to all applicable Standard Requirements. Outline all additional tests in detail and state the minimum requirement for each satisfactory test.
A. Purity.
B. Safety.
C. Potency.
D. Moisture, if desiccated.
E. Any other tests.
VI. Post preparatory steps. A. Form and size of final containers in which the product is to be distributed.
B. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
C. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test. If applicable, give the date of lyophilization.
D. Use, dosage, and route of administration for each animal species for which the biological product is recommended.
(e) Outlines of Production for allergenic extracts shall be written according to the following:
I. Composition of the product. A. Source and type of raw material.
B. Weight/volume concentration.
II. Preparation of the product. A. Describe fully and show each step of preparation to the completion of the finished product in true containers. In describing the preparation of the product, emphasize the following:
1. Method of extraction.
2. Composition of preservative, adjuvant or stabilizer, and proportions used; stage and method of addition.
3. Method and degree of concentration.
4. Standardization of the product.
5. (a) Assembly of units to make a serial.
(b) Volume of average serial.
(c) Maximum serial.
6. Volume of fill for each size vial.
7. Method and technique of filling and sealing of final containers.
8. Amount material per dose or doses in final container.
III. Testing. Indicate the stages in the preparation of the biological product at which the samples are collected. Refer to all applicable Standard Requirements. Outline all additional tests in detail and state the minimum requirement for each satisfactory test.
A. Purity.
B. Safety.
C. Potency.
D. Any other tests.
E. Include any additional pertinent information.
IV. Post preparatory steps. A. Form and size of final containers in which the product is to be distributed.
B. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
C. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test.
D. Use, dosage, and route of administration for each animal species for which the biological product is recommended.
(f) Outlines of Production for diagnostic test kits based on antigen-antibody reactions, and other diagnostics whose production methods are amenable to description as described herein shall be written according to the following requirements:
Provide a brief description of the kit as follows:
1. Principle of the test (ELISA, latex agglutination, etc.).
2. Antigen or antibody detection test.
3. Sample(s) used for testing (serum, whole blood, tears, etc.).
4. List reagents, references, and equipment included.
5. Identify materials obtained under split manufacturing agreements.
6. General description of test interpretations and their limitations, including followup tests.
A. Production of polyclonal antibody components.
1. If purchased, list suppliers, criteria for acceptability, and describe all tests performed after receipt to determine that specifications have been met.
2. If produced in-house, describe the species, age, weight, conditions, and general health of all animals used in antiserum production.
a. Preinjection considerations:
Describe the examination, preparation, care, quarantine procedures, and treatments administered before immunization(s). Describe all tests used to determine suitability for use. Describe the preparation of any standard negative serum(s) collected prior to immunization.
b. Immunization of animals.
i. Describe the character and dose of the antigen; if adjuvant is used provide details on its preparation. If commercial product is used include its true name as shown on the label, the manufacturer, serial number, and expiration date.
ii. Describe the method and schedule for immunizations.
iii. Describe the method for harvesting and evaluating the immunization product, including tests for acceptability.
iv. Provide number and intervals between harvests, volume obtained, and any other pertinent information.
B. Production of Monoclonal Antibody Components.
1. Hybridoma components:
a. If hybridoma components are purchased, list suppliers and criteria for acceptability; if tests are performed after receipt, describe fully.
b. If hybridomas are prepared inhouse, identify the antigen(s) used, describe the immunization scheme, and the species of animal used.
c. Identify the tissue of origin, and the procedures for harvesting, isolating, and identifying the immune cells.
d. Describe the source, identity, and the product secreted (light or heavy chain) by the parent Myeloma Cell Line.
e. Summarize cloning and recloning procedures, including clone characterization and propagation, if appropriate.
f. If appropriate, describe procedures for establishing and maintaining seed lots.
g. Describe any other pertinent tests or procedures performed on the hybridoma cell line.
2. Antibody production:
a. Describe the production method. If produced in cell culture, animal serum additives must conform to 9 CFR 113.53. If produced in animals, describe fully including husbandry practices and passage procedures.
b. Provide the criteria for acceptable monoclonal antibody, including tests for purity.
c. Describe all tests or other methods used to ensure uniformity between production lots of monoclonal antibody. Include all reaction conditions, equipment used, and reactivity of the component.
d. Describe all characterization procedures and include the expected reactivity of all reference monoclonal antibodies.
A. Identify the microorganism(s) or antigen being used. If previously approved Master Seed virus, bacteria, or antigen derived therefrom is used, provide pertinent information on the testing performed, and details of dates of United States Department of Agriculture confirmatory tests and approval, as appropriate.
B. Describe all propagation steps, including identification of cell cultures, media ingredients, cell culture conditions, and harvest methods. For antigen produced in eggs, give the egg source, age, and route of inoculation. If cell lines are being used, give dates of testing and approval as specified in 9 CFR 113.52.
C. Describe procedures used for extracting and characterizing the antigen.
D. Describe the method used to standardize the antigen.
E. If the antigen is purchased, identify the supplier and describe the criteria for acceptable material, including all tests performed by the producer and/or the recipient to determine acceptability.
A. Describe the positive and negative controls included in the kit. If purchased, list suppliers and criteria for acceptance.
B. Describe the preparation and standardization of the conjugate(s). If purchased, list suppliers and criteria for acceptance.
C. Describe the preparation and standardization of the substrate(s). If purchased, list suppliers and criteria for acceptance.
D. Identify buffers, diluents, and other reagents included in the kit. The preparation of these components may be described in this section or in filed Special Outlines.
Fully describe methods used to standardize antigens, reference standards, positive control serum, negative control serum, and standard reagents from production/purchase to completion of finished product in final containers, including the following:
1. Composition and quantity of preservative in each.
2. Method of filling, plating, or attaching the antigen or antibody component to a solid phase.
3. Minimum and maximum acceptable fill volumes for each final container of reagent included in the kit.
4. The disposition of unsatisfactory material.
Refer to all applicable standard requirements.
A. Purity.
Describe all tests of the kit for purity or specify the exemption as provided in 9 CFR 113.4.
B. Safety.
In vitro products are exempt from safety tests.
C. Potency.
Provide details of tests used to determine the relative reactivity of the kit including minimum requirements for a satisfactory test. Reference standards and control serum used for this purpose should be identified by unique codes or lot numbers.
A. Describe the form and size of final containers of each reagent/component included in the kit.
B. Describe the collection, storage, and submission of representative samples. Refer to 9 CFR 113.3(b)(7).
C. Specify the expiration date. Refer to 9 CFR 114.13.
D. Provide details of recommendations for use, including all limitations, qualifications, and interpretation of results.
E. Submit confidentiality statement identifying specific parts of the outline containing information, the release of which would cause harm to the submitter.
Antibiotics are authorized for use as preservatives for biological products if used within the limitations as to kinds and amounts prescribed in this section.
(a) When an antibiotic or combination of antibiotics, with or without a fungistat is to be used in the preparation of a biological product, the kind(s) and amount(s) of each shall be specified in the outline for such product in such a way that the concentration in the final product may be calculated. Except as may be approved by the Administrator, only those individual antibiotics or combinations of antibiotics listed in paragraphs (b) and (c) of this section shall be used.
(b) Permitted individual antibiotics:
(1) The antibiotic level of a specified individual antibiotic in one ml. of a biological product, when prepared as recommended for use, shall not exceed the amounts listed in this paragraph: Provided, That in the case a desiccated biological product is to be used with an indefinite quantity of water or other menstruum, the determination shall be based on 30 ml. per 1,000 dose vial or equivalent.
(2) Except as prescribed in paragraph (c) of this section, only one antibiotic shall be used as a preservative in a biological product. The kind and maximum amount per ml. of such antibiotic shall be restricted to:
| Amphotericin B | 2.5 mcg. |
| Nystatin (Mycostatin) | 30.0 units |
| Tetracyclines | 30.0 mcg. |
| Penicillin | 30.0 units |
| Streptomycin | 30.0 mcg. |
| Polymyxin B | 30.0 mcg. |
| Neomycin | 30.0 mcg. |
| Gentamicin | 30.0 mcg. |
(c) Permitted combinations:
(1) Penicillin and streptomycin.
(2) Either amphotericin B or nystatin, but not both, may be used with one of the other antibiotics listed in paragraph (b) of this section, or with a combination of penicillin and streptomycin, or with a combination of polymyxin B and neomycin.
(3) The maximum amount of each antibiotic in a combination shall be the amount prescribed for such antibiotic in paragraph (b) of this section.
(d) Antibiotics used in virus seed stock purification are not restricted as to kind or amounts provided carryover into the final product is controlled and specified in outlines of production.
Biological products at licensed establishments must be protected at all times against improper storage and handling. Completed product must be kept under refrigeration at 35 to 46 °F (2 to 8 °C), unless the inherent nature of the product makes storage at different temperatures advisable, in which case, the proper storage temperature must be specified in the filed Outline of Production. All biological products to be shipped or delivered must be securely packed.
Unless otherwise provided for in a Standard Requirement or filed Outline of Production, each serial or subserial of a biological product prepared in a licensed establishment shall be given an expiration date according to the dating period of the product when computed from a date no later than the date of the initiation of the first potency test of the serial or subserial. A licensed biological product shall be considered worthless under the Virus-Serum-Toxin Act after the expiration date appearing on the label.
The following requirements do not apply to those biological products used for diagnostic purposes.
(a) Stability criteria. Stability criteria include the specifications for potency at release, potency throughout the dating period, and the length of the dating period.
(b) Stability study requirement. The dating period of each fraction of each product shall be confirmed by conducting a stability study.
(c) Licensure prior to completion of a stability study. Prior to licensure, the licensee shall propose a dating period for the product based on preliminary information available about the stability of each of its fractions. If the preliminary stability information is acceptable, the product may be licensed with the provision that the proposed dating period must be confirmed by conducting a real-time stability study with a stability-indicating potency assay that can detect changes over time in the potency of the product.
(d) Use of stability-indicating assay. Stability studies must be conducted with a stability-indicating assay, with the following exceptions:
(1) If the potency test specified in the filed Outline of Production of a licensed product is the one stated in the regulations, that potency test may be used in place of a stability-indicating assay for that fraction.
(2) If the initial confirmation of dating study of a product in development on April 13, 2018 has an approved potency assay, that assay may be used.
(e) Number of serials. At least three production serials of the product shall be selected for testing in the stability study.
(f) Testing sequences—(1) Initial test. The first test in the sequence shall be as close as practical to the day of filling into final containers or the date of final formulation if the potency of the product is tested in bulk form.
(2) Subsequent testing for in vitro assays. (i) One test every 3 months during the first year of storage;
(ii) One test every 6 months during the second year of storage; and
(iii) One test annually thereafter throughout the proposed dating period.
(3) Subsequent testing for in vivo assays. One test at the end of the proposed dating period.
(g) When to conduct a stability study. Stability studies must be conducted for the following:
(1) Newly licensed products whose dating has not been confirmed;
(2) Licensed products with confirmed dating but a major change to the product or to the potency test has occurred; and
(3) Licensed products with confirmed dating in which a change in one or more of the stability criteria is requested.
(h) Submitting data. At the completion of the real-time stability study to confirm or change the dating period, the data shall be submitted to Animal and Plant Health Inspection Service for approval for filing and the approved for filing date shall be specified in section VI of the filed Outline of Production at the next revision.
(i) Monitoring stability of the product. For products licensed subsequent to April 13, 2018, the licensee or permittee shall submit a plan to monitor the stability of the product and the suitability of its dating period that includes regularly testing selected serials for potency during and at the end of dating.
(a) Unless otherwise provided for in a filed Outline of Production for the product, the expiration date shall not be extended:
(1) If all fractions of the product are not evaluated for potency by tests designated in the filed Outline of Production for such product in accordance with § 113.4(b) of this subchapter.
(2) For any serial or portion of any serial which has left licensed premises: Provided, That product which has been shipped from one licensed premises to another licensed premises shall be exempt from this requirement.
(3) For a serial or portion of a serial if the expiration date has been extended previously, unless otherwise authorized in accordance with § 114.1.
(b) An extension of the expiration date may be granted by Animal and Plant Health Inspection Service if a request from the licensee is substantiated by valid test data which demonstrate the potency of the product meets or exceeds the requirements for release. The new expiration date shall be calculated from the date the latest satisfactory potency test was initiated. The extension of the expiration date shall not exceed the maximum dating allowed in the filed Outline of Production.
(1) Serials are approved for redating under the condition that Animal and Plant Health Inspection Service may require the firm to retest the redated serial for potency during the extended dating period and if found unsatisfactory require it be removed from the market by the licensee.
(2) [Reserved]
All biological products found to be unsatisfactory for marketing, all biological products which have become worthless subsequent to the expiration date, all refuse, other materials deemed unsatisfactory for production purposes, all carcasses (part or whole) of production or test animals, and any undesirable byproducts of manufacture shall be disposed of as may be required by the Administrator.
A serial or subserial of a biological product may be produced jointly by a licensee and one or more subsidiaries, or by two or more subsidiaries. The exact amount of each serial or subserial credited to each participating producer shall be determined at the time of labeling and packaging and shall be noted in the records for such serial or subserial.
The Administrator may authorize the rebottling of a completed product in liquid form subject to the conditions prescribed in this section.
(a) All or part of a serial which has not left the licensed establishment may be aseptically returned to the mixing tank, thoroughly mixed, and rebottled in new final containers.
(b) The rebottled product shall be adequately identified by serial number or subserial number, as the case may be.
(c) Required purity tests for final container samples of the product shall be conducted on new samples selected from the rebottled product (serial or subserials). Rebottled product found to be unsatisfactory by such tests shall not be released.
(d) New test samples from each serial or subserial and copies of test reports of all tests conducted on the rebottled product shall be submitted to Animal and Plant Health Inspection Service.
(e) The licensee shall not release the rebottled product unless notified by Animal and Plant Health Inspection Service that such product is eligible for release. Production records shall show the results of all tests conducted and shall accurately reflect the actions taken.
The Administrator may authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this section.
(a) Reprocessing shall not include any method or procedure which would be deleterious to the product.
(b) All appropriate tests for purity, safety, potency, and efficacy for the product shall be conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be released.
(c) The reprocessed serial shall be identified by a new serial number and the records for the serial shall accurately reflect the action taken.
(d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee shall not release the serial until notified by Animal and Plant Health Inspection Service that the serial is eligible for release.
(a) Any inspector shall be permitted to enter any establishment where any biological product is prepared, at any hour during the day or night, and shall be permitted to inspect, without previous notification, the entire premises of the establishment, including all buildings, compartments, and other places, all biological products, and organisms and vectors in the establishment, and all materials and equipment, such as chemicals, instruments, apparatus, and the like, and the methods used in the manufacture of, and all records maintained relative to, biological products produced at such establishment.
(b) Each inspector will have in his or her possession a numbered USDA badge or identification card. Either shall be sufficient identification to entitle him/her to admittance at all regular entrances and to all parts of such establishment and premises and to any place at any time for the purpose of making an inspection pursuant to paragraph (a) of this section.
(a) Any biological product, the container of which bears a United States veterinary license number or a United States veterinary permit number or other mark required by these regulations, may be inspected at any time or place. If, as a result of such inspection, it appears that any such product is worthless, contaminated, dangerous, or harmful, the Secretary shall give notice to stop distribution and sale to the manufacturer (licensee) or importer (permittee) and may proceed against such product pursuant to the provisions of part 118 of this subchapter.
(b) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product by the Secretary, veterinary biologics licensees or permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange, shipment, or importation of the affected serial(s) or subserial(s) of any such veterinary biological product pending further instructions from APHIS.
(2) Immediately, but no later than 2 days, send stop distribution and sale notifications to any jobbers, wholesalers, dealers, foreign consignees, or other persons known to have any such veterinary biological product in their possession, which instruct them to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any such veterinary biological product. All notifications shall be documented in writing by the licensee or permittee.
(3) Account for the remaining quantity of each serial(s) or subserial(s) of any such veterinary biological product at each location in the distribution channel known to the manufacturer (licensee) or importer (permittee).
(4) When required by the Administrator, submit complete and accurate reports of all notifications concerning stop distribution and sale actions to the Animal and Plant Health Inspection Service pursuant to § 116.5 of this subchapter.
(c) Unless and until the Secretary shall otherwise direct, no persons so notified shall thereafter sell, barter, or exchange any such product in any place under the jurisdiction of the United States or ship or deliver for shipment any such product in or from any State, Territory, or the District of Columbia. However, failure to receive such notice shall not excuse any person from compliance with the Virus-Serum-Toxin Act.
(a) Each licensee, permittee, and foreign manufacturer of biological products imported into the United States shall maintain, at the licensed or foreign establishment in which the products are prepared, detailed records of information necessary to give a complete accounting of all the activities within each establishment. Such records shall include, but shall not be limited to, the items enumerated in this part.
(1) Records shall be made concurrently with the performance of successive steps in the development and preparation of biological products, including new products under development. Such records shall include the date and where critical, the time that each essential step was taken, the identity and quantity of ingredients added or removed at each step, and any gain or loss of product from the beginning to the end of product preparation.
(2) Records shall be legible and indelible; shall be as detailed as necessary for a clear understanding of each step by one experienced in the preparation of biological products; and shall be verified by initials or signature of the person immediately responsible for the action taken.
(3) Records (other than disposition records and adverse event records) required by this part must be completed by the licensee, permittee, or foreign manufacturer, as the case may be, before any portion of a serial of any product may be marketed in the United States or exported.
(b) In the case of imported products, each permittee shall maintain at the permittee's place of business detailed and accurate records that are relevant to each imported product and that include, but are not limited to, importation documents, sampling records, test summaries, shipping records, and inventory and disposition records as required in § 116.2.
(c) When authorized by the Administrator, the licensee, permittee, or foreign manufacturer may maintain and retain records required under this part at an alternative location. Such authorization shall be confirmed by the filing of an addendum to the plot plan legend. The addendum shall list the location of the records and the condition of their storage and shall permit the inspection of the records by APHIS inspectors, or foreign inspectors acting on behalf of APHIS.
(a) Records shall show the quantity and location of each biological product being prepared, in storage, and in distribution channels.
(b) Detailed disposition records, in a form satisfactory to the Administrator, shall be maintained by each licensee, each distributor, and each permittee showing the sale, shipment, or other disposition made of the biological products handled by such person.
(a) Each licensee and permittee shall maintain a list of all approved labels currently being used. Each label shall be identified as to:
(1) Name and product code number as it appears on the product license or permit for the product;
(2) Where applicable, the size of the package (doses, ml, cc, or units) on which the label shall be used;
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the producer.
(b) All labels printed shall be accounted for and an inventory maintained.
Records shall be made by means of automatic recording devices or an equivalent accurate and reliable system. Such records shall be identified with the ingredients, equipment, or biological product subjected to sterilization or pasteurization.
(a) When required by the Administrator, reports containing accurate and complete information concerning biological products, including but not limited to, product development and preparation, and market suspensions and recalls, shall be prepared and submitted to the Animal and Plant Health Inspection Service by the licensee, permittee, or foreign manufacturer (whose products are being imported or offered for importation). Unless otherwise authorized by the Administrator, records necessary to make such reports shall be maintained in each establishment.
(b) If, at any time, there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product, the licensee, permittee, or foreign manufacturer must immediately notify the Animal and Plant Health Inspection Service concerning the circumstances and the action taken, if any. Notification may be made by mail to Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; by electronic mail to (cvb@aphis.usda.gov); by fax to (515) 337-6120; or by telephone to (515) 337-6100.
Complete records shall be kept for all animals at a licensed establishment. Results of tests performed, antigens or treatment administered, maintenance and production records, disposition records, necropsy records, if any, and all other pertinent records shall be included.
Detailed records of all tests conducted on each serial and each subserial shall be maintained by the licensee. Summaries of such tests shall be prepared from such records and submitted to the Animal and Plant Health Inspection Service using APHIS Form 2008 or an acceptable equivalent form prior to release of the serial or subserial. Blank forms for such summaries shall be available from Animal and Plant Health Inspection Service upon request.
All records (other than disposition records and adverse event records) required by this part must be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. All records must be retained at the licensed or foreign establishment or permittee's place of business for a period of 2 years after the expiration date of a product or longer as may be required by the Administrator.
(a) Licensees and permittees must maintain a detailed record for every adverse event report the licensee or permittee receives for any biological product it produces or distributes. These records shall be maintained for a period of 3 years after the date the adverse event report is received. The adverse event report form and guidance on how to complete it, including guidance specific to the various information blocks on the form, is available on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics or by writing to APHIS Center for Veterinary Biologics, 1920 Dayton Avenue, P.O. Box 844, Ames, Iowa 50010.
(b) A report of all adverse events reports received by a licensee or permittee must be compiled and submitted to the Animal and Plant Health Inspection Service. The frequency of report submission is as follows:
(1) Immediate notification is required if at any time there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product.
(2) Adverse event reports determined by the licensee or permittee to be product-related, serious, and unexpected must also be reported immediately.
(3) All other adverse event reports must be reported within 90 calendar days of the date the report was first received.
(a) All animals used in licensed establishments in the preparation or testing of biological products shall meet the regulations in this subchapter and special requirements as may be prescribed by the Administrator to prevent the preparation, sale, and distribution of worthless, contaminated, dangerous, or harmful biological products.
(b) Unless otherwise authorized or directed by the Administrator, animals used in the preparation or testing of biological products shall be admitted to and maintained at the licensed establishment and ultimately disposed of in accordance with the regulations in this part, and with the Act of August 24, 1966 (Pub. L. 89-544) as amended by the Animal Welfare Act of 1970 (Pub. L. 91-579) and the regulations in parts 1, 2, and 3 of this chapter. Personnel who supervise the care and welfare of such animals shall be qualified by education, training, and experience to carry out the regulations in this part.
Animal facilities shall comply with the requirements provided in part 108 of this chapter.
(a) No animal which shows clinical signs or other evidence of disease shall be admitted to the premises of licensed establishments, except as provided in paragraphs (d) and (e) of this section. The health status of all animals offered for admission shall be determined by or under the direction of a veterinarian prior to admission. If the determination cannot be made prior to admission, the animals shall be kept separate from animals already on the premises and in a quarantine area to be provided by the licensee for this purpose until the animal's health status is determined.
(b) If special test requirements for admittance of the animals are specified in the Outline of Production for the product to be produced, the animals shall remain in the quarantine area until such tests have been performed and the results obtained. Animals which do not meet the requirements shall not be admitted to the production area or allowed to contact production animals.
(c) All animals admitted to the premises of a licensed establishment shall be permanently identified either collectively or individually by the licensee with tags, marks, or other means acceptable to the Administrator.
(d) When an animal which has a disease is to be used to prepare a biological product for control of such disease, the animal shall be admitted directly to the processing facilities in which the product is to be prepared but shall not be permitted contact with other animals on the premises.
(e) The Administrator may authorize the maintenance of diagnostic facilities at the licensed establishment: Provided, That safeguards proposed by the licensee are adequate to prevent diseased or dead animals brought into such facilities from being a threat to biological products prepared in such establishment or to other animals on the premises used in the preparation of biological products.
(a) All test animals shall be examined for clinical signs of illness, injury, or abnormal behavior prior to the start of a test and throughout the observation period specified in the test protocol.
(b) All animals used for test purposes shall be identified either collectively or individually in a manner conducive to an accurate interpretation of the results of the test.
(c) No test animals shall be given a biological product during the preconditioning period which would affect its eligibility according to the test requirements. No treatment, with a biological product or otherwise, shall be administered to a test animal during a test period which could interfere with a true evaluation of the biological product being tested.
(d) During the course of a test, animals that are injured or show clinical signs of illness or unfavorable reactions that are not due to the test may be removed from the test and treated or humanely destroyed. If sufficient animals do not remain for the test to be evaluated, the test shall be declared inconclusive and may be repeated.
(e) Test animals that show clinical signs of illness that are due to the test may be treated or humanely destroyed if the illness has progressed to a point (defined in the filed Outline of Production) when death is certain to occur without therapeutic intervention. When interpreting the results of the test, the animals that were treated or humanely destroyed because of illness due to the test and the animals that have died from illness due to the test prior to being humanely destroyed shall be combined into a common statistic of mortality due to the test.
Animals which have been infected with or exposed to a dangerous, infectious, contagious, or communicable disease shall be kept effectively segregated at a licensed establishment until such time as they are humanely destroyed or successfully treated and removed as healthy animals.
Production animals or ex-test animals which are no longer useful at the licensed establishment may be removed from the premises of the licensed establishment; provided, such removal is accomplished in a manner as shall preclude the dissemination of disease and in accordance with the following conditions:
(a) Meat-producing animals which received a biological product containing inactivated microorganisms and adjuvants within 21 days shall not be removed; or
(b) Animals which received virulent microorganisms within 30 days shall not be removed; or
(c) Only animals that are in a healthy condition as determined by a veterinarian shall be removed, except as provided in paragraph (d) of this section.
(d) Other animals that are injured or otherwise unhealthy, except when affected with a communicable disease, may be removed for immediate slaughter to an abattoir operated in accordance with the Federal Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act of 1967, 81 Stat. 585 (21 U.S.C. sec. 601 et seq.): Provided, That such animals shall be properly marked for identification and the inspector in charge of slaughter operations is given due notice in advance.
(e) All animals on the premises shall be disposed of in accordance with the provisions of the regulations in this part and where specific provision is not made therefor shall be disposed of as required by the Administrator.
Whenever any biological product which is prepared, sold, bartered, exchanged, or shipped in violation of the Act or regulations is found by any authorized representative of the Administrator upon any premises, it may be detained by such representative for a period not to exceed 20 days, pending action under § 118.4, and shall not be moved by any person from the place at which it is located when so detained, until released by such representative.
An authorized representative of the Administrator shall detain any biological product subject to detention under this part by:
(a) Giving oral notification to the owner of the biological product if such owner can be ascertained, and, if not, to the agent representing the owner or to the immediate custodian of the biological product; and
(b) Promptly furnishing the person so notified with a preliminary notice of detention which shall include identity and quantity of the product detained, the location where detained, the reason for the detention, and the name of the authorized representative of the Administrator.
(c) Within 48 hours after the detention of any biological product, an authorized representative of the Administrator shall, if the detention is to continue, give written notification to the owner of the biological product detained by furnishing a written statement which shall include the identity and quantity of the product detained, the location where detained, specific description of the alleged noncompliance including reference to the provisions in the Act or the regulations which have resulted in the detention, and the identity of the authorized representative of the Administrator; or, if such owner cannot be ascertained and notified within such period of time, furnish such notice to the agent representing such owner, or the carrier or other person having custody of the biological product detained. The notification, with a copy of the preliminary notice of detention shall be served by either delivering the notification to the owner or to the agent or to such other person, or by certifying and mailing the notification, addressed to such owner, agent, or other person, at the last known residence or principal office or place of business.
Except as provided in paragraphs (a) and (b) of this section, no biological product detained in accordance with the provisions in this part shall be moved by any person from the place at which such product is located when it is detained.
(a) A detained biological product may be moved from the place at which it is located when so detained for the purpose of providing proper storage conditions if such movement has been approved by an authorized representative of the Administrator; Provided, That, the biological product so moved shall be detained by an authorized representative of the Administrator after such movement.
(b) A detained biological product may be moved from the place at which it is detained on written notification by an authorized representative of the Administrator that the detention is terminated; Provided, That, the conditions under which the detained biological product may be moved will be specified in the written notification of the termination. The notification of termination shall be served by either personally delivering the notification, or by certifying and mailing the notification addressed to such person at the last known residence or principal office or place of business of the owner, agent, or other person having custody of the biological product.
Any biological product which is prepared, sold, bartered, exchanged, or shipped in violation of the Act or regulations shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court within the jurisdiction of which the product is found. If the product is condemned, it shall, after entry of the decree, be disposed of by destruction or sale as the court may direct, and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the product shall not be sold contrary to the provisions of the Act or the laws of the jurisdiction in which it is sold; Provided, That, upon the execution and delivery of a good and sufficient bond conditioned that the product shall not be sold or otherwise disposed of contrary to the provisions of the Act or the laws or jurisdiction in which disposal is made, the court may direct that such product be delivered to the owner thereof subject to such supervision by authorized representatives of the Administrator as is necessary to ensure compliance with the applicable laws. When a decree of condemnation is entered against the product and it is released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant of the product. The proceedings in such libel cases shall conform, as nearly as may be practicable, to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Attorney General. The Attorney General of the United States or any person authorized to act for the Attorney General.
Biological agent. Any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing:
(1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(2) Deterioration of food, water, equipment, supplies, or material of any kind; or
(3) Deleterious alteration of the environment.
Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.
Diagnosis. The analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin, provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products.
Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.
HHS Secretary. The Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified.
HHS select agent and/or toxin. A biological agent or toxin listed in 42 CFR 73.3.
Import. To move into, or the act of movement into, the territorial limits of the United States.
Information security. Protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide:
(1) Integrity, which means guarding against improper information modification or destruction, and includes ensuring information authenticity;
(2) Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and
(3) Availability, which means ensuring timely and reliable access to and use of information.
Interstate. From one State into or through any other State, or within the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
Occupational exposure. Any reasonably anticipated skin, eye, mucous membrane, parenteral contact, or respiratory aerosol exposure to select agents or toxins that may result from the performance of an employee's duties.
Overlap select agent and/or toxin. A biological agent or toxin that is listed in § 121.4 and 42 CFR 73.4.
Permit. A written authorization by the Administrator to import or move interstate select agents or toxins, under conditions prescribed by the Administrator.
Principal investigator. The one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program.
Proficiency testing. The process of determining the competency of an individual or laboratory to perform a specified test or procedure.
Recombinant nucleic acids. (1) Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell; or
(2) Molecules that result from the replication of those described in paragraph (1) of this definition.
Responsible official. The individual designated by an entity with the authority and control to ensure compliance with the regulations in this part.
Security barrier. A physical structure that is designed to prevent entry by unauthorized persons.
Select agent and/or toxin. Unless otherwise specified, all of the biological agents or toxins listed in §§ 121.3 and 121.4.
Specimen. Samples of material from humans, animals, plants, or the environment, or isolates or cultures from such samples, for diagnosis, verification, or proficiency testing.
State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.
Synthetic nucleic acids. (1) Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
(2) Molecules that result from the replication of those described in paragraph (1) of this definition.
Toxin. The toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes:
(1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(2) Any poisonous isomer or biological product, homolog, or derivative of such a substance.
United States. All of the States.
USDA. The U.S. Department of Agriculture.
Validated inactivation procedure. A procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.
Verification. The demonstration of obtaining established performance (e.g., accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis.
Viability testing protocol. A protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.
VS. The Veterinary Services Programs of the Animal and Plant Health Inspection Service.
VS select agent and/or toxin. A biological agent or toxin listed in § 121.3.
This part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed in this part have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents and toxins are subject to regulation by both APHIS and CDC.
(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to animal health or to animal products. The select agents and toxins marked with an asterisk (*) are designated as Tier 1 select agents and toxins and are subject to additional requirements as listed in this part.
(b) VS select agents and toxins are:
(1) African swine fever virus;
(2) Avian influenza virus;
(3) Classical swine fever virus;
(4) * Foot-and-mouth disease virus;
(5) Goat pox virus;
(6) Lumpy skin disease virus;
(7) Mycoplasma capricolum;
(8) Mycoplasma mycoides;
(9) Newcastle disease virus;
(10) Peste des petits ruminants virus;
(11) * Rinderpest virus;
(12) Sheep pox virus; and
(13) Swine vesicular disease virus.
(c) Genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms:
(1) Nucleic acids that can produce infectious forms of any of the select agent viruses listed in paragraph (b) of this section.
(2) Recombinant and/or synthetic nucleic acids that encode for the functional forms of any toxin listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed in vivo or in vitro; or
(ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
(3) VS select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) VS select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any VS select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Nonviable VS select agents or nontoxic VS toxins.
(3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.
(4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.
(5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.
(6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS. A written decision granting or denying the request will be issued.
(7) A VS select toxin identified in an original food sample or clinical sample.
(8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care.
(9) Any low pathogenic strains of avian influenza virus, avian paramyxovirus serotype-1 (APMV-1) viruses which do not meet the criteria for Newcastle disease virus,
(e) An attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the requirements of this part based upon a determination by the Administrator that the attenuated strain or modified toxin does not pose a severe threat to animal health or animal products.
(1) To apply for exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification to the applicant. Exclusions will be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
(2) If an excluded attenuated strain or modified toxin is subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting select agent or toxin will be subject to the requirements of this part.
(3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(f) Any VS select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process.
(2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin.
(3) The Federal law enforcement agency reports the seizure of the select agent or toxin to APHIS or CDC.
(i) The seizure of any of the following VS select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), classical swine fever virus, foot-and-mouth disease virus, virulent Newcastle disease virus, rinderpest virus, and swine vesicular disease virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the select agent or toxin.
(ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(4) The Federal law enforcement agency reports the final disposition of the select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.
(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. The select agents and toxins marked with an asterisk (*) are designated as Tier 1 select agents and toxins and are subject to additional requirements as listed in this part.
(b) Overlap select agents and toxins are:
(1) * Bacillus anthracis;
(2) Bacillus anthracis (Pasteur strain);
(3) * Burkholderia mallei;
(4) * Burkholderia pseudomallei;
(5) Hendra virus;
(6) * Nipah virus;
(7) Rift Valley fever virus; and
(8) Venezuelan equine encephalitis virus.
(c) Genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms:
(1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section.
(2) Recombinant and/or synthetic nucleic acids that encode for the toxic forms of any overlap toxin listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed in vivo or in vitro; or
(ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
(3) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any overlap select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Nonviable overlap select agents or nontoxic overlap toxins.
(3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.
(4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.
(5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.
(6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator or HHS Secretary to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS or CDC. A written decision granting or denying the request will be issued.
(7) An overlap select toxin identified in an original food sample or clinical sample.
(8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care.
(9) Any subtypes of Venezuelan equine encephalitis virus except for Subtypes IAB or IC, provided that the individual or entity can identify that the agent is within the exclusion category.
(e) An attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the requirements of this part based upon a determination by the Administrator that the attenuated strain or modified toxin does not pose a severe threat to public health and safety, animal health, or animal products.
(1) To apply for exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification to the applicant. Exclusions will be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
(2) If an excluded attenuated strain or modified toxin is subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting select agent or toxin will be subject to the requirements of this part.
(3) An individual or entity may make a written request to the Administrator or HHS Secretary for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator or HHS Secretary will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(f) Any overlap select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process.
(2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin.
(3) The Federal law enforcement agency reports the seizure of the overlap select agent or toxin to APHIS or CDC.
(i) The seizure of any of the following overlap select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: Bacillus anthracis, Burkholderia mallei, or Burkholderia pseudomallei. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the overlap select agent or toxin.
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(4) The Federal law enforcement agency reports the final disposition of the overlap select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.
(a) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported;
(3) Unless otherwise directed by the Administrator, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care by heath care professionals has concluded; and
(4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.
(b) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator, within 90 calendar days of receipt, the agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(c) Diagnostic reagents and vaccines that are, bear, or contain VS select agents or toxins that are produced at USDA diagnostic facilities will be exempt from the requirements of this part.
(d) Unless the Administrator by order determines that additional regulation is necessary to protect animal health or animal products, products that are, bear, or contain VS select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131 et seq.).
(e) The Administrator may exempt from the requirements of this part an experimental product that is, bears, or contains a VS select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products. To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5. A written decision granting or denying the exemption will be issued. The applicant must notify APHIS when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect.
(f) In addition to the exemptions provided in paragraphs (a) through (e) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting animal health or animal products. An individual or entity may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(a) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported;
(3) Unless otherwise directed by the Administrator or HHS Secretary, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care by heath care professionals has concluded; and
(4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.
(b) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator or the HHS Secretary, within 90 days of receipt, the agent or toxin is transferred in accordance with § 121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of an overlap select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(c) Unless the Administrator by order determines that additional regulation of a specific product is necessary to protect animal health or animal products, products that are, bear, or contain overlap select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131 et seq.).
(d) After consultation with the HHS Secretary, the Administrator may exempt from the requirements of this part an investigational product that is, bears, or contains an overlap select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products.
(1) To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5.
(2) The Administrator will make a determination regarding an exemption within 14 calendar days after receipt of the application and notification that the investigation has been authorized under a Federal law. A written decision granting or denying the exemption will be issued.
(3) The applicant must notify APHIS or CDC when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect.
(e) If it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap select agent or toxin, the Administrator may exempt an individual or entity from the requirements, in whole or in part, of this part for up to 30 calendar days. The Administrator may extend the exemption once for an additional 30 days.
(f) Upon request of the Secretary of Health and Human Services, the Administrator may exempt an individual or entity from the requirements, in whole or in part, of this part for up to 30 calendar days if the Secretary of Health and Human Services has granted an exemption for a public health emergency involving an overlap select agent or toxin. The Administrator may extend the exemption once for an additional 30 days.
(a) Unless exempted under § 121.5, an individual or entity shall not possess, use, or transfer any VS select agent or toxin without a certificate of registration issued by the Administrator. Unless exempted under § 121.6 or 42 CFR 73.6, an individual or entity shall not possess, use, or transfer any overlap select agent or toxin without a certificate of registration issued by the Administrator and the HHS Secretary.
(b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxins currently in its possession.
(c) As a condition of registration, each entity must designate an individual to be its responsible official. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, the individual will be considered the responsible official.
(d)(1) As a condition of registration, the following must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General:
(i) The individual or entity;
(ii) The responsible official; and
(iii) Unless otherwise exempted under this section, any individual who owns or controls the entity.
(2) Federal, State, or local governmental agencies, including public accredited academic institutions, are exempt from the security risk assessments for the entity and the individual who owns or controls such entity.
(3) An individual will be deemed to own or control an entity under the following conditions:
(i) For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.
(ii) For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual:
(A) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or
(B) Is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.
(4) An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)).
(5) To obtain a security risk assessment, an individual or entity must submit the information necessary to conduct a security risk assessment to the Attorney General.
(e) To apply for a certificate of registration for only VS select agents or toxins, or for VS and PPQ select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS. To apply for a certificate of registration for overlap select agents or toxins, overlap select agents or toxins and any combination of PPQ or VS select agents or toxins, or HHS select agents or toxins and any combination of PPQ or VS select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS or CDC, but not both.
(f) Prior to the issuance of a certificate of registration, the responsible official must promptly provide notification of any changes to the application for registration by submitting the relevant page(s) of the registration application.
(g) The issuance of a certificate of registration may be contingent upon inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part.
(h) A certificate of registration will be valid for one physical location (a room, a building, or a group of buildings) where the responsible official will be able to perform the responsibilities required in this part, for specific select agents or toxins, and for specific activities.
(i) A certificate of registration may be amended to reflect changes in circumstances (e.g., replacement of the responsible official or other personnel changes, changes in ownership or control of the entity, changes in the activities involving any select agents or toxins, or the addition or removal of select agents or toxins).
(1) Prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application.
(2) The responsible official will be notified in writing if an application to amend a certificate of registration has been approved. Approval of an amendment may be contingent upon an inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part.
(3) No change may be made without such approval.
(j) An entity must immediately notify APHIS or CDC if it loses the services of its responsible official. In the event that an entity loses the services of its responsible official, an entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of this part.
(k) A certificate of registration will be terminated upon the written request of the entity if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered.
(l) A certificate of registration will be valid for a maximum of 3 years.
(a) An application may be denied or a certificate of registration revoked or suspended if:
(1) The individual or entity, the responsible official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b;
(2) The individual or entity, the responsible official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of:
(i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
(ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or
(iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801;
(3) The individual or entity does not meet the requirements of this part;
(4) It is determined that such action is necessary to protect animal health or animal products.
(b) Upon revocation or suspension of a certificate of registration, the individual or entity must:
(1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order;
(2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and
(3) Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension.
(c) Denial of an application for registration and revocation of registration may be appealed under § 121.20. However, any denial of an application for registration or revocation of a certificate of registration will remain in effect until a final agency decision has been rendered.
(a) An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must.
(1) Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General.
(2) Be familiar with the requirements of this part.
(3) Have authority and responsibility to act on behalf of the entity.
(4) Ensure compliance with the requirements of this part.
(5) Have a physical (and not merely a telephonic or audio/visual) presence at the registered entity to ensure that the entity is in compliance with the select agent regulations and be able to respond in a timely manner to onsite incidents involving select agents and toxins in accordance with the entity's incident response plan.
(6) Ensure that annual inspections are conducted for each registered space where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected and the corrections documented.
(7) Ensure that individuals are provided the contact information for the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins.
(8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the responsible official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives any report of any inactivation failure after the movement of material to another location, the responsible official must report immediately by telephone or email the inactivation or viable agent removal method failure to APHIS or CDC.
(9) Review, and revise as necessary, each of the entity's validated inactivation procedures or viable select agent removal methods. The review must be conducted annually or after any change in principal investigator, change in the validated inactivation procedure or viable select agent removal method, or failure of the validated inactivation procedure or viable select agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable select agent removal method, or viability testing protocol.
(b) An entity may designate one or more individuals to serve as an alternate responsible official who acts for the responsible official in his/her absence. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official.
(c) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification.
(1) The identification of any of the following select agents or toxins must be immediately reported by telephone, facsimile, or email: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), Bacillus anthracis, Burkholderia mallei, Burkholderia pseudomallei, classical swine fever virus, foot-and-mouth disease virus, virulent Newcastle disease virus, rinderpest virus, or swine vesicular disease virus. The final disposition of the agent or toxin must be reported by submission of APHIS/CDC Form 4 within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years.
(2) To report the identification and final disposition of any other select agent or toxin, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years.
(3) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas.
(d) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for proficiency testing. To report the identification and final disposition of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(a) An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin, unless the individual is approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General.
(b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (e.g., carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin.
(c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins.
(d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General.
(e) A person with valid approval from the HHS Secretary or Administrator to have access to select agents or toxins may request, through his or her Responsible Official, that the HHS Secretary or Administrator provide their approved access status to another registered individual or entity for a specified period of time. A responsible official must immediately notify the responsible official of the visited entity if the person's access to select agents and toxins has been terminated.
(f) An individual's security risk assessment may be expedited upon written request by the responsible official and a showing of good cause (e.g., public health or agricultural emergencies, national security, or a short-term visit by a prominent researcher). A written decision granting or denying the request will be issued.
(g) An individual's access approval for VS select agents or toxins may be denied, limited, or revoked if:
(1) The individual is within any of the categories described in 18 U.S.C. 175b;
(2) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801; or
(3) It is determined that such action is necessary to protect animal health or animal products.
(h) For overlap select agents or toxins, an individual's access approval will be denied or revoked if the individual is within any of the categories described in 18 U.S.C. 175b. An individual's access approval may be denied, limited, or revoked for the reasons set forth in paragraphs (f)(2) through (f)(3) of this section.
(i) An individual may appeal the Administrator's decision to deny, limit, or revoke access approval under § 121.20.
(j) Access approval is valid for a maximum of 3 years.
(k) The responsible official must immediately notify APHIS or CDC when an individual's access to select agents or toxins is terminated by the entity and the reasons therefore.
(a) An individual or entity required to register under this part must develop and implement a written security plan. The security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release.
(b) The security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. A current security plan must be submitted for initial registration, renewal of registration, or when requested.
(c) The security plan must:
(1) Describe procedures for physical security, inventory control, and information systems control;
(2) Contain provisions for the control of access to select agents and toxins, including the safeguarding of animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent, against unauthorized access, theft, loss or release.
(3) Contain provisions for routine cleaning, maintenance, and repairs;
(4) Establish procedures for removing unauthorized or suspicious persons;
(5) Describe procedures for addressing loss or compromise of keys, keycards, passwords, combinations, etc. and protocols for changing access permissions or locks following staff changes;
(6) Contain procedures for reporting unauthorized or suspicious persons or activities, loss or theft of select agents or toxins, release of select agents or toxins, or alteration of inventory records;
(7) Contain provisions for ensuring that all individuals with access approval from the Administrator or the HHS Secretary understand and comply with the security procedures.
(8) Describe procedures for how the responsible official will be informed of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins; and describe procedures for how the entity will notify the appropriate Federal, State, or local law enforcement agencies of such activity.
(9) Contain provisions for information security that:
(i) Ensure that all external connections to systems which manage security for the registered space are isolated or have controls that permit only authorized and authenticated users;
(ii) Ensure that authorized and authenticated users are only granted access to select agent and toxin related information, files, equipment (e.g., servers or mass storage devices), and applications as necessary to fulfill their roles and responsibilities, and that access is modified when the user's roles and responsibilities change or when their access to select agents and toxins is suspended or revoked;
(iii) Ensure that controls are in place that are designed to prevent malicious code (such as, but not limited to, computer viruses, worms, spyware) from compromising the confidentiality, integrity, or availability of information systems which manage access to spaces registered under this part or records as specified in § 121.17;
(iv) Establish a robust configuration management practice for information systems to include regular patching and updates made to operating systems and individual applications; and
(v) Establish procedures that provide backup security measures in the event that access control systems, surveillance devices, and/or systems that manage the requirements of § 121.17 are rendered inoperable.
(10) Contain provisions and policies for shipping, receiving, and storage of select agents and toxins, including documented procedures for receiving, monitoring, and shipping of all select agents and toxins. These provisions must provide that an entity will properly secure containers on site and have a written contingency plan for unexpected shipments.
(d) An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security:
(1) Allow access only to individuals with access approval from the Administrator or the HHS Secretary;
(2) Allow individuals not approved for access by the Administrator or the HHS Secretary to conduct routine cleaning, maintenance, repairs, and other activities not related to select agents or toxins only when continuously escorted by an approved individual if the potential to access to select agents or toxins exists;
(3) Provide for the control of select agents and toxins by requiring freezers, refrigerators, cabinets, and other containers where select agents or toxins are stored to be secured against unauthorized access (e.g., card access system, lock boxes);
(4) Inspect all suspicious packages before they are brought into or removed from an area where select agents or toxins are used or stored;
(5) Establish a protocol for intra-entity transfers under the supervision of an individual with access approval from the Administrator or the HHS Secretary, including chain-of-custody documents and provisions for safeguarding against theft, loss, or release; and
(6) Require that individuals with access approval from the Administrator or the HHS Secretary refrain from sharing with any other person their unique means of accessing a select agent or toxin (e.g., keycards or passwords);
(7) Require that individuals with access approval from the Administrator or the HHS Secretary immediately report any of the following to the responsible official:
(i) Any loss or compromise of keys, passwords, combinations, etc.;
(ii) Any suspicious persons or activities;
(iii) Any loss or theft of select agents or toxins;
(iv) Any release of a select agent or toxin;
(v) Any sign that inventory or use records for select agents or toxins have been altered or otherwise compromised; and
(vi) Any loss of computer, hard drive or other data storage device containing information that could be used to gain access to select agents or toxins; and
(8) Separate areas where select agents and toxins are stored or used from the public areas of the building.
(e) Entities must conduct complete inventory audits of all affected select agents and toxins in long-term storage when any of the following occur:
(1) Upon the physical relocation of a collection or inventory of select agents or toxins for those select agents or toxins in the collection or inventory;
(2) Upon the departure or arrival of a principal investigator for those select agents and toxins under the control of that principal investigator; or
(3) In the event of a theft or loss of a select agent or toxin, all select agents and toxins under the control of that principal investigator.
(f) In addition to the requirements contained in paragraphs (c) and (d) of this section, the security plan for an individual or entity possessing a Tier 1 select agent or toxin must also:
(1) Describe procedures for conducting a pre-access suitability assessment of persons who will have access to a Tier 1 select agent or toxin;
(2) Describe procedures for how an entity's responsible official will coordinate their efforts with the entity's safety and security professionals to ensure security of Tier 1 select agents and toxins and share, as appropriate, relevant information; and
(3) Describe procedures for the ongoing assessment of the suitability of personnel with access to a Tier 1 select agent or toxin. The procedures must include:
(i) Self- and peer-reporting of incidents or conditions that could affect an individual's ability to safely have access to or work with select agents and toxins, or to safeguard select agents and toxins from theft, loss, or release;
(ii) The training of employees with access to Tier 1 select agents and toxins on entity policies and procedures for reporting, evaluation, and corrective actions concerning the assessment of personnel suitability; and
(iii) The ongoing suitability monitoring of individuals with access to Tier 1 select agents and toxins.
(4) Entities with Tier 1 select agents and toxins must prescribe the following security enhancements:
(i) Procedures that will limit access to a Tier 1 select agent or toxin to only those individuals who are approved by the HHS Secretary or Administrator following a security risk assessment by the Attorney General, have had an entity-conducted pre-access suitability assessment, and are subject to the entity's procedures for ongoing suitability assessment;
(ii) Procedures that limit access to laboratory and storage facilities outside of normal business hours to only those specifically approved by the responsible official or designee;
(iii) Procedures for allowing visitors, their property, and vehicles at the entry and exit points to the registered space, or at other designated points of entry to the building, facility, or compound that are based on the entity's site-specific risk assessment;
(iv) A minimum of three security barriers where each security barrier adds to the delay in reaching secured areas where select agents and toxins are used or stored. One of the security barriers must be monitored in such a way as to detect intentional and unintentional circumventing of established access control measures under all conditions (day/night, severe weather, etc.) The final barrier must limit access to the select agent or toxin to personnel approved by the HHS Secretary or Administrator, following a security risk assessment by the Attorney General.
(v) All registered space or areas that reasonably afford access to the registered space must be protected by an intrusion detection system (IDS) unless physically occupied;
(vi) Personnel monitoring the IDS must be capable of evaluating and interpreting the alarm and alerting the designated security response force or law enforcement;
(vii) For powered access control systems, describe procedures to ensure that security is maintained in the event of the failure of access control systems due to power disruption affecting registered space;
(viii) The entity must:
(A) Determine that the response time for security forces or local police will not exceed 15 minutes where the response time is measured from the time of an intrusion alarm, or report of a security incident, to the arrival of the responders at the first security barrier or;
(B) Provide security barriers that are sufficient to delay unauthorized access until the response force arrives in order to safeguard the select agents and toxins from theft, intentional release, or unauthorized access. The response time is measured from the time of an intrusion alarm, or report of a security incident, to the arrival of the responders at the first security barrier.
(5) Entities that possess foot-and-mouth disease virus and rinderpest virus must have the following additional security requirements:
(i) A minimum of four barriers, one of which must be a perimeter security fence or equivalent which is monitored 24 hours a day, 7 days a week (24/7) to detect the presence of unauthorized persons, vehicles, materials, or unauthorized activities;
(ii) Onsite 24/7 armed security response force with roving patrol. Response time must not exceed 5 minutes from the time of an intrusion alarm or report of a security incident;
(iii) CCTV surveillance with 24/7 monitoring and recording; and
(iv) Transport vehicle with GPS tracking designed to serve as a containment vehicle.
(g) In developing a security plan, an individual or entity should consider the document entitled, “Security Plan Guidance.” This document is available on the National Select Agent Registry at http://www.selectagents.gov/.
(h) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personal participants.
(a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.
(1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biosafety risk associated with laboratory procedures related to the select agent or toxin;
(2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards;
(3) Written procedures for each validated method used for disinfection, decontamination, or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding (if applicable), animal carcasses or extracted tissues and fluids (if applicable), laboratory surfaces and equipment, and effluent material; and
(4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination.
(b) The biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).
(c) In developing a biosafety plan, an individual or entity should consider the following:
(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document is available on the National Select Agent Registry at http://www.selectagents.gov/.
(2) The “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.” This document is available on the Internet at http://www.selectagents.gov/.
(d) The biosafety plan must include an occupational health program for individuals with access to Tier 1 select agents and toxins, and those individuals must be enrolled in the occupational health program.
(e) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.
(a) An individual or entity may not conduct, or possess products resulting from, the following experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator:
(1) Experiments that involve the deliberate transfer of, or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of synthetic or recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] <100 ng/kg body weight.
(b) The Administrator may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part.
(c) To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued.
(a) An individual or entity required to register under this part must develop and implement a written incident response plan
(b) The incident response plan must fully describe the entity's response procedures for the theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, and other natural and man-made events.
(c) The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent.
(d) The incident response plan must also contain the following information:
(1) The name and contact information (e.g., home and work) for the individual or entity (e.g., responsible official, alternate responsible official(s), biosafety officer, etc.);
(2) The name and contact information for the building owner and/or manager, where applicable;
(3) The name and contact information for tenant offices, where applicable;
(4) The name and contact information for the physical security official for the building, where applicable;
(5) Personnel roles and lines of authority and communication;
(6) Planning and coordination with local emergency responders;
(7) Procedures to be followed by employees performing rescue or medical duties;
(8) Emergency medical treatment and first aid;
(9) A list of personal protective and emergency equipment, and their locations;
(10) Site security and control;
(11) Procedures for emergency evacuation, including type of evacuation, exit route assignments, safe distances, and places of refuge; and
(12) Decontamination procedures.
(e) Entities with Tier 1 select agents and toxins must have the following additional incident response policies or procedures:
(1) The incident response plan must fully describe the entity's response procedures for failure of intrusion detection or alarm system; and
(2) The incident response plan must describe procedures for how the entity will notify the appropriate Federal, State, or local law enforcement agencies of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins.
(f) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.
(a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to:
(1) Each individual with access approval from the Administrator or HHS Secretary. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the Administrator or the HHS Secretary for access, whichever is earlier.
(2) Each individual not approved for access to select agents and toxins by the Administrator or HHS Secretary before that individual enters areas under escort where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.).
(b) Entities with Tier 1 select agents and toxins must conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors.
(c) Refresher training must be provided annually for individuals with access approval from the HHS Secretary or Administrator or at such time as the registered individual or entity significantly amends its security, incident response, or biosafety plans.
(d) The responsible official must ensure a record of the training provided to each individual with access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors, etc.) is maintained. The record must include the name of the individual, the date of the training, a description of the training provided, and the means used to verify that the employee understood the training.
(e) The responsible official must ensure and document that individuals are provided the contact information of the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.
(a) Except as provided in paragraphs (c) and (d) of this section, a select agent or toxin may only be transferred to individuals or entities registered to possess, use, or transfer that agent or toxin. A select agent or toxin may only be transferred under the conditions of this section and must be authorized by APHIS or CDC prior to the transfer.
(b) A transfer may be authorized if:
(1) The sender:
(i) Has at the time of transfer a certificate of registration that covers the particular select agent or toxin to be transferred and meets all the requirements of this part;
(ii) Meets the exemption requirements for the particular select agent or toxin to be transferred; or
(iii) Is transferring the select agent or toxin from outside of the United States and meets all import requirements.
(2) At the time of transfer, the recipient has a certificate of registration that includes the particular select agent or toxin to be transferred and meets all of the requirements of this part.
(c) A select agent or toxin that is contained in a specimen for proficiency testing may be transferred without prior authorization from APHIS or CDC provided that, at least 7 calendar days prior to the transfer, the sender reports to APHIS or CDC the select agent or toxin to be transferred and the name and address of the recipient.
(d) On a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under this part under conditions prescribed by the Administrator.
(e) To obtain authorization for a transfer, APHIS/CDC Form 2 must be submitted.
(f) After authorization is provided by APHIS or CDC, the packaging of the select agent(s) and toxin(s) is performed by an individual approved by the HHS Secretary or Administrator to have access to select agents and toxins and is in compliance with all applicable laws concerning packaging.
(g) The sender must comply with all applicable laws governing shipping.
(h) Transportation in commerce starts when the select agent(s) or toxin(s) are packaged for shipment and ready for receipt by a courier transporting select agent(s) or toxin(s) and ends when the package is received by the intended recipient who is an individual approved by the HHS Secretary or Administrator to have access to select agents and toxins, following a security risk assessment by the Attorney General.
(i) The recipient must submit a completed APHIS/CDC Form 2 within 2 business days of receipt of a select agent or toxin.
(j) The recipient must immediately notify APHIS or CDC if the select agent or toxin has not been received within 48 hours after the expected delivery time or if the package containing the select agent or toxin has been damaged to the extent that a release of the select agent or toxin may have occurred.
(k) An authorization for a transfer shall be valid only for 30 calendar days after issuance, except that such an authorization becomes immediately null and void if any facts supporting the authorization change (e.g., change in the certificate of registration for the sender or recipient, change in the application for transfer).
(l) Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Information to be documented includes, but is not limited, to the recipient information, toxin and amount transferred, and declaration that the recipient has legitimate purpose to store and use such toxins.
(a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include:
(1) An accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials), including:
(i) The name and characteristics (e.g., strain designation, GenBank Accession number, etc.);
(ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source;
(iii) Where stored (e.g., building, room, and freezer or other storage container);
(iv) When moved from storage and by whom and when returned to storage and by whom;
(v) The select agent used, purpose of use, and, when applicable, final disposition;
(vi) Records created under § 121.16 or 42 CFR 73.16 (Transfers);
(vii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient; and
(viii) Records created under § 121.19 or 42 CFR 73.19 (Notification of theft, loss, or release);
(2) An accurate, current accounting of any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition);
(3) An accurate, current inventory for each toxin held, including:
(i) The name and characteristics;
(ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source;
(iii) The initial and current quantity amount (e.g., milligrams, milliliters, grams, etc.);
(iv) The toxin used and purpose of use, quantity, date(s) of the use and by whom;
(v) Where stored (e.g., building, room, and freezer or other storage container);
(vi) When moved from storage and by whom and when returned to storage and by whom, including quantity amount;
(vii) Records created under § 121.16 or 42 CFR 73.16 (Transfers);
(viii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the toxin, the quantity transferred, the date of transfer, the sender, and the recipient;
(ix) Records created under § 121.19 or 42 CFR 73.19 (Notification of theft, loss, or release);
(x) If destroyed, the quantity of toxin destroyed, the date of such action, and by whom.
(4) A current list of all individuals that have been granted access approval by the Administrator or the HHS Secretary;
(5) Information about all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and the date and time of entry;
(6) Accurate, current records created under § 121.9 or 42 CFR 73.9 (Responsible official), § 121.11 or 42 CFR 73.11 (Security), § 121.12 or 42 CFR 73.12 (Biosafety), § 121.14 or 42 CFR 73.14 (Incident response), and § 121.15 or 42 CFR 73.15 (Training);
(7) A written explanation of any discrepancies; and
(8) For select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent:
(i) A written description of the validated inactivation procedure or viable select agent removal method used, including validation data;
(ii) A written description of the viability testing protocol used;
(iii) A written description of the investigation conducted by the entity responsible official involving an inactivation or viable select agent removal failure and the corrective actions taken;
(iv) The name of each individual performing the validated inactivation or viable select agent removal method;
(v) The date(s) the validated inactivation or viable select agent removal method was completed;
(vi) The location where the validated inactivation or viable select agent removal method was performed; and
(vii) A certificate, signed by the principal investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the principal investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material.
(b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate and legible, have controlled access, and that their authenticity may be verified.
(c) The individual or entity must promptly produce upon request any information that is related to the requirements of this part but is not otherwise contained in a record required to be kept by this section. The location of such information may include, but is not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.
(a) Without prior notification, APHIS must be allowed to inspect any site at which activities regulated under this part are conducted and must be allowed to inspect and copy any records relating to the activities covered by this part.
(b) Prior to issuing a certificate of registration to an individual or entity, APHIS may inspect and evaluate the premises and records to ensure compliance with this part.
(a) An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified.
(1) The theft or loss of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided:
(i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);
(ii) An estimate of the quantity stolen or lost;
(iii) An estimate of the time during which the theft or loss occurred;
(iv) The location (building, room) from which the theft or loss occurred; and
(v) The list of Federal, State, or local law enforcement agencies to which the individual or entity reported, or intends to report, the theft or loss.
(2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days.
(b) An individual or entity must immediately notify APHIS or CDC upon discovery of a release of a select agent or toxin causing occupational exposure or a release of a select agent or toxin outside of the primary barriers of the biocontainment area.
(1) The release of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided:
(i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);
(ii) An estimate of the quantity released;
(iii) The time and duration of the release;
(iv) The environment into which the release occurred (e.g., in building or outside of building, waste system);
(v) The location (building, room) from which the release occurred; and
(vi) The number of individuals potentially exposed at the entity;
(vii) Actions taken to respond to the release; and
(viii) Hazards posed by the release.
(2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days.
(a) An individual or entity may appeal a denial, revocation, or suspension of registration under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 30 calendar days of the decision.
(b) An individual may appeal a denial, limitation, or revocation of access approval under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 180 calendar days of the decision.
(c) The Administrator's decision constitutes final agency action.
The following words, when used in the regulations in this part 122, shall be construed, respectively, to mean:
(a) Department. The U.S. Department of Agriculture.
(b) Secretary. “Secretary” means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
(c) Administrator. The Administrator, Animal and Plant Health Inspection Service, United States Department of Agriculture, or any person authorized to act for the Administrator.
(d) Organisms. All cultures or collections of organisms or their derivatives, which may introduce or disseminate any contagious or infectious disease of animals (including poultry).
(e) Vectors. All animals (including poultry) such as mice, pigeons, guinea pigs, rats, ferrets, rabbits, chickens, dogs, and the like, which have been treated or inoculated with organisms, or which are diseased or infected with any contagious, infectious, or communicable disease of animals or poultry or which have been exposed to any such disease.
(f) Permittee. A person who resides in the United States or operates a business establishment within the United States, to whom a permit to import or transport organisms or vectors has been issued under the regulations.
(g) Person. Any individual, firm, partnership, corporation, company, society, association, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.
No organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof: Provided, That no permit shall be required under this section for importation of organisms for which an import permit has been issued pursuant to part 102 of this subchapter or for transportation of organisms produced at establishments licensed under part 102 of this subchapter. As a condition of issuance of permits under this section, the permittee shall agree in writing to observe the safeguards prescribed by the Administrator for public protection with respect to the particular importation or transportation.
The Secretary may issue, at his discretion, a permit as specified in § 122.2 when proper safeguards are set up as provided in § 122.2 to protect the public. Application for such a permit shall be made in advance of shipment, and each permit shall specify the name and address of the consignee, the true name and character of each of the organisms or vectors involved, and the use to which each will be put.
(a) Any permit for the importation or transportation of organisms or vectors issued under this part may be formally suspended or revoked after opportunity for hearing has been accorded the permittee, as provided in part 123 of this subchapter, if the Secretary finds that the permittee has failed to observe the safeguards and instructions prescribed by the Administrator with respect to the particular importation or transportation or that such importation or transportation for any other reason may result in the introduction or dissemination from a foreign country into the United States, or from one State, Territory or the District of Columbia to another, of the contagion of any contagious, infectious or communicable disease of animals (including poultry).
(b) In cases of wilfulness or where the public health, interest or safety so requires, however, the Secretary may without hearing informally suspend such a permit upon the grounds set forth in paragraph (a) of this section, pending determination of formal proceedings under part 123 of this subchapter for suspension or revocation of the permit.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the Virus-Serum-Toxin Act.
(a) This parts sets forth procedures and requirements for APHIS review of applications for the extension of the term of certain patents for veterinary biological products pursuant to 35 U.S.C. 156—Extension of patent term. Responsibilities of APHIS include:
(1) Assisting PTO in determining eligibility for patent term restoration;
(2) Determining the length of a product's regulatory review period;
(3) If petitioned, reviewing and ruling on due diligence challenges to APHIS's regulatory review period determinations; and
(4) Conducting hearings to review initial APHIS findings on due diligence challenges.
(b) The regulations in this part are designed to be used in conjunction with regulations issued by PTO concerning patent term extension which may be found at 37 CFR 1.710 through 1.791.
Animal and Plant Health Inspection Service (APHIS). The agency in the Department of Agriculture responsible for licensing veterinary biological products under the Virus-Serum-Toxin Act.
Applicant. Any person who submits an application or an amendment or supplement to an application under 35 U.S.C. 156 seeking extension of the term of a patent.
Due diligence petition. A petition submitted under § 124.30 of this part.
Informal hearing. A hearing that is not subject to the provisions of 5 U.S.C. 554, 556, and 557 and that is conducted as provided in 21 U.S.C. 321(x).
License applicant. Any person who, in accordance with part 102 of this chapter, submits an application to the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture for a U.S. Veterinary Biological Product License.
Patent. A patent issued by the Patent and Trademark Office of the United States Department of Commerce.
Person. Any individual, firm, partnership, corporation, company, association, educational institution, State or local government agency, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.
PTO. The Patent and Trademark Office of the United States Department of Commerce.
Upon receipt of a copy of an application for extension of the term of a veterinary biologic patent from PTO, APHIS will assist PTO in determining whether a patent related to a biological product is eligible for patent term extension by:
(a)(1) Verifying whether the product was subject to a regulatory review period before its commercial marketing or use;
(2) Determining whether the permission for commercial marketing or use of the product after the regulatory review period was the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred, and, if so, whether it was the first permitted commercial marketing or use of the veterinary biological product for administration to a food-producing animal;
(3) Ascertaining whether the patent term restoration application was submitted within 60 days after the product was approved for marketing or use; and
(4) Providing such other information as may be necessary and relevant to PTO's determination of whether a patent related to a product is eligible for patent term restoration.
(b) APHIS will notify PTO of its findings in writing, send a copy of this notification to the applicant, and make a copy available for public inspection in room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
(a) As provided in 37 CFR 1.779 of PTO's regulations, in order to determine a product's regulatory review period, APHIS will review the information in each application to determine the lengths of the following phases of the review period, and will then find their sum:
(1) The number of days in the period beginning on the date authorization to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective and ending on the date an application for a license was initially submitted under the Virus-Serum-Toxin Act; and
(2) The number of days in the period beginning on the date an application for a license was initially submitted for approval under the Virus-Serum-Toxin Act and ending on the date such license was issued.
(b) A license application is “initially submitted” on the date it contains sufficient information to allow APHIS to commence review of the application. A product license is issued on the date of the APHIS letter informing the applicant of the issuance. The issuance of a license releases the product for commercial marketing or use.
(a) Not later than 30 days after the receipt of an application from PTO, APHIS shall determine the regulatory review period. Once the regulatory review period for a product has been determined, APHIS will notify PTO in writing of the determination, send a copy of the determination to the applicant, and make a copy available for public inspection in room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
(b) APHIS will also publish a notice of the regulatory review period determination in the
(1) The name of the applicant;
(2) The trade name and true name of the product;
(3) The number of the patent for which an extension of the term is sought;
(4) The approved indications or uses for the product;
(5) The regulatory review period determination, including a statement of the length of each phase of the review period and the dates used in calculating each phase.
(a) Any interested person may request a revision of the regulatory review period determination within the 30 day period beginning on its publication in the
(1) The identity of the product;
(2) The identity of the applicant for patent term restoration;
(3) The docket number of the
(4) The basis for the request for revision, including any documentary evidence.
(b) If APHIS decides to revise its prior determination, APHIS will notify PTO of the decision, and will send a copy of notification to the applicant and the person requesting the revision (if different from the applicant) with a request for comments within 10 days of notification. If no comment on the proposed revision is received, APHIS will publish the revision in the
APHIS will consider its regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 124.30 unless it receives:
(a) New information from PTO records, or APHIS records, that affects the regulatory review period determination;
(b) A request under § 124.22 for revision of the regulatory review period determination;
(c) A due diligence petition filed under § 124.30; or
(d) A request for a hearing filed under § 124.40.
(a) Any interested person may file a petition with APHIS, no later than 180 days after the publication of a regulatory review period determination under § 124.21, alleging that a license applicant did not act with due diligence in seeking APHIS approval of the product during the regulatory review period.
(b) The petition must be filed with APHIS under the docket number of the
(c) The petition must allege that the applicant failed to act with due diligence sometime during the regulatory review period and must set forth sufficient facts to merit an investigation by APHIS of whether the applicant acted with due diligence.
(d) The petition must contain a certification that the petitioner has served a true and complete copy of the petition on interested parties by certified or registered mail (return receipt requested) or by personal delivery.
(a) The applicant may file with APHIS a written response to the petition no later than 20 days after the applicant's receipt of a copy of the petition.
(b) The applicant's response may present additional facts and circumstances to address the assertions in the petition, but shall be limited to the issue of whether the applicant acted with due diligence during the regulatory review period. The applicant's response may include documents that were not in the original patent term extension application.
(c) If the applicant does not respond to the petition, APHIS will decide the matter on the basis of the information submitted in the patent term restoration application, the due diligence petition, and APHIS records.
(a) Within 90 days after APHIS receives a petition filed under § 124.30, the Under Secretary for Marketing and Regulatory Programs shall make a determination under paragraphs (b) or (c) of this section or under § 124.33 whether the applicant acted with due diligence during the regulatory review period. APHIS will publish its determination in the
(b) APHIS may deny a due diligence petition without considering the merits of the petition if:
(1) The petition is not filed in accordance with § 124.30;
(2) The petition does not contain information or allegations upon which APHIS may reasonably determine that the applicant did not act with due diligence during the applicable regulatory review period; or
(3) The petition fails to allege a sufficient total amount of time during which the applicant did not exercise due diligence so that, even if the petition were granted, the petition would not affect the maximum patent term extension which the applicant is entitled to under 35 U.S.C. 156.
(a) In determining the due diligence of an applicant, APHIS will examine the facts and circumstances of the applicant's actions during the regulatory review period to determine whether the applicant exhibited the degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. APHIS will take into consideration all relevant factors, such as the amount of time between the approval of an experimental use permit and licensure of the veterinary biological product.
(b) For purposes of this Part, the actions of the marketing applicant shall be imputed to the applicant for patent term restoration. The actions of an agent, attorney, contractor, employee, licensee, or predecessor in interest of the marketing applicant shall be imputed to the applicant for patent term restoration.
(a) Any interested person may request, within 60 days beginning on the date of publication of a due diligence determination by APHIS in accordance with § 124.32, that APHIS conduct an informal hearing on the due diligence determination.
(b) The request for a hearing must:
(1) Be in writing;
(2) Contain the docket number of the
(3) Be delivered to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010.
(4) Contain a full statement of facts upon which the request for hearing is based;
(5) Contain the name, the address, and the principal place of business of the person requesting the hearing; and
(6) Contain a certification that the person requesting the hearing has served a true and complete copy of the request upon the petitioner of the due diligence determination and the applicant for patent term extension by certified or registered mail (return receipt requested) or by personal service.
(c) The request must state whether the requesting party seeks a hearing not later than 30 days after the date APHIS receives the request, or, at the request of the person making the request, not later than 60 days after such date.
No later than ten days before the hearing, APHIS will notify the requesting party, the applicant, the petitioner, and any other interested person of the date, time, and location of the hearing.
(a) The presiding officer shall be appointed by the Administrator of APHIS from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.
(b) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.
(c) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and any general summary of the information which will be presented at the hearing in support of such action.
(d) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral and written information relevant to such action.
(e) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.
(f) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.
(g) The due diligence hearing will be conducted in accordance with rules of practice adopted for the proceeding. APHIS will provide the requesting party, the applicant, and the petitioner with an opportunity to participate as a party in the hearing. The standard of due diligence set forth in § 124.33 will apply at the hearing. The party requesting the due diligence hearing will have the burden of proof at the hearing.
Within 30 days after completion of the due diligence hearing, the Under Secretary for Marketing and Regulatory Programs, taking into consideration the recommendation of the Administrator, will affirm or revise the determination made under § 124.32. APHIS will publish the due diligence redetermination in the
As used in this part, the following terms shall have the meaning set forth in this section.
Administrator. The Administrator of the Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal. All animals except birds, but including poultry.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animal Import Center. Quarantine facilities operated by APHIS in Newburgh, New York, and Miami, Florida.
APHIS representative. An individual, including, but not limited to, an animal health technician or veterinarian, authorized by the Administrator to perform the services for which the user fees in this part are charged.
Bird. Any member of the class aves, other than poultry.
Consumer price index. The measure of the average change over time in prices paid by urban consumers for a market basket of consumer goods and services, as determined by the Bureau of Labor Statistics annually.
Cost of living. The adjusted annual rate used to determine the cost of maintaining a certain standard of living based on the economic assumptions in the Office of Management and Budget's Presidential Economic Assumptions.
Diagnostic reagent. Substances used in diagnostic tests to detect disease agents or antibodies by causing an identifiable reaction.
Direct operating costs. Costs attributed to travel and transportation for personnel; materials, supplies, and other necessary items; training; general office supplies; rent; facility maintenance; equipment purchase and maintenance; utilities; contractual services; and information system operations, maintenance, and development.
Direct pay (including benefits). The wage labor costs (on board and in the hiring process), including benefits, for employees who specifically support and provide the required service.
Equine. Any horse, ass, mule, or zebra.
Export health certificate. An official document that, as required by the importing country, is endorsed by an APHIS representative and states that animals, animal products, organisms, vectors, or birds to be exported from the United States were found to be healthy and free from evidence of communicable diseases and pests.
Feeder animal. Any animal imported into the United States under part 93 of this chapter for feeding.
Germplasm. Semen, embryos, or ova.
Import compliance assistance. Services provided to an importer whose shipment arrives at a port of entry without the necessary paperwork or with incomplete paperwork and who requires assistance to meet the requirements for entry into the United States. Fees for import compliance assistance are charged in addition to the flat rate user fees.
Imputed costs. Office of Workers' Compensation costs from the Department of Labor; costs of employee leave earned in a prior fiscal year and used in the current fiscal year; Office of Personnel Management and Department of State (State Department) costs to provide retirement, health, and life insurance benefits to employees; unemployment compensation costs; and Department of Justice judgment fund costs.
In-bond animal. Any animal imported into the United States under a United States Customs Service bond, as described in 19 CFR part 113.
National Veterinary Services Laboratories (NVSL). The National Veterinary Services Laboratories of the Animal and Plant Health Inspection Service, located in Ames, Iowa.
National Veterinary Services Laboratories, Foreign Animal Disease Diagnostic Laboratory (FADDL). The National Veterinary Services Laboratories, Foreign Animal Disease Diagnostic Laboratory, located in Greenport, New York.
Person. An individual, corporation, partnership, trust, association, or any other public or private entity, or any officer, employee, or agent thereof.
Pet birds. Birds, except hatching eggs and ratites, that are imported or exported for the personal pleasure of their individual owners and are not intended for resale.
Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys.
Privately operated permanent import-quarantine facility. Any permanent facility approved under part 93 of this chapter to quarantine animals or birds, except facilities operated by APHIS.
Program, Agency, and Department support. Indirect or direct costs of the program, including supporting services provided to the industry.
Reserve. Funds above expected obligations that are required to effectively manage uncertainties in demand and timing to ensure sufficient operating funds in cases of bad debt, customer insolvency, fluctuations in activity volumes, information technology development costs, cash flow, facilities capital needs, or fluctuations in activity volumes caused by unforeseen global and national events.
Standard feed. Seed, or dry feeds such as dog food or monkey biscuits, whether soaked in water or not.
Test. A single analysis performed on a single specimen from an animal, animal product, commercial product, or animal feed.
United States. The several States of the United States, the District of Columbia, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.
(a) Except as set forth in paragraphs (b) through (d) of this section, for setting fee rates for each calendar year based upon the previous fiscal year, APHIS will calculate the rates for services as follows:
(1) APHIS will prorate the total Veterinary Services (VS) inspection, certification, or laboratory service program personnel direct pay (on board and in hiring process including benefits) for the previous fiscal year to each fee based upon the direct time factor percentage of employee's average time to perform and complete each fee code process and then multiply by the next year's percentage of cost of living increase.
(2) APHIS will prorate total direct operating costs for the previous fiscal year based upon the direct time factor percentage of employee's average time to perform and complete each fee code process to each fee and then multiply by the anticipated percentage of inflation for the next year.
(3) APHIS will add estimates for Program, Agency, and Department support costs, imputed costs, and reserves by applying a percentage based on information from Program, Agency, and Department officials and the Department of Treasury to the sum of the direct pay plus direct operating costs.
(4) The amounts derived via the process described in this paragraph (a) and paragraphs (b) and (c) of this section will be added and then APHIS will round up to the next $0.25 for all fees less than $10 or round up to the nearest dollar for all fees greater than $10 to develop the new rate for each code.
(b) If there is no identifiable volume in the previous year for the service provided by the fee, if the fee is rarely charged, or if APHIS cannot readily identify level of effort, APHIS will calculate the fee based on the last available historic data encompassing multiple instances of use and add any intervening inflation, overhead and support costs, imputed costs, and reserve.
(c) Fees for the exclusive use of space in animal import centers will be calculated using the following formula:
(1) APHIS will calculate fees by using direct employee average time (with benefits) and adding a prorated portion of currently identifiable expenses (facilities, rent, support cost, and admin support costs), program and support overhead expenses, imputed costs, and reserve.
(2) APHIS will combine the costs to determine the monthly cost of providing the service at a single location within the animal import center.
(3) APHIS will calculate the costs of the other locations within the animal import center based on the square footage of the location.
(d) Services listed in § 130.4 will be charged an hourly rate-based user fee in accordance with the provisions of that section.
(a) General standards. (1) User fee rates may be found online at www.aphis.usda.gov/business-services/vs-fees or by contacting LAIE@usda.gov. Changes in rates will be proposed annually in the following manner:
(i) APHIS will propose changes to the fee rates found at www.aphis.usda.gov/business-services/vs-fees through publication of a notice in the
(ii) Following the comment period, APHIS will issue a subsequent notice in the
(iii) When this subsequent notice is issued, APHIS will update the fee rates found at www.aphis.usda.gov/business-services/vs-fees accordingly.
(2) The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of user fees in accordance with this section.
(b) User fees for individual animals and certain birds quarantined in the APHIS-owned or -operated quarantine facilities, including APHIS Animal Import Centers. (1) Each user fee is assessed per animal or bird quarantined by APHIS. Special requirements may be requested by the importer or required by an APHIS representative. Certain conditions or traits, such as pregnancy or aggression, may necessitate special requirements for certain birds or poultry.
(2) For any animal or bird that requires a diet other than standard feed, including but not limited to diets of fruit, insects, nectar, or fish, the importer must either provide feed or pay for it on an actual cost basis, including the cost of delivery to the APHIS owned or operated Animal Import Center or quarantine facility.
(c) User fees for exclusive use of space at APHIS Animal Import Centers. (1) An importer may request to exclusively occupy a space at an APHIS animal import center. Any importer who occupies space for more than 30 days must pay 1/30th of the 30-day fee for each additional day or part of a day.
(2) Unless the importer cancels the reservation for exclusive use of space in time to receive a refund of the reservation fee in accordance with §§ 93.103, 93.204, 93.304, 93.404, or 93.504 of this chapter, as appropriate, the 30-day user fee will be effective as of the first day for which the importer has reserved the space and for the entirety of the reservation, regardless of whether the user occupies the space on that date or not.
(3) Users must provide APHIS personnel at the Animal Import Center, at the time they make a reservation for quarantine space, with the following information:
(i) Species of animals and birds to be quarantined;
(ii) Ages of animals and birds to be quarantined; and
(iii) Sizes of animals and birds to be quarantined.
(4)(i) APHIS personnel at the Animal Import Center will determine, based on the information provided by the importer under paragraph (b)(3) of this section, and on routine husbandry needs, the maximum number of animals and birds permitted in the requested building.
(ii) If APHIS personnel at the Animal Import Center determine the number of animals and birds requested by the importer can be housed in the space requested, but two animal health technicians cannot fulfill the routine husbandry needs of the number of animals or birds proposed by the importer, then the importer must either:
(A) Pay for additional services on an hourly basis; or
(B) Reduce the number of animals or birds to be quarantined to a number which APHIS personnel at the Animal Import Center determine can be handled by two animal health technicians.
(iii) If the importer requests additional services, then APHIS will calculate the user fees for any service rendered by an APHIS representative at the hourly rate user fee found online at www.aphis.usda.gov/business-services/vs-fees.
(iv) The importer must either provide feed or pay for it on an actual cost basis, including the cost of delivery to the APHIS owned or operated Animal Import Center or quarantine facility, for any animal or bird that requires a diet other than standard feed, including but not limited to diets of fruit, insects, nectar, or fish.
(d) User fees for inspection of live animals at land border ports along the United States-Canada border. If a service must be conducted on a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this chapter, must be paid for each service, in addition to the user fee found online at www.aphis.usda.gov/business-services/vs-fees.
(e) User fees for pet birds. (1) Based on the information provided to APHIS personnel, APHIS personnel at the Animal Import Center or other APHIS owned or supervised quarantine facility will determine the appropriate number of birds that should be housed per isolette.
(2) If the importer requests additional services, then APHIS will calculate the user fees for those services at the hourly rate user fee found online at www.aphis.usda.gov/business-services/vs-fees for each employee required to perform the service.
(f) User fees for endorsing export certificates. (1) User fees for the endorsement of export health certificates that require the verification of tests or vaccinations are found online at www.aphis.usda.gov/business-services/vs-fees. APHIS will calculate the user fees to apply to each export health certificate endorsed
(2) If an export certificate covers more than one animal, but the number of tests required for different animals are not the same, the user fee for the certificate is the fee which would be due if all the animals on the certificate required the same number of tests as the animal which requires the greatest number of tests.
(3) The user fees referenced in this section will not apply to an export health certificate if: (i) An APHIS veterinarian prepares the certificate for endorsement completely at the site of the inspection in the course of performing inspection or supervision services for the animals listed on the certificate; and
(ii) An APHIS user fee is payable under § 130.4 for the inspection or supervision services performed by the veterinarian.
(4) If a service must be conducted on a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this chapter, must be paid for each service, in addition to the user fee listed in this section.
(g) User fees for inspection services outside the United States. (1) If inspection services (including inspection, testing, and supervision services) are performed outside the United States, in accordance with this title, and the regulations do not contain a provision for payment of the cost of the service, the person requesting the service must pay a user fee.
(2) Any person who wants APHIS to provide inspection services outside the United States must contact the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, Live Animal Imports at LAIE@usda.gov, to make an agreement.
(3) All agreements for inspection services outside the United States must include:
(i) Name, mailing address, and telephone number of either the person requesting the inspection services, or his or her agent;
(ii) Explanation of inspection services to be provided, including the regulations in this chapter which provide for the services;
(iii) Date(s) and time(s) the inspection services are to be provided;
(iv) Location (including street address) where inspection services are to be provided;
(v) An estimate of the actual cost, as calculated by APHIS, to provide the described inspection services for 6 months;
(vi) A statement that APHIS agrees to provide the inspection services;
(vii) A statement that the person requesting the inspection services, or, if appropriate, his or her agent, agrees to pay, at the time the agreement is entered into, a user fee equal to the estimated cost of providing the described inspection services for 6 months; and
(viii) A statement that the person requesting the inspection services, or, if appropriate, his or her agent, agrees to maintain a user fee payment account equal to the cost of providing the described inspection services for 6 months, as calculated monthly by APHIS.
(4) APHIS will enter into an agreement only if qualified personnel can be made available to provide the inspection services.
(5) An agreement can be terminated by either party on 30 days written notice.
(6) If, at the time an agreement is terminated, any unobligated funds remain in the user fee payment account, APHIS will refund the funds to the person who requested the inspection services, or his or her agent.
(a) Services subject to hourly rate user fees. User fees for import- or export-related veterinary services listed in paragraphs (a)(1) through (18) of this section, except those services covered by flat rate user fees, will be calculated at the hourly rate found online at www.aphis.usda.gov/business-services/vs-fees, for each employee required to perform the service. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.6 and 130.7.
(1) Providing services to live animals for import or entry at airports, ocean ports, and rail ports.
(2) Conducting inspections, including inspections of laboratories and facilities (such as biosecurity level two facilities), required either to obtain import permits for animal products and byproducts, aquaculture products, or organisms or vectors, or to maintain compliance with import permits. This hourly rate does not apply to inspection and approval of import/export facilities and establishments.
(3) Obtaining samples required to be tested, either to obtain import permits or to ensure compliance with import permits.
(4) Providing services for imported birds or ratites that are not subject to quarantine, such as monitoring birds—including but not limited to pet birds—between flights.
(5) Supervising the opening of in-bond shipments.
(6) Providing services for in-bond or in-transit animals to exit the United States.
(7) Inspecting an export isolation facility and the animals in it.
(8) Supervising animal or bird rest periods prior to export.
(9) Supervising loading and unloading of animals or birds for export shipment.
(10) Inspecting means of conveyance used to export animals or birds.
(11) Conducting inspections under part 156 of this chapter.
(12) Inspecting and approving an artificial insemination center or a semen collection center or the animals in it.
(13) Import or entry services for feeder animals including, but not limited to, feeder goats and feeder bison not covered by a flat rate user fee in connection with activities described in § 130.3(d).
(14) Export-related bird banding for identification.
(15) Export-related inspection and approval of pet food facilities, including laboratories that perform pet food testing.
(16) Export-related services provided at animal auctions.
(17) Various export-related facility inspections, including, but not limited to, fertilizer plants that utilize poultry waste, rendering plants, and potential embarkation facilities.
(18) Providing other import-or export-related veterinary services for which no flat rate user fee is specified.
(b) When do I pay an additional amount for employee(s) working overtime? You must pay an additional amount if you need an APHIS employee to work on a Sunday, on a holiday, or at any time outside the normal tour of duty of that employee. Instead of paying the hourly rate user fee, you pay the rate found online at www.aphis.usda.gov/business-services/vs-fees for each employee needed to get the work done.
(a) Veterinary diagnostics. APHIS will not charge user fees for veterinary diagnostic services under the following conditions:
(1) When veterinary diagnostic services are provided in connection with Federal programs to control or eradicate diseases or pests of livestock or poultry in the United States (program diseases);
(2) When veterinary diagnostic services are provided in support of zoonotic disease surveillance when the Administrator has determined that there is a significant threat to human health; and
(3) When veterinary diagnostic reagents are distributed within the United States for testing for foreign animal diseases.
(b) [Reserved]
(a) Who must pay APHIS user fees? Any person for whom a service is provided related to the importation, entry, or exportation of an animal, article, or means of conveyance or related to veterinary diagnostics, and any person requesting such service, shall be jointly and severally liable for payment of fees assessed.
(b) Associated charges—(1) Reservation fee. Any reservation fee paid by an importer under part 93 of this chapter will be applied to the APHIS user fees described in § 130.3(b) and (c) for animals or birds quarantined in an animal import center.
(2) Special handling expenses. The user fees in this part do not include any costs that may be incurred due to special mail handling, including, but not limited to, express, overnight, or foreign mailing. If any service requires special mail handling, the user must pay all costs incurred, in addition to the user fee for the service.
(3) When do I pay an additional amount for employee(s) working overtime? You must pay an additional amount if you need an APHIS employee to work on a Sunday, on a holiday, or at any time outside the normal tour of duty of that employee. You pay the amount specified in this paragraph (b)(3) as relevant, for each employee needed to get the work done.
(i) What additional amount do I pay if I receive a flat rate user fee service? In addition to the flat rate user fee(s), you pay the overtime rate listed in Table 1 of this section for each employee needed to get the work done:
(ii) What amount do I pay if I receive an hourly rate user fee service? Instead of paying the normal hourly rate user fee described in § 130.4(a), you pay the premium rate described in § 130.4(b) for each employee needed to get the work done:
Table 1 to Paragraph (
| Service provided | Outside of the employee's
normal tour of duty | Overtime rates by hour | ||
|---|---|---|---|---|
| Nov. 2, 2015-Sept. 30, 2016 | Oct. 1, 2016-Sept. 30, 2017 | Beginning
Oct. 1, 2017 | ||
| Rate for inspection, testing, certification or quarantine of animals, animal products or other commodities 3 | Monday through Saturday and holidays | $75 | $75 | $75 |
| Sundays | 99 | 99 | 100 | |
| Rate for commercial airline inspection services 4 | Monday through Saturday and holidays | 64 | 65 | 65 |
| Sundays | 85 | 86 | 86 | |
1 APHIS will charge a minimum charge of 2 hours, unless performed on the employee's regular workday and performed in direct continuation of the regular workday or begun within an hour of the regular workday.
2 When the 2-hour minimum applies, you may need to pay commuted travel time. (See § 97.1(b) of this chapter for specific information about commuted travel time.)
3 See § 97.1(a) of this chapter or 7 CFR 354.3 for details.
4 See § 97.1(a)(3) of this chapter for details.
(c) When are APHIS user fees due?—(1) Animal and bird quarantine and related tests. User fees for animals and birds in an Animal Import Center or privately operated permanent or temporary import quarantine facilities, including user fees for tests conducted on these animals or birds, must be paid prior to the release of those animals or birds from quarantine.
(2) Supervision and inspection services for export animals, animal products and byproducts. User fees for supervision and inspection services described in § 130.4 must be paid when billed, or, if covered by a compliance agreement signed in accordance with this chapter, must be paid as specified in the agreement.
(3) Export health certificates. User fees for export health certificates described in § 130.3(f) must be paid prior to receipt of endorsed certificates. If APHIS determines that the user has established an acceptable credit history, the user may request to pay when billed.
(4) Veterinary diagnostics. User fees specified for veterinary diagnostic services, such as tests on samples submitted to NVSL or FADDL, diagnostic reagents, slide sets, tissue sets, and other veterinary diagnostic services, must be paid when the veterinary diagnostic service is requested. If APHIS determines that the user has established an acceptable credit history, the user may request to pay when billed.
(5) Other user fee services. User fees for import or entry services for land border ports along the United States-Mexico or United States-Canada border, inspection of germplasm being exported, release from export agricultural hold, and other services described in § 130.4 must be paid when service is provided (for example when live animals are inspected when presented for importation at a port of entry). If APHIS determines that the user has established an acceptable credit history, the user may request to pay when billed.
(d) What payment methods are acceptable? Payment must be for the exact amount due and may be paid by:
(1) Cash. Cash will be accepted only during normal business hours if payment is made at an APHIS office or an Animal Import Center;
(2) Checks. All types of checks, including traveler's checks, drawn on a U.S. bank in U.S. dollars and made payable to the U.S. Department of Agriculture or USDA;
(3) Money orders. Money orders, drawn on a U.S. bank in U.S. dollars and made payable to the U.S. Department of Agriculture or USDA; or
(4) Credit cards. Credit cards (VISA
(a) Unpaid debt. If any person for whom the service is provided fails to pay when due any debt to APHIS, including any user fee due under 7 CFR chapter III or this chapter, then:
(1) Subsequent user fee payments. Payment must be made for subsequent user fees before the service is provided if:
(i) For unbilled fees, the user fee is unpaid 60 days after the date the pertinent regulatory provision indicates payment is due;
(ii) For billed fees, the user fee is unpaid 60 days after date of bill;
(iii) The person for whom the service is provided or the person requesting the service has not paid the late payment penalty or interest on any delinquent APHIS user fee; or
(iv) Payment has been dishonored.
(2) Resolution of difference between estimate and actual. APHIS will estimate the user fee to be paid; any difference between the estimate and the actual amount owed to APHIS will be resolved as soon as reasonably possible following the delivery of the service, with APHIS returning any excess to the payor or billing the payor for the additional amount due.
(3) Prepayment form. The prepayment must be in guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the debtor pays the delinquent debt.
(4) Denied service. Service will be denied until the debt is paid if:
(i) For unbilled fees, the user fee is unpaid 90 days after date the pertinent regulatory provision indicates payment is due; or
(ii) For billed fees, the user fee is unpaid 90 days after date of bill; or
(iii) The person for whom the service is provided or the person requesting the service has not paid the late payment penalty or interest on any delinquent APHIS user fee; or
(iv) Payment has been dishonored.
(b) Unpaid debt during service. If APHIS is in the process of providing a service for which an APHIS user fee is due, and the user has not paid the fee within the time required, or if the payment offered by the user is inadequate or unacceptable, then APHIS will take the following action:
(1) Animals or birds in quarantine. If an APHIS user fee is due for animals or birds in quarantine at an animal import center or at a privately operated import quarantine facility, APHIS will not release them.
(2) Export health certificate. If an APHIS user fee specified is due for an export health certificate, APHIS will not release the certificate.
(3) Veterinary diagnostics. If an APHIS user fee is due for a veterinary diagnostic test or service, APHIS will not release the test result, any endorsed certificate, or any other veterinary diagnostic service.
(c) Late payment penalty. In addition to the actions described in paragraph (b) of this section, APHIS will impose a late payment penalty and interest charges in accordance with 31 U.S.C. 3717 for:
(1) Unbilled user fees. Unbilled user fees, if the user fees are unpaid 30 days after the date the pertinent regulatory provisions indicates payment is due; or
(2) Billed user fees. Billed user fees, if the user fees are unpaid 30 days after the date of the bill.
(d) Dishonored payment penalties. User fees paid with dishonored forms of payment, such as a check returned for insufficient funds, will be subject to interest and penalty charges in accordance with 31 U.S.C. 3717. Administrative charges will be assessed at $20.00 per dishonored payment to be paid in addition to the original amount owed. Payment must be in guaranteed form, such as cash, money order, or certified check.
(e) Debt collection management. In accordance with the Debt Collection Improvement Act of 1996, the following provisions apply:
(1) Taxpayer identification number. APHIS will collect a taxpayer identification number from all persons, other than Federal agencies, who are liable for a user fee.
(2) Administrative offset. APHIS will notify the Department of Treasury of debts that are over 180 days delinquent for the purposes of administrative offset. Under administrative offset, the Department of Treasury will withhold funds payable by the United States to a person (i.e., Federal income tax refunds) to satisfy the debt to APHIS.
(3) Cross-servicing. APHIS will transfer debts that are over 180 days delinquent to the Department of Treasury for cross-servicing. Under cross-servicing, the Department of Treasury will collect debts on behalf of APHIS. Exceptions will be made for debts that meet certain requirements, for example, debts that are already at a collection agency or in payment plan.
(4) Report delinquent debt. APHIS will report all unpaid debts to credit reporting bureaus.
(f) Animals or birds abandoned after quarantine at an animal import center. Animals or birds left in quarantine at an animal import center for more than 30 days after the end of the required quarantine period will be deemed to be abandoned.
(1) Release of abandoned animals or birds from quarantine. After APHIS releases the abandoned animals or birds from quarantine, APHIS may seize them and sell or otherwise dispose of them, as determined by the Administrator, provided that their sale is not contrary to any Federal law or regulation. APHIS may recover all expenses of handling the animals or birds from the proceeds of their sale or disposition.
(2) Seizure and disposal of abandoned animals or bird. If animals or birds abandoned in quarantine at an animal import center cannot be released from quarantine, APHIS may seize and dispose of them, as determined by the Administrator, and may recover all expenses of handling the animals or birds from the proceeds of their disposition and from persons liable for user fees under § 130.6(a).
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. Except where the context otherwise requires, for the purposes of this part the following terms shall be construed, respectively, to mean:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Affiliated flockowner. A flockowner who is participating in the Plan through an agreement with a participating hatchery.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Authorized agent. Any person designated under § 145.11(a) to collect official samples for submission to an authorized laboratory in accordance with part 147 of this subchapter.
Authorized laboratory. An authorized laboratory is a laboratory that meets the requirements of § 147.52 and is thus qualified to perform assays in accordance with part 147 of this subchapter.
Authorized testing agent. Any person designated under § 145.11(a) to collect official samples for submission to an authorized laboratory in accordance with part 147 of this subchapter and to perform the stained antigen, rapid whole blood test for pullorum typhoid.
Avian influenza. Avian influenza is defined as an infection of poultry caused by any influenza A virus of the H5 or H7 subtypes or by any influenza A virus with an intravenous pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75 percent mortality).
Baby poultry. Newly hatched poultry (chicks, poults, ducklings, goslings, keets, etc.).
Colon bacilli. For the purpose of this chapter, those organisms which are gram negative, non spore-forming bacilli, which ferment lactose with gas formation, and serve as an index of fecal contamination.
Dealer. An individual or business that deals in commerce in hatching eggs, newly-hatched poultry, and started poultry obtained from breeding flocks and hatcheries. This does not include an individual or business that deals in commerce in buying and selling poultry for slaughter only.
Department. The U.S. Department of Agriculture.
Domesticated. Propagated and maintained under the control of a person.
Equivalent or equivalent requirements. Requirements which are equal to or exceed the program, conditions, criteria, or classifications with which they are compared, as determined by the Official State Agency and with the concurrence of the Service.
Exposed (Exposure). Contact with birds, equipment, personnel, supplies, or any article infected with, or contaminated by, communicable poultry disease organisms.
Flock—(1) As applied to breeding. All poultry of one kind of mating (breed and variety or combination of stocks) and of one classification on one farm;
(2) As applied to disease control. All of the poultry on one farm except that, at the discretion of the Official State Agency, any group of poultry which is segregated from another group and has been so segregated for a period of at least 21 days may be considered as a separate flock.
Fluff sample. Feathers, shell membrane, and other debris resulting from the hatching of poultry.
Fowl typhoid or typhoid. A disease of poultry caused by Salmonella enterica subspecies enterica serovar Gallinarum biovar Gallinarum (Salmonella Gallinarum).
Franchise breeder. A breeder who normally sells products under a specific strain or trade name and who authorizes other hatcheries to produce and sell products under this same strain or trade name.
Franchise hatchery. A hatchery which has been authorized by a franchise breeder to produce and sell products under the breeder's strain or trade name.
H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry caused by an influenza A virus of H5 or H7 subtype that has an intravenous pathogenicity index in 6-week-old chickens less than or equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-old chickens infected intravenously, or an infection with influenza A viruses of H5 or H7 subtype with a cleavage site that is not consistent with a previously identified highly pathogenic avian influenza virus.
Hatchery. Hatchery equipment on one premises operated or controlled by any person for the production of baby poultry and/or embryonated eggs.
Independent flock. A flock that produces hatching eggs and that has no ownership affiliation with a specific hatchery.
Infected flock. A flock in which an authorized laboratory has discovered one or more birds infected with a communicable poultry disease for which a program has been established under the Plan.
Midlay. Approximately 2-3 months after a flock begins to lay or after a molted flock is put back into production.
Multiplier breeding flock. A flock that is intended for the production of fertile eggs used for the purpose of producing progeny for commercial egg or meat production or for other nonbreeding purposes.
Newcastle disease. Newcastle disease (ND) is defined as an infection of poultry caused by Newcastle disease virus (NDV), which is an avian paramyxovirus serotype 1 (APMV-1) that meets one of the following criteria for virulence:
(1) The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallusgallus) of 0.7 or greater; or
(2) Multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term 'multiple basic amino acids' refers to at least three arginine or lysine residues between residues 113 and 116. Failure to demonstrate the characteristic pattern of amino acid residues as described in the preceding sentences would require characterization of the isolated virus by an ICPI test.
NPIP Program Standards. A document that contains tests and sanitation procedures approved by the Administrator in accordance with § 147.53 of this subchapter for use under this subchapter. This document may be obtained from the National Poultry Improvement Plan (NPIP) website at http://www.poultryimprovement.org/ or by writing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.
NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound.
Official State Agency. The State authority recognized by the Department to cooperate in the administration of the Plan.
Official supervision—(1) As applied to Plan programs. The direction, inspection, and critical evaluation by the Official State Agency of compliance with the provisions of the Plan;
(2) As applied to non-Plan but equivalent State poultry improvement programs. The direction, inspection, and critical evaluation by an officer or agency of a State government, of compliance with a publicly announced State poultry improvement program.
Person. A natural person, firm, or corporation.
Plan. The provisions of the National Poultry Improvement Plan contained in this part.
Poultry. Domesticated fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, waterfowl, and game birds, except doves and pigeons, which are bred for the primary purpose of producing eggs or meat.
Primary breeding flock. A flock composed of one or more generations that is maintained for the purpose of establishing, continuing, or improving parent lines.
Products. Poultry breeding stock and hatching eggs, baby poultry, and started poultry.
Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, designation of a flock, products produced from the flock, or a state by an official Plan classification and illustrative design, as described in § 145.10 of this part.
Public exhibition. A public show of poultry.
Pullorum disease or pullorum. A disease of poultry caused by Salmonella enterica subspecies enterica serovar Gallinarum biovar Pullorum (Salmonella Pullorum).
Reactor. A bird that has a positive reaction to a test, required or recommended in this part or in accordance with part 147 of this subchapter, for any poultry disease for which a program has been established under the Plan. A reactor is considered suspect until additional confirmatory testing has been conducted by an authorized laboratory or Federal Reference Laboratory as outlined in § 145.14.
Salmonella. Any bacteria belonging to the genus Salmonella, including the arizona group.
Salmonella Enteritidis. A bacteria found in poultry caused by Salmonella enterica subspecies enterica serovar Enteritidis (Salmonella Enteritidis).
Sanitize. To treat with a product which is registered by the Environmental Protection Agency as germicidal, fungicidal, pseudomonocidal, or tuberculocidal, in accordance with the specifications for use as shown on the label of each product. The Official State Agency, with the concurrence of the Service, shall approve each product or procedure according to its specified usage.
Senior Coordinator. An employee of the Service whose duties may include, but will not necessarily be limited to:
(1) Serving as executive secretary of the General Conference Committee;
(2) Serving as chairperson of the Plan Conference described in § 147.47;
(3) Planning, organizing, and conducting the Plan Conference;
(4) Reviewing NPIP authorized laboratories as described in § 147.52;
(5) Coordinating the State administration of the NPIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding;
(6) Coordinating rulemaking to incorporate the proposed changes of the provisions approved at the Plan conference into the regulations in parts 145, 146, and 147 of this subchapter;
(7) Directing the production of official NPIP publications;
(8) Proposing an annual budget for plan activities and the General Conference Committee; and
(9) Providing overall administration of the NPIP.
Service. The Animal and Plant Health Inspection Service, Veterinary Services, of the Department.
Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number.
Sexual maturity. The average age at which a species of poultry is biologically capable of reproduction.
Started poultry. Young poultry (chicks, pullets, cockerels, capons, poults, ducklings, goslings, keets, etc.) that have been fed and watered and are less than 6 months of age.
State. Any State, the District of Columbia, or Puerto Rico.
State Inspector. Any person employed or authorized under § 145.11(b) to perform functions under this part.
Stock. A term used to identify the progeny of a specific breeding combination within a species of poultry. These breeding combinations may include pure strains, strain crosses, breed crosses, or combinations thereof.
Strain. Poultry breeding stock bearing a given name produced by a breeder through at least five generations of closed flock breeding.
Succeeding flock. A flock brought onto a premises during the 12 months following removal of an infected flock.
Suspect flock. A flock shall be considered, for the purposes of the Plan, to be a suspect flock if any evidence exists that it has been exposed to a communicable poultry disease.
Trade name or number. A name or number compatible with State and Federal laws and regulations applied to a specified stock or product thereof.
(a) The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency.
(b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.
(c) An Official State Agency may accept for participation an affiliated flock located in another State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision.
(d) The Official State Agency of any State may, except as limited by § 145.3(f), adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards compatible with the Plan.
(e) An authorized laboratory of the National Poultry Improvement Plan will conduct tests in accordance with part 147 of this subchapter when determining the status of a participating flock with respect to an official Plan classification.
(a) The National Poultry Improvement Plan is a cooperative Federal-State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by controlling or eliminating specific poultry diseases. The Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards specified in the Plan. Participants shall maintain records to demonstrate that they adhere to the disease control programs in which they participate.
(b) Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agency, that his facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan, and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under § 145.2. Affiliated flockowners may participate without signing an agreement with the Official State Agency.
(c) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency.
(d) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. The participant shall report to the Official State Agency on VS Form 9-2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, and cassowaries, before the birds reach 20 months of age. This report will include:
(1) Name and address of flockowner;
(2) Flock location and designation;
(3) Type: Primary or Multiplier;
(4) Breed, variety, strain, or trade name of stock;
(5) Source of males;
(6) Source of females;
(7) Number of birds in the flock; and
(8) Intended classification of flock.
(e) To ensure that Plan diseases are not spread, flocks must be qualified for their intended Plan classifications before being moved into breeder production facilities.
(f) No person shall be compelled by the Official State Agency to qualify products for any of the other classifications described in § 145.10 as a condition of qualification for the U.S. Pullorum-Typhoid Clean classification.
(g) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below:
(a) Records of purchases and sales and the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency.
(b) Products, records of sales and purchase of products, and material used to advertise products shall be subject to inspection by the Official State Agency at any time.
(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in his advertising reference to associated or franchised hatcheries only when such hatcheries produce the same kind of products of the same classification.
(d) Except as provided by this paragraph, participants in the Plan may not buy or receive products for any purpose from nonparticipants unless they are part of an equivalent program, as determined by the Official State Agency. Participants in the Plan may buy or receive products from flocks that are neither participants nor part of an equivalent program, for use in breeding flocks or for experimental purposes, under the following conditions only:
(1) With the permission of the Official State Agency and the concurrence of the Service; and
(2) By segregation of all birds before introduction into the breeding flock. Upon reaching sexual maturity, the segregated birds must be tested and found negative for pullorum-typhoid and any other disease for which the flock into which the birds are being introduced holds a disease classification. The Official State Agency may require a second test at its discretion.
(e) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the official approval number of the participant and may be used on each certificate, invoice, shipping label, or other document used by the participant in the sale of his products. Each Official State Agency which requires an approval or permit number for out-of-State participants to ship into its State should honor this number. The approval number shall be withdrawn when the participant no longer qualifies for participation in the Plan.
(a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition in accordance with part 147 of this subchapter. The participating flock, its eggs, and all equipment used in connection with the flock shall be separated from nonparticipating flocks, in a manner acceptable to the Official State Agency.
(b) All flocks shall consist of healthy, normal individuals characteristic of the breed, variety, cross, or other combination which they are stated to represent.
(c) A flock shall be deemed to be a participating flock at any time only if it has qualified for the U.S. Pullorum-Typhoid Clean classification, as prescribed in subparts B, C, D, E, F, G, H, I, or J of this part.
(d) Each bird shall be identified with a sealed and numbered band obtained through or approved by the Official State Agency: Provided, That exception may be made at the discretion of the Official State Agency.
(a) Hatcheries must be kept in sanitary condition, acceptable to the Official State Agency. The sanitary procedures outlined in the NPIP Program Standards, or other procedures approved by the Administrator in accordance with § 147.53(d), will be considered as a guide in determining compliance with this provision. The minimum requirements with respect to sanitation include the following:
(1) Egg room walls, ceilings, floors, air filters, drains, and humidifiers should be cleaned and disinfected at least two times per week. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.
(2) Incubator room walls, ceilings, floors, doors, fan grills, vents, and ducts should be cleaned and disinfected after each set or transfer. Incubator rooms should not be used for storage. Plenums should be cleaned at least weekly. Egg trays and buggies should be cleaned and disinfected after each transfer. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.
(3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts should be cleaned and disinfected after each hatch. Hatcher rooms should be cleaned and disinfected after each hatch and should not be used for storage. Plenums should be cleaned after each hatch. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.
(4) Chick/poult processing equipment and rooms should be thoroughly cleaned and disinfected after each hatch. Chick/poult boxes should be cleaned and disinfected before being reused. Vaccination equipment should be cleaned and disinfected after each use. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.
(5) Hatchery residue, such as chick/poult down, eggshells, infertile eggs, and dead germs, should be disposed of promptly and in a manner satisfactory to the Official State Agency.
(6) The entire hatchery should be kept in a neat, orderly condition and cleaned and disinfected after each hatch.
(7) Effective insect and rodent control programs should be implemented.
(b) A hatchery that keeps started poultry must keep such poultry separated from the incubator room in a manner satisfactory to the Official State Agency.
(c) All baby and started poultry offered for sale under Plan terminology should be normal and typical of the breed, variety, cross, or other combination represented.
(d) Eggs incubated should be sound in shell, typical for the breed, variety, strain, or cross thereof and reasonably uniform in shape. Hatching eggs should be trayed and the baby poultry boxed with a view to uniformity of size.
(e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
(f) If a person is responsibly connected with more than one hatchery, all of such hatcheries must participate in the Plan if any of them participate. A person is deemed to be responsibly connected with a hatchery if he or she is a partner, officer, director, holder, owner of 10 percent or more of the voting stock, or an employee in a managerial or executive capacity.
Dealers in hatching eggs, newly hatched poultry, or started poultry shall comply with the provisions in this part (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter).
(a) The official classification terms defined in §§ 145.9 and 145.10 and the various designs illustrative of the official classifications reproduced in § 145.10 may be used only by participants and to describe products that have met all the specific requirements of such classifications.
(b) Products produced under the Plan shall lose their identity under Plan terminology when they are purchased for resale by or consigned to nonparticipants.
(c) Participating flocks, their eggs, and the baby and started poultry produced from them may be designated by their strain or trade name. When a breeder's trade name or strain designation is used, the participant shall be able by records to substantiate that the products so designated are from flocks that are composed of either birds hatched from eggs produced under the direct supervision of the breeder of such strain, or stock multiplied by persons designated and so reported by the breeder to each Official State Agency concerned.
Participating hatcheries and dealers shall be designated as “National Plan Hatchery” and “National Plan Dealer”, respectively. All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification.
Participating flocks, products produced from them, and States that have met the requirements of a classification in this part may be designated by the corresponding illustrative design in this section.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. (See § 145.23(b), § 145.33(b), § 145.43(b), §§ 145.53(b), 145.63(a), 145.73(b), 145.83(b), 145.93(b), and 145.103(b).)
(c) U.S. M. Gallisepticum Clean. (See §§ 145.23(c), 145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and 145.83(c).)
(d) U.S. Sanitation Monitored. (See § 145.33(d).)
(e) U.S. M. Synoviae Clean. (See § 145.23(e), § 145.23(g), § 145.33(e), § 145.33(g), § 145.43(e), and § 145.53(d)).
(f) U.S. M. Meleagridis Clean—(See § 145.43(d)).
(g) U.S. Pullorum-Typhoid Clean State. (See §§ 145.24(a), 145.34(a), 145.44(a), 145.54(a), 145.94(a), and 145.104(a).)
(h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See § 145.44(b).)
(i) U.S.M. Gallisepticum Clean State, Turkeys. (See § 145.44(c).)
(j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (See § 145.34(b).)
(k) U.S. Sanitation Monitored, Turkeys. (See § 145.43(f).)
(l) [Reserved]
(m) U.S. S. Enteritidis Clean. (See §§ 145.23(d), 145.73(d), and 145.83(e).)
(n) U.S. M. Synoviae Clean State, Turkeys. (See § 145.44(d).)
(o) U.S. Salmonella Monitored. (See §§ 145.53(f), 145.73(g), 145.83(f), 145.93(d), and 145.103(d).)
(p) U.S. M. Gallisepticum Monitored. (See § 145.33(j).)
(q) U.S. M. Synoviae Monitored. (See § 145.33(k).)
(r) U.S. Avian Influenza Clean. (See §§ 145.23(h), 145.33(l), 145.63(b), 145.73(f), and 145.83(g).)
(s) U.S. M. Meleagridis Clean State, Turkeys. (See § 145.44(e).)
(t) U.S. H5/H7 Avian Influenza Clean. (See §§ 145.43(g), 145.53(e), 145.93(c), and 145.103(c).)
(u) U.S. Newcastle Clean. (See §§ 145.43(h), 145.73(h), and 145.83(h).)
(v) U.S. Avian Influenza Clean Compartment. (See §§ 145.45, 145.74, and 145.84.)
(w) U.S. Newcastle Disease Clean Compartment. (See §§ 145.45, 145.74, and 145.84.)
(a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing Agents to do the sample collecting and blood testing provided for in § 145.14.
(b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official inspections necessary to verify compliance with the requirements of the Plan.
(c) Authorities issued under the provisions of this section shall be subject to cancellation by the official State agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the official State agency. Such actions shall not be taken until a thorough investigation has been made by the official State agency and the authorized person has been given notice of the proposed action and the basis therefor and an opportunity to present his views.
(a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agency that the operations of the hatchery are in compliance with the provisions of the Plan.
(b) The records of all flocks maintained primarily for production of hatching eggs shall be made available to and examined annually by a State Inspector. Records shall include VS Form 9-2, “Flock Selecting and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults”; set and hatch records; egg receipts; and egg/chick orders or invoices. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified.
Participants in the Plan, who after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency, shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Agency may deem appropriate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his views with respect to the debarment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall continue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Administrator to determine the eligibility of the debarred participant for participation in the Plan. In such event the Administrator shall determine the matter de novo in accordance with the rules of practice in 7 CFR part 50, which are hereby made applicable to proceedings before the Administrator under this section. The definitions in 7 CFR 50.10 and the following definitions shall apply with respect to terms used in such rules of practice:
(a) Administrator means the Administrator, Animal and Plant Health Inspection Service of the U.S. Department of Agriculture or any officer or employee to whom authority has heretofore been delegated or to whom authority may hereafter be delegated to act in his stead.
Poultry must be more than 4 months of age when tested for an official classification with the following exceptions: Turkey candidates under subpart D of this part may be tested at more than 12 weeks of age; game bird candidates under subpart E or subpart J of this part may be tested when more than 4 months of age or upon reaching sexual maturity, whichever comes first; and ostrich, emu, rhea, and cassowary candidates under subpart F of this part may be tested when more than 12 months of age. Samples for official tests shall be collected by an Authorized Agent, Authorized Testing Agent, or State Inspector and tested by an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be conducted by an Authorized Testing Agent or State Inspector. Testing must be conducted as specified within the Subpart Plan program, with at least 1 bird tested from each pen and unit in the house and a minimum of 30 birds tested per house. The ratio of samples collected from male and female birds must be representative of birds throughout the house and flock. In houses containing fewer than 30 birds other than ostriches, emus, rheas, and cassowaries, all birds in the house must be tested, unless otherwise specified within the Plan program.
(a) For Pullorum-Typhoid. (1) The official blood tests for pullorum-typhoid shall be the standard tube agglutination test, the microagglutination test, the enzyme-linked immunosorbent assay test (ELISA), or the rapid serum test for all poultry; and the stained antigen, rapid whole-blood test for all poultry except turkeys. Official blood tests must be conducted in accordance with part 147 of this subchapter (within the Program Standards document, Program Standard A applies to blood testing; alternatives to the program standards may also be approved by the Administrator under § 145.73 of this chapter) or according to literature provided by the producer. Only antigens approved by the Department and of the polyvalent type shall be used for the rapid whole-blood and tube agglutination tests. Each serial of tube antigen shall be submitted by the antigen producer to the Department for approval upon manufacture and once a year thereafter as long as antigen from that serial continues to be made available for use. All microtest antigens and enzyme-linked immunosorbent assay reagents shall also be approved by the Department.
(2) [Reserved]
(3) There shall be an interval of at least 21 days between any official blood test and any previous test with pullorum-typhoid antigen.
(4) [Reserved]
(5) The official blood test shall include the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see applicable provisions of §§ 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, 145.93, and 145.103) the testing of a portion or sample of the birds may be used in lieu of testing each bird.
(6) Poultry from flocks undergoing qualification testing for participation in the Plan that have a positive reaction to an official blood test named in paragraph (a)(1) of this section shall be evaluated for pullorum-typhoid as follows:
(i) Serum samples that react on rapid serum test or enzyme-labeled immunosorbent assay test (ELISA), or blood from birds that react on the stained antigen, rapid whole-blood test for all birds except turkeys, shall be tested with either the standard tube agglutination test or the microagglutination test.
(ii) Reactors to the standard tube agglutination test (in dilutions of 1:50 or greater) or the microagglutination test (in dilutions of 1:40 or greater) shall be submitted to an authorized laboratory for bacteriological examination. If there are more than four reactors in a flock, a minimum of four reactors shall be submitted to the authorized laboratory; if the flock has four or fewer reactors, all of the reactors must be submitted. Bacteriological examination must be conducted in accordance with part 147 of this subchapter (within the Program Standards document, Program Standard B addresses bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 145.73). When reactors are submitted to the authorized laboratory within 10 days of the date of reading an official blood test named in paragraph (a)(6)(i) of this section, and the bacteriological examination fails to demonstrate pullorum-typhoid infection, the Official State Agency shall presume that the flock is determined not to be infected with Salmonella Pullorum or Salmonella Gallinarum.
(iii) If a flock owner does not wish to submit reactors for bacteriological examination, then the reactors shall be isolated and retested within 30 days using an official blood test named in paragraph (a)(1) of this section. If this retest is positive, additional examination of the reactors and flock will be performed in accordance with paragraph (a)(6)(ii) of this section. During this 30-day period, the flock must be maintained under a security system, specified or approved by the Official State Agency, that will prevent physical contact with other birds and assure that personnel, equipment, and supplies that could be a source of pullorum-typhoid spread are sanitized.
(7) When Salmonella Pullorum or Salmonella Gallinarum organisms are isolated by an authorized laboratory from baby poultry, or from fluff samples produced by hatching eggs, the infected flock shall qualify for participation in the Plan with two consecutive negative results to an official blood test named in paragraph (a)(1) of this section. A succeeding flock must be qualified for participation in the Plan's pullorum-typhoid program with a negative result to an official blood test named in paragraph (a)(1) of this section. Testing to qualify flocks for Plan participation must include the testing of all birds in infected flocks and succeeding flocks for a 12-month period, and shall be performed or physically supervised by a State Inspector; Provided, That at the discretion of the Official State Agency, a sample of at least 500 birds, rather than all birds in the flock, may be tested by the State Inspector if it is agreed upon by the Official State Agency, the flockowner, and the Administrator. If the State Inspector determines that a primary breeding flock has been exposed to Salmonella Pullorum or Salmonella Gallinarum,
(i) The taking of blood samples—performed by or in the presence of a State Inspector—from all birds on premises exposed to birds, equipment, supplies, or personnel from the primary breeding flock during the period when the State Inspector determined that exposure to Salmonella Pullorum or Salmonella Gallinarum occurred.
(ii) The banding of all birds of these premises—performed or physically supervised by a State Inspector—in order to identify any bird that tests positive; and
(iii) The testing of blood samples at an authorized laboratory using an official blood test named in paragraph (a)(1) of this section.
(8) All domesticated fowl, except waterfowl, on the farm of the participant shall either be properly tested to meet the same standards as the participating flock or these birds and their eggs shall be separated from the participating flock and its eggs.
(9) All tests for pullorum-typhoid in flocks participating in or candidates for participation in the Plan shall be reported to the Official State Agency within 10 days following the completion of such tests. All reactors shall be considered in determining the classification of the flock.
(10) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of Salmonella organisms, shall not be fed or administered to poultry within 3 weeks prior to a test or bacteriological examination upon which a Salmonella classification is based.
(11) When suitable evidence, as determined by the Official State Agency or the State Animal Disease Control Official, indicates that baby or started poultry produced by participating hatcheries are infected with organisms for which the parent flock received an official control classification and this evidence indicates that the infection was transmitted from the parent flock, the Official State Agency may, at its discretion, require additional testing of the flock involved. If infection is found in the parent flock, its classification shall be suspended until the flock is requalified under the requirements for the classification. Furthermore, the Official State Agency may require that the hatching eggs from such flocks be removed from the incubator and destroyed prior to hatching. When Salmonella organisms are isolated from a specimen which originated in a participating hatchery, the Official State Agency shall attempt to locate the source of the infection. The results of the investigation and the action taken to eliminate the infection shall be reported by the Official State Agency to the Service.
(b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. (1) The official tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent assay (ELISA) test,
A.A. Ansari, R.F. Taylor, T.S. Chang, “Application of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Mycoplasma gallisepticum Infections in Poultry,” Avian Diseases, Vol. 27, No. 1, pp. 21-35, January-March 1983; and
H.M. Opitz, J.B. Duplessis, and M.J. Cyr, “Indirect Micro-Enzyme-Linked Immunosorbent Assay for the Detection of Antibodies to Mycoplasma synoviae and M. gallisepticum,” Avian Diseases, Vol. 27, No. 3, pp. 773-786, July-September 1983; and
H.B. Ortmayer and R. Yamamoto, “Mycoplasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),” Proceedings, 30th Western Poultry Disease Conference, pp. 63-66, March 1981.
(2) The serological tests shall be conducted using M. gallisepticum, M. meleagridis, or M. synoviae antigens approved by the Department or the Official State Agency and shall be performed in accordance with the recommendations of the producer of the antigen.
(3) When reactors to the test for which the flock was tested are submitted to a laboratory as prescribed by the Official State Agency, the final status of the flock will be determined in accordance with part 147 of this subchapter.
(4) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of mycoplasma organisms, shall not be fed or administered to poultry within three weeks prior to a test or bacteriological examination upon which a Mycoplasma classification is based.
(5) The official molecular examination procedures for M. gallisepticum are the PCR test described in § 147.30 of this subchapter and the real-time PCR test described in § 147.31 of this subchapter. The official molecular examination procedure for M. synoviae is the PCR test described in § 147.30 of this subchapter.
(c) [Reserved]
(d) For avian influenza. The official tests for avian influenza are described in paragraphs (d)(1) and (d)(2) of this section.
(1) Antibody detection tests—(i) Enzyme-linked immunosorbent assay (ELISA) test. (A) The ELISA test must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.
(B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.
(B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards document, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza agar gel immunodiffusion (AGID) test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl.
(C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(2) Agent detection tests. Agent detection tests may be used to detect influenza A virus but not to determine hemagglutinin or neuraminidase subtypes. Samples for agent detection testing should be collected from naturally occurring flock mortality or clinically ill birds.
(i) The real time reverse transcriptase/polymerase chain reaction (RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRT-PCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT-PCR or a test kit licensed by the Department and approved by the Official State Agency and the State Animal Health Official, and must be conducted by personnel who have passed an NVSL proficiency test. For non-National Animal Health Laboratory Network (NAHLN) authorized laboratories:
(1) RRT-PCR testing may be used by primary breeder company authorized laboratories.
(2) RRT-PCR testing can only be performed on their own breeding flocks and only used for routine surveillance.
(3) The authorized laboratory must have a quality system that is accredited as ISO/IEC 17025 or equivalent to perform the avian influenza RRT-PCR assay.
(4) The use of the RRT-PCR test by the authorized laboratory must be approved in the memorandum of understanding (MOU) between the authorized laboratory, the Official State Agency, and the State Animal Health Official(s) of both the location of the authorized laboratory and the location where the breeding flocks reside.
(5) Split samples for testing must occur between the authorized laboratory and a NAHLN laboratory at a frequency designated in the MOU.
(B) Positive results from the RRT-PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.
(B) Chicken and turkey flocks that test positive on the ACIA must be further tested using the RRT-PCR or virus isolation. Positive results from the RRT-PCR or virus isolation must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(3) The official determination of a flock as positive for the H5 or H7 subtypes of avian influenza may be made only by NVSL.
(e) For Newcastle Disease (ND). The official tests for ND are serological tests for antibody detection or molecular-based tests for antigen detection.
(a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans.
(b) Avian influenza must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addition, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the importance of prompt reporting of clinical symptoms consistent with avian influenza.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Chicks. Newly hatched chickens.
Egg type chicken breeding flocks. Flocks that are composed of stock that has been developed for egg production and are maintained for the principal purpose of producing chicks for the ultimate production of eggs for human consumption.
Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age.
Participating flocks of multiplier egg type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart B.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of the following paragraphs (b)(1) through (4) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a multiplier breeding flock and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1) that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section.
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, that fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or
(B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum; or
(C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter.
(2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(d) U.S. S. Enteritidis Clean. This classification is intended for egg-type breeders wishing to assure their customers that the hatching eggs and chicks produced are certified free of Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock originated from a U.S. Salmonella Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped.
(ii) All feed fed to the flock shall meet the following requirements:
(A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program. The protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F., or above, or to a minimum temperature of 165 °F. for at least 20 minutes, or to a minimum temperature of 184 °F. under 70 lbs. pressure during the manufacturing process.
(B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: Provided, that mash feed may contain nonpelleted APPI animal protein product supplements if the finished feed is treated with a salmonella control product approved by the Food and Drug Administration.
(iii) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(iv) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled;
(v) Environmental samples shall be collected from the flock by an Authorized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The authorized agent shall also collect samples every 30 days after the first sample has been collected.
(vi) Hatching eggs are collected as quickly as possible, and their sanitation is maintained in accordance with part 147 of this subchapter.
(vii) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized either by a procedure approved by the Official State Agency or in accordance with part 147 of this subchapter.
(2) A flock shall not be eligible for this classification if Salmonella Enteritidis (SE) is isolated from a specimen taken from a bird in the flock. Isolation of SE from an environmental or other specimen, as described in paragraph (d)(1)(v) of this section, will require bacteriological examination for SE in an authorized laboratory, in accordance with part 147 of this subchapter, of a random sample of 60 live birds from a flock of 5,000 birds or more, or 30 live birds from a flock with fewer than 5,000 birds. If only one specimen is found positive for SE, the participant may request bacteriological examination of a second sample, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification.
(3) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(e) U.S.M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this section.
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(f) U.S. M. Gallisepticum Clean Started Poultry. (1) A flock which originated from U.S. M. Gallisepticum Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Gallisepticum Clean chicks.
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Gallisepticum Clean sources.
(3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management.
(4) The flock's freedom from M. Gallisepticum is demonstrated by a negative blood test, as provided in § 145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15-20 days prior to the flock being moved to laying quarters.
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter.
(g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which originated from U.S. M. Synoviae Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for production of U.S. M. Synoviae Clean chicks.
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources.
(3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management.
(4) The flock's freedom from M. synoviae is demonstrated by a negative blood test, as provided in § 145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15-20 days prior to the flock being moved to laying quarters.
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter.
(h) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1) It is a multiplier breeding flock in which a minimum of 30 birds have been tested and found negative to avian influenza when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; or
(iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and
(2) A sample of at least 11 birds must be tested and found negative to avian influenza within 21 days prior to slaughter.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying.
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Chicks. Newly hatched chickens.
Meat type chicken breeding flocks. Flocks that are composed of stock that has been developed for meat production and are maintained for the principal purpose of producing chicks for the ultimate production of meat.
Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age.
Participating flocks of multiplier meat type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart C.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of paragraphs (b)(1) through (4) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a multiplier breeding flock and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section.
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or
(B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum; or
(C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter.
(2) A participant handling U.S. M. Gallisepticum Clean products must keep these products separate from other products through the use of separate hatchers and incubators, separate hatch days, and proper hatchery sanitation and biosecurity in a manner satisfactory to the Official State Agency and in accordance with part 147 of this subchapter.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. gallisepticum as provided in § 145.14(b), or by a polymerase chain reaction (PCR)-based procedure in accordance with part 147 of this subchapter. If fewer than 30 male breeding birds are being added, all the birds shall be tested as described above. The male birds shall be tested no more than 14 days prior to their intended introduction into the flock. If the serologic testing of the birds yields hemagglutination inhibition titers of 1:40 or higher as provided in § 145.14(b), or if the PCR testing is positive for M. gallisepticum, the male birds may not be added to the flock and must be either retested or destroyed.
(d) U.S. Sanitation Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of Salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products.
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock shall originate from a source where sanitation and management practices, as outlined in § 145.33(d)(1) of this paragraph, are conducted;
(ii) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management;
(iii) If pelletized feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fisheries Service. The protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F. or above, or to a minimum temperature of 165 °F. for at least 20 minutes, or to a minimum temperature of 184 °F. under 70 lbs. pressure during the manufacturing process;
(iv) If mash feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fisheries Service;
(v) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(vi) Chicks shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter;
(vii) An Authorized Agent shall take environmental samples, in accordance with part 147 of this subchapter, from each flock at 4 months of age and every 90 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically.
(2) The Official State Agency may monitor the effectiveness of the sanitation practices in accordance with part 147 of this subchapter.
(3) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this section.
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the official State Agency.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. synoviae as provided in § 145.14(b) or by a polymerase chain reaction (PCR)-based procedure in accordance with part 147 of this subchapter. If fewer than 30 male breeding birds are being added, all the birds shall be tested as described above. The male birds shall be tested no more than 14 days prior to their intended introduction into the flock. If the serologic testing of the birds yields hemagglutination inhibition titers of 1:40 or higher as provided in § 145.14(b), or if the PCR testing is positive for M. synoviae, the male birds may not be added to the flock and must be either retested or destroyed.
(f) U.S. M. Gallisepticum Clean Started Poultry. (1) A flock which originated from U.S. M. Gallisepticum Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Gallisepticum Clean chicks.
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Gallisepticum Clean sources.
(3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management.
(4) The flock's freedom from M. gallisepticum is demonstrated by a negative blood test, as provided in § 145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15-20 days prior to the flock being moved to laying quarters.
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter.
(g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which originated from U.S. M. Synoviae Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Synoviae Clean chicks.
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources.
(3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management.
(4) The flock's freedom from M. synoviae is demonstrated by a negative blood test, as provided in § 145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15-20 days prior to the flock being moved to laying quarters.
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter.
(h)-(i) [Reserved]
(j) U.S. M. Gallisepticum Monitored. (1) A multiplier breeding flock in which all birds or a sample of at least 30 birds per house has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 30 birds per house shall be tested again at 36 to 38 weeks and at 48 to 50 weeks at a minimum: And provided further, That each 30-bird sample should come from 2 locations within the house (15 from the front half of the house and 15 from the back half of the house). A representative sample of males and females should be sampled. The samples shall be marked “male” or “female.”
(2) A participant handling U.S. M. Gallisepticum Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Gallisepticum Monitored chicks from multiplier breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (j)(1) of this section are set. Eggs from U.S. M. Gallisepticum Monitored multiplier breeding flocks shall not be set in hatchers or incubators in which eggs from U.S. M. Gallisepticum Clean primary breeding flocks qualified under § 145.83(c)(1)(i) are set.
(3) U.S. M. Gallisepticum Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(k) U.S. M. Synoviae Monitored. (1) A multiplier breeding flock in which all birds or a sample of at least 30 birds per house has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 30 birds per house shall be tested again at 36 to 38 weeks and at 48 to 50 weeks at a minimum: And provided further, That each 30-bird sample should come from 2 locations within the house (15 from the front half of the house and 15 from the back half of the house). A representative sample of males and females should be sampled. The samples shall be marked “male” or “female.”
(2) A participant handling U.S. M. Synoviae Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Synoviae Monitored chicks from multiplier breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (k)(1) of this section are set. Eggs from U.S. M. Synoviae Monitored multiplier breeding flocks shall not be set in hatchers or incubators in which eggs from U.S. M. Synoviae Clean primary breeding flocks qualified under § 145.83(d)(1)(i) are set.
(3) U.S. M. Synoviae Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(l) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in multiplier breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza using an approved test as described in § 145.14 when more than 4 months of age. To retain this classification:
(i) A sample of at least 15 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 15 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 15 birds is tested within each 90-day period; or
(iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 15 samples are collected and tested within each 90-day period; and
(iv) Fifteen (15) birds are tested and found negative for avian influenza within 21 days prior to movement to slaughter regardless of the date of the previous test.
(2) [Reserved]
(m) U.S. Salmonella Enteritidis Monitored. This classification is intended for multiplier meat-type breeders wishing to monitor their breeding flocks for Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean primary meat-type breeding flock.
(ii) The flock is maintained in accordance with part 147 of this subchapter with respect to Salmonella isolation, sanitation, and management.
(iii) Environmental samples are collected from the flock in accordance with part 147 of this subchapter at 16-18 and 40-45 weeks of age. The samples shall be examined bacteriologically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped.
(2) The following actions must be taken with respect to the test results that are generated from this Salmonella Enteritidis monitoring program:
(i) If Salmonella Enteritidis is isolated from an environmental sample collected from the flock in accordance with paragraph (m)(1)(iii) of this section, a thorough evaluation of the practices and programs associated with the sampled flock shall be conducted by the company with the goal of ascertaining the reason(s) for the positive finding.
(ii)-(iv) [Reserved]
(3) This classification may be revoked by the Official State Agency if the participant fails to comply with the requirements of this classification. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(a) U.S. Pullorum-Typhoid-Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible from qualifying.
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (1) A State will be declared a U.S. M. Gallisepticum Clean State, Meat-Type Chickens, when it has been determined by the Service that:
(i) No M. gallisepticum is known to exist nor to have existed in meat-type chicken breeding flocks in production within the State during the preceding 12 months;
(ii) All meat-type chicken breeding flocks in production are classified as U.S. M. Gallisepticum Clean in accordance with §§ 145.33(c) and 145.83(c) or have met equivalent requirements for M. gallisepticum control under official supervision;
(iii) All hatcheries within the State which handle products from meat-type chicken breeding flocks only handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum control under official supervision;
(iv) All shipments of products from meat-type chicken breeding flocks other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all specimens from chickens from meat-type chicken breeding flocks that have been identified as being infected with M. gallisepticum;
(vi) All reports of M. gallisepticum infection in chickens from meat-type chicken breeding flocks are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(vii) All chickens from meat-type chicken breeding flocks found to be infected with M. gallisepticum are quarantined until marketed under supervision of the Official State Agency.
(2) Discontinuation of any of the conditions described in paragraph (b)(1) of this section, or if repeated outbreaks of M. gallisepticum occur in meat-type chicken breeding flocks described in paragraph (b)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Poults. Newly hatched turkeys.
(a) Participating turkey flocks, and the eggs and poults produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart D.
(b) Hatching eggs should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to poults must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and poults produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All turkey hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All turkey hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) [Reserved]
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), and (vi) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in turkey breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months.
(5) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4) of this section and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by APHIS may be used in lieu of blood testing.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management, and in which no M. Gallisepticum infected birds are found when a random sample of at least 10 percent of the birds in the flock, or 300 birds in flocks of more than 300 and each bird in flocks of 300 or less, is tested when more than 12 weeks of age, in accordance with the procedures described in § 145.14(b); provided, that to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks or 60 samples from mixed, male and female flocks (the ratio of samples collected from male and female birds must be representative of birds throughout the house) shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter.
(2) A flock qualified as U.S. M. Gallisepticum Clean may retain the classification through its first egg-laying cycle, provided it is maintained in isolation and no evidence of M. gallisepticum infection is revealed. A flock which is molted following completion of an egg-laying cycle and subsequently brought back into production, shall be retested within 2 weeks prior to production, as described in paragraph (c)(1) of this section. A State inspector shall visit with the owner or manager of each flock at least once during each laying cycle to discuss and ascertain whether the flock is being maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. If a flock proves to be infected with M. gallisepticum, it shall lose this classification.
(3) In order to sell hatching eggs or poults of this classification, all hatching eggs and poults handled by the participant must be of this classification.
(d) U.S. M. Meleagridis Clean. (1) A flock in which freedom from M. meleagridis has been demonstrated under the following criteria:
(i) A sample of 100 birds from each flock has been tested for M. meleagridis when more than 12 weeks of age: Provided, That to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks or 60 samples from mixed male and female flocks (the ratio of samples collected from male and female birds must be representative of birds throughout the house) shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter.
(ii) [Reserved]
(2)-(3) [Reserved]
(4) When reactors to the official test are found and can be identified, 10 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted to a laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than 5 reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination.
(5) If a mycoplasma is isolated, the organism must be serotyped. If M. meleagridis is isolated, the flock shall be considered infected.
(e) U.S. M. Synoviae Clean. (1) All birds, or a sample of at least 100 birds from flocks of more than 100 and each bird in flocks of 100 or less, have been tested for M. synoviae when more than 12 weeks of age in accordance with the procedures in § 145.14(b): Provided, That to retain this classification a minimum of 30 samples from male flocks and 60 samples from female flocks or 60 samples from mixed male and female flocks (the ratio of samples collected from male and female birds must be representative of birds throughout the house) shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter. It is recommended that any birds that are showing clinical signs of M. synoviae infection be included in samples taken.
(2) When reactors to the official test are found and can be identified, tracheal swabs and their corresponding blood samples from 10 (all if fewer than 10) reacting birds shall be submitted to an authorized laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than five reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination. When reactors to the official test are found, the procedures outlined in part 147 of this subchapter will be used to determine the status of the flock.
(f) U.S. Sanitation Monitored, Turkeys. A flock or hatchery whose owner is controlling or reducing the level of salmonella through compliance with sanitation and management practices in accordance with part 147 of this subchapter, and where the following monitoring, testing, and management practices are conducted:
(1) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, from each hatch or a candidate breeding flock produced by a primary breeder, are examined bacteriologically at an authorized laboratory for Salmonella.
(2) The poults for the candidate breeding flock are placed in a building that has been cleaned and disinfected. An Authorized Agent must collect environmental samples from the building and submit them to an authorized laboratory for a bacteriological examination for the presence of Salmonella, in accordance with part 147 of this subchapter.
(3) Feed for turkeys in the candidate and breeding flock should meet the following requirements:
(i) All feed manufactured in pellet form must have a maximum moisture content of 13.5 percent upon delivery to the farm. It should have been preconditioned to the minimum of one of the following parameters before pelleting:
(A) Feed is to reach a minimum temperature of 185 °F for a minimum of 6 minutes of retention in the conditioning chamber. The conditioned mash feed moisture must be a minimum of 16 percent during the conditioning process. This method utilizes time retention to allow permeation to the center core of each feed particle; or
(B) The feed is to be pressurized in order to expedite the transfer of the heat and moisture to the core of each feed particle. The feed should be conditioned to the parameters of a minimum of 16 percent moisture and 200 °F; or
(C) The feed should be submitted to pressurization to the extent that the initial feed temperature rises to 235 °F for 4 seconds; or
(D) The feed should be submitted to an equivalent thermal lethality treatment; or
(E) A Food and Drug Administration (FDA)-approved product for Salmonella control should be added to the finished pellets.
(ii) Mash feed should be treated with an FDA-approved Salmonella control product.
(iii) All feed is to be stored and transported in such a manner as to prevent possible contamination with pathogenic bacteria.
(iv) FDA-approved products for Salmonella control may be added to either unfinished or finished feed.
(4) Environmental samples shall be taken by an Authorized Agent, in accordance with part 147 of this subchapter, from each flock at 12-20 weeks of age and examined bacteriologically at an authorized laboratory for Salmonella.
(5) Environmental samples shall be taken by an Authorized Agent, in accordance with part 147 of this subchapter, from each flock at 35-50 weeks of age and from each molted flock at midlay, and examined bacteriologically at an authorized laboratory for Salmonella.
(6) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, shall be cultured as a means of evaluating the effectiveness of the control procedures.
(g) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the turkey breeding industry may conduct a program for the prevention and control of the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in breeding turkeys through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and poults produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies for avian influenza to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(3) All spent fowl being marketed for meat from flocks that have been tested as required by this paragraph shall be tested at a rate of 6 birds per flock within 21 days prior to movement to slaughter.
(4) For both primary and multiplier breeding flocks, if a killed influenza vaccine against avian influenza subtypes other than H5 and H7 is used, then the hemagglutinin and the neuraminidase subtypes of the vaccine must be reported to the Official State Agency for laboratory and reporting purposes.
(h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding turkeys through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and poults produced from it will qualify for classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age, and meets the criteria in paragraph (h)(2) of this section to retain classification; or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h) for vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days or a sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and
(ii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.
(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), § 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying.
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) U.S. Pullorum-Typhoid Clean State, Turkeys. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State, Turkeys, when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in § 145.43(b)(3)(i) through (vi).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months.
(2) Discontinuation of any of the conditions described in paragraph (b)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (b)(1)(ii) of this section, or if an infection spreads from the originating premises, Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(c) U.S. M. Gallisepticum Clean State, Turkeys. (1) A State will be declared a U.S. M. Gallisepticum Clean State, Turkeys when it has been determined by the Service that:
(i) No M. gallisepticum is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months.
(ii) All turkey breeding flocks in production are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum control under official supervision.
(iii) All turkey hatcheries within the State handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum control under official supervision.
(iv) All shipments of turkey products other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited.
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with M. gallisepticum.
(vi) All reports of M. gallisepticum infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection.
(vii) All turkey flocks found to be infected with M. gallisepticum are quarantined until marketed under supervision of the Official State Agency.
(2) Discontinuation of any of the conditions described in paragraph (c)(1) of this section, or if repeated outbreaks of M. gallisepticum occur in turkey breeding flocks described in paragraph (c)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(3) If a State retains this status for 2 or more years, individual breeding flocks in the State may qualify for an M. gallisepticum classification based on a negative test of a sample of 100 birds.
(d) U.S. M. Synoviae Clean State, Turkeys. (1) A State will be declared a U.S. M. Synoviae Clean State, Turkeys, if the Service determines that:
(i) No Mycoplasma synoviae is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months;
(ii) All turkey breeding flocks in production are tested and classified as U.S. M. Synoviae Clean or have met equivalent requirements for M. synoviae control under official supervision;
(iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Synoviae Clean or have met equivalent requirements for M. synoviae control under official supervision;
(iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Synoviae Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with M. synoviae;
(vi) All reports of M. synoviae infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; and
(vii) All turkey breeding flocks found to be infected with M. synoviae are quarantined until marketed under supervision of the Official State Agency.
(2) The Service may revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service shall not revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator of the Service.
(e) U.S. M. Meleagridis Clean State, Turkeys. (1) A State will be declared a U.S. M. Meleagridis Clean State, Turkeys, if the Service determines that:
(i) No Mycoplasma meleagridis is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months;
(ii) All turkey breeding flocks in production are tested and classified as U.S. M. Meleagridis Clean or have met equivalent requirements for M. meleagridis control under official supervision;
(iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Meleagridis Clean or have met equivalent requirements for M. meleagridis control under official supervision;
(iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Meleagridis Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with M. meleagridis;
(vi) All reports of M. meleagridis infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; and
(vii) All turkey breeding flocks found to be infected with M. meleagridis are quarantined until marketed under supervision of the Official State Agency.
(2) The Service may revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service will not revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(a) US H5/H7 AI and ND Clean Compartment. The program in this section is intended to be the basis from which the primary turkey breeding-hatchery industry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and APHIS to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI) and ND. This compartment has the purpose of protecting the defined subpopulation and avoiding the introduction and spread of H5/H7 AI and ND within that subpopulation by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the following:
(1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to H5/H7 AI and ND. Specifically, the company will use a comprehensive biosecurity program to define the compartment as a subpopulation of poultry with a health status for H5/H7 AI and ND that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must approve all documentation submitted to substantiate the defined compartment as adequate to qualify for epidemiological separation from other potential sources of infection of H5/H7 AI and ND. Guidelines for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and their health status. All birds included in the compartment must be U.S. H5/H7 Avian Influenza Clean in accordance with § 145.43(g) and ND Clean in accordance with § 145.43(h). The poultry must also be located in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveillance program for H5/H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI and ND, as described in § 145.14(d) and (e), must be conducted in State or Federal laboratories or in NPIP authorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Service upon request any relevant historical and current H5/H7 AI and ND-related data for reference regarding surveillance for the disease within the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State.
(ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including examples of Veterinary Services (VS) Form 9-5, “Report of Hatcheries, Dealers and Independent Flocks”; VS Form 9-2, “Flock Selection and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks and Poults”; VS Form 9-9, ” Hatchery Inspection Report”; set and hatch records; egg receipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place.
(iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide documentation establishing that the defined compartment is epidemiologically separated from other poultry and bird populations. The documentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compartment's separate health status with respect to H5/H7 AI and ND. The documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment.
(B) Relevant environmental factors that may affect exposure of the birds to AI and ND.
(C) The functional boundary and fencing that are used to control access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment.
(iv) Definition and description of the functional relationships between components of the defined compartment. Functional relationships between components of the compartment include traffic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the compartment. All physical components of the compartment must be maintained in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter. In addition, the company must provide a biosecurity plan for the compartment and all included components. The biosecurity plan should include:
(A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment.
(B) An education and training program for company employees and contractors.
(C) Standard operating procedures for company employees, contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environmental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may affect risk of exposure to H5/H7 AI and ND. This assessment must include a description of internal monitoring and auditing systems (e.g., quality assurance and quality control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of H5/H7 AI and ND and the associated risk pathways in which the components of the compartment are located.
(vi) Approval or denial. Based on this documentation provided under this paragraph (a)(1), as well as any other information the Service and the Official State Agency determine to be necessary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. H5/H7 Avian Influenza and ND Clean.
(2) Company activities for maintenance of the compartment. (i) The primary breeder company's management of biosecurity, surveillance, and disease control efforts must be uniform and equivalent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company's licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment.
(iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied.
(iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency.
(3) Service and Official State Agency activities for maintenance of the compartment. The Service will work in cooperation with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities will include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S. H5/H7 Avian Influenza and ND Clean Compartments under paragraph (a)(1) of this section;
(iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. H5/H7 Avian Influenza Clean program as described in § 145.43(g) and ND Clean program as described in § 145.43(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15;
(v) Conducting audits of compartments at least once every 2 years to:
(A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and
(B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15 and 145.43(g) and (h).
(4) Emergency response and notification. In the case of a confirmed positive of H5/H7 AI and ND in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A compartment will be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that H5/H7 AI and ND is not present in the compartment and the Service has reevaluated the management and biosecurity measures of the compartment and approved said compartment for trade.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Exhibition Poultry. Domesticated fowl which are bred for the combined purposes of meat or egg production and competitive showing.
Hobbyist poultry. Domesticated fowl which are bred for the purpose of meat and/or egg production on a small scale as determined by the Official State Agency.
Raised-for-release waterfowl. Domesticated fowl that normally swim, such as ducks and geese, grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild.
Participating flocks of hobbyist and exhibition poultry, raised-for-release waterfowl, and the eggs, chicks, started, and mature poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. The special provisions that apply to meat-type waterfowl flocks are found in subpart I of this part. The special provisions that apply to game bird flocks are found in subpart J of this part.
(a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated or otherwise sanitized in accordance with part 147 of this subchapter.
(c) It is recommended that waterfowl flocks and gallinaceous flocks be kept separate.
(d) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using a hatchery invoice form (9-3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the selling hatchery uses the 9-3I form, the following information must be included on the form:
(1) The form number “9-3I”, printed or stamped on the invoice;
(2) The hatchery name and address;
(3) The date of shipment;
(4) The hatchery invoice number;
(5) The purchaser name and address;
(6) The quantity of products sold;
(7) The NPIP hatchery approval number of the shipping hatchery;
(8) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91-55-078 appendix; and
(9) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design:
(i) The NPIP State number and NPIP hatchery approval number; and
(ii) The NPIP classification for which product is qualified (e.g., U.S. Pullorum-Typhoid Clean).
(e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
(f) All participating raised-for-release waterfowl flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart.
Participating flocks, and the eggs, chicks, started, and mature poultry produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section (See § 145.14 relating to the official blood test where applicable.):
(1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months.
(5) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4) of this section, and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum: Provided, That a bacteriological examination monitoring program or serological examination monitoring program for game birds acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And Provided further, That when a flock is a hobbyist or exhibition poultry primary breeding flock located in a State which has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, a bacteriological examination monitoring program or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section.
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 30 birds may be tested at any one time, with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds, or all birds in the flock if flock size is less than 30, is tested within each 90-day period; or
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and from which a random sample of birds has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity. For flocks of more than 400 birds, 200 birds shall be tested. For flocks of 60 to 400 birds, 50 percent of the birds shall be tested. For flocks of fewer than 60 birds, all birds shall be tested up to a maximum of 30 birds: Provided, that to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs from all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested; or
(B) At intervals of not more than 30 days, a sample of 25 cull baby poultry produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum.
(2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set.
(3) U.S. M. Gallisepticum Clean baby poultry shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from Mycoplasma synoviae has been demonstrated under the criteria specified in paragraph (d)(1)(i) or (d)(1)(ii) of this section.
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs (C.P. swabs) from all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 30 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds is tested within each 90-day period; or
(ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a random sample of birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity. For flocks of more than 400 birds, 200 birds shall be tested. For flocks of 60 to 400 birds, 50 percent of the birds shall be tested. For flocks of fewer than 60 birds, all birds shall be tested up to a maximum of 30 birds: Provided, that to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds shall be tested: Provided, That a sample of fewer than 30 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds, or the entire flock if flock size is less than 30, is tested each time and a total of at least 30 birds is tested within each 90-day period; or
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep those products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (d)(1)(i) or (d)(1)(ii) of this section are set.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in in accordance with part 147 of this subchapter.
(e) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in hobbyist and exhibition poultry, and raised-for-release waterfowl breeding flocks through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and chicks produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs for virus isolation. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs for virus isolation. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(3) A sample of at least 30 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter.
(f) U.S. Salmonella Monitored. The program in this paragraph (f) is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and day-old poultry through an effective and practical sanitation and testing program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock or hatchery to be eligible for the classification in this paragraph (f) as determined by the Official State Agency:
(1) Hatcheries must be kept in a sanitary condition as applicable and as outlined in § 145.6 (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter).
(2) An Authorized Agent shall collect and submit to an authorized laboratory:
(i) A minimum of five samples from the hatchery at least every 30 days while in operation. These samples may include: Hatchery debris, swabs from hatchers, setters, hatchery environment, hatchery equipment, sexing tables and belts, meconium, chick box papers, hatching trays, or chick transfer devices. Samples will be examined bacteriologically at an authorized laboratory for Salmonella; and
(ii) Annual environmental samples from each pullet and breeder farm in accordance with this section (within the NPIP Program Standards document, Program Standard B applies to bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter). Samples will be examined bacteriologically at an authorized laboratory for Salmonella.
(3) If Salmonella is identified through this testing:
(i) A qualified poultry health professional knowledgeable with the operation will be consulted and will:
(A) Review test results to evaluate the Salmonella monitoring program.
(B) Use the Salmonella monitoring program test results to develop appropriate and practical Salmonella intervention measures.
(ii) [Reserved]
(4) To claim products are of the classification in this paragraph (f), all products shall be derived from a farm or hatchery that meets the requirements of the classification.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying.
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Chicks. Newly hatched ostriches, emus, rheas, or cassowaries.
Ostrich. Birds of the species Struthio camelus, including all subspecies and subspecies hybrids.
Participating flocks of ostriches, emus, rheas, and cassowaries, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart.
(a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated or otherwise sanitized in accordance with part 147 of this subchapter.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and baby poultry produced from them, that have met the respective requirements specified in this section may be designated by the following terms and their corresponding designs illustrated in § 145.10.
(a) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (a)(1) or (a)(2) of this section. (See § 145.14(a) relating to the official blood test for pullorum-typhoid where applicable.)
(1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a breeding flock that meets one of the following criteria:
(i)(A) It is a multiplier or primary breeding flock of fewer than 300 birds in which a sample of 10 percent of the birds in a flock or at least 1 bird from each pen, whichever is more, has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum; or
(B) It is a multiplier or primary breeding flock of 300 birds or more in which a sample of a minimum of 30 birds has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(ii) It is a flock that has already been designated U.S. Pullorum-Typhoid Clean and uses a subsequent bacteriological examination monitoring program of hatcher debris or eggs for ostriches, emus, rheas, or cassowaries acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing.
(iii) It is a multiplier breeding flock located in a State that has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, that uses a bacteriological examination monitoring program of hatcher debris or eggs or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing.
(b) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in all ostrich, emu, rhea, and cassowary breeding flocks through routine serological surveillance of each participating breeding flock. Acceptable tests include antigen and antibody detection tests, as approved by the Official State Agency. A flock, and the hatching eggs and chicks produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a primary breeding flock in which 10 percent of the flock, up to a maximum of 30 birds, has been tested negative for type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or
(ii) A sample of less than 10 percent of the birds, up to a maximum of 30 birds, may be tested and found to be negative at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or
(ii) A sample of at least 10 percent of birds from each pen with all pens being represented must be tested negative at intervals of 180 days; or
(iii) A sample of less than 10 percent of the birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 10 percent of the birds are tested within each 180-day period.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Chicks. Newly hatched chickens.
Primary egg-type chicken breeding flocks. Foundation flocks that are composed of pedigree, great-grandparent, and grandparent stock that has been developed for egg production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce table egg layers.
Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age.
Participating flocks of primary egg-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart G.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a primary breeding flock that meets the following criteria:
(i) The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks during the preceding 12 months and in which it has been determined by the Service that:
(A) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(E) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation;
(F) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by APHIS may be used in lieu of blood testing.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) of this section.
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of fewer than 150 birds may be tested at any one time, if all pens are equally represented and a total of 150 birds is tested within each 90-day period.
(ii) [Reserved]
(2) A participant handling U.S. M. Gallisepticum Clean products shall handle only products of equivalent status.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147.
(d) U.S. Salmonella Enteritidis Clean. This classification is intended for primary egg-type breeders wishing to assure their customers that the hatching eggs and multiplier chicks produced are certified free of Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory. Cultures from serogroup D positive samples shall be serotyped.
(ii) All feed fed to the flock shall meet the following requirements:
(A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program. The protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F, or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process.
(B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: Provided, That mash feed may contain nonpelleted APPI animal protein product supplements if the finished feed is treated with a salmonella control product approved by the U.S. Food and Drug Administration.
(iii) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(iv) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled;
(v) Environmental samples shall be collected from the flock by an Authorized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The Authorized Agent shall also collect samples every 30 days after the first sample has been collected.
(vi) Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this subchapter and are sanitized or fumigated (see § 147.25 of this subchapter).
(vii) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized either by a procedure approved by the Official State Agency or in accordance with part 147 of this subchapter.
(2) A flock shall not be eligible for this classification if Salmonella enteritidis serotype enteritidis (SE) is isolated from a specimen taken from a bird in the flock. Isolation of SE from an environmental or other specimen, as described in paragraph (d)(1)(v) of this section, will require bacteriological examination for SE in an authorized laboratory, in accordance with part 147 of this subchapter, of a random sample of 60 live birds from a flock of 5,000 birds or more, or 30 live birds from a flock with fewer than 5,000 birds. If only one specimen is found positive for SE, the participant may request bacteriological examination of a second sample, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification.
(3) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (e)(1)(i) of this section.
(i) It is a flock in which a minimum of 300 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age: Provided, That to retain this classification, a sample of at least 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of fewer than 150 birds may be tested at any one time if all pens are equally represented and a total of 150 birds is tested within each 90-day period.
(ii) [Reserved]
(2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(f) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested and found negative for avian influenza when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; or
(iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and
(2) A sample of at least 11 birds must be tested and found negative for avian influenza within 21 days prior to movement to slaughter.
(g) U.S. Salmonella Monitored. This program is intended to be the basis from which the primary egg-type breeder industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products.
(1) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency:
(i) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management.
(ii) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport.
(iii) Chicks shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter.
(iv) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for Salmonella shall examine the samples bacteriologically.
(v) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically. All Salmonella isolates from a flock shall be serogrouped. Owners of flocks shall report the presence or absence of Salmonella in their flocks on a monthly basis to the Official State Agency.
(vi) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age to allow for serological testing.
(vii) Any flock entering the production period that is in compliance with all the requirements of this paragraph (g) with no history of Salmonella isolations shall be considered “Salmonella negative” and may retain this definition as long as no environmental or bird Salmonella isolations are identified and confirmed from the flock or flock environment by sampling on four separate collection dates over a minimum of a 2-week period. Sampling and testing must be performed as described in paragraph (g)(1)(vi) of this section. An unconfirmed environmental Salmonella isolation shall not change this Salmonella negative status.
(2) The Official State Agency may monitor the effectiveness of the sanitation practices in accordance with part 147 of this subchapter.
(3) In order for a hatchery to sell products of paragraphs (g)(1)(i) through (vii) of this section, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h) for vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days or a sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and
(ii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.
(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.
(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. This program is intended to be the basis from which the primary egg-type chicken breeding-hatchery industry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and the Service to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI) and Newcastle disease (ND). This compartment has the purpose of protecting the defined subpopulation and avoiding the introduction and spread of H5/H7 AI and ND within that subpopulation by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the following:
(1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to H5/H7 AI and ND. Specifically, the company will use a comprehensive biosecurity program to define the compartment as a subpopulation of poultry with a health status for H5/H7 AI and ND that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must first approve all documentation submitted by the company to substantiate the defined compartment as adequate to qualify for epidemiological separation from other potential sources of infection of H5/H7 AI and ND. Guidelines for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and their health status. All birds included in the compartment must be U.S. Avian Influenza Clean in accordance with § 145.73(f) and ND Clean in accordance with § 145.73(h). The poultry must also be located in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveillance program for H5/H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI and ND, as described in § 145.14(d) and (e), must be conducted in State or Federal laboratories or in NPIP authorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Service upon request any relevant historical and current H5/H7 AI and ND-related data for reference regarding surveillance for the disease within the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State.
(ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including examples of Veterinary Services (VS) Form 9-5, “Report of Hatcheries, Dealers and Independent Flocks”; VS Form 9-2, “Flock Selection and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks and Poults”; VS Form 9-9, ” Hatchery Inspection Report”; set and hatch records; egg receipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place.
(iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide documentation establishing that the defined compartment is epidemiologically separated from other poultry and bird populations. The documentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compartment's separate health status with respect to H5/H7 AI and ND. The documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment.
(B) Relevant environmental factors that may affect exposure of the birds to AI and ND.
(C) The functional boundary and fencing that are used to control access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment.
(iv) Definition and description of the functional relationships between components of the defined compartment. Functional relationships between components of the compartment include traffic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the compartment. All physical components of the compartment must be maintained in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter. In addition, the company must provide a biosecurity plan for the compartment and all included components. The biosecurity plan should include but not be limited to:
(A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment.
(B) An education and training program for company employees and contractors.
(C) Standard operating procedures for company employees, contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environmental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may affect risk of exposure to H5/H7 AI and ND. This assessment must include a description of internal monitoring and auditing systems (e.g., quality assurance and quality control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of H5/H7 AI and ND and the associated risk pathways in which the components of the compartment are located.
(vi) Approval or denial. Based on the documentation provided under this paragraph (a)(1), as well as any other information the Service and the Official State Agency determine to be necessary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. Avian Influenza and ND Clean.
(2) Company activities for maintenance of the compartment. (i) The primary breeder company's management of biosecurity, surveillance, and disease control efforts must be uniform and equivalent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company's licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment.
(iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied.
(iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency.
(3) Service and Official State Agency activities for maintenance of the compartment. The Service will work in cooperation with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S. Avian Influenza and ND Clean Compartments under paragraph (a)(1) of this section;
(iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as described in § 145.73(f) and ND Clean program as described in § 145.73(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15;
(v) Conducting audits of compartments at least once every 2 years to:
(A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and
(B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15, 145.73(f), and 145.73(h).
(4) Emergency response and notification. In the case of a confirmed positive of H5/H7 AI and/or ND in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A compartment will be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that H5/H7 AI and/or ND is not present in the compartment and the Service has reevaluated the management and biosecurity measures of the compartment and approved said compartment for trade.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Chicks. Newly hatched chickens.
Primary meat-type chicken breeding flocks. Foundation flocks that are composed of pedigree, great-grandparent, and grandparent stock that has been developed for meat production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce commercial broilers.
Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age.
Participating flocks of primary meat-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart H.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
(d) Poultry must be protected from vectors known to be in the wild and thus must be housed in enclosed structures during brooding, rearing, grow-out, or laying periods with no intentional access to the outdoors, creatures found in the wild, or raised on open range or pasture, or be provided with untreated open source water such as that directly from a pond, stream, or spring that wild birds or vermin have access to for usage for drinking water, as a cooling agent, or during a wash down/clean out process.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a primary breeding flock that meets the following criteria:
(i) The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months and in which it has been determined by the Service that:
(A) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(E) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation;
(F) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5) of this subchapter, and all birds fail to demonstrate pullorum or typhoid infection;
(G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by APHIS may be used in lieu of blood testing.
(c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) of this section.
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) of this subchapter when more than 4 months of age: Provided, That to retain this classification, a minimum of 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
(ii) [Reserved]
(2) A participant handling U.S. M. Gallisepticum Clean products must handle only products of equivalent status.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (d)(1)(i) of this section.
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in § 145.14(b) of this subchapter when more than 4 months of age: Provided, That to retain this classification, a sample of at least 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
(ii) [Reserved]
(2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
(e) U.S. Salmonella Enteritidis Clean. This classification is intended for primary meat-type breeders wishing to assure their customers that the chicks produced are certified free of Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for Salmonella Enteritidis at an authorized laboratory in accordance with part 147 of this subchapter and any group D Salmonella samples have been serotyped:
(A) A sample of chick papers, hatcher tray swabs, or fluff collected and cultured in accordance with part 147 of this subchapter; and
(B) Samples of intestinal and liver or spleen tissues from a minimum of 30 chicks that died within 7 days after hatching and have been preserved daily by freezing prior to shipment to an authorized laboratory.
(ii) The flock is maintained in compliance with isolation, sanitation, and management procedures for Salmonella in accordance with part 147 of this subchapter.
(iii) Environmental samples are collected from the flock by or under the supervision of an Authorized Agent, in accordance with part 147 of this subchapter, when the flock reaches 4 months of age and every 30 days thereafter. Once the flock is in egg production and chicks are hatching from it, the samples must include at least 4 individual test assay results every 30 days in flocks of more than 500 birds or 2 individual assays per month in flocks of 500 birds or fewer. One of these results must come from samples collected from hatched chicks at a participating hatchery derived from said flock. These individual test assays may be derived from pooled samples from the farm or hatchery in accordance with part 147 of this subchapter, but must be run as separate test assays in the laboratory. The environmental samples shall be examined bacteriologically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped.
(iv) Hatching eggs produced by the flock are collected as quickly as possible and their sanitation is maintained in accordance with part 147 of this subchapter.
(v) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation in accordance with part 147 of this subchapter.
(2) If Salmonella enteritidis serotype enteritidis (SE) is isolated from a specimen taken from a bird in the flock, except as provided in paragraph (e)(3) of this section, the flock shall not be eligible for this classification.
(3) If SE is isolated from an environmental sample collected from the flock in accordance with paragraph (e)(1)(iii) of this section, an additional environmental sampling and 25 live cull birds or fresh dead birds (if present), or other randomly selected live birds if fewer than 25 culls can be found in the flock, must be bacteriologically examined for SE in accordance with part 147 of this subchapter. If only 1 bird from the 25-bird sample is found positive for SE., the participant may request bacteriological examination of a second 25-bird sample from the flock. In addition, if the flock with the SE isolation is in egg production and eggs are under incubation, the next four consecutive hatches shall be examined bacteriologically in accordance with part 147 of this subchapter. Samples shall be collected from all of the hatching unit's chick trays and basket trays of hatching eggs, or from all chick box papers from the flock, and tested, pooling the samples into a minimum of 10 separate assays. Any followup hatchery-positive SE isolations shall result in discontinuation of subsequent hatches until the flock status is determined by bird culture. The flock will be disqualified for the U.S. S. Enteritidis Clean classification if a bird or subsequent flock environmental assay results in isolation of SE.
(4) In order for a hatchery to sell products of this classification, all products handled by the hatchery must meet the requirements of this paragraph.
(5) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(6) A pedigree, experimental, great-grandparent, or grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met:
(i) The owner attests that corrective measures have been implemented, which may include one or more of the following:
(A) Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed Salmonella enteritidis enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age.
(B) Perform other corrective actions including, but not limited to, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement of uninfected birds to premises that have been determined to be environmentally negative for Salmonella Enteritidis in accordance with par 147 of this subchapter.
(C) One hundred percent of blood samples from the birds moved to the clean premises are tested negative for Salmonella Pullorum and group D Salmonella. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D Salmonella, in accordance with part 147 of this subchapter. Cultures from positive samples shall be serotyped.
(D) Two consecutive environmental drag swabs taken at the clean premises collected in accordance with part 147 of this subchapter 4 weeks apart are negative for Salmonella Enteritidis.
(E) Other corrective measures at the discretion of the Official State Agency.
(ii) Following reinstatement, a flock will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the requirements set forth in § 145.83(e).
(f) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products.
(1) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency.
(i) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport.
(ii) Chicks shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter.
(iii) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for Salmonella shall examine the samples bacteriologically;
(iv) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically. All Salmonella isolates from a flock shall be serogrouped. Owners of flocks shall report the presence or absence of Salmonella in their flocks on a monthly basis to the Official State Agency;
(v) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age to allow for serological testing.
(vi) Any flock entering the production period that is in compliance with all the requirements of § 145.83(f) with no history of Salmonella isolations shall be considered “Salmonella negative” and may retain this definition as long as no environmental or bird Salmonella isolations are identified and confirmed from the flock or flock environment by sampling on 4 separate collection dates over a maximum of a 4-week period. Sampling and testing must be performed as described in paragraph (f)(1)(iv) of this section. An unconfirmed environmental Salmonella isolation shall not change this Salmonella negative status.
(2) The Official State Agency may monitor the effectiveness of the sanitation practices in accordance with part 147 of this subchapter.
(3) In order for a hatchery to sell products of paragraphs (f)(1)(i) through (f)(1)(vi) of this section, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(g) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza using an approved test as described in § 145.14 when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; or
(iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and
(2) During each 90-day period, all primary spent fowl, up to a maximum of 30, must be tested serologically and found negative for antibodies for avian influenza within 21 days prior to movement to slaughter.
(h) U.S. Newcastle Disease (ND) Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h) for vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using approved serological tests as described in § 145.14 and the results are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production, and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days or a sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and
(ii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.
(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.
(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. This program is intended to be the basis from which the primary meat-type chicken breeding-hatchery industry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and the Service to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI) and Newcastle disease (ND). This compartment has the purpose of protecting the defined subpopulation and avoiding the introduction and spread of H5/H7 AI and ND within that subpopulation by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the following:
(1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to H5/H7 AI and ND. Specifically, the company will use a comprehensive biosecurity program to define the compartment as a subpopulation of poultry with a health status for H5/H7 AI and ND that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must first approve all documentation submitted by the company to substantiate the defined compartment as adequate to qualify for epidemiological separation from other potential sources of infection of H5/H7 AI and ND. Guidelines for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and their health status. All birds included in the compartment must be U.S. Avian Influenza Clean in accordance with § 145.83(g) and ND Clean in accordance with § 145.83(h). The poultry must also be located in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveillance program for H5/H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI and ND, as described in § 145.14(d) and (e), must be conducted in State or Federal laboratories or in NPIP authorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Service upon request any relevant historical and current H5/H7 AI and ND-related data for reference regarding surveillance for the disease and the health status of the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State.
(ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including examples of Veterinary Services (VS) Form 9-5, “Report of Hatcheries, Dealers and Independent Flocks”; VS Form 9-2, “Flock Selection and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks and Poults”; VS Form 9-9, ” Hatchery Inspection Report”; set and hatch records; egg receipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place.
(iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide documentation establishing that the defined compartment is epidemiologically separated from other poultry and bird populations. The documentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compartment's separate health status with respect to H5/H7 AI and ND. The documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment.
(B) Relevant environmental factors that may affect exposure of the birds to AI and ND.
(C) The functional boundary and fencing that are used to control access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment.
(iv) Definition and description of the functional relationships between components of the defined compartment. Functional relationships between components of the compartment include traffic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the compartment. All physical components of the compartment must be maintained in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter. In addition, the company must provide a biosecurity plan for the compartment and all included components. The biosecurity plan should include but not be limited to:
(A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment.
(B) An education and training program for company employees and contractors.
(C) Standard operating procedures for company employees, contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environmental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may affect risk of exposure to H5/H7 AI and ND. This assessment must include a description of internal monitoring and auditing systems (e.g., quality assurance and quality control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of H5/H7 AI and ND and the associated risk pathways in which the components of the compartment are located.
(vi) Approval or denial. Based on the documentation provided under this paragraph (a)(1), as well as any other information the Service and the Official State Agency determine to be necessary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. Avian Influenza and ND Clean.
(2) Company activities for maintenance of the compartment. (i) The primary breeder company's management of biosecurity, surveillance, and disease control efforts must be uniform and equivalent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company's licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment.
(iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied.
(iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency.
(3) Service and Official State Agency activities for maintenance of the compartment. The Service will work in cooperation with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S. Avian Influenza Clean and/or ND Clean Compartments under paragraph (a)(1) of this section;
(iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as described in § 145.83(g) and ND Clean program as described in § 145.83(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15;
(v) Conducting audits of compartments at least once every 2 years to:
(A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and
(B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15 and 145.83(g) and (h).
(4) Emergency response and notification. In the case of a confirmed positive of H5/H7 AI in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A compartment would be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that H5/H7 AI is not present in the compartment and the Service has reevaluated the management and biosecurity measures of the compartment and approved said compartment for trade.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following term shall be construed to mean:
Meat-type waterfowl breeding flocks. Flocks of domesticated duck or goose that are composed of stock that has been developed and is maintained for the primary purpose of producing baby poultry that will be raised under confinement for the primary purpose of producing meat for human consumption.
Participating flocks of meat-type waterfowl and the eggs and baby poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart I.
(a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary and multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
(c) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and baby poultry produced from them, that have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in one of the following paragraphs (b)(1) through (b)(5) of this section (See § 145.14 relating to the official blood test where applicable.):
(1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, that an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and infected wild birds, contaminated feed or waste, or birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months.
(5) It is a primary breeding flock located in a State determined to be in compliance with provisions of paragraph (b)(3) of this section, and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum: Provided, That when a flock is a primary breeding flock located in a State which has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, a bacteriological examination monitoring program or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing.
(c) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in meat-type waterfowl breeding flocks through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and baby poultry produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested and found to be negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(3) A sample of at least 11 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter.
(d) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and day-old waterfowl through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products.
(1) A flock and the hatching eggs and day-old waterfowl produced from it must meet the following requirements, as determined by the Official State Agency, to be eligible for this classification:
(i) The flock is maintained in compliance with isolation, sanitation, and management procedures for Salmonella in accordance with part 147 of this subchapter.
(ii) If feed contains animal protein, the protein products must have been heated throughout to a minimum temperature of 190 °F or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process.
(iii) Feed shall be stored and transported in a manner that prevents contamination.
(iv) Waterfowl shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter.
(v) An Authorized Agent shall take environmental samples from the hatchery every 30 days, i.e., meconium or box liner paper. An authorized laboratory for Salmonella shall examine the samples bacteriologically.
(vi) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically.
(vii) Flocks may be vaccinated with a paratyphoid vaccine: Provided, that a sample of at least 100 birds will be segregated and shall remain unvaccinated until the flock reaches at least 4 months of age.
(2) The Official State Agency may monitor the effectiveness of the egg sanitation practices in accordance with part 147 of this subchapter.
(3) To claim products are of this classification, all products shall be derived from a hatchery and flock that meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State that is otherwise eligible from qualifying.
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Egg/meat-type bird. Birds grown under confinement for the primary purpose of producing eggs and/or meat for human consumption.
Game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons.
Raised-for-release bird. Birds grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild.
Participating flocks of egg/meat-type game birds, raised-for-release game birds, and the products produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. Participation is broken into the following categories of operation and products:
(a) The categories for operation are:
(1) Breeder. An individual or business that maintains a breeding flock for the purpose of producing eggs, chicks, started, or mature birds. A breeder that is also a hatchery and/or grower shall be categorized as a breeder.
(2) Hatchery. A category of operations in which an individual or business does not have a breeding flock, but hatches eggs for the purpose of producing chicks, started, or mature birds. A hatchery that is also a grower shall be categorized as a hatchery.
(3) Grower. A category of operations in which an individual or business does not have a breeding flock or hatchery, but raises birds for the purpose of selling started or mature birds.
(4) Dealer. An individual or business that resells eggs, chicks, started, or mature birds. Products a dealer handles are typically resold within 30 days or less.
(b) The categories for products are:
(1) Egg. An egg laid by a female bird for the purpose of hatching a chick.
(2) Chick. A bird that is newly hatched from an egg.
(3) Started bird. A bird that is between the age of a newly hatched chick and a mature bird.
(4) Mature bird. A bird that is fully colored and has reached the average maximum size specific to each species.
(c) Products shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(d) Hatching eggs produced by breeding flocks shall be nest clean, fumigated, or otherwise sanitized in accordance with part 147 of this subchapter.
(e) Under this subpart, gallinaceous flocks and waterfowl flocks may not be raised on the same premises. If they are on the same premises, they must be registered under subpart E of this part.
(f) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
(g) A flock of game birds that are not breeders, but are located on the same premise as game bird breeders, shall be covered under the same NPIP hatchery approval number as long as the appropriate testing requirements have been met.
(h) All participating raised-for-release game bird flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart.
(i) A breeder, hatchery, or grower may also be a dealer without being categorized as a dealer. To resell products under the assigned NPIP number and avoid losing NPIP flock classifications, products must be purchased from an NPIP participant with equal or greater classifications or from a flock with equivalent or greater testing requirements under official supervision.
(j) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using an invoice form (9-3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the 9-3I form is used, the following information must be included on the form:
(1) The form number “9-3I”, printed or stamped on the invoice;
(2) The seller name and address;
(3) The date of shipment;
(4) The invoice number;
(5) The purchaser name and address;
(6) The quantity of products sold;
(7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91-55-078 appendix; and
(8) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design:
(i) The NPIP State number and NPIP approval number; and
(ii) The NPIP classification for which product is qualified (e.g., U.S. Pullorum-Typhoid Clean).
Participating flocks, and the eggs, chicks, started, and mature birds produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under paragraph (b)(1), (2), or (3) of this section. (See § 145.14 relating to the official blood test where applicable.):
(1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Pullorum or Salmonella Gallinarum.
(2) It is a started or mature bird flock that meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and infected wild birds, contact between the flock for which qualification is being sought and contaminated feed or waste, or contact between the flock for which qualification is being sought and birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
(3) It is a breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors or reactors that upon bacteriologic examination fail to reveal Pullorum-Typhoid: Provided, That a bacteriological examination monitoring program or serological examination monitoring program for game birds acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And provided further, That it is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which Salmonella Pullorum or Salmonella Gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(viii) The flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months.
(ix) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i) through (viii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph (c) is intended to be the basis from which the game bird industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in game bird flocks through routine surveillance of each participating flock. A flock or premises, and the hatching eggs, chicks, started, and mature birds produced from it, will qualify for the classification in this paragraph (c) when the Official State Agency determines that it has met the following requirements:
(1) It is a flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain the classification in this paragraph (c):
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(2) For participants with non-breeding flocks retained for raised-for-release or other purposes on the same premises as a breeding flock, a representative sample of at least 30 birds from the participating premises must be tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age, every 90 days.
(d) U.S. Salmonella Monitored. The program in this paragraph (d) is intended to be the basis from which the game bird industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in day-old poultry through an effective and practical sanitation program in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock to be of this classification in this paragraph (d):
(1) An Authorized Agent shall collect a minimum of five environmental samples, e.g., chick papers, hatching trays, and chick transfer devices, from the hatchery at least every 30 days. Testing must be performed at an authorized laboratory.
(2) To claim products are of the classification in this paragraph (d), all products shall be derived from a hatchery that meets the requirements of the classification.
(3) The classification in this paragraph (d) may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:
(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying.
(2) If there is discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification in this paragraph (a). Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Affiliated flock. A meat-type flock that is owned by or has an agreement to participate in the Plan with a slaughter plant and that participates in the Plan through that slaughter plant.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Authorized Agent. Any person designated under § 146.10(a) to perform functions under this part.
Authorized laboratory. An authorized laboratory is a laboratory that meets the requirements of § 147.52 and is thus qualified to perform the assays in accordance with part 147 of this subchapter.
Classification. A designation earned by participation in a Plan program.
Commercial meat-type flock. All of the meat-type chickens, spent fowl, meat-type turkeys, commercial upland game birds, or commercial waterfowl on one farm. However, at the discretion of the Official State Agency, any group of poultry which is segregated from another group in a manner sufficient to prevent the transmission of H5/H7 LPAI and has been so segregated for a period of at least 21 days may be considered as a separate flock.
Commercial table-egg layer flock. All table-egg layers of common age or pullet source on one premises.
Commercial table-egg layer premises. A farm containing contiguous flocks of commercial table-egg layers under common ownership.
Commercial table-egg layer pullet flock. A table-egg layer flock prior to the onset of egg production.
Cooperating State Agency. Any State authority recognized by the Department to cooperate in the administration of the provisions of part 56 of this chapter. This may include the State animal health authority or the Official State Agency.
Department. The U.S. Department of Agriculture.
Domesticated. Propagated and maintained under the control of a person.
Equivalent. Requirements which are equal to or exceed the program, conditions, criteria, or classifications with which they are compared, as determined by the Official State Agency and with the concurrence of the Service.
H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry caused by an influenza A virus of H5 or H7 subtype that has an intravenous pathogenicity index in 6-week-old chickens less than or equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-old chickens infected intravenously, or an infection with influenza A viruses of H5 or H7 subtype with a cleavage site that is not consistent with a previously identified highly pathogenic avian influenza virus.
H5/H7 LPAI virus infection (infected). (1) Poultry will be considered to be infected with H5/H7 LPAI for the purposes of this part if:
(i) H5/H7 LPAI virus has been isolated and identified as such from poultry; or
(ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry; or
(iii) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry. If vaccine is used, methods should be used to distinguish vaccinated birds from birds that are both vaccinated and infected. In the case of isolated serological positive results, H5/H7 LPAI infection may be ruled out on the basis of a thorough epidemiological investigation that does not demonstrate further evidence of H5/H7 LPAI infection, as determined by the Cooperating State Agency, the Official State Agency, and APHIS.
(2) The official determination that H5/H7 LPAI virus has been isolated and identified, viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, or antibodies to the H5 or H7 subtype of AI virus have been detected may only be made by the National Veterinary Services Laboratories.
NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound.
Official State Agency. The State authority recognized by the Department to cooperate in the administration of the Plan.
Person. A natural person, firm, or corporation.
Plan. The provisions of the National Poultry Improvement Plan contained in this part.
Poultry. Domesticated fowl, including chickens, turkeys, waterfowl, and game birds, except doves and pigeons, that are bred for the primary purpose of producing eggs or meat.
Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, designation of a flock, a slaughter plant, or a State by an official Plan classification and illustrative design, as described in § 146.9 of this part.
Service. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
State. Any of the States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands of the United States, or any territory or possession of the United States.
State Inspector. Any person employed or authorized under § 146.10(b) to perform functions under this part.
United States. All of the States.
(a) The Department cooperates through a Memorandum of Understanding with the Official State Agency in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency.
(b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.
(c)(1) An Official State Agency may accept for participation a commercial table-egg layer pullet flock, commercial table-egg layer flock, or a commercial meat-type flock (including an affiliated flock) located in another participating State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision.
(2) An Official State Agency may accept for participation a commercial table-egg layer pullet flock, commercial table-egg layer flock, or a commercial meat-type flock (including an affiliated flock) located in a State that does not participate in the Plan under a mutual understanding and agreement, in writing, between the owner of the flock and the Official State Agency regarding conditions of participation and supervision.
(d) The Official State Agency of any State may adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards, compatible with the Plan.
(e) An authorized laboratory will conduct tests in accordance with part 147 of this subchapter when determining the status of a participating flock with respect to an official Plan classification.
(f) Cooperating State Agencies will be responsible for making the determination to request Federal assistance under part 56 of this chapter in the event of an outbreak of H5/H7 LPAI.
(a) Any commercial table-egg layer pullet flock, table-egg producer, egg/meat-type game bird, egg/meat-type waterfowl, meat-type chicken or meat-type turkey slaughter plant, including its affiliated flocks, may participate in the Plan when the producer or plant has demonstrated, to the satisfaction of the Official State Agency, that its facilities, personnel, and practices are adequate for carrying out the relevant special provisions of this part and has signed an agreement with the Official State Agency to comply with the relevant special provisions of this part.
(b) Each participant shall comply with the Plan throughout the operating year, or until released by the Official State Agency.
(c) A participating slaughter plant shall participate with all of the egg/meat-type game bird, egg/meat-type waterfowl, meat-type chicken, spent fowl, and/or meat-type turkey flocks that are processed at the facility, including affiliated flocks. Affiliated flocks must participate through a written agreement with a participating slaughter plant that is approved by the Official State Agency.
(d) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced as follows:
(a) Records that establish the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency.
(b) Material that is used to advertise products shall be subject to inspection by the Official State Agency at any time.
(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in their advertising reference to associated or franchised slaughter or production facilities only when such facilities produce products of the same classification.
(d) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the official approval number of the participant and may be used on each certificate, invoice, shipping label, or other document used by the participant in the sale of the participant's products. Each Official State Agency which requires an approval number for out-of-State participants to ship into its State shall honor this number.
(a) Participating flocks, and all equipment used in connection with the flocks, shall be separated from non-participating flocks in a manner acceptable to the Official State Agency.
(b) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition in accordance with part 147 of this subchapter.
(a) Only meat-type game bird, meat-type waterfowl, meat-type chicken, and meat-type turkey slaughter plants that are under continuous inspection by the Food Safety and Inspection Service of the Department or under State inspection that the Food Safety and Inspection Service has recognized as equivalent to Federal inspection may participate in the Plan.
(b) To participate in the Plan, meat-type chicken, meat-type turkey, and meat-type game bird and meat-type waterfowl slaughter plants must follow the relevant special provisions in §§ 146.33(a), 146.43(a), and 146.53(a), respectively, for sample collection and flock monitoring, unless they are exempted from the special provisions under §§ 146.32(b), 146.42(b), or 146.52(b), respectively.
The official classification terms defined in §§ 146.8 and 146.9 and the various designs illustrative of the official classifications reproduced in § 146.9 may be used only by participants and to describe products that have met all of the specific requirements of such classifications.
Participating slaughter plants shall be designated as “U.S. H5/H7 Avian Influenza Monitored.” All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification.
Participating flocks, products produced from them, and States that have met the requirements of a classification in this part may be designated by the corresponding illustrative design in this section.
(a) U.S. H5/H7 Avian Influenza Monitored. (See §§ 146.23(a), 146.33(a), 146.43(a), and 146.53(a).)
(b) U.S. H5/H7 Avian Influenza Monitored State, Layers. (See § 146.24.)
(c) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (See § 146.44.)
(a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 146.13 of this part.
(b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks and to perform the official inspections necessary to verify compliance with the requirements of the Plan.
(c) Authorities issued to Authorized Agents or State Inspectors under the provisions of this section shall be subject to cancellation by the Official State Agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the Official State Agency. Such actions shall not be taken until thorough investigation has been made by the Official State Agency and the authorized person has been given notice of the proposed action and the basis thereof and an opportunity to present his or her views.
(a) Each participating slaughter plant shall be audited at least once annually or a sufficient number of times each year to satisfy the Official State Agency that the participating slaughter plant is in compliance with the provisions of this part. The yearly audit will consist of an evaluation of 2 weeks' worth of records, selected at random, of the following data:
(1) The actual flock slaughter date for each flock. This information must come from a verifiable source. Verifiable sources include electronic record systems that have oversight from the Department's Grain Inspectors, Packers and Stockyards Administration or Food Safety and Inspection Service (FSIS) documents such as FSIS Form 9061-2.
(2) Laboratory test results for each flock slaughtered with the sample collection date and test result. The test must be NPIP-approved and performed in an authorized laboratory of the NPIP.
(b) A flock will be considered to be conforming to protocol if it meets the requirements as described in § 146.33(a), § 146.43(a), or § 146.53(a).
(c) Two or more flocks that are found to be not conforming to protocol in the yearly audit for a slaughter plant shall be cause for a deficiency rating for that plant. However, if the root cause for the deficiency was identified, corrected, and documented, the plant will be eligible for an immediate reevaluation of 2 additional weeks' worth of records, again selected at random. If no more than one missed flock is identified in this reevaluation, the plant will be considered in compliance and no further action will be required. Plants found to be deficient must provide a written corrective action plan to the auditor within 2 weeks of receipt of the deficiency rating. A followup audit on the information in paragraphs (a)(1) and (a)(2) of this section will occur within 90 days from the receipt of the corrective action plan. Slaughter plants will retain their classification and may continue to use the Plan emblem in § 146.9(a) during this process. A failure on the followup audit may result in disbarment from participation according to the procedures in § 146.12.
(d) On-site inspections of any participating flocks and premises will be conducted if a State Inspector determines that a breach of testing has occurred for the Plan programs for which the flocks are certified.
(e) The official H5/H7 LPAI testing records of all participating flocks and slaughter plants shall be examined annually by a State Inspector. Official H5/H7 LPAI testing records shall be maintained for 3 years.
Participants in the Plan who, after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Official State Agency may deem appropriate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his or her views with respect to the debarment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall continue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Administrator to determine the eligibility of the debarred participant for participation in the Plan. In such an event, the Administrator shall determine the matter de novo in accordance with the rules of practice in 7 CFR part 50, which are hereby made applicable to proceedings before the Administrator under this section. The definitions in 7 CFR 50.10 and the following definitions shall apply with respect to terms used in such rules of practice:
(a) Administrator means the Administrator, Animal and Plant Health Inspection Service of the U.S. Department of Agriculture, or any officer or employee to whom authority has heretofore been delegated or to who authority may hereafter be delegated to act in his or her stead.
(b) [Reserved]
(a) Samples. Either egg or blood samples may be used for testing. Samples must be collected in accordance with the following requirements:
(1) Egg samples. Egg samples must be collected and prepared in accordance with part 147 of this subchapter.
(2) Blood samples. Blood samples obtained in the slaughter plant should be collected after the kill cut with birds remaining on the kill line. Hold an open 1.5 mL snap cap micro-centrifuge tube under the neck of the bird directly after the kill cut and collect drips of blood until the tube is half full. Keep the blood tubes at room temperature for the clot to form, which should require a minimum of 4 hours and a maximum of 12 hours. Refrigerate the tube after the clot has formed. Put tubes in a container and label it with plant name, date, shift (A.M. or Day, P.M. or Night), and flock number. After the clot is formed, the clot should be removed by the Authorized Agent in order to ensure good-quality sera. Prepare a laboratory submission form and ship samples with submission forms to the laboratory in a polystyrene foam cooler with frozen ice packs. Submission forms and the manner of submission must be approved by the Official State Agency and the authorized laboratory to ensure that there is sufficient information to identify the samples and that the samples are received in an acceptable condition for further tests to be reliably performed. Blood samples should be shipped routinely to the laboratory. Special arrangements should be developed for samples held over the weekend to ensure that the samples can be reliably tested. Blood samples for official tests shall be drawn by an Authorized Agent or State Inspector.
(b) Avian influenza. The official tests for avian influenza are described in paragraphs (b)(1) and (b)(2) of this section:
(1) Antibody detection tests—(i) Enzyme-linked immunosorbent assay (ELISA) test. (A) The ELISA test must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.
(B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.
(B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza AGID test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl.
(C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(2) Agent detection tests. Agent detection tests may be used to detect influenza A virus but not to determine hemagglutinin or neuraminidase subtypes. Samples for this testing should be collected from naturally occurring flock mortality or clinically ill birds.
(i) The real time reverse transcriptase/polymerase chain reaction (RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRT-PCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT-PCR and must be conducted by personnel who have passed an NVSL proficiency test.
(B) Positive results from the RRT-PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.
(B) Chicken and turkey flocks that test positive on the ACIA must be retested using the RRT-PCR or virus isolation. Positive results from the RRT-PCR or virus isolation must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(3) The official determination of a flock as positive for the H5 or H7 subtypes avian influenza may be made only by NVSL.
(a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans.
(b) Avian influenza must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addition, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the importance of prompt reporting of clinical symptoms consistent with avian influenza.
Table-egg layer. A domesticated chicken grown for the primary purpose of producing eggs for human consumption.
Table-egg layer pullet. A sexually immature domesticated chicken grown for the primary purpose of producing eggs for human consumption.
(a) Participating commercial table-egg layer flocks shall comply with the applicable general provisions of subpart A of this part and the special provisions of subpart B of this part.
(b) Commercial table-egg laying premises with fewer than 75,000 birds are exempt from the special provisions of subpart B of this part.
Participating flocks which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored—(1) Table-egg layer pullet flocks. This program is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in table-egg layer pullets through routine surveillance of each participating commercial table-egg layer pullet flock. A flock will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(i) It is a commercial table-egg layer pullet flock in which a minimum of 11 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 21 days prior to movement; or
(ii) It is a commercial table-egg layer pullet flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1)(i) of this section and that is approved by the Official State Agency and the Service.
(2) Table-egg layer flocks. This program is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in table-egg layer through routine surveillance of each participating commercial table-egg layer flock. A flock will qualify for this classification when the Official State Agency determines that it has met the following requirements:
(i) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 21 days prior to disposal; and either
(ii) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative for the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within a 12-month period; or
(iii) It is a commercial table-egg layer flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section and that is approved by the Official State Agency and the Service.
(b) [Reserved]
(a) U.S. H5/H7 Avian Influenza Monitored State, Layers. (1) A State will be declared a U.S. H5/H7 Avian Influenza Monitored State, Layers when it has been determined by the Service that:
(i) All commercial table-egg layer flocks and all commercial table-egg layer pullet flocks that supply those flocks in production within the State that are not exempt from the special provisions of this subpart B under § 146.22 are classified as U.S. H5/H7 Avian Influenza Monitored under § 146.23(a) of this part;
(ii) All egg-type chicken breeding flocks in production within the State are classified as U.S. Avian Influenza Clean under § 145.23(h) of this subchapter;
(iii) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency, within 24 hours, the source of all table-egg layer and table-egg layer pullet specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter;
(iv) All table-egg layer and table-egg layer pullet specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and
(v) All table-egg layer and table-egg layer pullet flocks within the State that are found to be infected with the H5/H7 subtypes of avian influenza are quarantined, in accordance with an initial State response and containment plan as described in part 56 of this chapter and under the supervision of the Official State Agency.
(2) If there is a discontinuation of any of the conditions described in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/H7 subtypes of avian influenza occur in commercial table-egg layer flocks as described in paragraph (a)(1)(i) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) [Reserved]
Meat-type chicken. A domesticated chicken grown for the primary purpose of producing meat, including but not limited to broilers, roasters, fryers, and cornish.
Meat-type chicken slaughter plant. A meat-type chicken slaughter plant that is federally inspected or under State inspection that the Food Safety Inspection Service has recognized as equivalent to federal inspection.
Shift. The working period of a group of employees who are on duty at the same time.
Spent fowl. Domesticated poultry that were in production of hatching eggs or commercial table eggs and have been removed from such production.
(a) Participating meat-type chicken slaughter plants shall comply with applicable general provisions of subpart A of this part and the special provisions of this subpart C.
(b) Meat-type chicken slaughter plants that slaughter fewer than 200,000 meat-type chickens in an operating week are exempt from the special provisions of this subpart C.
(c) If spent fowl are slaughtered at meat-type chicken slaughter plants that participate in the Plan, they may participate in the Plan through the provisions of this subpart C.
Participating meat-type chicken slaughter plants that have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended to be the basis from which the meat-type chicken industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in meat-type chickens through routine surveillance of each participating meat-type chicken slaughter plant. A meat-type chicken slaughter plant will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a meat-type chicken slaughter plant where a minimum of 11 birds per shift are tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), at slaughter; Provided, that with the approval of the Official State Agency, fewer than 11 birds per shift may be tested on any given shift if the total number of birds tested during the operating month is equivalent to testing 11 birds per shift; or
(2) It is a meat-type chicken slaughter plant which accepts only meat-type chickens from flocks where a minimum of 11 birds have been tested negative for antibodies to the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), no more than 21 days prior to slaughter; or
(3) It is a meat-type chicken slaughter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1) or (a)(2) and that is approved by the Official State Agency and the Service.
(b) [Reserved]
Meat-type turkey. A domesticated turkey grown for the primary purpose of producing meat.
Meat-type turkey slaughter plant. A meat-type turkey slaughter plant that is federally inspected or under State inspection that the Food Safety Inspection Service has recognized as equivalent to federal inspection.
(a) Participating meat-type turkey slaughter plants shall comply with applicable general provisions of subpart A of this part and the special provisions of this subpart D.
(b) Meat-type turkey slaughter plants that slaughter fewer than 2 million meat-type turkeys in a 12-month period are exempt from the special provisions of this subpart D.
Participating meat-type turkey slaughter plants which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended to be the basis from which the meat-type turkey industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of avian influenza in meat-type turkeys through routine surveillance of each participating meat-type turkey slaughter plant. A participating meat-type turkey slaughter plant will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(1) It is a meat-type turkey slaughter plant that accepts only meat-type turkeys from flocks where a minimum of 6 samples per flock have been collected no more than 21 days prior to movement to slaughter and tested negative with an approved test for type A avian influenza, as provided in § 146.13(b). It is recommended that samples be collected from flocks over 10 weeks of age with respiratory signs such as coughing, sneezing, snicking, sinusitis, or rales; depression; or decreases in food or water intake.
(2) It is a meat-type turkey slaughter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1) and that is approved by the Official State Agency and the Service.
(b) [Reserved]
(a) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (1) A State will be declared a U.S. H5/H7 Avian Influenza Monitored State, Turkeys when it has been determined by the Service that:
(i) All meat-type turkey slaughter plants within the State that are not exempt from the special provisions of this subpart D under § 146.42 are classified as U.S. H5/H7 Avian Influenza Monitored under § 146.43(a) of this part;
(ii) All turkey breeding flocks in production within the State are classified as U.S. H5/H7 Avian Influenza Clean under § 145.43(g) of this subchapter;
(iii) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency, within 24 hours, the source of all meat-type turkey specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter;
(iv) All meat-type turkey specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and
(v) All meat-type turkey flocks within the State that are found to be infected with the H5/H7 subtypes of avian influenza are quarantined, in accordance with an initial State response and containment plan as described in part 56 of this chapter, and under the supervision of the Official State Agency.
(2) If there is a discontinuation of any of the conditions described in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/H7 subtypes of avian influenza occur in meat-type turkey flocks as described in paragraph (a)(1)(i) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Egg/meat-type game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons grown under confinement for the primary purposes of producing eggs and/or meat for human consumption.
Egg/meat-type waterfowl. Domesticated ducks or geese grown under confinement for the primary purposes of producing eggs and/or meat for human consumption.
Meat-type game bird slaughter plant. A meat-type game bird slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety and Inspection Service has recognized as equivalent to Federal inspection.
Meat-type waterfowl slaughter plant. A meat-type waterfowl slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety and Inspection Service has recognized as equivalent to Federal inspection.
Shift. The working period of a group of employees who are on duty at the same time.
(a) Participating meat-type game bird slaughter plants, meat-type waterfowl slaughter plants, and egg-type game bird and egg-type waterfowl premises producing eggs for human consumption shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart.
(b) Meat-type game bird slaughter plants and meat-type waterfowl slaughter plants that slaughter fewer than 50,000 birds annually are exempt from the special provisions of this subpart.
(c) Egg-type game bird and egg-type waterfowl premises with fewer than 25,000 birds are exempt from the special provisions of this subpart.
Participating slaughter plants and flocks which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9:
(a) U.S. H5/H7 Avian Influenza Monitored. The program in this paragraph (a) is intended to be the basis from which the egg/meat-type game bird and egg/meat-type waterfowl industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in egg/meat-type game birds and egg/meat-type waterfowl through routine surveillance of each participating slaughter plant or, in the case of egg-producing flocks, the regular surveillance of these flocks. A slaughter plant or flock will qualify for the classification in this paragraph (a) when the Official State Agency determines that it has met one of the following requirements:
(1) It is a meat-type game bird slaughter plant or meat-type waterfowl slaughter plant where a minimum of 11 birds per shift are tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), at slaughter;
(2) It is a meat-type game bird slaughter plant or meat-type waterfowl slaughter plant that only accepts egg/meat-type game birds or egg/meat-type waterfowl from flocks where a minimum of 11 birds per flock have been tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), no more than 21 days prior to slaughter;
(3) It is a meat-type game bird slaughter plant or meat-type waterfowl slaughter plant that has an ongoing active and passive surveillance program for H5/H7 subtypes of avian influenza that is approved by the Official State Agency and the Service.
(4) It is an egg-type game bird or egg-type waterfowl flock that produces eggs for human consumption where a minimum of 11 birds per flock have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 30 days of disposal or within a 12 month period.
(5) It is an egg-type game bird or egg-type waterfowl flock that has an on-going active and passive surveillance program for H5/H7 subtypes of avian influenza that is approved by the Official State Agency and the Service.
(b) [Reserved]
Blood testing must be conducted in a manner approved by the Administrator. Approved blood testing procedures are listed in the NPIP Program Standards, as defined in § 147.51. Blood testing procedures may also be approved by the Administrator in accordance with § 147.53(d)(1).
Bacteriological examination must be conducted in a manner approved by the Administrator. Approved bacteriological examination procedures are listed in the NPIP Program Standards, as defined in § 147.51. Bacteriological examination procedures may also be approved by the Administrator in accordance with § 147.53(d)(1).
Sanitation must be maintained in a manner approved by the Administrator. Approved procedures for maintaining sanitation are listed in the NPIP Program Standards, as defined in § 147.51. Sanitation procedures may also be approved by the Administrator in accordance with § 147.53(d)(2).
Molecular examination must be conducted in a manner approved by the Administrator. Approved molecular examination procedures are listed in the NPIP Program Standards, as defined in § 147.51. Molecular examination procedures may also be approved by the Administrator in accordance with § 147.53(d)(1).
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Department. The U.S. Department of Agriculture.
Egg type chickens. Chickens bred for the primary purpose of producing eggs for human consumption.
Exhibition Poultry. Domesticated fowl which are bred for the combined purposes of meat or egg production and competitive showing.
Game birds. Domesticated fowl, such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons.
Meat type chickens. Chickens bred for the primary purpose of producing meat.
NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound.
Plan Conference. A meeting convened for the purpose of recommending changes in the provisions of the Plan.
Plan or NPIP. The National Poultry Improvement Plan.
Service. The Animal and Plant Health Inspection Service, Veterinary Services, of the Department.
State. Any State, the District of Columbia, or Puerto Rico.
Waterfowl. Domesticated fowl that normally swim, such as ducks and geese.
Changes in this subchapter shall be made in accordance with the procedure described in this subpart: Provided, That the Department reserves the right to make changes in this subchapter without observance of such procedure when such action is deemed necessary in the public interest.
(a) The General Conference Committee Chairperson and the Vice Chairperson shall be elected by the members of the General Conference Committee. A representative of the Animal and Plant Health Inspection Service will serve as Executive Secretary and will provide the necessary staff support for the General Conference Committee. The General Conference Committee shall consist of one member-at-large who is a participant in the National Poultry Improvement Plan and one member to be elected, as provided in paragraph (b) of this section, from each of the following regions:
(1) North Atlantic: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, and Pennsylvania.
(2) East North Central: Ohio, Indiana, Illinois, Michigan, and Wisconsin.
(3) West North Central: Minnesota, Iowa, Missouri, North Dakota, South Dakota, Nebraska, and Kansas.
(4) South Atlantic: Delaware, District of Columbia, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, and Puerto Rico.
(5) South Central: Kentucky, Tennessee, Alabama, Mississippi, Arkansas, Louisiana, Oklahoma, and Texas.
(6) Western: Montana, Idaho, Wyoming, Colorado, New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, Alaska, and Hawaii.
(b) The regional committee members and their alternates will be elected by the official delegates of their respective regions, and the member-at-large will be elected by all official delegates. There must be at least two nominees for each position, the voting will be by secret ballot, and the results will be recorded. The ballots for electing regional committee members and their alternates will be printed in such a way as to allow the specific selection of one nominee for member, and one nominee for alternate from the remaining nominees. At least one nominee from each region must be from an underrepresented group (minorities, women, or persons with disabilities). The process for soliciting nominations for regional committee members will include, but not be limited to: Advertisements in at least two industry journals, such as the newsletters of the American Association of Avian Pathologists, the National Chicken Council, the United Egg Producers, and the National Turkey Federation; a
(c) Three regional members shall be elected at each Plan Conference. All members shall serve for a period of 4 years, subject to the continuation of the Committee by the Secretary of Agriculture, and may not succeed themselves: Provided, That an alternate member who assumed a Committee member vacancy following mid-term would be eligible for re-election to a full term. When there is a vacancy for the member-at-large position, the General Conference Committee shall make an interim appointment and the appointee shall serve until the next Plan Conference at which time an election will be held. If a vacancy occurs due to both a regional member and alternate being unable to serve, the vacant position will be filled by an election at the earliest regularly scheduled national or regional Plan Conference, where members of the affected region have assembled.
(d) The duties and functions of the General Conference Committee shall be as follows:
(1) Advise and make recommendations to the Department on the relative importance of maintaining, at all times, adequate departmental funding for the NPIP to enable the Senior Coordinator and staff to fully administer the provisions of the Plan.
(2) Advise and make yearly recommendations to the Department with respect to the NPIP budget well in advance of the start of the budgetary process.
(3) Assist the Department in planning, organizing, and conducting the biennial National Poultry Improvement Plan Conference.
(4) Consider each proposal submitted as provided in § 147.44 and make recommendations to subpart Committees and the Conference. Meet jointly with the NPIP Technical Committee and consider the technical aspects and accuracy of each proposal. Recommend whether new proposals (i.e., proposals that have not been submitted as provided in § 147.44) should be considered by the delegates to the Plan Conference.
(5) During the interim between Plan Conferences, represent the cooperating States in:
(i) Advising the Department with respect to administrative procedures and interpretations of the Plan provisions as contained in 9 CFR.
(ii) Assisting the Department in evaluating comments received from interested persons concerning proposed amendments to the Plan provisions.
(iii) Recommending to the Secretary of Agriculture any changes in the provisions of the Plan as may be necessitated by unforeseen conditions when postponement until the next Plan Conference would seriously impair the operation of the program. Such recommendations shall remain in effect only until confirmed or rejected by the next Plan Conference, or until rescinded by the committee.
(6) Serve as an official advisory committee for the study of problems relating to poultry health and as the need arises, to make specific recommendations to the Secretary of Agriculture concerning ways in which the Department may assist the industry in solving these problems.
(7) Serve as a direct liaison between the NPIP and the United States Animal Health Association.
(8) Advise and make recommendations to the Department regarding NPIP involvement or representation at poultry industry functions and activities as deemed necessary or advisable for the purposes of the NPIP.
(a) Changes in this subchapter may be proposed by any participant, Official State Agency, the Department, or other interested person or industry organization.
(b) Except as provided in § 147.43(d)(4), proposed changes shall be submitted in writing so as to reach the Service not later than 150 days prior to the opening date of the Plan Conference, and participants in the Plan shall submit their proposed changes through their Official State Agency.
(c) The name of the proponent shall be indicated on each proposed change when submitted. Each proposal should be accompanied by a brief supporting statement.
(d) The Service will notify all persons on the NPIP mailing lists concerning the dates and general procedure of the conference. Hatchery and dealer participants will be reminded of their privilege to submit proposed changes and to request copies of all the published proposed changes.
(e) The proposed changes, together with the names of the proponents and supporting statements, will be compiled by the Service and issued in processed form. When two or more similar changes are submitted, the Service will endeavor to unify them into one proposal acceptable to each proponent. Copies will be distributed to officials of the Official State Agencies cooperating in the NPIP. Additional copies will be made available for meeting individual requests.
Each cooperating State shall be entitled to one official delegate for each of the programs prescribed in parts 145 and 146 of this subchapter in which it has one or more participants at the time of the Conference. The official delegates shall be elected by a representative group of participating industry members and be certified by the Official State Agency. It is recommended but not required that the official delegates be Plan participants. Individuals may be allowed to be an official delegate or alternate delegate for up to three States in which that delegate has flocks or is a plan participant with acknowledgement and approval of the Official State Agencies. Each official delegate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of their State with respect to each proposed change.
(a) The following committees shall be established to give preliminary consideration to the proposed changes falling in their respective fields:
(1) Egg-type breeding chickens.
(2) Meat-type breeding chickens.
(3) Breeding turkeys.
(4) Breeding waterfowl, exhibition poultry, and game birds.
(5) Breeding ostriches, emus, rheas, and cassowaries.
(6) Egg-type commercial chickens.
(7) Meat-type commercial chickens.
(8) Meat-type commercial turkeys.
(9) Egg/meat-type game birds and waterfowl.
(b) Each official delegate shall be appointed a voting member in one of the committees specified in paragraph (a) of this section.
(c) Since several of the proposals may be interrelated, the committees shall consider them as they may relate to others, and feel free to discuss related proposals with other committees.
(d) The committees shall make recommendations to the conference as a whole concerning each proposal. The committee report shall show any proposed change in wording and the record of the vote on each proposal, and suggest an effective date for each proposal recommended for adoption. The individual committee reports shall be submitted to the chairman of the conference, who will combine them into one report showing, in numerical sequence, the committee recommendations on each proposal. Once completed, the combined committee report will be distributed electronically to the Official State Agencies prior to the delegates voting on the final day of the biennial conference.
(e) The committee meetings shall be open to any interested person. Advocates for or against any proposal should feel free to appear before the appropriate committee and present their views.
(a) The chairman of the conference shall be a representative of the Department.
(b) At the time designated for voting on proposed changes by the official delegates, the chairman of the General Conference Committee and the four committee chairmen shall sit at the speaker's table and assist the chairman of the conference.
(c) Each committee chairman shall present the proposals which his committee approves or recommends for adoption as follows: “Mr. Chairman. The committee for Egg-type chickens recommends the adoption of Proposal No. ______, for the following reasons (stating the reasons): I move the adoption of Proposal No. ______.” A second will then be called for. If the recommendation is seconded, discussion and a formal vote will follow.
(d) Each committee chairman shall present the proposals which his committee does not approve as follows: “Mr. Chairman. The Committee for Egg-type chickens does not approve Proposal No. ______.” The chairman will then ask if any official delegate wishes to move for the adoption of the proposal. If moved and seconded, the proposal is subject to discussion and voted. If there is no motion for approval, or if moved but not seconded, there can be no discussion or vote.
(e) Discussion on any motion must be withheld until the motion has been properly seconded, except that the delegate making the motion is privileged, if he desires, to give reasons for his motion at the time of making it. To gain the floor for a motion or for discussion on a motion, the official delegate in the case of a motion, or anyone in case of discussion on a motion, shall rise, address the chair, give his name and State, and be recognized by the chair before proceeding further. While it is proper to accept motions only from official delegates and to limit voting only to such delegates, it is, however, equally proper to accept discussion from anyone interested. To conserve time, discussion should be pointed and limited to the pertinent features of the motion.
(f) Proposals that have not been submitted in accordance with § 147.44 will be considered by the conference only with the unanimous consent of the General Conference Committee. Any such proposals must be referred to the appropriate committee for consideration before being presented for action by the conference.
(g) Voting will be by States, and each official delegate, as determined by § 147.45, will be allowed one vote on each proposal pertaining to the program prescribed by the subpart which he represents.
(h) A roll call of States for a recorded vote will be used when requested by a delegate or at the discretion of the chairman.
(i) All motions on proposed changes shall be for adoption.
(j) Proposed changes shall be adopted by a majority vote of the official delegates present and voting.
(k) The conference shall be open to any interested person.
Proposals adopted by the official delegates will be recommended to the Department for incorporation into the provisions of the National Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this chapter and this subpart. The Department reserves the right to approve or disapprove the recommendations of the conference as an integral part of its sponsorship of the National Poultry Improvement Plan. The Department will publish the recommendations in the
The following definitions apply in this subpart:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any other employee of the Animal and Plant Health Inspection Service delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service (APHIS, the Service). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
NPIP or Plan. The National Poultry Improvement Plan.
NPIP Program Standards. A document that contains tests and sanitation procedures approved by the Administrator under § 147.53 for use under this subchapter. This document may be obtained from the NPIP Web site at http://www.poultryimprovement.org/ or by writing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.
NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound.
These minimum requirements are intended to be the basis on which an authorized laboratory of the Plan can be evaluated to ensure that official Plan assays are performed in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with § 147.53(d)(1) and reported as described in paragraph (f) of this section. A satisfactory evaluation will result in the laboratory being recognized by the NPIP office of the Service as an authorized laboratory qualified to perform the assays provided for in this part.
(a) Check-test proficiency. The NPIP will serve as the lead agency for the coordination of available check tests from the National Veterinary Services Laboratories. Further, the NPIP may approve and authorize additional laboratories to produce and distribute a check test as needed. The authorized laboratory must use the next available check test for each assay that it performs.
(b) Trained technicians. Testing procedures at all authorized laboratories must be run or overseen by a laboratory technician who every 4 years has attended, and satisfactorily completed, Service-approved laboratory workshops for Plan-specific diseases.
(c) Laboratory protocol. Official Plan assays must be performed and reported as described in the NPIP Program Standards or in accordance with other procedures approved by the Administrator in accordance with § 147.53(d)(1). Assays must be performed using control reagents approved by the Plan or the reagent manufacturer.
(d) State site visit. The Official State Agency will conduct a site visit and recordkeeping audit at least once every 2 years. This will include, but may not be limited to, review of technician training records, check test proficiency, and test results. The information from the site visit and recordkeeping audit will be made available to the NPIP upon request.
(e) Service review. Authorized laboratories will be reviewed by the Service (NPIP staff) every 3 years. The Service's review may include, but will not necessarily be limited to, checking records, laboratory protocol, check-test proficiency, technician training, and peer review.
(f) Reporting. (1) A memorandum of understanding or other means shall be used to establish testing and reporting criteria to the Official State Agency, including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service.
(2) All Salmonella Pullorum and Mycoplasma Plan disease infected flocks as confirmed by testing in accordance with § 145.14 must be reported to the Official State Agency within 48 hours.
(g) Verification. Random samples may also be required to be submitted for verification as specified by the Official State Agency.
(a)(1) All tests that are used to qualify flocks for NPIP classifications must be approved by the Administrator as effective and accurate at determining whether a disease is present in a poultry flock or in the environment.
(2) All sanitation procedures performed as part of qualifying for an NPIP classification must be approved by the Administrator as effective at reducing the risk of incidence of disease in a poultry flock or hatchery.
(b) Tests and sanitation procedures that have been approved by the Administrator may be found in the NPIP Program Standards. In addition, all tests that use veterinary biologics (e.g., antiserum and other products of biological origin) that are licensed or produced by the Service and used as described in the NPIP Program Standards are approved for use in the NPIP.
(c) New tests and sanitation procedures, or changes to existing tests and sanitation procedures, that have been approved by the NPIP in accordance with the process described in subpart E of this part are subject to approval by the Administrator. NPIP participants may submit new tests and sanitation procedures, or changes to current tests and sanitation procedures, through that process.
(d)(1) Persons who wish to have a test approved by the Administrator as effective and accurate at determining whether a disease is present in a flock or in the environment may apply for approval by submitting the test, along with any supporting information and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an application, the NPIP Technical Committee will review the test and any supporting information and data supplied with the application. If the NPIP Technical Committee determines the test to be of potential general use, the test will be submitted for consideration by the General Conference Committee of the NPIP in accordance with subpart E of this part, and the Administrator will respond with approval or denial of the test.
(2) Persons who wish to have a sanitation procedure approved by the Administrator as effective at reducing the risk of incidence of disease in a poultry flock or hatchery may apply for approval by submitting the sanitation procedure, along with any supporting information and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an application, the NPIP Technical Committee will review the sanitation procedure and any supporting information and data supplied with the application. If the NPIP Technical Committee determines the sanitation procedure to be of potential general use, the sanitation procedure will be submitted for consideration by the General Conference Committee of the NPIP in accordance with subpart E of this part, and the Administrator will respond with approval or denial of the test.
(e)(1) When the Administrator approves a new test or sanitation procedure or a change to an existing test or sanitation procedure, APHIS will publish a notice in the
(2)(i) After the close of the public comment period, APHIS will publish a notice in the
(A) No comments were received on the notice;
(B) The comments on the notice supported the action described in the notice; or
(C) The comments on the notice were evaluated but did not change the Administrator's determination that approval of the test or sanitation procedure is appropriate based on the standards in paragraph (a) of this section.
(ii) If comments indicate that changes should be made to the test or sanitation procedure as it was made available in the initial notice, APHIS will publish a notice in the
(iii) Whenever APHIS adds or makes changes to tests or sanitation procedures, APHIS will make available a new version of the NPIP Program Standards that reflects the additions or changes.
(iv) If comments present information that causes the Administrator to determine that approval of the test or sanitation procedure would not be appropriate, APHIS will publish a notice informing the public of this determination after the close of the comment period.
(a) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure:
(1) The sensitivity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Administrator. Field samples, for which the presence or absence of the target organism or analyte has been determined by the current NPIP test, are the preferred samples and should be used when possible. Samples from a variety of field cases representing a range of low, medium, and high analyte concentrations should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added) should only be used in the event that no other sample types are available. When the use of spiked samples may be necessary, prior approval from the NPIP Technical Committee is required. Pure cultures should never be used. Additionally, laboratories should be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. (e.g., a Salmonella test should be evaluated by NPIP authorized laboratories that test for Salmonella routinely). If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(2) The specificity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known negative samples, as determined by tests conducted in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with § 147.53(d)(1). If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(3) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive samples. In addition, each laboratory must test at least 50 known negative samples obtained from several sources, to provide a representative sampling of the general population. The cooperating laboratories must perform a current NPIP procedure or NPIP approved test on the samples alongside the test kit for comparison and must provide an outline of the method on the worksheet for diagnostic test evaluation. Reproducibility and robustness data should also be included.
(4) Cooperating laboratories will submit to the kit manufacturer all compiled output data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. A completed worksheet for diagnostic test evaluation is required to be submitted with the compiled output data and may be obtained by contacting the NPIP Senior Coordinator. Data and the completed worksheet for diagnostic test evaluation must be submitted to the NPIP Senior Coordinator 4 months prior to the next scheduled General Conference Committee meeting, which is when approval will be sought.
(5) The findings of the cooperating laboratories will be evaluated by the NPIP Technical Committee, and the Technical Committee will make a majority recommendation whether to approve the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends approval, the final approval will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48.
(6) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) and that have been approved for use in the NPIP in accordance with this section are listed in the NPIP Program Standards.
(b) Approved tests modification and removal. (1) The specific data required for modifications of previously approved tests will be taken on a case-by-case basis by the technical committee.
(2) If the Technical Committee determines that only additional field data is needed at the time of submission for a modification of a previously approved test, allow for a conditional approval for 60 days for data collection side-by-side with a current test. The submitting party must provide complete protocol and study design, including criteria for pass/fail to the Technical Committee. The Technical Committee must review the data prior to final approval. This would only apply to the specific situation where a modified test needs additional field data with poultry to be approved.
(3) Approved diagnostic tests may be removed from the Plan by submission of a proposed change from a participant, Official State Agency, the Department, or other interested person or industry organization. The data in support of removing an approved test will be compiled and evaluated by the NPIP Technical Committee, and the Technical Committee will make a majority recommendation whether to remove the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends removal, the final decision to remove the test will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48.
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. As used in this part, the following words, names, or terms shall have the meanings set forth in this section, unless otherwise clearly indicated by the context.
The Act. Item 100.01 in part 1, schedule 1, of title I of the Tariff Act of 1930, as amended (19 U.S.C. 1202, schedule 1, part 1, item 100.01).
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Agent. Custom broker or other person authorized to act as agent for the importer or owner of an animal.
Animal. Any purebred animal imported specially for breeding purposes except a black, silver, or platinum fox, or any fox which is a mutation or type developed therefrom.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).
Book of record. A printed book or an approved microfilm record sponsored by a registry association and containing breeding data relative to a large number of registered purebred animals used as a basis for the issuance of pedigree certificates.
Certificates of pure breeding. A certificate issued by the Administrator, for Bureau of Customs use only, certifying that the animal to which the certificate refers is a purebred animal of a recognized breed and duly registered in a book of record recognized under the regulations in this part for that breed.
Department. The United States Department of Agriculture.
Inspector. An inspector of APHIS or of the Bureau of Customs of the United States Treasury Department authorized to perform functions under the regulations in this part.
Pedigree certificate. A document issued by a registry association giving the pedigree of an animal and certifying that it is registered in the book of record of the association issuing the document, and containing all pertinent information relating to the registered animal, such as color and natural and artificial markings, a record of the name and address of the breeder, and the name and address of each subsequent owner of the animal.
Port of entry. Any port designated under § 92.102 for birds, § 92.203 for poultry, § 92.303 for horses, § 92.403 for ruminants, or § 92.503 for swine of this chapter.
Purebred. A term applicable to animals which are the progeny of known and registered ancestors of the same recognized breed and for which at least three generations of ancestry can be traced: Provided, however, That in the case of sheep registered on the basis of flocks, the term is applicable to animals of a recognized breed which originate in a flock for which available breeding data, as shown in the registry association's records, establish that the flock has been in existence at least ten years.
The Administrator will issue a certificate of pure breeding for an animal claimed to be entitled to free entry under the act provided the requirements of the regulations in this part are complied with. Such certificate will be presented to the owner, agent, or importer who in turn shall present it to the collector of customs at the port where customs entry is made.
An application for a certificate of pure breeding executed by the owner, agent, or importer of an animal shall be made on ANH Form 17-338 (available from the collector of customs) before the animal will be examined as provided in § 151.7. Such application shall be made to the inspector at the port of entry for all animals: Provided, however, That the application for a certificate of pure breeding for dogs, other than those regulated under § 92.600 of this chapter, and cats may be made to the inspector either at the port of entry or at any other port where customs entry is made. An agent shall show the inspector written authorization from the owner or importer authorizing him to act for the owner or importer in connection with the application for a certificate of pure breeding.
A pedigree certificate for an animal of a breed listed in § 151.9 issued by the custodian of the appropriate book of record listed in said section and on which there has been entered in accordance with the rules of entry of the registry association, a complete record of transfers of ownership from the breeder to and including the United States importer, or a complete record of transfers of ownership from the breeder to and including the person who owns the animal when it is imported into the United States and the name of the United States importer (for example, a lessee), shall be furnished by the owner, agent, or importer to the inspector at the time of the examination of the animal as provided in § 151.7. The inspector will return the document to the party who submitted it. A verbatim translation of the description relating to color and markings shall appear in English in the pedigree certificate for the animal or in a separate certificate appended to the pedigree certificate.
No pedigree certificate which in the opinion of the Administrator has been substantially altered will be accepted.
The owner, agent, or importer who applies for a certificate of pure breeding for any animal offered for duty-free entry under this part, shall execute on ANH Form 17-338 a statement that the animal so offered for entry is the animal described in the pedigree certificate furnished to the inspector as prescribed in § 151.4. This form shall be presented to the inspector before the animal and pedigree certificate are examined as provided in § 151.7.
(a) For the purpose of determining identity, an examination shall be made by an inspector of each animal for which free entry is claimed under the act. All animals shall be examined at the port of entry: Provided, however, That dogs, other than those regulated under § 92.600 of this chapter, and cats may be examined either at the port of entry or at any other port where customs entry is made.
(b) The owner, agent, or importer shall provide adequate assistance and facilities for restraining and otherwise handling the animal and present it in such manner and under such conditions as in the opinion of the inspector will make a proper examination possible. Otherwise, the examination of the animal will be refused or postponed by the inspector until the owner, agent, or importer meets these requirements.
(c) A pedigree certificate, as required by § 151.4 shall be presented at the time of examination to the inspector making the examination in order that proper identification of the animal may be made. When upon such examination of any animal, the color, markings, or other identifying characteristics do not conform with the description given in the pedigree certificate and the owner, agent, or importer desires to pursue the matter further, the inspector shall issue ANH Form 17-419 to the owner, agent, or importer, and shall forward the pedigree certificate for this animal, together with ANH Form 17-419, to the Washington office of APHIS by certified mail. A determination will be made by such office as to the identity of the animal in question and the eligibility of the animal for certification under § 151.2. The pedigree certificate will be returned to the party who submitted it as soon as such determination is made. Removal of an animal from the port where examination is made prior to presentation of the pedigree certificate or other failure to comply with the requirements of this paragraph shall constitute a waiver of any further claim to certification under the regulations in this part.
To be eligible for certification under the act, an animal must be purebred of a recognized breed and have been registered in good faith in a book of record listed in § 151.9 and must not have been registered on inspection without regard to purity of breeding.
Breeds of animals and books of record listed in paragraphs (a) and (b) are hereby recognized. Recognition of such breeds and books of record will be continued, however, only if the books of record involved are kept by the custodians thereof in a form which is reasonably current and the book otherwise meets the requirements of this part, in the opinion of the Administrator. When a registry association which publishes a book of record that was recognized in printed form ceases to publish the book in such form and in lieu thereof publishes the book in microfilm form, the recognition of such book of record will be continued only if the book meets the requirements of this part. A copy of each printed volume and microfilm record of a book of record published after the book is recognized under this part shall be sent to APHIS immediately following such publication. All books of record sent to the Animal and Plant Health Inspection Service, United States Department of Agriculture, shall be submitted through the Veterinary Services, Operational Support, 4700 River Road, Unit 33, Riverdale, Maryland 20737-1231.
(a) Breeds and books of record in countries other than Canada. Books of the registry associations listed below are recognized for the following breeds: Provided, That no Belted Galloway cattle, horse of Criolla, Fjordhest (formerly known as Westland), Holstein, Shetland Pony or Welsh Pony and Cob breed, dog or cat registered in any of the books named shall be certified under the act as purebred unless a pedigree certificate showing three complete generations of known and recorded purebred ancestry of the particular breed involved, issued by the appropriate association listed below, is submitted for such animal.
Cattle
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 1101 | Aberdeen-Angus | Aberdeen-Angus Herd Book | Aberdeen-Angus Cattle Society, Hugh R. Neilson, secretary, Pedigree House, 17 Bon-Accord Sq., Aberdeen, Scotland. |
| 1112 | ......do | New Zealand Aberdeen-Angus Herd Book | New Zealand Aberdeen-Angus Cattle Breeders' Association, Post Office Box 83, Hastings, New Zealand. |
| 116 | ......do | Irish Angus Herd Book | Irish Angus Cattle Society Ltd., John L. Murphy, Secretary, Agriculture House, Kildare Street, Dublin 2, Ireland. |
| 1102 | Africander | Africander Cattle Herd Book | The Africander Cattle Breeders' Society, under the supervision and authority of the South African Stud Book Association, E.L. Househam, secretary, 40 Henry St., Bloemfontein, Union of South Africa. |
| 1201 | Alderney | Herd Book of the Bailiwick of Guernsey (Alderney Branch) | Royal Alderney Agricultural Society (The Alderney Branch of the Royal Guernsey A. and H. Society), P.D. Sumner, secretary, The Bungalow, Butes, Alderney, Channel Isles. |
| 1202 | Ayrshire | Ayrshire Herd Book | Ayrshire Cattle Herd Book Society of Great Britain and Ireland, John Graham, secretary, 1 Racecourse Rd., Ayr, Scotland. |
| 1301 | Devon | Davy's Devon Herd Book | Devon Cattle Breeders' Society, Cyril Ernest Berry, secretary, Court House, The Square, Wiveliscombe, Somerset, England. |
| 1302 | Dexter | Dexter Herd Book | Dexter Cattle Society, T. S. Pick, secretary, Manor Farm, Stubbs Lane, Lower Kingswood, Tadworth, Surrey, England. |
| 1103 | Belted Galloway | Belted Galloway Herd Book | Belted Galloway Cattle Society, J. Campbel Laing, secretary, Galloway Estate Office, Newton Stewart, Wigtownshire, Scotland. |
| 1104 | Galloway | Galloway Herd Book | Galloway Cattle Society of Great Britain and Ireland, Donald M. McQueen, secretary, Roughhills, Dalbeattie, Scotland. |
| 1113 | Gelbvieh | Herd Book of the Gelbvieh | American Gelbvieh Association, 10900 Dover Street, Westminster, CO 80021. |
| 1203 | Guernsey | English Guernsey Herd Book | English Guernsey Cattle Society, J. W. Barker, secretary, Mappin House, Winsley St., Oxford St., London, W. 1, England. |
| 1204 | ......do | Herd Book of the Baliwick of Guernsey (Guernsey Branch) | Royal Guernsey Agricultural and Horticultural Society, H. C. Le Page, secretary, States Arcade Balcony, St. Peter Port, Guernsey, Channel Isles. |
| 1105 | Hereford | Herd Book of Hereford Cattle | Hereford Herd Book Society, R.J. Bentley, secretary, 3 Offa St., Hereford, England. |
| 1106 | Highland | Highland Herd Book | Highland Cattle Society of Scotland, Donald G. Noble, secretary, 17 York Pl., Perth, Scotland. |
| 1205 | Holstein-Friesian | Friesch Rundvee-Stamboek | Vereeniging: “Het Friesch Rundvee-Stamboek,” Dr. J. M. Dijkstra, secretary, Zuiderplein 2-6, Leeuwarden, The Netherlands. |
| 1206 | ......do | Nederlandsch Rundvee-Stamboek | Vereeniging: “Het Nederlandsche Rundvee-Stamboek,” H. W. J. Dekker, Chief Administrator, Stadhouders-plantsoen 24, 's-Gravenhage, The Netherlands. |
| 1207 | Jersey | Jersey Herd Book | Royal Jersey Agricultural and Horticultural Society, H. G. Shepard, secretary, 3 Mulcaster St., St. Helier, Jersey, Channel Isles. |
| 1208 | ......do | Jersey Herd Book of United Kingdom | Jersey Cattle Society of the United Kingdom, Edward Ashby, secretary, 19 Bloomsbury Sq., London, W. C. 1, England. |
| 1303 | Kerry | British Kerry Cattle Herd Book | British Kerry Cattle Society, R. O. Hubl, secretary, The Milestone, Stanmore Hill, Stanmore, Middlesex, England. |
| 1304 | ......do | Kerry Cattle Herd Book | Royal Dublin Society, Horace H. Poole, registrar, Ball's Bridge, Dublin, Ireland. |
| 1305 | Lincoln Red | Lincoln Red Herd Book | Lincoln Red Cattle Society, W. Dunnaway secretary, Agriculture House, Park St., Lincoln, England. |
| 1209 | Red Danish | Stambog over Koer af Rod Dansk Malkerace
Stambog over Tyre af Rod Dansk Malkerace Register-Stambog over Kvaeg af Rod Dansk Malkerace | De Samvirkende Danske Landboforeninger, A. Wulff Pedersen, secretary, Vindegade 72, Odense, Denmark. |
| 1306 | Red Poll | Red Poll Herd Book | Red Poll Cattle Society of Great Britain and Ireland, Inc., A. C. Burton, secretary, 32 Princes St., Ipswich, Suffolk, England. |
| 1307 | Shorthorn | Coates's Herd Book | Shorthorn Society of Great Britain and Ireland, Arthur Greenhalgh, secretary, Victoria House, Southampton Row, London, W.C. 1, England. |
| 1107 | South Devon | Herd Book of South Devon Cattle | South Devon Herd Book Society, W. G. Turpitt, secretary, 16 Sherborne Rd., Newton Abbot, Devon, England. |
| 1115 | Simmental | Irish Simmental Cattle Society | Irish Simmental Cattle Society Ltd., Springhill Carrigtwohill, Co. Cork, Ireland. |
| 1308 | Sussex | Sussex Herd Book | Sussex Herd Book Society, A. G. Holland, secretary, 17 Devonshire St., London, W. 1, England. |
| 1309 | Welsh | Welsh Black Cattle Herd Book | Welsh Black Cattle Society, G. Williams Edwards, secretary, 13 Bangor St., Caernarvon, No. Wales. |
Horses
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 2201 | Arabian | Arab Horse Stud Book | The Arab Horse Society, Col. R. C. de V. Askin, secretary, Beechmead, Rowledge, Farnham, Surrey, England. |
| 2202 | ......do | Polska Ksiega Stadna Koni, Arabskich Czystej Krwi | Towarzystwo Hodowli Konia Arabskiego, Maria Brykczynska, secretary, Krako 1w, Sarego 2, Poland. |
| 2203 | ......do | General Stud Book | Weatherby & Sons, 15 Cavendish Sq., London, W. 1, England. |
| 2204 | ......do | Registro-Matricula de Caballos de Pura Sangre | Jefatura de Cria Caballar y Remonta, Don Manuel Diaz Calderon, Secretario Stud-book, Ministerio del Ejercito, Madrid, Spain. |
| 2205 | ......do | Stud Book Argentino | Ministerio de Hacienda de la Nacion, Loteria de Beneficencia Nacional y Casinos, Ricardo A. Maestri, Jefe, Av. Libertador General San Martin 4101, Capital Federal, Republica Argentina. |
| 2206 | ......do | Stud Book Francais Registre des Chevaux de Pur Sang | Commission du Studbook Francais de Pur Sang, M. Maze-Sencier, Inspecteur General, Chef, Service des Haras, Ministere de l'Agriculture, 78 rue de Varenne (7), Paris, France. |
| 2207 | ......do | Stud Book de Venezuela | Instituto Nacional de Hipodromos, Jorge Coll Nunez, Jefe, Hipodromo “La Rinconada,” Caracas, Venezuela. |
| 2208 | ......do | The Arabian Stud Book. (Recognition of this book will be restricted to Arabian horses which originate for importation in Saudi Arabia, or trace to pure Arabian stock of that country.) | The Arabian Horse Club Registry of America, Inc., Henry B. Babson, secretary, 120 So. La Salle St., Chicago 3, Ill. |
| 2304 | ......do | Russian Arabian Stud Book of Moscow, Union of Soviet Socialist Republics | Ministry of Agriculture USSR, All-Union Research Institute of Horsebreeding. |
| 2101 | Belgian | Stud-Book des Chevaux de Trait Belges | Societe 1 Royale “Le Cheval de Trait Belge,” Edgard Bedoret, Secretaire general, 45a rue de l'Ecuyer, Brussels, Belgium. |
| 2209 | Cleveland Bay | Cleveland Bay Stud Book | Cleveland Bay Horse Society, Oswald Welford, secretary, The Angelus, Roxby, Staithes, Saltburn, Yorkshire, England. |
| 2102 | Clydesdale | Clydesdale Stud-Book | Clydesdale Horse Society of Great Britain & Ireland, Robert Jarvis, secretary, 19 Hillington Gardens, Glasgow, S.W. 2, Scotland. |
| 2210 | Criolla | “Registre Definitivo Seccion” de Registro Genealogico para la Raza Criolla | Sociedad Rural Argentina, E. F. Garay, Gerente Tecnico, Florida 460, Buenos Aires, Argentina. |
| 2301 | Fjordhest (formerly known as Westland) | Stambok over Fjordhest | Statens Stambokkontor, Arne Hogstad, Statens Stambokforer, Munkedamsveien 35 VI, Oslo, Norway. |
| 2211 | Hackney | Hackney Stud Book | Hackney Horse Society, R. A. Brown, secretary, 16 Bedford Sq., London, W.C. 1, England. |
| 2212 | Holstein | Holsteinisches Gestutbuch | Verband der Zuchter des Holsteiner Pferdes e. V., Herr H. Horstmann, Geschaftsfuhrer, Klostersande 93, Elmshorn, Germany. |
| 2112 | Morab | Morab Stud Book | North American Morab Horse Association, Inc., W 3174 Fero Springs Road, Hilbert, WI 54129. |
| 2103 | Percheron | British Percheron Stud Book | British Percheron Horse Society, A. E. Vyse, secretary, Owen Webb House, Gresham Rd., Cambridge, England. |
| 2104 | ......do | Stud-Book Percheron de France | Societe 1 Hippique Percheronne de France, E. Lemarie, secretaire general, 7 rue Villette-Gate 1. Nogent-le-Rotrou (E-&-L), France. |
| 2302 | Shetland Pony | Shetland Pony Stud-Book | Shetland Pony Stud-Book Society, Thomas H. F. Myles, secretary, 61 George St., Perth, Scotland. |
| 2105 | Shire | Shire Horse Stud Book | Shire Horse Society, A. G. Holland, secretary, 17 Devonshire St., London, W. 1, England. |
| 2106 | Suffolk | Suffolk Stud-Book | Suffolk Horse Society, Raymond Keer, secretary, 6 Church St., Woodbridge, Suffolk, England. |
| 2213 | Thoroughbred | Australian Stud Book | Australian Jockey Club and Victoria Racing Club, W. J. McFadden, Keeper of the Stud Book, 6 Bligh St., Sydney, N.S.W., Australia. |
| 2214 | ......do | General Stud Book | Weatherby & Sons, 15 Cavendish Sq., London, W. 1, England. |
| 2215 | ......do | Jamaica Stud-Book | The Jockey Club of Jamaica, Miss L. Pike, secretary, 10 Duke St., Kingston, Jamaica, B.W.I. |
| 2216 | ......do | Stud Book de Chile | Club Hipico de Santiago, Alejandro Obolensky Dadian, Jefe de Stud-Book, Casilla 3674, Santiago, Chile. |
| 2217 | ......do | Stud Book de Venezuela | Instituto Nacional de Hipodromos, Jorge Coll Nunez, Jefe, Hipodromo “La Rinconada,” Caracas, Venezuela. |
| 2218 | ......do | New Zealand Stud Book | New Zealand Racing Conference, A. M. McBeath, secretary, P.O. Box 1430, Wellington, C. 1, New Zealand. |
| 2219 | ......do | Registro-Matricula de Caballos de Pura Sangre | Jefatura de Cria Caballar y Remonta, Don Manuel Diaz Calderon, Secretario Stud-book, Ministerio del Ejercito, Madrid, Spain. |
| 2220 | ......do | Stud Book Francais Registre des Chevaux de Pur Sang | Commission du Studbook Francais de Pur Sang, M. Maze-Sencier, Inspecteur General, Chef, Service des Haras, Ministere de l'Agriculture, 78 rue de Varenne (7), Paris, France. |
| 2221 | ......do | Libro Genealogico dei Cavalli di Puro Sangue | Jockey Club Italiano, Gen. Federico Garofoli, segretario, Corso Vittorio Emanuele 87, Rome, Italy. |
| 2222 | ......do | Registre des Chevaux de Pur Sang | Jockey-Club de Belgique, Lt. Col. Baron Jacques van Zuylen van Nyevelt, Secretaire general, 1 rue Guimard, Brussels 4, Belgium. |
| 2223 | ......do | Stud Book Brasileiro | Jockey Club Brasileiro, Ricardo Xavier da Silveira, Diretor do Stud Book, Av., Rio Branco 197, Rio de Janeiro, Brazil. |
| 2224 | ......do | Stud Book Peruano | Jockey Club del Pera, Alberto Alvarez Calderon, Gerente, Union 1066, Lima, Peru. |
| 2225 | ......do | Stud Book Argentino | Ministerio de Hacienda de la Nacion, Loteria de Beneficencia Nacional y Casinos, Ricardo A. Maestri, Jefe, Av. Libertador General San Martin 4101, Capital Federal, Republica Argentina. |
| 2226 | ......do | American Stud Book. (Recognition of this book will be restricted to Thoroughbreds imported as follows: (a) Horses bred or born in the United States, shipped to a foreign country and returned to this country; (b) horses bred or born in Great Britain, Northern Ireland, Eire, or France, whose pedigrees trace wholly, or in part, to horses bred or born in the United States; (c) horses from countries where a book of purebred registration for Thoroughbreds does not exist; or (d) horses previously certified for entry under the act and for which Certificates of Foreign Registration were issued by The Jockey Club of New York, and which were subsequently exported to any country and returned to the United States with such certificates.) | The Jockey Club, Mrs. L. Brennan, Registrar, 300 Park Ave., New York 22, N.Y. |
| 2233 | ......do | Allgemeines deutsches Gestubuch fur Vollblut | Direktorium fur Vollblutzucht und Rennen, 6 Cologne Weidenpesch, Rennbahnstrasse 100, Postfach 180, Republic of Germany. |
| 2234 | ......do | Stud Book Uruguayo | Jefe del Stud Book Uruguayo, Jose C. Frigerio, Head, Uruguayan Jockey Club, Montevideo, Uruguay. |
| 2235 | ......do | The General Stud Book of South Africa | The Jockey Club of South Africa, Box 3409, Johannesburg, Union of South Africa. |
| 2113 | Trakehner | Trakehner Stud Book | American Trakehner Association, 2305 November Lane, Reston, VA 22091. |
| 2303 | Welsh Pony and Cob | Welsh Stud Book | Welsh Pony & Cob Society, J. A. George, secretary, Offices of the Royal Welsh Agricultural Society, Queen's Rd., Aberystwyth, Cardiganlshire, Wales. |
| 2240 | Wielkopolskich | Ksiega Stadna Koni Wielkopolskich | Warm Blood & Full Blood Breeders of the Great Polish Horses, Pulewski 14, 02-152 Warsaw, Poland. |
Asses
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 3001 | Poitou | Jack and Jennet Section of Stud-Book ou Livre Genealogique des Animaux Mulassiers due Poitou | Societe Centrale d'Agriculture des Deux-Sevres R. Martinet, Secretaire, Cite Administrative, rue Duguesclin, Niort (Deux-Sevres), France. |
Sheep
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 4101 | Border Leicester | Border Leicester Flock Book | Society of Border Leicester Sheep Breeders, Robert Jarvis, secretary, Room 273, 93 Hope St., Glasgow, C. 2, Scotland. |
| 4102 | Cheviot | Cheviot Sheep Flock Book | Cheviot Sheep Society, Guy H. Armstrong, secretary, Commercial Bank Bldgs., Hawick, Scotland. |
| 4103 | Corriedale | Flock Book for Corriedale Sheep in Australia | The Australian Corriedale Association, H.T.C. Woodfull, secretary, Royal Showgrounds, Epsom Road, Ascot Vale, W. 2, Victoria, Australia. |
| 4104 | ......do | Corriedale Flock Book (New Zealand) | The Corriedale Sheep Society, Inc., C. H. Lawrence, secretary, 154 Hereford St., Christchurch, New Zealand. |
| 4201 | Dorset Horn | Dorset Horn Flock Book | Dorset Horn Sheep Breeders' Association, E. F. B. Lucas, secretary, Bank Chambers, Dorchester, Dorset, England. |
| 4202 | Hampshire Down | Hampshire Down Flock Book | Hampshire Down Sheep Breeders' Association, Miss Doris M. Stanbury, secretary, 38 Endless St., Salisbury, Wilts., England. |
| 4105 | Kent or Romney Marsh | Kent or Romney Marsh Flock Book | Kent or Romney Marsh Sheep-Breeders' Association, G. W. Tuffrey, secretary, Station Rd., Ashford, Kent, England. |
| 4203 | Kerry Hill | Kerry Hill Flock Book | Kerry Hill (Wales) Flock Society, Ralph P. Evans, secretary, c/o The Radnorshire Co., Ltd., Knighton, Radnorshire, Wales. |
| 4106 | Leicester | Leicester Flock Book | Leicester Sheep Breeders' Association, P. S. Atkinson, secretary, The Exchange, Exchange St., Driffield, E. Yorks., England. |
| 4107 | Lincoln | Flock Book of Lincoln Longwool Sheep | Lincoln Longwool Sheep Breeders' Association, Brian Shelley, secretary, Westminster Bank Chambers, 8 Guildhall St., Lincoln, England. |
| 4204 | Oxford Down | Flock Book of Oxford Down Sheep | Oxford Down Sheep Breeders' Association, Mrs. L. I. Deacon, secretary, Thornyfields, Billing Rd., Brafield-on-the-Green, Northampton, England. |
| 4108 | Romney Marsh | New Zealand Romney Marsh Flock Book | New Zealand Romney Marsh Sheep Breeders' Association, Inc., R. J. J. Campbell, secretary, 117 Kimbolton Rd., Feilding, New Zealand. |
| 4205 | Ryeland | Ryeland Flock Book | Ryeland Flock Book Society, Ltd., P. J. Hoskins, secretary, 20 King St., Hereford, England. |
| 4206 | Shropshire | Shropshire Flock Book | Shropshire Sheep Breeders' Association and Flock Book Society, Ivor Guy Mansell, secretary, College Hill, Shrewsbury, Shropshire, England. |
| 4207 | Southdown | Southdown Flock Book | Southdown Sheep Society, Inc., R. G. Noakes, secretary, Westways, Barming Woods, Maidstone, Kent, England. |
| 4218 | ......do | Southdown Sheep Society of New Zealand (Inc.) | The Southdown Sheep Society of New Zealand (Inc.), S. I. McKenzie, secretary, A.M.P., Chambers, 14 Broadway, Palmerston North, New Zealand. |
| 4208 | Suffolk | Suffolk Flock Book | Suffolk Sheep Society, Harry A. Byford, secretary, 30 Museum St., Ipswich, Suffolk, England. |
| 4109 | Wensleydale | Wensleydale Longwool Sheep Flock Book | The Wensleydale Longwool Sheep Breeders' Association, W. Dickinson, secretary, “Cartmel,” Church Walk, Ulverston, Lancashire, England. |
| 4001 | Various recognized breeds | Flock Book for British Breeds of Sheep in Australia | Australian Society of Breeders of British Sheep, H.T.C. Woodfull, secretary, Royal Show Grounds, Epsom Rd., Ascot Vale, W. 2, Victoria, Australia. |
| 4002 | ......do | New Zealand Flock Book | New Zealand Sheep Breeders' Association, H.M. Studholme, secretary, P.O. Box 9002, Addington, Christchurch, New Zealand. |
Goats
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 5001 | Saanen and Toggenburg | British Goat Society Herd Book (Saanen and Toggenburg Sections) | British Goat Society, Miss M.F. Rigg, secretary, Diss, Norfolk, England. |
Swine
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 6001 | Irish Large White | Herd Book of Irish Large White Pigs | Royal Dublin Society, Horace H. Poole, registrar, Ball's Bridge, Dublin, Ireland. |
| Berkshire | |||
| Gloucestershire Old | |||
| Spots. | |||
| Large Black | |||
| 6002 | Large White
Middle White | Herd Book of the National Pig Breeders' Association | National Pig Breeders' Association, E.G. Wake, secretary, 69 Clarendon Rd., Watford, Herts, England |
| Tamworth | |||
| British Saddleback |
Dogs
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 7306 | Australian Kelpie | The Working Kelpie Council National Stud Book | The Working Kelpie Council, P.O. Box E31 St. James, Sidney 2000, Australia. |
| 7301 | Boxer | Boxer-Zuchtbuch | Boxer-Klub e. V. Sitz Munchen, Bernhard Schmitz, Prasident, 38 Otkerstrasse, Munchen 9, Germany. |
| 7201 | Dachshund | Teckel-Stammbuch | Deutscher Teckelklub e. V., Josef Chateau, Stammbuchfuhrer, Vallendar/Rhein, Haus Rheinnieder, Germany. |
| 7202 | Foxhound | Foxhound Kennel Stud Book | Masters of Foxhounds Association, Lt. Col. J. E. S. Chamberlayne, Hon. secretary, 51 Victoria St., London, S. W. 1, England. |
| 7203 | ......do | Welsh Hound Stud Book | Welsh Hound Association, Islwyn E. E. Davies, Hon. secretary, Berthddu, Llandinam, Montgomeryshire, East Wales. |
| 7302 | German Shepherd | Zuchtbuch fur deutsche Schaferhunde (SZ) | Verein fur deutsche Schaferhunde (SV), Hann Kremhelmer, Hauptgeschaftsfuhrer, Beim Schnarrbrunnen 4, Augsburg 5, Germany. |
| 7303 | Great Dane | Zuchtbuch fur Deutsche Doggen | Deutscher Doggen-Club, Richard Staadt, Prasident, Ellerstrasse 25, Solingen-Ohligs, Germany. |
| 7204 | Greyhound | Australian Greyhound Stud Book | The Australian and New Zealand Greyhound Association, Robert John Maidment, secretary, 349 Collins St., Melbourne, C. 1, Australia. |
| 7205 | ......do | Greyhound Stud Book | National Coursing Club, Sydney H. Dalton, secretary, College Hill Chambers, London, E.C. 4. England. |
| 7206 | ......do | Irish Greyhound Stud Book | Irish Coursing Club, Miss K. Butler, secretary, Davis Rd., Clonmel, Co. Tipperary, Ireland. |
| 7207 | Harrier and Beagle | Harrier and Beagle Stud Book | Association of Masters of Harriers and Beagles, J. J. Kirkpatrick, Hon. secretary, East Wing, Kirtlington Park, Oxford, England. |
| 7304 | Rottweiler | Zucht- und Korbuch | Allgemeiner Deutscher Rottweiler-Klub, Mrs. Josephine Rieble, Sekretarin, Vorsteigstrasse 5, Stuttgart-West, Germany. |
| 7305 | St. Bernard | Bernhardiner-Zuchtbuch | St. Bernhardsklub e. V., Franz Hrachowina, Zuchtbuchfuhrer, Bergmannstrasse 35, Munchen 12, Germany. |
| 7001 | Various recognized breeds | Irish Kennel Club Stud Book | Irish Kennel Club, Miss Maud C. Fox, secretary, 23 Eden Quay, Dublin, C. 8, Ireland. |
| 7002 | ......do | Kennel Club Stud Book | English Kennel Club, E. Holland Buckley, secretary, 1-4 Clarges St., Piccadilly, London, W. 1, England. |
| 7003 | ......do | Livre des Origines Francais | Societe 1 Centrale Canine pour l'Amelioration des Races de Chiens en France, Col. Raoul Nicole, Directeur Administrateur, 3 Rue de Choiseul, Paris 2, France. |
| 7004 | ......do | Livre des Origines de la Societe 1 Royale Saint-Hubert | Societe 1 Royale Saint-Hubert, R. Willocq, Secretaire 1, 391 Chaussee Saint-Pierre, Brussels 4, Belgium. |
| 7005 | ......do | Norsk Kennelklubs Stambok | Norsk Kennel Klub, Olaf A. Roig, secretary, Bjorn Farmannsgate 16, Oslo, Norway. |
| 7006 | ......do | Zuchtbuch des Klub fur Terrier e. V | Klub fur Terrier e.V., Wilhelm Vahle, Sekretar, Schone Aussicht 9, Kelsterbach b. Frankfurt/Main, Germany. |
| 7007 | ......do | Schweizerisches Hunde-Stammbuch | Schweizerische Kynologischen Gesellschaft, Carl Wittwer, secretary, Seestrasse 64, Kilchberg/Zurich, Switzerland. |
| 7008 | ......do | Svenska Kennelklubbens Register | Svenska Kennelklubben, Ivan Swedrup, secretary, Linnegatan 25, Stockholm O 4, Sweden. |
Cats
| Code | Name of breed | Book of record | By whom published |
|---|---|---|---|
| 8001 | Long-haired and short-haired | The Governing Council of the Cat Fancy Stud Book | The Governing Council of the Cat Fancy, W.A. Hazeldine, secretary, 1 Roundwood Way, Banstead, Surrey, England. |
(b) Breeds and books of record in Canada—(1) Animals generally. The books of record of the Canadian National Live Stock Records, Ottawa, Canada, of which F. G. Clark is Director, are recognized for the following breeds: Provided, That no animals registered in the Canadian National Live Stock Records shall be certified under the act as purebred unless such animals trace only to animals which are proved to the satisfaction of Veterinary Services to be of the same breed: Provided further, That no Dexter cattle, Karakul sheep, Alpine goat, Nubian goat, or horse of the American Saddle Horse, Arabian, Canadian, Morgan, Shetland Pony or Welsh Pony and Cob breed in Canada shall be certified under the act as purebred unless a pedigree certificate showing three complete generations of known and recorded purebred ancestry of the particular breed involved, issued by the Canadian National Live Stock Records, is submitted for such animal.
| Code | Name of breed | Code | Name of breed |
|---|---|---|---|
| 1108 | Aberdeen, Angus. | ||
| 1210 | Ayrshire. | 1111 | Highland. |
| 1110 | Belgian Blue | ||
| 1211 | Brown Swiss. | 1214 | Jersey. |
| 1212 | Canadian. | 1311 | Lincoln Red. |
| 1310 | Dexter. | 1312 | Red Poll. |
| 1109 | Galloway. | 1313 | Shorthorn. |
| 1114 | Gelbvieh | ||
| 1213 | Guernsey. | ||
| 2227 | American Saddle Horse. | 2109 | Percheron. |
| 2228 | Arabian. | 2304 | Shetland Pony. |
| 2107 | Belgian Draft. | 2110 | Shire
Suffolk. |
| 2229 | Canadian. | 2111 | Thoroughbred. |
| 2108 | Clydesdale. | 2232 | Welsh Pony. |
| 2230 | Hackney. | 2305 | and Cob. |
| 2236 | Morgan. | ||
| 4110 | Blackface. | 4115 | Lincoln. |
| 4111 | Cheviot. | 4116 | Merino. |
| 4112 | Corriedale. | 4213 | Oxford Down. |
| 4113 | Cotswold. | 4117 | Rambouillet. |
| 4209 | Dorset Horn. | 4214 | Ryeland. |
| 4210 | Hampshire. | 4215 | Shropshire. |
| 4211 | Karakul. | 4216 | Southdown. |
| 4212 | Kerry Hill. | 4217 | Suffolk. |
| 4114 | Leicester. | ||
| Alpine. | |||
| Angora. | |||
| 5002 | Nubian. | ||
| Saanen. | |||
| Toggenburg. | |||
| Berkshire. | |||
| Chester White. | |||
| Duroc-Jersey. | |||
| Hampshire. | |||
| Lacombe. | |||
| 6003 | Landrace. | ||
| Large Black. | |||
| Poland China. | |||
| Tamworth. | |||
| British Saddleback. | |||
| Yorkshire. | |||
(2) Holstein-Friesian cattle in Canada (Code 1215). The Holstein-Friesian Association of Canada, Brantford, Ontario, Canada, of which G. M. Clemons is secretary and editor, is recognized for the Holstein-Friesian breed registered in the Holstein-Friesian Herd Book of that Association.
(3) Dogs in Canada (Code 7009). The Stud Book of the Canadian Kennel Club, Incorporated (Canadian National Live Stock Records) is recognized for all the breeds of dogs registered therein: Provided, That no dog so registered shall be certified under the act as purebred unless a pedigree certificate showing three complete generations of known and recorded purebred ancestry of the particular breed involved, issued by the Canadian Kennel Club, Incorporated, is submitted for such dog.
(4) Standardbred horses in Canada (Code 2231). The Canadian Standard Bred Stud Book kept by the Canadian Standard Bred Horse Society, 122 Brown's Line, Toronto 14, Ontario, Canada, is recognized for all Standardbred horses registered therein: Provided, That no Standard bred so registered shall be certified under the act as purebred unless a pedigree certificate showing three complete generations of known and recorded purebred Standardbred ancestry, issued by the Canadian Standard Bred Horse Society, is submitted for each such horse.
(5) Charolais cattle in Canada (Code 1112). The full French book of record of the Canadian Charolais Association, Calgary, Alberta, Canada, is recognized for the Charolais breed registered therein.
(6) Maine-Anjou cattle in Canada (Code 1113). The full French book of record of the Canadian Maine-Anjou Association, which is maintained by the Canadian National Live Stock Records, is recognized for the Maine-Anjou breed registered in the Canadian Maine-Anjou Herd Book: Provided, That no Maine-Anjou cattle so registered shall be certified under the act as purebred unless a pedigree certificate showing at least three generations of known and recorded purebred ancestry of the breed involved, issued by the Canadian National Live Stock Records, is submitted for each such animal.
(7) Simmental cattle in Canada (Code 1114). The Canadian Simmental Association, Calgary, Alberta, Canada, of which Mr. John Kish is Executive Secretary, is recognized for the Simmental breed registered in the Canadian Simmental Association Full Blood Herd Book: Provided, That no simmental cattle so registered shall be certified under the act as purebred unless a pedigree certificate showing at least three generations of known and recorded purebred ancestry of the breed involved, issued by the Canadian Simmental Association is submitted for each such animal.
(8) Hereford cattle in Canada (Code 1110). The Canadian Hereford Herd Book of The Canadian Hereford Association, 5160 Skyline Way NE., Calgary, Alberta, Canada, of which Dr. Duncan J. Porteous is General-Manager, is recognized for the Hereford breed registered therein.
Before a breed or a book of record shall be added to those listed in this part, the custodian of the book of record involved shall submit to APHIS a complete copy of the book of record, consisting of any published printed volumes and any microfilm records issued by the registry association up to date of application, together with a copy of all rules and forms in force on said date affecting the registration of animals in said book.
(a) If a registry association has not published its book of record in printed form, a record in approved microfilm form which the Administrator finds provides a system for determining the recorded ancestry of the animals identified therein will be acceptable. When a registry association which has published its book of record in printed form ceases such publication and in lieu thereof publishes a microfilm record, the microfilm record shall commence with the first pedigree recorded by the association which is not in the printed volumes and shall otherwise be in approved form.
(b) A microfilm record will be approved under this part only if it is 16 mm. non-perforated safety film exposed at a reduction ratio not to exceed 24 diameters. All information on the original document shall be reproduced onto the microfilm so that it is clearly readable. The microfilm carton shall be indexed to state the numbers of the pedigree certificates on the roll of film it contains.
Words used in this part in the singular form shall import the plural, and vice versa, as the case may demand.
For the purposes of this part, unless the context otherwise requires, the following terms shall be construed, respectively, to mean:
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal product. Anything made of, derived from, or containing any material of animal origin.
Applicant. Any person who requests service under this part.
Department. The United States Department of Agriculture.
Inspector. Any officer or employee of the Department of cooperating agency authorized to perform any duties at any plant furnished service under this part.
Inspector in charge. An inspector of the Department assigned by the Administrator to supervise, review, and perform official work pertaining to a plant furnished service under this part.
Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other form of organization.
Laws, regulations or other requirements of foreign countries and specifications of contracts for the purchase and sale of animal products, on occasion require vendors of such products to furnish official certificates concerning the class, quality, quantity, or condition of such products to be imported into such countries or to be delivered under the contracts. The service under this part, shall consist of the inspection of the processing, handling, and storage of the products at any plant at which service is furnished and the certification, on the basis of such requirements of foreign countries or such contract specifications, of the class, quality, quantity, or condition of such of the products as are found to conform to such requirements or specifications as the case may be. Processing procedures will be actually supervised. The operator of the plant shall fully inform the inspector with respect to, and the inspector shall actually observe, the processing procedures, handling, and storage of the products intended for certification. The inspector shall keep such records of the temperatures reached, the duration of time the temperatures are maintained, and the pounds of pressure under which the products are cooked in the course of processing, and such other information, as are needed to justify the issuance of the certificates required.
Any person who is eligible to receive service under this part may apply therefor to the Administrator, upon an application form which will be furnished by the Administrator upon request. The application form shall require the applicant to state, among other things, the forms of certificates desired.
Subject to § 156.8, service under this part will be furnished, upon application, within the limits of available Department personnel and facilities, at any plant the operator of which applies for or endorses the application for the service if the Administrator finds that: the forms of certificates desired by the applicant require the certification of class, quality, quantity, or condition; the plant and its methods of processing, handling and storage of the products intended for certification are adequate to warrant the issuance of the desired certificates; the requirements of part 130 of this title are met; and the requirements of § 156.7 are met.
The inspector shall sign and issue certificates in forms approved by the Administrator for animal products, if the inspector finds that the requirements as stated in the certification have been met. The original and one copy of each certificate shall be furnished to the applicant, and one copy of each certificate shall be retained by the Department until disposal is authorized in accordance with law. Additional copies may be furnished the applicant at his request upon payment of the fees prescribed in § 156.7. Copies of the certificates may be furnished without charge to other properly interested Federal agencies or under compulsory process.
User fees under part 130 of this chapter for service (including travel and other expenses incurred in connection with the furnishing of service) under this part shall be paid by the applicant. If required by the Administrator, the user fees under part 130 of this chapter shall be paid in advance. Since the user fees under part 130 of this chapter are for the purpose of reimbursing the Department for all costs incurred in connection with the furnishing of service under this part, the appropriate user fees under part 130 of this chapter to cover any such costs shall be paid even if service is withheld pursuant to § 156.8.
(a) Service under this part will be refused if the conditions stated in §§ 156.5 and 156.6 are not met.
(b) Service under this part may be withdrawn from, or denied to, any applicant by the Administrator, for such period as the Administrator may prescribe, when the Administrator is satisfied, after opportunity for hearing before a proper official has been accorded the applicant, that the applicant or other operator of the plant where service has been or would be furnished under the application, or the agent or employee of such applicant or operator within the scope of his employment, has persistently failed to give the inspector full and correct information with respect to the processing procedures, handling, and storage of animal products intended for certification or certified; or has given to any employee of the Department false information in connection with service under this part; or has altered or imitated any certificate, mark, or device provided for under this part; or has used any such certificate, mark, or device without authority from the Administrator, or any imitation of any such certificate, mark, or device, on or with respect to any animal products; or has knowingly and without promptly notifying the Administrator retained possession of any such device or imitation thereof or altered or imitation certificate or of any animal products marked with any such device without authority from the Administrator or marked with any imitation of such device; or has given or attempted to give, for any purpose whatsoever, any money, favor, or other thing of value, to any employee of the Department authorized to perform any function under this part; or has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee of the Department in or with respect to the performance of his duties under this part by intimidation, threats, assaults, or any other improper means. The inspector assigned to any plant may suspend service at such plant for any of the reasons set forth in this paragraph, without hearing, and in that event shall report his actions to the Administrator, and the Administrator may continue such suspension or otherwise deny or suspend service at any plant for any of such reasons, without hearing, pending final disposal of the matter under this paragraph.
(c) All final orders in any proceeding to deny or withdraw the service for any of the reasons set forth in paragraph (b) of this section (except orders required for good cause to be held confidential and not cited as precedents) shall be filed with the Hearing Clerk of the Department and be available to public inspection.
For the purposes of this subchapter the following words, phrases, names and terms shall be construed, respectively, to mean:
Accreditation. The action of the Administrator initially approving a veterinarian in accordance with the provisions of part 161 of this subchapter to perform functions specified in subchapters B, C, D, and G of this chapter, in one State.
Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this subchapter to perform functions specified in subchapters B, C, D, and G of this chapter.
Administrator. The Administrator of the Animal and Plant Health Inspection Service or any individual authorized to act for the Administrator.
Animal, animals. All animals except humans, including but not limited to cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, birds, and poultry.
Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service, United States Department of Agriculture.
APHIS. The Animal and Plant Health Inspection Service.
Approved digital signature. Digital signatures approved by the Administrator for electronic transmission, for example, via a computer. To be approved, a digital signature must be able to verify the identity of the accredited veterinarian signing the document and indicate if the integrity of the data in the signed document was compromised.
Authorization. The action of the Administrator approving an accredited veterinarian in accordance with the provisions of part 161 of this subchapter to perform functions specified in subchapters B, C, D, and G of this chapter, in a State or States other than the State in which the veterinarian was initially accredited.
Category I animals. All animals except: Food and fiber species, horses, birds, farm-raised aquatic animals, all other livestock species, and zoo animals that can transmit exotic animal diseases to livestock.
Category II animals. All animals.
Examine, examination. Physical study of an individual animal that enables an accredited veterinarian to determine if any abnormality in physical condition or bodily function is suggestive of clinical signs of communicable disease.
Herd or flock health plan. A written herd or flock health management plan, which may include an agreement signed by the owner of a herd or flock, the accredited veterinarian, and a State or APHIS representative, in which each participant agrees to undertake actions specified in the agreement to maintain the health of the animals and detect signs of communicable disease.
Inspect, inspection. Visual study of the physical appearance, physical condition, and behavior of animals (singly or in groups) that enables an accredited veterinarian to determine whether any abnormality in physical condition or bodily function is evident.
Issue. The distribution, including electronic transmission, of an official animal health document that has been signed.
Official certificate, document, seal, form, record, report, tag, band, or other identification. Any certificate, document, seal, form, record, report, tag, band, or other identification, prescribed by statute or regulations, or prescribed by a State form approved by the Administrator, for use by an accredited veterinarian performing official functions under this subchapter.
Qualified accredited veterinarian (QAV). An accredited veterinarian who has been granted a program certification by the Administrator pursuant to § 161.5 of this subchapter based on completion of an APHIS-approved orientation or training program.
Regular health maintenance program. An arrangement between an accredited veterinarian and a livestock producer whereby the veterinarian inspects every animal on the premises of the producer at least once every 30 days.
Sign, (Signed). For an accredited veterinarian to put his or her signature in his or her own hand, or by means of an approved digital signature, on a certificate, form, record, or report. No certificate, form, record, or report is signed if:
(1) Someone other than the accredited veterinarian has signed it on behalf of or in the name of the accredited veterinarian, regardless of the authority granted them by the accredited veterinarian; or
(2) If any mechanical device, other than an approved digital signature, has been used to affix the signature.
State. Any State, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands, the Virgin Islands of the United States, and any other territory or possession of the United States.
State Animal Health Official. The State animal health official who is responsible for the livestock and poultry disease control and eradication programs of a State.
Veterinary Official. The APHIS veterinarian who is assigned by the Administrator to supervise and perform the official work of APHIS in a State or group of States.
(a) This subchapter concerns a program administered by APHIS to accredit veterinarians and thereby authorize them to perform, on behalf of APHIS, certain activities specified in this chapter. This program is intended to ensure that an adequate number of qualified veterinarians are available in the United States to perform such activities.
(b) Categories of accreditation. A veterinarian may be accredited as a Category I veterinarian or a Category II veterinarian. A veterinarian who is accredited under Category I is only authorized to perform accredited duties on Category I animals, as defined in § 160.1. A veterinarian who is accredited under Category II is authorized to perform accredited duties on both Category I animals and Category II animals.
(c) Application for initial accreditation. A veterinarian may apply for accreditation by completing an application for accreditation and submitting it to APHIS. In completing the application, the veterinarian will choose one of the accreditation activity categories, either Category I or Category II, as discussed in paragraph (b) of this section. Applications for Category I accreditation must include certification that the applicant is able to perform the tasks listed in paragraph (g)(1) of this section. Applications for Category II accreditation must include certification that the applicant is able to perform the tasks listed in paragraph (g)(2) of this section. An accredited veterinarian must not perform duties requiring a program certification unless he or she is accredited under Category II and qualified to perform such duties in accordance with § 161.5 of this part.
(d) Review of application. Applications for accreditation received by APHIS shall be forwarded to the State Animal Health Official for the State in which the veterinarian wishes to perform accredited duties for approval. Within 14 days after receiving an application, a State Animal Health Official shall either endorse the application or send a written statement to the Administrator explaining why it was not endorsed; but if the State Animal Health Official fails to take one of these actions within 14 days, APHIS shall proceed to review the application. The Administrator will review the application and the written statement, if any, and determine whether the applicant meets the requirements for accreditation contained in this part.
(e) Accreditation requirements. The Administrator is hereby authorized to accredit a veterinarian when he or she determines that:
(1) The veterinarian is a graduate with a Doctorate of Veterinary Medicine or an equivalent degree (any degree that qualifies the holder to be licensed by a State to practice veterinary medicine) from a college of veterinary medicine;
(2) The veterinarian is licensed to practice veterinary medicine in the State in which the veterinarian wishes to perform accredited duties. An unlicensed veterinarian is legally able to practice veterinary medicine in a State provided that the veterinarian is granted written authorization by that State's veterinary licensing authority or given legal authority through State statute to provide veterinary services for a veterinary employer (such as a cooperative, corporation, laboratory, or other institution recognized by the State authority but not involving contact with animals owned by the public, or a college or school of veterinary medicine). Such authorizations may limit accredited duties to specific geographical areas and/or activities within the State. APHIS will confirm the licensing or legal status of the applicant by contacting the State board of veterinary medical examiners or any similar State organization that maintains records of veterinarians licensed or otherwise legally able to practice in a State;
(3) The veterinarian has completed initial accreditation training, using content provided by APHIS; and
(4) The veterinarian has completed an orientation program approved by the Veterinary Official for the State in which the veterinarian wishes to perform accredited duties, and upon completion of the orientation, has signed a written statement listing the date and place of orientation, the subjects covered in the orientation, and any written materials provided to the veterinarian at the orientation. The Veterinary Official shall also give the State Animal Health Official an opportunity to review the contents of the orientation, and invite him or her to participate in developing orientation materials and conducting the orientation. The veterinarian applying for accreditation must have completed the orientation program within 3 years prior to submitting the application for accreditation. The orientation program shall include the following topics:
(i) Federal animal health laws, regulations, and rules;
(ii) Interstate movement requirements for animals;
(iii) Import and export requirements for animals;
(iv) USDA animal disease eradication and control programs;
(v) Laboratory support in confirming disease diagnoses;
(vi) Ethical and professional responsibilities of an accredited veterinarian;
(vii) Foreign animal disease awareness;
(viii) Animal health emergency management; and
(ix) Animal health procedures, issues, and information resources relevant to the State in which the veterinarian wishes to perform accredited duties.
(f) Change in accreditation category—(1) Category I to Category II. A veterinarian who is accredited under Category I may become accredited under Category II if the veterinarian applies for accreditation under Category II by completing an application for accreditation, including certification that the applicant is able to perform the tasks listed in paragraph (g)(2) of this section, and submitting it to APHIS. The veterinarian must also have fulfilled the training requirements in § 161.3(b) that are associated with renewal of accreditation under Category II.
(2) Category II to Category I. A veterinarian who is accredited under Category II may become accredited under Category I if the veterinarian applies for accreditation under Category I by completing an application for accreditation, including certification that the applicant is able to perform the tasks listed in paragraph (g)(1) of this section, and submitting it to APHIS. The veterinarian must also have fulfilled the training requirements in § 161.3(b) that are associated with renewal of accreditation under Category I.
(g) Tasks that applicants for accredited status must be able to perform. Applicants for accredited status must be able to:
(1) Category I. (i) Perform physical examination of individual Category I animals to determine whether they are free from any clinical signs suggestive of communicable disease.
(ii) Recognize the common breeds of Category I animals and accurately record breed information on official documents.
(iii) Apply common animal identification for Category I animals.
(iv) Properly complete certificates for domestic and international movement of Category I animals.
(v) Perform necropsies on Category I animals.
(vi) Recognize and report clinical signs and lesions of exotic animal diseases that occur in Category I animals.
(vii) Vaccinate Category I animals and accurately complete the vaccination certificates.
(viii) Properly collect and ship specimen samples to the appropriate laboratory for testing with complete and accurate paperwork.
(ix) Develop appropriate biosecurity protocols, as well as cleaning and disinfection protocols, to control communicable disease spread in Category I animals.
(2) Category II. (i) Perform physical examination of individual animals and visually inspect herds or flocks to determine whether the animals are free from any clinical signs suggestive of communicable disease.
(ii) Recognize the common breeds of Category I and Category II animals, including the types of poultry as defined by the National Poultry Improvement Plan in subchapter G of this chapter and the common breeds of livestock, and be able to accurately record breed information on official documents.
(iii) Recognize all USDA animal identification systems.
(iv) Estimate the age of livestock using a dental formula.
(v) Apply USDA-recognized identification (e.g., eartag, microchip, tattoo) for the USDA animal identification system.
(vi) Certify the health status of an avian flock regarding diseases of domestic or international regulatory concern, and evaluate records pertaining to poultry flock testing and participation in Federal and State poultry health programs and classifications.
(vii) Properly complete certificates for domestic and international movement of animals.
(viii) Apply and remove official seals.
(ix) Perform necropsies on animals.
(x) Recognize and report clinical signs and lesions of exotic animal diseases.
(xi) Develop a herd or flock health plan consistent with requirements in subchapters B, C, D, and G of this chapter.
(xii) Vaccinate for USDA program diseases and accurately complete the vaccination certificate.
(xiii) Properly collect and ship sample specimens to an appropriate laboratory for testing with complete and accurate paperwork.
(xiv) Properly perform testing for tuberculosis (e.g., caudal fold test).
(xv) Develop appropriate biosecurity protocols, as well as cleaning and disinfection protocols, to control communicable disease spread.
(xvi) Explain basic principles for control of diseases for which APHIS or APHIS-State cooperative programs presently exist.
(h) Authorization to perform duties. An accredited veterinarian may not perform accredited duties in a State until after receiving written authorization from APHIS. If a Category I accredited veterinarian completes the necessary training requirements and becomes a Category II accredited veterinarian, the veterinarian may not perform Category II accredited duties in a State until after receiving written authorization from APHIS.
(a) If an accredited veterinarian wishes to perform accredited duties in a State other than the State in which the veterinarian was initially accredited in accordance with § 161.1(e), the accredited veterinarian must complete an application to request authorization to perform accredited duties in the additional State from the Veterinary Official of that State. The Veterinary Official of the additional State may require the accredited veterinarian to complete, prior to performing any accredited duties in the additional State, an orientation in animal health procedures and issues relevant to the additional State. The Veterinary Official shall review the content of each such orientation and shall approve its use after determining that it includes adequate information about animal health agencies, regulatory requirements, administrative procedures, and animal disease issues in the additional State, to prepare an accredited veterinarian from another State to perform accredited duties in the additional State. The Veterinary Official shall also give the State Animal Health Official of the additional State an opportunity to review the contents of the orientation, and invite him or her to participate in developing orientation materials and conducting the orientation.
(b) An accredited veterinarian may not perform accredited duties in a State in which the accredited veterinarian is not licensed or otherwise permitted by the State's veterinary licensing authority to practice veterinary medicine in that State without a license.
(c) An accredited veterinarian may not perform accredited duties in a State other than the one in which the veterinarian was initially accredited until the veterinarian receives written authorization from APHIS to perform accredited duties in the additional State.
(a) Accredited veterinarians who wish to continue participating in the National Veterinary Accreditation Program must renew their accreditation every 3 years by completing an application for accreditation renewal and submitting it to APHIS. Newly accredited veterinarians must renew their accreditation within 3 years of completing the orientation program described in § 161.1(e)(4) of this part, regardless of when their accreditation was granted. Other veterinarians must renew their accreditation within 3 years of the previous renewal.
(b) Accredited veterinarians who wish to renew their accreditation under Category I must complete 3 supplemental training units approved by APHIS by the end of their 3-year tenure as an accredited veterinarian. Accredited veterinarians who wish to renew their accreditation under Category II must complete 6 supplemental training units approved by APHIS by the end of their 3-year tenure as an accredited veterinarian. Accredited veterinarians who wish to change the category in which they are accredited, rather than renew accreditation in their current accreditation category, should follow the procedure in § 161.1(f) of this part.
(c) Accredited veterinarians who do not complete the required training within 3 years as specified in paragraph (a) of this section will have their accredited status expire. Veterinarians whose accreditation has expired will not be allowed to perform accredited duties until they receive notification of their reinstatement from APHIS. Veterinarians who perform duties that only accredited veterinarians are authorized to perform while their accredited status has expired will be subject to such criminal and civil penalties as are provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or other applicable Federal statutes or regulations. To be reinstated, the veterinarian must complete the necessary supplemental training units for the appropriate category and submit an application for renewal of veterinary accreditation to APHIS. A veterinarian who allows his or her accredited status to expire must have completed the required number of supplemental training units within 3 years of his or her application for renewal in order to be approved for renewal. Supplemental training units completed since the veterinarian's last renewal but more than 3 years before the veterinarian's application for renewal will not count towards fulfilling his or her training requirement.
(d) Veterinarians who are accredited as of February 1, 2010, may continue to perform accredited duties between February 1, 2010, and the date of their first renewal. APHIS will provide notice for 3 months to accredited veterinarians who are accredited as of February 1, 2010, to notify them that they must elect to participate in the NVAP as a Category I or Category II veterinarian. Veterinarians must elect to continue to participate by October 1, 2011, or their accredited status will expire. When APHIS receives notice from an accredited veterinarian that he or she elects to participate, APHIS will notify the accredited veterinarian of his or her date for first renewal. The accredited veterinarian must then complete all the training requirements for renewal, as described in this section, by his or her first renewal date.
An accredited veterinarian shall perform the functions of an accredited veterinarian only in a State in which the accredited veterinarian is licensed or legally able to practice veterinary medicine. An accredited veterinarian shall perform the functions of an accredited veterinarian and carry out all responsibilities under applicable Federal programs and cooperative programs subject to direction provided by the Veterinary Official and in accordance with any regulations and instructions issued to the accredited veterinarian by the Veterinary Official, and shall observe the following specific standards:
(a) An accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any inspection, test, vaccination or treatment performed by him or her with respect to any animal, other than those in regular health maintenance programs, unless he or she has personally inspected that animal within 10 days prior to issuance. Inspections under this paragraph must be conducted in a location that allows the accredited veterinarian sufficient space to observe the animal in such a manner as to detect abnormalities related to areas such as, but not limited to, locomotion, body excretion, respiration, and skin conditions. An accredited veterinarian shall examine such an animal showing abnormalities, in order to determine whether or not there is clinical evidence compatible with the presence or absence of a communicable disease.
(1) Following the first two inspections of a herd or flock as part of a regular health maintenance program, an accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any inspection, test, vaccination or treatment performed by him or her with respect to any animal in that program, unless he or she has personally inspected that animal within 10 days prior to issuance.
(2) Following the third and subsequent inspections of a herd or flock in a regular health maintenance program, an accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any inspection, test, vaccination or treatment performed by him or her with respect to any animal in that program, unless he or she has personally inspected that animal within 30 days prior to issuance.
(b) An accredited veterinarian shall not issue, or allow to be used, any certificate, form, record or report, until, and unless, it has been accurately and fully completed, clearly identifying the animals to which it applies, and showing the dates and results of any inspection, test, vaccination, or treatment the accredited veterinarian has conducted, except as provided in paragraph (c) of this section, and the dates of issuance and expiration of the document. Certificates, forms, records, and reports shall be valid for 30 days following the date of inspection of the animal identified on the document, except that origin health certificates may be valid for a longer period of time as provided in § 91.3(a) of this chapter. The accredited veterinarian must distribute copies of certificates, forms, records, and reports according to instructions issued to him or her by the Veterinary Official.
(c) An accredited veterinarian shall not issue any certificate, form, record, or report which reflects the results of any inspection, test, vaccination, or treatment performed by another accredited veterinarian, unless:
(1) The signing accredited veterinarian has exercised reasonable care, that is, a standard of care that a reasonably prudent person would use under the circumstances in the course of performing professional duties, to determine that the certificate, form, or report is accurate;
(2) The certificate, form, or report indicates that the inspection, test, vaccination, or treatment was performed by the other accredited veterinarian; identifies the other accredited veterinarian by name; and includes the date and the place where such inspection, test, or vaccination was performed; and,
(3) For a certificate, form, or report indicating results of a laboratory test, the signing accredited veterinarian shall keep a copy of the certificate, form, or report and shall attach to it either a copy of the test results issued by the laboratory, or a written record (including date and participants' names) of a conversation between the signing accredited veterinarian and the laboratory confirming the test results.
(d) An accredited veterinarian shall perform official tests, inspections, treatments, and vaccinations and shall submit specimens to designated laboratories in accordance with Federal and State regulations and instructions issued to the accredited veterinarian by the Veterinary Official.
(e) An accredited veterinarian shall identify or be physically present to supervise the identification of reactor animals by tagging or such other method as may be prescribed in instructions issued to him or her by the Veterinary Official or by a State Animal Health Official through the Veterinary Official.
(f) An accredited veterinarian shall immediately report to the Veterinary Official and the State Animal Health Official all diagnosed or suspected cases of a communicable animal disease for which a APHIS has a control or eradication program in 9 CFR chapter I, and all diagnosed or suspected cases of any animal disease not known to exist in the United States as provided by § 71.3(b) of this chapter.
(g) While performing accredited work, an accredited veterinarian shall take such measures of sanitation as are necessary to prevent the spread of communicable diseases of animals by the accredited veterinarian.
(h) An accredited veterinarian shall keep himself or herself currently informed on Federal and State regulations that are provided to him or her by the Veterinary Official, or by a State official through the Veterinary Official, governing the movement of animals, and on procedures applicable to disease control and eradication programs, including emergency programs.
(i) An accredited veterinarian shall not use or dispense in any manner, any pharmaceutical, chemical, vaccine or serum, or other biological product authorized for use under any Federal regulation or cooperative disease eradication program, in contravention of applicable Federal or State statutes, regulations, and policies.
(j) An accredited veterinarian shall be responsible for the security and proper use of all official certificates, forms, records, and reports; tags, bands, or other identification devices; and approved digital signature capabilities used in his or her work as an accredited veterinarian and shall take reasonable care to prevent the misuse thereof. An accredited veterinarian shall immediately report to the Veterinary Official the loss, theft, or deliberate or accidental misuse of any such certificate, form, record, or report; tag, band, or other identification device; or approved digital signature capability.
(k) An accredited veterinarian may issue an origin health certificate for export use pursuant to part 91 of this chapter without including test results from a laboratory, if the Veterinary Official has determined that such action is necessary to save time in order to meet an exportation schedule and agrees to add the test results to the certificate at a later time. In such cases, the accredited veterinarian shall state on a removable attachment to the certificate that such test results are to be added by the Veterinary Official.
A program certification recognized by the Administrator may be granted to an accredited veterinarian in Category II upon completion of an additional orientation or training program approved by APHIS that focuses on the specific area for which the veterinarian is seeking program certification. Veterinarians accredited under Category I are not eligible to earn program certifications. Accredited veterinarians may elect to participate in a program certification on a voluntary basis. Participants in these program certifications will be qualified in a particular area or specialty. In addition to Category II training, qualification for a program certification will include additional specialized training, which may include periodic training updates. For certain program certifications, the cost of orientation or training may be borne by the accredited veterinarian. An accredited veterinarian granted a program certification will be referred to as a qualified accredited veterinarian or QAV. A QAV will be authorized to perform those accredited duties related to the program certification he or she has earned; accredited veterinarians not granted program certifications will not be permitted to perform accredited duties related to that particular program certification. If a QAV allows his or her Category II accreditation to expire, the QAV's program certification expires as well, and the QAV must be qualified for the program certification again in accordance with this section.
(a) The Administrator is authorized to suspend for a given period of time, or to revoke, the accreditation of a veterinarian when he or she determines that the accredited veterinarian has not complied with the “Standards for Accredited Veterinarian Duties” as set forth in § 161.4 of this part or with any of the other regulations in this subchapter, or is otherwise found to be unfit to be accredited. Veterinarians who perform duties that only accredited veterinarians are authorized to perform while their accredited status is suspended or revoked will be subject to such criminal and civil penalties as are provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or other applicable Federal statutes or regulations. Performing accredited duties while accreditation status is suspended or revoked will be considered grounds for the Administrator to suspend accreditation, revoke accreditation, or deny application for reaccreditation, as circumstances warrant. A veterinarian whose accreditation has been suspended or revoked or whose application for reaccreditation has been denied may request a hearing under § 162.13 to challenge the Administrator's decision.
(b) Reinstatement after suspension. A veterinarian whose accreditation has been suspended for less than 6 months (other than a summary suspension that is changed to a revocation as a result of an adjudicatory proceeding) will be automatically reinstated as an accredited veterinarian upon completion of the suspension. A veterinarian whose accreditation has been suspended for 6 months or more must complete a reaccreditation orientation program in accordance with paragraph (c)(2)(ii) of this section before accreditation will be reinstated.
(c) Reaccreditation after revocation. A veterinarian whose accreditation has been revoked may apply for reaccreditation by completing an application for reaccreditation and submitting it to the Veterinary Official of the State or area where he or she wishes to perform accredited work. The application may be submitted when the revocation has been in effect for not less than 2 years, unless the revocation order specifies that the veterinarian whose accreditation has been revoked may not submit an application for reaccreditation until the revocation has been in effect for a period of time longer than 2 years.
(1) Completed applications for reaccreditation received by a Veterinary Official shall be reviewed by the State Animal Health Official for the State in which the veterinarian wishes to perform accredited duties. Within 14 days after receiving an application, the State Animal Health Official shall either endorse the application or send a written statement to the Administrator explaining why it was not endorsed; but if the State Animal Health Official fails to take one of these actions within 14 days, the Veterinary Official shall proceed to review the application. The Administrator will review the application and the written statement, if any, and determine whether the applicant meets the requirements for reaccreditation contained in this part.
(2) Once a veterinarian whose accreditation has been revoked has correctly applied for reaccreditation in accordance with the requirements of paragraph (c) of this section, the Administrator will determine whether to reaccredit or to deny reaccreditation. This determination will be based on whether the veterinarian has fulfilled the following conditions:
(i) The veterinarian is licensed or legally able to practice veterinary medicine in the State in which the veterinarian wishes to perform accredited duties;
(ii) The veterinarian has completed a reaccreditation orientation program approved by the Veterinary Official for the State in which the veterinarian wishes to perform accredited work, and upon completion of the orientation, has signed a written statement listing the date and place of orientation, the subjects covered in the orientation, and any written materials provided to the veterinarian at the orientation. The Veterinary Official shall also give the State Animal Health Official an opportunity to review the contents of the reaccreditation orientation, and invite him or her to participate in developing orientation materials and conducting the orientation. The orientation program shall include topics addressing the subject areas which led to loss of accreditation for the applicant, and subject areas which have changed since the applicant lost accreditation; and
(iii) The professional integrity and reputation of the applicant support a conclusion that the applicant will faithfully fulfill the duties of an accredited veterinarian in the future. In making this conclusion, the Administrator shall review all available information about the applicant, including recommendations of the State Animal Health Official, and shall consider:
(A) Any criminal conviction records indicating that the applicant may lack the honesty, integrity, and reliability to appropriately and effectively perform accredited duties and to uphold the integrity of the National Veterinary Accreditation Program;
(B) Official records of the applicant's actions participating in Federal, State, or local veterinary programs;
(C) Judicial determinations in civil litigation adversely reflecting on the honesty, integrity, and reliability of the applicant; and
(D) Any other evidence reflecting on the honesty, professional integrity, reliability and reputation of the applicant.
(3)(i) If a veterinarian is reaccredited under paragraph (c)(2) of this section, the veterinarian may begin performing accredited duties again upon receipt of notification from the Administrator that he or she is eligible to do so.
(ii) If an application for reaccreditation is denied under paragraph (c)(2) of this section, the veterinarian may apply for reaccreditation in accordance with this paragraph (c) not less than 2 years after the application was last denied, unless the decision specifies that the veterinarian may not reapply for reaccreditation until a period of time longer than 2 years has passed.
(d) Accreditation shall be automatically terminated when an accredited veterinarian is not licensed or legally able to practice veterinary medicine in at least one State.
(e) Accreditation shall be automatically revoked when an accredited veterinarian is convicted of a crime in either State or Federal court, if such conviction is based on the performance or nonperformance of any act required of the veterinarian in his or her capacity as an accredited veterinarian.
(f) Any accredited veterinarian who knowingly issues or signs a false, incorrect, or mislabeled animal health or inspection certificate, blood sample, official brucellosis vaccination certificate, or official tuberculin test certificate in accordance with this chapter, shall be subject to such civil penalties and such criminal liabilities as are provided by 7 U.S.C. 8313, 18 U.S.C. 1001, or other applicable Federal statutes. Such action may be in addition to, or in lieu of, suspension or revocation of accredited veterinarian status in accordance with this section.
(g) Notice of warning. In lieu of suspension or revocation, the Administrator is authorized to issue a written notice of warning to an accredited veterinarian when the Administrator determines a notice of warning will be adequate to attain compliance with the Standards for Accredited Veterinarian Duties in § 161.4 of this part.
(a) Full-time Federal (including military) and State employed veterinarians are authorized to perform functions specified in subchapters B, C, D, and G of this chapter, pursuant to delegation of authority by the Administrator or cooperative agreements, without specific accreditation under the provisions of this subchapter.
(b) Except as provided by paragraph (a) of this section, anyone who performs accredited veterinarian duties that he or she is not authorized to perform will be subject to such criminal and civil penalties as are provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or other applicable Federal statutes or regulations. Performing accredited duties without having been accredited will be considered grounds for the Administrator to deny an application for accreditation.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings for the revocation or suspension of accreditation of veterinarians (9 CFR parts 160 and 161). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
In any situation where the Administrator has reason to believe that any veterinarian accredited under the provisions of parts 160 and 161 of this subchapter has knowingly violated the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Administrator may summarily suspend the accreditation of such veterinarian pending final determination in either a suspension or revocation proceeding, effective upon oral or written notification, whichever is earlier. In the event of oral notification, a written confirmation thereof shall be given to such veterinarian as promptly as circumstances permit.
The Veterinary Official shall notify an accredited veterinarian when there is reason to believe that the accredited veterinarian has not complied with the “Standards for Accredited Veterinarian Duties” as contained in § 161.4 of this subchapter. The notification shall be in writing, with a copy to the State Animal Health Official, and shall include a statement of the basis for the belief that the accredited veterinarian has failed to comply with the Standards and shall notify the accredited veterinarian if the Veterinary Official has arranged to hold an informal conference to discuss the matter.
(a) The Veterinary Official, in consultation with the State Animal Health Official and the accredited veterinarian, shall designate the time and place for the holding of an informal conference to review the matter, unless the Veterinary Official determines that an informal conference is inappropriate. An informal conference is inappropriate only if the Veterinary Official decides to dismiss the case based on available facts, or if civil or criminal charges based on the actions or inactions believed to be in violation of the “Standards for Accredited Veterinarian Duties” contained in § 161.4 of this subchapter are pending against the accredited veterinarian. An informal conference shall include the Veterinary Official or his or her representative, the accredited veterinarian, and any other persons the Veterinary Official requests to attend due to their involvement in or knowledge of the possible violation. The State Animal Health Official will be invited to attend each informal conference held regarding activities in his or her State.
(b) If prior to, during, or after the informal conference, but prior to the issuance of a formal complaint, the accredited veterinarian is found not to have violated the regulations, the Veterinary Official will issue a letter dismissing the case, and provide a copy of the letter to the accredited veterinarian and to the State Animal Health Official. Prior to, during, or after the informal conference, the Veterinary Official may issue a letter identifying actions of the accredited veterinarian that were minor violations of the Standards, instructing the accredited veterinarian in proper procedures, and admonishing the accredited veterinarian to use greater care in performing these procedures in the future.
(c) Prior to, during, or at the conclusion of the informal conference, the Veterinary Official may issue a written warning to the accredited veterinarian without further procedure after determining that a warning with appropriate instructions will be adequate to attain compliance with the Standards.
(d) If prior to, during, or at the conclusion of, the informal conference, the accredited veterinarian consents, in writing, to the issuance of an order revoking or suspending his or her accreditation for a specified period of time, in lieu of further procedure, the Veterinary Official may issue such a consent order without further procedure.
If a consent order has not been issued, or if, after an informal conference, the Veterinary Official has not issued a letter of dismissal or letter of warning to the accredited veterinarian, a formal complaint may be issued by the Administrator in accordance with § 1.135 of the Uniform Rules of Practice (7 CFR 1.135).
The Animal and Plant Health Inspection Service regulations relating to availability of information to the public and disclosure of records under 5 U.S.C. 552, which are set forth in 7 CFR part 370, are incorporated into this subchapter.
For the purposes of this part, the following terms shall have the meanings assigned them in this section. Unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa. Words undefined in the following paragraphs shall have the meaning attributed to them in general usage as reflected by definitions in a standard dictionary.
Act. The Swine Health Protection Act (Pub. L. 96-468) as amended by the Farm Credit Act Amendments of 1980 (Pub. L. 96-592).
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.
Animals. All domesticated and wild mammalian, poultry, and fish species, and wild and domesticated animals, including pets such as dogs and cats.
Area Veterinarian in Charge. The veterinarian of APHIS who is assigned by the Administrator to supervise and perform the official work of APHIS in a State or States or any other official to whom authority has heretofore been delegated or to whom authority may hereafter be delegated to act in his stead.
Facility. The site and all objects at this site including equipment and structures where garbage is accumulated, stored, handled, and cooked as a food for swine and which are fenced in or otherwise constructed so that swine are unable to have access to untreated garbage.
Garbage. All waste material derived in whole or in part from the meat of any animal (including fish and poultry) or other animal material, and other refuse of any character whatsoever that has been associated with any such material, resulting from the handling, preparation, cooking or consumption of food, except that such term shall not include waste from ordinary household operations which is fed directly to swine on the same premises where such household is located.
Inspector. Any individual employed by the United States Department of Agriculture or by a State for the purposes of enforcing the Act and this part.
License. A permit issued to a person for the purpose of allowing such person to operate a facility to treat garbage that is to be fed to swine.
Licensee. Any person licensed pursuant to the Act and regulations.
Person. Any individual, corporation, company, association, firm, partnership, society or joint stock company or other legal entity.
Premises. The location of a garbage treatment facility, as defined in this part, and any areas owned or controlled by the operator of the facility where swine are kept or fed by the operator.
Processed product. Material derived in whole or in part from the meat of any animal (including fish and poultry) or other animal material, and other refuse of any character whatsoever that has been associated with any such material, that has undergone an industrial manufacturing procedure to prevent spoilage or add shelf stability, and that has, at a minimum, been cooked to a temperature of 167 °F (75 °C) for at least 30 minutes or has been subjected to an industrial process demonstrated to provide an equivalent level of inactivation of disease organisms, as approved by the Administrator.
Rendered product. Waste material derived in whole or in part from the meat of any animal (including fish and poultry) or other animal material, and other refuse of any character whatsoever that has been associated with any such material, resulting from the handling, preparation, cooking or consumption of food that has been ground and heated to a minimum temperature of 230 °F. to make products such as, but not limited to, animal, poultry, or fish protein meal, grease or tallow.
State. The fifty States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands of the United States, American Samoa, the Commonwealth of the Northern Mariana Islands, and the territories and possessions of the United States.
State animal health official. The individual employed by a State who is responsible for livestock and poultry disease control and eradication programs or any other official to whom authority is delegated to act for the State animal health official.
Treated garbage. Edible waste for animal consumption derived from garbage (as defined in this section) that has been heated throughout at boiling or equivalent temperature (212 °F. or 100 °C. at sea level) for 30 (thirty) minutes under the supervision of a licensee.
Treatment. The heating of garbage to specifications as set forth in this part.
Untreated garbage. Garbage that has not been treated in accordance with the Act and these regulations.
(a) No person shall feed or permit the feeding of garbage to swine unless the garbage is treated to kill disease organisms, pursuant to this part, at a facility operated by a person holding a valid license for the treatment of garbage; except that the treatment and license requirements shall not apply to the feeding or the permitting of the feeding to swine of garbage only because the garbage consists of any of the following: Processed products; rendered products; bakery waste; candy waste; eggs; domestic dairy products (including milk); fish from the Atlantic Ocean within 200 miles of the continental United States or Canada; or fish from inland waters of the United States or Canada which do not flow into the Pacific Ocean.
(b) No person operating such a facility may be licensed to treat garbage unless he or she meets the requirements of this part designed to prevent the introduction or dissemination of any infectious or communicable disease of animals and unless the facility is so constructed that swine are unable to have access to untreated garbage or equipment and material coming in contact with untreated garbage.
(c) The regulations of this part shall not be construed to repeal or supersede State laws that prohibit feeding of garbage to swine or to prohibit any State from enforcing requirements relating to the treatment of garbage that is to be fed to swine or the feeding thereof which are more stringent than the requirements contained in this part. In a State which prohibits the feeding of garbage to swine, a license under the Act will not be issued to any applicant.
(a) Access by swine to garbage handling and treatment areas shall be prevented by construction of facilities to exclude all ages and sizes of swine.
(b) All areas and drainage therefrom, used for the handling and treatment of untreated garbage shall be inaccessible to swine on the premises. This shall include the roads and areas used to transport and handle untreated garbage on the premises.
(a) Untreated garbage at a treatment facility shall be stored in covered and leakproof containers until treated.
(b) Treated garbage shall be transported to a feeding area from the treatment facility only in (1) containers used only for such treated garbage; (2) containers previously used for garbage which have been cleaned and disinfected in accordance with § 166.14 of this part; or (3) containers in which the garbage was treated.
Garbage-treatment facilities shall be maintained as set forth in this section.
(a) Insects and animals shall be controlled. Accumulation of any material at the facility where insects and rodents may breed is prohibited.
(b) Equipment used for handling untreated garbage, except for the containers in which the garbage has been treated, may not be subsequently used in the feeding of swine unless first cleaned and disinfected as set forth in § 166.14(b).
(c) Untreated garbage that is not to be fed to swine and materials in association with such garbage shall be disposed of in a manner consistent with all applicable governmental environmental regulations and in an area inaccessible to swine.
Untreated garbage shall not be allowed into swine feeding areas. Any equipment or material associated with untreated garbage, except for containers holding treated garbage which was treated in such containers, shall not be allowed into swine feeding areas at treatment premises until properly cleaned and disinfected as set forth in § 166.14(b) of this part.
(a) Garbage shall be heated throughout at boiling (212 °F. or 100 °C. at sea level) for 30 (thirty) minutes.
(b) Garbage shall be agitated during cooking, except in steam cooking equipment, to ensure that the prescribed cooking temperature is maintained throughout the cooking container for the prescribed length of time.
Vehicles used by a licensee to transport untreated garbage, except those that have also been used to treat the garbage so moved, shall not be used for hauling animals or treated garbage until cleaned and disinfected as set forth in § 166.14(c) of this part.
(a) Each licensee shall record the destination and date of removal of all treated or untreated garbage removed from the licensee's premises.
(b) Such records shall be legible and indelible.
(c) Each entry in a record shall be certified as correct by initials or signature of the licensee or an authorized agent or employee of the licensee.
(d) Such records shall be maintained by the licensee for a period of 1 year from the date made and shall be made available to inspectors upon request during normal business hours at that treatment facility.
(a) Application. Any person operating or desiring to operate a treatment facility for garbage that is to be treated and fed to swine shall apply for a license on a form which will be furnished, upon request, by the Area Veterinarian in Charge or, in States with primary enforcement responsibility, by the State animal health official in the State in which the person operates or intends to operate. When a person operates more than one treatment facility, a separate application to be licensed shall be made for each facility. Exemptions to the requirements of this paragraph may be granted in States other than those with primary enforcement responsibility by the Administrator, if he finds that there would not be a risk to the swine industry in the United States. Any person operating or desiring to operate a facility to treat garbage to be fed to swine who would otherwise be required under this part to obtain a license to treat garbage only because it contains one or more of the items allowed to be fed to swine under § 166.2(a) of this part is exempted from the requirements of this paragraph.
(b) Acknowledgement of Act and regulations. A copy of the Act and regulations shall be supplied to the applicant at the time the applicant is given a license application. The applicant shall sign a receipt at the time of the prelicensing inspection acknowledging that the applicant has received a copy of the Act and regulations, that the applicant understands them, and agrees to comply with the Act and regulations.
(c) Demonstration of compliance with the regulations. (1) Prior to licensing, each applicant shall demonstrate during an inspection of the premises, facilities, and equipment that the facilities and equipment to be used in the treatment of garbage comply with these regulations. If the applicant's facilities and equipment do not meet the standards established by the regulations, the applicant shall not be licensed and shall be advised of the deficiencies and the measures that must be taken to comply with the regulations.
(2) The licensee shall make the premises, facilities, and equipment available during normal business hours for inspections by an inspector to determine continuing compliance with the Act and regulations.
(3) The facilities and equipment of an applicant for a license shall be in compliance with all applicable governmental environmental regulations before the applicant will be licensed.
(d) Issuance of license. A license will be issued to an applicant when the requirements of paragraphs (a), (b), and (c) of this section have been met, provided that such facility is not located in a State which prohibits the feeding of garbage to swine; and further, that if the Administrator has reason to believe that the applicant for a license is unfit to engage in the activity for which application has been made by reason of the fact that the applicant is engaging in or has, in the past, engaged in any activity in apparent violation of the Act or the regulations which has not been the subject of an administrative proceeding under the Act, an administrative proceeding shall be promptly instituted in which the applicant will be afforded an opportunity for a hearing in accordance with the rules of practice under the Act, for the purpose of giving the applicant an opportunity to show cause why the application for license should not be denied. In the event it is determined that the application should be denied, the applicant shall be precluded from reapplying for a license for 1 year from the date of the order denying the application.
(a) Suspension or revocation after notice. In addition to the imposition of civil penalties and the issuance of cease and desist orders under the Act, the license of any facility may be suspended or revoked for any violation of the Act or the regulations in this part. Before such action is taken, the licensee of the facility will be informed in writing of the reasons for the proposed action and, upon request, shall be afforded an opportunity for a hearing with respect to the merits or validity of such action, in accordance with rules of practice which shall be adopted for the proceeding.
(b) Summary suspension. If the Administrator has reason to believe that any licensee has not complied or is not complying with any provisions of the Act or regulations in this part and the Administrator deems such action necessary in order to protect the public health, interest, or safety, the Administrator may summarily suspend the license of such persons pending a final determination in formal proceedings and any judicial review thereof, effective upon verbal or written notice of such suspension and the reasons therefor. In the event of verbal notification, written confirmation shall follow as soon as circumstances permit. This summary suspension shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(c) The license of a person shall be automatically revoked, without action of the Administrator, upon the final effective date of the second criminal conviction of such person, as is stated in section 5(c) of the Act. The licensee will be notified in writing of such revocation by the Area Veterinarian in Charge or, in States having primary enforcement responsibility, by the State animal health official.
(d) Any person whose license has been suspended or revoked for any reason shall not be licensed in such person's own name or in any other manner, nor shall any of such person's employees be licensed for the purpose of operating the facility owned or operated by said licensee while the order of suspension or revocation is in effect. Any person whose license has been revoked shall not be eligible to apply for a new license for a period of 1 year from the effective date of such revocation. Any person who desires the reinstatement of a license that has been revoked must follow the procedure for new licensees set forth in § 166.10 of this part.
(a) The Area Veterinarian in Charge or, in States referenced in § 166.15(a), the State animal health official shall cancel the license of a licensee when the Area Veterinarian in Charge or, in States referenced in § 166.15(a), the State animal health official finds that no garbage has been treated for a period of 4 consecutive months at the facility operated by the licensee. Before such action is taken, the licensee of the facility will be informed in writing of the reasons for the proposed action and be given an opportunity to respond in writing. In those instances where there is a conflict as to the facts, the licensee shall, upon request, be afforded a hearing in accordance with rules of practice which shall be adopted for the proceeding.
(b) Any licensee may voluntarily have his or her license canceled by requesting such cancellation in writing and sending such request to the Area Veterinarian in Charge,
(c) Any person whose license is canceled in accordance with paragraph (a) or (b) of this section may apply for a new license at any time by following the procedure for obtaining a license set forth in § 166.10.
(a) A licensed facility shall be subject to inspections. Each inspector will be furnished with an official badge or identification card, either of which shall be sufficient identification to entitle access during normal business hours to the facility for the purposes of inspection. At such time the inspector is duly authorized to:
(1) Inspect the facility, including cooker function;
(2) Take samples of garbage;
(3) Observe and physically inspect the health status of all species of animals on the premises;
(4) Review records and make copies of such records; and
(5) Take photographs. A copy of each photograph will be provided to the licensee within 14 days.
(b) A licensee shall notify an inspector immediately upon detection of illness or death not normally associated with the licensee's operation in any animal species on the licensee's premises.
(c) A licensee shall notify an inspector or the State animal health official or the Area Veterinarian in Charge, as appropriate, of any change in the name, address, management or substantial control or ownership of his business or operation within 30 days after making such change.
(d) A licensee shall supply, upon request by an inspector, information concerning sources of garbage. Such information shall include the dates of supply and the names and addresses of the person and/or organization from which the garbage was received.
(a) Disinfectants to be used. Disinfection required under the regulations in this Part shall be performed with one of the following:
(1) A permitted brand of sodium orthophenylphenate that is used in accordance with directions on the Environmental Protection Agency (EPA) approved label.
(2) A permitted cresylic disinfectant that is used in accordance with directions on the EPA-approved label, provided such disinfectant also meets the requirements set forth in §§ 71.10(b) and 71.11 of this chapter.
(3) Distinfectants which are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), with tuberculocidal claims and labeled as efficacious against any species within the viral genus Herpes, that are used for purposes of this Part in accordance with directions on the EPA-approved label.
(b) All premises at which garbage has been fed to swine in violation of the Act or regulations in this part shall, prior to continued use for swine feeding purposes, be cleaned and disinfected under the supervision of an inspector or an accredited veterinarian as defined in Part 160 of this chapter as follows: Empty all troughs and other feeding and watering appliances, remove all litter, garbage, manure, and other organic material from the floors, posts, or other parts of such equipment, and handle such litter, garbage, manure, and other organic material in such manner as not to allow animal contact with such material; clean all surfaces with water and detergent and saturate the entire surface of the equipment, fencing, troughs, chutes, floors, walls, and all other parts of the facilities, with a disinfectant prescribed in paragraph (a) of this section. An exemption to the requirements of this paragraph may be given by the Administrator or, in States with primary enforcement responsibility, by the State animal health official, when it is determined that a threat to the swine industry does not exist.
(c) Any vehicle or other means of conveyance and its associated equipment which has been used by the licensee to move garbage, except any vehicle or other means of conveyance which also has been used to treat the garbage so moved, shall, prior to use for livestock-related or treated garbage hauling purposes, be cleaned and disinfected as follows: Remove all litter, garbage, manure, and other organic material from all portions of each means of conveyance, including all ledges and framework inside and outside, and handle such litter, garbage, manure, and other organic material in such manner as not to allow animal contact with such material; clean the interior and the exterior of such vehicle or other means of conveyance and its associated equipment with water and detergent; and saturate the entire interior surface, including all doors, endgates, portable chutes, and similar equipment with a disinfectant prescribed in paragraph (a) of this section.
(d) The owner of such facilities and vehicles shall be responsible for cleaning and disinfecting as required under this section, and the cleaning and disinfecting shall be done without expense to the United States Department of Agriculture.
(a) The Animal and Plant Health Inspection Service (APHIS) will maintain on its website
(1) States that prohibit the feeding of garbage to swine;
(2) States that allow the feeding of treated garbage to swine;
(3) States that have primary enforcement responsibility under the Act; and
(4) States that issue licenses under cooperative agreements with APHIS, but do not have primary responsibility under the Act.
(b) For information concerning the feeding of garbage to swine, the public may contact the APHIS Area Veterinarian in Charge, the State animal health official, or Veterinary Services, 4700 River Road, Unit 37, Riverdale, MD 20737-1231.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under sections 5 and 6 of the Swine Health Protection Act (7 U.S.C. 3804, 3805). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to a specified order which may include an agreement to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the order in settlement of the particular matter conditioned upon timely payment of the penalty if the order includes an agreement to pay a penalty.
(b) If the order includes an agreement to pay a penalty and the penalty is not paid within the time designated in such a stipulation, the amount of the penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.
The definitions of terms contained in the Act shall apply to such terms when used in Administering the Packers and Stockyards Act, 9 CFR part 201; Rules of Practice Governing Proceedings Under the Packers and Stockyards Act, 9 CFR part 202; and Statements of General Policy Under the Packers and Stockyards Act, 9 CFR part 203. In addition, the following terms used in these parts shall be construed to mean:
Act means the Packers and Stockyards Act, 1921, as amended and supplemented (7 U.S.C. 181 et seq.).
Additional capital investment means a combined amount of $12,500 or more per structure paid by a poultry grower or swine production contract grower over the life of the poultry growing arrangement or swine production contract beyond the initial investment for facilities used to grow, raise, and care for poultry or swine. Such term includes the total cost of upgrades to the structure, upgrades of equipment located in and around each structure, and goods and professional services that are directly attributable to the additional capital investment. The term does not include costs of maintenance or repair.
Administrator or agency head means the Administrator of the Agricultural Marketing Service or any person authorized to act for the Administrator.
Agency means the Agricultural Marketing Service of the United States Department of Agriculture.
Breeder facility identifier means the identification that a live poultry dealer permanently assigns to distinguish among breeder facilities supplying eggs for the poultry placed at the poultry grower's facility.
Breeder flock age means the age in weeks of the egg-laying flock that is the source of poultry placed at the poultry grower's facility.
Broiler means any chicken raised for meat production.
Broiler grower means a poultry grower engaged in the production of broilers.
Broiler growing arrangement means a poultry growing arrangement pertaining to the production of broilers.
Commerce means commerce between any State, Territory, or possession, or the District of Columbia, and any place outside thereof; or between points within the same State, Territory, or possession, or the District of Columbia, but through any place outside thereof; or within any Territory or possession, or the District of Columbia.
Complex means a group of local facilities under the common management of a live poultry dealer. A complex may include, but not be limited to, one or more hatcheries, feed mills, slaughtering facilities, or poultry processing facilities.
Custom feedlot means any facility which is used in its entirety or in part for the purpose of feeding livestock for the accounts of others, but does not include feeding incidental to the sale or transportation of livestock.
Department means the United States Department of Agriculture.
Gross payments are the total compensation a poultry grower receives from the live poultry dealer, including, but not limited to, base payments, new housing allowances, energy allowances, square footage payments, extended lay-out time payments, equipment allowances, bonus payments, additional capital investment payments, poultry litter payments, etc., before deductions or assignments are made.
Grower variable costs means those costs related to poultry production that may be borne by the poultry grower, which may include, but are not limited to, utilities, fuel, water, labor, repairs and maintenance, and liability insurance.
Housing specifications means a description of—or a document relating to—a list of equipment, products, systems, and other technical poultry housing components required by a live poultry dealer for the production of live poultry.
Inputs means the various contributions to be made by the live poultry dealer and the poultry grower as agreed upon by both under a poultry growing arrangement. Such inputs may include, but are not limited to, animals, feed, veterinary services, medicines, labor, utilities, and fuel.
Letter of intent means a document that expresses a preliminary commitment from a live poultry dealer to engage in a business relationship with a prospective poultry grower and that includes the chief terms of the agreement.
Live poultry dealer means any person engaged in the business of obtaining live poultry by purchase or under a poultry growing arrangement for the purpose of either slaughtering it or selling it for slaughter by another, if poultry is obtained by such person in commerce, or if poultry obtained by such person is sold or shipped in commerce, or if poultry products from poultry obtained by such person are sold or shipped in commerce.
Live Poultry Dealer Disclosure Document means the complete set of disclosures and statements that the live poultry dealer must provide to the poultry grower.
Minimum number of placements means the least number of flocks of poultry the live poultry dealer will deliver to the grower for growout annually under the terms of the poultry growing arrangement.
Minimum stocking density means the ratio that reflects the minimum weight of poultry per facility square foot the live poultry dealer intends to harvest from the grower following each growout.
Number of placements means the number of flocks of poultry the live poultry dealer will deliver to the grower for growout during each year of the poultry growing arrangement period.
Original capital investment means the initial financial investment for facilities used to grow, raise, and care for poultry or swine.
Packers and Stockyards Division (PSD) means the Packers and Stockyards Division of the Fair Trade Practices Program (FTPP), Agricultural Marketing Service.
Person means individuals, partnerships, corporations, and associations.
Placement means delivery of a poultry flock to the poultry grower for growout in accordance with the terms of a poultry growing arrangement.
Poultry grower means any person engaged in the business of raising and caring for live poultry for slaughter by another, whether the poultry is owned by such person or by another, but not an employee of the owner of such poultry.
Poultry grower ranking system means a system where the contract between the live poultry dealer and the poultry grower provides for payment to the poultry grower based upon a grouping, ranking, or comparison of poultry growers delivering poultry during a specified period.
Poultry growing arrangement means any growout contract, marketing agreement, or other arrangement under which a poultry grower raises and cares for live poultry for delivery, in accord with another's instructions, for slaughter.
Poultry growout means the process of raising and caring for poultry in anticipation of slaughter.
Poultry growout period means the period of time between placement of poultry at a grower's facility and the harvest or delivery of such animals for slaughter, during which the feeding and care of such poultry are under the control of the grower.
Principal part of performance means the raising of and caring for livestock or poultry, when used in connection with a livestock or poultry production contract.
Prospective broiler grower means a person or entity with whom the live poultry dealer is considering entering into a broiler growing arrangement.
Prospective poultry grower means a person or entity with whom the live poultry dealer is considering entering into a poultry growing arrangement.
Regional director means the regional director of the Packers and Stockyards Division (PSD) for a given region or any person authorized to act for the regional director.
Registrant means any person registered pursuant to the provisions of the Act and the regulations in this part.
Schedule means a tariff of rates and charges filed by stockyard owners and market agencies.
Secretary means the Secretary of Agriculture of the United States, or any officer or employee of the Department authorized to act for the Secretary.
Stocking density means the ratio that reflects the number of birds in a placement, expressed as the number of poultry per facility square foot.
Stockyard means a livestock market which has received notice under section 302(b) of the Act that it has been determined by the Secretary to come within the definition of “stockyard” under section 302(a) of the Act.
The regulations in this part, when governing or affecting contracts, shall apply to any poultry growing arrangement, swine production contract, or any other livestock or poultry contract entered into, amended, altered, modified, renewed or extended after February 7, 2012.
The Administrator shall perform such duties as the Secretary may require in enforcing the provisions of the act and the regulations in this part.
(a) The regulations in this part shall not prevent the legitimate application or enforcement of any valid bylaw, rule or regulation, or requirement of any exchange, association, or other organization, or any other valid law, rule or regulation, or requirement to which any packer, stockyard owner, market agency, or dealer shall be subject which is not inconsistent or in conflict with the act and the regulations in this part.
(b) Market agencies selling livestock on commission shall not, in carrying out the statutory duty imposed upon them by section 307 of title III of the act, permit dealers, packers, or others representing interests which conflict with those of consignors, to participate, directly or indirectly, in determination of the need for, or in the establishment of, regulations governing, or practices relating to, the responsibilities, duties, or obligations of such market agencies to their consignors.
(a) Every person operating or desiring to operate as a market agency or dealer as defined in section 301 of the Act (7 U.S.C. 201) must apply for registration. To apply, such persons must file a properly executed application for registration on a form furnished by the Agency. Each applicant must file an application for registration with the regional office for the region where the applicant has his or her primary place of business, and file and maintain a bond as required in §§ 201.27 through 201.34 (9 CFR 201.27 through 201.34).
(b) If, upon review of an application, the Administrator has reason to believe the applicant is unfit to engage in the activity for which application has been made, a proceeding shall be instituted promptly affording the applicant the opportunity for a full hearing, in accordance with the Department's Rule of Practice Governing Formal Adjudicatory Proceedings (7 CFR Subpart H), to show cause why the application for registration should not be denied. If after the hearing the application is denied, as soon as the issue(s) that formed the basis of the denial have been remedied, the applicant may file a new application for registration.
(c) Any person regularly employed on salary, or other comparable method of compensation, by a packer to buy livestock for such packer is subject to the regulation requirements of this section. Such person must be registered as a dealer to purchase livestock for slaughter on behalf of the packer.
(d) Every person clearing or desiring to clear the buying operations of other registrants must apply for registration as a market agency providing clearing services by filing a properly executed application on a form furnished by the Agency, and file and maintain a bond as required in §§ 201.27 through 201.34.
(e) If an application for registration is granted, a market agency or dealer receives an acceptance letter from the Agency that issues the registration number and the effective date of the registration. Each registration issued in accordance with this section will not expire, provided that the registrant timely files its annual report with the Agency as required in section 201.97. Failure of a registrant to file an annual report by the date required in section 201.97 will result in the issuance of a default notice. Thirty days after receipt of the default notice, the registration will expire if the Agency does not receive an annual report from the registrant. A registrant who fails to renew its registration in a timely manner, and continues to operate, will be engaged in business subject to the Act without a valid registration in violation of section 303 of the Act (7 U.S.C. 203).
(f) Registrations that expire during a period of suspension imposed as a result of an order or injunction may be renewed, but the renewal will not be effective until the specified suspension period terminates.
Any person whose registration has been suspended, or any person who was responsible for or participated in the violation on which the order of suspension was based, may not register in his own name or in any other manner within the period during which the order of suspension is in effect, and no partnership or corporation in which any such person has a substantial financial interest or exercises management responsibility or control may be registered during such period.
(a) Schedules of rate changes for stockyard services. Each stockyard owner and market agency operating at a posted stockyard shall file with the Regional Director for the region in which they operate a signed copy of all schedules of rates and charges, supplements and amendments thereto. The schedules, supplements and amendments must be conspicuously posted for public inspection at the stockyard, and filed with the Regional Director, at least 10 days before their effective dates, except as provided in paragraphs (b) and (c) of this section. Each schedule, supplement and amendment shall set forth its effective date, a description of the stockyard services rendered, the stockyard at which it applies, the name and address of the stockyard owner or market agency, the kind of livestock covered by it, and any rules or regulations which affect any rate or charge contained therein. Each schedule of rates and charges filed shall be designated by successive numbers. Each supplement and amendment to such schedule shall be numbered and shall designate the number of the schedule which it supplements or amends.
(b) Feed charges. When the schedule in effect provides for feed charges to be based on an average cost plus a specified margin, the 10-day filing and notice provision contained in section 306(c) of the Act is waived. A schedule of the current feed charges based on average feed cost and showing the effective date shall be conspicuously posted at the stockyard at all times. Changes in feed charges may become effective 2 days after the change is posted at the stockyard.
(c) Professional veterinary services. The 10-day filing and notice provision contained in section 306(a) of the Act is waived for a schedule of charges for professional veterinary services. A schedule of charges for professional veterinary services rendered by a veterinarian at a posted stockyard shall be conspicuously posted at the stockyard at all times. The schedule of charges and any supplement or amendment thereto may become effective 2 days after the schedule, supplement, or amendment is posted at the stockyard.
(d) Joint schedules. If the same schedule is to be observed by more than one market agency operating at any one stockyard, one schedule will suffice for such market agencies. The names and business addresses of those market agencies adhering to such schedule must appear on the schedule.
(a) The surety on bonds maintained under the regulations in this part shall be a surety company which is currently approved by the United States Treasury Department for bonds executed to the United States; and which has not failed or refused to satisfy its legal obligations under bonds issued under said regulations.
(b) Any packer, market agency, or dealer required to maintain a surety bond under these regulations may elect to maintain, in whole or partial substitution for such surety bond, a bond equivalent as provided below. The total amount of any such surety bond, equivalent, or combination thereof, must be the total amount of the surety bond otherwise required under these regulations. Any such bond equivalent must be in the form of:
(1) A trust fund agreement governing funds actually deposited or invested in fully negotiable obligations of the United States or Federally-insured deposits or accounts in the name of and readily convertible to currency by a trustee as provided in § 201.32, or
(2) A trust agreement governing funds which may be drawn by a trustee as provided in § 201.32, under one or more irrevocable, transferrable, standby letters of credit, issued by a Federally-insured bank or institution and physically received and retained by such trustee.
(c) The provisions of §§ 201.27 through 201.34 shall be applicable to the trust fund agreements, trust agreements and letters of credit authorized in paragraph (b) of this section.
(d) Bonds, trust fund agreements, letters of credit and trust agreements shall be filed on forms approved by the Administrator.
Fully executed duplicates of bonds, trust fund agreements, and trust agreements maintained under the regulations in this part, and fully executed duplicates of all endorsements, amendments, riders, indemnity agreements, and other attachments thereto, and photographically reproduced copies of any letter of credit or amendment thereto, shall be filed with the Regional Director for the region in which the registrant, packer, or person applying for registration resides, or in the case of a corporation, where the corporation has its home office: Provided, that if such registrant, packer, or person does not engage in business in such area, the foregoing documents shall be filed with the Regional Director for the region in which the place of business of the registrant or packer or person is located.
(a) Every market agency, packer, and dealer, except as provided in paragraph (d) of this section, and except packer buyers registered as dealers to purchase livestock for slaughter only, shall execute and maintain a reasonable bond on forms approved by the Administrator containing the appropriate condition clauses, as set forth in § 201.31 of the regulations, applicable to the activity or activities in which the person or persons propose to engage, to secure the performance of obligations incurred by such market agency, packer, or dealer. No market agency, packer, or dealer required to maintain a bond shall conduct his operations unless there is on file and in effect a bond complying with the regulations in this part.
(b) Every market agency buying on a commission basis and every dealer buying for his own account or for the accounts of others shall file and maintain a bond. If a registrant operates as both a market agency buying on a commission basis and as a dealer, only one bond to cover both buying operations need be filed. Any person operating as a market agency selling on a commission basis and as a market agency buying on a commission basis or as a dealer shall file and maintain separate bonds to cover his selling and buying operations.
(c) Each market agency and dealer whose buying operations are cleared by another market agency shall be named as clearee in the bond filed and maintained by the market agency registered to provide clearing services. Each market agency selling livestock on a commission basis shall file and maintain its own bond.
(d) Every packer purchasing livestock, directly or through an affiliate or employee or a wholly-owned subsidiary, except those packers whose annual purchases do not exceed $500,000, shall file and maintain a reasonable bond. In the event a packer maintains a wholly-owned subsidiary or affiliate to conduct its livestock buying, the wholly-owned subsidiary or affiliate shall be registered as a packer buyer for its parent packer firm, and the required bond shall be maintained by the parent packer firm.
(a) Market agency selling livestock on commission. To compute the required amount of bond coverage, divide the dollar value of livestock sold during the preceding business year, or the substantial part of that business year, in which the market agency did business, by the actual number of days on which livestock was sold. The divisor (the number of days on which livestock was sold) shall not exceed 130. The amount of bond coverage must be the next multiple of $5,000 above the amount so determined. When the computation exceeds $50,000, the amount of bond coverage need not exceed $50,000 plus 10 percent of the excess over $50,000, raised to the next $5,000 multiple. In no case shall the amount of bond coverage for a market agency selling on commission be less than $10,000 or such higher amount as required to comply with any State law.
(b) Market agency buying on commission or dealer. The amount of bond coverage must be based on the average amount of livestock purchased by the dealer or market agency during a period equivalent to 2 business days. To compute the required amount of bond coverage, divide the total dollar value of livestock purchased during the preceding business year, or substantial part of that business year, in which the dealer or market agency or both did business, by one-half the number of days on which business was conducted. The number of days in any business year, for purposes of this regulation, shall not exceed 260. Therefore, the divisor (one-half the number of days on which business was conducted) shall not exceed 130. The amount of the bond coverage must be the next multiple of $5,000 above the amount so determined. When the computation exceeds $75,000, the amount of bond coverage need not exceed $75,000 plus 10 percent of the excess over $75,000, raised to the next $5,000 multiple. In no case shall the amount of bond coverage be less than $10,000 or such higher amount as required to comply with any State law.
(c) Market agency acting as clearing agency. The amount of bond coverage must be based on the average amount of livestock purchased by all persons for whom the market agency served as a clearor during a period equivalent to 2 business days. To compute the required amount of bond coverage, divide the total dollar value of livestock purchased by all persons for whom the market agency served as a clearor during the preceding business year, or substantial part of that business year, in which the market agency acting as clearing agency did business, by one-half the number of days on which business was conducted. The number of days in any business year, for purposes of this regulation, shall not exceed 260. Therefore, the divisor (one-half the number of days on which business was conducted) shall not exceed 130. The amount of bond coverage must be the next multiple of $5,000 above the amount so determined. When the computation exceeds $75,000, the amount of bond coverage need not exceed $75,000 plus 10 percent of the excess over $75,000, raised to the next $5,000 multiple. In no case shall the amount of bond coverage be less than $10,000 or such higher amount as required to comply with any State law.
(d) Packer. The amount of bond coverage must be based on the average amount of livestock purchased by the packer during a period equivalent to 2 business days. To compute the required amount of bond coverage, divide the total dollar value of livestock purchased during the preceding business year, or substantial part of that business year, in which the packer did business, by one-half the number of days on which business was conducted. The number of days in any business year, for purposes of this regulation, shall not exceed 260. Therefore, the divisor (one-half the number of days on which business was conducted) shall not exceed 130. The amount of the bond coverage must be the next multiple of $5,000 above the amount so determined. In no case shall the amount of bond coverage for a packer be less than $10,000.
(e) If a person applying for registration as a market agency or dealer has been engaged in the business of handling livestock before the date of the application, the value of the livestock handled, if representative of future operations, must be used in computing the required amount of bond coverage. If the applicant for registration is a successor in business to a registrant formerly subject to these regulations, the amount of bond coverage of the applicant must be at least that amount required of the prior registrant, unless otherwise determined by the Administrator. If a packer becomes subject to these regulations, the value of livestock purchased, if representative of future operations, must be used in computing the required amount of bond coverage. If a packer is a successor in business to a packer formerly subject to these regulations, the amount of bond coverage of the successor must be at least that amount required of the prior packer, unless otherwise determined by the Administrator.
(f) Whenever the Administrator has reason to believe that a bond is inadequate to secure the performance of the obligations of the market agency, dealer or packer covered thereby, the Administrator shall notify such person to adjust the bond to meet the requirements the Administrator determines to be reasonable.
Each market agency, dealer and packer bond shall contain conditions applicable to the activity or activities in which the person or persons named as principal or clearees in the bond propose to engage, which conditions shall be as follows or in terms to provide equivalent protection:
(a) Condition Clause No. 1: When the principal sells livestock for the accounts of others. If the said principal shall pay when due to the person or persons entitled thereto the gross amount, less lawful charges, for which all livestock is sold for the accounts of others by said principal.
(b) Condition Clause No. 2: When the principal buys livestock for his own account or for the accounts of others. If the said principal shall pay when due to the person or persons entitled thereto the purchase price of all livestock purchased by said principal for his own account or for the accounts of others, and if the said principal shall safely keep and properly disburse all funds, if any, which come into his hands for the purpose of paying for livestock purchased for the accounts of others.
(c) Condition Clause No. 3: When the principal clears other registrants buying livestock and thus is responsible for the obligations of such other registrants. If the said principal, acting as a clearing agency responsible for the financial obligations of other registrants engaged in buying livestock, viz: (Insert here the names of such other registrants as they appear in the application for registration), or if such other registrants, shall (1) pay when due to the person or persons entitled thereto the purchase price of all livestock purchased by such other registrants for their own account or for the accounts of others; and (2) safely keep and properly disburse all funds coming into the hands of such principal or such other registrants for the purpose of paying for livestock purchased for the accounts of others.
(d) Condition Clause No. 4: When the principal buys livestock for his own account as a packer. If the said principal shall pay when due to the person or persons entitled thereto the purchase price of all livestock purchased by said principal for his own account.
Bonds may be in favor of a trustee who shall be a financially responsible, disinterested person satisfactory to the Administrator. State officials, secretaries or other officers of livestock exchanges or of similar trade associations, attorneys at law, banks and trust companies, or their officers, are deemed suitable trustees. If a trustee is not designated in the bond and action is taken to recover damages for breach of any condition thereof, the Administrator shall designate a person to act as trustee. In those States in which a State official is required by statute to act or has agreed to act as trustee, such official shall be designated by the Administrator as trustee when a designation by the Administrator becomes necessary.
Each bond and each bond equivalent filed pursuant to the regulations in this part shall contain provisions that:
(a) Any person damaged by failure of the principal to comply with any condition clause of the bond or bond equivalent may maintain suit to recover on the bond or bond equivalent even though such person is not a party named in the bond or bond equivalent;
(b) Any claim for recovery on the bond or bond equivalent must be filed in writing with either the surety, if any, or the trustee, if any, or the Administrator, and whichever of these parties receives such a claim shall notify the other such party or parties at the earliest practical date;
(c) The Administrator is authorized to designate a trustee pursuant to § 201.32;
(d) The surety on the bond, or the trustee on the bond equivalent, as the case may be, shall not be liable to pay any claim if it is not filed in writing within 60 days from the date of the transaction on which the claim is based or if suit thereon is commenced less than 120 days or more than 547 days from the date of the transaction on which the claim is based;
(e) The proceeds of the bond or bond equivalent, as the case may be, shall not be used to pay fees, salaries, or expenses for legal representation of the surety or the principal.
(a) Each bond shall contain a provision requiring that, prior to terminating such bond, at least 30 days notice in writing shall be given to the Administrator, Agricultural Marketing Service (AMS), U.S. Department of Agriculture, Washington, DC 20250, by the party terminating the bond. Such provision may state that in the event the surety named therein writes a replacement bond for the same principal, the 30-day notice requirement may be waived and the bond will be terminated as of the effective date of the replacement bond.
(b) Each bond filed by a market agency who clears other registrants who are named in the bond shall contain a provision requiring that, prior to terminating the bond coverage of any clearee named therein, at least 30 days notice in writing shall be given to the Administrator, Agricultural Marketing Service (AMS), U.S. Department of Agriculture, Washington, DC 20250, by the surety. Such written notice shall be in the form of a rider or endorsement to be attached to the bond of the clearing agency.
(c) Each trust fund agreement and trust agreement shall contain a provision requiring that, prior to terminating such agreement, at least 30 days notice in writing shall be given to the Administrator, Agricultural Marketing Service, U.S. Department of Agriculture, Washington, DC 20250, by the party terminating the agreement. Such provision shall state that in the event the principal named therein files an acceptable bond or bond equivalent to replace the agreement, the 30-day notice requirement may be waived and the agreement will be terminated as of the effective date of the replacement bond or bond equivalent.
(a) No market agency shall, except as provided in paragraph (b) of this section, pay the net proceeds or any part thereof, arising from the sale of livestock consigned to it for sale, to any person other than the consignor or shipper of such livestock except upon an order from the Secretary or a court of competent jurisdiction, unless (1) such market agency has reason to believe that such person is the owner of the livestock, (2) such person holds a valid, unsatisfied mortgage or lien upon the particular livestock, or (3) such person holds a written order authorizing such payment executed by the owner at the time of or immediately following the consignment of such livestock: Provided, That this paragraph shall not apply to deductions made from sales proceeds for the purpose of financing promotion and research activities, including educational activities, relating to livestock, meat, and other products covered by the Act, carried out by producer-sponsored organizations.
(b) The net proceeds arising from the sale of livestock, the ownership of which has been questioned by a market agency duly authorized to inspect brands, marks, and other identifying characteristics of livestock may be paid in accordance with the directions of such brand inspection agency if the laws of the State from which such livestock originated or was shipped to market make provision for payment of the proceeds in the manner directed by the brand inspection agency and if the market agency to which the livestock was consigned, and the consignor or consignors concerned, are unable to establish the ownership of the livestock within a reasonable period of time, not to exceed 60 days after sale.
(a) Payments for livestock are trust funds. Each payment that a livestock buyer makes to a market agency selling on commission is a trust fund. Funds deposited in custodial accounts are also trust funds.
(b) Custodial accounts for shippers' proceeds. Every market agency engaged in selling livestock on a commission or agency basis shall establish and maintain a separate bank account designated as “Custodial Account for Shippers' Proceeds,” or some similar identifying designation, to disclose that the depositor is acting as a fiduciary and that the funds in the account are trust funds.
(c) Deposits in custodial accounts. The market agency shall deposit in its custodial account before the close of the next business day (the next day on which banks are customarily open for business whether or not the market agency does business on that day) after livestock is sold (1) the proceeds from the sale of livestock that have been collected, and (2) an amount equal to the proceeds receivable from the sale of livestock that are due from (i) the market agency, (ii) any owner, officer, or employee of the market agency, and (iii) any buyer to whom the market agency has extended credit. The market agency shall thereafter deposit in the custodial account all proceeds collected until the account has been reimbursed in full, and shall, before the close of the seventh day following the sale of livestock, deposit an amount equal to all the remaining proceeds receivable whether or not the proceeds have been collected by the market agency.
(d) Withdrawals from custodial accounts. The custodial account for shippers' proceeds shall be drawn on only for payment of (1) the net proceeds to the consignor or shipper, or to any person that the market agency knows is entitled to payment, (2) to pay lawful charges against the consignment of livestock which the market agency shall, in its capacity as agent, be required to pay, and (3) to obtain any sums due the market agency as compensation for its services.
(e) Accounts and records. Each market agency shall keep such accounts and records as will disclose at all times the handling of funds in such custodial accounts for shippers' proceeds. Accounts and records must at all times disclose the name of the consignors and the amount due and payable to each from funds in the custodial account for shippers' proceeds.
(f) Insured banks. Such custodial accounts for shippers' proceeds must be established and maintained in banks whose deposits are insured by the Federal Deposit Insurance Corporation.
(g) Certificates of deposit and/or savings accounts. Funds in a custodial account for shippers' proceeds may be maintained in an interest-bearing savings account and/or invested in one or more certificates of deposit, to the extent that such deposit or investment does not impair the ability of the market agency to meet its obligations to its consignors. The savings account must be properly designated as a part of the custodial account of the market agency in its fiduciary capacity as trustee of the custodial funds and maintained in the same bank as the custodial account. The certificates of deposit, as property of the custodial account, must be issued by the bank in which the custodial account is kept and must be made payable to the market agency in its fiduciary capacity as trustee of the custodial funds.
(a) Market agencies to make prompt accounting and transmittal of net proceeds. Each market agency shall, before the close of the next business day following the sale of any livestock consigned to it for sale, transmit or deliver to the consignor or shipper of the livestock, or the duly authorized agent, in the absence of any knowledge that any other person, or persons, has any interest in the livestock, the net proceeds received from the sale and a true written account of such sale, showing the number, weight, and price of each kind of animal sold, the date of sale, the commission, yardage, and other lawful charges, and such other facts as may be necessary to complete the account and show fully the true nature of the transaction.
(b) Prompt payment for livestock and live poultry—terms and conditions. (1) No packer, market agency, or dealer shall purchase livestock for which payment is made by a draft which is not a check, unless the seller expressly agrees in writing before the transaction that payment may be made by such a draft. (In cases of packers whose average annual purchases exceed $500,000, and market agencies and dealers acting as agents for such packers, see also § 201.200).
(2)(i) No packer, market agency, or dealer purchasing livestock for cash and not on credit, whether for slaughter or not for slaughter, shall mail a check in payment for the livestock unless the check is placed in an envelope with proper first class postage prepaid and properly addressed to the seller or such person as he may direct, in a post office, letter box, or other receptacle regularly used for the deposit of mail for delivery, from which such envelope is scheduled to be collected (A) before the close of the next business day following the purchase of livestock and transfer of possession thereof, or (B) in the case of a purchase on a “carcass” or “grade and yield” basis, before the close of the first business day following determination of the purchase price.
(ii) No packer, market agency, or dealer purchasing livestock for slaughter, shall mail a check in payment for the livestock unless (A) the check is made available for actual delivery and the seller or his duly authorized representative is not present to receive payment, at the point of transfer of possession of such livestock, on or before the close of the next business day following the purchase of the livestock and transfer of possession thereof, or, in the case of a purchase on a “carcass” or “grade and yield” basis, on or before the close of the first business day following determination of the purchase price; or unless (B) the seller expressly agrees in writing before the transaction that payment may be made by such mailing of a check.
(3) Any agreement referred to in paragraph (b) (1) or (2) of this section shall be disclosed in the records of any market agency or dealer selling such livestock, and in the records of the packer, market agency, or dealer purchasing such livestock, and retained by such person for such time as is required by any law, or by written notice served on such person by the Administrator, but not less than two calendar years from the date of expiration thereof.
(4) No packer, live poultry dealer, market agency, or livestock dealer shall as a condition to its purchase of livestock or poultry, impose, demand, compel or dictate the terms or manner of payment, or attempt to obtain a payment agreement from a seller through any threat of retaliation or other form of intimidation.
(c) Purchaser to promptly reimburse agents. Each packer, market agency, or dealer who utilizes or employs an agent to purchase livestock for him, shall, in transactions where such agent uses his own funds to pay for livestock purchased on order, transmit or deliver to such agent the full amount of the purchase price before the close of the next business day following receipt of notification of the payment of such purchase price, unless otherwise expressly agreed between the parties before the purchase of the livestock. Any such agreement shall be disclosed in the records of the principal and in the records of any market agency or dealer acting as such agent.
Each market agency shall, promptly following the purchase of livestock on a commission or agency basis, transmit or deliver to the person for whose account such purchase was made, or the duly authorized agent, a true written account of the purchase showing the number, weight, and price of each kind of animal purchased, the names of the persons from whom purchased, the date of purchase, the commission and other lawful charges, and such other facts as may be necessary to complete the account and show fully the true nature of the transaction.
Each market agency engaged in the business of selling or buying livestock on a commission or agency basis shall, on request from an owner, consignor, or purchaser, make available copies of bills covering charges paid by such market agency for and on behalf of the owner, consignor, or purchaser which were deducted from the gross proceeds of the sale of livestock or added to the purchase price thereof when accounting for the sale or purchase.
(a) When livestock, poultry or feed is weighed for the purpose of purchase, sale, acquisition, or settlement, a scale ticket must be issued which must be serially numbered and used in numerical sequence. Sufficient copies must be executed and provided to all parties to the transaction. Unused and partially executed scale tickets must not be left exposed or accessible to other parties and, except in feed mills, must be kept under lock when the weigher is not at the scale. In instances where the weight values are automatically recorded directly on the account of purchase, account of sale, or other basic transaction record, this record may serve in place of a scale ticket.
(b) Livestock. When livestock is weighed for the purpose of purchase or sale, or when livestock is purchased on a carcass weight or carcass grade and weight basis, the live or hot carcass weights must be recorded using a scale equipped with a printing device, and such printed weights must be retained as part of the person or firm's business records to substantiate settlement on each transaction. In instances where the weight values are automatically recorded directly on the account of purchase, account of sale, or other basic transaction record, this record may serve in place of a scale ticket. Scale tickets or other basic transaction records issued under this section must show:
(1) The name and location of the agency performing the weighing service;
(2) The date of the weighing;
(3) The name of the buyer and seller or consignor, or a designation by which they may be readily identified;
(4) The number of head;
(5) Kind of livestock;
(6) Actual weight of each draft of livestock; and
(7) The name, initials, or identification number of the person who weighed the livestock, or if required by State law, the signature of the weigher, except for an automated weighing system where a weigher is not stationed at the scale.
(c) Poultry. When live poultry is weighed for the purpose of purchase, sale, acquisition, or settlement by a live poultry dealer, the scale ticket or other basic transaction record must show:
(1) The name of the agency performing the weighing service;
(2) The name of the live poultry dealer;
(3) The name and address of the grower or seller, and purchaser, or a designation by which they may be readily identified;
(4) The name, initials, or identification number of the person who weighed the poultry, or if required by State law, the signature of the weigher;
(5) The city and state in which the scale is located, and, if more than one scale is used to obtain the weight of poultry within the same facility, the identity of the scale;
(6) The zero balance for both the gross weight and tare weight;
(7) The date and time zero balance was determined;
(8) The gross weight, tare weight, and net weight;
(9) The date and time gross weight and tare weight are determined;
(10) The number of poultry weighed;
(11) The weather conditions;
(12) Whether the driver was on or off the truck at the time of weighing, if applicable; and
(13) The license number or other identification numbers on the truck and trailer, if weighed together, or trailer if only the trailer is weighed; provided, that when live poultry is weighed on a scale other than a vehicle scale, the scale ticket or other basic transaction record need not show the information specified in paragraphs (c)(11) and (c)(12) of this section.
(d) Feed. Whenever feed is weighed and the weight of the feed is a factor in determining payment or settlement to a livestock producer or poultry grower, the scale ticket or other basic transaction record must show:
(1) The name of the agency performing the weighing service, or the name and location of the firm responsible for supplying the feed;
(2) The name and address of the livestock producer or poultry grower, or a designation by which they may be readily identified;
(3) The name, initials or identification number of the person who weighed the feed, or if required by State law, the signature of the weigher;
(4) The city and state in which the scale is located, and, if a facility has more than one scale on which feed is weighed, the identity of the scale;
(5) The zero balance; provided that when using a vehicle scale to weigh feed for more than one producer or grower on the same multi-compartment truck, the preceding producer's or grower's gross weight can be used for the next producer's or grower's tare weight without printing a zero balance, and repeated until the unit is full;
(6) The date and time zero balance was determined;
(7) The gross weight, tare weight, and net weight of each lot assigned to an individual producer or grower, if applicable;
(8) The date and time gross weight and, if applicable, tare weight, are determined;
(9) The identification of each lot assigned to an individual producer or grower by vehicle or trailer compartment number and seal number, if applicable;
(10) Whether the driver was on or off the truck at the time of weighing, if applicable; and
(11) The license number or other identification numbers on the truck and trailer, if weighed together, or trailer if only the trailer is weighed, if applicable.
No packer, swine contractor, live poultry dealer, stockyard owner, market agency, or dealer shall knowingly make, issue, or circulate any false or misleading reports, records, or representation concerning the market conditions or the prices or sale of any livestock, meat, or live poultry.
(a) Except as provided in paragraph (b) of this section, whenever livestock or live poultry is bought, sold, acquired, paid, or settled on a weight basis, or whenever the weight of feed is a factor in determining payment or settlement to a livestock grower or poultry grower by a stockyard owner, market agency, dealer, packer, or live poultry dealer when livestock or poultry is produced under a growing arrangement, payment or settlement shall be on the basis of the actual weight of the livestock, live poultry, and/or feed shown on the scale ticket. If the actual weight used is not obtained on the date and at the place of transfer of possession, this information shall be disclosed with the date and location of the weighing on the accountings, bills, or statements issued. Any adjustment to the actual weight shall be fully and accurately explained on the accountings, bills, or statements issued, and records shall be maintained to support such adjustment.
(b) Whenever the weight of feed is a factor in determining payment or settlement to such livestock grower or poultry grower when the livestock or poultry is produced under a livestock or poultry growing arrangement, any feed that is picked up from or returned by a livestock grower or poultry grower must be weighed or its weight must be reasonably determined. When feed is picked up or returned and not weighed, the stockyard owner, market agency, dealer, packer, or live poultry dealer must document that the method used reasonably determines weight and is mutually acceptable to it and the livestock grower or poultry grower. The stockyard owner, market agency, dealer, packer, or live poultry dealer must document and account for the picked up or returned feed weight.
(a) Livestock to be sold openly at highest available bid. Every market agency engaged in the business of selling livestock on a commission or agency basis shall sell the livestock consigned to it openly, at the highest available bid, and in such a manner as to best promote the interest of each consignor.
(b) Purchases from consignment. No market agency engaged in the business of selling livestock on a commission basis shall purchase livestock from consignments, and no such market agency shall permit its owners, officers, agents, employees or any firm in which such market agency or its owners, officers, agents, or employees have an ownership or financial interest to purchase livestock consigned to such market agency, without first offering the livestock for sale in an open and competitive manner to other available buyers, and then only at a price higher than the highest available bid on such livestock.
(c) Key employees not to purchase livestock out of consignments. No market agency engaged in selling livestock on commission shall permit its auctioneers, weighmasters, or salesmen to purchase livestock out of consignment for any purpose for their own account, either directly or indirectly.
(d) Purchase from consignments; disclosure required. When a market agency purchases consigned livestock or sells consigned livestock to any owner, officer, agent, employee, or any business in which such market agency, owner, officer, agent, or employee has an ownership or financial interest, the market agency shall disclose on the account of sale the name of the buyer and the nature of the relationship existing between the market agency and the buyer.
(a) Market agencies selling on commission. No market agency selling consigned livestock shall enter into any agreement, relationship or association with dealers or other buyers which has a tendency to lessen the loyalty of the market agency to its consignors or impair the quality of the market agency's selling services. No market agency selling livestock on commission shall provide clearing services for any independent dealer who purchases livestock from consignment to such market agency without disclosing, on the account of sale to the consignor, the name of the buyer and the nature of the financial relationship between the buyer and the market agency.
(b) Market agencies buying on commission. No market agency purchasing livestock on commission shall enter into any agreement, relationship, or association with dealers or others which will impair the quality of the buying services furnished to its principals. No market agency purchasing livestock on commission shall, in filling orders, purchase livestock from a dealer whose operations it clears or finances without disclosing the relationship between the market agency and dealer to its principals on the accountings furnished to the principals.
No packer subject to the Act shall have an ownership interest in, finance, or participate in the management or operation of a market agency selling livestock on a commission basis, nor shall such a market agency permit a packer to have an ownership interest in, finance, or participate in the management or operation of such market agency.
No packer, dealer, or market agency, in connection with transactions subject to the provisions of the act, shall, in person, or through employed buyers, for the purpose of restricting or limiting competition, manipulating livestock prices, or controlling the movement of livestock, prior to, or during the conduct of, his buying operations: (a) Furnish competitor packers, dealers, market agencies, or their buyers or representatives, similarly engaged in buying livestock, with information concerning his proposed buying operations, such as the species, classes, volume of livestock to be purchased, or prices to be paid; or (b) furnish any other buying information to competitor buyers.
Each packer and dealer engaged in purchasing livestock, in person or through employed buyers, shall conduct his buying operations in competition with, and independently of, other packers and dealers similarly engaged.
(a) All scales used by stockyard owners, swine contractors, market agencies, dealers, packers, and live poultry dealers to weigh livestock, livestock carcasses, live poultry, or feed for the purposes of purchase, sale, acquisition, payment, or settlement shall be installed, maintained, and operated to ensure accurate weights. All electronic evaluation devices or systems for measuring the composition or quality constituents of live animals, livestock and poultry carcasses, and individual cuts of meat or a combination thereof for the purpose of determining value shall be installed, maintained, and operated to ensure accuracy. Such scales or electronic evaluation devices or systems shall meet applicable requirements contained in the General Code, Scales Code, Weights Code, and Electronic Livestock, Meat, and Poultry Evaluation Systems and/or Devices Code of the NIST Handbook 44. The 2013 edition of the National Institute of Standards and Technology (NIST) Handbook 44, “Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices” is hereby incorporated by reference and was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. These materials are incorporated as they exist on the date of approval and a notice of any change in these materials will be published in the
(b) All scales used by stockyard owners, swine contractors, market agencies, dealers, packers, and live poultry dealers to weigh livestock, livestock carcasses, live poultry, or feed for the purpose of purchase, sale, acquisition, payment, or settlement of livestock or live poultry and all scales used for the purchase, sale acquisition, payment, or settlement of livestock on a carcass weight basis shall be equipped with a printing device which shall record weight values on a scale ticket or other document.
(c) All vehicle scales used to weigh livestock, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock or live poultry shall be of sufficient length and capacity to weigh the entire vehicle as a unit: Provided, That a trailer may be uncoupled from the tractor and weighed as a single unit.
(d) No scales shall be operated or used by any stockyard owners, swine contractors, market agencies, dealers, packers, or live poultry dealers to weigh livestock, livestock carcasses, live poultry, or feed for the purposes of purchase, sale, acquisition, payment, or settlement of livestock, livestock carcasses or live poultry unless it has been found upon test and inspection, as specified in § 201.72, to be in a condition to give accurate weight. If a scale is inspected or tested and adjustments or replacements are made to a scale, it shall not be used until it has been inspected and tested and determined to meet all accuracy requirements specified in the regulations in this section.
(a) As a stockyard owner, swine contractor, market agency, dealer, packer, or live poultry dealer who weighs livestock, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock or live poultry, or who weighs livestock carcasses for the purpose of purchase on a carcass weight basis, or who furnishes scales for such purposes, you must have your scales tested by competent persons at least twice during each calendar year. You must complete the first of the two scale tests between January 1 and June 30 of the calendar year. The remaining scale test must be completed between July 1 and December 31 of the calendar year. You must have a minimum period of 120 days between these two tests. More frequent testing will be required in cases where the scale does not maintain accuracy between tests. Except that if scales are used on a limited seasonal basis (during any continuous 8-month period) for purposes of purchase, sale, acquisition, payment or settlement, the stockyard owner, swine contractor, market agency, dealer, live poultry dealer, or packer using such scales may use the scales within a 8-month period following each test.
(b) As a stockyard owner, swine contractor, market agency, dealer, packer, or live poultry dealer who weighs livestock, livestock carcasses, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock, livestock carcasses or live poultry, you must furnish reports of tests and inspections on forms approved by the Administrator. You must retain one copy of the test and inspection report for yourself, and file a second copy with the PSD regional office for the geographical region where the scale is located.
(c) When scales used for weighing livestock, livestock carcasses, live poultry, or feed are tested and inspected by a State agency, municipality, or other governmental subdivision, the forms used by such agency for reporting such scale tests and inspections may be accepted in lieu of the forms approved for this same purpose by the Administrator if the forms contain substantially the same information.
Stockyard owners, market agencies, dealers, packers, and live poultry dealers shall employ qualified persons to operate scales for weighing livestock, livestock carcasses, live poultry, or feed for the purposes of purchase, sale, acquisition, payment, or settlement of livestock, livestock carcasses, or live poultry, and they shall require such employees to operate the scales in accordance with the regulations in this part.
Stockyard operators, market agencies, dealers, and packers who operate scales on which livestock is weighed in purchase or sales transactions are responsible for the accurate weighing of such livestock. They shall supply copies of the instructions in this section to all persons who perform weighing operations for them and direct such person to familiarize themselves with the instructions and to comply with them at all times. This section shall also apply to any additional weighers who are employed at any time. Weighers must acknowledge their receipt of these instructions and agree to comply with them, by signing in duplicate, Form PSD 4000 provided by the Packers and Stockyards Division. One copy of the form is to be filed with a regional office of the Packers and Stockyards Division and the other retained by the agency employing the weighers.
(a) Balancing the empty scale. (1) The empty scale shall be balanced each day before weighing begins, and maintained in correct balance which weighing operations continue. The zero balance shall be verified at intervals of not more than 15 drafts or 15 minutes, whichever is completed first. In addition, the zero balance of the scale shall be verified whenever a weigher resumes weighing duties after an absence from the scale and also whenever a load exceeding half the scale capacity or 10,000 pounds (whichever is less) has been weighed and is followed by a load of less than 1,000 pounds, verification to occur before the weighing of the load of less than 1,000 pounds.
(2) The time at which the empty scale is balanced or its zero balance verified shall be recorded on scale tickets or other permanent records. Balance tickets must be filed with other scale tickets issued on that date.
(3) Before balancing the empty scale, the weigher shall assure himself that the scale gates are closed and that no persons or animals are on the scale platform or in contact with the stock rack, gates, or platform. If the scale is balanced with persons on the scale platform, the zero balance shall be verified whenever there is a change in such persons. When the scale is properly balanced and ready for weighing, the weigher shall so indicate by an appropriate signal.
(4) Weighbeam scales shall be balanced by first seating each poise securely in its zero notch and then moving the balance ball to such position that a correct zero balance is obtained. A scale equipped with a balance indicator is correctly balanced when the pointer comes to rest at zero. A scale not equipped with a balance indicator is correctly balanced if the weighbeam, when released at the top or bottom of the trig loop, swings freely in the trig loop in such manner that it will come to rest at the center of the trig loop.
(5) Dial scales shall be balanced by releasing all drop weights and operating the balance ball or other balancing device to obtain a correct zero balance. The indicator must visually indicate zero on the dial and the ticket printer must record a correct zero balance.
(6) Electronic digital scales should be properly warmed up before use. In most cases, it is advisable to leave the electric power on continuously. The zero load balance shall be verified by recording the zero balance on a scale ticket. The main indicating element and the remote visual weight display shall indicate zero when the balance is verified. The proper procedure for balancing this type of scale will vary according to the manufacturer. Refer to the operator's manual for specific instructions.
(b) Weighing the load. (1) Before weighing a draft of livestock, the weigher shall assure himself that the entire draft is on the scale platform with the gates closed and that no persons or animals off the scale are in contact with the platform, gates, or stock rack.
(i) On a weighbeam scale with a balance indicator, the weight of a draft shall be determined by seating the poises at such positions that the pointer will come to rest within the central target area or within
(ii) On a weighbeam scale without a balance indicator, the weight shall be determined by seating the poises at such positions that the weighbeam, when released from the top or bottom of the trig loop, will swing freely and come to rest at the approximate center of the trig loop.
(iii) On a dial scale, the weight is indicated automatically when the indicator moves around the dial face and comes to rest.
(iv) On an electronic digital scale, the weight of a draft is indicated automatically when the weight value indicated stabilized.
(2) The correct weight of a livestock draft is the value in pounds indicated when a correct load balance is obtained. The weigher should always concentrate his attention upon the beam tip, balance indicator or dial indicator while weighing and not concern himself with reading the visible weight indications until correct load balance is obtained. On electronic digital scales, the weigher should concentrate on the pulsing or flickering of weight values to assure that the unit indicates a stable weight before activating the print button.
(c) Recording the weight. (1) The weight of each draft shall be recorded immediately after the load balance is obtained and before any poises are moved or the load is removed from the scale platform. The weigher shall make certain that the printed weight record agrees with the weight value visually indicated when correct load balance is obtained. He shall also assure himself that the printed weight value is distinct and legible.
(2) The weight printing device on a scale shall be operated only to produce a printed or impressed record of the weight value while the livestock load is on the scale and correctly balanced. If the weight value is not printed clearly and correctly, the ticket shall be marked void and a new one printed before the livestock is removed from the scale.
(d) Scale tickets. (1) Scale tickets used to record the weight values of livestock in purchase or sales transactions shall be used, at any given scale, in the order of their consecutive serial numbers unless otherwise marked to show the order of their use. All tickets shall show the date of the weighing and the name or initials of the weigher performing the weighing service.
(2) No scale tickets shall be destroyed or otherwise disposed of because they are soiled, damaged, incorrectly executed, or voided. They shall be preserved and filed to comprise a complete serial number sequence.
(3) No scale ticket shall be used to record the weight of a livestock draft for “catch-weight,” inventory, transportation charge or other nonsale purposes unless the ticket is clearly marked to show why the weight was determined.
(4) When weight values are recorded by means of automatic recording equipment directly on the accounts of sale or other basic records, such record may serve in lieu of a scale ticket.
(e) Weigher's responsibilities. (1) The primary responsibility of a weigher is to determine and accurately record the weight of livestock drafts without prejudice or favor to any person or agency and without regard for livestock ownership, price, condition, fill, shrink, or other considerations. A weigher shall not permit the representations or attitudes of any persons or agencies to influence his judgment or action in performing his duties.
(2) Unused scale tickets, or those which are partially executed but without a printed weight value, shall not be left exposed or accessible to unauthorized personnel. All such tickets shall be kept under lock when the weigher is not at his duty station.
(3) Accurate weighing and correct weight recording require that a weigher shall not permit his operations to be hurried to the extent that inaccurate weights or incorrect weight records may result. Each draft of livestock must be weighed accurately to the nearest minimum weight value that can be indicated or recorded. Manual operations connected with balancing, weighing, and recording shall be performed with the care necessary to prevent damage to the accurately machined and adjusted parts of weighbeams, poises, and printing devices.
(4) Livestock owners, buyers, or others having legitimate interest in a livestock draft must be permitted to observe the balancing, weighing, and recording procedures, and a weigher shall not deny them that right or withhold from them any information pertaining to the weight of that draft. He shall check the zero balance of the scale or reweigh a draft of livestock when requested by such parties.
(f) Sensitivity control. (1) A scale must be sensitive in response to platform loading if it is to yield accurate weights. It, therefore, is the duty of a weigher to assure himself that interferences, weighbeam friction, or other factors do not impair sensitivity. He should satisfy himself, at least twice each day, that the scale is sufficiently sensitive, and if the following requirements are not met, he should report the facts to his superior or employer immediately.
(2) A weighbeam scale with a balance indicator is sufficiently sensitive if, when the scale is balanced with the pointer at the center of the target, movement of the fractional poise one graduation will change the indicator rest point
(3) A weighbeam scale without a balance indicator is sufficiently sensitive if, when the scale is balanced with the weighbeam at the center of the trig loop, movement of the fractional poise two graduations will cause the weighbeam to come to rest at the bottom of the trig loop.
(4) Adjustable damping devices are incorporated in balance indicators and in dial scales to absorb the effects of load impact and assist in bringing the indicator to rest. The weigher should be familiar with the location and adjustment of these damping devices and should keep them adjusted so that the pointer will oscillate freely through at least one complete cycle of movement before coming to rest at its original position.
(5) Friction at weighbeam bearings may reduce the sensitivity of the scale, cause sluggish weighbeam action and affect weighing accuracy. A weigher should inspect the weighbeam assembly daily to make certain that there is clearance between the weighbeam and the pivot bearings.
(6) Interferences or binding of the scale platform, stock rack, gates or other “live” parts of the scale are common causes of weighing inaccuracy. A weigher should satisfy himself, at the beginning of each weighing period, that all such “live” parts have sufficient clearance to prevent interferences.
(g) General precautions. (1) The poises of weighbeam scales are carefully adjusted and sealed to a definite weight at the factory and any change in that weight seriously affects weighing accuracy. A weigher, therefore, should be certain that poise parts do not become broken, loose or lost and that no material is added to a poise. Balancing or weighing shall not be performed while a scale ticket is in the slot of a weighbeam poise.
(2) Stops are provided on scale weighbeams to prevent movement of poises back of the zero graduation when balancing or weighing. When the stops become worn or broken and allow a poise to be set behind the zero position, this condition should be reported and corrected without delay.
(3) Foreign objects or loose material in the form of nuts, bolts, washers or other material on any part of the weighbeam assembly, including the counter-balance hanger or counter-balance weights, are potential sources of weighing error. Loose balancing material must be enclosed in the shot cup of the counter-balance hanger, and counter-balance weights must not be of the slotted type which can readily be removed.
(4) Whenever for any reason a weigher has reason to believe that a scale is not functioning properly or not yielding correct weight values, he shall discontinue weighing, report the facts to the parties responsible for scale maintenance, and request inspection, test, or repair of the scale.
(5) When a scale has been adjusted, modified, or repaired in any manner which may affect the accuracy of weighing or weight recording, the weigher shall not use the scale until it has been tested and inspected and found to be accurate.
(6) Count-off men, gate men, or others assigned to open or close scale gates or to drive livestock on or off the scale, shall perform those functions as directed by the weigher's signals or spoken instructions. They shall prevent persons or animals off the scale from being in contact with any part of the scale platform, stock rack, or gates while the scale is being balanced or used for weighing. They shall not open gates or remove livestock from the scale until directed by the weigher.
Stockyard owners, market agencies, dealers, packers, swine contractors and live poultry dealers must reweigh livestock, livestock carcasses, and live poultry or feed on request of any authorized representative of the Secretary.
No stockyard owner, packer, market agency, or dealer shall employ any person who has been suspended as a registrant to perform activities in connection with livestock transactions subject to the jurisdiction of the Secretary under the Act during the period of such suspension: Provided, That the provisions of this section shall not be construed to prohibit the employment of any person who has been suspended as a registrant until such time as the person demonstrates solvency or obtains the bond required under the Act and regulations. No such person shall be employed, however, until after the expiration of any specified period of suspension contained in the order of suspension.
(a) Each stockyard owner, market agency, dealer, packer, swine contractor and live poultry dealer must exercise reasonable care and promptness with respect to loading, transporting, holding, yarding, feeding, watering, weighing, or otherwise handling livestock, or live poultry to prevent waste of feed, shrinkage, injury, death or other avoidable loss.
(b) Whenever live poultry is obtained under a poultry growing arrangement and the weight of the live poultry is a factor in calculating payment to the grower, the poultry must be transported promptly after loading. The process of obtaining the gross weight must commence immediately upon arrival at the processing plant, holding yard, or other scale normally used for such purpose. The process of obtaining the gross weight which may include, but is not limited to, fueling, uncoupling the trailer, changing the road tractor to a yard tractor or weighing the trailer only, must be conducted without delay; specifically, the time period between arrival and completion of the process of obtaining the gross weight must not exceed thirty (30) minutes.
(c) Live poultry dealers must not place poultry from multiple growers on a single live poultry transport trailer or other live poultry transport equipment, creating what is commonly referred to as a “split load.”
(a) Application for authorization. Any department or agency or duly-organized livestock association of any State in which branding or marking of livestock as a means of establishing ownership prevails by custom or statute, which desires to obtain an authorization to charge and collect a fee for the inspection of brands, marks, and other identifying characteristics of livestock, as provided in section 317 of the Act, shall file with the Administrator an application in writing for such authorization. In case two or more applications for authorization to collect a fee for the inspection of brands, marks, and other identifying characteristics of livestock are received from the same State, a hearing will be held to determine which applicant is best qualified.
(b) Registration and filing of schedules. Upon the issuance of an authorization to an agency or an association, said agency or association shall register as a market agency in accordance with the provisions of § 201.10, except that no bond need be filed or maintained, and shall file a schedule of its rates and charges for performing the service in the manner and form prescribed by § 201.17.
(c) Reciprocal arrangements. Any authorized agency or association may make arrangements with an association or associations in the same or in another State, where branding or marking livestock prevails by custom or statute, to perform inspection service at stockyards on such terms and conditions as may be approved by the Administrator: Provided, That such arrangements will tend to further the purpose of the Act and will not result in duplication of charges or services.
(d) Maintenance of identity of consignments. All persons having custody at the stockyard of livestock subject to inspection shall preserve the identity of the consignment until inspection has been completed by the authorized inspection agency. Agencies authorized to conduct such inspection shall perform the work as soon after receipt of the livestock as practicable and as rapidly as is reasonably possible in order to prevent delay in marketing, shrinkage in weight, or other avoidable losses.
Each packer, swine contractor, live poultry dealer, stockyard owner, market agency, and dealer, upon proper request, shall give to the Secretary or his duly authorized representatives in writing or otherwise, and under oath or affirmation if requested by such representatives, any information concerning the business of the packer, swine contractor, live poultry dealer, stockyard owner, market agency, or dealer which may be required in order to carry out the provisions of the Act and regulations in this part within such reasonable time as may be specified in the request for such information.
Each stockyard owner, market agency, dealer, packer, swine contractor, and live poultry dealer, upon proper request, shall permit authorized representatives of the Secretary to enter its place of business during normal business hours and to examine records pertaining to its business subject to the Act, to make copies thereof and to inspect the facilities of such persons subject to the Act. Reasonable accommodations shall be made available to authorized representatives of the Secretary by the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer for such examination of records and inspection of facilities.
No agent or employee of the United States shall, without the consent of the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer concerned, divulge or make known in any manner, any facts or information regarding the business of such person acquired through any examination or inspection of the business or records of the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer, or through any information given by the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer pursuant to the Act and regulations, except to such other agents or employees of the United States as may be required to have such knowledge in the regular course of their official duties or except insofar as they may be directed by the Administrator or by a court of competent jurisdiction, or except as they may be otherwise required by law.
Every packer, live poultry dealer, stockyard owner, market agency, and dealer (except a packer buyer registered to purchase livestock for slaughter only) shall file annually with the Administration a report on prescribed forms not later than April 15 following the calendar year end or, if the records are kept on a fiscal year basis, not later than 90 days after the close of his fiscal year. The Administrator on good cause shown, or on his own motion, may grant a reasonable extension of the filing date or may waive the filing of such reports in particular cases.
No packer or dealer shall, in connection with the purchase of livestock in commerce, charge, demand, or collect from the seller of the livestock any compensation in the form of commission, yardage, or other service charge unless the charge is for services mandated by law or statute and is not inconsistent with the provisions of the Act.
(a) Each packer purchasing livestock on a carcass grade, carcass weight, or carcass grade and weight basis shall, prior to such purchase, make known to the seller, or to his duly authorized agent, the details of the purchase contract. Such details shall include, when applicable, expected date and place of slaughter, carcass price, condemnation terms, description of the carcass trim, grading to be used, accounting, and any special conditions.
(b) Each packer purchasing livestock on a carcass grade, carcass weight, or carcass grade and weight basis, shall maintain the identity of each seller's livestock and the carcasses therefrom and shall, after determination of the amount of the purchase price, transmit or deliver to the seller, or his duly authorized agent, a true written account of such purchase showing the number, weight, and price of the carcasses of each grade (identifying the grade) and of the ungraded carcasses, an explanation of any condemnations, and any other information affecting final accounting. Packers purchasing livestock on such a basis shall maintain sufficient records to substantiate the settlement of each transaction.
(c) When livestock are purchased by a packer on a carcass weight or carcass grade and weight basis, purchase and settlement therefor shall be on the basis of carcass price. This paragraph does not apply to purchases of livestock by a packer on a guaranteed yield basis.
(d) Settlement and final payment for livestock purchased by a packer on a carcass weight or carcass grade and weight basis shall be on actual hot weights. The hooks, rollers, gambrels or other similar equipment used at a packing establishment in connection with the weighing of carcasses of the same species of livestock shall be uniform in weight. The tare shall include only the weight of such equipment.
(e) Settlement and final payment for livestock purchased by a packer on a USDA carcass grade shall be on an official (final—not preliminary) grade. If settlement and final payment are based upon any grades other than official USDA grades, such other grades shall be set forth in detailed written specifications which shall be made available to the seller or his duly authorized agent. For purposes of settlement and final payment for livestock purchased on a grade or grade and weight basis, carcasses shall be final graded before the close of the second business day following the day the livestock are slaughtered.
(a) Poultry growing arrangement; timing of disclosure. A live poultry dealer who offers a poultry growing arrangement to a poultry grower must provide the poultry grower with a true written copy of the offered poultry growing arrangement on the date the dealer provides the poultry grower with poultry housing specifications.
(b) Right to discuss the terms of poultry growing arrangement offer. A live poultry dealer, notwithstanding any confidentiality provision in the poultry growing arrangement, may not prohibit a poultry grower or prospective poultry grower from discussing the terms of a poultry growing arrangement offer or, if applicable, the accompanying Live Poultry Dealer Disclosure Document described in § 201.102 (b) through (d) of this part with any of the following:
(1) A Federal or State agency.
(2) The grower's financial advisor or lender.
(3) The grower's legal advisor.
(4) An accounting services representative hired by the grower.
(5) Other growers for the same live poultry dealer.
(6) A member of the grower's immediate family or a business associate. A business associate is a person not employed by the grower, but with whom the grower has a valid business reason for consulting with when entering into or operating under a poultry growing arrangement.
(c) Contracts; contents. Each live poultry dealer that enters into a poultry growing arrangement with a poultry grower shall furnish the grower with a true written copy of the poultry growing arrangement, which shall clearly specify:
(1) The duration of the contract and conditions for the termination of the contract by each of the parties;
(2) All terms relating to the payment to be made to the poultry grower, including among others, where applicable, the following:
(i) The party liable for condemnations, including those resulting from plant errors;
(ii) The method for figuring feed conversion ratios;
(iii) The formula or method used to convert condemnations to live weight;
(iv) The per unit charges for feed and other inputs furnished by each party; and
(v) The factors to be used when grouping or ranking poultry growers; and
(3) Whether a performance improvement plan exists for that grower, and if so specify any performance improvement plan guidelines, including the following:
(i) The factors considered when placing a poultry grower on a performance improvement plan;
(ii) The guidance and support provided to a poultry grower while on a performance improvement plan; and
(iii) The factors considered to determine if and when a poultry grower is removed from the performance improvement plan and placed back in good standing, or when the poultry growing arrangement will be terminated.
(d) Settlement sheets; contents; supporting documents. Each live poultry dealer, who acquires poultry pursuant to a contract with a poultry grower, shall prepare a true and accurate settlement sheet (final accounting) and furnish a copy thereof to the poultry grower at the time of settlement. The settlement sheet shall contain all information necessary to compute the payment due the poultry grower. For all such arrangements in which the weight of birds affects payment, the settlement sheet shall show, among other things, the number of live birds marketed, the total weight and the average weight of the birds, and the payment per pound.
(e) Condemnation and grading certificates. Each live poultry dealer, who acquires poultry pursuant to a contract with a poultry grower which provides that official U.S. Department of Agriculture condemnations or grades, or both, are a consideration affecting payment to the grower, shall obtain an official U.S. Department of Agriculture condemnation or grading certificate, or both, for the poultry and furnish a copy thereof to the poultry grower prior to or at the time of settlement.
(f) Grouping or ranking sheets. Where the contract between the live poultry dealer and the poultry grower provides for payment to the poultry grower based upon a grouping or ranking of poultry growers delivering poultry during a specified period, the live poultry dealer shall furnish the poultry grower, at the time of settlement, a copy of a grouping or ranking sheet which shows the grower's precise position in the grouping or ranking sheet for that period. The grouping or ranking sheet need not show the names of other growers, but shall show the actual figures upon which the grouping or ranking is based for each grower grouped or ranked during the specified period.
(g) Live poultry purchases. Each live poultry dealer who purchases live poultry shall prepare and deliver a purchase invoice to the seller at time of settlement. The purchase invoice shall contain all information necessary to compute payment due the seller. When U.S. Department of Agriculture condemnations or U.S. Department of Agriculture grades, or both, of poultry purchased affect final payment, copies of official U.S. Department of Agriculture condemnation certificates or grading certificates, or both, shall be furnished to the seller at or prior to the time of settlement.
(h) Written termination notice; furnishing, contents. (1) A live poultry dealer that ends a poultry growing arrangement with a poultry grower due to a termination, non-renewal, or expiration and subsequent non-replacement of a poultry growing arrangement shall provide the poultry grower with a written termination notice at least 90 days prior to the termination of the poultry growing arrangement. Written notice issued to a poultry grower by a live poultry dealer regarding termination shall contain the following:
(i) The reason(s) for termination;
(ii) When the termination is effective; and
(iii) Appeal rights, if any, that a poultry grower may have with the live poultry dealer.
(2) A live poultry dealer's poultry growing arrangement with a poultry grower shall also provide the poultry grower with the opportunity to terminate its poultry growing arrangement in writing at least 90 days prior to the termination of the poultry growing arrangement.
(a) Obligation to furnish information and documents. In addition to the requirements of § 201.100 of this part, a live poultry dealer engaged in the production of broilers must provide the documents described in this section to the prospective or current broiler grower.
(1) Except as provided in paragraph (e) of this section, when a live poultry dealer seeks to renew, revise, or replace an existing broiler growing arrangement, or to establish a new broiler growing arrangement that does not contemplate modifications to the existing housing specifications, the live poultry dealer must provide the following documents at least 14 calendar days before the live poultry dealer executes the broiler growing arrangement (provided that the grower may waive up to 7 calendar days of that time period):
(i) A true, written copy of the renewed, revised, replacement, or new broiler growing arrangement.
(ii) The Live Poultry Dealer Disclosure Document, as described in paragraphs (b), (c), and (d) of this section.
(2) When a live poultry dealer seeks to enter a broiler growing arrangement with a broiler grower or prospective broiler grower that will require an original capital investment, the live poultry dealer must provide the following to the broiler grower or prospective broiler grower simultaneously with the housing specifications:
(i) A copy of the broiler growing arrangement that is affiliated with the current housing specifications.
(ii) The Live Poultry Dealer Disclosure Document, as described in paragraphs (b), (c), and (d) of this section.
(iii) A letter of intent that can be relied upon to obtain financing for the original capital investment.
(3) When a live poultry dealer seeks to offer or impose modifications to existing housing specifications that could reasonably require a broiler grower or prospective broiler grower to make an additional capital investment, the live poultry dealer must provide the following to the broiler grower or prospective broiler grower simultaneously with the modified housing specifications:
(i) A copy of the broiler growing arrangement that is affiliated with the modified housing specifications.
(ii) The Live Poultry Dealer Disclosure Document, as described in paragraphs (b), (c), and (d) of this section.
(iii) A letter of intent that can be relied upon to obtain financing for the additional capital investment.
(b) Prominent Disclosures. The Live Poultry Dealer Disclosure Document must include a cover page followed by the disclosures as required in paragraphs (c) and (d) of this section. The order, form, and content of the cover page shall be and include:
(1) The title “LIVE POULTRY DEALER DISCLOSURE DOCUMENT” in capital letters and bold type.
(2) The live poultry dealer's name, type of business organization, principal business address, telephone number, email address, and, if applicable, primary internet website address.
(3) The length of the term of the broiler growing arrangement.
(4) The following statement: “The income from your poultry farm may be significantly affected by the number of flocks the poultry company places on your farm each year, the density or number of birds placed with each flock, and the target weight at which poultry is caught. The poultry company may have full discretion and control over these and other factors. Please carefully review the information in this document.”
(5) The following minimums established under the terms of the broiler growing arrangement:
(i) The minimum number of placements on the broiler grower's farm annually.
(ii) The minimum stocking density for each flock to be placed on the broiler grower's farm.
(6) The applicable of the following two statements:
(i) “This disclosure document summarizes certain provisions of your broiler growing arrangement and other information. You have the right to read this disclosure document and all accompanying documents carefully. At least 14 calendar days before the live poultry dealer executes the broiler growing arrangement (provided that the grower may waive up to 7 calendar days of that time period), the poultry company is required to provide you with: (1) this disclosure document, and (2) a copy of the broiler growing arrangement.” or
(ii) “This disclosure document summarizes certain provisions of your broiler growing arrangement and other information. You have the right to read this disclosure document and all accompanying documents carefully. The live poultry dealer is required to provide this disclosure document to you simultaneously with (a) a copy of the broiler growing arrangement, (b) any new or modified housing specifications that would require you to make an original or additional capital investment, and (c) a letter of intent.”
(7) The following statement: “Even if the broiler growing arrangement contains a confidentiality provision, by law you still retain the right to discuss the terms of the broiler growing arrangement and the Live Poultry Dealer Disclosure Document with a Federal or State agency, your financial advisor or lender, your legal advisor, your accounting services representative, other growers for the same live poultry dealer, and your immediate family or business associates. A business associate is a person not employed by you but with whom you have a valid business reason for consulting when entering into or operating under a broiler growing arrangement.”
(8) The following statement in bold type: “Note that USDA has not verified the information contained in this document. If this disclosure by the live poultry dealer contains any false or misleading statement or a material omission, a violation of Federal and/or State law may have occurred.”
(c) Required disclosures following the cover page. The live poultry dealer shall disclose, in the Live Poultry Dealer Disclosure Document following the cover page, the following information:
(1) A summary of litigation over the prior 5 years between the live poultry dealer and any broiler grower, including the nature of the litigation, its location, the initiating party, a brief description of the controversy, and any resolution.
(2) A summary of all bankruptcy filings in the prior 5 years by the live poultry dealer and any parent, subsidiary, or related entity of the live poultry dealer.
(3) A statement that describes the live poultry dealer's policies and procedures regarding the potential sale of the broiler grower's facility or assignment of the broiler growing arrangement to another party, including the circumstances under which the live poultry dealer will offer the successive buyer a broiler growing arrangement.
(4) A statement describing the live poultry dealer's policies and procedures, as well as any appeal rights arising from the following events described in paragraphs (c)(4)(i) through (c)(4)(vi) of this section. If no policy or procedure exists, the live poultry dealer will acknowledge “no policy exists” relating to the items in paragraphs (c)(4)(i) through (c)(4)(vi) of this section.
(i) Increased lay-out time.
(ii) Sick, diseased, and high early-mortality flocks.
(iii) Natural disasters, weather events, or other events adversely affecting the physical infrastructure of the local complex or the grower facility.
(iv) Other events potentially resulting in massive depopulation of flocks, affecting grower payments.
(v) Feed outages, including outage times.
(vi) Grower complaints relating to feed quality, formulation, or suitability.
(5) A table showing the average annual broiler grower turnover rates for the previous calendar year and the average of the 5 previous calendar years at a company level and at a local complex level.
(d) Financial Disclosures. The live poultry dealer must include in the Live Poultry Dealer Disclosure Document the following information:
(1) Tables showing average annual gross payments to broiler growers at the local complex for each of the 5 previous years. The tables must express average payments in U.S. dollars per farm facility square foot. The tables must be organized to present the following elements:
(i) Year.
(ii) Housing specification tier (lowest to highest).
(iii) Distribution of payments, specifically either—
(A) Quintile (lowest to highest), for a local complex comprising 10 or more growers, or
(B) Mean and one standard deviation from the mean, for a local complex comprising 9 or fewer growers.
(2) If poultry housing specifications for broiler growers under contract with the complex are modified such that an additional capital investment may be required, or if the 5-year averages provided under paragraph (d)(1) of this section do not accurately represent projected grower gross annual payments under the terms of the applicable broiler growing arrangement for any reason, the live poultry dealer must provide the following information:
(i) Tables providing projections of average annual gross payments to broiler growers under contract with the complex with the same housing specifications for the term of the broiler growing arrangement at five quintile levels or by mean and standard deviation expressed as dollars per farm facility square foot.
(ii) An explanation of why the annual gross payment averages for the previous 5 years, as provided under paragraph (d)(1) of this section, do not provide an accurate representation of projected future payments, including the basic assumptions underlying the projections provided under paragraph (d)(2)(i) of this section.
(3) A summary of information the live poultry dealer collects or maintains relating to grower variable costs inherent in broiler production.
(4) Current contact information for the State university extension service office or the county farm advisor's office that can provide relevant information about broiler grower costs and broiler farm financial management in the broiler grower's geographic area.
(e) Small Live Poultry Dealer Financial Disclosures. A live poultry dealer engaged in the production of broilers is exempt from the requirements in paragraph (a)(1) of this section if the live poultry dealer, together with all companies controlled by or under common control with the live poultry dealer, slaughters fewer than 2 million live pounds of broilers weekly (104 million pounds annually).
(f) Governance and Certification. (1) The live poultry dealer engaged in the production of broilers must establish, maintain, and enforce a governance framework that is reasonably designed to:
(i) Audit the accuracy and completeness of the disclosures required under paragraphs (a) through (d) of this section.
(ii) Ensure compliance with all obligations under the Packers and Stockyards Act and regulations thereunder.
(2) The principal executive officer or officers, or persons performing similar functions, must certify in the Live Poultry Dealer Disclosure Document that the live poultry dealer has established, maintains, and enforces the governance framework and that, based on the officer's knowledge, the Live Poultry Dealer Disclosure Document does not contain any untrue statement of a material fact or omit to state a material fact which would render it misleading.
(g) Receipt by Growers. (1) The Live Poultry Dealer Disclosure Document must include a broiler grower's signature page that contains the following statement: “If the live poultry dealer does not deliver this disclosure document within the timeframe specified herein, or if this disclosure document contains any false or misleading statement or a material omission (including any discrepancy with other oral or written statements made in connection with the broiler growing arrangement), a violation of Federal and State law may have occurred. Violations of Federal and State laws may be determined to be unfair, unjustly discriminatory, or deceptive and unlawful under the Packers and Stockyards Act, as amended. You may file a complaint at farmerfairness.gov or call 1-833-DIAL-PSD (1-833-342-5773) if you suspect a violation of the Packers and Stockyards Act or any other Federal law governing fair and competitive marketing, including contract growing, of livestock and poultry. Additional information on rights and responsibilities under the Packers and Stockyards Act may be found at www.ams.usda.gov.”
(2) The live poultry dealer must obtain the broiler grower's or prospective broiler grower's dated signature on the broiler grower's signature page in paragraph (g)(1) of this section as evidence of receipt or obtain alternative documentation to evidence delivery and that best efforts were used to obtain grower receipt. The live poultry dealer must provide a copy of the dated signature page or alternative documentation to the broiler grower or prospective broiler grower and must retain a copy of the dated signature page or alternative documentation in the dealer's records for 3 years following expiration, termination, or non-renewal of the broiler growing arrangement.
(3) Information in the Live Poultry Dealer Disclosure Document must be presented in a clear, concise, and understandable manner for growers. Live poultry dealers may refer to Form PSD 6100 for further instructions on the presentation of information and certain calculations.
(4) The live poultry dealer must make reasonable efforts to ensure that growers are aware of their right to request translation assistance, and to assist the grower in translating the Disclosure Document at least 14 calendar days before the live poultry dealer executes the broiler growing arrangement that does not contemplate modifications to the existing housing specifications (provided that the grower may waive up to 7 calendar days of that time period) or where modifications to the existing housing specifications are contemplated when the live poultry dealer provides the grower with the Disclosure Document. Reasonable efforts include but are not limited to providing current contact information for professional translation service providers, trade associations with translator resources, relevant community groups, or any other person or organization that provides translation services in the broiler grower's geographic area. A live poultry dealer may not restrict a broiler grower or prospective broiler grower from discussing or sharing the Disclosure Document for purposes of translation with a person or organization that provides language translation services.
(h) Contract terms. A live poultry dealer engaged in the production of broilers must specify in the true written copy of the broiler growing arrangement the following:
(1) The minimum number of placements of poultry at the broiler grower's facility annually.
(2) The minimum stocking density for each flock placed with the broiler grower under the broiler growing arrangement.
(a) Poultry grower ranking system records. If a live poultry dealer engaged in the production of broilers uses a poultry grower ranking system to calculate broiler grower payments, the live poultry dealer must produce records in accordance with paragraphs (b) and (c) of this section. The live poultry dealer must maintain these records for 5 years.
(b) Placement Disclosure. Within 24 hours of flock delivery to a broiler grower's facility, the live poultry dealer must provide all the following information to the broiler grower regarding the placement:
(1) The stocking density of the placement.
(2) Names and all ratios of breeds of the poultry delivered.
(3) If the live poultry dealer has determined the sex of the birds, all ratios of male and female poultry delivered.
(4) The breeder facility identifier.
(5) The breeder flock age.
(6) Information regarding any known health impairments of the breeder flock or of the poultry delivered.
(7) Adjustments, if any, that the live poultry dealer may make to the calculation of the grower's pay based on the inputs in paragraphs (b)(1) through (b)(6) of this section.
(c) Poultry grower ranking system settlement documents. In addition to the requirements of § 201.100 of this part, a live poultry dealer must provide disclosures to all broiler growers on the grouping or ranking sheets as described in paragraphs (c)(1) and (c)(2) of this section. The disclosures need not show the names of other growers.
(1) Live poultry dealers must disclose the housing specification for each broiler grower grouped or ranked during the specified period.
(2) Live poultry dealers must disclose all the following information to each broiler grower participant ranked under a poultry grower ranking system:
(i) The stocking density for each placement in the ranking.
(ii) The names and all ratios of breeds of the poultry for each placement in the ranking.
(iii) If the live poultry dealer has determined the sex of the birds, all ratios of male and female poultry for each placement in the ranking.
(iv) All breeder facility identifiers for each placement in the ranking.
(v) The breeder flock age(s) for each placement in the ranking.
(vi) The number of feed disruptions each ranked broiler grower endured during the growout period where the grower was completely out of feed for 12 hours or more.
Live poultry dealers who operate scales on which live poultry or feed is weighed for purposes of purchase, sale, acquisition, or settlement are responsible for the accurate weighing of such poultry or feed. They shall supply copies of the instructions in this section to all persons who perform weighing operations for them and direct such persons to familiarize themselves with the instructions and to comply with them at all times. This section shall also apply to any additional weighers who are employed at any time. Weighers must acknowledge their receipt of these instructions and agree to comply with them by signing in duplicate, a form provided by the Packers and Stockyards Division, Agricultural Marketing Service. One copy of this form is to be filed with a regional office of the Packers and Stockyards Division, Agricultural Marketing Service and the other copy retained by the Agency employing the weighers. The following instructions shall be applicable to the weighing of live poultry on all scales, except that paragraph (c)(1) of this section is only applicable to the weighing of live poultry on vehicle scales.
(a) Balancing the empty scale. (1) The scale must be maintained in zero balance at all times. The empty scale must be balanced each day before weighing begins and thereafter the scale must be balanced; and the zero balance, the time and date the empty scale was balanced must be mechanically printed on the scale ticket or other basic transaction record before any poultry or feed is weighed. In addition, the zero balance of the scale must be verified whenever a weigher resumes weighing duties after an absence from the scale.
(2) Before balancing the empty scale, the weigher shall notify parties outside the scale house of his/her intention and shall be assured that no persons or vehicles are in contact with the platform. When the empty scale is balanced and ready for weighing, the weigher shall so indicate by appropriate signal.
(3) Weighbeam scales shall be balanced by first seating each poise securely in its zero notch and then moving the balance ball to such position that a correct zero balance is obtained. A scale equipped with a balance indicator is correctly balanced when the indicator comes to rest in the center of the target area. A scale not equipped with a balance indicator is correctly balanced if the weighbeam, when released at the top or bottom of the trig loop, swings freely in the trig loop in such manner that it will come to rest at the center of the trig loop.
(4) Dial scales shall be balanced by releasing all drop weights and operating the balance ball or other balancing device to obtain a correct zero balance. The indicator must visibly indicate zero on the dial reading face and the ticket printer must record a correct zero balance. “Balance tickets” shall be filed with other scale tickets issued on that date.
(5) Electronic digital scales should be properly warmed up before use. In most cases it is advisable to leave the electric power on continuously. The zero balance shall be verified by recording the zero balance on a scale ticket. The main indicating element and the remote visual weight display shall indicate zero when the balance is verified. The proper procedure for balancing this type of scale will vary according to the manufacturer. Refer to the operator's manual for specific instructions.
(6) A balance ball or other balancing device shall be operated only when balancing the empty scale and shall not be operated at any time or for any other purpose.
(b) Sensitivity control. (1) A scale must be sensitive in response to platform loading if it is to yield accurate weights. It, therefore, is the duty of a weigher to assure himself that interferences, weighbeam friction, or other factors do not impair sensitivity. He shall satisfy himself, at least twice each day, that the scale is sufficiently sensitive, and, if the following requirements are not met, he must report the facts to his superior or employer immediately.
(2) A weighbeam scale with a balance indicator is sufficiently sensitive if, when the scale is balanced with the indicator at the center of the target, movement of the fractional poise one graduation will change the indicator rest point (
(3) A weighbeam scale without a balance indicator is sufficiently sensitive if, when the scale is balanced with the weighbeam at the center of the trig loop, movement of the fractional poise two graduations will cause the weighbeam to come to rest at the bottom of the trig loop.
(4) Adjustable damping devices are incorporated in balance indicators and in dial scales to absorb the effects of load impact and to bring the indicator to rest. The weigher must be familiar with the location and adjustment of these damping devices and keep them so adjusted that when the indicator is displaced from a position of rest, it will oscillate freely through at least one complete cycle of movement before coming to rest at its original position.
(5) Friction at weighbeam bearings may reduce the sensitiveness of the scale, cause sluggish weighbeam action and affect weighing accuracy. A weigher must inspect the weighbeam assembly daily to make certain that there is clearance between the weighbeam and the pivot bearings.
(6) Interferences or binding of the scale platform, or other “live” parts of the scale, are common causes of weighing inaccuracy. A weigher shall satisfy himself, at the beginning of each weighing period, that all such “live” parts have sufficient clearance to prevent interference.
(c) Weighing the load. (1) Vehicle scales used to weigh live poultry shall be of sufficient length and capacity to weigh an entire vehicle as a unit; provided, that a trailer may be uncoupled from a tractor and weighed as a single unit. Before weighing a vehicle, either coupled or uncoupled, the weigher shall be assured that the entire vehicle is on the scale platform and that no persons are on the scale platform.
(i) On a weighbeam scale with a balance indicator the weight of a vehicle shall be determined by moving the poises to such positions that the indicator will come to rest within the central target area.
(ii) On a weighbeam scale without a balance indicator the weight shall be determined by moving the poises to such positions that the weighbeam, when released from the top or bottom of the trig loop, will swing freely in the trig loop and come to rest at the approximate center of the trig loop.
(iii) On a dial scale the weight of a vehicle is indicated automatically when the indicator revolves around the dial face and comes to rest.
(iv) On an electronic digital scale the weight of a vehicle is indicated automatically when the weight value indicated is stable.
(v) A feed hopper attached to an electronic digital scale must be empty of feed and the electronic digital scale must be balanced at zero prior to first weighment for each grower or per truckload, whichever is applicable. The date and time that the empty hopper scale is balanced with proof of the zero balance must be mechanically printed on the scale ticket or other permanent record that must be attached to the grower's copy of the scale ticket.
(vi) An onboard weighing system must be level and locked in position and zero balanced prior to weighing. The date and time the onboard scale is balanced with proof of the zero balance must be mechanically printed on the scale ticket or other permanent record that must be attached to the grower's copy of the scale ticket. When more than one grower's feed is weighed, the preceding grower's gross weight can be used for the next grower's tare weight, and can be repeated until the unit is full.
(2) The correct weight is the value in pounds indicated by a weighbeam, dial or digital scale when a stable load balance is obtained. In any case, the weigher should concentrate on the beam tip, balance indicator, dial or digital indicator while weighing and not be concerned with reading the visible weight indications until a stable load balance is obtained. On electronic digital scales, the weigher should concentrate on the pulsing or flickering of weight values to assure that the unit indicates a stable weight before activating the print button.
(d) Recording the weight. (1) The gross or tare weight shall be recorded immediately after the load balance is obtained and before any poises are moved or load removed from the scale platform. The weigher shall make certain that the printed weight record agrees with the weight value visibly indicated on the weighbeam, dial or digital indicator when correct load balance is obtained. The weigher shall also assure that the printed weight value is sufficiently distinct and legible.
(2) The weight printing device on a scale shall be operated only to produce a printed or impressed record of the weight while the load is on the scale and correctly balanced. If the weight is not printed clearly and correctly, the ticket shall be marked void and a new one printed before the load is removed from the scale.
(3) When returned feed from a contract poultry grower is picked up and weighed on an onboard weighing system, the weight of the feed must be recorded and a ticket printed. That weight must be used as the tare weight when feed from another contract poultry grower is picked up on the same load. The procedure must be followed each time another grower's feed is added to the load.
(e) Weigher's responsibilities. (1) The primary responsibility of a weigher is to determine and record the true weight of live poultry without prejudice or favor to any person or agency and without regard for poultry ownership, price, condition, shrink, or other considerations. A weigher shall not permit the representations or attitudes of any persons or agencies to influence their judgment or action in performing his/her duties.
(2) Accurate weighing and weight recording require that a weigher shall not permit operations to be hurried to the extent that inaccurate weights or incorrect weight records may result. The gross, tare and net weights must be determined accurately to the nearest minimum graduation. Manual operations connected with balancing, weighing, and recording shall be performed with the care necessary to prevent damage to the accurately machined and adjusted parts of weighbeams, poises, and printing devices. Rough handling of these parts shall be avoided.
(3) Poultry growers, live poultry dealers, sellers, or others having legitimate interest in a load of poultry are entitled to observe the balancing, weighing, and recording procedures. A weigher shall not deny such persons that right or withhold from them any information pertaining to the weight. The weigher shall check the zero balance of the scale or reweigh a load of poultry when requested by such parties or duly authorized representatives of the administrator.
(f) General precautions. (1) The poises of weighbeam scales are carefully adjusted and sealed to a definite weight at the factory and any change in that weight seriously affects weighing accuracy. A weigher, therefore, shall observe if poise parts are broken, loose or lost or if material is added to a poise and shall report any such condition to his/her superior or employer. Balancing or weighing shall not be performed while a scale ticket is in the slot of a weighbeam poise.
(2) Stops are provided on scale weighbeams to prevent movement of poises back of the zero graduation when balancing or weighing. When the stops become worn or broken and allow a poise to be set behind the zero position, this condition must be reported by the weigher to their superior or employer and corrected without delay.
(3) Motion detection circuits are a part of electronic scales. They are designed to prevent the printing of weight values if the load has not stabilized within prescribed limits. The weighmaster's duty is to print the actual weight of the load within these limits. This requires printing the actual weight of the load, not one of the other weights that may be within the motion detection limits.
(4) Foreign objects or loose material in the form of nuts, bolts, washers, or other material on any part of the weighbeam assembly, including the counter-balance hanger or counter-balance weights, are potential sources of weighing error. Loose balancing material must be enclosed in the shot cup of the counter-balance hanger and counter-balance weights must not be of the slotted type which can readily be removed.
(5) Whenever, for any reason, a weigher has reason to believe that a scale is not functioning properly or not yielding correct weight values, the weigher shall discontinue weighing, report the facts to the parties responsible for scale maintenance and request inspection, test or repair of the scale.
(6) When a scale has been adjusted, modified, or repaired in any manner which can affect the accuracy of weighing or weight recording, the weigher shall not use the scale until it has been tested and inspected and found to be accurate.
(a) No packer whose average annual purchases of livestock exceed $500,000 shall purchase livestock on credit, and no dealer or market agency acting as an agent for such a packer shall purchase livestock on credit, unless: (1) Before purchasing such livestock the packer obtains from the seller a written acknowledgment as follows:
On this date I am entering into a written agreement for the sale of livestock on credit to ________________, a packer, and I understand that in doing so I will have no rights under the trust provisions of section 206 of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 196, Pub. L. 94-410), with respect to any such credit sale. The written agreement for such selling on credit
(2) Such packer retains such acknowledgment, together with all other documents, if any, setting forth the terms of such credit sales on which the purchaser and seller have agreed, and such dealer or market agency retains a copy thereof, in his records for such time as is required by any law, or by written notice served on such person by the Administrator, but not less than two calendar years from the date of expiration of the written agreement referred to in such acknowledgment; and
(3) Such seller receives a copy of such acknowledgment.
(b) No dealer whose average annual purchases of livestock exceed $100,000 shall purchase livestock on credit unless:
(1) Before purchasing livestock on credit, the dealer obtains from the seller a written acknowledgement that includes the information described in this paragraph (b)(1).
(i) The following statement:
On this date I am entering into a written agreement for the sale of livestock on credit to ___, a dealer, and I understand that in doing so I will have no rights under the trust provisions of section 318 of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 217b), with respect to any such credit sale.
(ii) A statement about whether the credit sales agreement covers a single sale; covers multiple sales and remains in effect through a certain date and states the date; or remains in effect until canceled in writing by either party.
(iii) The date the seller signed the agreement.
(iv) The seller's signature.
(2) The dealer retains the written acknowledgment, together with all other documents, if any, setting forth the terms of credit sales on which the purchaser and seller have agreed, and the dealer retains a copy thereof, in their records for such time as is required by any law, or by written notice served on the dealer by the Administrator, but not less than two calendar years from the date of expiration of the written agreement referred to in the acknowledgment.
(3) The dealer provides a copy of the acknowledgment to the seller.
(c) Purchasing livestock for which payment is to be made by a draft which is not a check shall constitute purchasing such livestock on credit within the meaning of paragraphs (a) and (b) of this section. (See also § 201.43(b)(1).)
(d) The provisions of this section shall not be construed to permit any transaction prohibited by § 201.61(a) relating to financing by market agencies selling on a commission basis.
The Secretary will consider the following criteria, and may consider additional criteria, when determining whether a packer, swine contractor, or live poultry dealer has made or given any undue or unreasonable preference or advantage to any particular person or locality in any respect in violation of section 202(b) of the Act. The criteria include whether the preference or advantage under consideration:
(a) Cannot be justified on the basis of a cost savings related to dealing with different producers, sellers, or growers;
(b) Cannot be justified on the basis of meeting a competitor's prices;
(c) Cannot be justified on the basis of meeting other terms offered by a competitor; and
(d) Cannot be justified as a reasonable business decision.
The Secretary may consider various criteria when determining whether or not reasonable notice has been given by a live poultry dealer to a poultry grower for suspension of delivery of birds. These criteria include, but are not limited to:
(a) Whether the written notice adequately states the reason for the suspension of delivery, the length of the suspension of delivery, and the anticipated date the delivery of birds will resume; and
(b) Whether a catastrophic or natural disaster, or other emergency, such as an unforeseen bankruptcy, has occurred that has prevented a live poultry dealer from providing reasonable notice.
The Secretary may consider various criteria in determining whether a requirement that a poultry grower or swine production contract grower make additional capital investments over the life of a production contract or growing arrangement constitutes a violation of the Act. These criteria include, but are not limited to:
(a) Whether a packer, swine contractor or live poultry dealer failed to give a poultry grower or swine production contract grower discretion to decide against the additional capital investment requirement;
(b) Whether the additional capital investment is the result of coercion, retaliation or threats of coercion or retaliation by the packer, swine contractor or live poultry dealer;
(c) Whether the packer, swine contractor or live poultry dealer intends or does substantially reduce or end operations at the slaughter plant or processing facility or intends or does substantially reduce or end production operations within 12 months of requiring the additional capital investment, absent the occurrence of a catastrophic or natural disaster, or other emergency, such as unforeseen bankruptcy;
(d) Whether the packer, swine contractor, or live poultry dealer required some poultry growers or swine production contract growers to make additional capital investments, but did not require other similarly situated poultry growers or swine production contract growers to make the same additional capital investments;
(e) The age and number of recent upgrades to, or capital investments in, the poultry grower's or swine production contract grower's operations;
(f) Whether the cost of the required additional capital investments can reasonably be expected to be recouped by the poultry grower or swine production contract grower;
(g) Whether a reasonable time period to implement the required additional capital investments is provided to the poultry grower or swine production contract grower; and
(h) Whether equipment changes are required with respect to equipment previously approved and accepted by the packer, swine contractor, or live poultry dealer, if existing equipment is functioning as it was intended to function unless the packer, swine contractor, or live poultry dealer provides adequate compensation incentives to the poultry grower or swine production contract grower.
The Secretary may consider various criteria when determining whether a packer, swine contractor or live poultry dealer has provided a poultry grower or swine production contract grower a reasonable period of time to remedy a breach of contract that could lead to contract termination. These criteria do not limit a packer, swine contractor or live poultry dealer's rights under a contract or agreement where food safety or animal welfare is concerned. These criteria, include, but are not limited to:
(a) Whether the packer, swine contractor or live poultry dealer provided written notice of the breach of contract to the poultry grower or swine production contract grower upon initial discovery of that breach of contract if the packer, swine contractor or live poultry dealer intends to take an adverse action, including termination of a contract, against the poultry grower or swine production contract grower based on that breach of contract by the poultry grower or swine production contract grower;
(b) Whether the notice in paragraph (a) of this section includes the following:
(1) A description of the act or omission believed to constitute a breach of contract, including identification of the section of the contract believed to have been breached;
(2) The date of the breach;
(3) The means by which the poultry grower or swine production contract grower can satisfactorily remedy the breach, if possible, based on the nature of the breach; and
(4) A date that provides a reasonable time, based on the nature of the breach, by which the breach must be remedied.
(c) Whether the packer, swine contractor or live poultry dealer took into account the poultry grower's or swine production contract grower's ongoing responsibilities related to the raising and handling of the poultry or swine under their care when establishing the date by which a breach should be remedied; and
(d) Whether the poultry grower or swine production contract grower was afforded adequate time from the date of the notice of the alleged breach to rebut the allegation of a breach.
(a) In any livestock or poultry production contract that requires the use of arbitration the following language must appear on the signature page of the contract in bold conspicuous print: “Right to Decline Arbitration. A poultry grower, livestock producer or swine production contract grower has the right to decline to be bound by the arbitration provisions set forth in this agreement. A poultry grower, livestock producer or swine production contract grower shall indicate whether or not it desires to be bound by the arbitration provisions by signing one of the following statements; failure to choose an option will be treated as if the poultry grower, livestock producer or swine production contract grower declined to be bound by the arbitration provisions set forth in this Agreement:
I decline to be bound by the arbitration provisions set forth in this Agreement __________________________
I accept the arbitration provisions as set forth in this Agreement________________________”
(b) The Secretary may consider various criteria when determining whether the arbitration process provided in a production contract provides a meaningful opportunity for the poultry grower, livestock producer, or swine production contract grower to participate fully in the arbitration process. These criteria include, but are not limited to:
(1) Whether the contract discloses sufficient information in bold, conspicuous print describing all the costs of arbitration to be paid by the poultry grower, swine production contract grower, or livestock producer, and the arbitration process and any limitations on legal rights and remedies in such a manner as to allow the poultry grower, livestock producer or swine contract production grower to make an informed decision on whether to elect arbitration for dispute resolution;
(2) Whether provisions in the entire arbitration process governing the costs and time limits are reasonable;
(3) Whether the poultry grower, livestock producer, or swine production contract grower is provided access to and opportunity to engage in reasonable discovery of information held by the packer, swine contractor or live poultry dealer;
(4) Whether arbitration is required to be used to resolve only disputes relevant to the contractual obligations of the parties; and
(5) Whether a reasoned, written opinion based on applicable law, legal principles and precedent for the award is required to be provided to the parties.
For purposes of this subpart, the following definitions apply:
Covered producer means a livestock producer as defined in this section or a swine production contract grower or poultry grower as defined in section 2(a) of the Act (7 U.S.C. 182(8), (14)).
Livestock producer means any person, except an employee of the livestock owner, engaged in the raising of and caring for livestock.
Regulated entity means a swine contractor or live poultry dealer as defined in section 2(a) of the Act (7 U.S.C. 182(8)) or a packer as defined in section 201 of the Act (7 U.S.C. 191).
(a) Prohibited bases. (1) Except as provided in paragraph (a)(3) of this section, a regulated entity may not prejudice, disadvantage, inhibit market access, or otherwise take an adverse action against a covered producer with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry based upon the following characteristics:
(i) On the basis of the covered producer's race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age.
(ii) On the basis of the covered producer's status as a cooperative.
(2) Actions that prejudice, disadvantage, inhibit market access, or are otherwise adverse under paragraph (a)(1) of this section are as follows:
(i) Offering contract terms that are less favorable than those generally or ordinarily offered to similarly situated covered producers.
(ii) Refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers.
(iii) Performing under or enforcing a contract differently than with similarly situated covered producers.
(iv) Requiring a contract modification or renewal on terms less favorable than similarly situated covered producers.
(v) Terminating or not renewing a contract.
(vi) Any other action that a reasonable covered producer would find materially adverse.
(3) The following actions by a regulated entity do not prejudice, disadvantage, inhibit market access, or constitute adverse action under paragraph (a)(1) of this section:
(i) Fulfilling a religious commitment relating to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry.
(ii) A Federally recognized Tribe, including its wholly or majority-owned entities, corporations, or Tribal organizations, performing its Tribal governmental functions.
(b) Retaliation prohibited. (1) A regulated entity may not retaliate or otherwise take an adverse action against a covered producer based upon the covered producer's participation in an activity described in paragraph (b)(2) of this section.
(2) The following activities by covered producers are protected under paragraph (b)(1) of this section unless otherwise prohibited by Federal, Tribal, or State law, including antitrust laws:
(i) Communicating with a government entity or official or petitioning a government entity or official for redress of grievances with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry.
(ii) Refusing a request of the regulated entity to engage in a communication with a government entity or official that is not required by law.
(iii) Asserting the right to form or join, or to refuse to form or join, a producer or grower association or organization, or cooperative or to collectively process, prepare for market, handle, or market livestock or poultry.
(iv) Communicating or cooperating with a person for the purposes of improving production or marketing of livestock or poultry.
(v) Communicating, negotiating, or contracting with a regulated entity, another covered producer, or with a commercial entity or consultant, for the purpose of exploring or entering into a business relationship.
(vi) Supporting or participating as a witness in any proceeding under the Act, or any proceeding that relates to an alleged violation of any law by a regulated entity.
(vii) Asserting any of the rights granted under Act or this part, or asserting contract rights.
(3) The following actions are considered retaliation or an otherwise adverse action under paragraph (b)(1) of this section:
(i) Terminating or not renewing a contract.
(ii) Performing under or enforcing a contract differently than with similarly situated covered producers.
(iii) Requiring a contract modification or a renewal on terms less favorable than similarly situated covered producers.
(iv) Refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers.
(v) Interfering in a farm real estate transaction or a contract with third parties.
(vi) Any other action that a reasonable covered producer would find materially adverse.
(c) Recordkeeping of compliance practices. (1) The regulated entity shall retain all records relevant to its compliance with paragraphs (a) and (b) of this section for no less than 5 years from the date of record creation.
(2) Relevant records to paragraph (c)(1) of this section may include: policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and the number and nature of complaints received relevant to this section.
(a) Prohibited practices. A regulated entity may not engage in the deceptive practices in paragraphs (b) through (e) of this section with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry.
(b) Contract formation. A regulated entity may not make or modify a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading.
(c) Contract performance. A regulated entity may not perform under or enforce a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading.
(d) Contract termination. A regulated entity may not terminate a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading.
(e) Contract refusal. A regulated entity may not provide false or misleading information to a covered producer or association of covered producers concerning a refusal to contract.
If any provision of this subpart, or any component of any provision, is declared invalid or the applicability thereof to any person or circumstances is held invalid, it is the Agricultural Marketing Service's intention that the validity of the remainder of this subpart or the applicability thereof to other persons or circumstances shall not be affected thereby with the remaining provision, or component of any provision, to continue in effect.
The Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes, 7 CFR part 1, subpart H, are applicable to all rate proceedings under Sections 304, 305, 306, 307 and 310 of the Packers and Stockyards Act, 1921, as amended, 7 U.S.C. 205, 206, 207, 208 and 211, except insofar as those Rules are in conflict with any provision herein.
As used in these rules:
(a) Rate proceeding means a proceeding involving the determination and prescription of any rate or charge made or proposed to be made for any stockyard service furnished at a stockyard by a stockyard owner or market agency, or a proceeding involving any rule, regulation or practice affecting any such rate or charge; and
(b) Administrator means the Administrator of the Agricultural Marketing Service (AMS), or any officer or employee of AMS to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act for the Administrator.
(a) Informal complaint. Any interested person desiring to complain of the lawfulness of any rate or charge made or proposed to be made for any stockyard service furnished at a stockyard by a stockyard owner or market agency, or rule, regulation or practice affecting any such rate or charge, may file an informal complaint with the Administrator.
(b) Investigation. If there appears to be any reasonable ground for doing so, the Administrator will investigate the matter complained of. If the Administrator reasonably believes that there are not sufficient facts to form the basis for further proceeding, the matter may be dropped. If it is dropped, the person filing the informal complaint will be informed.
(c) Status of person filing. A person filing an informal complaint will be a party to a rate proceeding if the Administrator files such person's informal complaint as a formal complaint, or if the Judge permits such person to intervene upon written application.
(d) Formal complaint. A rate proceeding may be instituted only upon filing of a formal complaint by the Administrator. A formal complaint may be filed on the initiative of the Administrator, or on the basis of an informal complaint, or by filing the informal complaint as a formal complaint. A formal complaint filed by the Administrator, or a summary thereof, will be published in the
Respondent is not required to file an answer. If an answer is filed, complainant is not required to file a reply.
The hearing will be oral unless all parties waive oral hearing. It will be written if not oral. Notice of the date, time and place of oral hearing, or of the date and place for filing of written submissions in a written hearing, will be served on the Administrator and the respondent, and on such other persons as have requested in writing to be heard.
The proceeding may be instituted by filing of the informal complaint as a formal complaint, and the Administrator may take no position on the merits of the case.
(a) Informal petition. Any interested person may file an informal petition to modify or vacate a final order at any time. Any such petition must be filed with the Administrator, be based on matters arising after the issuance of the final order, and set forth such matters, and the reasons or conditions relied on, with such particularity as is practicable. Any such informal petition will be handled as otherwise provided for an informal complaint.
(b) Formal motion. A final order may be modified or vacated at any time only upon filing of a formal motion by the Administrator. Such a motion may be filed on the initiative of the Administrator, on the basis of an informal petition, or by filing of an informal petition as a formal motion.
(c) Publication. If the modification or vacation sought would involve an increase of a rate or charge lawfully prescribed by the Secretary, or involve a rate or charge in addition to what is specified in the final order, or involve a regulation or practice so affecting such a rate or charge, the formal motion, or a summary thereof, will be published in the
(d) Proceedings. Proceedings upon such a formal motion will be as otherwise provided for a formal complaint.
In these rules, words in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.
Terms defined in the Act shall mean the same in these rules as in the Act. In addition, and except as may be provided otherwise in these rules:
Act means the Packers and Stockyards Act, 1921, and legislation supplementary thereto and amendatory thereof, 7 U.S.C. 181 et seq.;
Agency means those divisions and offices of the Agricultural Marketing Service (AMS) of the Department which are charged with administration of the Act;
Agency Head means the Administrator, Agricultural Marketing Service (AMS) of the Department, or any officer or employee of the Agency to whom authority is lawfully delegated to act for the Administrator;
Complainant means the party who files a complaint and claims reparation, or on whose behalf a complaint is filed and reparation is claimed, in a reparation proceeding;
Department means the United States Department of Agriculture;
Docketing of a reparation proceeding means transmittal of papers to the Hearing Clerk and assignment of a docket number as provided in Rule 8, § 202.108, of these rules;
Hearing means that part of a reparation proceeding which involves the submission of evidence for the record and means either an oral or a written hearing;
Hearing Clerk means the Hearing Clerk of the Department (see 7 CFR 2.25(a)(3));
Judicial Officer means the official of the Department delegated authority by the Secretary, pursuant to the Act of April 4, 1940 (7 U.S.C. 450c-450g) and Reorganization Plan No. 2 of 1953, to perform the function involved (see 7 CFR 2.35);
Mail means to deposit an item in the United States mail with postage affixed and addressed as necessary to cause it to be delivered to the address shown by ordinary mail, or by certified or registered mail if specified.
Presiding Officer means any attorney who is employed in the Office of the General Counsel of the Department and is assigned so to act in a reparation proceeding;
Re-mail means to mail by ordinary mail to an address an item that has been returned after being sent to the same address by certified or registered mail.
Reparation proceeding or Proceeding means a proceeding under the Act before the Secretary, in which an order for the payment of money is claimed and in which the Secretary is not a party of record;
Report means the report to the Judicial Officer of the presiding officer's recommended findings of fact and conclusions with respect to all material issues of fact, law or discretion, as well as the reasons or basis therefor, and order, in a reparation proceeding.
Respondent means the party against whom a complaint is filed and reparation is claimed, in a reparation proceeding;
Secretary means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority is lawfully delegated to act for the Secretary;
(a) Filing. A reparation proceeding is begun by filing a complaint. Any interested person (including any agency of a state or territory having jurisdiction over persons subject to the Act in such state or territory) desiring to complain of anything done or omitted to be done by any stockyard owner, market agency, or dealer in violation of sections 304, 305, 306, or 307, or of an order of the Secretary made under title III, of the Act, may file a complaint to begin a reparation proceeding.
(b) Form. The complaint must be in writing, state the facts of the matter complained of, identify each person complained against (respondent), and identify each person who complains against such respondent and claims reparation from such respondent. It may be on a printed form supplied by the Agency, or may be a formal document, or may be a letter, mailgram, or telegram. It may be typewritten or handwritten. If it is not on a printed form supplied by the Agency, the Agency Head may, prior to docketing of the proceeding, recommend to the complainant that an amended complaint be filed on such a printed form.
(c) Contents and attachments. So far as practicable, the complaint should include the following items as applicable:
(1) Date and place where the alleged violation occurred;
(2) Quantity and quality of the livestock involved;
(3) Whether a sale is involved and, if so, the date, sale price, and amount actually paid and received;
(4) Whether a consignment is involved and, if so the date, reported proceeds, gross, net;
(5) Amount of reparation claimed, and method of computation;
(6) Name and address of each partner or member, if a partnership or joint venture is involved;
(7) Name and address of each person involved, including any agent representing the complainant or the respondent in the transaction involved;
(8) Other material facts, including terms of contract; and
(9) True copies of all available papers relating to the transaction complained about, including shipping documents, letters, telegrams, invoices, manifests, accounts of sales, and special contracts or agreements, and checks and drafts. If it appears that any such item has been omitted from the complaint, the Agency Head may, prior to docketing of the proceeding, recommend to the complainant that such item be supplied by written amendment to the complaint.
(d) Where to file. The complaint should be transmitted or delivered to any regional office of the Packers and Stockyards Division (PSD), or to the PSD headquarters in Washington, DC, or delivered to any full time PSD employee.
(e) Time for filing. The complaint must be received by the Department within 90 days after accrual of the cause of action alleged in it. If a complaint is transmitted or delivered to an office of the Department, it shall be deemed to be received by the Department when it reaches such office. If a complaint is delivered to a full-time PSD employee, it shall be deemed to be received by the Department when it is received by such employee.
(f) Amendment. The complaint may be amended at any time prior to the close of an oral hearing or the filing of the last evidence in a written hearing, except that:
(1) An amendment cannot add a respondent if it is filed more than 90 days after accrual of the cause of action against such respondent;
(2) An amendment cannot state a new and different cause of action if it is filed more than 90 days after accrual of such new and different cause of action; and
(3) After the first amendment, or after the filing of an answer by the respondent, an amendment may not be filed without the written consent of the respondent, or leave of the presiding officer, or, prior to docketing of the proceeding, leave of the Agency Head. Any such amendment must be filed in writing and signed by the complainant or the attorney or representative of the complainant. If any such amendment is filed before the initial service of the complaint on the respondent, it shall be served on the respondent only if the complaint is served as provided in Rule 4(b), § 202.104(b). If any such amendment is filed after such service, it shall be served on the respondent in any case.
(g) Withdrawal. At any time, a complainant may withdraw a complaint filed by or on behalf of the same complainant, thus terminating the reparation proceeding on such complaint unless a counterclaim or another complaint is pending therein. If a complainant fails to cooperate with the Secretary in the disposition of the matter complained of, such complainant may be presumed to desire to withdraw the complaint filed by or on behalf of such complainant, after service on the parties of written notice of the facts of such failure and reasonable opportunity for such complainant to state whether such presumption is correct.
(a) Informal disposition. If there appears to be any reasonable ground for doing so, the Agency Head shall investigate the matter complained of. If the Agency Head reasonably believes that there are not sufficient facts to form the basis for further proceeding, the matter may be dropped, without prejudice to subsequent court action on the same cause of action; if it is dropped, the person filing the complaint shall be informed. If the statements in the complaint, and information obtained in the investigation, seem to warrant such action, the Agency Head may make an effort to obtain the consent of the parties to an amicable or informal adjustment of the matter by communication with the parties or their attorneys or representatives. Such communication may be written or oral or both.
(b) Service of complaint. If the matter is not disposed of as provided in paragraph (a), the complaint, together with any amendment which has been filed, shall be served on the respondent with a notice that an answer is required.
(c) Service of report of investigation. A report prepared by the Agency, of its investigation of the matter complained of, and supplements to such a report, may be served on the parties and made a part of the record of the proceeding. Whether such a report or supplement shall be prepared, and whether it shall be served on the parties and made a part of the record, and its contents, shall be in the discretion of the Agency Head. The Judicial Officer shall consider information in such a report or supplement as part of the evidence in the proceeding, to the extent that such information is relevant and material to the proceeding. Any party may submit evidence in rebuttal of such information as is provided generally in these rules for the submission of evidence. Oral testimony, to the extent credible, shall be given greater weight as evidence than such information.
(a) Filing; number of copies. Prior to docketing of a proceeding under these rules, all documents and papers other than the initial complaint, filed in the proceeding, shall be filed with the Agency. After such docketing of a proceeding, all such documents and papers shall be filed with the hearing clerk, Provided, That all such documents and papers, except a petition for disqualification of a presiding officer, shall be filed with the presiding officer if the parties have been served with written notice to do so. Each such document or paper shall be filed in quadruplicate with an extra copy for each party in excess of two, except as otherwise provided in these rules. Any document or paper not filed in the required number of copies, except an initial complaint, may be returned to the party filing it.
(b) Effective date of filing. Any document or paper other than an initial complaint, filed in a proceeding under these rules, shall be deemed to be filed at the time when it reaches the headquarters of the Department in Washington DC, or, if authorized to be filed with an officer or employee of the Department at any place outside the District of Columbia, it shall be deemed to be filed at the time when it reaches the office of such officer or employee.
(c) Additional time for filing. The time for the filing of any document or paper other than an initial complaint, in a proceeding under these rules, may upon request be extended as reasonable, by the agency head prior to docketing of the proceeding, or by the presiding officer, or by the judicial officer; notice of any extension of time shall be served on all parties. After docketing of the proceeding, in all instances in which time permits, notice of a request for extension of time shall be given to parties other than the one filing such request, with opportunity to submit views concerning the request.
(d) Computation of time. Saturdays, Sundays, and Federal holidays shall be included in computing the time allowed for the filing of any document or paper: Provided, That, when such time expires on a Saturday, Sunday, or Federal holiday, such time shall be extended to include the next following business day.
(e) Who shall make service. Copies of all documents or papers required or authorized by the rules in this part to be filed with the Agency shall be served on the parties by the Agency, and copies of all documents or papers required or authorized by the rules in this part to be filed with the Hearing Clerk shall be served on the parties by the Hearing Clerk, unless any such document or paper is served by some other employee of the Department, or by a U.S. marshal or deputy marshal, or as otherwise provided herein, or as otherwise directed by the presiding officer or Judicial Officer.
(f) Service on party. (1) Any complaint or other document initially served on a person to make that person a party respondent in a proceeding, a final order, or other document specifically ordered by the presiding officer or Judicial Officer to be served by certified or registered mail, shall be deemed to be received by any party to a proceeding on the date of delivery by certified or registered mail to the last known principal place of business of such party, last known principal place of business of the attorney or representative of record of such party, or last known residence of such party if an individual, provided that, if any such document or paper is sent by certified on registered mail but is returned marked by the postal service as unclaimed or refused, it shall be deemed to be received by such party on the date of remailing by ordinary mail to the same address.
(2) Any document or paper, other than one specified in paragraph (f)(1) of this section or written questions for a deposition as provided in § 202.109(c)(3), shall be deemed to be received by any party to a proceeding on the date of mailing by ordinary mail to the last known principal place of business of such party, last known principal place of business of the attorney or representative or record of such party, or last known residence of such party if an individual.
(3) Any document or paper served other than by mail on any party to a proceeding shall be deemed to be received by such party on the date of:
(i) Delivery to any responsible individual at, or leaving in a conspicuous place at, the last known principal place of business of such party, last known principal place of business of the attorney or representative of record of such party, or last known residence of such party if an individual, or
(ii) Delivery to such party if an individual, to an officer or director of such party if a corporation, or to a member of such party if a partnership, at any location.
(g) Service on another. Any subpoena or other document or paper served on any person other than a party to a proceeding shall be deemed to be received by such person on the date of:
(1) Delivery by certified mail or registered mail to the last known principal place of business of such person, last known principal place of business of the attorney or representative of record of such person, or last known residence of such person if an individual;
(2) Delivery other than by mail to any responsible individual at, or leaving in a conspicuous place at, any such location; or
(3) Delivery to such party if an individual, to an officer or director of such party if a partnership, at any location.
(h) Proof of service. Any of the following, in the possession of the Department, showing such service, shall be deemed to be accurate:
(1) A certified or registered mail receipt returned by the postal service with a signature;
(2) An official record of the postal service;
(3) An entry on a docket record or a copy placed in a docket file by the Hearing Clerk of the Department or by an employee of the Hearing Clerk in the ordinary course of business;
(4) A certificate of service, which need not be separate from and may be incorporated in the document or paper of which it certifies service, showing the method, place and date of service in writing and signed by an individual with personal knowledge thereof, Provided that such certificate must be verified by oath or declaration under penalty of perjury if the individual certifying service is not a party to the proceeding in which such document or paper is served, an attorney or representative of record for such a party, or an official or employee of the United States or of a State of political subdivision thereof.
(a) Filing and service. Within 20 days after service on a respondent, of a complaint or amendment of a complaint, such person shall file an answer in writing, signed by such person or by the attorney or representative of such person. If a respondent desires an oral hearing, a request for it should be included with the answer of such person. If any answer or amended answer is filed, it shall be served on the complainant.
(b) Required contents. If a respondent desires to make a defense, the answer of such person shall contain a precise statement of the facts which constitute the grounds of defense, and shall specifically admit, deny, or explain each of the allegations of the complaint, except that, if the respondent is without knowledge, such answer shall state that. If a respondent does not desire to make a defense, the answer of such person shall contain an admission of all the allegations of the complaint, or an admission of liability to the complainant in the full amount claimed by the complainant as reparation, or both. An answer may be stricken for failure to comply with these requirements; notice of an order so striking an answer shall be served on the parties; within 20 days after service on a respondent of such a notice, such person shall file an answer which complies with these requirements.
(c) Setoff, counterclaim or cross-claim. The answer may assert a setoff, counterclaim, or cross-claim, or any combination thereof. No counterclaim or cross-claim shall be considered unless it is based on a violation for which the act authorizes reparation to be ordered to be paid, and filed within 90 days after accrual of the cause of action alleged therein: Provided, That a counterclaim not filed within such time limit may be considered if based on a transaction complained of in the complaint. Any cross-claim asserted against a co-respondent, based on a violation for which the act authorizes reparation to be ordered to be paid, and filed within 90 days after accrual of the cause of action alleged therein, shall be served on such person as a complaint; within 20 days after such service, such person shall file an answer thereto in compliance with the above requirements for an answer to a complaint.
(d) Failure to file. If a respondent fails to file an answer as required above, such persons shall be deemed to have admitted all the allegations of the complaint or cross-claim against such person, and to have consented to the issuance of a final order in the proceeding, based on all evidence in the record. For this purpose, the evidence in the record may include information contained in a report of investigation made a part of the record pursuant to rule 4(c), § 202.104(c), and evidence received in a hearing, oral or written, held subsequent to the expiration of the time for filing such answer, but shall not be limited to such information and evidence. Such a respondent shall not be entitled to service provided in these rules, of any notice or document except the final order in the proceeding.
(a) Filing and service. If the answer asserts a counterclaim or a setoff, the complainant may file a reply in writing within 20 days after service of the answer on such person. If any reply or amended reply is filed, it shall be served on the respondent.
(b) Contents. The reply shall be confined strictly to the matters alleged in the counterclaim or setoff asserted in the answer. It shall contain a precise statement of the facts which constitute the grounds of defense to the counterclaim or setoff and shall specifically admit, deny, or explain each of the allegations of the answer constituting such counterclaim or setoff, except that, if the complainant is without knowledge, the reply shall state that.
(c) Failure to file. If no reply is filed, the allegations of the answer shall be regarded as denied.
Promptly following receipt of the answer, or the reply (if the answer asserts a counterclaim or a setoff), or following the expiration of the period of time prescribed above for the filing of the answer or of the reply, the agency head shall transmit all of the papers which have been filed in the proceeding (including the investigation report if any has been served on the parties) to the hearing clerk, who shall assign a docket number to the proceeding. Thereafter the proceeding shall be referred to by such number. The hearing clerk shall promptly transmit all such papers to the Office of the General Counsel for assignment of a presiding officer.
(a) Application. Any party may file an application for an order for the taking of testimony by deposition, at any time after docketing of a proceeding and before the close of an oral hearing or the filing of such party's evidence in a written hearing therein. The application shall set forth: (1) The name and address of the proposed deponent; (2) the name and address of the person (referred to in this section as the “officer”) before whom the proposed examination is to be made; (3) the reasons why such deposition should be taken, which must show that it may be able to be used as set forth in paragraph (i) of this section; (4) whether the proposed examination is to be on interrogatories or oral; and (5) if oral, a suggested time and place where the proposed deposition is to be made and a suggested manner in which the proposed deposition is to be conducted (telephone, audio-visual telecommunication, or by personal attendance of the individuals who are expected to participate in the deposition). The application for an order for the taking of testimony by deposition shall be made in writing, unless it is made orally on the record at an oral hearing.
(b) Response; service. If any such application is made orally on the record at an oral hearing, each party other than the applicant, present at such hearing, may respond to it orally. If any such application is in writing it shall be served on each party other than the applicant, and each such other party shall have not less than 20 days, from the date of service on such party of the application, to file a written response to it.
(c) Written questions (interrogatories). (1) If the examination will be oral, parties who will not be present or represented at it may file written questions with the officer prior to the time of the examination.
(2) The presiding officer may direct, or the parties may agree, that the deposition, if taken, shall be taken by means of written questions. If the presiding officer finds, upon the protest of a party to the proceeding, that such party has a principal place of business or residence more than 100 miles from the place of the examination and that it would constitute an undue hardship on such party to be present or represented at an oral examination at such place, the deposition, if taken, shall be taken by means of written questions. In any such case, the presiding officer shall state on the record at the oral hearing that, or shall serve the parties with notice that, the deposition, if taken, shall be taken by means of written questions.
(3) If the examination is conducted by means of written questions, copies of the applicant's questions must be received by the other party to the proceeding and the officer at least 10 days prior to the date set for the examination unless otherwise agreed, and any cross questions of a party other than the applicant must be received by the applicant and the officer at any time prior to the time of the examination.
(d) Order. (1) The presiding officer, if satisfied that good cause for taking the deposition is present, may order the taking of the deposition.
(2) The order shall be served on the parties and shall include:
(i) The name and address of the officer before whom the deposition is to be made;
(ii) The name of the deponent;
(iii) Whether the deposition will be oral or on written questions;
(iv) If the deposition is oral, the manner in which the deposition is to be conducted (telephone, audio-visual telecommunication, or personal attendance of those who are to participate in the deposition); and
(v) The time, which shall not be less than 20 days after the issuance of the order, and place.
(3) The officer, time, place, and manner of the deposition as stated in the presiding officer's order need not be the same as the officer, time, place, and manner suggested in the application.
(4) The deposition shall be conducted in the manner (telephone, audio-visual telecommunication, or personal attendance of those who are to participate in the deposition) agreed to by the parties.
(5) If the parties cannot agree on the manner in which the deposition is to be conducted:
(i) The deposition shall be conducted by telephone unless the presiding officer determines that conducting the deposition by audio-visual telecommunication:
(A) Is necessary to prevent prejudice to a party;
(B) Is necessary because of a disability of any individual expected to participate in the deposition; or
(C) Would cost less than conducting the deposition by telephone.
(ii) If the deposition is not conducted by telephone, the deposition shall be conducted by audio-visual telecommunication unless the presiding officer determines that conducting the deposition by personal attendance of any individual who is expected to participate in the deposition:
(A) Is necessary to prevent prejudice to a party;
(B) Is necessary because of a disability of any individual expected to participate in the deposition; or
(C) Would cost less than conducting the deposition by telephone or audio-visual telecommunication.
(e) Qualifications of officer. No deposition shall be made except before an officer authorized by the law of the United States or by the law of the place of the examination to administer oaths, or before an officer authorized by the Secretary to administer oaths, or before the presiding officer. No deposition shall be made before an officer who is a relative (within the third degree by blood or marriage), employee, attorney, or representative of any party (or an employee of an attorney or representative of any party), or who is financially interested in the result of the proceeding.
(f) Procedure on examination. The deponent shall be examined under oath or affirmation, and the testimony of the deponent shall be recorded by the officer, or by some person under the direction and in the presence of the officer. If the examination is on interrogatories, they shall be propounded by the officer. If the examination is oral, the deponent shall be examined first by the party at whose instance the deposition is taken, or the representative of such party, and shall be subject to cross-examination by any other party or the representative thereof who is present at the examination; the officer shall propound any interrogatories filed with the officer by parties not present or represented at the examination.
(g) Certification and filing by officer. The officer shall certify on the transcript or recording that the deponent was duly sworn by the officer and that the transcript or recording is a true record of the deponent's testimony, with such exceptions as the certificate shall specify. The officer shall then securely seal the transcript or recording, together with three copies of the transcript or recording, with an extra copy for each party in excess of two, in an envelope, and mail the same by registered or certified mail to the presiding officer.
(h) Service; correction. After the transcript or recording is received by the presiding officer, it shall promptly be served on all parties. Any party, within 20 days after such service, may file a written motion proposing corrections to the transcript or recording. Any such motion shall be served on each party other than the one filing it, who shall have 10 days to file a written response to it. Any such response shall be served on each party other than the one filing it. Such documents, if filed, shall be a part of the record of the proceeding if any portion of the transcript or recording is made a part of the record. All portions of the transcript or recording which are not referred to in any such motion shall be presumed to be accurate except for obvious typographical errors.
(i) Use. If a written hearing is held, a transcript or recording, of a deposition ordered and taken in accord with this section, may be made a part of the record as evidence by any party, by written motion filed with such party's evidence. If an oral hearing is held, except as otherwise provided in these rules, such a transcript or recording may be made a part of the record as evidence, on written motion filed by any party, or oral motion of any party made at the oral hearing, if no party objects after reasonable notice and opportunity to do so, or if the presiding officer finds that the evidence is otherwise admissible and:
(1) That the witness is dead;
(2) That the witness is unable to attend or testify for any good reason including age, sickness, infirmity, or imprisonment;
(3) That the party offering the transcript or recording has tried without success to procure the attendance of the witness by subpoena; or
(4) That such exceptional circumstances exist as to make it desirable, in the interests of justice and with due regard to the importance of presenting the testimony orally before the presiding officer, to allow the transcript or recording to be used.
(j) Expenses. Fees and reimbursements payable to an officer taking a deposition, or other person recording the testimony in the deposition, shall be paid by the party at whose instance the deposition is taken.
(k) Subpoenas. No subpoena can issue, to compel attendance, testimony, or production of documentary evidence, at an examination under this rule 9.
(l) Agreement of parties. In any case, any transcript or recording of any deposition, or any part of such a transcript or recording, may be made a part of the record as evidence by agreement of the parties other than a party failing to file an answer as required in these rules.
(a) The presiding officer, at any time prior to the commencement of the hearing, may request the parties or their counsel to appear at a conference before the presiding officer to consider:
(1) The simplification of issues;
(2) The necessity of amendments to pleadings;
(3) The possibility of obtaining stipulations of fact and of the authenticity, accuracy, and admissibility of documents, which will avoid unnecessary proof;
(4) The limitation of the number of expert or other witnesses;
(5) The negotiation, compromise, or settlement of issues;
(6) The exchange of copies of proposed exhibits;
(7) The identification of documents or matters of which official notice may be requested;
(8) A schedule to be followed by the parties for completion of the actions decided at the conference; or
(9) Such other matters as may expedite and aid in the disposition of the proceeding.
(b) Manner of the prehearing conference. (1) The prehearing conference shall be conducted by telephone or correspondence unless the presiding officer determines that conducting the prehearing conference by audio-visual telecommunication:
(i) Is necessary to prevent prejudice to a party;
(ii) Is necessary because of a disability of any individual expected to participate in the prehearing conference; or
(iii) Would cost less than conducting the prehearing conference by telephone or correspondence. If the presiding officer determines that a prehearing conference conducted by audio-visual telecommunication would measurably increase the United States Department of Agriculture's cost of conducting the prehearing conference, the prehearing conference shall be conducted by personal attendance of any individual who is expected to participate in the prehearing conference, by telephone, or by correspondence.
(2) If the prehearing conference is not conducted by telephone or correspondence, the prehearing conference shall be conducted by audio-visual telecommunication unless the presiding officer determines that conducting the prehearing conference by personal attendance of any individual who is expected to participate in the prehearing conference:
(i) Is necessary to prevent prejudice to a party;
(ii) Is necessary because of a disability of any individual expected to participate in the prehearing conference; or
(iii) Would cost less than conducting the prehearing conference by audio-visual telecommunication.
(a) When held. A hearing, oral or written, shall be held unless:
(1) Each respondent admits or is deemed to admit sufficient allegations of the complaint to support the full amount claimed by the complainant as reparation;
(2) Each respondent admits liability to the complainant in the full amount claimed by the complainant as reparation;
(3) Before a hearing has been completed the parties agree in writing that the proceeding may be decided on the basis of the record as it stands at the time such agreement is filed; or
(4) Before a hearing has been completed the parties settle their dispute or the complainant withdraws the complaint.
(b) Whether oral or written. The hearing provided for in paragraph (a) of this section shall be oral if:
(1) $10,000 or more is in controversy and any respondent files a written request for an oral hearing with such respondent's answer; or
(2) $10,000 or more is in controversy and any complainant files a written request for an oral hearing on or before the 20th day after service on such complainant of notice that no respondent has filed a timely request for an oral hearing; or
(3) Less than $10,000 is in controversy and the presiding officer determines, upon written request by any party thereto, that an oral hearing is necessary to establish the facts and circumstances giving rise to the controversy. The hearing shall be written if not oral.
(c) Withdrawal of request. If $10,000 or more is in controversy and a party has timely filed a request for oral hearing, such party may withdraw such request at any time prior to completion of an oral hearing. If such a withdrawal leaves no pending request for oral hearing in the proceeding, and if the presiding officer has not decided that the hearing should be oral, each other party shall be served with notice of this and shall be given 20 days to request an oral hearing. If any party files a request for oral hearing in such time, the hearing shall be oral in accordance with paragraph (b) of this section.
(d) Presiding Officer's recommendation. The presiding officer may recommend voluntary withdrawal of a request for oral hearing, timely filed. Declining to make such withdrawal shall not affect the rights or interests of any party.
(e) Representation. Any party may appear in an oral hearing, or file evidence in a written hearing, in person or by counsel or other representative. For unethical or contumacious conduct in or in connection with a proceeding, the presiding officer may preclude a person from further acting as attorney or representative for any party to the proceeding; any such order of the presiding officer shall be served on the parties; an appeal to the Judicial Officer may be taken from any such order immediately.
(a) Time, place, and manner. (1) If and when the proceeding has reached the stage where an oral hearing is to be held, the presiding officer shall set a time, place, and manner for oral hearing. The time shall be set based upon careful consideration to the convenience of the parties. The place shall be set in accordance with paragraph (a)(2) of this section and careful consideration to the convenience of the parties. The manner in which the hearing is to be conducted shall be determined in accordance with paragraphs (a)(3) and (a)(4) of this section.
(2) The place shall be set in accordance with paragraphs (e) and (f) of section 407 of the Act, if applicable. In essence, under paragraphs (e) and (f) of section 407 of the Act, if the complainant and the respondent, or all of the parties, if there are more than two, have their principal places of business or residence within a single unit of local government, a single geographical area within a State, or a single State, the oral hearing is to be held as near as possible to such places of business or residence, depending on the availability of an appropriate location for conducting the hearing. If the parties have such places of business or residence distant from each other, then paragraphs (e) and (f) of section 407 of the Act are not applicable.
(3) The oral hearing shall be conducted by audio-visual telecommunication unless the presiding officer determines that conducting the oral hearing by personal attendance of any individual who is expected to participate in the hearing:
(i) Is necessary to prevent prejudice to a party;
(ii) Is necessary because of a disability of any individual expected to participate in the hearing; or
(iii) Would cost less than conducting the hearing by audio-visual telecommunication. If the presiding officer determines that a hearing conducted by audio-visual telecommunication would measurably increase the United States Department of Agriculture's cost of conducting the hearing, the hearing shall be conducted by personal attendance of any individual who is expected to participate in the hearing or by telephone.
(4) The presiding officer may, in his or her sole discretion or in response to a motion by a party to the proceeding, conduct the hearing by telephone if the presiding officer finds that a hearing conducted by telephone:
(i) Would provide a full and fair evidentiary hearing;
(ii) Would not prejudice any party; and
(iii) Would cost less than conducting the hearing by audio-visual telecommunication or personal attendance of any individual who is expected to participate in the hearing.
(b) Notice. (1) A notice stating the time, place, and manner of oral hearing shall be served on each party prior to the time of the oral hearing. The notice shall state whether the oral hearing will be conducted by telephone, audio-visual telecommunication, or personal attendance of any individual expected to participate in the hearing. If any change is made in the time, place, or manner of the oral hearing, a notice of the change shall be served on each party prior to the time of the oral hearing as changed, unless the change is made during the course of an oral hearing and shown in the transcript or on the recording. Any party may waive such notice, in writing, or orally on the record at an oral hearing and shown in the transcript or on the recording.
(2) If the presiding officer orders an oral hearing, any party may move that the hearing be conducted by telephone or personal attendance of any individual expected to attend the hearing rather than by audio-visual telecommunication. Any motion that the hearing be conducted by telephone or personal attendance of any individual expected to attend the hearing must be accompanied by a memorandum in support of the motion stating the basis for the motion and the circumstances that require the hearing to be conducted other than by audio-visual telecommunication.
(3) Within 10 days after the presiding officer issues a notice stating the manner in which the hearing is to be conducted, any party may move that the presiding officer reconsider the manner in which the hearing is to be conducted. Any motion for reconsideration must be accompanied by a memorandum in support of the motion stating the basis for the motion and the circumstances that require the hearing to be conducted other than in accordance with the presiding officer's notice.
(c) Failure to appear. If any party to the proceeding, after being duly notified, fails to appear at the oral hearing in person or by counsel or other representative, such party shall be deemed to have waived the right to add any further evidence to the record in the proceeding, or to object to the admission of any evidence; if the parties who are present are all adverse to such party, they shall have an election to present evidence, in whole or in part, in the form of oral testimony before the presiding officer, affidavits, or depositions.
(d) Order of proceeding. Complainant shall proceed first, if present at the commencement of the oral hearing.
(e) Written statements of direct testimony. (1) Except as provided in paragraph (e)(2) of this section, each party must exchange with all other parties a written narrative verified statement of the oral direct testimony that the party will provide at any hearing to be conducted by telephone; the direct testimony of each employee or agent of the party that the party will call to provide oral direct testimony at any hearing to be conducted by telephone; and the direct testimony of each expert witness that the party will call to provide oral direct testimony at any hearing to be conducted by telephone. The written direct testimony of witnesses shall be exchanged by the parties at least 10 days prior to the hearing. The oral direct testimony provided by a witness at a hearing conducted by telephone will be limited to the presentation of the written direct testimony, unless the presiding officer finds that oral direct testimony which is supplemental to the written direct testimony would further the public interest and would not constitute surprise.
(2) The parties shall not be required to exchange testimony in accordance with this paragraph if the hearing is scheduled to begin less than 20 days after the presiding officer's notice stating the time of the hearing.
(f) Evidence—(1) In general. The testimony of witnesses at an oral hearing shall be on oath or affirmation and subject to cross-examination. Any witness other than a party may be examined separately and apart from all other witnesses, in the discretion of the presiding officer. The presiding officer shall exclude evidence which is immaterial, irrelevant, or unduly repetitious, or which is not of the sort on which responsible persons are accustomed to rely, insofar as practicable.
(2) Objections. If a party objects to the admission of any evidence or to the limitation of the scope of any examination or cross-examination or to any other ruling of the presiding officer, such party shall state briefly the grounds of such objection, and the presiding officer shall rule on it. The transcript or recording shall include argument or debates on objections, except as ordered by the presiding officer, and shall include the ruling of the presiding officer. Objections not made before the presiding officer may not subsequently be relied on in the proceeding.
(3) Offer of proof. Whenever evidence is excluded by the presiding officer, the party offering such evidence may make an offer of proof. The offer of proof shall consist of a brief statement, which shall be included in the transcript or recording, describing the evidence excluded. If the evidence consists of a brief oral statement, it shall be included in full in the transcript or recording. If the evidence consists of an exhibit, it shall be marked for identification and inserted in the record. In either such event, if the judicial officer decides that the presiding officer's ruling in excluding the evidence was erroneous and prejudicial, such evidence shall be considered a part of the record. If the taking of such evidence will consume a considerable length of time at the hearing, the presiding officer shall not allow the insertion of such evidence in full and, if the judicial officer decides that the presiding officer's ruling in excluding the evidence was erroneous and prejudicial, the hearing shall be reopened to permit the taking of such evidence.
(4) Depositions and affidavits. Except as is otherwise provided in these rules, admission of the deposition of any witness shall be subject to the provisions of rule 9, § 202.109, and affidavits, and statements under penalty of perjury as provided in 28 U.S.C. 1746, Pub. L. 94-550, may be admitted only if the evidence is otherwise admissible and no party objects.
(5) Department records. A true copy of any written entry in any record of the Department, made by an officer or employee of the Department in the course of the official duty of such officer or employee, and relevant to the issues involved in the hearing, shall be admissible as prima facie evidence of the facts stated in the record of the Department, without the production of such officer or employee.
(6) Exhibits. (i) For each exhibit offered by a party, copies in addition to the original shall be filed with the presiding officer for the use of all other parties to the proceeding, except where the presiding officer finds that the furnishing of copies is impracticable. The presiding officer shall tell the parties the number of copies required to be filed, make the proper distribution of the copies, and have this noted on the record.
(ii) If the testimony of a witness refers to any document, the presiding officer shall determine whether it shall be produced at the hearing and made a part of the record as an exhibit, or whether it shall be incorporated in the record by reference.
(iii) If relevant and material matter is embraced in a document containing irrelevant or immaterial matter, such irrelevant or immaterial matter shall be designated by the party offering the document in evidence, and shall be segregated and excluded, insofar as practicable.
(g) Subpoenas—(1) Issuance. The attendance and testimony of witnesses and the production of documentary evidence, from any place in the United States, on behalf of any party to the proceeding, may be required by subpoena at any designated place for oral hearing. Subpoenas may be issued by the presiding officer, on a written application filed by a party, showing the grounds and necessity thereof, and, with respect to subpoenas for the production of documentary evidence, showing their competency, relevancy, and materiality and the necessity for their production. Subpoenas may be issued on the motion of the presiding officer.
(2) Service; proof of service. A subpoena may be served by any natural person over the age of 18 years. The party at whose instance a subpoena is issued shall be responsible for serving it, however, at the request of such party the Secretary will attempt to serve it.
(h) Oral argument. The presiding officer shall permit oral argument by the parties or their counsel who are present at an oral hearing, but may limit such argument to any extent that the presiding officer finds necessary for the expeditious or proper disposition of the case.
(i) Transcript or recording. (1) Hearings to be conducted by telephone shall be recorded verbatim by electronic recording device. Hearings conducted by audio-visual telecommunication or the personal attendance of any individual who is expected to participate in the hearing shall be transcribed, unless the presiding officer finds that recording the hearing verbatim would expedite the proceeding and the presiding officer orders the hearing to be recorded verbatim. The presiding officer shall certify that to the best of his or her knowledge and belief any recording made pursuant to this paragraph with exhibits that were accepted into evidence is the record of the hearing.
(2) If a hearing is recorded verbatim, a party requests the transcript of a hearing or part of a hearing, and the presiding officer determines that the disposition of the proceeding would be expedited by a transcript of the hearing or part of a hearing, the presiding officer shall order the verbatim transcription of the recording as requested by the party.
(3) Parties to the proceeding who desire copies of the transcript or recording of the oral hearing may make arrangements with the reporter, who will furnish and deliver such copies direct to such parties, upon receipt from such parties of payment for the transcript or recording, at the rate provided by the contract between the reporter and the Department for such reporting service.
(j) Filing, and presiding officer's certificate, of the transcript or recording. As soon as practicable after the close of the oral hearing, the reporter shall transmit to the presiding officer the original transcript or recording of the testimony, and as many copies of the transcript or recording as may be required by paragraph (i) of this section for the PSD regional offices and as may be required for the PSD headquarters office in Washington. At the same time the reporter shall also transmit a copy of the transcript or recording to each party who shall have arranged and paid for it, as provided in paragraph (h) of this section. Upon receipt of the transcript or recording, the presiding officer shall attach to the original transcript or recording a certificate stating that, to the best of the presiding officer's knowledge and belief, the transcript or recording is a true, correct, and complete transcript or recording of the testimony given at the hearing and that the exhibits mentioned in it are all the exhibits received in evidence at the hearing, with such exceptions as the certificate shall specify. Such certificate shall be served on each party and a copy thereof shall be attached to each copy of the transcript or recording received by the presiding officer. In accordance with such certificate the presiding officer shall note, on the original transcript or recording, each correction detailed in such certificate by adding or crossing out (but without obscuring the texts as originally transcribed or recorded) at the appropriate places any words necessary to make the text conform to the correct meaning, as certified by the presiding officer. The presiding officer shall send the copies of the transcript or recording to the hearing clerk who shall send them to PSD headquarters.
(k) Keeping of copies of the transcript or recording. During the period in which the proceeding has an active status in the Department, a copy of the transcript or recording shall be kept at the PSD regional office most convenient to the respondent; however, if there are two or more respondents and they are located in different regions, such copy of the transcript or recording shall be kept at the PSD regional office nearest to the place where the hearing was held. In addition, a copy of the transcript or recording shall be kept at the PSD regional office most convenient to the complainant. Any such copy shall be available for examination during official hours of business at the regional office, but shall remain the property of the Department and shall not be removed from such office.
(a) Evidence. As used in this section, the term “evidence” shall mean depositions, affidavits, or statements under penalty of perjury as provided in 28 U.S.C. 1746, Pub. L. 94-550, of persons having knowledge of the facts, or documents properly identified by such deposition, affidavit, or statement, or otherwise authenticated in such a manner that they would be admissible in evidence at an oral hearing, except as provided hereinafter. Testimony on deposition, to the extent credible, shall be given greater weight as evidence, than such affidavits or statements. In a case in which a party, entitled to oral hearing as provided in rule 11, § 202.111, withdraws such party's request for oral hearing on condition that only depositions be used if a written hearing is held, only depositions, and documents properly identified therein, shall be made a part of the record as evidence by the parties if a written hearing is held.
(b) Verification. Any facts must be verified, by oath or affirmation before a person legally authorized to administer oaths or before a person designated by the Secretary for the purpose (except in the case of a statement under penalty of perjury as provided in 28 U.S.C. 1746, Pub. L. 94-550), by a person who states, in the deposition, affidavit, or statement, that such person has actual knowledge of the facts. Except under unusual circumstances, which shall be set forth in the deposition, affidavit, or statement, any such person shall be one who would appear as a witness if an oral hearing were held.
(c) Complainant's evidence. The complainant shall be served with notice of an opportunity to file evidence. Within 20 days after such service, the complainant may file evidence. What the complainant files in response to that notice shall be served promptly on the respondent.
(d) Respondent's evidence. After expiration of the time for the filing of complainant's evidence, the respondent shall be served with notice of an opportunity to file evidence. Within 20 days after such service, the respondent may file evidence. What the respondent files in response to that notice shall be served promptly on the complainant.
(e) Complainant's rebuttal. If the respondent files anything pursuant to paragraph (d) of this section, the complainant shall be served with notice of an opportunity to file evidence in rebuttal of what the respondent has filed. Within 20 days after such service, the complainant may file such evidence, which shall be confined strictly to rebuttal of what the respondent has filed. What the complainant files in response to that notice shall be served promptly on the respondent.
(f) Failure to file. Failure to file any evidence authorized under this section, within the time prescribed, shall constitute a waiver of the right to file such evidence.
(g) Extension of time for depositions. If any party timely files an application for an order for the taking of testimony by deposition pursuant to rule 9, § 202.109, time for the filing of such party's evidence shall be extended as reasonable, to permit consideration of the application, and taking of depositions if ordered.
(h) Investigation report. No provision of this rule 13 shall change the status of an investigation report served on the parties and made a part of the record pursuant to rule 4, § 202.104.
(a) Oral hearing. Any party present or represented at an oral hearing, desiring to file any written argument or brief, proposed findings of fact, conclusions, and order, or statement of objections to rulings made by the presiding officer, must so inform the presiding officer at the oral hearing; upon being so informed, the presiding officer shall set a reasonable time for the filing of such documents, and state it on the record at the oral hearing.
(b) Written hearing. After filing of the last evidence in a written hearing, notice shall be served on each party that such party may file, within 20 days after such service on such party, written argument of brief, proposed findings or fact, conclusions, and order.
(c) Service; delay in preparation of report. If any such document is filed by any party, it shall be served on all other parties. The report shall not be prepared before expiration of such time for filing.
(a) Report. The presiding officer, with the assistance and collaboration of such employees of the Department as may be assigned for the purpose, shall prepare a report. The report shall be prepared on the basis of the evidence in the record, including the investigation report if one is prepared by the agency head and served on the parties, and any allegations admitted or deemed to be admitted, and any stipulations. The report shall be prepared in the form of a final order for signature by the judicial officer, and shall be filed with the hearing clerk. The report shall not be served on the parties unless and until it is signed by the judicial officer.
(b) Record. At the same time as the report is filed with the hearing clerk, the record shall also be filed with the hearing clerk. The record shall include: Pleadings; motions and requests filed and rulings thereon; the investigation report if one is prepared by the agency head and served on the parties; the transcript or recording of an oral hearing, and exhibits received, if an oral hearing was held; evidence filed by the parties if a written hearing was held; documents filed in connection with pre-hearing conferences; any proposed findings of fact, conclusions and orders, statements of objections, and briefs; any stipulations; and proof of service.
(c) Submission to judicial officer. Unless the hearing clerk reasonably believes that the record is not complete and in proper order, the record and the report shall be submitted to the judicial officer for decision.
(d) Oral argument. There shall be no right to oral argument other than that provided in rule 12(h), § 202.112(h).
(a) As soon as practicable after the receipt of the record and report from the hearing clerk, the judicial officer, on the basis of and after due consideration of the record, shall issue an order in the proceeding, which shall be served on the parties.
(b) If the judicial officer deems it advisable to do so, the order may be made a tentative order. In such event, a presiding officer shall be assigned and the tentative order shall be served on each party, and each party shall have 20 days in which to file written exceptions to it, and arguments or briefs in support of such exceptions. If no party timely files exceptions, the tentative order shall automatically become the final order in the proceeding, and notice of such fact shall be served on the parties. If any party timely files such exceptions, they shall be handled in the same manner as a petition filed under rule 17, § 202.117.
(a) Filing of petition—(1) To reopen a hearing. Any party may file a petition to reopen a hearing to take further evidence, at any time prior to the issuance of the final order, or prior to a tentative order becoming final. Such a petition must state the nature and purpose of the evidence to be offered, show that it is not merely cumulative, and state a good reason why it was not offered at the hearing if oral, or filed in the hearing if written.
(2) To rehear or reargue a proceeding or reconsider an order. Any party may file a petition to rehear or reargue a proceeding or reconsider an order of the judicial officer, at any time within 20 days after service on such party of such order. Such a petition must specify the matters claimed to have been erroneously decided, and the basis for the petitioner's claim that such matters were erroneously decided.
(3) To set aside a default order. Any respondent against whom an order is issued by the judicial officer, upon failure to file an answer as required, may file a petition to set aside such order, at any time within 20 days after service on such respondent of such order. Such a petition must state a good reason why an answer was not filed as required.
(b) Brief or memorandum of law. If such a petitioner wishes to file a brief or memorandum of law in support of such a petition, it must be filed with such petition.
(c) Procedure. A presiding officer shall be assigned upon the filing of any such petition, or upon notice to the hearing clerk (which may be written or oral, or by telephone) that any party intends to file any such petition. The party filing any such petition shall be referred to as the complainant or respondent, depending on the original designation of such party in the proceeding; such party shall have the burden of establishing that such petition should be granted. If a petition to reopen is timely filed, the order shall not be issued pending decision whether to grant or deny the petition. If a petition to rehear or reargue or reconsider, or to set aside a default order, is timely filed, operation of the order shall be stayed automatically pending decision whether to grant or deny it; if such a petition is not timely filed, operation of the order shall not be stayed unless the Judicial Officer shall determine otherwise.
(d) Service; answer. No such petition shall be granted unless it, with the brief or memorandum of law in support of it, if any, is first served on each party to the proceeding other than the one filing it. Each such other party, within 20 days after such service on such party, may file an answer to such petition. If any such party wishes to file a brief or memorandum of law in support of such an answer, it must be filed with such answer. Any such answer, with the brief or memorandum of law in support of it, if any, shall be served on each party to the proceeding other than the one filing it. Any such petition may be denied without such service.
(e) Submission for decision; service of order. The presiding officer shall prepare a recommendation with respect to the petition, and submit it to the judicial officer for decision. Such a recommendation shall be prepared in the form of a final order for signature by the judicial officer. It shall not be served on the parties unless and until it is signed by the judicial officer. The order of the judicial officer shall be served on the parties.
(f) Practice upon decision. If the judicial officer decides to reopen a hearing, or to rehear or permit reargument of a proceeding, or to set aside a default order, a presiding officer shall be assigned and the rules of practice shall be followed thereafter as applicable.
(a) Powers. Subject to review as provided elsewhere in these rules, the presiding officer assigned to any proceeding shall have power to:
(1) Set the time, place, and manner of a prehearing conference and an oral hearing, adjourn the oral hearing from time to time, and change the time, place, and manner of oral hearing;
(2) Administer oaths and affirmations;
(3) Issue subpoenas requiring the attendance and testimony of witnesses and the production of documentary evidence at an oral hearing;
(4) Summon and examine witnesses and receive evidence at an oral hearing;
(5) Take or order the taking of depositions;
(6) Admit or exclude evidence;
(7) Hear oral argument on facts or law;
(8) Require each party to provide all other parties and the presiding officer with a copy of any exhibit that the party intends to introduce into evidence prior to any oral hearing to be conducted by telephone or audio-visual telecommunication;
(9) Require each party to provide all other parties with a copy of any document that the party intends to use to examine a deponent prior to any deposition to be conducted by telephone or audio-visual telecommunication;
(10) Require that any hearing to be conducted by telephone or audio-visual telecommunication be conducted at locations at which the parties and the presiding officer are able to transmit and receive documents during the hearing;
(11) Require that any deposition to be conducted by telephone or audio-visual telecommunication be conducted at locations at which the parties are able to transmit and receive documents during the deposition; and
(12) Do all acts and take all measures necessary for the maintenance of order and the efficient conduct of the proceeding, including the exclusion of contumacious counsel or other persons.
(b) Motions and requests. The presiding officer is authorized to rule on all motions and requests filed in the proceeding prior to submission of the presiding officer's report to the judicial officer, Provided, That a presiding officer is not authorized to dismiss a complaint. Submission or certification of any question to the judicial officer, prior to submission of the report, shall be in the discretion of the presiding officer.
(c) Reassignment. For any good reason, including absence, illness, resignation, death, or inability to act, of the attorney assigned to act as a presiding officer in any proceeding under these rules, the powers and duties of such attorney in the proceeding may be assigned to any other attorney who is employed in the Office of the General Counsel of the Department, without abatement of the proceeding.
(d) Disqualification. No person shall be assigned to act as a presiding officer in any proceeding who (1) has any material pecuniary interest in any matter or business involved in the proceeding; (2) is related within the third degree by blood or marriage to any party to the proceeding; or (3) has any conflict of interest which might impair such person's objectivity in the proceeding. A person assigned to act as a presiding officer shall ask to be replaced, in any proceeding in which such person believes that reason exists for disqualification of such person.
(e) Procedure on petition for disqualification. Any party may file a petition for disqualification of the presiding officer, which shall set forth with particularity the grounds of alleged disqualification. Any such petition shall be filed with the hearing clerk, who shall immediately transmit it to the judicial officer and inform the presiding officer. The record of the proceeding also shall immediately be transmitted to the judicial officer. After such investigation or hearing as the judicial officer deems necessary, the judicial officer shall either deny the petition or direct that another presiding officer be assigned to the proceeding. The petition, and notice of the order of the judicial officer, shall be made a part of the record and served on the parties; if any record is made on such a petition, it shall be a part of the record of the proceeding.
Witnesses subpoenaed before the presiding officer, and witnesses whose depositions are taken, shall be entitled to the same fees and mileage as are paid for like services in the courts of the United States. Fees and mileage shall be paid by the party at whose instance the witness appears or the deposition is taken.
Official notice shall be taken of such matters as are judicially noticed by the courts of the United States and of any other matter of technical or scientific fact of established character: Provided, That the parties shall be given notice of matters so noticed, and shall be given adequate opportunity to show that such facts are erroneously noticed.
At any time after docketing of a proceeding and before commencement of a hearing, oral or written, therein, the presiding officer may, upon petition, and for good cause shown, permit any person to intervene therein. The petition shall state with preciseness and particularity: (a) The petitioner's relationship to the matters involved in the proceeding; (b) the nature of the material the petitioner intends to present in evidence; (c) the nature of the argument the petitioner intends to make; and (d) the reasons why the petitioner should be allowed to intervene. Any such petition, and notice of the order thereon, shall be served on the parties and made a part of the record in the proceeding.
(a) At no stage of the proceeding between its docketing and the issuance of the final decision shall the presiding officer or judicial officer discuss ex parte the merits of the proceeding with any party, or attorney or representative of a party: Provided, That procedural matters shall not be included within this limitation; and Provided further, That the presiding officer or judicial officer may discuss the merits of the case with such a person if all parties to the proceeding or their attorneys or representatives have been served with notice and an opportunity to participate. A memorandum of any such discussion shall be included in the record.
(b) No party, or attorney or representative of a party, or other person not an employee of the Department, shall make or knowingly cause to be made to the presiding officer or judicial officer an ex parte communication relevant to the merits of the proceeding.
(c) If the presiding officer or judicial officer receives an ex parte communication in violation of this section, the one who receives the communication shall place in the public record of the proceeding:
(1) Such communication if written, or a memorandum stating the substance of such communication if oral; and
(2) A copy of any written response or a memorandum stating the substance of any oral response thereto.
(d) Copies of all such items placed or included in the record, as provided in this section, shall be served on all parties.
(e) For purposes of this section “ex parte communication” means an oral or written communication not on the public record with respect to which reasonable prior notice to all parties is not given, but it shall not include a request for a status report on any matter or the proceeding.
The Secretary may act in the place and stead of a presiding officer or the judicial officer in any proceeding hereunder, or any matter in connection therewith.
The Uniform Rules of Practice for the Department of Agriculture promulgated in Subpart H of Part 1, Subtitle A, Title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the Packers and Stockyards Act, as amended (7 U.S.C. 181 et seq.). In addition, the Supplemental Rules of Practice set forth in this part shall be applicable to such proceedings.
(a) The Administrator may enter into a stipulation with any person operating subject to the Packers and Stockyards Act, as amended (P&S Act), prior to issuing a complaint that seeks a civil penalty against that person.
(1) The Administrator will give the person notice of an alleged violation of the P&S Act or regulations and provide an opportunity for a hearing;
(2) The person has the option to expressly waive the opportunity for a hearing and agree to pay a specified civil penalty within a designated time;
(3) The Administrator will agree to settle the matter by accepting payment of the specified civil penalty within a designated time;
(4) If the person does not agree to the stipulation, or does not pay the penalty within the specified time, the Administrator may issue an administrative complaint citing the alleged violation; and
(5) The civil penalty that the Administrator proposed in a stipulation agreement has no bearing on the civil penalty amount that may be sought in a formal administrative proceeding against the same person for the same alleged violation.
(b) [Reserved]
(a) In recent months, the Department has received information, confirmed by investigation, that a number of packers subject to the Packers and Stockyards Act have made gifts of meat to Government employees responsible for conducting service activities of the Department. Such gifts have the implications of fraud, even if not made specifically for the purpose of influencing these employees in the performance of their duties.
(b) It is a violation of the Meat Inspection Act for any person, firm, or corporation to give to any employee of the Department performing duties under such act anything of value with intent to influence such employee in the discharge of his duties, or for such employee to receive from any person, firm, or corporation engaged in interstate or foreign commerce any gift given with any intent or purpose whatsoever (21 U.S.C. 90). Under the Federal meat grading regulations, the giving or attempting to give by a packer of anything of value to any employee of the Department authorized to perform any function under such regulations is a basis for the withdrawal of Federal meat grading service (7 CFR 53.13). The receiving by an employee of the Department of any gift from any person for whom grading, inspection, or other service work is performed is specifically prohibited by Departmental regulations.
(c) Upon the basis of paragraphs (a) and (b) of this section, it is the view of the Department that it is an unfair and deceptive practice in violation of section 202(a) of the Packers and Stockyards Act (7 U.S.C. 192(a)) for any person subject to the provisions of Title II of said Act to give or offer to give meat, money, or anything of value to any Government employee who performs inspection, grading, reporting, or regulatory duties directly relating to the purchase or sale of livestock or the preparation or distribution of meats, meat food products, livestock products in unmanufactured form, poultry or poultry products.
(a) Records to be kept. Section 401 of the Packers and Stockyards Act (7 U.S.C. 221) provides, in part, that every packer, live poultry dealer, stockyard owner, market agency, and dealer shall keep such accounts, records, and memoranda as fully and correctly disclose all transactions involved in his business, including the true ownership of such business by stockholding or otherwise. In order to properly administer the P&S Act, it is necessary that records be retained for such periods of time as may be required to permit the Packers and Stockyards Division (PSD) a reasonable opportunity to examine such records. Section 401 of the Act does not, however, provide for the destruction or disposal of records. Therefore, the Department has formulated this policy statement to provide guidance as to the periods of time after which records may be disposed of or destroyed.
(b) Records may be disposed of after two years except as otherwise provided. Except as provided in paragraph (c) of this section, each packer, live poultry dealer, stockyard owner, market agency, and dealer may destroy or dispose of accounts, records, and memoranda which contain, explain, or modify transactions in its business subject to the Act after such accounts, records, and memoranda have been retained for a period of two full years; Provided, That the following records made or kept by a packer may be disposed of after one year: cutting tests; departmental transfers; buyers' estimates; drive sheets; scale tickets received from others; inventory and products in storage; receiving records; trial balances; departmental overhead or expense recapitulations; bank statements, reconciliations and deposit slips; production or sale tonnage reports (including recapitulations and summaries of routes, branches, plants, etc.); buying or selling pricing instructions and price lists; correspondence; telegrams; teletype communications and memoranda relating to matters other than contracts, agreements, purchase or sales invoices, or claims or credit memoranda; and Provided further, That microfilm copies of records may be substituted for and retained in lieu of the actual records.
(c) Retention for longer periods may be required. The periods specified in paragraph (b) of this section shall be extended if the packer, live poultry dealer, stockyard owner, market agency, or dealer is notified in writing by the Administrator that specified records should be retained for a longer period pending the completion of any investigation or proceedings under the Act.
(d) Unauthorized disposal of records. If it is found that any person subject to the Act has disposed of accounts, records, and memoranda which are necessary to fully and correctly disclose all transactions in its business prior to the periods specified in this statement, consideration will be given to the issuance of a complaint charging a violation of section 401 of the Act and seeking an appropriate order. The administrative proceeding initiated will be conducted in accordance with the Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary (7 CFR 1.130 et seq.).
It has become a practice in certain areas of the country for market agencies, engaged in the business of selling consigned livestock on a commission basis, to pay certain of the business or personal expenses incurred by buyers attending livestock sales conducted by such market agencies, such as, expenses for meals, lodging, travel, entertainment and long distance telephone calls. Investigation by the Department, discloses that this practice tends to become a method of competition between similarly engaged market agencies and results in undue and unreasonable cost burdens on such market agencies and the livestock producers who sell their livestock through such market agencies.
It is the view of the Department that it constitutes violations of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 181 et seq.), for any market agency engaged in the business of selling consigned livestock on a commission basis, to pay, directly or indirectly, any personal or business expenses of livestock buyers attending sales conducted by such market agency. In the future, if any market agency engages in such practice, consideration will be given by the PSD to the issuance of a complaint charging the market agency with violation of the Act. In the formal administrative proceeding initiated by any such complaint, the Judicial Officer of the Department will determine, after full hearing, whether the market agency has violated the Act and should be ordered to cease and desist from continuing such violation, and whether the registration of such market agency should be suspended for a reasonable period of time.
(a) The PSD receives numerous complaints concerning the failure or refusal of buyers to pay the full purchase price for, or to accept delivery of, their purchases of meat and meat food products and sellers failing to meet contractual specifications. Most such complaints arise out of disputes concerning condition, grade, weight, or shipping instructions.
(b) It is believed that both seller and buyer should take the following points into consideration when selling and buying meat and meat food products:
(1) Terms of shipment and time of arrival. Terms and conditions of shipment and delivery should be specified in the contract and both parties should understand fully all terms and conditions of the contract. Any deviation from normal practices, such as a guaranty by the shipper as to the date of arrival at destination, or a deviation from the normal meaning of terms, should also be fully understood and made a part of the contract.
(2) Quality and condition. (i) A seller has the responsibility of making certain that the meat and meat food products shipped are in accordance with the terms of the contract specifications.
(ii) When a buyer believes that the shipment does not meet the terms of the contract, he should immediately contact the seller or the seller's agent and advise him of the nature of the complaint. This affords the seller an opportunity to renegotiate the contract, to personally inspect the meat or meat food products, or to have an impartial party inspect or examine the meat or meat food products. Inspection and examination service of this type is available nationally through the USDA meat grading service and locally through various impartial persons or agencies.
(iii) All terms of a transaction should be made clear in the contract, whether written or verbal. If there is any chance of misunderstanding, a written confirmation should be exchanged between the parties. In any case where a contract dispute cannot be settled between the parties and either party intends to file a complaint, such complaint should be brought to the attention of the nearest PSD regional office as soon as possible. However, a concerted effort on the part of both buyer and seller to negotiate clear and complete contracts will greatly reduce misunderstandings which can result in the filing of complaints with PSD.
(c) If the PSD has reason to believe that any packer unjustifiably (1) has refused to pay the contractual price for meat or meat food products purchased, (2) has refused to accept a shipment of meat or meat food products, or (3) has failed to ship meat or meat food products in accordance with the terms of the contract specifications, consideration will be given to the issuance of a complaint charging the packer with violation of section 202 of the Act. In the formal administrative proceeding initiated by any such complaint, the Judicial Officer of the Department will determine, upon the basis of the record in the proceeding, whether the packer has violated the Act and should be ordered to cease and desist from continuing such violation.
(a) Under the Packers and Stockyards Act, 1921, as amended and supplemented (7 U.S.C. 181 et seq.), the principal test of insolvency is to determine whether a person's current liabilities exceed his current assets. This current ratio test of insolvency under the Act has been reviewed and affirmed by a United States Court of Appeals. Bowman v. United States Department of Agriculture, 363 F. 2d 81 (5th Cir. 1966).
(b) For the purposes of the administration of the Packers and Stockyards Act, 1921, the following terms shall be construed, respectively, to mean:
(1) Current assets means cash and other assets or resources commonly identified as those which are reasonably expected to be realized in cash or sold or consumed during the normal operating cycle of the business, which is considered to be one year.
(2) Current liabilities means obligations whose liquidation is reasonably expected to require the use of existing resources principally classifiable as current assets or the creation of other current liabilities during the one year operating cycle of the business.
(c) The term current assets generally includes: (1) Cash in bank or on hand; (2) sums due a market agency from a custodial account for shippers' proceeds; (3) accounts receivable, if collectible; (4) notes receivable and portions of long-term notes receivable within one year from date of balance sheet, if collectable; (5) inventories of livestock acquired for purposes of resale or for purposes of market support; (6) feed inventories and other inventories which are intended to be sold or consumed in the normal operating cycle of the business; (7) accounts due from employees, if collectable; (8) accounts due from officers of a corporation, if collectable; (9) accounts due from affiliates and subsidiaries of corporations if the financial position of such subsidiaries and affiliates justifies such classification; (10) marketable securities representing cash available for current operations and not otherwise pledged as security; (11) accrued interest receivable; and (12) prepaid expenses.
(d) The term current assets generally excludes: (1) Cash and claims to cash which are restricted as to withdrawal, such as custodial funds for shippers' proceeds and current proceeds receivable from the sale of livestock sold on a commission basis; (2) investments in securities (whether marketable or not) or advances which have been made for the purposes of control, affiliation, or other continuing business advantage; (3) receivables which are not expected to be collected within 12 months; (4) cash surrender value of life insurance policies; (5) land and other natural resources; and (6) depreciable assets.
(e) The term current liabilities generally includes: (1) Bank overdrafts (per books); (2) amounts due a custodial account for shippers' proceeds; (3) accounts payable within one year from date of balance sheet; (4) notes payable or portions thereof due and payable within one year from date of balance sheet; (5) accruals such as taxes, wages, social security, unemployment compensation, etc., due and payable as of the date of the balance sheet; and (6) all other liabilities whose regular and ordinary liquidation is expected to occur within one year.
(a) Section 304 of the Packers and Stockyards Act (7 U.S.C. 205) provides that: “All stockyard services furnished pursuant to reasonable request made to a stockyard owner or market agency at such stockyard shall be reasonable and nondiscriminatory and stockyard services which are furnished shall not be refused on any basis that is unreasonable or unjustly discriminatory….”
(b) Section 305 of the Act (7 U.S.C. 206) states that: “All rates or charges made for any stockyard services furnished at a stockyard by a stockyard owner or market agency shall be just, reasonable, and nondiscriminatory….”
(c) Section 307 (7 U.S.C. 208) provides that: “It shall be the duty of every stockyard owner and market agency to establish, observe, and enforce just, reasonable, and nondiscriminatory regulations and practices in respect to the furnishing of stockyard services….”
(d) Section 312(a) (7 U.S.C. 213(a)) provides that: “It shall be unlawful for any stockyard owner, market agency, or dealer to engage in or use any unfair, unjustly discriminatory, or deceptive practice or device in connection with determining whether persons should be authorized to operate at the stockyards, or with the receiving, marketing, buying, or selling on a commission basis or otherwise, feeding, watering, holding, delivery, shipment, weighing or handling, in commerce, of livestock.”
(e) Section 301(b) (7 U.S.C. 201(b)) defines “stockyard services” as any “services or facilities furnished at a stockyard in connection with the receiving, buying, or selling on a commission basis or otherwise, marketing, feeding, watering, holding, delivery, shipment, weighing, or handling, in commerce, of livestock.”
(f) It is the view of the Department that it is a violation of sections 304, 307, and 312(a) of the Act for a stockyard owner or market agency to discriminate, in the furnishing of stockyard services or facilities or in establishing rules or regulations at the stockyard, because of race, religion, color, or national origin of those persons using the stockyard services or facilities. Such services and facilities include, but are not limited to, the restaurant, restrooms, drinking fountains, lounge accommodations, those furnished for the selling, weighing, or other handling of the livestock, and facilities for observing such services.
(g) If the PSD has reason to believe that any stockyard owner or market agency has so discriminated in the furnishing of stockyard services or facilities, consideration will be given to the issuance of a complaint charging the stockyard or market agency with violations of the Act.
1. Who is a customer? (a) A customer is a person who buys for resale directly from the packer, or through the packer's agent or broker; and in addition, a customer is any buyer of the packer's product for resale who purchases from or through a wholesaler or other intermediate reseller.
In determining whether a packer has fulfilled its obligations toward its customers, the PSD will recognize that there may be some exceptions to this general definition of “customer.” For example, the purchaser of distress merchandise would not be considered a “customer” simply on the basis of such purchase. Similarly, a retailer who purchases solely from other retailers or one who makes only sporadic purchases, or one who does not regularly sell the packer's product or who is a type of retail outlet not usually selling such products will not be considered a “customer” of the packer unless the packer has been put on notice that such retailer is selling its product.)
(b) Competing customers are all businesses that compete in the resale of the packer's products of like grade and quality at the same functional level of distribution, regardless of whether they purchase direct from the packer or through some intermediary.
2. Definition of services. Services are any kind of advertising or promotion of a packer's product, including but not limited to, cooperative advertising, handbills, window and floor displays, demonstrators and demonstrations, customer coupons, and point of purchase activity.
3. Need for a plan. If a packer makes payments or furnishes services, it should do so under a plan that meets several requirements. If there are many competing customers to be considered, or if the plan is at all complex, the packer would be well advised to put its plan in writing. The requirements are:
(a) Proportionally equal terms—The payments or services under the plan should be made available to all competing customers on proportionally equal terms. This means that payments or services should be made proportionately on some basis that is fair to all customers who compete in the resale of the packer's products. No single way to achieve the proper proportion is prescribed, and any method that treats competing customers on proportionally equal terms may be used. Generally, this can best be done by basing the payments made or the services furnished on the dollar volume or on the quantity of goods purchased during a specified period. Other methods which are fair to all competing customers are also acceptable.
(b) Packer's duty to inform—The packer should take reasonable action, in good faith, to inform all its competing customers of the availability of its promotional program. Such notification should include all the relevant details of the offer in time to enable customers to make an informed judgment whether to participate. Where such one-step notification is impracticable, the packer may, in lieu thereof, maintain a continuing program of first notifying all competing customers of the types of promotions offered by the packer and a specific source for the customer to contact in order to receive full and timely notice of all relevant details of the packer's promotions. Such notice should also inform all competing customers that the packer offers advertising allowances and/or other promotional assistance that are usable in a practical business sense by all retailers regardless of size. When a customer indicates its desire to be put on the notification list, the packer should keep that customer advised of all promotions available in its area as long as the customer so desires. The packer may make the required notification by any means it chooses; but in order to show later that it gave notice to a certain customer, it is in a better position to do so if it was given in writing or a record was prepared at the time of notification showing date, person notified, and contents of notification.
If more direct methods of notification are impracticable, a packer may employ one or more of the following methods, the sufficiency of which will depend upon the complexity of its own distribution system. Different packers may find that different notification methods are most effective for them:
(1) The packer may enter into contracts with its wholesaler, distributors or other third parties which conform to the requirements of item 5, infra.
(2) The packer may place appropriate announcements on product containers or inside thereof with conspicuous notice of such enclosure on the outside.
(3) The packer may publish notice of the availability and essential features of a promotional plan in a publication of general distribution in the trade.
(A packer should not rely on a written agreement authorizing an intermediary to receive notice of and/or payment under a promotional plan for a retailer if the packer knows, or should know, that the retailer was coerced into signing the agreement. In addition, a packer should assume that an intermediary is not authorized to receive notice of and/or payment under a promotional plan for a retailer unless there is a written authorization signed by such retailer.)
(c) Availability to all competing customers—The plan should be such that all types of competing customers may participate. It should not be tailored to favor or discriminate against a particular customer or class of customers but should, in its terms, be usable in a practical business sense by all competing customers. This may require offering all such customers more than one way to participate in the plan or offering alternative terms and conditions to customers for whom the basic plan is not usable and suitable. The packer should not, either expressly or by the way the plan operates, eliminate some competing customers, although it may offer alternative plans designed for different customer classes. If it offers alternative plans, all of the plans offered should provide the same proportionate equality and the packer should inform competing customers of the various alternative plans.
When a packer, in good faith, offers a basic plan, including alternatives, which is reasonably fair and nondiscriminatory and refrains from taking any steps which would prevent any customer, or class of customers, from participating in its program, it shall be deemed to have satisfied its obligation to make its plan functionally available to all customers, and the failure of any customer or customers to participate in the program shall not be deemed to place the packer in violation of the provisions of the Packers and Stockyards Act.
(d) Need to understand terms—In informing customers of the details of a plan, the packer should provide them sufficient information to give a clear understanding of the exact terms of the offer, including all alternatives, and the conditions upon which payment will be made or services furnished.
(e) Checking customer's use of payments—The packer should take reasonable precautions to see that services it is paying for are furnished and also that it is not overpaying for them. Moreover, the customer should expend the allowance solely for the purpose for which it was given. If the packer knows or should know that what it pays or furnishes is not being properly used by some customers, the improper payments or services should be discontinued.
A packer who, in good faith, takes reasonable and prudent measures to verify the performance of its competing customers will be deemed to have satisfied its obligations under the Act. Also, a packer who, in good faith, concludes a promotional agreement with wholesalers or other intermediaries and who otherwise conforms to the standards of Item 5 shall be deemed to have satisfied this obligation. If a packer has taken such steps, the fact that a particular customer has retained an allowance in excess of the cost, or approximate cost if the actual cost is not known, of services performed by the customer shall not alone be deemed to place a packer in violation of the Act.
(When customers may have different but closely related costs in furnishing services that are difficult to determine such as the cost for distributing coupons from a bulletin board or using a window banner, the packer may furnish to each customer the same payment if it has a reasonable relationship to the cost of providing the service or is not grossly in excess thereof.)
4. Competing customers. The packer is required to provide in its plan only for those customers who compete with each other in the resale of the packer's products of like grade and quality. Therefore a packer should make available to all competing wholesalers any plan providing promotional payments or services to wholesalers, and similarly should make available to all competing retailers any plan providing promotional payments or services to retailers. With these requirements met, a packer can limit the area of its promotion. However, this section is not intended to deal with the question of a packer's liability for use of an area promotion where the effect may be to injure the packer's competition.
5. Wholesaler or third party performance of packer's obligations. A packer may, in good faith, enter into written agreements with intermediaries, such as wholesalers, distributors or other third parties, including promoters of tripartite promotional plans, which provide that such intermediaries will perform all or part of the packer's obligations under this part. However, the interposition of intermediaries between the packer and its customers does not relieve the packer of its ultimate responsibility of compliance with the provisions of the Packers and Stockyards Act. The packer, in order to demonstrate its good faith effort to discharge its obligations under this part, should include in any such agreement provisions that the intermediary will:
(1) Give notice to the packer's customers in conformity with the standards set forth in items 3(b) and (d), supra;
(2) Check customer performance in conformity with the standards set forth in item 3(e), supra;
(3) Implement the plan in a manner which will insure its functional availability to the packer's customers in conformity with the standards set forth in item 3(c), supra (This must be done whether the plan is one devised by the packer itself or by the intermediary for use by the packer's customers.); and
(4) Provide certification in writing and at reasonable intervals that the packer's customers have been and are being treated in conformity with the agreement.
A packer who negotiates such agreements with its wholesalers, distributors or third party promoters will be considered by the Administration to have justified its “good faith” obligations under this section only if it accompanies such agreements with the following supplementary measures: At regular intervals the packer takes affirmative steps to verify that its customers are receiving the proportionally equal treatment to which they are entitled by making spot checks designed to reach a representative cross section of its customers. Whenever such spot checks indicate that the agreements are not being implemented in such a way that its customers are receiving such proportionally equal treatment, the packer takes immediate steps to expand or to supplement such agreements in a manner reasonably designed to eliminate the repetition or continuation of any such discriminations in the future.
Intermediaries, subject to the Packers and Stockyards Act, administering promotional assistance programs on behalf of a packer may be in violation of the provisions of the Packers and Stockyards Act, if they have agreed to perform the packer's obligations under the Act with respect to a program which they have represented to be usable and suitable for all the packer's competing customers if it should later develop that the program was not offered to all or, if offered, was not usable or suitable, or was otherwise administered in a discriminatory manner.
6. Customer's liability. A customer, subject to the Packers and Stockyards Act, who knows, or should know, that it is receiving payments or services which are not available on proportionally equal terms to its competitors engaged in the resale of the same packer's products may be in violation of the provisions of the Act. Also, customers (subject to the Packers and Stockyards Act) that make unauthorized deductions from purchase invoices for alleged advertising or other promotional allowances may be proceeded against under the provisions of the Act.
7. Meeting competition. A packer charged with discrimination under the provisions of the Packers and Stockyards Act may defend its actions by showing that the payments were made or the services were furnished in good faith to meet equally high payments made by a competing packer to the particular customer, or to meet equivalent services furnished by a competing packer to the particular customer. This defense, however, is subject to important limitations. For instance, it is insufficient to defend solely on the basis that competition in a particular market is very keen, requiring that special allowances be given to some customers if a packer is “to be competitive.”
8. Cost justification. It is no defense to a charge of unlawful discrimination in the payment of an allowance or the furnishing of a service for a packer to show that such payment or service could be justified through savings in the cost of manufacture, sale, or delivery.
(a) Within the times specified under sections 206(b), 207(d), and 318(b) of the Act, any livestock seller, live poultry seller or grower, to preserve their interest in the statutory trust, must give written notice to the appropriate packer, live poultry dealer, or livestock dealer and file such notice with the Secretary within the prescribed time by letter, fax, email, or other electronic transmission. The written notice should provide:
(1) Notification to preserve trust benefits;
(2) Identification of packer, live poultry dealer, or livestock dealer;
(3) Identification of seller or poultry grower;
(4) Date of the transaction;
(5) Date of seller's or poultry grower's receipt of notice that payment instrument has been dishonored (if applicable); and
(6) Amount of money due; and to make certain that a copy of such letter, fax, email, or other electronic transmission is filed with a PSD regional office or with the PSD headquarters office within the prescribed time.
(b) While the information in paragraphs (a)(1) through (6) of this section is desirable, any written notice which informs the packer, live poultry dealer, or livestock dealer, and the Secretary that the packer, live poultry dealer, or livestock dealer has failed to pay is sufficient to meet the statutory requirement in paragraph (a) of this section if it is given within the prescribed time.
(c) For purposes of administering statutory trusts under the Act, a cash sale means a sale in which the seller does not expressly extend credit to the buyer.
(a) The Department recognizes that one who sells livestock to a packer, market agency, or dealer, who is purchasing for slaughter, may not intend to be present at the point of transfer of possession of the livestock, to receive payment, at the time a check in payment for such livestock may be delivered by the purchaser, and may not wish to authorize a representative to receive such a check; or for other reasons such a seller may prefer that such a purchaser make payment by mailing a check within the time limit as prescribed in section 409(a) of the Act. In cases when the seller does not intend to be present, he may use the following form of notification to the purchaser:
I do not intend to be present at the point of transfer of possession of livestock sold by me to (name of packer, market agency, or dealer) for the purpose of receiving a check in payment for such livestock.
I hereby direct (name of packer, market agency, or dealer) to make payment for livestock purchased from me, by mailing a check for the full amount of the purchase price before the close of the next business day following the purchase of livestock and transfer of possession thereof or, in the case of a purchase on a “carcass” or “grade and yield” basis, not later than the close of the first business day following determination of the purchase price.
This does not constitute an extension of credit to (name of packer, market agency or dealer). This is subject to cancellation by me at any time, and if not cancelled by (date), it shall terminate on that date.
(b) The Department believes that such an agreement would not constitute an extension of credit within the meaning of section 206 of the Act because it would not give the purchaser any more time to issue a check than is provided in section 409(a).
(a) Requests have been received from stockyard operators, market agencies, and livestock producers urging a reduction of rate regulation at posted stockyards. Their requests are based on the belief that competition among markets will set a level of rates and charges fair to both the market operator and to the livestock producer. PSD will accept for filing tariffs containing any level of charges after 10 days' notice to the public and to the Secretary as required by the Act.
(b) PSD will not investigate the level of rates and charges established by stockyard owners and market agencies for reasonableness except upon receipt of a valid complaint or under compelling circumstances warranting such an investigation. Stockyard owners and market agencies will have substantial flexibility in setting their own rates and charges.
(c) Complaints filed about the reasonableness of rates and charges will be investigated to determine the validity of such complaints and appropriate action taken if warranted.
(d) PSD will continue to insure that the schedules of rates and charges filed with the Department are applied uniformly and in a nondiscriminatory manner.
(a) In its administration of the Packers and Stockyards Act, the Department has sought to promote and maintain open and fair competition in the livestock and packing industries, and to prevent unfair or anticompetitive practices when they are found to exist. It is the opinion of the Department that the ownership or operation of custom feedlots by packers presents problems which may under some circumstances result in violations of the Packers and Stockyards Act.
(b) Packers contemplating entering into such arrangements with custom feedlots are encouraged to consult with the Administration prior to the commencement of such activities. Custom feedlots are not only places of production, but are also important marketing centers, and in connection with the operation of a custom feedlot, it is customary for the feedlot operator to assume responsibility for marketing fed livestock for the accounts of feedlot customers. When a custom feedlot is owned or operated by a packer, and when such packer purchases fed livestock from the feedlot, this method of operation potentially gives rise to a conflict of interest. In such situations, the packer's interest in the fed livestock as a buyer is in conflict with its obligations to feedlot customers to market their livestock to the customer's best advantage. Under these circumstances, the packer should take appropriate measures to eliminate any conflict of interest. At a minimum, such measures should insure:
(1) That feedlot customers are fully advised of the common ties between the feedlot and the packer, and of their rights and options with respect to the marketing of their livestock;
(2) That all feedlot customers are treated equally by the packer/custom feedlot in connection with the marketing of fed livestock; and
(3) That marketing decisions rest solely with the feedlot customer unless otherwise expressly agreed.
(c) Packer ownership or operation of custom feedlots may also give rise to competitive problems in some situations. Packers contemplating or engaging in the business of operating a custom feedlot should carefully review their operations to assure that no restriction of competition exists or is likely to occur.
(d) The Department does not consider the existence of packer/custom feedlot relationships, by itself, to constitute a violation of the Act. In the event it appears that a packer/custom feedlot arrangement gives rise to a violation of the Act, an investigation will be made on a case-by-case basis, and, where warranted, appropriate action will be taken.
(a) In its administration of the Packers and Stockyards Act, the Department has sought to prevent conflicts of interest and to maintain open and fair competition in the livestock and meat packing industries. The ownership or operation of livestock dealers or buying agencies by packers, under some circumstances, may result in violations of the Packers and Stockyards Act.
(b) Traditionally, livestock dealers and buying agencies purchase livestock for resale or to fill orders for farmers, ranchers, producers, other livestock firms and packers. When a livestock dealer or buying agency is owned or operated by a packer, and when such packer is also buying livestock for its own operational requirements, there is a potential conflict of interest. Furthermore, the purchase and sale of livestock by meat packers may result in control of markets and prices which could adversely affect both livestock producers, competing packers, and consumers.
(c) Arrangements between packers and dealers or buying agencies which do not normally create a conflict of interest or result in a restraint of competition include:
(1) Operations utilizing different species or classes of livestock;
(2) Operations where the business activities are widely separated geographically; and
(3) Operations where tie-in purchases or sales are not involved. Packers contemplating engaging in the business of a livestock dealer or a buying agency are encouraged to consult with the PSD prior to the commencement of such activities.
(d) In the event a packer/dealer or a packer/buying agency arrangement appears to give rise to a violation of the Act, an investigation will be made on a case-by-case basis and, where warranted, appropriate action will be taken.
Terms defined in section 1324 of the Food Security Act of 1985, Pub. L. 99-198, 99 Stat. 1535, 7 U.S.C. 1631, shall mean the same in this part as therein. In addition, except as otherwise specified, as used in this part:
Approved Unique Identifier means a combination of numbers selected by the Secretary of State using a selection system or method approved by the Secretary of Agriculture.
EFS means effective financing statement as defined in subsection (c)(4);
Master list means the accumulation of data in paper, electronic, or other form, described in subsection (c)(2)(C);
Portion means portion of the master list distributed to registrants under subsection (c)(2)(E);
Registrant means any buyer of farm products, commission merchant, or selling agent, as referred-to in the Section, registered with a system under subsection (c)(2)(D);
The Secretary means the Secretary of Agriculture of the United States;
The Section means section 1324 of the above-cited Act, and “subsection” means a subsection of that Section;
System means central filing system as defined in subsection (c)(2);
System operator means Secretary of State or other person designated by a State to operate a system;
UCC or Uniform Commercial Code means the Uniform Commercial Code prepared under the joint sponsorship of the American Law Institute and the National Conference of Commissioners on Uniform State Laws, and in effect in most States of the United States at the time of enactment of Pub. L. 99-198.
(a) To obtain certification of a system, a written request for certification must be filed together with such documents as show that the system complies with the Section. If such material is voluminous, a summary, table of contents, and index must accompany it as necessary to facilitate review.
(b) The request must:
(1) Include an introductory explanation of how the system will operate;
(2) Identify the information which will be required to be supplied on an EFS;
(3) Identify where an EFS, amendment thereto, or continuation thereof, will be filed and, if elsewhere than with the system operator, explain how and in what form the system operator will receive information needed to compile and update the master list;
(4) Explain the method for recording the date and hour of filing of an EFS, amendment thereto, or continuation thereof;
(5) Explain how the master list will be compiled, including the method and form of storage and arrangement of information, explain the method and form of retrieval of information from the master list, the method and form of distribution of portions of the master list to registrants as required by subsection (c)(2)(E), and the method and form of furnishing of information orally with written confirmation as required by subsection (c)(2)(F) (details of computer hardware and software need not be furnished but the results it will produce must be explained);
(6) Explain how the list of registrants will be compiled, including identification of where and how they will register, what information they must supply in connection with registration, and the method and form of storage and retrieval of such information (details of computer hardware and software need not be furnished but the results it will produce must be explained);
(7) Show how frequently portions of the master list will be distributed regularly to registrants;
(8) Show the farm products according to which the master list will be organized;
(9) Show how the system will interpret the term “crop year” and how it will classify as to crop year an EFS not showing crop year;
(10) Show what fee will be charged and explain how the costs of the system will be covered if not by such fee and the general revenue of the State;
(11) If a unique identifier will be used in the system, explain how the unique identifier will be selected and how it will be used by the system, including, but not limited to, how lists will be organized, and how searches may be performed, using the unique identifier.
(12) Include copies of:
(i) All State legislation or other legal authority under which the system is created and operated, and the system operator is designated;
(ii) All regulations, rules, and requirements issued under such legislation or other legal authority and governing operation of the system, designation of the system operator, and use of the system by members of the public; and
(iii) All printed and electronic forms required to be used in connection with the system.
(c) Any such request and attachments must be filed in triplicate (one copy for public inspection, as second copy for use in AMS, and a third copy for use in the Office of the General Counsel, USDA). All three copies must be received in the headquarters of the Packers and Stockyards Division, Agricultural Marketing Service (AMS), USDA, Washington, DC 20250.
(d) A refusal to certify such a system, if any, will be explained in writing. Reconsideration of such a refusal must be requested in writing with specification of errors believed to have been made.
(e) To make changes to an existing certified central filing system, including changes necessitated or made possible by amendments to the Section, a written request to amend the existing certified central filing system must be filed together with such documents as are necessary to show that the system complies with the Section. The request must contain relevant new information consistent with the requirements specified elsewhere in this section.
On an EFS, and on a master list, the name of the person subjecting a farm product to a security interest must appear as follows:
(a) In the case of a natural person, the surname (last name or family name) must appear first;
(b) In the case of a corporation or other entity not a natural person, the name must appear beginning with the first word or character not an article or punctuation mark.
(a) The minimum information necessary on an EFS is as follows:
(1) Crop year unless every crop of the farm product in question, for the duration of the EFS, is to be subject to the particular security interest;
(2) Farm product name (see §§ 205.106, 205.206);
(3) Each county or parish in the same State where the farm product is produced or located;
(4) Name and address of each person subjecting the farm product to the security interest, whether or not a debtor (see § 205.102);
(5) Social security number or other approved unique identifier or, if other than a natural person, IRS taxpayer identification number or other approved unique identifier of each such person;
(6) Further details of the farm product subject to the security interest if needed to distinguish it from other such product owned by the same person or persons but not subject to the particular security interest (see § 205.207); and
(7) Secured party name and address.
(b) A requirement of additional information on an EFS is discretionary with the State.
(c) Whether to permit one EFS to reflect multiple products, or products in multiple counties, is discretionary with the State.
(a) The minimum information necessary on a registration of a buyer, commission merchant, or selling agent is as follows:
(1) Buyer, commission merchant, or selling agent name and address;
(2) Farm product or products (see §§ 205.106, 205.206) in which registrant is interested; and
(3) If registrant is interested only in such product or products produced or located in a certain county or parish, or certain counties or parishes, in the same State, the name of each such county or parish.
(b) A registrant, if not registered for any specified county or parish, or counties or parishes, must be deemed to have registered for all counties and parishes shown on the master list.
(c) A requirement of additional information on a registration form is discretionary with the State.
(a) The master list must contain all the information on all the EFS's filed in the system, so arranged that it is possible to deliver to any registrant all such information relating to any product, produced or located in any county or parish (or all counties or parishes), for any crop year, covered by the system. The system must be able to deliver all such information to any registrant, either in alphabetical order by the word appearing first in the name of each person subjecting a product to a security interest (see § 205.102), in numerical order by social security number or approved unique identifier (or, if other than a natural person, IRS taxpayer identification number or approved unique identifier) of each such person, or in both alphabetical and numerical orders, as requested by the registrant.
(b) Section (c)(2)(E) requires the portion to be distributed in “written or printed form.” This means recording on paper by any technology in a form that can be read by humans without special equipment. The system may, however, honor requests from registrants to substitute recordings on any medium by any technology including, but not limited to, electronic recording on tapes or discs in machine-readable form, and on photographic recording on microfiche. It also includes, if requested by registrants, electronic transmissions whereby registrants can print their own paper copies.
(c) After distribution of a portion of a master list, there can be supplementary distribution of a portion showing only changes from the previous one. However, if this is done, cumulative supplements must be distributed often enough that readers can find all the information given to them for any one crop year in no more than three distributions.
The farm products, according to which the master list must be organized as required by subsection (c)(2), and which must be identified on an EFS as required by subsection (c)(4)(C)(iv), must be specific commodities, species of livestock, and specific products of crops or livestock. The Section does not permit miscellaneous categories.
(a) The crop year, according to which subsection (c)(2)(C)(ii)(IV) requires the master list to be arranged “within each such product,” must be:
(1) For a crop grown in soil, the calendar year in which it is harvested or to be harvested;
(2) For animals, the calendar year in which they are born or acquired;
(3) For poultry or eggs, the calendar year in which they are sold or to be sold.
(b) An EFS or notice thereof which does not show crop year (the Section does not require it to do so) must be regarded as applicable to the crop or product in question for every year for which subsection (c)(4)(E) makes the EFS effective.
The system operator can be the Secretary of State of a State, or any designee of the State pursuant to its laws. Note that the provision in subsection (c)(2) for a system refers to operation by the Secretary of State of a State, but the definition in (c)(11) of “Secretary of State” includes “designee of the State.”
(a) An EFS under subsection (c)(4) need not be the same as a financing statement or security agreement under the Uniform Commercial Code (or equivalent document under future successor State law), but can be an entirely separate document meeting the definition in (c)(4). Note that (c)(4) contains a comprehensive definition of the term which does not include any requirement that the EFS be the instrument by which a security interest is created or perfected. Note also the House Committee Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 1985, at page 110: “[T]he bill would not preempt basic state-law rules on the creation, perfection, or priority of security interests.”
(b) An EFS may be filed electronically provided a State allows electronic filing of financing statements without the signature of the debtor under applicable State law under provisions of the Uniform Commercial Code or may be a paper document. An electronically filed EFS need not be a paper document and need not be signed. If an original or reproduced paper document of an EFS is filed with the State, it must be signed, authorized, or otherwise authenticated by the debtor and be filed by the secured party.
(c) Countermeasures against mishandling after filing, such as a requirement that a copy be date stamped and returned to the secured party, are discretionary with the State. If a State chooses to adopt such countermeasures, it is responsible for establishing procedures for recording the date and time when an EFS is received, and for meeting all legal requirements associated with filing and distributing information about security interests as required by § 205.101.
The place of filing an EFS is wherever State law requires, which need not be with the system operator so long as the system operator receives the information needed for the master list, including the information required in subsection (c)(4)(C). Note that the requirements in subsection (c)(4) for an EFS include the requirement that it be “filed with the Secretary of State,” but the definition in (c)(11) of “Secretary of State” includes ”designee of the State,” and the requirements in (c)(2) for a system refer in (A) to filing with the system operator of “effective financing statements or notice of such financing statements.” (emphasis added)
(a) If an EFS is filed somewhere other than with the system operator, and if notice of it is filed with the system operator, such notice could be electronic filing, telephoned information, or any other form of notice which gives the system operator the information needed for the master list. Such notice need not be signed. Note that the Section does not contain any requirement for such notice except the one in subsection (c)(4)(B) that an EFS must be filed somewhere pursuant to State law as discussed above.
(b) Countermeasures against falsifications, errors or omissions in such notices or in the handling of them by the system operator, such as requirements that the notices be on paper and signed, with copies date-stamped and returned to the persons filing them, however advisable they might be from other standpoints, are discretionary with the State and not required by the Section.
The Section provides at subsection (c)(4)(G) for a fee for filing an EFS. The fee can be set in any manner provided by the law of the State in which such EFS is filed. The basis for this is that (c)(4)(G) provides for the fee to be set by the “Secretary of State” but (c)(11) defines the latter term to include “designee of the State.” The fee structure is discretionary with the State.
(a) The master list must be organized by farm product as required by subsection (c)(2) and the farm product must be identified on an EFS as required by subsection (c)(4)(C)(iv). The following is a list of such farm products.
(b) Note the definition of the term “farm product” at subsection (c)(5), and the Conference Report on Pub. L. 99-198, No. 99-447, December 17, 1985, at page 486.
(c) A State may establish a system for specified products and not for all. A State establishing a system for specified products and not for all will be deemed to be “a State that has established a central filing system” as to the specified products, and will be deemed not to be such a State as to other products.
(a) The “amount” of farm products and “county or parish,” on an EFS and on the master list under subsection (c)(4)(C)(iv) and (2)(C)(iii), need not be shown on every EFS and master list entry.
(b) Any EFS and master list entry will identify a product. If they do not show an amount, this constitutes a representation that all of such product owned by the person in question is subject to the security interest in question.
(c) Any EFS and master list entry will identify each county or parish in the same State where the product is produced or located. If they do not show any further identification of the location of the product, this constitutes a representation that all such product produced in each such county or parish, owned by such person, is subject to the security interest.
(d) The need to supply additional information arises only where some of that product owned by that person is subject to the security interest and some is not.
(e) The additional information about amount must be sufficient to enable a reader of the information to identify what product owned by that person is subject, as distinguished from what of the same product owned by the same person is not subject. The precision needed, in the description of the amount, would vary from case to case.
(f) The basis for this is the purpose of the entire exercise, to make information available as necessary to enable an identification of what product is subject to a security interest as distinguished from what is not.
(a) The provisions in the Section regarding registration of “buyers of farm products, commission merchants, and selling agents,” “regular” distribution of “portions” of the master list, furnishing of “oral confirmation * * * on request,” and the effect of all this, that is, subsections (c)(2) (D), (E) and (F), (e) (2) and (3), and (g)(2) (C) and (D), must be read together.
(b) The Section does not require such persons to register. Not registering with a particular system operator has the effect, under subsections (e)(2) and (g)(2)(C), of making such persons, whether they are inside or outside the State covered by that system, subject to security interests shown on that system's master list whether or not such persons know about them, so that such persons for their own protection will need to query the system operator about any seller “engaged in farming operations,” of a farm product produced in the State covered by that system, with whom they deal.
(c) The effect of registration by such persons with a particular system is to get them on the list for regular distribution of portions of that system's master list, the portions to be determined by the registration. They are subject only to security interests shown on the portions which they receive, and are not subject to such interests as are shown on the master list but not shown on portions which they receive. Also, if a particular security interest is shown on the master list, but has been placed on it since the last regular distribution of portions of that list to registrants, registrants would not be subject to that security interest. These conclusions are based on the provisions in subsections (e)(3)(A) and (g)(2)(D)(i) that such persons are subject to a security interest only if they receive “written notice * * * that specifies both the seller and the farm product.”
(d) A question arises as to the length of time for which a registration is effective, and whether a registrant, wishing to change registration as to county or product, can amend an existing registration or must file a new one. This is discretionary with the State since the Section is silent about it.
(e) A question arises whether persons can register to receive only portions of the list for products in which they do not deal, and thus not be subject to security interests in products in which they deal because they are registrants but do not receive written notice of them. For example, can cattle dealers register to receive portions of the master list only for oranges, and thus take cattle free and clear of security interests shown on the master list, but as to which they do not receive written notice because they have not registered to receive the portion for cattle? Registrants will be deemed to be registered only as to those portions of the master list for which they register, and will be deemed to have failed to register as to those portions for which they do not register.
(f) The Section requires “regular” distribution, to registrants, of portions of the master list as amended from time to time by the filing of EFS's and amendments to EFS's. The requirement that the distribution be “regular” necessarily refers to an interval specified in advance. The interval may vary according to product and region. The frequency of such distribution must be a consideration in review for certification since distribution must be timely to serve its purpose. While subsection (c)(2)(E) (providing that distribution be made “regularly as prescribed by the State”) gives each State discretion to choose the interval between distributions, whatever interval a State chooses will inevitably make possible some transactions in which security interests are filed in the system but registrants are not subject to them.
(g) Legislative history of the Section shows that buyers, commission merchants, and selling agents are not intended to be liable for errors or other inaccuracies generated by the system. See Nov. 22, 1985 Cong. Rec., Senate, pg. S16300, and Dec. 18, 1985 Cong. Rec., House, pg. H12523.
(h) In furnishing to non-registrants “oral confirmation within 24 hours of any [EFS] on request followed by written confirmation,” by a system operator pursuant to subsection (c)(2)(F), any failure in use of a telephone caused by a “busy signal” could not be the basis of liability of the system operator. The basis for this is that subsection (c)(2)(F) does not mention telephones. Also, while it mentions furnishing information orally, it does not contain any provision as to how queries are to be received, that is, orally, in writing, or otherwise.
(i) Of course it is to be expected that telephones would be used in most cases, but use of them is not required by the legislation and is discretionary with the State.
(j) In the matter of receiving queries and giving oral replies to them, subsection (c)(2)(F) will be complied with if a system operator maintains an office and staff where a query can be received on business days and during business hours such as are regular in the State, and where an oral reply will be available on the regular business day following the day on which the query is received, at or before the time of day when it was received.
(k) Written confirmation is required, by subsection (c)(2)(F), to be given to any non-registered buyer, commission merchant, or selling agent.
(l) Such a written confirmation pursuant to subsection (c)(2)(F) does not alter the liability of the non-registrant querying the system and receiving information about a security interest recorded in it. The basis of this, as above, is that non-registrants are subject to security interests recorded in a system whether or not they know about them, and must query the system for their own protection.
(m) The Section does not specify when or how the written confirmation must be furnished, but provides only that it must follow the oral information. Thus the time and method of furnishing written confirmation is discretionary with the State.
(a) The “material change,” required by subsection (c)(4)(D) to be reflected in an amendment to an EFS and master list entry, is whatever change would render the master list entry no longer informative as to what is subject to the security interest in question. That will vary from case to case. The basis for this is the purpose for which the information is supplied, that is, to make information available, to a buyer, commission merchant, or selling agent who proposes to enter into a transaction in a product, whether it is subject to a security interest. The requirement to amend arises when the information already made available no longer serves the purpose and other information is needed in order to do so.
(b) Where an owner of a product makes a change, such as planting a different crop or purchasing different animals from what was represented, without informing the secured party, so that the master list entry is rendered not informative, but the EFS and master list are not amended through no fault of the secured party, the Section is silent as to the consequences. However, see the legislative history cited in § 205.208(f).
(c) The amendment must be filed in the same manner as the original filing. Note the requirement of subsection (c)(4)(D). The amendment may be filed electronically provided a State allows electronic filing of financing statements without the signature of the debtor under applicable State law under provisions of the Uniform Commercial Code. An electronically filed amendment need not be signed. However, if an original or reproduced paper document is filed, the amendment must be signed, authorized, or otherwise authenticated by the debtor, and be filed by the secured party.
(d) An effective financing statement remains effective for a period of 5 years from the date of filing and may be continued in increments of 5-year periods beyond the initial 5-year filing period by refiling an effective financing statement or by filing a continuation statement within 6 months before expiration of the effective financing statement. A continuation statement may be filed electronically or as a paper document, and need not be signed, authorized, or otherwise authenticated by the debtor.
(a) A question arises whether, if an EFS is filed in one State, a notice of it can be filed in another State and shown on the master list for the second State. There is nothing in the Section to prevent this, but it would serve no purpose.
(b) The Section provides only for filing an EFS, covering a given product, in the system for the State in which it is produced or located. Upon such filing in such system, subsections (e)(2) and (g)(2)(C) make buyers, commission merchants and selling agents not registered with that system subject to the security interest in that product whether or not they know about it, even if they are outside that State. Subsections (e)(3) and (g)(2)(D) make persons registered with that system subject if they receive written notice of it even if they are outside that State. All of these provisions apply only where an EFS is filed in the system for the State in which the product is produced or located. They do not apply to a filing in another system.
(c) What constitutes “receipt” of notice is determined by the law of the State in which the intended recipient of notice resides. This is based on subsection (f) which follows provisions for notice to buyers, and (g)(3) which follows provisions for notice to commission merchants and selling agents. Each of those provisions uses the word “buyer” but it means “intended recipient of notice.”
(a) Court decisions under the Uniform Commercial Code (UCC), about the scope of the “farm products” exception in Section 9-307(1) thereof, and interpreting the terms therein, particularly “person engaged in farming operations” which is not defined in the Section, are applicable to an extent in interpreting the Section. The basis of this is the legislative intent of the Section to pre-empt State laws reflecting that “farm products” exception, as shown in the House Committee Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 1985, at pages 108 et seq.
(b) That UCC Section 9-307(1) reads as follows:
(1) A buyer in ordinary course of business (subsection (9) of Section 1-201) other than a person buying farm products from a person engaged in farming operations takes free of a security interest created by his seller even though the security interest is perfected and even though the buyer knows of its existence. (emphasis added)
The terms “buyer in ordinary course of business” and “security interest” are defined in subsections (c) (1) and (7). There are differences between those definitions and the UCC definitions of the same terms. In interpreting those differences, the following would be pertinent:
(a) The legislative intent discussed above in § 205.211, to pre-empt State laws reflecting the “farm products” exception; and
(b) The legislative intent shown in subsections (a) and (b) that certain persons take free and clear of certain interests of a “secured lender” “when the seller fails to repay the lender,” unless such persons have information about such interests made available to them as provided in the Section.
(a) A debt need not exist at the time of filing of an EFS. The basis for this is that subsection (c)(4) does not require the EFS, and subsection (c)(2)(C) does not require the master list, to show any amount of debt.
(b) The Section does not provide for the transaction in which one person subjects a product to a security interest for another's debt. However the terms “person indebted” and “debtor” in the Section refer to the person who owns a product and subjects it to a security interest, whether or not that person owes a debt to the secured party. The basis for this is the purpose for which the information is supplied. Any buyer of a farm product, commission merchant, or selling agent querying a master list or system operator about a prospective seller of a farm product is interested in whether that seller has subjected that product to a security interest, not in whether the debt is owed by that seller or by another.
(c) Security interests existing prior to establishment of a system can be filed in such a system and reflected in the master list if documents are in existence or are created which meet the requirements of subsection (c)(4) besides filing, if such documents are filed wherever State law requires, and if the system operator receives the information about them needed for the master list.
(d) A system can be in compliance with the Section, although it reflects security interests not supported by EFS's as defined in the legislation, and although it reflects security interests on items other than farm products. However, subsections (e) (2) and (3), and (g)(2) (C) and (D), will apply only as to entries reflecting farm products and supported by EFS's as defined in the Section, and it must be possible to distinguish the entries to which these provisions apply from the other entries.
(a) The requirements for a system in subsection (c) are written as the definition of the term “central filing system,” so that failure of a system to meet any such requirement, either at the time of its establishment or later, will mean that it is not a “central filing system” as defined.
(b) The issue whether a system, after certification, is operating in compliance, thus whether it is a “central filing system” as defined, could be litigated and ruled on in a case involving only private parties, such as a lender and a buyer of a farm product. The only immediate effect of a finding in such a case, that a system is not a “central filing system” as defined, would be that the rights of the secured party in the case would be as if the State had no system. However, others would be in doubt as to whether they could safely rely on the same system.
The definitions in this section apply to the regulations in this part. The definitions in this section do not apply to other regulations issued under the Packers and Stockyards Act (P&S Act) or to the P&S Act as a whole.
Accrual account. (Synonymous with the term “ledger,” as defined in this section.) An account held by a packer on behalf of a producer that accrues a running positive or negative balance as a result of a pricing determination included in a contract that establishes a minimum and/or maximum level of base price paid. Credits and/or debits for amounts beyond these minimum and/or maximum levels are entered into the account. Further, the contract specifies how the balance in the account affects producer and packer rights and obligations under the contract.
Base price. The price paid for swine before the application of any premiums or discounts, expressed in dollars per unit.
Boar. A sexually-intact male swine.
Ceiling price. The maximum market price that will be paid for swine. Adjustments may be made to the base price if the market price rises above this price.
Contract. Any agreement, whether written or verbal, between a packer and a producer for the purchase of swine for slaughter, except a negotiated purchase (as defined in this section).
Contract type. The classification of contracts or risk management agreements for the purchase of swine committed to a packer, by the determination of the base price and the presence or absence of an accrual account or ledger (as defined in this section). The contract type categories are:
(1) Swine or pork market formula purchases with a ledger,
(2) Swine or pork market formula purchases without a ledger,
(3) Other market formula purchases with a ledger,
(4) Other market formula purchases without a ledger,
(5) Other purchase arrangements with a ledger, and
(6) Other purchase arrangements without a ledger.
Floor price. The minimum market price that will be paid for swine. Adjustments may be made to the base price if the market price falls below this price.
Formula price. A price determined by a mathematical formula under which the price established for a specified market serves as the basis for the formula.
Ledger. (Synonymous with “accrual account,” as defined in this section.) An account held by a packer on behalf of a producer that accrues a running positive or negative balance as a result of a pricing determination included in a contract that establishes a minimum and/or maximum level of base price paid. Credits and/or debits for amounts beyond these minimum and/or maximum levels are entered into the account. Further, the contract specifies how the balance in the account affects producer and packer rights and obligations under the contract.
Negotiated purchase. A purchase, commonly known as a “cash” or “spot market” purchase, of swine by a packer from a producer under which:
(1) The buyer-seller interaction that results in the transaction and the agreement on actual base price occur on the same day; and
(2) The swine are scheduled for delivery to the packer not later than 14 days after the date on which the swine are committed to the packer.
Noncarcass merit premium or discount. An increase or decrease in the price for the purchase of swine made available by an individual packer or packing plant, based on any factor other than the characteristics of the carcass, if the actual amount of the premium or discount is known before the purchase and delivery of the swine.
Other market formula purchase. A purchase of swine by a packer in which the pricing determination is a formula price based on any market other than the markets for swine, pork, or a pork product. This includes a formula purchase where the price formula is based on one or more futures or options contracts.
Other purchase arrangement. A purchase of swine by a packer that is not a negotiated purchase, swine or pork market formula purchase, or other market formula purchase, and does not involve packer-owned swine. This contract type includes long term contract agreements, fixed price contracts, cost of production formulas, and formula purchases with a floor, window or ceiling price.
Packer. Any person engaged in the business of buying swine in commerce for purposes of slaughter, of manufacturing or preparing meats or meat food products from swine for sale or shipment in commerce, or of marketing meats or meat food products from swine in an unmanufactured form, acting as a wholesale broker, dealer, or distributor in commerce. The regulations in this part apply only to a packer that meets the conditions in either paragraph (1) or (2) of this definition:
(1) A packer purchasing at least 100,000 swine per year and slaughtering swine at one or more federally inspected processing plants that meet either of the following conditions:
(i) A swine processing plant that slaughtered an average of at least 100,000 head of swine per year during the immediately preceding 5 calendar years, with the average based on those periods in which the plant slaughtered swine; or
(ii) A swine processing plant that did not slaughter swine during the immediately preceding 5 calendar years that has the capacity to slaughter at least 100,000 swine per year, based on plant capacity information.
(2) Any packer purchasing an average of at least 200,000 sows, boars, or any combination thereof, per year and slaughtering at least 200,000 sows, boars, or any combination thereof at one or more federally inspected processing plants during the immediately preceding 5 calendar years, with the average based on those periods in which the plant slaughtered swine.
Producer. Any person engaged, either directly or through an intermediary, in the business of selling swine to a packer for slaughter (including the sale of swine from a packer to another packer).
Sow. An adult female swine that has produced one or more litters.
Swine. A porcine animal raised to be a feeder pig, raised for seedstock, or raised for slaughter.
Swine or pork market formula purchase. A purchase of swine by a packer in which the pricing mechanism is a formula price based on a market for swine, pork, or pork product, other than any formula purchase with a floor, window or ceiling price, or a futures or option contract for swine, pork, or a pork product.
Window price. The range of market prices that will be paid for swine. Adjustments may be made to the base price if the market prices fall outside this range. The window price contains both the floor and ceiling prices.
(a) Do I need to provide swine contract information? Each packer, as defined in § 206.1, must provide information for each swine processing plant that it operates or at which it has swine slaughtered that has the slaughtering capacity, alone or in combination with other plants, specified in the definition of packer in § 206.1.
(b) What existing or available contracts do I need to provide and when are they due? Each packer must send, to the Packers and Stockyards Division (PSD), an example of each contract it currently has with a producer or producers or that is currently available at each plant that it operates or at which it has swine slaughtered that meets the definition of packer in § 206.1. This initial submission of example contracts is due to PSD on the first business day of the month following the determination that the plant has the slaughtering capacity, alone or in combination with other plants, specified in the definition of packer in § 206.1.
(c) What available contracts do I need to provide and when are they due? After the initial submission, each packer must send PSD an example of each new contract it makes available to a producer or producers within 1 business day of the contract being made available at each plant that it operates or at which it has swine slaughtered that meets the definition of packer in § 206.1.
(d) What criteria do I use to select example contracts? For purposes of distinguishing among contracts to determine which contracts may be represented by a single example, contracts will be considered to be the same if they are identical with respect to all of the following four example-contract criteria:
(1) Base price or determination of base price;
(2) Application of a ledger or accrual account (including the terms and conditions of the ledger or accrual account provision);
(3) Carcass merit premium and discount schedules (including the determination of the lean percent or other merits of the carcass that are used to determine the amount of the premiums and discounts and how those premiums and discounts are applied); and
(4) Use and amount of noncarcass merit premiums and discounts.
(e) Where and how do I send my contracts? Each packer may submit the example contracts, notifications required by this section, and Form PSD 342, Contract Submission Cover Sheet, by either of the following two methods:
(1) Electronic report. Example contracts and notifications required by this section may be submitted by electronic means. Electronic submission may be by any form of electronic transmission that has been determined to be acceptable to the Administrator. To obtain current options for acceptable methods to submit example contracts electronically, contact PSD through the Internet on the AMS website (https://www.ams.usda.gov) or at USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309.
(2) Printed report. Each packer that chooses to submit printed example contracts and notifications must deliver the printed contracts and notifications to USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309.
(f) What information from the swine contract library will be made available to the public? PSD will summarize the information it has received on contract terms, including, but not limited to, base price determination and the schedules of premiums or discounts. PSD will make the information available by region and contract type, as defined in § 206.1, for public release 1 month after the initial submission of contracts. Geographic regions will be defined in such a manner to provide as much information as possible while maintaining confidentiality in accordance with section 251 of the Agricultural Marketing Act (7 U.S.C. 1636).
(g) How can I review information from the swine contract library? The information will be available on the Internet on the AMS website (https://www.ams.usda.gov) and at USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309. The information will be updated as PSD receives information from packers.
(h) What do I need to do when a previously submitted example contract is no longer a valid example due to contract changes, expiration, or withdrawal? Each packer must submit a new example contract when contract changes result in changes to any of the four example-contract criteria specified in paragraph (d) of this section and notify PSD if the new example contract replaces the previously submitted example contract. Each packer must notify AMS when an example contract no longer represents any existing or available contract (expired or withdrawn). Each packer must submit these example contracts and notifications within 1 business day of the change, expiration, or withdrawal.
(a) Do I need to provide monthly reports? Each packer, as defined in § 206.1, must provide information for each swine processing plant that it operates or at which it has swine slaughtered that has the slaughtering capacity, alone or in combination with other plants, specified in the definition of packer.
(b) When is the monthly report due? Each packer must send a separate monthly report for each plant that has the slaughtering capacity, alone or in combination with other plants specified in the definition of packer in § 206.1. Each packer must deliver the report to the AMS Regional Office in Des Moines, Iowa, by the close of business on the 15th of each month, beginning at least 45 days after the initial submission of example contracts. If the 15th day of a month falls on a Saturday, Sunday, or federal holiday, the monthly report is due no later than the close of the next business day following the 15th.
(c) What information do I need to provide in the monthly report? The monthly report that each packer files must be reported on Form PSD 341, which will be available on the Internet on the AMS website (https://www.ams.usda.gov) and at USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309. In the monthly report, each packer must provide the following information:
(1) Number of swine to be delivered under existing contracts. Existing contracts are contracts the packer currently is using for the purchase of swine for slaughter at each plant. Each packer must provide monthly estimates of the number of swine committed to be delivered under all of its existing contracts (even if those contracts are not currently available for renewal or to additional producers) in each contract type as defined in § 206.1.
(2) Available contracts. Available contracts are the contracts the packer is currently making available to producers, or is making available for renewal to currently contracted producers, for the purchase of swine for slaughter at each plant. On the monthly report, a packer will indicate each contract type, as defined in § 206.1, that the packer is currently making available.
(3) Estimates of committed swine. Each packer must provide an estimate of the total number of swine committed under existing contracts for delivery to each plant for slaughter within each of the following 12 calendar months beginning with the 1st of the month immediately following the due date of the report. The estimate of total swine committed will be reported by contract type as defined in § 206.1.
(4) Expansion clauses. Any conditions or circumstances specified by clauses in any existing contracts that could result in an increase in the estimates specified in paragraph (c)(3) of this section. Each packer will identify the expansion clauses in the monthly report by listing a code for the following conditions:
(i) Clauses that allow for a range of the number of swine to be delivered.
(ii) Clauses that require a greater number of swine to be delivered as the contract continues.
(iii) Other clauses that provide for expansion in the numbers of swine to be delivered.
(5) Maximum estimates of swine. The packer's estimate of the maximum total number of swine that potentially could be delivered to each plant within each of the following 12 calendar months, if any or all of the types of expansion clauses identified in accordance with the requirement in paragraph (c)(4) of this section are executed. The estimate of maximum potential deliveries must be reported for all existing contracts by contract type as defined in § 206.1.
(d) What if a contract does not specify the number of swine committed? To meet the requirements of paragraphs (c)(3) and (c)(5) of this section, the packer must estimate expected and potential deliveries based on the best information available to the packer. Such information might include, for example, the producer's current and projected swine inventories and planned production.
(e) When do I change previously reported estimates? Regardless of any estimates for a given future month that may have been previously reported, current estimates of deliveries reported as required by paragraphs (c)(3) and (c)(5) of this section must be based on the most accurate information available at the time each report is prepared.
(f) Where and how do I send my monthly report? Each packer must submit monthly reports required by this section by either of the following two methods:
(1) Electronic report. Information reported under this section may be reported by electronic means, to the maximum extent practicable. Electronic submission may be by any form of electronic transmission that has been determined to be acceptable to the Administrator. To obtain current options for acceptable methods to submit information electronically, contact PSD through the Internet on the AMS website (https://www.ams.usda.gov) or at USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309.
(2) Printed report. Each packer may deliver its printed monthly report to USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309.
(g) What information from monthly reports will be made available to the public and when and how will the information be made available to the public? (1) Availability. PSD will provide a monthly report of estimated deliveries by contract types as reported by packers in accordance with this section, for public release on the first business day of each month. The monthly reports will be available on the Internet on the AMS website (https://www.ams.usda.gov) and at USDA, AMS, Suite 317, 210 Walnut Street, Des Moines, Iowa 50309.
(2) Regions. Information in the report will be aggregated and reported by geographic regions. Geographic regions will be defined in such a manner to provide as much information as possible while maintaining confidentiality in accordance with section 251 of the Agricultural Marketing Act (7 U.S.C. 1636) and may be modified from time to time.
(3) Reported information. The monthly report will provide the following information:
(i) The existing contract types for each geographic region.
(ii) The contract types currently being made available to additional producers or available for renewal to currently contracted producers in each geographic region.
(iii) The sum of packers' reported estimates of the total number of swine committed by contract for delivery during the next 6 and 12 months beginning with the month the report is published. The report will indicate the number of swine committed by geographic reporting region and by contract type.
(iv) The types of conditions or circumstances as reported by packers that could result in expansion in the numbers of swine to be delivered under the terms of expansion clauses in the contracts at any time during the following 12 calendar months.
(v) The sum of packers' reported estimates of the maximum total number of swine that potentially could be delivered during each of the next 6 and 12 months if all expansion clauses in current contracts are executed. The report will indicate the sum of estimated maximum potential deliveries by geographic reporting region and by contract type.
(h) Where and how do I file a waiver request? The waiver request must be submitted in writing and include a statement that the packer does not procure swine using marketing agreements. The packer must send the waiver request to the PSD Regional Office in Des Moines, Iowa. If the waiver request is approved, PSD will inform the packer in writing that it has been granted a waiver for 12 months following the date of receipt of the waiver request unless the status of the packer changes during that year. The packer will be notified to submit the information required in this part if it begins using marketing agreements during the waiver period or if PSD determines that the packer utilizes marketing agreements.
This part describes the duties and organization of the Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA). It also includes rules on the access of government employees to regulated places of business.
(a) Delegations of authority. The Secretary of Agriculture and Under Secretary for Food Safety have delegated to the Administrator of the Food Safety and Inspection Service the responsibility for exercising the functions of the Secretary of Agriculture under various statutes (see 7 CFR 2.7, 2.18, and 2.53).
(b) Implementing regulations. This chapter of title 9 of the Code of Federal Regulations (9 CFR chapter III) includes, in addition to administrative rules, rules and regulations that implement provisions of the following statutes:
(1) The Federal Meat Inspection Act, as amended (FMIA) (21 U.S.C. 601 et seq.), except provisions pertaining to the inspection and certification of the condition of animals for export, and related legislation;
(2) The Poultry Products Inspection Act, as amended (PPIA) (21 U.S.C. 451 et seq.);
(3) The Egg Products Inspection Act, as amended (EPIA) (21 U.S.C. 1031 et seq.), except for the shell egg surveillance program, voluntary laboratory analyses of egg products, and the voluntary grading program;
(4) The Humane Slaughter Act (7 U.S.C. 1901-1906);
(5) The Talmadge-Aiken Act (7 U.S.C. 450), with respect to cooperation with States in the administration of the Federal Meat Inspection Act and the Poultry Products Inspection Act;
(6) The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), relating to voluntary inspection of poultry and edible products thereof; voluntary inspection and certification of technical animal fat; certified products for dogs, cats, and other carnivora; voluntary inspection of rabbits and edible products thereof; and voluntary inspection and certification of edible meat and other products; and
(7) The National Laboratory Accreditation Program (7 U.S.C. 138-138i) with respect to laboratories accredited only for pesticide residue analysis in meat and poultry products.
(a) General. The organization of FSIS reflects the Agency's primary regulatory responsibilities: implementation of the FMIA, including fish of the order Siluriformes, the PPIA, and the EPIA. FSIS implements the inspection provisions of the FMIA, the PPIA, and the EPIA through its field structure.
(b) Headquarters. FSIS has eight principal components or offices, each of which is under the direction of a Deputy Administrator. The Deputy Administrators, along with their staffs, and the Administrator, along with the Office of the Administrator and three staff offices that report to the Administrator, are located at U.S. Department of Agriculture headquarters in Washington, DC.
(1) Program Offices. FSIS's headquarters offices are the Office of Public Health and Science, which provides scientific analysis, advice, data, and recommendations on matters involving public health and science; the Office of Management, which provides centralized administrative and support services; the Office of Policy and Program Development, which develops and articulates the Agency's policies regarding food safety and other consumer protections; the Office of Field Operations, which manages regulatory oversight and inspection (see paragraph (c) of this section); the Office of Food Security and Emergency Preparedness, which works to prevent or, if necessary, coordinate a response to an intentional attack on the food supply; the Office of Program Evaluation, Enforcement, and Review, which acts to ensure that Agency programs are functioning in an efficient and effective manner; the Office of Public Affairs, Education, and Outreach, which is responsible for facilitating communications between FSIS and Congress, the Agency's constituents, and the media; and the Office of International Affairs, which is responsible for recommending and developing international policy activities.
(2) [Reserved]
(c) Field. FSIS's field structure consists of eighteen district offices and a technical center.
(1) District offices. Each district office, under the direction of a District Manager, manages a farm-to-table food safety program of regulatory oversight and inspection in a district consisting of a State or several States and territories.
The locations of the district offices and the districts' geographic boundaries are as follows:
| California. | |
| Arizona, Colorado, Nevada, New Mexico, Utah, Alaska, American Samoa, Guam, Hawaii, Idaho, Northern Mariana Islands, Oregon, and Washington. | |
| Minnesota, Montana, North Dakota, South Dakota, and Wyoming. | |
| Iowa and Nebraska. | |
| Kansas and Missouri. | |
| Arkansas, Louisiana, and Oklahoma. | |
| Texas. | |
| Michigan and Wisconsin. | |
| Illinois, Ohio, and Indiana. | |
| Pennsylvania and New Jersey. | |
| Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. | |
| Delaware, District of Columbia, Maryland, Virginia, and West Virginia. | |
| North Carolina, South Carolina, and Kentucky. | |
| Florida, Georgia, Puerto Rico, and the Virgin Islands. | |
| Alabama, Mississippi, and Tennessee. |
(2) Technical Service Center. The Technical Service Center, which is located in Omaha, Nebraska, provides technical guidance, review, and training on the interpretation and application of regulatory requirements.
(a) Unless otherwise specifically provided or required in the context of a particular part of the regulations:
Administrator means the Administrator of the Food Safety and Inspection Service or any other officer or employee of the Department to whom authority has been or may in the future be delegated to act in his or her stead.
Circuit Supervisor means the official of the Inspection Service who is assigned responsibility for supervising the conduct of inspection at a specific group of official establishments.
Inspection program, inspection service, or program means the organizational unit within the Department with responsibility for carrying out the FMIA, the PPIA, and the EPIA.
Inspection program employee, inspection service employee, or program employee means an inspector or other government employee who is authorized to conduct any inspection or perform any other duty in connection with the inspection program, inspection service, or program.
Inspection service supervisor or Inspection program supervisor means an inspection program or service employee or program employee who is delegated authority to exercise supervision over one or more phases of the inspection program.
Inspector means an inspector of the inspection program, inspection service, and program. (“Inspector” includes an employee or official of the Federal government or the government of a State or territory or the District of Columbia who is authorized by the Administrator to inspect meat and meat products or poultry and poultry products under the authority of the FMIA or the PPIA, respectively, under an agreement entered into between the Administrator and the appropriate State or other agency.)
Inspector in charge or IIC means an inspection program employee, inspection service employee, or program employee who has primary responsibility for inspection program functions at a particular official establishment.
Secretary means the Secretary of Agriculture of the United States or his or her delegate.
(b) FSIS has replaced the regional office and import field office structure referenced in some parts of subchapter A of this chapter. Authority previously delegated to Regional Directors now is delegated to district managers; authority previously delegated to area supervisors and import supervisors now is delegated to inspection program supervisors in the successor district offices.
(a) General. Upon presentation of credentials—
(1) Persons subject to provisions of the FMIA or the PPIA must afford representatives of the Secretary access to establishments that slaughter or otherwise prepare livestock products or process poultry products and to other places of business subject to regulation thereunder; and
(2) Persons subject to provisions of the EPIA must afford representatives of the Secretary access as specified in part 590 of this chapter.
(b) Meat and poultry establishments and related industries. (1) At all times, by day or night, whether the establishment is being operated or not, inspection program employees must have access to the premises and to every part of an establishment that slaughters livestock or otherwise prepares meat products or slaughters poultry or otherwise processes poultry products that are subject to inspection for the purpose of conducting an inspection or performing any other inspection program duty. The numbered official badge of an inspection program employee is sufficient identification to entitle him or her to admittance to all parts of such an establishment and its premises.
(2) At all ordinary business hours, upon presentation of credentials by a representative of the Secretary, any person (including any firm or corporation or other business unit) subject to recordkeeping requirements under section 202 of the FMIA or section 11(b) of the PPIA must permit such representative to enter his or her place of business to examine the facilities and inventory and to examine and copy the records specified in § 320.1 and § 381.175, respectively, of this chapter and, upon payment of the fair market value therefor, take reasonable samples of the inventory.
For purposes of this chapter and unless otherwise specifically provided by regulation or required in the context of particular regulations:
(a) Terms have the meanings set forth in this part;
(b) The singular form also imports the plural, and the masculine form also imports the feminine and vice versa.
As used in this subchapter, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:
The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., sec. 601 et seq.).
Adulterated. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:
(1) If it bears or contains any such poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(2)(i) If it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is:
(A) A pesticide chemical in or on a raw agricultural commodity;
(B) A food additive; or
(C) A color additive which may, in the judgment of the Administrator, make such article unfit for human food;
(ii) If it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
(iii) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
(iv) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, That an article which is not deemed adulterated under paragraphs (aa)(2) (ii), (iii), or (iv) of this section shall nevertheless be deemed adulterated if use of the pesticide chemical food additive, or color additive in or on such article is prohibited by the regulations in this subchapter in official establishments;
(3) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;
(4) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(5) If it is, in whole or in part, the product of an animal which has died otherwise than by slaughter;
(6) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(7) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act;
(8) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or,
(9) If it is margarine containing animal fat and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise adulterated.
Anesthesia. Loss of sensation or feeling.
Animal food. Any article intended for use as food for dogs, cats, or other animals derived wholly, or in part, from the carcass or parts or products of the carcass of any livestock, except that the term animal food as used herein does not include:
(1) Processed dry animal food or
(2) Livestock or poultry feeds manufactured from processed livestock byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and feed grade animal fat).
Animal food manufacturer. Any person engaged in the business of manufacturing or processing animal food.
Artificial coloring. A coloring containing any dye or pigment, which dye or pigment was manufactured by a process of synthesis or other similar artifice, or a coloring which was manufactured by extracting a natural dye or natural pigment from a plant or other material in which such dye or pigment was naturally produced.
Artificial flavoring. A flavoring containing any sapid or aromatic constituent, which constituent was manufactured by a process of synthesis or other similar artifice.
Biological residue. Any substance, including metabolites, remaining in livestock at time of slaughter or in any of its tissues after slaughter as the result of treatment or exposure of the livestock to a pesticide, organic or inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other therapeutic or prophylactic agent.
Capable of use as human food. This term applies to any carcass, or part or product of a carcass, of any livestock, unless it is denatured or otherwise identified as required by the applicable provisions of §§ 314.3, 314.10, 325.11, and 325.13 of this subchapter to deter its use as a human food, or it is naturally inedible by humans; e.g., hoofs or horns in their natural state.
Captive bolt. A stunning instrument which when activated drives a bolt out of a barrel for a limited distance.
Carbon dioxide. A gaseous form of the chemical formula CO
Carbon dioxide concentration. Ratio of carbon dioxide gas and atmospheric air.
Carcass. All parts, including viscera, of any slaughtered livestock.
Chemical preservative. Any chemical that, when added to a meat or meat food product, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices or substances added to meat and meat food products by exposure to wood smoke.
Other definitions, if any, that are applicable only for purposes of a specific part of the regulations in this subchapter, are set forth in such part.
Commerce. Commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.
Consciousness. Responsiveness of the brain to the impressions made by the senses.
Cutting up. Any division of any carcass or part thereof, except that the trimming of carcasses or parts thereof to remove surface contaminants is not considered as cutting up.
Dead livestock. The body (cadaver) of livestock which has died otherwise than by slaughter.
Dying, diseased, or disabled livestock. Livestock which has or displays symptoms of having any of the following:
(1) Central nervous system disorder;
(2) Abnormal temperature (high or low);
(3) Difficult breathing;
(4) Abnormal swellings;
(5) Lack of muscular coordination;
(6) Inability to walk normally or stand;
(7) Any of the conditions for which livestock is required to be condemned on ante-mortem inspection in accordance with the regulations in part 309 of this subchapter.
Edible. Intended for use as human food.
Experimental animal. Any animal used in any research investigation involving the feeding or other administration of, or subjection to, an experimental biological product, drug, or chemical or any nonexperimental biological product, drug, or chemical used in a manner for which it was not intended.
Exposure time. The period of time an animal is exposed to an anesthesia-producing carbon dioxide concentration.
Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.
Firm. Any partnership, association, or other unincorporated business organization.
Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments.
Immediate container. The receptacle or other covering in which any product is directly contained or wholly or partially enclosed.
Inedible. Adulterated, uninspected, or not intended for use as human food.
Inhumane slaughter or handling in connection with slaughter. Slaughter or handling in connection with slaughter not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 Stat. 1069) and part 313 of this subchapter.
“Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof). This term means that the product so identified has been inspected and passed under the regulations in this subchapter, and at the time it was inspected, passed, and identified, it was found to be not adulterated.
Label. A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.
Labeling. All labels and other written, printed, or graphic matter:
(1) Upon any article or any of its containers or wrappers, or
(2) Accompanying such article.
Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine.
Meat. (1) The part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing. As applied to products of equines, this term has a comparable meaning.
(i) Meat does not include the muscle found in the lips, snout, or ears.
(ii) Meat may not include significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).
(2) [Reserved]
Meat broker. Any person engaged in the business of buying or selling carcasses, parts of carcasses, meat or meat food products of livestock on commission, or otherwise negotiating purchases or sales of such articles other than for his/her own account or as an employee of another person.
Meat byproduct. Any part capable of use as human food, other than meat, which has been derived from one or more cattle, sheep, swine, or goats. This term, as applied to products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.
Meat food product. Any article capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, except those exempted from definition as a meat food product by the Administrator in specific cases or by the regulations in part 317 of this subchapter, upon a determination that they contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and provided that they comply with any requirements that are imposed in such cases or regulations as conditions of such exemptions to assure that the meat or other portions of such carcasses contained in such articles are not adulterated and that such articles are not represented as meat food products. This term, as applied to food products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.
Misbranded. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:
(1) If its labeling is false or misleading in any particular;
(2) If it is offered for sale under the name of another food;
(3) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated;
(4) If its container is so made, formed, or filled as to be misleading;
(5) If in a package or other container unless it bears a label showing:
(i) The name and place of business of the manufacturer, packer, or distributor; and
(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in part 317 of this subchapter with respect to the quantity of contents;
(6) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(7) If it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations in part 319 of this subchapter unless:
(i) It conforms to such definition and standard, and
(ii) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;
(8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;
(9) If it is not subject to the provisions of paragraph (vv)(7)(ii) of this section unless its label bears:
(i) The common or usual name of the food, if any there be, and
(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except as otherwise provided in part 317 of this subchapter;
(10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as is required by the regulations in part 317 of this subchapter.
(11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided by the regulations in part 317 of this subchapter; or
(12) If it fails to bear, directly thereon or on its containers, when required by the regulations in part 316 or 317 of this subchapter, the inspection legend and, unrestricted by any of the foregoing, such other information as the Administrator may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.
Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of meat food and meat products, excluding labeling and packaging materials as covered in part 317 of the subchapter.
Official certificate. Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act.
Official device. Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark.
Official establishment. Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter.
Official import inspection establishment. This term means any establishment, other than an official establishment as defined in paragraph (zz) of this section, where inspections are authorized to be conducted as prescribed in § 327.6 of this subchapter.
Official inspection legend. Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act.
Official mark. The official inspection legend or any other symbol prescribed by the regulations in this subchapter to identify the status of any article or animal under the Act.
Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for meat products.
Person. Any individual, firm, or corporation.
Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for purposes of the Act and the regulations in this subchapter as under the Federal Food, Drug, and Cosmetic Act.
Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.
Process authority. A person or organization with expert knowledge in meat production process control and relevant regulations. This definition does not apply to part 431 of this chapter.
Process schedule. A written description of processing procedures, consisting of any number of specific, sequential operations directly under the control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. This definition does not apply to part 431 of this chapter.
Product. Any carcass, meat, meat byproduct, or meat food product, capable of use as human food.
Ready-to-cook (RTC) pork product. Any slaughtered pork product sufficiently free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor, which is suitable for cooking without need of further processing.
Renderer. Any person engaged in the business of rendering carcasses or parts or products of the carcasses of any livestock except rendering conducted under inspection or exemption under Title I of the Act.
Shipping container. The outside container (box, bag, barrel, crate, or other receptacle or covering) containing or wholly or partly enclosing any product packed in one or more immediate containers.
State. Any State of the United States or the Commonwealth of Puerto Rico.
Supervision. The controls, as prescribed in instructions to Program employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations in this subchapter.
Surgical anesthesia. A state of unconsciousness measured in conformity with accepted surgical practices.
Territory. Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.
U.S. Condemned. This term means that the livestock so identified has been inspected and found to be in a dying condition, or to be affected with any other condition or disease that would require condemnation of its carcass.
U.S. Inspected and Condemned (or any authorized abbreviation thereof). This term means that the carcass, viscera, other part of carcass, or other product so identified has been inspected, found to be adulterated, and condemned under the regulations in this subchapter.
U.S. Passed for Cooking. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be cooked or rendered as prescribed by the regulations in part 315 of this chapter.
U.S. Passed for Refrigeration. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be refrigerated or otherwise handled as prescribed by the regulations in part 311 of this subchapter.
U.S. Retained. This term means that the carcass, viscera, other part of carcass, or other product, or article so identified is held for further examination by an inspector to determine its disposal.
U.S. Suspect. This term means that the livestock so identified is suspected of being affected with a disease or condition which may require its condemnation, in whole or in part, when slaughtered, and is subject to further examination by an inspector to determine its disposal.
United States. The States, the District of Columbia, and the Territories of the United States.
(a) Inspection under the regulations in this subchapter is required at:
(1) Every establishment, except as provided in § 303.1 (a) and (b), or (c) of this subchapter, in which any livestock are slaughtered for transportation or sale as articles of commerce, or in which any products of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale as articles of commerce, which are intended for use as human food;
(2) Every establishment, except as provided in § 303.1 (a) and (b), or (d) of this subchapter, within any State or organized Territory which is designated pursuant to paragraph 301(c) of the Act, at which any livestock are slaughtered or any products of any livestock are prepared, for use as human food solely for distribution within such jurisdiction; and
(3) Every establishment, except as provided in § 303.1 (a) and (b) of this subchapter, that is designated by the Administrator pursuant to paragraph 301(c) of the Act as one producing adulterated products which would clearly endanger the public health.
Special provisions with respect to establishments and their operations and transactions by any persons in designated States and Territories and with respect to establishments designated as producing adulterated products which clearly endanger public health, and the operators thereof, in any State or Territory appear in part 331 of this subchapter, and apply to such establishments, operations and transactions in lieu of the regulations elsewhere in this subchapter except insofar as such regulations are made applicable by the provisions in part 331 of this subchapter.
All livestock and all products entering any official establishment and all products prepared, in whole or in part, therein, shall be inspected, handled, stored, prepared, packaged, marked, and labeled as required by the regulations in this subchapter.
(a) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to:
(1) The slaughtering by any individual of livestock of his own raising, and the preparation by him and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock exclusively for use by him and members of his household and his nonpaying guests and employees;
(2) The custom slaughter by any person of cattle, sheep, swine, or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat or meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That the following requirements are met by such custom operator;
(i) Establishments that conduct custom operations must be maintained and operated in accordance with the provisions of §§ 416.1 through 416.6, except for: § 416.2(g)(2) through (6) of this chapter, regarding water reuse and any provisions of part 416 of this chapter relating to inspection or supervision of specified activities or other action by a Program employee. If custom operations are conducted in an official establishment, however, all of the provisions of part 416 of this chapter of shall apply to those operations.
(ii) If the custom operator prepares or handles any products for sale, they are kept separate and apart from the custom prepared products at all times while the latter are in his custody;
(iii) The custom prepared products are plainly marked “Not for Sale” as provided in § 316.16 of this subchapter, immediately after being prepared and are kept so identified until delivered to the owner; and
(iv) If exempted custom slaughtering or other preparation of products is conducted in an official establishment, all facilities and equipment in the official establishment used for such custom operations shall be thoroughly cleaned and sanitized before they are used for preparing any products for sale.
(b)(1) The exempted custom prepared products shall be prepared and handled in accordance with the provisions of §§ 318.5, 318.6, 381.300 through 318.311 of this subchapter and § 424.21 of subchapter E, and shall not be adulterated as defined in paragraph 1(m) of the Act. The provisions of §§ 318.5, 318.6, and 318.300 through 318.311 related to inspection or supervision of specified activities or other action by an inspection program employee and the provisions of § 318.6(b)(9) and (10) shall not apply to the preparation and handling of such exempted products.
(2) The exempted custom prepared products shall comply with the requirements of §§ 316.16 and 317.16 of this subchapter.
(3) The custom operators claiming exemption under paragraph (a)(2) of this section shall keep records, in addition to records otherwise required by part 320 of this subchapter, showing the numbers and kinds of livestock slaughtered on a custom basis, the quantities and types of products prepared on a custom basis, and the names and addresses of the owners of the livestock and products.
(4) Articles capable of use as human food, resulting from the exempted custom slaughter or other preparation of products shall be promptly denatured or otherwise identified in accordance with § 325.13 of this subchapter and not removed from the establishment where the custom operations are conducted until so identified, unless they are delivered to the owner of the articles for use in accordance with paragraph (a)(2) of this section.
(c) It has been determined that it is impracticable to provide inspection of the preparation of products at establishments in any unorganized Territory at which livestock are slaughtered or their products are prepared for distribution solely within such jurisdiction and that exempting such establishments from requirements of the Act for such inspections under the conditions stated in this section will otherwise facilitate enforcement of the Act. Therefore, such inspection requirements of the Act and of the regulations in this subchapter shall not apply at such establishments if they are operated in accordance with the regulations in part 416, §§ 416.1 through 416.5 of this chapter. However, the Administrator may refuse, withdraw, or modify any exemption under this paragraph when he determines in any specific case in accordance with the applicable rules of practice that such action is necessary to effectuate the purposes of this Act.
(d)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments.
(2) For purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at retail stores and restaurants are the following:
(a) Cutting up, slicing, and trimming carcasses, halves, quarters, or wholesale cuts into retail cuts such as steaks, chops, and roasts, and freezing such cuts;
(b) Grinding and freezing products made from meat;
(c) Curing, cooking, smoking, rendering or refining of livestock fat, or other preparation of products, except slaughtering or the retort processing of canned products;
(d) Breaking bulk shipments of products;
(e) Wrapping or rewrapping products.
(ii) Any quantity or product purchased by a consumer from a particular retail supplier shall be deemed to be a normal retail quantity if the quantity so purchased does not in the aggregate exceed one-half carcass. The following amounts of product will be accepted as representing one-half carcass of the species identified:
| One-half carcass pounds | |
|---|---|
| Cattle | 300 |
| Calves | 37.5 |
| Sheep | 27.5 |
| Swine | 100 |
| Goats | 25 |
(iii) A retail store is any place of business where:
(a) The sales of product are made to consumers only;
(b) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Administrator. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $500. Notice of the adjusted dollar limitation will be published in the
(c) Only federally or State inspected and passed product is handled or used in the preparation of any product, except that product resulting from the custom slaughter or custom preparation of product may be handled or used in accordance with paragraph (a)(2) and (b) of this section but not for sale;
(d) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section;
(e) The preparation of products for sale to household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section; and
(f) The preparation of products for sale to other than household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail store at which custom slaughtering or preparation of products is conducted is not thereby disqualified from exemption as a retail store under this paragraph (d).)
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Product is prepared only for sale or service in meals or as entrees directly to individual consumers at such establishments;
(2) Only federally or State inspected and passed product or such product prepared at a retail store exempted under paragraph (d)(2)(iii) of this section is handled or used in the preparation of any product;
(3) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and
(4) The preparation of product is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.
(b) The definition of a restaurant includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meets the requirements of this paragraph.
(c) For purposes of this paragraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirements of this paragraph: Provided, That the requirements of §§ 320.1 through 320.4 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary, if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator's determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.
(v) Similar retail-type establishment: Any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as prescribed in paragraphs (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.
(vi) Consumer: Any household consumer, hotel, restaurant, or similar institution as determined by the Administrator in specific cases.
(3) Whenever any complaint is received by the Administrator from any person alleging that any retail store claiming exemption under this paragraph (d), in any designated State or organized Territory that is identified under section 205 of the Act (as one that does not have or is not exercising adequate authority with respect to recordkeeping requirements) has been operated in violation of the conditions prescribed in this section for exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail store and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator still has reason to believe that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail store would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of total monthly purchases and of total monthly sales of meat, meat byproducts, and meat food products, in terms of dollar values of the products involved. Such records shall separately show total sales to household consumers and total sales to other consumers and shall be maintained for the period prescribed in § 320.3 of this subchapter. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this subparagraph.
(e)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to meat pizzas containing meat food product ingredients which were prepared, inspected, and passed in a cured or cooked form as ready-to-eat (i.e., no further cooking or other preparation is needed) in compliance with the requirements of the Act and these regulations; and the meat pizzas are to be served in public or private nonprofit institutions, provided that the meat pizzas are ready-to-eat (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to the receiving institution by employees of the preparing firm, receiving institution, or a food service management company contracted to conduct food service at the public or private nonprofit institution, without intervening transfer or storage.
(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-203, and 6-105, part IV, of the Food and Drug Administration's Food Service Sanitation Manual (1976 Recommendations), DHEW Publication No. (FDA) 78-2081, which is incorporated by reference, shall apply to the facilities and operations of businesses claiming this exemption. (These materials are incorporated as they exist on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(3) Facilities and operations of businesses claiming this exemption shall also conform to the following requirements:
(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing and sanitizing of utensils and equipment, a sink with not fewer than three compartments shall be provided and used. Sink compartments shall be large enough to permit the accommodation of the equipment and utensils, and each compartment of the sink shall be supplied with hot and cold potable running water. Fixed equipment and utensils and equipment too large to be cleaned in sink compartments shall be washed manually or cleaned through pressure spray methods.
(B) Drain boards or easily movable dish tables of adequate size shall be provided for proper handling of soiled utensils prior to washing and for cleaned utensils following sanitizing and shall be located so as not to interfere with the proper use of the dishwashing facilities.
(C) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil.
(D) Except for fixed equipment and utensils too large to be cleaned in sink compartments, manual washing, rinsing and sanitizing shall be conducted in the following sequence:
(1) Sinks shall be cleaned prior to use.
(2) Equipment and utensils shall be thoroughly washed in the first compartment with a hot detergent solution that is kept clean.
(3) Equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment.
(4) Equipment and utensils shall be sanitized in the third compartment according to one of the methods prescribed in paragraph (e)(3)(i)(E) (1) through (4) of this section.
(E) The food-contact surfaces of all equipment and utensils shall be sanitized by:
(1) Immersion for at least
(2) Immersion for at least 1 minute in a clean solution containing at least 50 parts per million of available chlorine as a hypochlorite and at a temperature of at least 75 °F; or
(3) Immersion for at least 1 minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and at a temperature of at least 75 °F; or
(4) Immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 that will provide the equivalent bactericidal effect of a solution containing at least 50 parts per million of available chlorine as a hypochlorite at a temperature of at least 75 °F for 1 minute; or
(5) Treatment with steam free from materials or additives other than those specified in 21 CFR 173.310 in the case of equipment too large to sanitize by immersion, but in which steam can be confined; or
(6) Rinsing, spraying, or swabbing with a chemical sanitizing solution of at least twice the strength required for that particular sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in the case of equipment too large to sanitize by immersion.
(F) When hot water is used for sanitizing, the following facilities shall be provided and used:
(1) An integral heating device or fixture installed in, on, or under the sanitizing compartment of the sink capable of maintaining the water at a temperature of at least 170 °F; and
(2) A numerically scaled indicating thermometer, accurate to ±3 °F, convenient to the sink for frequent checks of water temperature; and
(3) Dish baskets of such size and design to permit complete immersion of the tableware, kitchenware, and equipment in the hot water.
(G) When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted under 21 CFR 178.1010 and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.
(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils. These machines and devices shall be properly installed and maintained in good repair.
Machines and devices shall be operated in accordance with manufacturers' instructions, and utensils and equipment placed in the machine shall be exposed to all dishwashing cycles. Automatic detergent dispensers, wetting agent dispensers, and liquid sanitizer injectors, if any, shall be properly installed and maintained.
(B) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than 15 nor more than 25 pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A
(C) Machine or water line mounted numerically scaled indicating thermometers, accurate to ±3 °F, shall be provided to indicate the temperature of the water in each tank of the machine and the temperature of the final rinse water as it enters the manifold.
(D) Rinse water tanks shall be protected by baffles, curtains, or other effective means to minimize the entry of wash water into the rinse water. Conveyors in dishwashing machines shall be accurately timed to assure proper exposure times in wash and rinse cycles in accordance with manufacturers' specifications attached to the machines.
(E) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of easily movable dishtables for the storage of clean utensils following sanitization.
(F) Equipment and utensils shall be flushed or scraped and, when necessary, soaked to remove gross food particles and soil prior to being washed in a dishwashing machine unless a prewashcycle is a part of the dishwashing machine operation. Equipment and utensils shall be placed in racks, trays, or baskets, or on conveyors, in a way that food-contact surfaces are exposed to the unobstructed application of detergent wash and clean rinse waters and that permits free draining.
(G) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washers) using chemicals for sanitization may be used: Provided, That,
(1) The temperature of the wash water shall not be less than 120 °F.
(2) The wash water shall be kept clean.
(3) Chemicals added for sanitization purposes shall be automatically dispensed.
(4) Utensils and equipment shall be exposed to the final chemical sanitizing rinse in accordance with manufacturers' specifications for time and concentration.
(5) The chemical sanitizing rinse water temperature shall be not less than 75 °F nor less than the temperature specified by the machine's manufacturer.
(6) Chemical sanitizers used shall meet the requirements of 21 CFR 178.1010.
(7) A test kit or other device that accurately measures the parts per million concentration of the solution shall be available and used.
(H) Machines using hot water for sanitizing may be used provided that wash water and pumped rinse water shall be kept clean and water shall be maintained at not less than the following temperatures:
(1) Single-tank, stationary-rack, dual-temperature machine:
(2) Single-tank, stationary-rack, single-temperature machine:
(3) Single-tank, conveyor machine:
(4) Multitank, conveyor machine:
(5) Single-tank, pot, pan, and utensil washer (either stationary or moving-rack):
(I) All dishwashing machines shall be thoroughly cleaned at least once a day or more often when necessary to maintain them in a satisfactory operating condition.
(iii) Steam. Steam used in contact with food or food-contact surfaces shall be free from any materials or additives other than those specified in 21 CFR 173.310.
(4) For purposes of this paragraph, the term “private nonprofit institution” means “a corporation, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals, no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation, and which does not participate in, or intervene in (including the publishing or distribution of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”
(5) The Administrator may withdraw or modify the exemption set forth in § 303.1(e)(1) for a particular establishment when he or she determines that such action is necessary to ensure food safety and public health. Before such action is taken, the owner or operator of the particular establishment shall be notified, in writing, of the reasons for the proposed action and shall be given an opportunity to respond, in writing, to the Administrator within 20 days after notification of the proposed action. The written notification shall be served on the owner or operator of the establishment in the manner prescribed in section 1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). In those instances where there is conflict of any material fact, the owner or operator of the establishment, upon request, shall be afforded an opportunity for a hearing with respect to the disputed fact, in accordance with rules of practice which shall be adopted for the proceeding. However, such withdrawal or modification shall become effective pending final determination in the proceeding when the Administrator determines that an imminent threat to food safety or public health exists, and that such action is, therefore, necessary to protect the public health, interest or safety. Such withdrawal or modification shall be effective upon oral or written notification, whichever is earlier, to the owner or operator of the particular establishment as promptly as circumstances permit. In the event of oral notification, written confirmation shall be given to the owner or operator of the establishment as promptly as circumstances permit. This withdrawal or modification shall continue in effect ending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(f) The adulteration and misbranding provisions of the Act and the regulations in this subchapter, other than the requirement of the official inspection legend, apply to articles which are exempted from inspection or not required to be inspected under this section.
(g) The Administrator may extend the requirements of titles I and IV of the Act to any establishment in any State or organized Territory at which products are prepared for distribution solely within such jurisdiction, if he determines in accordance with the provisions of paragraph 301(c)(1) of the Act that it is producing adulterated products which would clearly endanger the public health.
(h) The Administrator may in specific classes of cases waive for limited periods any provisions of the regulations in this subchapter in order to permit appropriate and necessary action in the event of a public health emergency or to permit experimentation so that new procedures, equipment, and/or processing techniques may be tested to facilitate definite improvements: Provided, That such waivers of the provisions of such regulations are not in conflict with the purposes or provisions of the Act.
(a) Pursuant to the Processed Products Inspection Improvement Act of 1986, Title IV of the Futures Trading Act of 1986 (Pub. L. 99-641), in establishments preparing products at which inspection under the Act and regulations is required, the frequency with which and the manner in which meat food products made from livestock previously slaughtered in official establishments are examined and inspected by Program employees is to be based on considerations relevant to effective regulation of meat food products and protection of the health and welfare of consumers. In order to test procedures for use in making such determinations and, in particular, for determining whether and, is so, to what extent the intensity of inspection coverage exceeds that which should be considered necessary pursuant to section 6 of the Act, as amended by section 403(a) of the Futures Trading Act of 1986, the Administrator is initiating experimentation of a new system of inspection for reviewing the performance of establishments and for designing the supervision and other conditions and methods of inspection coverage. For the period of such experimentation, the Administrator shall identify establishments for review, and the frequency and the manner of inspection by Program employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.
(b) The determinations referred to in paragraph (a) of this section shall be made by the program and shall reflect evaluations of the performance and the characteristics and such establishments.
(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:
(i) The history of compliance with applicable regulatory requirements by the person conducting operations at such establishment or by anyone responsibly connected with the business conducting operations at such establishment, as “responsibly connected” is defined in section 401(g) of the Act,
(ii) The competence of the person conducting operations at such establishment, as indicated by:
(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,
(B) Demonstrated ability to apply such knowledge in a timely and consistent manner, and
(C) Commitment to correcting deficiencies noted by Program employees and otherwise assuring compliance with applicable regulatory requirements, and
(iii) The procedures used in such establishment to control the production process, environment, and resulting product in order to assure and monitor compliance with the requirements of the Act and the rules and regulations promulgated thereunder.
(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:
(i) The complexity of the processing operation(s) conducted at such establishment,
(ii) The frequency with which each such operation is conducted at such establishment,
(iii) The volume of product resulting from each such operation at such establishment,
(iv) Whether and to what extent slaughter operations also are conducted at such establishment,
(v) What, if any, food products not regulated under this Act or the Poultry Products Inspection Act also are prepared at such establishment, and
(vi) The size of such establishment.
(c)(1) For the period of experimentation described in paragraph (a) of this section, the frequency of inspection by Program employees of operations other than slaughter may be reduced in an establishment in which the procedures referred to therein are being tested if and only if the evaluation of the performance of such establishment described in paragraph (b)(1) indicates that there are:
(i) No instances, documented in records compiled no earlier than 10 years before, of substantial and recent noncompliance with applicable regulatory requirements (taking into account both the nature and frequency of any such noncompliance), and
(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.
(2)(i) The frequency of Federal inspection and other conditions and methods of inspection coverage in any establishment in which the frequency of Federal inspection is reduced shall be based on:
(A) The evaluation of the characteristics of such establishment described in paragraph (b)(2) of this section,
(B) The significance of potential public health consequences of noncompliance, and
(C) The availability of Program employees.
(ii) To the extent that such frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this subchapter, the Administrator will waive such provisions for the period of experimentation, in accordance with § 303.1(g) of this subchapter.
(a) Before the inspection is granted, each person conducting operations at an establishment subject to the Act, whether tenant, subsidiary, or landlord, shall make application therefor to the Administrator as provided for in this part.
(b) Every application under this section shall be made on an official form furnished by the Program, available from any Regional Director identified in § 301.2(kkk) of this subchapter, and shall be completed to include all information requested. Trade names of the applicant for labeling purposes, shall be inserted in the appropriate blank in the application. Each applicant for inspection will be held responsible for compliance with the Act and the regulations in this subchapter if inspection is granted. Preparation of product and other operations at the establishment for which inspection is granted may be conducted only by the applicant named in the application.
(c) In cases of change of ownership or location, a new application shall be made.
(a) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the establishment, including the limits of the establishment's premises, to which the grant pertains.
(b) The Administrator is authorized to grant inspection upon his determination that the applicant and the establishment are eligible therefor and to refuse to grant inspection at any establishment if he determines that it does not meet the requirements of this part or the regulations in parts 305, 307, and part 416, §§ 416.1 through 416.6 of this chapter or that the applicant has not received approval of labeling and containers to be used at the establishment as required by the regulations in parts 316 and 317. Any application for inspection may be refused in accordance with the rules of practice in part 500 of this chapter.
(c)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters in the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), to provide the Administrator with a certification as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless such certification has been obtained, or is waived because of failure or refusal of the State, interstate agency or the Secretary of the Interior to act on a request for certification within a reasonable period (which shall not exceed 1 year after receipt of such request).
(2) However, certification is not initially required in connection with an application for inspection granted after April 3, 1970, for facilities existing or under construction on April 3, 1970, although certification for such facilities is required to be obtained within the 3-year period immediately following April 3, 1970. Failure to obtain such certification and meet the other requirements of subsection 21(b) prior to April 3, 1973, will result in the termination of inspection at such facilities on that date.
(a) Before being granted Federal inspection, an official establishment or an official import inspection establishment must have developed written Sanitation Standard Operating Procedures, as required by part 416 of this chapter, and written recall procedures as required by part 418 of this chapter.
(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, as required by §§ 417.2 and 417.4 of this chapter. A conditional grant of inspection shall be issued for a period not to exceed 90 days, during which period the establishment must validate its HACCP plan.
(c) Before producing new product for distribution in commerce, an establishment shall have conducted a hazard analysis and developed a HACCP plan applicable to that product in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP plan, in accordance with § 417.4 of this chapter.
(a) An official number shall be assigned to each establishment granted inspection. Such number shall be used to identify all inspected and passed products prepared in the establishment. More than one number shall not be assigned to an establishment.
(b) Two or more official establishments under the same ownership or control may be granted the same official number, provided a serial letter is added in each case to identify each establishment and the products thereof.
(c) When inspection has been granted to any applicant at an establishment, it shall not be granted to any other person at the same establishment. However, persons operating as separate entities in the same building or structure may operate separate establishments therein only under their own grant of inspection. All such persons operating separate establishments in the same building or structure shall be responsible for compliance with the Act and regulations in their own establishments, which shall include common areas, e.g., hallways, stairways, and elevators.
(a) Each official establishment shall be separate and distinct from any unofficial establishment except a poultry products processing establishment operated under Federal inspection under the Poultry Products Inspection Act or under State inspection.
(b) The slaughter or other preparation of products of horses, mules, or other equines required to be conducted under inspection pursuant to the regulations in this subchapter shall be done in establishments separate from any establishment in which cattle, sheep, swine, or goats are slaughtered or their products are prepared.
(c) Inspection shall not be inaugurated in any building, any part of which is used as living quarters, unless the part for which inspection is requested is separated from such quarters by floors, walls, and ceilings of solid concrete, brick, wood, or similar material, and the floors, walls, and ceilings are without openings that directly or indirectly communicate with any part of the building used as living quarters.
Inspection shall not be inaugurated if an establishment is not in a sanitary condition nor unless the establishment agrees to maintain a sanitary condition and provides adequate facilities for conducting such inspection.
When inspection is granted, the circuit supervisor shall, at or prior to the inauguration of inspection, inform the operator of the establishment of the requirements of the regulations in this subchapter. If the establishment, at the time inspection is inaugurated, contains any product which has not theretofore been inspected, passed, and marked in compliance with the regulations in this subchapter, the identity of the same shall be maintained, and it shall not be distributed in commerce, or otherwise subject to the requirements of such regulations, or dealt with as inspected and passed under the regulations. The establishment shall adopt and enforce all necessary measures and shall comply with all such directions as the circuit supervisor may prescribe, for carrying out the purposes of this section.
Program employees shall report, in a manner prescribed by the Administrator, all violations of the Act or regulations in this subchapter of which they have information.
[See §§ 300.3 and 300.4 of this chapter regarding FSIS' organization and inspection program supervisors.]
[See § 300.6 of this chapter regarding access to establishments and other places of business.]
Each inspector will be furnished with a numbered official badge, which he shall not allow to leave his possession, and which he shall wear in such manner and at such times as the Administrator may prescribe.
(a) Except as specifically authorized by the Administrator, no Program employee shall be detailed for duty at an establishment where any member of his family is employed by the operator of the establishment, or any tenant or subsidiary of such operator nor shall any circuit supervisor or other employee acting in a supervisory capacity be continued on duty at a circuit where any member of his family is so employed at any establishment under his jurisdiction. Program employees are forbidden to solicit, for any person, employment at any official establishment, or by any officer, manager, or employee thereof.
(b) Program employees shall not procure product from any official establishment or any other establishment if its operations or products are inspected or regulated under the Poultry Products Inspection Act or the Agricultural Marketing Act of 1946, as amended, or any other law administered by the Department unless the store or outlet from which the purchase is made is open to the general public and the price paid by such employee is the same as the price paid by the general public. Program employees must pay, and obtain receipts for money paid to such establishments for all such product and keep such receipts subject to inspection by supervisory employees or other authorized Department employees.
Any appeal from a decision of any Program employee shall be made to his/her immediate supervisor having jurisdiction over the subject matter of the appeal, except as otherwise provided in the applicable rules of practice.
Office space, including necessary furnishings, light, heat, and janitor service, shall be provided by official establishments, rent free, for the exclusive use for official purposes of the inspector and other Program employees assigned thereto. The space set aside for this purpose shall meet with approval of the circuit supervisor and shall be conveniently located, properly ventilated and provided with lockers suitable for the protection and storage of Program supplies and with facilities suitable for Program employees to change clothing if such clothes changing facilities are deemed necessary by the circuit supervisor. At the discretion of the Administrator, small plants requiring the services of less than one full time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Laundry service for inspectors' outer work clothing shall be provided by each establishment.
When required by the circuit supervisor, the following facilities and conditions, and such others as may be found to be essential to efficient conduct of inspection and maintenance of sanitary conditions, shall be provided by each official establishment:
(a) Satisfactory pens, equipment, and assistants for conducting ante-mortem inspection and for separating, marking and holding apart from passed livestock those marked “U.S. suspect” and those marked “U.S. condemned” (pens, alleys, and runways shall be paved, drained, and supplied with adequate hose connections for cleanup purposes);
(b) Sufficient light to be adequate for proper conduct of inspection;
(c) Racks, receptacles, or other suitable devices for retaining such parts as the head, tongue, tail, thymus gland, and viscera, and all parts and blood to be used in the preparation of meat food products or medical products, until after the post-mortem examination is completed, in order that they may be identified in case of condemnation of the carcass; equipment, trucks, and receptacles for the handling of viscera of slaughtered animals so as to prevent contact with the floor; and trucks, racks, marked receptacles, tables, and other necessary equipment for the separate and sanitary handling of carcasses or parts passed for cooking;
(d) Tables, benches, and other equipment on which inspection is to be performed, of such design, material, and construction as to enable Program employees to conduct their inspection in a ready, efficient and clean manner;
(e) Watertight metal trucks or receptacles for holding and handling diseased carcasses and parts, so constructed as to be readily cleaned; such trucks or receptacles to be marked in a conspicuous manner with the phrase “U.S. condemned” in letters not less than 2 inches high, and, when required by the circuit supervisor, to be equipped with facilities for locking or sealing;
(f) Adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, for sterilizing all implements used in dressing diseased carcasses, floors, and such other articles and places as may be contaminated by diseased carcasses or otherwise;
(g) In establishments in which slaughtering is done, rooms, compartments, or specially prepared open places, to be known as “final inspection places,” at which the final inspection of retained carcasses may be conducted (competent assistants for handling retained carcasses and parts shall be provided by the establishment; final inspection places shall be adequate in size and their rail arrangement and other equipment shall be sufficient to prevent carcasses and parts passed for food or cooking, from being contaminated by contact with condemned carcasses or parts; they shall be equipped with hot water, lavatory, sterilizer, tables, and other equipment required for ready, efficient, and sanitary conduct of the inspection; the floors shall be of such construction as to facilitate the maintenance of sanitary conditions and shall have proper drainage connections, and when the final inspection place is part of a larger floor, it shall be separated from the rest of the floor by a curb, railing, or otherwise);
(h) Retention rooms, cages, or other compartments, and receptacles in which carcasses and product may be held for further inspection (these shall be in such number and in such locations as the needs of the inspection in the establishment may require; they shall be equipped for secure locking or sealing and shall be held under locks or official seals furnished by the Department; the keys of such locks shall not leave the custody of Program employees. Every such room, compartment, or receptacle shall be marked conspicuously with the phrase “U.S. retained” in letters not less than 2 inches high; rooms or compartments for these purposes shall be secure and susceptible of being kept clean, including a sanitary disposal of the floor liquids; establishment employees shall not enter any retention rooms or compartments or open any retention receptacles unless authorized by Program employees);
(i) Adequate facilities, including denaturing materials, for the proper disposal of condemned articles in accordance with the regulations in this subchapter (tanks or other rendering equipment which, under the regulations in this subchapter, must be sealed, shall be properly equipped for sealing as specified by the regulations in part 314 of this subchapter or by the circuit supervisor in specific cases);
(j) Docks and receiving rooms, to be designated by the operator of the official establishment, with the circuit supervisor, for the receipt and inspection of all products as provided in § 318.3 of this subchapter.
(k) Suitable lockers in which brands bearing the official inspection legend and other official devices (excluding labels) and official certificates shall be kept when not in use (all such lockers shall be equipped for sealing or locking with locks or seals to be supplied by the Department; the keys of such locks shall not leave the custody of Program employees);
(l) Sanitary facilities and accommodations as prescribed by § 416.2(c), (d), (e), (f), and (h) of this chapter.
(m) In addition to any facilities required to accomplish sanitary dressing procedures, the following inspection station facilities for cattle and swine slaughter lines described in § 310.1(b) of this subchapter are required:
(1) An inspection station consisting of 5 feet of unobstructed line space for each head or carcass inspector and, for viscera table kills, 8 feet for each viscera inspector on the inspector's side of the table.
(2) A minimum of 50 foot candles of shadow-free lighting at the inspection surfaces of the head, viscera, and carcass.
(3) A handwash lavatory (other than one which is hand operated), furnished with soap, towels, and hot and cold water, and located adjacent to the inspector's work area. In addition, for each head and viscera inspector on cattle slaughter lines, and each head inspector on swine slaughter lines, a sterilizer located adjacent to the inspector's work area.
(4) For mechanized operations, a line control switch located adjacent to each inspection station.
(5) Facilities to position tally sheets or other recording devices, such as digital counters, and facilities to contain condemned brands.
(6) For swine slaughter lines requiring three or more inspectors, and for those one- and two-inspector configurations where the establishment installs a mirror: At the carcass inspection station one glass or plastic, distortion-free mirror, at least 5 feet × 5 feet, mounted far enough away from the vertical axis of the moving line to allow the carcass to be turned, but not over 3 feet away, and so mounted that any inspector standing at the carcass inspection station can readily view the back of the carcass.
Inspectors shall furnish their own work clothing and implements, such as flashlights and triers, for conducting inspection and shall maintain their implements in sanitary condition as prescribed by § 416.3(a) of this chapter.
(a) No operations requiring inspection shall be conducted except under the supervision of a Program employee. All slaughtering of animals and preparation of products shall be done with reasonable speed, considering the official establishment's facilities.
(b) A shift is a regularly scheduled operating period, exclusive of mealtime. One lunch period is the only official authorized interruption in the inspector's tour of duty once it begins. Lunch periods may be 30 minutes, 45 minutes, or in any case may not exceed one hour in duration. Once established, the lunch period must remain relatively constant as to time and duration. Lunch periods for inspectors shall not, except as provided herein, occur prior to 4 hours after the beginning of scheduled operations nor later than 5 hours after operations begin. In plants where a company rest break of not less than 30 minutes is regularly observed, approximately midpoint between start of work and the lunch period, and the inspector is allowed this time to meet his personal needs, the lunch period may be scheduled as long as 5
(c) Official establishments, importers, and exporters shall be provided inspection service, without charge, up to 8 consecutive hours per shift during the basic workweek subject to the provisions of § 307.5: Provided, That any additional shifts meet requirements as determined by the Administrator or his designee. The basic workweek shall consist of 5 consecutive 8-hour days within the administrative workweek Sunday through Saturday, except that, when possible, the Department shall schedule the basic workweek so as to consist of 5 consecutive 8-hour days Monday through Friday. The 8-hour day excludes the lunch period but shall include activities deemed necessary by the Agency to fully carry out an inspection program, including the time for FSIS inspection program personnel to put on required gear and to walk to a work station; to prepare the work station; to return from a work station and remove required gear; to sharpen knives, if necessary; and to conduct duties scheduled by FSIS, including administrative duties. The Department may depart from the basic workweek in those cases where maintaining such a schedule would seriously handicap the Department in carrying out its function. These provisions are applicable to all official establishments except in certain cases as provided in § 318.4(h) of this subchapter.
(d)(1) Each official establishment shall submit a work schedule to the area supervisor for approval. In consideration of whether the approval of an establishment work schedule shall be given, the area supervisor shall take into account the efficient and effective use of inspection personnel. The work schedule must specify daily clock hours of operation and lunch periods for all departments of the establishment requiring inspection.
(2) Establishments shall maintain consistent work schedules. Any request by an establishment for a change in its work schedule involving an addition or elimination of shifts shall be submitted to the area supervisor at least 2 weeks in advance of the proposed change. Frequent requests for change shall not be approved: Provided, however, minor deviations from a daily operating schedule may be approved by the inspector in charge, if such request is received on the day preceding the day of change.
(3) Request for inspection service outside an approved work schedule shall be made as early in the day as possible for overtime work to be performed within that same workday; or made prior to the end of the day's operation when such a request will result in overtime service at the start of the following day: Provided, That an inspector may be recalled to his assignment after completion of his daily tour of duty under the provisions of § 307.6(b).
(a) The management of an official establishment, an importer, or an exporter shall reimburse the Program, at the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday as specified in paragraph (b) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.
(b) Holidays for Federal employees shall be New Year's Day, January 1; Birthday of Martin Luther King, Jr., the third Monday in January; Washington's Birthday, the third Monday in February; Memorial Day, the last Monday in May; Independence Day, July 4; Labor Day, the first Monday in September; Columbus Day, the second Monday in October; Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in November; Christmas Day, December 25. When any of the above-listed holidays falls outside the basic workweek, the nearest workday within that week shall become a holiday.
(a) Each recipient of overtime or holiday inspection service, or both, shall be billed as provided for in § 307.5(a) and at the rates specified in § 391.3, in increments of quarter hours. For billing purposes, 8 or more minutes shall be considered a full quarter hour. Billing will be for each quarter hour of service rendered by each Program employee.
(b) Official establishments, importers, or exporters requesting and receiving the services of a Program employee after he has completed his day's assignment and left the premises, or called back to duty during any overtime or holiday period, shall be billed for a minimum of 2 hours overtime or holiday inspection service at the established rate.
(c) Bills are payable upon receipt and become delinquent 30 days from the date of the bill. Overtime or holiday inspection will not be performed for anyone having a delinquent account.
(a) General. Electrical stimulating (EST) equipment is equipment that provides electric shock treatment to carcasses for the purpose of accelerating rigor mortis of facilitating blood removal. These provisions do not apply to electrical equipment used to stun and/or slaughter animals or to facilitate hide removal. Electrical stimulating equipment consists of two separate pieces—the control system and the applicator. The EST control system contains the circuitry to generate pulsed DC or AC voltage for stimulation and is separate from the equipment used to apply the voltage to the carcass. The voltage is applied by inserting a probe that penetrates the carcass or is inserted in the rectum, placing a clamp in the nose, a carcass rub-bar, a conveyor with energized surfaces traveling with the carcass, or any other acceptable method.
(b) Safety requirements—(1) Circuits, grounding. Either a bonded grounding conductor shall lead from each section of the carcass rail within the stimulating enclosure to the service ground, or the secondary voltage (stimulating circuit) shall be insulated from the service ground. If the stimulating section of the carcass rail and carcass drive mechanisms are insulated from the service ground then the stimulating rail or the return path shall be electrically bonded to the transformer secondary to isolate the stimulation voltage.
(2) Enclosure. Electrical stimulation shall occur in an area that will prevent persons from contacting an energized surface. If the area is surrounded by physical barriers, the enclosure shall be either electrically grounded or it shall be made of materials that do not conduct electricity. The interior of the stimulating area shall be visible from the start switch so the operator can be assured that there is no person, equipment or material present that should not be there prior to starting the stimulating sequence. If light or sound beam sensors form the enclosure, the stimulating equipment shall be automatically shut off when the sensor signals are broken.
(3) Mandatory Warning Devices and Signals. The following warning devices or signals shall be installed at each opening to the stimulating area through which a person would normally enter:
(i) A red light that flashes distinctly during the operating cycle of the stimulating equipment.
(ii) An ANSI Z53.1-Color Code sign reading (a) “Danger Electrical Hazard” for stimulating voltage below 50 or (b) “Danger High Voltage” for stimulating voltage above 50.
(iii) An emergency stop button.
(4) Optional Warning Device—Horn or Bell. If a warning horn or bell is installed, the signal shall be audible above background noises in the vicinity, and it shall sound for at least 1 second before each manual stimulation or before the carcass chain is started in an automatic system.
(c) Operation—(1) Training. Only persons who have received safety instruction by the equipment manufacturer or designee may operate electrical stimulating equipment.
(2) Cleaning and Maintenance. To prevent an electrical shock to personnel, the electricity supplied to the stimulating surfaces shall be locked-off when cleaning, mechanical inspection, maintenance or testing are performed.
(3) Water. To prevent an electrical shock, personnel shall not spray streams of water on energized carcasses or on energized stimulating surfaces.
(d) Special provisions for manually operated equipment. (1) Stimulating probes or clamps shall be stored in a sanitary container which is insulated with a material approved by the Administrator.
(2) The electric wires attached to a clamp or probe shall not allow for contact between the probe or clamp and an electrical ground and shall not extend outside the enclosure.
(a) All livestock offered for slaughter in an official establishment shall be examined and inspected on the day of and before slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Administrator have been made in specific cases by the circuit supervisor for such examination and inspection to be made on a different day before slaughter.
(b) Such ante-mortem inspection shall be made on the premises of the establishment at which the livestock are offered for slaughter before the livestock shall be allowed to enter into any department of the establishment where they are to be slaughtered or dressed or in which edible products are handled. When the holding pens of an official establishment are located in a public stockyard and are reserved for the exclusive use of the establishment, such pens shall be regarded as part of the premises of that establishment and the operator of the establishment shall be responsible for compliance with all requirements of the regulations in this subchapter with respect to such pens.
(a) Any livestock which, on ante-mortem inspection, do not clearly show, but are suspected of being affected with any disease or condition that, under part 311 of this subchapter, may cause condemnation of the carcass on post-mortem inspection, and any livestock which show, on ante-mortem inspection, any disease or condition that, under part 311 of this subchapter would cause condemnation of only part of the carcass on post-mortem inspection, shall be so handled as to retain its identity as a suspect until it is given final post-mortem inspection, when the carcass shall be marked and disposed of as provided in parts 310 and 311 of this subchapter, or until it is disposed of as otherwise provided in this part.
(b) All seriously crippled animals and non-ambulatory disabled livestock shall be identified as U.S. Suspects and disposed of as provided in § 311.1 of this subchapter unless they are required to be classed as condemned under § 309.3. Non-ambulatory disabled livestock are livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.
(c) Livestock which have reacted to a test for leptospirosis, or anaplasmosis, but which show no symptoms of the disease, shall be identified as U.S. Suspects and disposed of as provided in § 311.10 of this subchapter.
(d) Livestock which are known to have reacted to the tuberculin test shall be identified as U.S. Suspects and disposed of as provided in § 311.2 of this subchapter, except that livestock bearing an official “USDA Reactor” or similar State reactor tag shall not be tagged as U.S. Suspects.
(e) Any cattle found on ante-mortem inspection to be affected with epithelioma of the eye or of the orbital region to a lesser extent than as described in § 309.6 shall be identified as a U.S. Suspect and disposed of as provided in § 311.12 of this subchapter.
(f) Cattle found on ante-mortem inspection to be affected with anasarca to a lesser extent than as described in § 309.8 shall be identified as U.S. Suspects and disposed of as provided in § 311.8 of this subchapter or paragraph (g) of this section.
(g) Any livestock suspected of being affected with anasarca may be set apart and held for treatment under Program or other responsible official supervision approved by the area supervisor. If at the expiration of the treatment period the livestock upon examination is found to be free from disease, it may be released for any purpose. Otherwise, it shall be identified as U.S. Suspect and disposed of as provided in § 311.8 of this subchapter or condemned and disposed of as provided in § 309.8, whichever is appropriate.
(h) All hogs suspected on ante-mortem inspection of being affected with swine erysipelas shall be identified as U.S. Suspects and disposed of as provided in § 311.5 of this subchapter or paragraph (i) of this section.
(i) A hog suspected of being affected with swine erysipelas may be set apart and held for treatment under Program or other responsible official supervision approved by the area supervisor. If at the expiration of the treatment period the animal upon examination is found to be free from disease, it may be released for any purpose. Otherwise, it shall be identified as U.S. Suspect and disposed of as provided in § 311.5 of this subchapter, or condemned and disposed of as provided in § 309.13, whichever is appropriate.
(j) Any livestock which is affected with vesicular exanthema or vesicular stomatitis, but which has recovered to the extent that the lesions are in process of healing, the temperature is within normal range, and the livestock shows a return to normal appetite and activity, shall be identified as U.S. Suspect and disposed of as provided in § 311.32 of this subchapter, except that if desired, such livestock may be set apart and held under supervision of a Program employee or other official designated by the area supervisor for treatment. If the livestock is set aside for treatment, the U.S. Suspect identification device will be removed by a Program employee, following such treatment, if the livestock is found to be free from any such disease. Such livestock found to be free from any such disease may be released for slaughter or for purposes other than slaughter, provided that in the latter instance, the operator of the official establishment or the owner of the animal shall first obtain permission from the local, State, or Federal livestock sanitary official having jurisdiction over the movement of such livestock.
(k) Livestock which are offered for ante-mortem inspection under this part, and which are regarded by the inspector as immature, shall be identified as U.S. Suspects and, if slaughtered, the disposition of their carcasses shall be determined by the post-mortem findings in connection with the ante-mortem conditions. If not slaughtered as suspects, such livestock shall be held under supervision of a Program employee or other official designated by the area supervisor, and after sufficient development may be released for slaughter or may be released for any other purpose, provided they have not been exposed to any infectious or contagious disease. If such exposure occurs, permission should be obtained from the nearest Veterinary Services unit of the Animal and Plant Health Inspection Service prior to release of such livestock.
(l) Livestock previously condemned for listeriosis, if released for slaughter under § 309.13(b) shall be identified as a U.S. Suspect in accordance with § 309.13(c).
(m) Each animal required by this part to be treated as a U.S. Suspect shall be identified as such by or under the supervision of a Program employee with an official device in accordance with § 309.18. No such device shall be removed except by a Program employee.
(n) Each animal identified as a U.S. Suspect on ante-mortem inspection shall be set apart and shall be slaughtered separately from other livestock at that establishment unless disposed of as otherwise provided in this part.
(o) Each animal identified as a U.S. Suspect on ante-mortem inspection, when presented for slaughter shall be accompanied with a form MP 402-2 on which the inspector at the establishment shall record the U.S. Suspect identification number and any other identifying tag numbers present and a brief description of the animal and of the disease or condition for which the animal was classed as a suspect, including its temperature when the temperature of such animal might have a bearing on the disposition of the carcass on post-mortem inspection.
(p) When any animal identified as a U.S. Suspect is released for any purpose or reason, as provided in this part, the official identification device shall be removed only by a Program employee and he shall report his action to the area supervisor. When a suspect is to be released under the provisions of this part for a purpose other than slaughter, the operator of the official establishment or the owner of the animal shall first obtain permission for the removal of such animal from the local, State or Federal livestock sanitary official having jurisdiction.
(a) Livestock found to be dead or in a dying condition on the premises of an official establishment shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(b) Livestock plainly showing on ante-mortem inspection any disease or condition that, under part 311 of this subchapter, would cause condemnation of their carcasses on post-mortem inspection shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(c) Any swine having a temperature of 106 °F. or higher and any cattle, sheep, goats, horses, mules, or other equines having a temperature of 105 °F. or higher shall be identified as U.S. Condemned. In case of doubt as to the cause of the high temperature, or when for other reasons a Program employee deems such action warranted, any such livestock may be held for a reasonable time under the supervision of a Program employee for further observation and taking of temperature before final disposition of such livestock is determined. Any livestock so held shall be reinspected on the day it is slaughtered. If, upon such reinspection, or when not held for further observation and taking of temperature, then on the original inspection, the animal has a temperature of 106 °F. or higher in the case of swine, or 105 °F. or higher in the case of other livestock, it shall be condemned and disposed of in accordance with § 309.13.
(d) Any livestock found in a comatose or semicomatose condition or affected with any condition not otherwise covered in this part, which would preclude release of the animal for slaughter for human food, shall be identified “U.S. Condemned” and disposed of in accordance with § 309.13, except that such animal may be set apart and held for further observation or treatment under supervision of a Program employee or other official designated by the area supervisor and for final disposition in accordance with this part.
(e) Establishment personnel must notify FSIS inspection personnel when cattle become non-ambulatory disabled after passing ante-mortem inspection. Non-ambulatory disabled cattle that are offered for slaughter must be condemned and promptly disposed of in accordance with § 309.13.
(a) All livestock showing, on ante-mortem inspection, symptoms of anaplasmosis, ketosis, leptospirosis, listeriosis, parturient paresis, pseudorabies, rabies, scrapie, tetanus, grass tetany, transport tetany, strangles, purpura hemorrhagica, azoturia, infectious equine encephalomyelitis, toxic encephalomyelitis (forage poisoning), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness or extensive fistula shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(b) If any equine is suspected on ante-mortem inspection of being infected with glanders or dourine, the nearest Veterinary Services unit of the Animal and Plant Health Inspection Service shall be so informed by a Program employee. Tests shall be performed by said unit to determine whether the animal is, in fact, infected with such disease. If it is found on such tests to be infected, the animal shall be disposed of in accordance with paragraph (a) of this section. Otherwise, the animal shall be identified as a U.S. Suspect and disposed of as provided in § 311.10 of this subchapter.
(a) All swine found by an inspector to be affected with hog cholera shall be identified as U.S. Condemned and disposed of in accordance with § 309.13. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for the control of swine diseases in the State where the swine are located.
(b) All swine, even though not themselves identified as U.S. Suspects, which are of lots in which one or more animals have been condemned or identified as U.S. Suspect for hog cholera, shall, as far as possible, be slaughtered separately and apart from all other livestock passed on ante-mortem inspection.
Any animal found on ante-mortem inspection to be affected with epithelioma of the eye and the orbital region in which the eye has been destroyed or obscured by neoplastic tissue and which shows extensive infection, suppuration, and necrosis, usually accompanied with foul odor, or any animal affected with epithelioma of the eye or of the orbital region which, regardless of extent, is accompanied with cachexia shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(a) Any livestock found on ante-mortem inspection to be affected with anthrax shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(b) No other livestock of a lot in which anthrax is found on ante-mortem inspection shall be slaughtered and presented for post-mortem inspection until it has been determined by a careful ante-mortem inspection that no anthrax infected livestock remains in the lot.
(c) Apparently healthy livestock (other than hogs) from a lot in which anthrax is detected, and any apparently healthy livestock which have been treated with anthrax biologicals which do not contain living anthrax organisms, may be slaughtered and presented for post-mortem inspection if they have been held not less than 21 days following the last treatment or the last death of any livestock in the lot. Alternatively, if desired, all apparently healthy livestock of the lot may be segregated and held for treatment by a State licensed veterinarian under supervision of a Program employee or other official designated by the area supervisor. No anthrax vaccine (live organisms) shall be used on the premises of an official establishment.
(d) Livestock which have been injected with anthrax vaccines (live organisms) within 6 weeks, and those bearing evidence of reaction to such treatment, such as inflammation, tumefaction, or edema at the site of the injection, shall be condemned on ante-mortem inspection, or such animals may be held under supervision of a Program employee or other official designated by the area supervisor until the expiration of the 6-week period and the disappearance of any evidence of reaction to the treatment.
(e) When livestock are found on ante-mortem inspection to be affected with anthrax, all exposed livestock pens and driveways of the official establishment shall be cleaned and disinfected by promptly and thoroughly removing and burning all straw, litter, and manure. This shall be followed immediately by a thorough disinfection of the exposed premises by soaking the ground, fences, gates, and all exposed material with a 5 percent solution of sodium hydroxide or commercial lye prepared as outlined in § 310.9(e)(1) of this subchapter, or other disinfectant that may be approved in specific cases by the Administrator specifically for this purpose.
All cattle found on ante-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive and generalized edema shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
All hogs plainly showing on ante-mortem inspection that they are affected with acute swine erysipelas shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
Any livestock showing signs of the onset of parturition shall be withheld from slaughter until after parturition and passage of the placenta. Slaughter or other disposition may then be permitted if the animal is otherwise acceptable.
Vaccine livestock with unhealed lesions of vaccinia, accompanied with fever, which have not been exposed to any other infectious or contagious disease, are not required to be slaughtered and may be released for removal from the premises.
In all cases of emergency slaughter, except as provided in § 311.27 of this subchapter, the animals shall be inspected immediately before slaughter, whether theretofore inspected or not. When the necessity for emergency slaughter exists, the establishment shall notify the inspector in charge so that such inspection may be made.
(a) Except as otherwise provided in this part, livestock identified as U.S. Condemned shall be killed by the official establishment, if not already dead. Such animals shall not be taken into the official establishment to be slaughtered or dressed; nor shall they be conveyed into any department of the establishment used for edible products; but they shall be disposed of in the manner provided for condemned carcasses in part 314 of this subchapter. The official U.S. Condemned tag shall not be removed from, but shall remain on the carcass until it goes into the tank, or is otherwise disposed of as prescribed in part 314 of this subchapter, at which time such tag may be removed by a Program employee only. The number of such tag shall be reported to the veterinary medical officer by the inspector who affixed it, and also by the inspector who supervised the tanking of the carcass.
(b) Any livestock condemned on account of ketosis, swine erysipelas, vesicular diseases, grass tetany, transport tetany, parturient paresis, anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory condition including pneumonia, enteritis, and peritonitis may be set apart and held for treatment under supervision of a Program employee or official designated by the area supervisor. The U.S. Condemned identification tag will be removed by a Program employee following treatment under such supervision if the animal is found to be free from any such disease.
(c) Livestock previously affected with listeriosis, including those released for slaughter after treatment under paragraph (b) of this section, shall be identified as U.S. Suspect.
(d) When livestock under the provisions of this section is to be released for a purpose other than slaughter, the operator of the official establishment or the owner of the livestock shall first obtain permission for the movement of such livestock from the local, State, or Federal livestock sanitary official having jurisdiction.
Goats which have reacted to a test for brucellosis shall not be slaughtered in an official establishment.
(a) Immediate notification shall be given by the inspector to the local, State, and Federal livestock sanitary officials having jurisdiction when any livestock is found to be affected with a vesicular disease.
(b) No livestock under quarantine by State or Federal livestock sanitary officials on account of a vesicular disease will be given ante-mortem inspection. If no quarantine is invoked, or if quarantine is invoked and later removed, upon ante-mortem inspection, any animal found to be affected with vesicular exanthema or vesicular stomatitis in the acute stages, as evidenced by acute and active lesions or an elevated temperature, shall be identified as U.S. Condemned and disposed of in accordance with § 309.13.
(a) Except as provided by paragraph (d) of this section, livestock suspected of having been treated with or exposed to any substance that may impart a biological residue which would make the edible tissues unfit for human food or otherwise adulterated shall be handled in compliance with the provisions of this paragraph. They shall be identified at official establishments as “U.S. Condemned.” These livestock may be held under the custody of a Program employee, or other official designated by the Administrator, until metabolic processes have reduced the residue sufficiently to make the tissues fit for human food and otherwise not adulterated. When the required time has elapsed, the livestock, if returned for slaughter, must be re-examined on ante-mortem inspection. To aid in determining the amount of residue present in the tissues, officials of the Program may permit the slaughter of any such livestock for the purpose of collecting tissues for analysis for the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of livestock.
(b) All carcasses and edible organs and other parts thereof, in which are found any biological residues which render such articles adulterated, shall be marked as “U.S. Condemned” and disposed of in accordance with § 314.1 or § 314.3 of this chapter.
(c) [Reserved]
(d) Calves shall not be presented for ante-mortem inspection in an official establishment except under the provisions of this paragraph.
(1) Definitions. For purposes of this paragraph, the following definitions shall apply:
(i) Calf. A calf up to 3 weeks of age or up to 150 pounds.
(ii) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.
(iii) Healthy calf. A calf that an inspector determines shows no visual signs of disease or treatment of disease at ante-mortem inspection.
(iv) Producer. The owner of the calf at the time of its birth.
(v) Sick calf. A calf that an inspector on ante-mortem inspection determines has either signs of treatment or signs of disease.
(vi) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.
(2) General requirements. (i) The identity of the producer of each calf presented for ante-mortem inspection shall be made available by the official establishment to the inspection prior to the animal being presented for ante-mortem inspection.
(ii) The inspector shall segregate the calves presented for ante-mortem inspection at the establishment and identify each calf as one of the following: (a) Certified, (B) noncertified, or (C) previous residue condemnation.
(3) Certified group. (i) For a calf to be considered certified, the producer and all other subsequent custodians of the calf must certify in writing that while the calf was in his or her custody, the calf was not treated with animal drugs or was treated with one or more drugs in accordance with FDA approved label directions and was withheld from slaughter for the period(s) of time specified by those label directions. All prior certifications must be presented with the animal at the time of slaughter. The certifications shall contain a list of the calves with accompanying identification numbers, as required by paragraph (d)(3)(ii) of this section, followed by the following language:
I hereby certify that, while in my custody, from ________ to ________ (time period of custody), the above-listed calf or calves have not been treated with drugs, or have been treated with one or more drugs in accordance with FDA approved label directions and have been withheld from slaughter for the period(s) of time specified by those label directions. I certify that, to the best of my knowledge and belief, all information contained herein is true, that the information may be relied upon at the official establishment, and that I understand that any willful falsification of this certification is a felony and may result in a fine of up to $250,000 for an individual or up to $500,000 for an organization, or imprisonment for not more than 5 years, or both (21 U.S.C. 677, 18 U.S.C. 1001 and 3571).
(ii) Each calf must be identified by use of backtag, eartag, or other type of secure identification which displays a number which shall be recorded on all written certifications.
(iii) The inspector shall have segregated for veterinary medical officer examination any certified calf which he or she determines to show any sign of disease or which is not identified individually. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21 (c) and (d).
(iv) The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c) and (d).
(4) Noncertified group. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(c). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c).
(5) Calves from producers with previous residue condemnation. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(e). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(e).
(e) The name of each and all person(s) who sold or consigned each swine to the establishment shall be made available by the establishment to any Program employee or other authorized employee of the United States Department of Agriculture upon that employee's request and presentation of his or her official credentials. Swine identification, by means approved by the Animal and Plant Health Inspection Service, USDA, under part 71 of this title, must be maintained throughout post-mortem inspection, in accordance with § 310.23(a) of this subchapter.
(a) No livestock used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless:
(1) The operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Program, or the Veterinary Services unit of the Animal and Plant Health Inspection Service of the Department of Agriculture or to the Environmental Protection Agency or to the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such livestock being adulterated, and a Program employee has approved such slaughter;
(2) Written approval by the Deputy Administrator, Meat and Poultry Inspection Field Operations is furnished the area supervisor prior to the time of slaughter;
(3) In the case of an animal administered any unlicensed, experimental veterinary biologic product regulated under the Virus-Serum Toxin Act (21 U.S.C. 151 et seq.), the product was prepared and distributed in compliance with Part 103 of the regulations issued under said Act (part 103 of this title), and used in accordance with the labeling approved under said regulations;
(4) In the case of an animal administered any investigational drug regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), the drug was prepared and distributed in compliance with the applicable provisions of part 135 of the regulations issued under said Act (21 CFR part 135), and used in accordance with the labeling approved under said regulations;
(5) In the case of an animal subjected to any experimental economic poison under section 2(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 135 et seq.), the product was prepared and distributed in accordance with § 362.17 of the regulations issued under said Act (7 CFR 362.17), and used in accordance with the labeling approved under said regulations.
(6) In the case of an animal administered or subjected to any substance that is a food additive or pesticide chemical under the Federal Food, Drug, and Cosmetic Act, supra, there has been compliance with all tolerance limitations established by said Act and the regulations promulgated thereunder (21 CFR 1.1 et seq.), and all other restrictions and requirements imposed by said Act and said regulations will be complied with at the time of slaughter.
(b) The inspector in charge may deny or withdraw the approval for slaughter of any livestock subject to the provision of this section when he deems it necessary to assure that all products prepared at the official establishment are free from adulteration.
(a) All livestock required by this part to be identified as U.S. Suspects shall be tagged with a serially numbered metal ear tag bearing the term “U.S. Suspect,” except as provided in § 309.2(d) and except that cattle affected with epithelioma of the eye, antinomycosis, or actinobacillosis to such an extent that the lesions would be readily detected on post-mortem inspection, need not be individually tagged on ante-mortem inspection with the U.S. Suspect tag, provided that such cattle are segregated and otherwise handled as U.S. Suspects.
(b) In addition, identification of U.S. Suspect swine must include the use of tattoos specified by the inspector to maintain the identity of the animals through the dehairing equipment when such equipment is used.
(c) All livestock required by this part to be identified as U.S. Condemned shall be tagged with a serially numbered metal ear tag bearing the term “U.S. Condemned.”
(d) The devices described in paragraphs (a), (b), and (c) of this section shall be the official devices for identification of livestock required to be identified as U.S. Suspect or U.S. Condemned as provided in this part.
(a) The establishment must conduct market hog sorting activities before the animals are presented for ante-mortem inspection. Market hogs exhibiting signs of moribundity, central nervous system disorders, or pyrexia must be disposed of according to paragraph (c) of this section.
(b) The establishment must develop, implement, and maintain written procedures to ensure that market hogs exhibiting signs of moribundity, central nervous system disorders, or pyrexia do not enter the official establishment to be slaughtered. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOPs, or other prerequisite programs.
(c) The establishment must identify livestock that establishment employees have sorted and removed from slaughter with a unique tag, tattoo, or similar device. The establishment must develop, implement, and maintain written procedures to ensure that the animals sorted and removed from slaughter do not enter the human food supply and are disposed of according to 9 CFR part 314.
(d) The establishment must maintain records to document the number of animals disposed of per day because they were removed from slaughter by establishment sorters before ante-mortem inspection by FSIS inspectors and the reasons that the animals were removed. These records are subject to review and evaluation by FSIS personnel.
(e) The establishment must immediately notify FSIS inspectors if the establishment has reason to believe that market hogs may have a notifiable animal disease. Notifiable animal diseases are designated by World Animal Health Organization.
(a) A careful post-mortem examination and inspection shall be made of the carcasses and parts thereof of all livestock slaughtered at official establishments. Such inspection and examination shall be made at the time of slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Administrator have been made in specific cases by the circuit supervisor for making such inspection and examination at a later time.
(b)(1) The staffing standards on the basis of the number of carcasses to be inspected per hour are outlined in the following tables. Standards for multiple inspector lines are based on inspectors rotating through the different types of inspection stations during each shift to equalize the workload. The inspector in charge shall have the authority to require the establishment to reduce slaughter line speeds where, in his judgment, the inspection procedure cannot be adequately performed at the current line speed because of particular deficiencies in carcass preparation and presentation by the plant at the higher speed, or because the health condition of the particular animals indicates a need for more extensive inspection.
(2) Cattle inspection. For all cattle staffing standards, an “a” in the “Number of Inspectors by Stations” column means that one inspector performs the entire inspection procedure and a “b” means that one inspector performs the head and lower carcass inspection and a second inspector performs the viscera and upper carcass inspection.
(i) Inspection Using the Viscera Truck.
Steers and Heifers
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 27 | a | a | a |
| 28 to 56 | b | b | b |
| 57 to 84 | 1 | 1 | 1 |
| 85 to 86 | 1 | 2 | 1 |
| 87 to 143 | 2 | 2 | 1 |
Cows and Bulls
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 27 | a | a | a |
| 28 to 55 | b | b | b |
| 56 to 77 | 1 | 1 | 1 |
| 78 to 81 | 1 | 2 | 1 |
| 82 to 134 | 2 | 2 | 1 |
(A) Rules for determining adjusted maximum slaughter rates for single-inspector kills considering walking distance according to the table in this subdivision: Determine the distances the inspector actually walks between the points shown in columns 2 through 14 of the following table. For each column, determine the deduction figure opposite the appropriate number of feet in column 1. Compute the total of the deduction figures for columns 2 through 14. The adjusted maximum rate is the maximum rate in paragraph (b)(2)(i) of this section minus total of the deduction figures. If the resultant number is not a whole number, it must be rounded off to the next lowest whole number.
One-Inspector Cattle Kill—Viscera Truck
[Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]
| 1
Number of feet between points | 2
Head rack and high rail | 3
Viscera and low rail | 4
Low rail and head rack | 5
Head rack and carcass 2 | 6
Carcass 2 and washbasin | 7
Tags—brands and low rail | 8
Viscera and washbasin | 9
Viscera and high rail | 10
Low rail and high rail | 11
Head rack and closest washbasin | 12
Washbasin and high rail 1 | 13
Head rack and washbasin 1 | 14
Viscera and tags—brands | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.1 | 0 |
| 5 | 0 | 0 | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.2 | 0.1 |
| 7 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.1 | 0 | 0 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.2 | 0.2 | 0.2 | 0.1 | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.3 | 0.3 |
| 9 | 0 | 0 | 0.2 | 0.1 | 0.1 | 0.1 | 0 | 0 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.3 | 0.3 | 0.3 | 0.1 | 0.1 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.4 | 0.4 |
| 11 | 0.1 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0 | 0 | 0 | 0 | 0.1 | 0.2 | 0.2 | 0.4 | 0.4 | 0.4 | 0.2 | 0.2 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.5 | 0.6 |
| 13 | 0.1 | 0.1 | 0.3 | 0.2 | 0.2 | 0.2 | 0 | 0 | 0 | 0 | 0.2 | 0.2 | 0.2 | 0.5 | 0.5 | 0.5 | 0.2 | 0.2 | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.6 | 0.7 |
| 15 | 0.1 | 0.1 | 0.4 | 0.3 | 0.3 | 0.3 | 0 | 0 | 0 | 0 | 0.2 | 0.3 | 0.3 | 0.5 | 0.6 | 0.6 | 0.3 | 0.3 | 0 | 0 | 0.2 | 0.2 | 0.2 | 0.2 | 0.7 | 0.9 |
| 17 | 0.1 | 0.1 | 0.4 | 0.3 | 0.3 | 0.3 | 0 | 0 | 0 | 0 | 0.3 | 0.3 | 0.3 | 0.6 | 0.7 | 0.7 | 0.3 | 0.3 | 0 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0.9 | 1.0 |
| 19 | 0.1 | 0.1 | 0.5 | 0.4 | 0.4 | 0.4 | 0 | 0 | 0 | 0 | 0.3 | 0.4 | 0.4 | 0.7 | 0.8 | 0.8 | 0.4 | 0.4 | 0 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 1.0 | 1.1 |
| 21 | 0.2 | 0.2 | 0.5 | 0.4 | 0.4 | 0.4 | 0 | 0 | 0 | 0 | 0.3 | 0.4 | 0.4 | 0.8 | 0.9 | 0.8 | 0.4 | 0.4 | 0 | 0.1 | 0.3 | 0.2 | 0.3 | 0.2 | 1.1 | 1.3 |
| 23 | 0.2 | 0.2 | 0.6 | 0.5 | 0.5 | 0.5 | 0 | 0 | 0 | 0 | 0.4 | 0.5 | 0.5 | 0.9 | 1.0 | 0.9 | 0.5 | 0.5 | 0 | 0.1 | 0.3 | 0.3 | 0.3 | 0.3 | 1.2 | 1.4 |
| 25 | 0.2 | 0.2 | 0.7 | 0.5 | 0.5 | 0.5 | 0 | 0 | 0 | 0 | 0.4 | 0.5 | 0.5 | 1.0 | 1.1 | 1.0 | 0.5 | 0.5 | 0 | 0.1 | 0.3 | 0.3 | 0.3 | 0.3 | 1.3 | 1.5 |
| 27 | 0.2 | 0.2 | 0.7 | 0.5 | 0.6 | 0.5 | 0 | 0 | 0 | 0 | 0.4 | 0.5 | 0.6 | 1.1 | 1.2 | 1.1 | 0.6 | 0.6 | 0 | 0.1 | 0.3 | 0.3 | 0.3 | 0.3 | 1.4 | 1.7 |
| 29 | 0.2 | 0.2 | 0.8 | 0.6 | 0.6 | 0.6 | 0 | 0 | 0 | 0 | 0.5 | 0.6 | 0.6 | 1.2 | 1.3 | 1.2 | 0.6 | 0.6 | 0 | 0.1 | 0.4 | 0.3 | 0.4 | 0.3 | 1.5 | 1.8 |
| 31 | 0.3 | 0.2 | 0.8 | 0.6 | 0.7 | 0.6 | 0 | 0 | 0 | 0 | 0.5 | 0.6 | 0.7 | 1.3 | 1.3 | 1.4 | 0.7 | 0.7 | 0 | 0.1 | 0.4 | 0.4 | 0.4 | 0.4 | 1.6 | 1.9 |
| 33 | 0.3 | 0.3 | 0.9 | 0.7 | 0.7 | 0.7 | 0 | 0 | 0 | 0 | 0.6 | 0.7 | 0.7 | 1.3 | 1.4 | 1.4 | 0.7 | 0.7 | 0 | 0.1 | 0.4 | 0.4 | 0.4 | 0.4 | 1.7 | 2.1 |
| 35 | 0.3 | 0.3 | 1.0 | 0.7 | 0.8 | 0.7 | 0 | 0 | 0 | 0 | 0.6 | 0.7 | 0.8 | 1.4 | 1.5 | 1.5 | 0.8 | 0.8 | 0 | 0.2 | 0.5 | 0.4 | 0.5 | 0.4 | 1.8 | 2.2 |
| 37 | 0.3 | 0.3 | 1.0 | 0.8 | 0.8 | 0.8 | 0 | 0 | 0 | 0 | 0.6 | 0.8 | 0.8 | 1.5 | 1.6 | 1.6 | .0.8 | 0.8 | 0 | 0.2 | 0.5 | 0.5 | 0.5 | 0.5 | 1.9 | 2.3 |
| 39 | 0.3 | 0.3 | 1.1 | 0.8 | 0.9 | 0.8 | 0 | 0 | 0 | 0 | 0.7 | 0.8 | 0.9 | 1.6 | 1.7 | 1.7 | 0.9 | 0.9 | 0 | 0.2 | 0.5 | 0.5 | 0.5 | 0.5 | 2.0 | 2.4 |
| 41 | 0.4 | 0.3 | 1.1 | 0.9 | 0.9 | 0.9 | 0 | 0.1 | 0 | 0.1 | 0.7 | 0.9 | 0.9 | 1.7 | 1.7 | 1.8 | 0.9 | 0.9 | 0 | 0.2 | 0.6 | 0.5 | 0.6 | 0.5 | 2.1 | 2.6 |
| 43 | 0.4 | 0.4 | 1.2 | 0.9 | 1.0 | 0.9 | 0 | 0.1 | 0 | 0.1 | 0.7 | 0.9 | 1.0 | 1.8 | 1.8 | 1.9 | 1.0 | 1.0 | 0.1 | 0.2 | 0.6 | 0.5 | 0.6 | 0.5 | 2.2 | 2.7 |
| 45 | 0.4 | 0.4 | 1.2 | 0.9 | 1.0 | 0.9 | 0 | 0.1 | 0 | 0.1 | 0.8 | 0.9 | 1.0 | 1.8 | 1.9 | 2.0 | 1.0 | 1.0 | 0.1 | 0.2 | 0.6 | 0.6 | 0.6 | 0.6 | 2.3 | 2.8 |
| 47 | 0.4 | 0.4 | 1.3 | 1.0 | 1.1 | 1.0 | 0 | 0.1 | 0 | 0.1 | 0.8 | 1.0 | 1.1 | 1.9 | 2.0 | 2.1 | 1.1 | 1.1 | 0.1 | 0.2 | 0.6 | 0.6 | 0.6 | 0.6 | 2.4 | 2.9 |
| 49 | 0.4 | 0.4 | 1.4 | 1.0 | 1.1 | 1.0 | 0 | 0.1 | 0 | 0.1 | 0.8 | 1.0 | 1.1 | 2.0 | 2.1 | 2.2 | 1.1 | 1.1 | 0.1 | 0.2 | 0.7 | 0.6 | 0.7 | 0.6 | 2.5 | 3.1 |
| 51 | 0.5 | 0.5 | 1.4 | 1.1 | 1.2 | 1.1 | 0 | 0.1 | 0 | 0.1 | 0.9 | 1.1 | 1.2 | 2.1 | 2.2 | 2.2 | 1.2 | 1.2 | 0.1 | 0.3 | 0.7 | 0.7 | 0.7 | 0.7 | 2.6 | 3.2 |
| 53 | 0.5 | 0.5 | 1.5 | 1.1 | 1.2 | 1.1 | 0 | 0.1 | 0 | 0.1 | 0.9 | 1.1 | 1.2 | 2.2 | 2.3 | 2.3 | 1.2 | 1.2 | 0.1 | 0.3 | 0.7 | 0.7 | 0.7 | 0.7 | 2.7 | 3.3 |
| 55 | 0.5 | 0.5 | 1.5 | 1.2 | 1.2 | 1.2 | 0 | 0.1 | 0 | 0.1 | 1.0 | 1.2 | 1.2 | 2.3 | 2.3 | 2.4 | 1.3 | 1.3 | 0.1 | 0.3 | 0.8 | 0.7 | 0.8 | 0.7 | 2.8 | 3.4 |
| 57 | 0.5 | 0.5 | 1.6 | 1.2 | 1.3 | 1.2 | 0 | 0.1 | 0 | 0.1 | 1.0 | 1.2 | 1.3 | 2.3 | 2.4 | 2.5 | 1.3 | 1.3 | 0.1 | 0.3 | 0.8 | 0.7 | 0.8 | 0.7 | 2.9 | 3.5 |
| 59 | 0.5 | 0.5 | 1.6 | 1.3 | 1.3 | 1.3 | 0 | 0.1 | 0 | 0.1 | 1.0 | 1.3 | 1.3 | 2.4 | 2.5 | 2.6 | 1.4 | 1.4 | 0.1 | 0.3 | 0.8 | 0.8 | 0.8 | 0.8 | 3.0 | 3.6 |
1 The washbasin referred to here is the one the inspector uses while enroute from the head rack to high rail inspection.
2 This refers to the carcass in the bleeding area.
(B) Rules for determining adjusted maximum slaughter rates for two-inspector kills considering walking distance according to the table in this subdivision: Determine the distances the inspectors actually walk between the points shown in columns 2 through 9 of the following table. Column 9 is used only if the condemned brands and tags the viscera inspector uses are kept at a location other than at the washbasin-sterilizer. For each column, determine the deduction figure opposite the appropriate number of feet in column 1. Compute the total of the deduction figures for columns 2 through 9. Divide this total by 2. The adjusted maximum rate is the maximum rate in paragraph (b)(2)(i) of this section minus the number calculated above. If the resultant number is not a whole number, it must be rounded off to the next lowest whole number.
Two-Inspector Cattle Kill—Viscera Truck
[Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]
| Heads and low rail inspection | Viscera and high rail inspection | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 1 | ||||||||
| Number of feet between points | Head rack and washbasin | Head rack and carcasses 2 | Washbasin and low rail | Head rack and low rail | Viscera and brands tags (washbasin) | Viscera and high rail | High rail and washbasin | Viscera and washbasin | ||||||||
| Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | Strs. Hfrs. | Cows Bulls | |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3 | 0.1 | 0 | 0.1 | 0 | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.1 | 0.2 |
| 5 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.8 | 0.7 | 0.4 | 0.5 | 0.5 | 0.5 | 0.1 | 0.2 | 0.2 | 0.3 |
| 7 | 0.1 | 0.2 | 0.1 | 0.1 | 0.1 | 0.1 | 1.5 | 1.4 | 0.7 | 0.9 | 1.0 | 0.9 | 0.3 | 0.3 | 0.3 | 0.4 |
| 9 | 0.2 | 0.2 | 0.1 | 0.2 | 0.1 | 0.2 | 2.2 | 2.0 | 1.1 | 1.3 | 1.5 | 1.3 | 0.4 | 0.5 | 0.4 | 0.5 |
| 11 | 0.2 | 0.3 | 0.1 | 0.2 | 0.2 | 0.2 | 2.8 | 2.7 | 1.4 | 1.7 | 1.9 | 1.8 | 0.5 | 0.6 | 0.4 | 0.6 |
| 13 | 0.2 | 0.4 | 0.1 | 0.3 | 0.2 | 0.2 | 3.5 | 3.3 | 1.7 | 2.1 | 2.4 | 2.2 | 0.6 | 0.7 | 0.5 | 0.8 |
| 15 | 0.3 | 0.4 | 0.1 | 0.3 | 0.2 | 0.3 | 4.1 | 3.9 | 2.0 | 2.5 | 2.9 | 2.6 | 0.7 | 0.9 | 0.6 | 0.9 |
| 17 | 0.3 | 0.5 | 0.1 | 0.4 | 0.2 | 0.3 | 4.8 | 4.5 | 2.4 | 2.9 | 3.3 | 3.0 | 0.8 | 1.0 | 0.7 | 1.0 |
| 19 | 0.3 | 0.6 | 0.2 | 0.4 | 0.3 | 0.4 | 5.4 | 5.1 | 2.7 | 3.3 | 3.7 | 3.4 | 0.9 | 1.2 | 0.7 | 1.2 |
| 21 | 0.3 | 0.6 | 0.2 | 0.4 | 0.3 | 0.4 | 6.0 | 5.7 | 3.0 | 3.7 | 4.2 | 3.7 | 1.0 | 1.3 | 0.8 | 1.3 |
| 23 | 0.4 | 0.7 | 0.2 | 0.5 | 0.3 | 0.5 | 6.6 | 6.3 | 3.3 | 4.0 | 4.6 | 4.1 | 1.2 | 1.4 | 0.9 | 1.4 |
| 25 | 0.4 | 0.7 | 0.2 | 0.5 | 0.3 | 0.5 | 7.2 | 6.8 | 3.6 | 4.4 | 5.0 | 4.5 | 1.3 | 1.6 | 1.0 | 1.6 |
| 27 | 0.4 | 0.8 | 0.2 | 0.6 | 0.4 | 0.5 | 7.8 | 7.4 | 3.9 | 4.7 | 5.4 | 4.9 | 1.4 | 1.7 | 1.0 | 1.7 |
| 29 | 0.5 | 0.9 | 0.2 | 0.6 | 0.4 | 0.6 | 8.3 | 7.9 | 4.2 | 5.1 | 5.8 | 5.2 | 1.5 | 1.8 | 1.1 | 1.8 |
| 31 | 0.5 | 0.9 | 0.2 | 0.7 | 0.4 | 0.6 | 8.9 | 8.5 | 4.5 | 5.4 | 6.2 | 5.6 | 1.6 | 2.0 | 1.2 | 2.0 |
| 33 | 0.5 | 1.0 | 0.2 | 0.7 | 0.4 | 0.7 | 9.4 | 9.0 | 4.8 | 5.8 | 6.5 | 5.9 | 1.7 | 2.1 | 1.3 | 2.1 |
| 35 | 0.6 | 1.1 | 0.3 | 0.8 | 0.5 | 0.7 | 10.0 | 9.5 | 5.0 | 6.1 | 6.9 | 6.3 | 1.8 | 2.2 | 1.3 | 2.3 |
| 37 | 0.6 | 1.1 | 0.3 | 0.8 | 0.5 | 0.7 | 10.5 | 10.0 | 5.3 | 6.4 | 7.3 | 6.6 | 1.9 | 2.4 | 1.4 | 2.4 |
| 39 | 0.6 | 1.2 | 0.3 | 0.9 | 0.5 | 0.8 | 11.0 | 10.5 | 5.6 | 6.8 | 7.6 | 6.9 | 2.0 | 2.5 | 1.5 | 2.5 |
| 41 | 0.7 | 1.2 | 0.3 | 0.9 | 0.6 | 0.8 | 11.5 | 11.0 | 5.9 | 7.1 | 8.0 | 7.2 | 2.1 | 2.6 | 1.5 | 2.6 |
| 43 | 0.7 | 1.3 | 0.3 | 0.9 | 0.6 | 0.9 | 12.0 | 11.4 | 6.1 | 7.4 | 8.3 | 7.6 | 2.2 | 2.8 | 1.6 | 2.8 |
| 45 | 0.7 | 1.4 | 0.3 | 1.0 | 0.6 | 0.9 | 12.5 | 11.9 | 6.4 | 7.7 | 8.7 | 7.9 | 2.4 | 2.9 | 1.7 | 2.9 |
| 47 | 0.8 | 1.4 | 0.3 | 1.0 | 0.6 | 1.0 | 13.0 | 12.4 | 6.7 | 8.0 | 9.0 | 8.2 | 2.5 | 3.0 | 1.8 | 3.0 |
| 49 | 0.8 | 1.5 | 0.3 | 1.1 | 0.7 | 1.0 | 13.4 | 12.8 | 6.9 | 8.3 | 9.4 | 8.5 | 2.6 | 3.2 | 1.8 | 3.1 |
| 51 | 0.8 | 1.6 | 0.3 | 1.1 | 0.7 | 1.0 | 13.9 | 13.3 | 7.2 | 8.6 | 9.7 | 8.8 | 2.7 | 3.3 | 1.9 | 3.3 |
| 53 | 0.9 | 1.6 | 0.4 | 1.2 | 0.7 | 1.1 | 14.4 | 13.7 | 7.4 | 8.9 | 10.0 | 9.1 | 2.8 | 3.4 | 2.0 | 3.4 |
| 55 | 0.9 | 1.7 | 0.4 | 1.2 | 0.7 | 1.1 | 14.8 | 14.1 | 7.7 | 9.2 | 10.3 | 9.4 | 2.9 | 3.5 | 2.0 | 3.5 |
| 57 | 0.9 | 1.7 | 0.4 | 1.3 | 0.8 | 1.2 | 15.2 | 14.6 | 7.9 | 9.5 | 10.6 | 9.7 | 3.0 | 3.7 | 2.1 | 3.6 |
| 59 | 0.9 | 1.8 | 0.4 | 1.3 | 0.8 | 1.2 | 15.7 | 15.0 | 8.2 | 9.7 | 10.9 | 9.9 | 3.1 | 3.8 | 2.2 | 3.8 |
1 This column to be used only if brands and tags are not located at the washbasin.
2 This refers to the carcasses in the bleeding area.
(ii) Inspection Using Viscera Table, Tongue-In Presentation of Heads.
Steers and Heifers
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 32 | a | a | a |
| 33 to 58 | b | b | b |
| 59 to 84 | 1 | 1 | 1 |
| 85 to 86 | 1 | 2 | 1 |
| 87 to 143 | 2 | 2 | 1 |
| 144 to 171 | 3 | 2 | 1 |
| 172 to 198 | 3 | 3 | 1 |
| 199 to 226 | 3 | 3 | 2 |
| 227 to 253 | 4 | 3 | 2 |
| 254 to 280 | 4 | 4 | 2 |
| 281 to 306 | 5 | 4 | 2 |
| 307 to 333 | 5 | 5 | 2 |
Cows and Bulls
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 29 | a | a | a |
| 30 to 56 | b | b | b |
| 57 to 77 | 1 | 1 | 1 |
| 78 to 81 | 1 | 2 | 1 |
| 82 to 134 | 2 | 2 | 1 |
| 135 to 159 | 2 | 3 | 1 |
| 160 to 187 | 3 | 3 | 1 |
| 188 to 213 | 3 | 4 | 1 |
| 214 to 234 | 3 | 4 | 2 |
| 235 to 264 | 4 | 4 | 2 |
| 265 to 289 | 5 | 4 | 2 |
| 290 to 314 | 5 | 5 | 2 |
(iii) Inspection Using Viscera Table, Tongue-Out Presentation of Heads.
Steers and Heifers
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 32 | a | a | a |
| 33 to 58 | b | b | b |
| 59 to 86 | 1 | 1 | 1 |
| 87 to 103 | 1 | 2 | 1 |
| 104 to 156 | 2 | 2 | 1 |
| 157 to 186 | 2 | 3 | 1 |
| 187 to 216 | 3 | 3 | 1 |
| 217 to 246 | 3 | 3 | 2 |
| 247 to 275 | 3 | 4 | 2 |
| 276 to 304 | 4 | 4 | 2 |
| 305 to 333 | 4 | 5 | 2 |
| 334 to 362 | 5 | 5 | 2 |
| 363 to 390 | 5 | 6 | 2 |
Cows and Bulls
| Maximum slaughter rates (head per hour) | Number of inspectors by stations | ||
|---|---|---|---|
| Head | Viscera | Carcass | |
| 1 to 29 | a | a | a |
| 30 to 56 | b | b | b |
| 57 to 79 | 1 | 1 | 1 |
| 80 to 98 | 1 | 2 | 1 |
| 99 to 147 | 2 | 2 | 1 |
| 148 to 174 | 2 | 3 | 1 |
| 175 to 205 | 3 | 3 | 1 |
| 206 to 233 | 3 | 4 | 1 |
| 234 to 256 | 3 | 4 | 2 |
| 257 to 288 | 4 | 4 | 2 |
| 289 to 316 | 5 | 4 | 2 |
| 317 to 343 | 5 | 5 | 2 |
(3) Swine inspection. There are two systems of post-mortem inspection: The New Swine Slaughter Inspection System (NSIS), which may be used for market hogs, and the traditional inspection system, which may be used for all swine.
(i) The NSIS may be used for market hogs if the official establishment requests to use it and meets or agrees to meet the requirements in 9 CFR 309.19 and § 310.26. The Administrator may permit establishments that slaughter classes of swine other than market hogs to use NSIS under a waiver from the provisions in 9 CFR 309.19 and § 310.26 as provided by 9 CFR 303.1(h). The Administrator also may permit establishments that slaughter both market hogs and other classes of swine to slaughter the market hogs under NSIS and slaughter the other classes of swine under traditional inspection.
(ii) Traditional inspection shall be used for swine when NSIS is not used. The following inspection staffing standards are applicable to swine slaughter configurations operating under traditional inspection when NSIS is not used. The inspection standards for all slaughter lines are based upon the observation rather than palpation, at the viscera inspection station, of the spleen, liver, heart, lungs, and mediastinal lymph nodes. In addition, for one- and two-inspector lines under traditional inspection, the standards are based upon the distance walked (in feet) by the inspector between work stations; and for three or more inspector slaughter lines, upon the use of a mirror, as described in § 307.2(m)(6) of this chapter, at the carcass inspection station. Although not required in a one- or two-inspector slaughter configuration, except in certain cases as determined by the inspection service, if a mirror is used, it must comply with the requirements of § 307.2(m)(6).
Table 1 to Paragraph (b)(3)—One Inspector—Staffing Standards for Swine
| Distance walked 1 in feet is— | Maximum inspection rates (head per hour) | |||
|---|---|---|---|---|
| Market hogs
(heads attached or detached) | Sows and boars
(heads detached) | |||
| Without mirror | With mirror | Without mirror | With mirror | |
| 0 to 5 | 140 | 150 | 131 | 143 |
| 6 to 10 | 134 | 144 | 126 | 137 |
| 11 to 15 | 129 | 137 | 122 | 132 |
| 16 to 20 | 124 | 132 | 117 | 127 |
| 21 to 35 | 120 | 127 | 113 | 122 |
| 26 to 30 | 116 | 122 | 110 | 118 |
| 31 to 35 | 112 | 118 | 106 | 114 |
| 36 to 40 | 108 | 114 | 103 | 110 |
| 41 to 45 | 105 | 110 | 100 | 106 |
| 46 to 50 | 101 | 107 | 97 | 103 |
| 51 to 55 | 98 | 103 | 94 | 100 |
| 56 to 60 | 96 | 100 | 91 | 97 |
| 61 to 65 | 93 | 97 | 89 | 94 |
| 66 to 70 | 90 | 95 | 87 | 92 |
| 71 to 75 | 88 | 92 | 85 | 89 |
| 76 to 80 | 86 | 89 | 82 | 87 |
| 81 to 85 | 84 | 87 | 80 | 85 |
| 86 to 90 | 82 | 85 | 79 | 83 |
| 91 to 95 | 80 | 83 | 77 | 81 |
| 96 to 100 | 78 | 81 | 75 | 79 |
1 Distance walked is the total distance that the inspector will have to walk between work stations during one inspection cycle (
Table 2 to Paragraph (b)(3)—Two Inspectors—Staffing Standards for Market Hogs
| Distance walked 1 in feet by inspector B is— | Maximum inspection rates
(head per hour with heads attached or detached) | ||
|---|---|---|---|
| Line configuration | |||
| Carcass, 2 head viscera 3 | Viscera, 2 head carcass 3 | Head, 2 viscera carcass 3 | |
| 0 to 5 | 151-253 | 151-271 | 151-296 |
| 6 to 10 | 151-239 | 151-255 | 151-277 |
| 11 to 15 | 151-226 | 151-240 | 151-260 |
| 16 to 20 | 151-214 | 151-227 | 151-244 |
| 21 to 25 | 151-204 | 151-215 | 151-231 |
| 0 to 5 | 151-253 | 151-303 | 151-318 |
| 6 to 10 | 151-239 | 151-283 | 151-304 |
| 11 to 15 | 151-226 | 151-265 | 151-289 |
| 16 to 20 | 151-214 | 151-249 | 151-270 |
| 21 to 25 | 151-204 | 151-235 | 151-254 |
1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (
2Inspector A.
3Inspector B.
Note 1 to Table 2 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions
Table 3 to Paragraph (b)(3)—Two Inspectors—Staffing Standards for Sows and Boars
| Distance walked 1 in feet by inspector B is— | Maximum inspection rates
(head per hour) | |||
|---|---|---|---|---|
| Line Configuration | ||||
| Carcass, 2 head viscera, 3 heads detached | Viscera, 2 head carcass, 3 heads detached | Head, 2 viscera carcass, 3 heads detached | Head, 2 viscera carcass, 3 heads attached | |
| 0 to 5 | 144-248 | 144-254 | 144-267 | 144-267 |
| 6 to 10 | 144-235 | 144-240 | 144-253 | 144-253 |
| 11 to 15 | 144-222 | 144-227 | 144-239 | 144-239 |
| 16 to 20 | 144-211 | 144-215 | 144-226 | 144-226 |
| 21 to 25 | 144-201 | 144-205 | 144-214 | 144-214 |
| 0 to 5 | 144-248 | 144-292 | 144-305 | 144-292 |
| 6 to 10 | 144-235 | 144-273 | 144-291 | 144-280 |
| 11 to 15 | 144-222 | 144-256 | 144-272 | 144-268 |
| 16 to 20 | 144-211 | 144-241 | 144-255 | 144-255 |
| 21 to 25 | 144-201 | 144-228 | 144-240 | 144-240 |
1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (
2Inspector A.
3Inspector B.
Table 4 to paragraph (b)(3)—Three Inspectors or More—Staffing Standards for Swine
| Maximum inspection rates
(head per hour with heads attached) | Number of inspectors by station | |||
|---|---|---|---|---|
| Head | Viscera | Carcass | Total | |
| Market hogs: | ||||
| 319 to 506 | 1 | 1 | 1 | 3 |
| 507 to 540 | 1 | 2 | 1 | 4 |
| 541 to 859 | 2 | 2 | 1 | 5 |
| 860 to 1,022 | 2 | 3 | 1 | 6 |
| 1,023 to 1,106 | 3 | 3 | 1 | 7 |
| Sows and boars: | ||||
| 306 to 439 | 1 | 1 | 1 | 3 |
| 306 to 462 1 | 1 | 1 | 1 | 3 |
| 440 to 475 | 2 | 1 | 1 | 4 |
| 476 to 752 | 2 | 2 | 1 | 5 |
| 753 to 895 | 3 | 2 | 1 | 6 |
| 896 to 964 | 3 | 3 | 1 | 7 |
1This rate applies if the heads of sows and boars are
(a) The head, tail, tongue, thymus gland, and all viscera of each slaughtered animal, and all blood and other parts of such animal to be used in the preparation of meat food products or medical products, shall be handled in such a manner as to identify them with the rest of the carcass and as being derived from the particular animal involved, until the post-mortem examination of the carcass and parts thereof has been completed. Such handling shall include the retention of ear tags, backtags, implants, and other identifying devices affixed to the animal, in such a way to relate them to the carcass until the post-mortem examination has been completed.
(b) The official State-Federal Department backtag on any carcass shall:
(1)(i) Be removed from the hide of the animal by an establishment employee and placed in a clear plastic bag. The bag containing the tag shall be affixed to the corresponding carcass.
(ii) The bag containing the tag shall be removed from the carcass by an establishment employee and presented with the viscera to the Program inspector at the point where such inspector conducts the viscera inspection.
(2)(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales tags, ear bangles, and similar identification devices shall be removed from the animal's hide or ear by an establishment employee and shall be placed in a clear plastic bag and affixed to the corresponding carcass.
(ii) The bag containing the tag shall be removed from the carcass by an establishment employee and presented with the viscera to the Program inspector at the point where such inspector conducts the viscera inspection.
(3) In cases where both types of devices described in paragraphs (b)(1) and (2) of this section are present on the same animal, both types may be placed in the same plastic bag or in two separate bags.
(4) The circuit supervisor may allow the use of any alternate method proposed by the operator of an official establishment for handling the type of devices described in paragraph (b)(2) of this section if such alternate method would provide a ready means of identifying a specific carcass with the corresponding devices by a Program inspector during the post-mortem inspection.
(5) Disposition and use of identifying devices.
(i) The official State-Federal Department backtags will be collected by a Program inspector and used to obtain traceback information necessary for proper disposition of the animal or carcass and otherwise handled according to instructions issued to the inspectors.
(ii) The devices described in paragraph (b)(2) of this section shall be collected by the Program inspector when required to obtain traceback information necessary for proper disposition of the animal or carcass and for controlling the slaughter of reactor animals. Devices not collected for these purposes shall be discarded after the post-mortem examination is complete.
(6) Plastic bags used by the establishment for collecting identifying devices will be furnished by the Department.
Each carcass, including all detached organs and other parts, in which any lesion or other condition is found that might render the meat or any part unfit for food purposes, or otherwise adulterated, and which for that reason would require a subsequent inspection, shall be retained by the Program employee at the time of inspection. The identity of every such retained carcass, detached organ, or other part shall be maintained until the final inspection has been completed. Retained carcasses shall not be washed or trimmed unless authorized by the Program employee.
Such devices and methods as may be approved by the Administrator may be used for the temporary identification of retained carcasses, organs, and other parts. In all cases, the identification shall be further established by affixing “U.S. Retained” tags as soon as practicable and before final inspection. These tags shall not be removed except by a Program employee.
Each carcass or part which is found on final inspection to be unsound, unhealthful, unwholesome, or otherwise adulterated shall be conspicuously marked, on the surface tissues thereof, by a Program employee at the time of inspection, as “U.S. Inspected and Condemned.” Condemned detached organs and other parts of such character that they cannot be so marked shall be placed immediately in trucks or receptacles which shall be kept plainly marked “U.S. Condemned,” in letters not less than 2 inches high. All condemned carcasses and parts shall remain in the custody of a Program employee and shall be disposed of as required in the regulations in part 314 of this subchapter at or before the close of the day on which they are condemned.
Carcasses and parts passed for cooking shall be marked conspicuously on the surface tissues thereof by a Program employee at the time of inspection, “U.S. Passed for Cooking.” All such carcasses and parts shall be cooked in accordance with part 315 of this subchapter, and until so cooked shall remain in the custody of a Program employee.
Spermatic cords and pizzles shall be removed from all carcasses. Preputial diverticuli shall be removed from hog carcasses.
Carcasses and parts found to be sound, healthful, wholesome, and otherwise not adulterated shall be passed and marked as provided in part 316 of this subchapter. In all cases where carcasses showing localized lesions are passed for food or for cooking and “U.S. Retained” tags are attached to the carcasses, the affected tissues shall be removed and condemned before the tags are removed. “U.S. Retained” tags shall be removed only by a Program employee.
(a) Carcasses found before evisceration to be affected with anthrax shall not be eviscerated but shall be retained, condemned, and immediately tanked or otherwise disposed of as provided in part 314 of this subchapter.
(b) All carcasses and all parts, including hides, hoofs, horns, hair, viscera and contents, blood, and fat of any livestock found to be affected with anthrax shall be condemned and immediately disposed of as provided in part 314 of this subchapter, except that the blood may be handled through the usual blood cooking and drying equipment.
(c) Any part of any carcass that is contaminated with anthrax-infected material through contact with soiled instruments or otherwise shall be immediately condemned and disposed of as provided in part 314 of this subchapter.
(d) The scalding vat water through which hog carcasses affected with anthrax have passed shall be immediately drained into the sewer and all parts of the scalding vat shall be cleaned and disinfected as provided in paragraph (e) of this section.
(e)(1) That portion of the slaughtering department, including the bleeding area, scalding vat, gambrelling bench, floors, walls, posts, platforms, saws, cleavers, knives, and hooks, as well as employees' boots and aprons, contaminated through contact with anthrax-infected material, shall, except as provided in paragraph (e)(2) of this section be cleaned immediately and disinfected with one of the following disinfectants or other disinfectant
(i) A 5 percent solution of sodium hydroxide or commercial lye containing at least 94 percent of sodium hydroxide. The solution shall be freshly prepared immediately before use by dissolving 2
(ii) A solution of sodium hypochlorite containing approximately one-half of 1 percent (5,000 parts per million) of available chlorine. The solution shall be freshly prepared.
(iii) When a disinfectant solution has been applied to equipment which will afterwards contact product, the equipment shall be rinsed with clean water before such contact.
(2) In case anthrax infection is found in the hog slaughtering department, an immediate preliminary disinfection shall be made from the head-dropper's station to the point where the disease is detected and the affected carcasses shall be cut down from the rail and removed from the room. Upon completion of the slaughtering of the lot of hogs of which the anthrax-infected animals were a part, slaughtering operations shall cease, and a thorough cleanup and disinfection shall be made, as provided in paragraph (e)(1) of this section. If the slaughter of the lot has not been completed by the close of the day on which anthrax was detected, the cleanup and disinfection shall not be deferred beyond the close of that day.
(3) The first and indispensable precautionary step for persons who have handled anthrax material is thorough cleansing of the hands and arms with liquid soap and running hot water. It is important that this step be taken immediately after exposure, before vegetative anthrax organisms have had time to form spores. In the cleansing, a brush or other appropriate appliance shall be used to insure the removal of all contaminating material from under and about the fingernails. This process of cleansing is most effective when performed in repeated cycles of lathering and rinsing rather than in spending the same amount of time in scrubbing with a single lathering. After the hands have been cleansed thoroughly and rinsed free of soap, they may, if desired, be immersed for about 1 minute in a 1:1,000 solution of bichloride of mercury, followed by thorough rinsing in clean running water. Supplies of bichloride of mercury for the purpose must be held in the custody of the veterinary medical officer. (As a precautionary measure, all persons exposed to anthrax infection should report promptly any suspicious condition (sore or carbuncle) or symptom to a physician, in order that anti-anthrax serum or other treatment may be administered as indicated.)
When a carcass is to be dressed with the skin or hide left on, the skin or hide shall be thoroughly washed and cleaned before any incision is made for the purpose of removing any part thereof or evisceration, except that where calves are slaughtered by the kosher method, the heads shall be removed from the carcasses, before washing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass infested with the larvae of the “oxwarble” fly (Hypoderma lineata and Hypoderma bovis), or external parasites, or affected with other pathological skin conditions.
The sternum of each carcass shall be split and the abdominal and thoracic viscera shall be removed at the time of slaughter in order to allow proper inspection.
(a) Establishments that slaughter livestock and prepare livestock carcasses and parts may inflate carcasses or parts of carcasses with air if they develop, implement, and maintain controls to ensure that the air inflation procedure does not cause insanitary conditions or adulterate product. Establishments shall incorporate these controls into their HACCP plans or Sanitation SOPs or other prerequisite programs.
(b)(1) Transferring the caul or other fat from a fat to a lean carcass is prohibited.
(2) Injecting compressed air into the skulls of cattle in conjunction with a captive bolt stunner to hold the animal still for dressing operations is prohibited.
When only a portion of a carcass is to be condemned on account of slight bruises, either the bruised portion shall be removed immediately and disposed of in accordance with part 314 of this subchapter, or the carcass shall be promptly placed in a retaining room and kept until chilled and the bruised portion shall then be removed and disposed of as provided in part 314 of this subchapter.
(a) Livestock thyroid glands and laryngeal muscle tissue shall not be used for human food.
(b) Livestock thyroid glands and laryngeal muscle tissue may be distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with § 314.9 or § 325.19(c) of this subchapter, if they are labeled in accordance with § 316.13(f) of this subchapter. Otherwise, they shall be disposed of at the official establishment in accordance with § 314.1 or § 314.3 of this subchapter.
(a) Livestock lungs shall not be saved for use as human food.
(b) Lungs found to be affected with disease or pathology and lungs found to be adulterated with chemical or biological residue shall be condemned and identified as “U.S. Inspected and Condemned.” Condemned lungs may not be saved for pet food or other nonhuman food purposes. They shall be maintained under inspectional control and disposed of in accordance with §§ 314.1 and 314.3 of this subchapter.
(c) Lungs not condemned under paragraph (b) of this section may be used in the preparation of pet food or for other nonhuman food purposes at the official establishment, provided they are handled in the manner prescribed in § 318.12 of this subchapter, or they may be distributed from the establishment in commerce, or otherwise, in accordance with the conditions prescribed in § 325.8 of this subchapter for nonhuman food purposes or they may be so distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with §§ 314.9 and 325.19(b) of this subchapter, if they are labeled as “Inedible [SPECIES] Lungs—for Pharmaceutical Use Only.” Otherwise, they shall be disposed of at the official establishment, in accordance with §§ 314.1 and 314.3 of this subchapter.
(a) Lactating mammary glands and diseased mammary glands of cattle, sheep, swine, and goats shall be removed without opening the milk ducts or sinuses. If pus or other objectionable material is permitted to come in contact with the carcass, the parts of the carcass thus contaminated shall be removed and condemned.
(b) Nonlactating cow udders may be saved for food purposes provided suitable facilities for handling and inspecting them are provided. Examination of udders by palpation shall be done by a Program employee. When necessary, in the judgment of the Program employee for adequate inspection, the official establishment employees shall incise udders in sections no greater than 2 inches in thickness. All udders showing disease lesions shall be condemned by a Program employee. Each udder shall be properly identified with its respective carcass and kept separate and apart from other udders until its disposal has been accomplished in accordance with the provisions of part 311 of this subchapter.
(c) Lactating mammary glands of cattle, sheep, swine, and goats shall not be saved for edible purposes.
(d) The udders from cows officially designated as “Brucellosis reactors” or as “Mastitis elimination cows” shall be condemned.
(a) Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector.
(b) Brains, cheek meat, and head trimmings from animals stunned by lead, sponge iron, or frangible bullets shall not be saved for use as human food but shall be handled as described in § 314.1 or § 314.3 of this subchapter.
(c) Official swine slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens, and visible fecal material, ingesta, and milk contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. These procedures must include sampling and analysis for microbial organisms in accordance with the sampling location and frequency requirements in paragraphs (c)(1) and (2) of this section to monitor their ability to maintain process control.
(1) Sampling locations. Official swine slaughter establishments, except for very low-volume establishments, must collect and analyze carcass samples for microbial organisms at the pre-evisceration and post-chill points in the process. Establishments that slaughter more than one type of livestock must test the type of livestock slaughtered in the greatest number. Establishments that bone their products before chilling (i.e., hot-boned products) must collect and analyze samples at the pre-evisceration point in the process and after the final wash instead of at post-chill. Very low-volume establishments must collect and analyze samples for microbial organisms at the post-chill point in the process. All swine establishments must sponge or excise tissue from the ham, belly, and jowl areas.
(i) Very low-volume establishments annually slaughter no more than 20,000 swine, or a combination of swine and other livestock not exceeding 6,000 cattle and 20,000 total of all livestock.
(ii) [Reserved]
(2) Sampling frequency. Establishments, except for very low-volume establishments as defined in paragraph (c)(1)(i) of this section, must collect and analyze samples at a frequency proportional to the establishment's volume of production at the following rates:
(i) Establishments, except for very low-volume establishments as defined in paragraph (c)(1)(i) of this section, must collect and analyze samples at a frequency of once per 1,000 carcasses, but a minimum of once during each week of operation.
(ii) Very low-volume establishments as defined in paragraph (c)(1)(i) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, very low-volume establishments can demonstrate that they are effectively maintaining process control, they may modify their sampling plans.
(iii) Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (d) of this section.
(d) Official swine slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS.
An employee of the establishment shall open the kidney capsule and expose the kidneys of all livestock at the time of slaughter for the purpose of examination by a Program employee.
Blood may be saved for edible purposes at official establishments provided it is derived from livestock, the carcasses of which are inspected and passed, and the blood is collected and handled in a manner so as not to render it adulterated under the Federal Meat Inspection Act and regulations issued pursuant thereto. The defibrination of blood intended for human food purposes shall not be done with the hands. Anticoagulants may be used in accordance with 21 CFR chapter I, subchapter A and subchapter B, or by regulation in 9 CFR chapter III, subchapter A or subchapter E.
(a) Calf carcasses from animals suspected of containing biological residues under § 309.16(d) of this subchapter shall, on post-mortem inspection, be handled in accordance with the provisions of this section.
(b) For purposes of this section, the following definitions shall apply:
(1) Calf. A calf up to 3 weeks of age or up to 150 pounds.
(2) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.
(3) Healthy carcass. A carcass that an inspector determines shows no lesions of disease or signs of disease treatment at post-mortem inspection
(4) Producer. The owner of the calf at the time of its birth.
(5) Sick calf carcass. A calf carcass that an inspector on post-mortem inspection determines has either signs of disease treatment or lesions of disease or was from an animal identified as sick on ante-mortem.
(6) Sign of treatment. Sign of treatment of a disease is indicated by leakage around jugular veins, subcutaneous, intramuscular or intraperitoneal injection lesions, or discoloration from particles or oral treatment in any part of the digestive tract.
(7) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.
(c) Selection of carcasses for testing. The inspector shall perform a swab bioassay test
(1) Any carcass from a calf tagged as “U.S. Suspect” at the time of ante-mortem inspection, except that calves whose carcasses are condemned for pathology shall not be tested for drug residues.
(2) Any carcass which he/she finds has either lesions of disease which is not condemned because of these lesions or a sign of treatment of disease at the time of post-mortem inspection,
(3) Any carcass of a calf from a producer whose calf or calves have previously been condemned for residues as prescribed in paragraph (e) of this section, and
(4) Carcasses from healthy-appearing certified and noncertified calves, as determined by the veterinary medical officer during ante-mortem inspection, will be selected for testing as set forth below:
| Testing level | Sampling Rate (percent of
estimated day's slaughter) | |
|---|---|---|
| Certified | Noncertified | |
| A | 100 | 100 |
| B | 50 | 50 |
| C | 20 | 30 |
| (Start) D | 5 | 10 |
| E | 2 | 5 |
| F | 1 | 2 |
(d) Testing of carcasses:
(1) The inspector shall test all carcasses as prescribed in paragraph (c) of this section.
(2) Upon initiation of this program at an establishment, the inspector shall begin the testing rate for carcasses from healthy-appearing certified and noncertified calves at Level D as prescribed in paragraph (c)(4) of this section. The inspector shall increase the testing rate to the next higher level the following business day when three carcasses in 100 or less consecutively tested show a positive test result for a drug residue. The inspector shall decrease it to the next lower level when no more than two calves show a positive test result for a drug residue in either 500 calves consecutively tested or all calves tested over a 60 working day period.
(3) Test results shall be determined by the veterinary medical officer.
(4) The establishment may designate one or more of its employees to aid the inspector in performing the swab bioassay test under the supervision of the veterinary medical officer who shall interpret the results, maintain animal identification with the test unit, and ensure integrity of the testing program.
(5) All carcasses and parts thereof from calves selected for testing shall be retained until all test results are complete.
(6) The veterinary medical officer shall condemn all carcasses and parts thereof for which there are positive test results and release for human consumption all carcasses and parts thereof for which there are negative test results.
(7) If there is a positive test result, subsequent calves from the producer of the calf shall be tested in accordance with paragraph (e) of this section. These test results will not be included in computations to determine an establishment's compliance record.
(8) The veterinary medical officer may reduce inspection line rates when, in his/her judgment, the prescribed testing cannot be adequately performed within the time available because the establishment's compliance history dictates a need for extensive testing.
(e) Calves from producers with a previous residue condemnation. The inspector shall perform a swab bioassay test on all carcasses of all calves in the group. The veterinary medical officer shall determine the test results and shall condemn any carcass and parts thereof for which there is a positive test result and pass for human consumption any such carcass and parts thereof for which there is a negative test result. All subsequent calves from the same producer which has previously sold or delivered to official establishments any carcass that was condemned because of drug residues must be tested according to this paragraph until five consecutive animals test completely free of animal drug residues.
(f) If the owner or operator of an official establishment disagrees with the veterinary medical officer's disposition of carcasses and parts thereof, the owner or operator may appeal as provided in section 306.5 of this chapter.
(a) The following materials from cattle are specified risk materials, except when they are from cattle from a country that can demonstrate that its bovine spongiform encephalopathy (BSE) risk status can reasonable be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States:
(1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from cattle 30 months of age and older and
(2) The distal ileum of the small intestine and the tonsils from all cattle.
(b) Specified risk materials are inedible and prohibited for use as human food.
(c) Specified risk materials must be removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with § 314.1 or § 314.3 of this subchapter. The spinal cord from cattle 30 months of age and older must be removed from the carcass at the establishment where the animal was slaughtered.
(d) Requirements for use of the small intestine for human food. (1) The small intestine from all cattle may be used for human food if:
(i) It is derived from cattle that were inspected and passed in an official establishment in the United States or in a certified foreign establishment in a country eligible to export meat and meat products to the United States under 9 CFR 327.2(b) and it is otherwise eligible for importation under 9 CFR 327.1(b), and
(ii) The distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine as measured from the ceco-colic junction and progressing proximally towards the jejunum or by a procedure that the establishment demonstrates is effective in ensuring complete removal of the distal ileum.
(iii) If the conditions in paragraphs (d)(1)(i) or (ii) of this section are not met, the entire small intestine must be removed from the carcass, segregated from edible materials, and disposed of in accordance with §§ 314.1 or 314.3 of this subchapter.
(2) The requirements in paragraph (d)(1) of this section do not apply to materials from cattle from countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States.
(e) Procedures for the removal, segregation, and disposition of specified risk materials. (1) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials. These procedures must address potential contamination of edible materials with specified risk materials before, during, and after entry into the establishment. Establishments must incorporate their procedures for the removal, segregation, and disposition of specified risk materials into their HACCP plans or Sanitation SOPs or other prerequisite programs.
(2) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must take appropriate corrective action when either the establishment or FSIS determines that the establishment's procedures for the removal, segregation, and disposition of specified risk materials, or the implementation or maintenance of these procedures, have failed to ensure that specified risk materials are adequately and effectively removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with paragraph (c) of this section.
(3) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures as necessary whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.
(4) Recordkeeping requirements. (i) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must maintain daily records sufficient to document the implementation and monitoring of the procedures for the removal, segregation, and disposition of the materials listed in paragraph (a) of this section, and any corrective actions taken.
(ii) Records required by this section may be maintained on computers provided that the establishment implements appropriate controls to ensure the integrity of the electronic data.
(iii) Records required by this section must be retained for at least one year and must be accessible to FSIS. All such records must be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.
(f) Sanitation of equipment used to cut through specified risk materials. (1) If an establishment that slaughters cattle, or that processes the carcasses or parts from cattle, does not segregate the carcasses and parts from cattle 30 months of age and older from the carcasses and parts from cattle younger than 30 months during processing operations it must:
(i) Use dedicated equipment to cut through specified risk materials; or
(ii) Clean and sanitize equipment used to cut through specified risk materials before the equipment is used on carcasses or parts from cattle younger than 30 months of age.
(2) If an establishments that slaughters cattle, or that process the carcasses or parts from cattle, segregates the carcasses and parts of cattle 30 months of age and older from cattle younger than 30 months of age during processing operations, and processes the carcasses or parts from the cattle younger than 30 months first, it may use routine operational sanitation procedures on equipment used to cut through specified risk materials.
(g) Slaughter establishments may ship beef carcasses or parts that contain vertebral columns from cattle 30 months of age and older to another federally-inspected establishment for further processing if the establishment shipping these materials:
(1) Maintains control of the carcasses or parts while they are in transit or ensures that the carcasses or parts move under FSIS control;
(2) Ensures that the carcasses or parts are accompanied by documentation that clearly states that the carcasses or parts contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter;
(3) Maintains records that identify the official establishment that received the carcasses or parts;
(4) Maintains records that verify that the official establishment that received the carcasses or parts removed the portions of the vertebral column designated as specified risk materials in paragraph (a)(1) of this section and disposed of them in accordance with § 314.1 or § 314.3 of this subchapter.
(h) The materials listed in paragraph (a)(1) of this section will be deemed to be from cattle 30 months of age and older unless the establishment can demonstrate through documentation that the materials are from an animal that was younger than 30 months of age at the time of slaughter.
(a) The identification of the carcasses and parts of swine identified in accordance with part 71 of this title shall be made available to the inspector upon the inspector's request throughout post-mortem inspection.
(b) If the establishment fails to provide required swine identification, the inspector shall order the retention of swine caracasses at the establishment until the completion of tests to confirm that the carcasses are not adulterated.
(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters livestock must test for Escherichia coli Biotype 1 (E.coli) Establishments that slaughter more than one type of livestock or both livestock and poultry, shall test the type of livestock or poultry slaughtered in the greatest number. The establishment shall:
(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and
(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request.
(ii) Sample collection. The establishment must collect samples from all chilled livestock carcasses, except those boned before chilling (hot-boned), which must be sampled after the final wash. Samples must be collected in the following manner;
(A) For cattle, establishments must sponge or excise tissue from the flank, brisket and rump, except for hide-on calves, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.
(B) For sheep, goat, horse, mule, or other equine carcasses, establishments must sponge from the flank, brisket and rump, except for hide-on carcasses, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.
(iii) Sampling frequency. Slaughter establishments, except very low volume establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the volume of production at the following rates:
(A) Cattle, sheep, goats, horses, mules, and other equines: 1 test per 300 carcasses, but, a minimum of one sample during each week of operation.
(iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with § 417.2(b) of this chapter may substitute an alternative frequency for the frequency of sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls.
(v) Sampling in very low volume establishments. (A) Very low volume establishments annually slaughter no more than 6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules or other equines, or a combination of livestock not exceeding 6,000 cattle and 20,000 total of all livestock. Very low volume establishments that collect samples by sponging shall collect at least one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever comes first. Very low volume establishments collecting samples by excising tissue from carcasses shall collect one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until one series of 13 tests meets the criteria set forth in paragraph (a)(5)(i) of this section.
(B) Upon the establishment's meeting requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists)
(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of CFU/cm
(5) Criteria for evaluation of test results. (i) An establishment excising samples from carcasses is operating within the criteria when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is three or fewer out of the most recent 13 samples (n) taken, as follows:
Table 1 to paragraph (a)(5)—Evaluation of E. Coli Test Results
| Type of livestock | Lower limit of
marginal range (m) | Upper limit of
marginal range (M) | Number of sample
tested (n) | Maximum number permitted in marginal range
(c) |
|---|---|---|---|---|
| Cattle | Negative a | 100 CFU/cm 2 | 13 | 3 |
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of at least 5 cfu/cm 2 carcass surface area.
(ii) Establishments sponging carcasses shall evaluate E. coli test results using statistical process control techniques.
(6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.
(7) Failure to test and record. Inspection shall be suspended in accordance with rules of practice that will be adopted for such proceedings upon a finding by FSIS that one or more provisions of paragraphs (a) (1)-(4) of this section have not been complied with and written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standard; Salmonella—(1) Raw meat product performance standards for Salmonella. An establishment's raw meat products, when sampled and tested by FSIS for Salmonella, as set forth in this section, may not test positive for Salmonella at a rate exceeding the applicable national pathogen reduction performance standard, as provided in Table 1 to this paragraph:
Table 1 to paragraph (b)(1)—Salmonella Performance Standards
| Class of product | Performance Standard (percent positive for | Number of samples tested
(n) | Maximum number of positives to achieve Standard
(c) |
|---|---|---|---|
| Steers/heifers | 1.0% | 82 | 1 |
| Cows/bulls | 2.7% | 58 | 2 |
| Ground beef | 7.5% | 53 | 5 |
a Performance Standards are FSIS's calculation of the national prevalence of
(2) Enforcement. FSIS will sample and test raw meat products in an individual establishment on an unannounced basis to determine prevalence of Salmonella in such products to determine compliance with the standard. The frequency and timing of such testing will be based on the establishment's previous test results and other information concerning the establishment's performance. In an establishment producing more than one class of product subject to the pathogen reduction standard, FSIS may sample any or all such classes of products.
(3) Noncompliance and establishment response. When FSIS determines that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the standard.
(ii) If the establishment fails to meet the standard on the next series of compliance tests for that product, the establishment shall reassess its HACCP plan for that product and take appropriate corrective actions.
(iii) Failure by the establishment to act in accordance with paragraph (b)(3)(ii) of this section, or failure to meet the standard on the third consecutive series of FSIS-conducted tests for that product, constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan, in accordance with part 417 of this chapter, for that product, and will cause FSIS to suspend inspection services. Such suspension will remain in effect until the establishment submits to the FSIS Administrator or his/her designee satisfactory written assurances detailing the action taken to correct the HACCP system and, as appropriate, other measures taken by the establishment to reduce the prevalence of pathogens.
(a) Facilities. The establishment must comply with the facilities requirements in 9 CFR part 307. The establishment must provide a mirror at the carcass inspection station in accordance with 9 CFR 307.2(m)(6).
(b) Carcass sorting and disposition. The establishment must conduct carcass sorting activities and identify any condemnable conditions or defects before carcasses are presented to online inspectors. Establishment sorters must incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases as part of their sorting activities. The establishment must develop, implement, and maintain written procedures to ensure that market hog carcasses adulterated with septicemia, toxemia, pyemia, or cysticercosis are properly removed before the point of post-mortem inspection of carcasses. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOPs, or other prerequisite program. These procedures must cover the establishment sorting activities required under this section.
(c) Line speed limits. The line speed limits in § 310.1 do not apply to the establishment, provided it is able to maintain effective process control and prevent contamination of carcasses and parts by enteric pathogens and visible fecal material, ingesta, and milk. Establishments operating under the NSIS must reduce their line speed as directed by the Inspector-in-Charge (IIC). The IIC is authorized to direct an establishment to operate at a reduced line speed when in their judgment a carcass-by-carcass inspection cannot be adequately performed within the time available due to the manner in which the carcasses are presented to the online inspector, the health conditions of a particular herd, or factors that may indicate a loss of process control.
(d) Records. (1) The establishment must maintain records to document that the products resulting from its slaughter operation meet the definition of Ready-to-cook pork product in § 301.2. These records are subject to review and evaluation by FSIS personnel.
(2) The establishment must maintain records to document the number of carcasses disposed of per day by establishment sorters before FSIS post-mortem inspection and the reasons that the carcasses were disposed of. These records are subject to review and evaluation by FSIS personnel.
Each establishment that participates in the NSIS must submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers, and that the program includes the following elements:
(a) Policies to encourage early reporting of symptoms of injuries and illnesses, and assurance that it has no policies or programs in place that would discourage the reporting of injuries and illnesses.
(b) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms.
(c) Monitoring, on a regular and routine basis, injury and illness logs, as well as nurse or medical office logs, workers' compensation data, and any other injury or illness information available.
Should a court of competent jurisdiction hold any provision of § 310.27 to be invalid, such action will not affect any other provision of 9 CFR part 309 or this part.
(a) The carcasses or parts of carcasses of all animals slaughtered at an official establishment and found at the time of slaughter or at any subsequent inspection to be affected with any of the diseases or conditions named in this part shall be disposed of according to the section pertaining to the disease or condition: Provided, That no product shall be passed for human food under any such section unless it is found to be otherwise not adulterated. Products passed for cooking or refrigeration under this part must be so handled at the official establishment where they are initially prepared unless they are moved to another official establishment for such handling or in the case of products passed for refrigeration are moved for such refrigeration to a freezing facility approved by the Administrator in specific cases: Provided, That when so moved the products are shipped in containers sealed in accordance with § 318.10(c) of this subchapter or in a sealed means of conveyance as provided in § 325.7 of this subchapter. Owning to the fact that it is impracticable to formulate rules covering every case and to designate at just what stage a disease process or a condition results in adulteration of a product, the decision as to the disposal of all carcasses, organs, or other parts not specifically covered in this part shall be left to the veterinary medical officer. The veterinary medical officer shall exercise his judgment regarding the disposition of all carcasses or parts of carcasses under this part in a manner which will insure that only wholesome, unadulterated product is passed for human food.
(b) In cases of doubt as to a condition, a disease, or the cause of a condition, or to confirm a diagnosis, representative specimens of the affected tissues, properly prepared and packaged, shall be sent for examination to one of the laboratories of the Biological Control Section of the Program.
The following principles shall apply to the disposition of carcasses of livestock based on the difference in the pathogenesis of tuberculosis in swine, cattle, sheep, goats, and equines.
(a) Carcasses condemned. The entire carcass of swine, cattle, sheep, goats, and equines shall be condemned if any of the following conditions occur:
(1) When the lesions of tuberculosis are generalized (tuberculosis is considered to be generalized when the lesions are distributed in a manner made possible only by entry of the bacilli into the systemic circulation);
(2) When on ante mortem inspection the animal is observed to have a fever found to be associated with an active tuberculosis lesion on post mortem inspection;
(3) When there is an associated cachexia;
(4) When a tuberculosis lesion is found in any muscle or intermuscular tissue, or bone, or joint, or abdominal organ (excluding the gastrointestinal tract) or in any lymph node as a result of draining a muscle, bone, joint, or abdominal organ (excluding the gastrointestinal tract);
(5) When the lesions are extensive in tissues of either the thoracic or the abdominal cavity;
(6) When the lesions are multiple, acute, and actively progressive; or
(7) When the character or extent of the lesions otherwise is not indicative of a localized condition.
(b) Organs or other parts condemned. An organ or other part of a swine, cattle, sheep, goat, or equine carcass affected by localized tuberculosis shall be condemned when it contains lesions of tuberculosis or when the corresponding lymph node contains lesions of tuberculosis.
(c) Carcasses of cattle passed without restriction for human food. Carcasses of cattle may be passed without restriction for human food only when the carcass of an animal not identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State, or accredited veterinarian
(d) Portions of carcasses and carcasses of cattle passed for cooking. (1) When a cattle carcass reveals a tuberculosis lesion or lesions not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.
(2) When the carcass of a cattle identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State or accredited veterinarian is found free of lesions of tuberculosis, the carcass may be passed for cooking in accordance with part 315 of this chapter.
(e) Portions of carcasses and carcasses of swine passed without restriction for human food. Swine carcasses found free of tuberculosis lesions during post mortem inspection may be passed for human food without restriction. When tuberculosis lesions in any swine carcass are localized and confined to one primary seat of infection, such as the cervical lymph nodes, the mesenteric lymph nodes, or the mediastinal lymph nodes, the unaffected portion of the carcass may be passed for human food without restriction after the affected organ or other part is condemned.
(f) Portions of carcasses of swine passed for cooking. When the carcass of any swine reveals lesions more severe or more numerous than those described in paragraph (e) of this section, but not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portions of such carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.
(g) Carcasses of sheep, goats, and equines passed without restriction for human food. Carcasses of sheep, goats, and equines may be passed without restriction for human food only if found free of tuberculosis lesions during post mortem inspection.
(h) Portions of carcasses of sheep, goats, and equines passed for cooking. If a carcass of any sheep, goat, or equine reveals a tuberculosis lesion or lesions that are not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.
(a) The carcasses of all hogs affected with hog cholera shall be condemned.
(b) Inconclusive but suspicious symptoms of hog cholera observed during the ante-mortem inspection of a U.S. suspect shall be duly considered in connection with post-mortem findings and when the carcass of such a suspect shows lesions in the kidneys and the lymph nodes which resemble lesions of hog cholera, they shall be regarded as those of hog cholera and the carcass shall be condemned.
(c) When lesions resembling those of hog cholera occur in kidneys and lymph nodes of carcasses of hogs which appeared normal on ante-mortem inspection, further inspection of such carcasses shall be made for corroborative lesions. If on such further inspection, characteristic lesions of hog cholera are found in some organ or tissue in addition to those in the kidneys or in the lymph nodes or in both, then all lesions shall be regarded as those of hog cholera and the carcass shall be condemned. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for control of swine diseases in the State where the swine are located.
Carcasses affected with swine erysipelas which is acute or generalized, or which show systemic change, shall be condemned.
Carcasses of hogs affected with diamond-skin disease when localized and not associated with systemic change may be passed for human food after removal and condemnation of the affected parts, provided such carcasses are otherwise healthy.
(a) Carcasses affected with arthritis which is localized and not associated with systemic change may be passed for human food after removal and condemnation of all affected parts. Affected joints with corresponding lymph nodes shall be removed and condemned. In order to avoid contamination of the meat which is passed, a joint capsule shall not be opened until after the affected joint is removed.
(b) Carcasses affected with arthritis shall be condemned when there is evidence of systemic involvement.
(a) Carcasses of cattle found on post-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive or well-marked generalized edema shall be condemned.
(b) Carcasses of cattle, including their detached organs and other parts, found on post-mortem inspection to be affected with anasarca to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the affected tissues, provided the lesion is localized.
(a) The definition of generalization as outlined for tuberculosis in § 311.2(a) shall apply for actinomycosis and actinobacillosis, and carcasses of livestock with generalized lesions of either such disease shall be condemned.
(b) Carcasses of livestock in a well-nourished condition showing uncomplicated localized lesions of actinomycosis or actinobacillosis may be passed for human food after the infected organs or other infected parts have been removed and condemned, except as provided in paragraphs (c) and (d) of this section.
(c) Heads affected with actinomycosis or actinobacillosis, including the tongue, shall be condemned, except that when the disease of the jaw is slight, strictly localized, and without suppuration, fistulous tracts, or lymph node involvement, the tongue, if free from disease, may be passed, or, when the disease is slight and confined to the lymph nodes, the head including the tongue, may be passed for human food after the affected nodes have been removed and condemned.
(d) When the disease is slight and confined to the tongue, with or without involvement of the corresponding lymph nodes, the head may be passed for human food after removal and condemnation of the tongue and corresponding lymph nodes.
(a) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned:
(1) Anthrax.
(2) Blackleg.
(3) Unhealed vaccine lesions (vaccinia).
(4) Strangles.
(5) Purpura hemorrhagica.
(6) Azoturia.
(7) Infectious equine encephalomye-litis.
(8) Toxic encephalomyelitis (forage poisoning).
(9) Infectious anemia (swamp fever).
(10) Dourine.
(11) Acute influenza.
(12) Generalized osteoporosis.
(13) Glanders (farcy).
(14) Acute inflammatory lameness.
(15) Extensive fistula.
(b) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned, except when recovery has occurred to the extent that only localized lesions persist, in which case the carcass may be passed for human food after removal and condemnation of the affected organs or other parts:
(1) Anaplasmosis.
(2) Bacillary hemoglobinuria in cattle.
(3) Babesiosis (piroplasmosis).
(4) Bluetongue.
(5) Hemorrhagic septicemia.
(6) Icterohematuria in sheep.
(7) Infectious bovine rhinotracheitis.
(8) Leptospirosis.
(9) Malignant epizootic catarrh.
(a) An individual organ or other part of a carcass affected with a neoplasm shall be condemned. If there is evidence of metastasis or that the general condition of the animal has been adversely affected by the size, position, or nature of the neoplasm, the entire carcass shall be condemned.
(b) Carcasses affected with malignant lymphoma shall be condemned.
(a) Carcasses of animals affected with epithelioma of the eye, or the orbital region shall be condemned in their entirety if one of the following three conditions exists:
(1) The affection has involved the osseous structures of the head with extensive infection, suppuration, and necrosis;
(2) There is metastasis from the eye, or the orbital region, to any lymph node including the parotid lymph node, internal organs, muscles, skeleton, or other structures, regardless of the extent of the primary tumor; or
(3) The affection, regardless of extent, is associated with cachexia or evidence of absorption or secondary changes.
(b) Carcasses of animals affected with epithelioma of the eye, or the orbital region, to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the head, including the tongue, provided the carcass is otherwise normal.
(a) Except as provided in § 311.19, carcasses of livestock showing generalized pigmentary deposits shall be condemned.
(b) The affected parts of carcasses showing localized pigmentary deposits of such character as to be unwholesome or otherwise adulterated shall be removed and condemned.
All slight, well-limited abrasions on the tongue and inner surface of the lips and mouth, when without lymph node involvement, shall be carefully excised, leaving only sound, normal tissue, which may be passed for human food. Any organ or other part of a carcass which is badly bruised or which is affected by an abscess, or a suppurating sore shall be condemned; and when the lesions are of such character or extent as to affect the whole carcass, the whole carcass shall be condemned. Portions of carcasses which are contaminated by pus or other diseased material shall be condemned.
Carcasses affected with localized lesions of brucellosis may be passed for human food after the affected parts are removed and condemned.
(a) All carcasses of animals so infected that consumption of the products thereof may give rise to food poisoning shall be condemned. This includes all carcasses showing signs of:
(1) Acute inflammation of the lungs, pleura, pericardium, peritoneum, or meninges.
(2) Septicemia or pyemia, whether puerperal, traumatic, or without any evident cause.
(3) Gangrenous or severe hemorrhagic enteritis or gastritis.
(4) Acute diffuse metritis or mammitis.
(5) Phlebitis of the umbilical veins.
(6) Septic or purulent traumatic pericarditis.
(7) Any acute inflammation, abscess, or suppurating sore, if associated with acute nephritis, fatty and degenerated liver, swollen soft spleen, marked pulmonary hyperemia, general swelling of lymph nodes, diffuse redness of the skin, cachexia, icteric discoloration of the carcass or similar condition, either singly or in combination.
(8) Salmonellosis.
(b) Implements contaminated by contact with carcasses affected with any of the disease conditions mentioned in this section shall be thoroughly cleaned and sanitized as prescribed in part 308 of this subchapter. The equipment used in the dressing of such carcasses, such as viscera trucks or inspection tables, shall be sanitized with hot water having a minimum temperature of 180 °F. Carcasses or parts of carcasses contaminated by contact with such diseased carcasses shall be condemned unless all contaminated tissues are removed within 2 hours.
From the standpoint of meat inspection, necrobacillosis may be regarded as a local infection at the beginning, and carcasses in which the lesions are localized may be passed for human food if in a good state of nutrition, after those portions affected with necrotic lesions are removed and condemned. However, when emaciation, cloudy swelling of the parenchymatous tissue of organs or enlargement of the lymph nodes is associated with the infection, it is evident that the disease has progressed beyond the condition of localization to a state of toxemia, and the entire carcass shall therefore be condemned as both unwholesome and noxious. Pyemia or septicemia may intervene as a complication of the local necrosis, and when present the carcass shall be condemned in accordance with § 311.16.
(a) A thin carcass showing well-marked lesions in the viscera and the skeletal lymph nodes, or a thin carcass showing extensive lesions in any part shall be condemned.
(b) A thin carcass showing well-marked lesions in the viscera with only slight lesions elsewhere or showing well-marked lesions in the skeletal lymph nodes with only slight lesions elsewhere may be passed for cooking.
(c) A thin carcass showing only slight lesions in the skeletal lymph nodes and in the viscera may be passed for human food without restriction.
(d) A well-nourished carcass showing well-marked lesions in the viscera and with only slight lesions elsewhere or showing well-marked lesions confined to the skeletal lymph nodes with only slight lesions elsewhere may be passed for human food without restriction.
(e) A well-nourished carcass showing well-marked lesions in the viscera and the skeletal lymph nodes may be passed for cooking; but where the lesions in a well-nourished carcass are both numerous and extensive, it shall be condemned.
(f) All affected organs and nodes of carcasses passed for human food without restriction or passed for cooking shall be removed and condemned.
(g) As used in this section, the term “thin” does not apply to a carcass which is anemic or emaciated; and the term “lesions” refers to lesions of caseous lymphadenitis.
Carcasses showing any degree of icterus shall be condemned. Yellow fat conditions caused by nutritional factors or characteristic of certain breeds of livestock and yellow fat sometimes seen in sheep shall not be confused with icterus. Such carcasses should be passed for human food, if otherwise normal.
(a) Carcasses of swine which give off a pronounced sexual odor shall be condemned.
(b) The meat of swine carcasses which give off a sexual odor less than pronounced may be passed for use in comminuted cooked meat food product or for rendering. Otherwise it shall be condemned.
Carcasses of livestock affected with mange or scab in advanced stages, showing cachexia or extensive inflammation of the flesh, shall be condemned. When the disease is slight, the carcass may be passed after removal of the affected portion.
Carcasses of hogs affected with urticaria (nettle rash), tinea tonsurans, demodex folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the carcass is otherwise not adulterated.
(a) Except as provided in paragraph (b) of this section, carcasses of cattle affected with lesions of cysticercus bovis shall be disposed of as follows:
(1) Carcasses of cattle displaying lesions of cysticercus bovis shall be condemned if the infestation is extensive or if the musculature is edematous or discolored. Carcasses shall be considered extensively infested if in addition to finding lesions in at least two of the usual inspection sites, namely the heart, diaphragm and its pillars, muscles of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, they are found in at least two of the sites exposed by (i) an incision made into each round exposing the musculature in cross section, and (ii) a transverse incision into each forelimb commencing 2 or 3 inches above the point of the olecranon and extending to the humerus.
(2) Carcasses of cattle showing one or more tapeworm lesions of cysticercus bovis but not so extensive as indicated in paragraph (a)(1) of this section, as determined by a careful examination, including examination of, but not limited to, the heart, diaphragm and its pillars, muscles of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, may be passed for human food after removal and condemnation of the lesions with surrounding tissues: Provided, That the carcasses, appropriately identified by retained tags, are held in cold storage under positive control of a USDA Food Inspector at a temperature not higher than 15 °F. continuously for a period of not less than 10 days, or in the case of boned meat derived from such carcasses, the meat, when in boxes, tierces, or other containers, appropriately identified by retained tags, is held under positive control of a Program Inspector at a temperature of not higher than 15 °F. continuously for a period of not less than 20 days. As an alternative to retention in cold storage as provided in this subparagraph, such carcasses and meat may be heated throughout to a temperature of at least 140 °F. under positive control of a Program Inspector.
(b) Edible viscera and offal shall be disposed of in the same manner as the rest of the carcass from which they were derived unless any lesion of cysticercus bovis is found in these byproducts, in which case they shall be condemned.
Carcasses of hogs affected with tapeworm cysts (Cysticercus cellulosae) may be passed for cooking, unless the infestation is excessive, in which case the carcass shall be condemned.
(a) In the disposal of carcasses, edible organs, and other parts of carcasses showing evidence of infestation with parasites not transmissible to man, the following general rules shall govern except as otherwise provided in this section: If the lesions are localized in such manner and are of such character that the parasites and the lesions caused by them can be completely removed, the nonaffected portion of the carcass, organ, or other part of the carcass may be passed for human food after the removal and condemnation of the affected portions. If an organ or other part of a carcass shows numerous lesions caused by parasites, or if the character of the infestation is such that complete extirpation of the parasitic infestation or invasion renders the part in any way unfit for human food, the affected part shall be condemned. If parasites are found to be distributed in a carcass in such a manner or to be of such character that their removal and the removal of the lesions caused by them is impracticable, no part of the carcass shall be passed for human food. If the infestation is excessive, the carcass shall be condemned. If the infestation is moderate, the carcass may be passed for cooking, but in case such carcass is not cooked as required by part 315 of this subchapter, it shall be condemned.
(b) In the case of sheep carcasses affected with tapeworm cysts (Cysticercus ovis, so-called sheep measles, not transmissible to man), such carcasses may be passed for human food after the removal and condemnation of the affected portions: Provided, however, That if, upon the final inspection of sheep carcasses retained on account of measles, the total number of cysts found embedded in muscular tissue, or in immediate relation with muscular tissue, excluding the heart, exceeds five, the entire carcass shall be condemned, or such carcass shall be heated throughout to a temperature of at least 140 °F. After removal and condemnation of all affected portions.
(c) Carcasses found infested with gid bladder-worms (Coenurus cerebralis, Multiceps multiceps) may be passed for human food after condemnation of the affected organ (brain or spinal cord).
(d) Organs or other parts of carcasses infested with hydatid cysts (echinococus) shall be condemned.
(e) Livers infested with flukes or fringed tapeworms shall be condemned.
Carcasses of livestock too emaciated to produce wholesome meat, and carcasses which show a serous infiltration of muscle tissues, or a serous or mucoid degeneration of the fatty tissue, shall be condemned. A gelatinous change of the fat of the heart and kidneys of well-nourished carcasses and mere leanness shall not be classed as emaciation.
When it is necessary for humane reasons to slaughter an injured animal at night or on Sunday or a holiday when the inspector cannot be obtained, the carcass and all parts of all livestock except for cattle shall be kept for inspection, with the head and all viscera except the stomach, bladder, and intestines held by the natural attachments. If all parts are not so kept for inspection, the carcass shall be condemned. If, on inspection of a carcass slaughtered in the absence of an inspector, any lesion or other evidence is found indicating that the animal was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante-mortem inspection, or if there is lacking evidence of the condition which rendered emergency slaughter necessary, the carcass shall be condemned. The parts and carcasses of cattle slaughtered in the absence of an inspector shall not be used for human food.
Carcasses of young calves, pigs, kids, lambs, and foals are unwholesome and shall be condemned if (a) the meat has the appearance of being water-soaked, is loose, flabby, tears easily, and can be perforated with the fingers; or (b) its color is grayish-red; or (c) good muscular development as a whole is lacking, especially noticeable on the upper shank of the leg, where small amounts of serous infiltrates or small edematous patches are sometimes present between the muscles; or (d) the tissue which later develops as the fat capsule of the kidneys is edematous, dirty yellow, or grayish-red, tough, and intermixed with islands of fat.
All unborn and stillborn animals shall be condemned and no hide or skin thereof shall be removed from the carcass within a room in which edible products are handled.
All livestock which have been suffocated in any way and hogs which have entered the scalding vat alive shall be condemned.
(a) Livers affected with carotenosis shall be condemned.
(b) Cattle livers and calf livers showing the conditions sometimes designated as “telangiectatic,” “sawdust,” or “spotted” shall be disposed of as follows:
(1) When any or all of the conditions are slight in the organ, the whole organ shall be passed for human food without restriction.
(2) When any or all of the conditions are more severe than slight and involve less than one-half of the organ, while in the remainder of the organ the conditions are slight or nonexistent, the remainder shall be passed for human food without restriction and the other portion shall be condemned.
(3) When any or all of the conditions are more severe than slight and involve one-half or more of the organ, the whole organ shall be condemned.
(4) The divisions of an organ into two parts as contemplated in this paragraph for disposition, shall be accomplished by one cut through the organ. This, of course, does not prohibit incisions which are necessary for inspection.
(c) “Telangiectatic,” “sawdust,” or “spotted” livers and parts of livers which are condemned for human food may be shipped from an official establishment for purposes other than human food in accordance with § 314.10 of this subchapter.
(a) Any carcass affected with vesicular disease shall be condemned if the condition is acute and if the extent of the condition is such that it affects the entire carcass or there is evidence of absorption or secondary change.
(b) Any carcass affected with vesicular disease to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the affected parts, if the carcass is otherwise healthy.
Carcasses of livestock identified as U.S. Suspects because of a history of listeriosis shall be passed for human food after condemnation of the head if the carcass is otherwise normal.
Carcasses of livestock too anemic to produce wholesome meat shall be condemned.
(a) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is impractical, the carcass shall be condemned.
(b) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is practical, the following rules shall govern the disposal of the carcasses, edible organs, and other parts of carcasses showing such muscular lesions. If the lesions are localized in such a manner and are of such a character that the affected tissues can be removed, the nonaffected parts of the carcass may be passed for human food after the removal and condemnation of the affected portion. If a part of the carcass shows numerous lesions, or if the character of the lesion is such that complete extirpation is difficult and uncertainly accomplished, or if the lesion renders the part in any way unfit for human food, the part shall be condemned.
(c) If the lesions are slight or of such character as to be insignificant from a standpoint of wholesomeness, the carcass or parts may be passed for use in the manufacture of comminuted cooked product, after removal and condemnation of the visibly affected portions.
(a) Carcasses which are affected with generalized coccidioidal granuloma or which show systemic changes because of such disease shall be condemned.
(b) Carcasses affected with localized lesions of this disease may be passed for human food after the affected parts are removed and condemned.
(a) Carcasses which give off a pronounced odor of medicinal, chemical, or other foreign substance shall be condemned.
(b) Carcasses which give off a pronounced urine odor shall be condemned.
(c) Carcasses, organs, or parts affected by odor to a lesser degree than as described in paragraphs (a) and (b) of this section and in which the odor can be removed by trimming or chilling may be passed for human food, after removal of affected parts or dissipation of the condition.
Meat and meat byproducts from livestock which have been administered radioactive material shall be condemned unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act.
Carcasses, organs, or other parts of carcasses of livestock shall be condemned if it is determined that they are adulterated because of the presence of any biological residues.
The marks, devices, and certificates prescribed or referenced in this part shall be official marks, devices, and certificates for purposes of the Act, and shall be used in accordance with the provisions of this part and the regulations cited therein.
(a) The official inspection legend required by part 316 of this subchapter to be applied to inspected and passed carcasses and parts of carcasses of cattle, sheep, swine and goats, meat food products in animal casings, and other products as approved by the Administrator, shall be in the appropriate form as hereinafter specified:
For application to sheep carcasses, the loins and ribs of pork, beef tails, and the smaller varieties of sausage and meat food products in animal casings.
For application to calf and goat carcasses and on the larger varieties of sausage and meat food products in animal casings.
For application to beef and hog carcasses primal parts and cuts therefrom, beef livers, beef tongues, beef hearts, and smoked meats not in casings.
For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.
(b)(1) The official inspection legend required by part 317 of this subchapter to be shown on all labels for inspected and passed products of cattle, sheep, swine, and goats shall be in the following form
(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.
(3) The official inspection legend described in paragraph (b)(1) of this section may also be used for purposes of part 316 of this subchapter on shipping containers, band labels, artificial casings, and other articles with the approval of the Administrator.
(c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark prescribed in paragraphs (a) or (b) of this section shall be an official device for purposes of the Act.
(a) The official inspection legend required by § 316.12 or § 317.2 of this subchapter to identify inspected and passed horse carcasses and parts of carcasses, or horse meat food products shall be in the appropriate form as hereinafter specified:
(b) The official inspection legend required by § 316.12 or § 317.2 of this subchapter to identify inspected and passed mule and other (nonhorse) equine carcasses and parts of carcasses, or equine meat food products shall be in whichever of the following form, is appropriate:
(c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark prescribed in paragraphs (a) or (b) of this section shall be an official device for purposes of the Act.
The official marks and devices used in connection with ante-mortem inspection are those prescribed in § 309.18 of this subchapter.
The official mark for use in sealing railroad cars or other means of conveyance as prescribed in part 325 of this subchapter shall be the inscription and a serial number as hereinafter shown
(a) The official marks required by parts 310 and 416 of this chapter for use in post-mortem inspection and identification of adulterated products and insanitary equipment and facilities are:
(1) The tag (Form MP-427) which is used to retain carcasses and parts of carcasses in the slaughter department; it is black and white, and bears the legend “U.S. Retained.”
(2) The “U.S. Retained” mark which is applied to products and articles as prescribed in part 310 of this subchapter by means of a paper tag (Form MP-35) bearing the legend “U.S. Retained.”
(3) The “U.S. Rejected” mark which is used to identify insanitary buildings, rooms, or equipment as prescribed in part 416, section 6, of this chapter and is applied by means of a paper tag (Form MP-35) bearing the legend “U.S. Rejected.”
(4) The “U.S. Passed for Cooking” mark is applied on products passed for cooking as prescribed in part 310 of this subchapter by means of a brand and is in the following form:
(5) The “U.S. Inspected and Condemned” mark shall be applied to products condemned as prescribed in part 310 by means of a brand and is in the following form:
(b) The “U.S. Retained” and “U.S. Rejected” tags, and all other brands, stamps, labels, and other devices approved by the Administrator and bearing any official mark prescribed in paragraph (a) of this section, shall be official devices for purposes of the Act.
The export inspection mark required in § 322.1 of this chapter must be either a mark that contains a unique identifier that links the consignment to the export certificate or an official mark with the following form:
The official mark for articles and livestock detained under part 329 of this subchapter shall be the designation “U.S. Detained” and the official device for applying such mark shall be the official “U.S. Detained” tag (FSIS Form 8400-2) as prescribed in § 329.2 of this subchapter.
The official mark for use in sealing containers of samples submitted under any requirements in this subchapter and section 202 of the Federal Meat Inspection Act shall bear the designation “Sample Seal” accompanied by the official USDA logo as shown below. Any seal approved by the Administrator for applying such mark shall be deemed an official device for purposes of the Act. Such device shall be supplied to inspectors, compliance officers, and other designated Agency officials by the United States Department of Agriculture.
(a) Livestock pens, driveways and ramps shall be maintained in good repair. They shall be free from sharp or protruding objects which may, in the opinion of the inspector, cause injury or pain to the animals. Loose boards, splintered or broken planking, and unnecessary openings where the head, feet, or legs of an animal may be injured shall be repaired.
(b) Floors of livestock pens, ramps, and driveways shall be constructed and maintained so as to provide good footing for livestock. Slip resistant or waffled floor surfaces, cleated ramps and the use of sand, as appropriate, during winter months are examples of acceptable construction and maintenance.
(c) U.S. Suspects (as defined in § 301.2(xxx)) and dying, diseased, and disabled livestock (as defined in § 301.2(y)) shall be provided with a covered pen sufficient, in the opinion of the inspector, to protect them from the adverse climatic conditions of the locale while awaiting disposition by the inspector.
(d) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized.
(a) Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.
(b) Electric prods, canvas slappers, or other implements employed to drive animals shall be used as little as possible in order to minimize excitement and injury. Any use of such implements which, in the opinion of the inspector, is excessive, is prohibited. Electrical prods attached to AC house current shall be reduced by a transformer to the lowest effective voltage not to exceed 50 volts AC.
(c) Pipes, sharp or pointed objects, and other items which, in the opinion of the inspector, would cause injury or unnecessary pain to the animal shall not be used to drive livestock.
(d) Disabled livestock and other animals unable to move.
(1) Disabled animals and other animals unable to move shall be separated from normal ambulatory animals and placed in the covered pen provided for in § 313.1(c).
(2) The dragging of disabled animals and other animals unable to move, while conscious, is prohibited. Stunned animals may, however, be dragged.
(3) Disabled animals and other animals unable to move may be moved, while conscious, on equipment suitable for such purposes; e.g., stone boats.
(e) Animals shall have access to water in all holding pens and, if held longer than 24 hours, access to feed. There shall be sufficient room in the holding pen for animals held overnight to lie down.
(f) Stunning methods approved in § 313.30 shall be effectively applied to animals prior to their being shackled, hoisted, thrown, cast, or cut.
The slaughtering of sheep, calves and swine with the use of carbon dioxide gas and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.
(a) Administration of gas, required effect; handling. (1) The carbon dioxide gas shall be administered in a chamber in accordance with this section so as to produce surgical anesthesia in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be exposed to the carbon dioxide gas in a way that will accomplish the anesthesia quickly and calmly, with a minimum of excitement and discomfort to the animals. In swine, carbon dioxide may be administered to induce death in the animals before they are shackled, hoisted, thrown, cast, or cut.
(2) The driving or conveying of the animals to the carbon dioxide chamber shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the anesthesia chamber is essential since the induction, or early phase, of anesthesia is less violent with docile animals. Among other things this requires that, in driving animals to the anesthesia chamber, electrical equipment be used as little as possible and with the lowest effective voltage.
(3) On emerging from the carbon dioxide tunnel, the animals shall be in a state of surgical anesthesia and shall remain in this condition throughout shackling, sticking, and bleeding, except for swine in which death has been induced by the administration of carbon dioxide. Asphyxia or death from any cause shall not be produced in animals before bleeding, except for swine in which death has been induced by the administration of carbon dioxide.
(b) Facilities and procedures—(1) General requirements for gas chambers and auxiliary equipment; operator. (i) The carbon dioxide gas shall be administered in a tunnel which is designed to permit the effective exposure of the animal. Two types of tunnels, based on the same principle, are in common use for carbon dioxide anesthesia. They are the “U” type tunnel and the “Straight Line” type tunnel, and are based on the principle that carbon dioxide gas has a higher specific gravity than air. The tunnels are open at both ends for entry and exit of animals and have a depressed central section. Anesthetizing, or, in the case of swine, death-inducing, carbon dioxide concentrations are maintained in the central sections of the tunnels. Effective anaesthetization is produced in these central sections. Animals are driven from holding pens through pathways constructed of large-diameter pipe or smooth metal and onto continuous conveyor devices that move the animals through the tunnels. The animals are either compartmentalized on the conveyors by mechanical impellers synchronized with the conveyor or they are otherwise prevented from crowding. While impellers are used to compartmentalize the animals, mechanically or manually operated gates are used to move the animals onto the conveyors. Surgically anaesthetized animals, or killed swine, are moved out of the tunnels by the same continuous conveyors that moved them into and through the carbon dioxide gas.
(ii) Flow of animals into and through the carbon dioxide chamber is dependent on one operator. The operation or stoppage of the conveyor is entirely dependent upon this operator. It is necessary that he be skilled, attentive, and aware of his responsibility. Overdosages and death of animals can be brought about by carelessness of this individual.
(2) Special requirements for gas chamber and auxiliary equipment. The ability of anesthetizing equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, gas chambers, and all other equipment used must be designed to accommodate properly the species of animals being anesthetized. They shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces or openings where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or well padded rigid material. Power activated gates designed for constant flow of animals to anesthetizing equipment shall be so fabricated that they will not cause injury. All equipment involved in anesthetizing animals shall be maintained in good repair.
(3) Gas. Maintenance of a uniform carbon dioxide concentration and distribution in the anesthesia chamber is a vital aspect of producing surgical anesthesia. This may be assured by reasonably accurate instruments which sample and analyze carbon dioxide gas concentration within the chamber throughout anesthetizing operations. Gas concentration shall be maintained uniform so that the degree of anesthesia in exposed animals will be constant. Carbon dioxide gas supplied to anesthesia chambers may be from controlled reduction of solid carbon dioxide or from a controlled liquid source. In either case the carbon dioxide shall be supplied at a rate sufficient to anesthetize adequately and uniformly the number of animals passing through the chamber. Sampling of gas for analysis shall be made from a representative place or places within the chamber and on a continuing basis. Gas concentrations and exposure time shall be graphically recorded throughout each day's operation. Neither carbon dioxide nor atmospheric air used in the anesthesia chambers shall contain noxious or irritating gases. Each day before equipment is used for anesthetizing animals, proper care shall be taken to mix adequately the gas and air within the chamber. All gas producing and control equipment shall be maintained in good repair and all indicators, instruments, and measuring devices must be available for inspection by Program inspectors during anesthetizing operations and at other times. An exhaust system must be provided so that, in case of equipment failure, non-uniform carbon dioxide concentrations in the gas tunnel or contamination of the ambient air of the establishment will be prevented.
The slaughtering of sheep, swine, goats, calves, cattle, horses, mules, and other equines by using captive bolt stunners and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.
(a) Application of stunners, required effect; handling. (1) The captive bolt stunners shall be applied to the livestock in accordance with this section so as to produce immediate unconsciousness in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be stunned in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.
(2) The driving of the animals to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the stunning areas is essential since accurate placement of stunning equipment is difficult on nervous or injured animals. Among other things, this requires that, in driving animals to the stunning areas, electrical equipment be used as little as possible and with the lowest effective voltage.
(3) Immediately after the stunning blow is delivered the animals shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.
(b) Facilities and procedures—(1) General requirements for stunning facilities; operator. (i) Acceptable captive bolt stunning instruments may be either skull penetrating or nonpenetrating. The latter type is also described as a concussion or mushroom type stunner. Penetrating instruments on detonation deliver bolts of varying diameters and lengths through the skull and into the brain. Unconsciousness is produced immediately by physical brain destruction and a combination of changes in intracranial pressure and acceleration concussion. Nonpenetrating or mushroom stunners on detonation deliver a bolt with a flattened circular head against the external surface of the animal's head over the brain. Diameter of the striking surface of the stunner may vary as conditions require. Unconsciousness is produced immediately by a combination of acceleration concussion and changes in intracranial pressures. A combination instrument utilizing both penetrating and nonpenetrating principles is acceptable. Energizing of instruments may be accomplished by detonation of measured charges of gunpowder or accurately controlled compressed air. Captive bolts shall be of such size and design that, when properly positioned and activated, immediate unconsciousness is produced.
(ii) To assure uniform unconsciousness with every blow, compressed air devices must be equipped to deliver the necessary constant air pressure and must have accurate, constantly operating air pressure gauges. Gauges must be easily read and conveniently located for use by the stunning operator and the inspector. For purposes of protecting employees, inspectors, and others, it is desirable that any stunning device be equipped with safety features to prevent injuries from accidental discharge. Stunning instruments must be maintained in good repair.
(iii) The stunning area shall be so designed and constructed as to limit the free movements of animals sufficiently to allow the operator to locate the stunning blow with a high degree of accuracy. All chutes, alleys, gates and restraining mechanisms between and including holding pens and stunning areas shall be free from pain-producing features such as exposed bolt ends, loose boards, splintered or broken planking, and protruding sharp metal of any kind. There shall be no unnecessary holes or other openings where feet or legs of animals may be injured. Overhead drop gates shall be suitably covered on the bottom edge to prevent injury on contact with animals. Roughened or cleated cement shall be used as flooring in chutes leading to stunning areas to reduce falls of animals. Chutes, alleys, and stunning areas shall be so designed that they will comfortably accommodate the kinds of animals to be stunned.
(iv) The stunning operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately place the stunning instrument to produce immediate unconsciousness. He must use the correct detonating charge with regard to kind, breed, size, age, and sex of the animal to produce the desired results.
(2) Special requirements and prohibitions. (i) Choice of instrument and force required to produce immediate unconsciousness varies, depending on kind, breed, size, age, and sex of the animal. Young swine, lambs, and calves usually require less stunning force than mature animals of the same kind. Bulls, rams, and boars usually require skull penetration to produce immediate unconsciousness. Charges suitable for smaller kinds of livestock such as swine or for young animals are not acceptably interchanged for use on larger kinds or older livestock, respectively.
(ii) Captive bolt stunners that deliberately inject compressed air into the cranium at the end of the penetration cycle shall not be used to stun cattle.
The slaughtering of cattle, calves, sheep, swine, goats, horses, mules, and other equines by shooting with firearms and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.
(a) Utilization of firearms, required effect; handling. (1) The firearms shall be employed in the delivery of a bullet or projectile into the animal in accordance with this section so as to produce immediate unconsciousness in the animal by a single shot before it is shackled, hoisted, thrown, cast, or cut. The animal shall be shot in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.
(2) The driving of the animals to the shooting areas shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the shooting area is essential since accurate placement of the bullet is difficult in case of nervous or injured animals. Among other things, this requires that, in driving animals to the shooting areas, electrical equipment be used as little as possible and with the lowest effective voltage.
(3) Immediately after the firearm is discharged and the projectile is delivered, the animal shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.
(b) Facilities and procedure—(1) General requirements for shooting facilities; operator. (i) On discharge, acceptable firearms dispatch free projectiles or bullets of varying sizes and diameters through the skull and into the brain. Unconsciousness is produced immediately by a combination of physical brain destruction and changes in intracranial pressure. Caliber of firearms shall be such that when properly aimed and discharged, the projectile produces immediate unconsciousness.
(ii) To assure uniform unconsciousness of the animal with every discharge where small-bore firearms are employed, it is necessary to use one of the following type projectiles: Hollow pointed bullets; frangible iron plastic composition bullets; or powdered iron missiles. When powdered iron missiles are used, the firearms shall be in close proximity with the skull of the animal when fired. Firearms must be maintained in good repair. For purposes of protecting employees, inspectors and others, it is desirable that all firearms be equipped with safety devices to prevent injuries from accidental discharge. Aiming and discharging of firearms should be directed away from operating areas.
(iii) The provisions contained in § 313.15(b)(1)(iii) with respect to the stunning area also apply to the shooting area.
(iv) The shooting operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately direct the projectile to produce immediate unconsciousness. He must use the correct caliber firearm, powder charge and type of ammunition to produce the desired results.
(2) Special requirements. Choice of firearms and ammunition with respect to caliber and choice of powder charge required to produce immediate unconsciousness of the animal may vary depending on age and sex of the animal. In the case of bulls, rams, and boars, small bore firearms may be used provided they are able to produce immediate unconsciousness of the animals. Small bore firearms are usually effective for stunning other cattle, sheep, swine, and goats, and calves, horses, and mules.
The slaughtering of swine, sheep, calves, cattle, and goats with the use of electric current and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.
(a) Administration of electric current, required effect; handling. (1) The electric current shall be administered so as to produce, at a minimum, surgical anesthesia, i.e., a state where the animal feels no painful sensation. The animals shall be either stunned or killed before they are shackled, hoisted, thrown, cast, or cut. They shall be exposed to the electric current in a way that will accomplish the desired result quickly and effectively, with a minimum of excitement and discomfort.
(2) The driving or conveying of the animals to the place of application of electric current shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the place of application is essential to ensure rapid and effective insensibility. Among other things, this requires that, in driving animals to the place of application, electrical equipment be used as little as possible and with the lowest effective voltage.
(3) The quality and location of the electrical shock shall be such as to produce immediate insensibility to pain in the exposed animal.
(4) The stunned animal shall remain in a state of surgical anesthesia through shackling, sticking, and bleeding.
(b) Facilities and procedures; operator—(1) General requirements for operator. It is necessary that the operator of electric current application equipment be skilled, attentive, and aware of his or her responsibility.
(2) Special requirements for electric current application equipment. The ability of electric current equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, current applicators, and all other equipment used must be designed to properly accommodate the species of animals being anesthetized. Animals shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces or openings where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or padded material. Power activated gates designed for constant flow of animals shall be so fabricated that they will not cause injury. All equipment used to apply and control the electrical current shall be maintained in good repair, and all indicators, instruments, and measuring devices shall be available for inspection by Program inspectors during the operation and at other times.
(3) Electric current. Each animal shall be given a sufficient application of electric current to ensure surgical anesthesia throughout the bleeding operation. Suitable timing, voltage and current control devices shall be used to ensure that each animal receives the necessary electrical charge to produce immediate unconsciousness. The current shall be applied so as to avoid the production of hemorrhages or other tissue changes which could interfere with inspection procedures.
When an inspector observes an incident of inhumane slaughter or handling in connection with slaughter, he/she shall inform the establishment operator of the incident and request that the operator take the necessary steps to prevent a recurrence. If the establishment operator fails to take such action or fails to promptly provide the inspector with satisfactory assurances that such action will be taken, the inspector shall follow the procedures specified in paragraph (a), (b), or (c) of this section, as appropriate.
(a) If the cause of inhumane treatment is the result of facility deficiencies, disrepair, or equipment breakdown, the inspector shall attach a “U.S. Rejected” tag thereto. No equipment, alleyway, pen or compartment so tagged shall be used until made acceptable to the inspector. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.
(b) If the cause of inhumane treatment is the result of establishment employee actions in the handling or moving of livestock, the inspector shall attach a “U.S. Rejected” tag to the alleyways leading to the stunning area. After the tagging of the alleyway, no more livestock shall be moved to the stunning area until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to the tagging may be dressed, processed, or prepared under inspection.
(c) If the cause of inhumane treatment is the result of improper stunning, the inspector shall attach a “U.S. Rejected” tag to the stunning area. Stunning procedures shall not be resumed until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.
(a) Carcasses, parts of carcasses, and other products condemned at official establishments having facilities for tanking shall, except as provided in paragraph (c) of this section or elsewhere in this part, be disposed of by tanking as follows:
(1) The lower opening of the tank shall first be sealed securely by a Program employee, except when permanently connected with a blow line; then the condemned products shall be placed in the tank in his presence, after which the upper opening shall also be sealed securely by such employee, who shall then see that the contents of the tank are subjected to sufficient heating for sufficient time to effectively destroy the contents for human food purposes.
(2) The use of equipment such as crushers or hashers for pretanking preparation of condemned products in the inedible products department has been found to give inedible character and appearance to the material. Accordingly, if condemned products are so crushed or hashed, conveying systems, rendering tanks, and other equipment used in the further handling of crushed or hashed material need not be locked or sealed during the tanking operations. If the rendering tanks or other equipment contain condemned material not so crushed or hashed, the equipment shall be sealed as prescribed in paragraph (a)(1) of this section. If the crushed or hashed material is not rendered in the establishment where produced, it shall be denatured as provided for in § 314.3 before leaving such establishment.
(b) The seals of tanks shall be broken only by a Program employee and only after the contents of the tanks have been treated as provided in paragraph (a) of this section. The rendered fat derived from condemned material shall be held until a Program employee shall have had an opportunity to determine whether it conforms with the requirements of this section. Samples shall be taken by Program employees as often as is necessary to determine whether the rendered fat is effectually denatured.
(c) Carcasses of animals condemned under § 309.3 of this subchapter may be disposed of as provided in § 314.3, in lieu of tanking, with the approval of the inspector.
All tanks and equipment used for rendering, otherwise preparing, or storing inedible products must be in rooms or compartments separate from those used for preparing or storing edible products. There may be a connection between rooms or compartments containing inedible products and those containing edible products as long as it does not cause the adulteration of edible product or create insanitary conditions.
(a) Carcasses, parts of carcasses, and other products condemned at an official establishment which has no facilities for tanking shall, except as provided in paragraph (b) of this section or elsewhere in this part, be destroyed in the presence of an inspector by incineration, or denatured with crude carbolic acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella or any other proprietary material approved by the Administrator in specific cases. When such product is to be denatured, it shall be freely slashed before the denaturing agent is applied, except that, in the case of dead animals that have not been dressed, the denaturant may be applied by injection. The denaturant must be deposited in all portions of the carcass or product to the extent necessary to preclude its use for food purposes.
(b) All carcasses and parts condemned on account of anthrax, as identified in § 310.9(b) of this subchapter, at official establishments which are not equipped with tanking facilities shall be disposed of by (1) complete incineration, or (2) by thorough denaturing with crude carbolic acid, or cresylic disinfectant, and then disposed of in accordance with the requirements of the particular State or municipal authorities, who shall be notified immediately by the area supervisor.
Tanks, fertilizer driers, and other equipment used in the preparation of inedible product must be operated in a manner that will suppress odors incident to such preparation which could adulterate edible product or create insanitary conditions.
Except as provided in § 325.11(b) of this subchapter, rendered animal fat derived from condemned or other inedible materials at official establishments shall be denatured to effectually distinguish it from an edible product, either with low grade offal during the rendering or by adding to, and mixing thoroughly with, such fat, denaturing oil, No. 2 fuel oil, or brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, and may be shipped in commerce in accordance with § 325.11(c) of this subchapter.
Except as provided in § 325.11(b) of this subchapter, inedible fats from outside the premises of any official establishment shall not be received into an official establishment except into the tank room provided for inedible products, and then only when they have been denatured in accordance with § 314.5 and are marked in accordance with § 316.15 of this subchapter, and when their receipt into the tank room produces no insanitary condition on the premises; nor shall such fats be received in such volume as interferes with prompt disposal of condemned or other inedible material produced at the establishment. When received, they shall not enter any room or compartment used for edible products.
Carcasses of livestock which have been condemned on ante-mortem inspection shall not be taken through rooms or compartments in which an edible product is prepared, handled, or stored.
(a) With the exception of dead livestock which have died en route and are received with livestock for slaughter at an official establishment, no dead animal or part of the carcass of any livestock that died otherwise than by slaughter may be brought on the premises of an official establishment unless advance permission therefore is obtained from the circuit supervisor.
(b) Under no circumstances shall the carcasses of any animal which has died otherwise than by slaughter, or any part thereof, be brought into any room or compartment in which any edible product is prepared, handled, or stored.
(a) Specimens of condemned or other inedible materials, including embryos and specimens of animal parasites, may be released for educational, research, or other nonfood purposes under permit issued by the inspector in charge: Provided, That the person desiring such specimens makes a written application to the inspector in charge for such permit on Form MP-403-10 and arranges with and receives permission from the official establishment to obtain the specimens. Permits shall be issued for a period not longer than 1 year. The permit may be revoked by the inspector in charge if the specimens are not used as stated in the application, or if the collection or handling of the specimens interferes with inspection or the maintenance of sanitary conditions in the establishment.
(b) The specimens referred to in paragraph (a) of this section shall be collected and handled only at such time and place and in such manner as not to interfere with the inspection or to cause any objectionable condition and shall be identified as inedible when they leave the establishment.
(a) Livers condemned on account of hydatid cysts shall be disposed of by tanking pursuant to the provisions of § 314.1 of this subchapter if condemned at official establishments having facilities for tanking; otherwise they shall be destroyed pursuant to the provisions of § 314.3 of this subchapter.
(b) Livers condemned because of parasites other than hydatid cysts; and livers condemned because of telangiectasis, angioma, “sawdust” condition, cirrhosis, carotenosis, or other nonmalignant change, benign abscesses, or contamination, when these conditions are not associated with infectious diseases in the carcasses, may be shipped from an official establishment only for purposes other than human food, and only if all tissue affected with abscesses is removed and destroyed within the establishment, and all livers are processed and denatured, with any agent prescribed in § 325.13(a)(1) or (2) or (5), and in accordance with § 325.13(a)(6) of this subchapter. This provision for movement from an official establishment is made solely under the Federal Meat Inspection Act and is not intended to relieve or modify any other applicable requirements under any other law regarding the movement of such articles, for purposes other than use as human food.
(c) Livers condemned because of conditions described in paragraph (b) of this section shall be in containers plainly marked “inedible”.
Condemned carcasses of animals affected with one or more of the following conditions may be shipped from an official establishment only for purposes other than human food and only if permission therefor is obtained from the circuit supervisor: Anasarca, Ocular Squamous Cell Carcinoma (after removal of neoplastic tissue), emaciation, eosinophilic myositis, immaturity, nonseptic bruises and injuries, and sarcosporidiosis. This provision also applies to unborn calves and to products such as paunches and udders when they have not been handled as required under this subchapter for products for human food purposes; provided, such articles have not been condemned for other pathological reasons. Such permission will be granted only if all parts to be so used will be promptly handled, freely slashed and adequately identified as required by § 325.13(a)(2) of this subchapter. The slashing, identification and packing of the product shall be accomplished in an inedible product area under the supervision of an inspector. Facilities must be adequate so that the carcasses or parts saved under these provisions are not contaminated with pus, manure, septic, or toxic materials, or similar substances. The operation must not result in unsanitary conditions within the establishment.
Carcasses and parts passed for cooking may be rendered into lard in accordance with § 319.702 of this subchapter or rendered into tallow, provided such rendering is done in the following manner:
(a) When closed rendering equipment is used, the lower opening, except when permanently connected with a blowline, shall first be sealed securely by a Program employee; then the carcasses or parts shall be placed in such equipment in his presence, after which the upper opening shall be securely sealed by such employee. When the product passed for cooking in the tank does not consist of a carcass or whole primal part, the requirements for sealing shall be at the discretion of the circuit supervisor. Such carcasses and parts shall be cooked for a time sufficient to render them effectually into lard or tallow, provided all parts of the products are heated to a temperature not lower than 170 °F. for a period of not less than 30 minutes.
(b) At establishments not equipped with closed rendering equipment for rendering carcasses and parts passed for cooking into lard and tallow, such carcasses or parts may be rendered in open kettles under the direct supervision of a Program employee. Such rendering shall be done during regular hours of work and in compliance with the requirements as to temperature and time specified in paragraph (a) of this section.
Carcasses and parts passed for cooking may be used for the preparation of meat food products, provided all such carcasses or parts are heated to a temperature not lower than 170 °F. for a period of not less than 30 minutes either before being used in or during the preparation of the finished product.
Products passed for cooking if not handled and processed in accordance with the provisions of this part, shall be disposed of in accordance with § 314.1 or § 314.3 of this subchapter.
No brand manufacturer, printer or other person shall cast, print, lithograph, or otherwise make or cause to be made any device containing any official mark or simulation thereof without prior written authority therefor from the Administrator as provided for in part 317 of this subchapter.
No device containing any official mark shall be made or caused to be made for use on any product until it has been approved by the Administrator as provided for in part 317 of this subchapter.
(a) No person shall affix or place, or cause to be affixed or placed, the official inspection legend or any other official mark, or any abbreviation or simulation of any official mark, to or on any product, or container thereof, except under the supervision of a Program employee, or as authorized by part 317 of this subchapter in connection with the manufacture of containers.
(b) No person shall fill, or cause to be filled, in whole or in part, with any product, any container bearing or intended to bear any official mark, or any abbreviation or simulation of any official mark, except under the supervision of a Program employee.
(c) Product bearing any official mark shall not be canned, cooked, cured, smoked, salted, packed, rendered, or otherwise prepared by any person for commercial purposes unless:
(1) Such preparation is performed at an official establishment; or
(2) Such preparation is conducted under State or other governmental inspection and the prepared product is marked to show that fact; or
(3) The official marks are removed, defaced, or otherwise destroyed before or during such preparation; or
(4) The preparation of the product consists solely of cutting up operations at any establishment exempted from inspection under paragraph 301(c)(2) of the Act or equal provisions of a law of a State or organized Territory or at any establishment in an unorganized Territory exempted under paragraph 23(b) of the Act.
(a) The operator of each official establishment or official import inspection establishment shall furnish such ink brands, burning brands, and any other device for marking products with official marks as the Administrator may determine is necessary for marking products at such establishment. The official inspection legend on such a device shall be as prescribed in part 312 of this subchapter.
(b) All official devices for marking products with the official inspection legend, or other official inspection marks, including self-locking seals, shall be used only under supervision of a Program employee, and, when not in use for marking shall be kept locked in properly equipped locks or compartments, the keys of which shall not leave the possession of a Program employee, or the locker or compartment shall be sealed with an official seal of the Department as prescribed in part 312 of this subchapter.
(a) The operator of each official establishment shall furnish all ink for marking products with the official marks at such establishment. Such ink must be made with harmless ingredients that are approved for the purpose by the Administrator. Samples of inks shall be submitted to the Program laboratory from time to time as may be deemed necessary by the inspector in charge.
(b) Only ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses of cattle, sheep, swine, or goats and fresh meat cuts derived therefrom. Any ink containing F.D. & C. Violet No. 1 shall not be considered an approved ink within the meaning of this paragraph.
(c) Green ink shall not be used to apply marks to carcasses of cattle, sheep, swine, or goats or fresh meat cuts derived therefrom.
(d) Except as provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose by the Administrator in specific cases, may be used to apply ink brands, bearing official marks, to processed meat cuts derived from cattle, sheep, swine, or goats.
(e) Only green ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses and parts of carcasses and meat cuts derived from horses, mules, and other equines.
(f) Ink used must assure legibility and permanence of the markings and the color of ink shall provide acceptable contrast with the color of the product to which it is applied.
No person shall remove or cause to be removed from an official establishment any products which the regulations in this subchapter require to be marked in any way unless they are clearly and legibly marked in compliance with such regulations.
No brand or other marking device shall be false or misleading. The letters and figures thereon shall be of such style and type as will make a clear and legible impression. All markings to be applied to products in an official establishment shall be approved prior to use by the Administrator as provided for in § 317.3 of this subchapter, except that official markings prescribed by the Federal meat grading regulations (7 CFR 53.19) need not be submitted to the Administrator for approval.
(a) Unmarked products which have been inspected and passed but do not bear the official inspection legend may be transported in compliance with part 325 of this subchapter from one official establishment to another official establishment, for further processing, in a railroad car, truck, or other closed container, if the railroad car, truck, or container is sealed with an official seal of the Department (as prescribed in part 312 of this subchapter) bearing the official inspection legend.
(b) Products which have been inspected and passed but do not bear the official inspection legend may be removed from an official establishment in closed containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: Provided, That upon removal from such closed container the product may not be further transported in commerce unless such removal is made under the supervision of a Program employee and such product is reinspected by a Program employee and packed under his supervision in containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: And provided further, That unmarked product shall not be brought into an official establishment in an open container.
(a) Each carcass that has been inspected and passed in an official establishment must be marked at the time of inspection with the official inspection legend containing the number of the official establishment, if the carcass is to be shipped into commerce from the establishment without further processing.
(b) A passed and inspected carcass that is to be further processed in the slaughtering establishment need not be marked with the official inspection legend at the time of inspection.
(c) Except as provided otherwise in § 316.8, each primal part of a carcass and each liver, beef tongue, and beef heart which has been inspected and passed shall be marked with the official inspection legend containing the number of the official establishment before it leaves the establishment in which it is first inspected and passed, and each such inspected and passed product shall be marked with the official inspection legend containing the number of the official establishment where it was last prepared. Additional official marks of inspection may be applied to products as desired to meet local conditions. Primal parts are the wholesale cuts of carcasses as customarily distributed to retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank are primal parts of beef carcasses. Veal, mutton, and goat primal parts are the leg; flank, loin, rack, breast, and shoulder. The ham, belly, loin, shoulder, and jowl are pork primal parts. Equine primal parts are the round, flank, loin, rib, plate, brisket, chuck, and shank.
(d) Beef livers shall be marked with the official inspection legend containing the number of the official establishment, at which the cattle involved were slaughtered, on the convex surface of the thickest portion of the organ.
(e) Inspected and passed parts of carcasses which are not marked with the official inspection legend under this section shall not enter any official establishment or be sold, transported, or offered for sale or transportation, in commerce, except as provided in § 316.8.
(a) Inspected and passed sausages and other products in casings or in link form, of the ordinary “ring” variety or larger shall be marked with the official inspection legend and list of ingredients in accordance with part 317 of this subchapter. The official marks required by this section shall be branded near each end of the sausage or similar product prepared in casings when the product is of a size larger than that customarily sold at retail intact.
(b) Inspected and passed sausage and other products, in casings or in link form, of the smaller varieties, shall bear one or more official inspection legends and one or more lists of ingredients in accordance with part 317 of this subchapter on each kilogram (2.205 lbs.) of product, except where such products leave the official establishment completely enclosed in properly labeled immediate containers having a capacity of 5 kilograms (11.025 lbs.) or less and containing a single kind of product: Provided, That such products in properly labeled closed containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to another official establishment for further processing or to a governmental agency, need only have the official inspection legend and list of ingredients shown twice throughout the contents of the container. When such products are shipped to another official establishment for further processing, the inspector in charge at the point of origin shall identify the shipment to the inspector in charge at destination by means of Form MP 408-1.
(c) The list of ingredients may be applied by stamping, printing, using paper bands, tags, or tissue strips, or other means approved by the Administrator in specific cases.
(d) All cured products shall be marked with the list of ingredients in accordance with part 317 of this subchapter.
(a) Meat food products prepared in casing or link form (whether or not thereafter subdivided), other than sausage, which possess the characteristics of or resemble sausage, shall bear on each link or piece the word “imitation” prominently displayed: Provided, That the following need not be so marked if they bear on each link or piece the name of the product in accordance with § 317.2 of this subchapter: Such products as coppa, capocollo, lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts of meat which are prepared without added substance other than curing materials or condiments; meat rolls, bockwurst, and similar products which do not contain cereal or vegetables; headcheese, souse, sulze, scrapple, blood pudding, and liver pudding; and other products such as loaves, chili con carne, and meat and cheese products when prepared with sufficient cheese to give definite characteristics to the finished products: And provided further, That imitation sausage packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact, need not bear the word “imitation” on each link or piece if no other marking or labeling is applied directly to the product.
(b) When cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, or calcium reduced dried skim milk is added to sausage in casing or in link form within the limits prescribed in part 319 of this subchapter, the products shall be marked with the name of each added ingredient, as for example “cereal added,” “potato flour added,” “cereal and potato flour added,” “soy flour added,” “isolated soy protein added,” “nonfat dry milk added,” “calcium reduced dried skim milk added,” or “cereal and nonfat dry milk added,” as the case may be.
(c)(1) When product is placed in a casing to which artificial coloring is thereafter applied, as permitted in part 318 of this subchapter, the product shall be legibly and conspicuously marked by stamping or printing on the casing the words “artificially colored.”
(2) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, the product from which the casing has been removed shall be marked by stamping directly thereon the words “artificially colored.”
(3) The casing containing product need not be marked to show that it is colored if it is colored prior to its use as a covering for the product, and the coloring is of a kind and so applied as not to be transferable to the product and not to be misleading or deceptive in any respect.
(d) When an approved artificial smoke flavoring or an approved smoke flavoring is added to the formula of any meat food product as permitted in part 318 of this subchapter, the product shall be legibly and conspicuously marked with the words “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” whichever may be applicable.
(e) Subject to the provisions in paragraph (a) of this section, in the case of sausage of the smaller varieties, the markings prescribed in this section may be limited to links bearing the official inspection legend, and such markings shall not be required if the sausages are packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact. Further, all markings otherwise required by this section (except those required by paragraph (a) of this section) may be omitted from the casings of sausage and other meat food products when these products are to be processed in sealed metal containers properly labeled in accordance with the requirements in part 317 of this subchapter.
(f) When an approved antioxidant is added to any meat food product as permitted in parts 318 and 319 of this subchapter, the products shall be legibly and conspicuously marked in an approved manner identifying the specific antioxidant used by its common name or approved abbreviation and the purpose for which it is added, such as, “BHA, BHT, and Propylgallate added to help protect flavor.”
(g) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of this subchapter shall be marked as prescribed in § 317.8(b)(28) of this subchapter).
(a) All inspected and passed equine carcasses and parts thereof prepared at any establishment shall be conspicuously marked at the time of inspection with the official inspection legend as prescribed in § 312.3 of this subchapter and with other information prescribed for marking products in this part.
(b) All equine carcasses and meat and other parts thereof shall be marked to show the kinds of animals from which they were derived, before the products are sold, transported, offered for sale or transportation, or received for transportation in commerce.
(a) Except as otherwise provided in part 325 of this subchapter, when any inspected and passed product for domestic commerce is moved from an official establishment, the outside container shall bear an official inspection legend as prescribed in part 312 of this subchapter.
(b) When any product prepared in an official establishment for domestic commerce has been inspected and passed and is enclosed in a cloth or other wrapping, such wrapping shall bear the official inspection legend and official establishment number applied by the approved 2
(c) The outside containers of products for export shall be marked in compliance with part 322 of this subchapter as well as this part.
(d) Slack barrels used as outside containers of products shall have a cloth or paper top covering bearing the official inspection legend containing the official establishment number. At the time of removal of the covering, the official inspection legend shall be destroyed.
(e) The outside containers of any product which has been inspected and passed for cooking, pork which has been refrigerated as provided in § 318.10(c) of this subchapter, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in § 325.7(b) of this subchapter.
(f) The outside containers of glands and organs which are not used for human food purposes, such as those described in § 325.19 of this subchapter, shall be plainly marked with the phrase “For pharmaceutical purposes,” “For organotherapeutic purposes” or “For technical purposes,” as appropriate, with no reference to inspection, and need not bear other markings otherwise required under the regulations in this subchapter.
(g) Stencils, box dies, labels, and brands may be used on shipping containers of properly labeled products and on such immediate containers, of properly marked products, as tierces, barrels, drums, boxes, crates, and large-size fiber-board containers, without approval as provided for in § 317.3 of this subchapter: Provided, That the stencils, box dies, labels, and brands are not false or misleading and are approved by the inspector in charge. The official inspection legend for use with such markings shall be approved by the Administrator as provided for in part 317 of this subchapter.
(h) The outside containers of livers prepared as described in § 314.10(b), shall be marked as prescribed in § 314.10(c) of this subchapter.
(i) The outside containers of any equine product shall be marked to show the kinds of animals from which derived, when the products are sold, transported, offered for sale or transported, or received for transportation in commerce.
Each tank car and each tank truck carrying inspected and passed product from an official establishment shall bear a label containing the name of the product in accordance with § 317.2 of this subchapter, the official inspection legend containing the number of the official establishment and the words “date of loading,” followed by a suitable space in which the date the tank car or tank truck is loaded shall be inserted. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label.
(a) Outside containers of inedible grease, inedible tallow, or other inedible animal fat, or mixture of any such articles, resulting from operations at any official establishment shall be marked conspicuously with the word “inedible” prior to removal from the point of filling. Containers, such as tierces, barrels, and half barrels shall have both ends painted white with durable paint, if necessary, to provide a contrasting background, and the word “inedible” shall be marked thereon in letters not less than 2 inches high, while on tank cars and tank trucks the letters shall be not less than 4 inches high.
(b) Inspected rendered animal fat which is intended not to be used for human food may also be marked “inedible” if handled as provided in paragraph (a) of this section and part 314 of this subchapter.
Carcasses and parts therefrom that are prepared on a custom basis under § 303.1(a)(2) of this subchapter shall be marked at the time of preparation with the term “Not for Sale” in letters at least three-eighths inch in height, except that such products need not be so marked if in immediate containers properly labeled in accordance with the regulations in § 317.16 of this subchapter. Ink used for marking such products must comply with the requirements of § 316.5.
(a) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in § 317.2 except that the following do not have to bear such a label.
(1) Wrappings of dressed carcasses and primal parts in an unprocessed state, bearing the official inspection legend, if such wrappings are intended solely to protect the product against soiling or excessive drying during transportation or storage, and the wrappings bear no information except company brand names, trade marks, or code numbers which do not include any information required by § 317.2;
(2) Uncolored transparent coverings, such as cellophane, which bear no written, printed, or graphic matter and which enclose any unpackaged or packaged product bearing all markings required by part 316 of this subchapter which are clearly legible through such coverings;
(3) Animal and transparent artificial casings bearing only the markings required by part 316 of this subchapter;
(4) Stockinettes used as “operative devices”, such as those applied to cured meats in preparation for smoking, whether or not such stockinettes are removed following completion of the operations for which they were applied;
(5) Containers such as boil-in bags, trays of frozen dinners, and pie pans which bear no information except company brand names, trademarks, code numbers, directions for preparation and serving suggestions, and which are enclosed in a consumer size container that bears a label as described in § 317.2;
(6) Containers of products passed for cooking or refrigeration and moved from an official establishment under § 311.1 of this subchapter.
(b) Folders and similar coverings made of paper or similar materials, whether or not they completely enclose the product and which bear any written, printed, or graphic matter, shall bear all features required on a label for an immediate container.
(c) No covering or other container which bears or is to bear a label shall be filled, in whole or in part, except with product which has been inspected and passed in compliance with the regulations in this subchapter, which is not adulterated and which is strictly in accordance with the statements on the label. No such container shall be filled, in whole or in part, and no label shall be affixed thereto, except under supervision of a Program employee.
(a) A label within the meaning of this part shall mean a display of any printing, lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the immediate container (not including package liners) of any product.
(b) Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this part. Except as provided in § 317.7, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend.
(c) Labels of all products shall show the following information on the principal display panel (except as otherwise permitted in this part), in accordance with the requirements of this part or, if applicable, part 319 of this subchapter:
(1) The name of the product, which in the case of a product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in part 319 of this subchapter, shall be the name of the food specified in the standard, and in the case of any other product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation, as prescribed in paragraph (e) of this section;
(2) If the product is fabricated from two or more ingredients, the word “ingredients” followed by a list of the ingredients as prescribed in paragraph (f) of this section;
(3) The name and place of business of the manufacturer, packer, or distributor for whom the product is prepared, as prescribed in paragraph (g) of this section;
(4) An accurate statement of the net quantity of contents, as prescribed in paragraph (h) of this section;
(5) An official inspection legend and, except as otherwise provided in paragraph (i) of this section, the number of the official establishment, in the form required by part 312 of this subchapter;
(6) Any other information required by the regulations in this part or part 319 of this subchapter.
(d) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part and part 319 of this subchapter with clarity and conspicuousness and without obscuring of such information by designs or vignettes or crowding. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. The principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area of which is at least the product of the height times the width of that side.
(2) In the case of a cylindrical or nearly cylindrical container:
(i) An area that is 40 percent of the product of the height of the container times the circumference of the container, or
(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, That if there is immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in paragraphs (c) (2), (3), and (5), such panel shall be known as the “20 percent panel” and such information may be shown on that panel in lieu of showing it on the principal display panel.
(3) In the case of a container of any other shape, 40 percent of the total surface of the container.
(e)(1) Any descriptive designation used as a product name for a product which has no common or usual name shall clearly and completely identify the product. Product which has been prepared by salting, smoking, drying, cooking, chopping, or otherwise shall be so described on the label unless the name of the product implies, or the manner of packaging shows that the product was subjected to such preparation. The unqualified terms “meat,” “meat byproduct,” “meat food product,” and terms common to the meat industry but not common to consumers such as “picnic,” “butt,” “cala,” “square,” “loaf,” “spread,” “delight,” “roll,” “plate,” “luncheon,” and “daisy” shall not be used as names of a product unless accompanied with terms descriptive of the product or with a list of ingredients, as deemed necessary in any specific case by the Administrator in order to assure that the label will not be false or misleading.
(2) The product name for a raw meat product that contains added solution and does not meet a standard of identity in 9 CFR part 319 must contain a descriptive designation that includes:
(i) The percentage of added solution (total weight of the solution ingredients divided by the weight of the raw meat without solution or any other added ingredients multiplied by 100). The percentage of added solution must appear as a number (such as, 15, 20, 30) and the percent symbol (%). The percentage of added solution may be declared by the words “containing” or “contains” (such as, “contains 15% added solution of water and salt,” or “containing 15% added solution of water and teriyaki sauce”).
(ii) The common or usual name of all individual ingredients or multi-ingredient components in the solution listed in descending order of predominance by weight.
(iii) When the descriptive designation includes all ingredients in the solution, a separate ingredients statement is not required on the label. When the descriptive designation includes multi-ingredient components and the ingredients of the component are not declared in the descriptive designation, all ingredients in the product must be declared in a separate ingredients statement on the label as required in § 317.2(c)(2) and (f).
(iv) The product name and the descriptive designation must be printed in a single easy-to-read type style and color and must appear on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third (
(v) The word “enhanced” cannot be used in the product name.
(3) Product name and required validated cooking instructions for needle- or blade-tenderized beef products.
(i) Unless the product is destined to be fully cooked or to receive another full lethality treatment at an official establishment, the product name for a raw or partially cooked beef product that has been mechanically tenderized, whether by needle or by blade, must contain the term “mechanically tenderized,” “needle tenderized,” or “blade tenderized,” as a descriptive designation and an accurate description of the beef component.
(ii) The product name must appear in a single easy-to-read type style and color and on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than
(iii) The labels on raw or partially cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions must contain validated cooking instructions, including the cooking method, that inform consumers that these products need to be cooked to a specified minimum internal temperature, whether the product needs to be held for a specified time at that temperature or higher before consumption to ensure that potential pathogens are destroyed throughout the product, and a statement that the internal temperature should be measured by a thermometer. These validated cooking instructions may appear anywhere on the label.
(f)(1) The list of ingredients shall show the common or usual names of the ingredients arranged in the descending order of predominance, except as otherwise provided in this paragraph.
(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner:
(A) The term “spice” means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10, and 184.
(B) The term “natural flavor,” “natural flavoring,” “flavor” or “flavoring” means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product or roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portion of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 172.510. The term natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powered onion, powdered garlic, and powdered celery.
(ii) The term “corn syrup” may be used to designate either corn syrup or corn syrup solids.
(iii) The term “animal and vegetable fats” or “vegetable and animal fats” may be used to designate the ingredients of mixtures of such edible fats in product designated “compound” or “shortening.” “Animal fats” as used herein means fat derived from inspected and passed cattle, sheep, swine, or goats.
(iv) When a product is coated with pork fat, gelatin, or other approved substance and a specific declaration of such coating appears contiguous to the name of the product, the ingredient statement need not make reference to the ingredients of such coating.
(v) When two meat ingredients comprise at least 70 percent of the meat and meat byproduct ingredients of a formula and when neither of the two meat ingredients is less than 30 percent by weight of the total meat and meat byproducts used, such meat ingredients may be interchanged in the formula without a change being made in the ingredients statement on labeling materials: Provided, That the word “and” in lieu of a comma shall be shown between the declaration of such meat ingredients in the statement of ingredients.
(vi)(A) Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as “Contains __________ percent of __________ ,” “Less than __________percent of __________ .” The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may also be utilized when an ingredients statement contains a listing of ingredients by individual components. Each component listing may utilize the required quantifying statement at the end of each component ingredients listing.
(B) Such ingredients may be adjusted in the product formulation without a change being made in the ingredients statement on the labeling, provided that the adjusted amount complies with part 319 of this subchapter and with § 424.21 of subchapter E, and does not exceed the amount shown in the quantifying statement. Any such adjustments to the formulation shall be provided to the inspector-in-charge.
(2) On containers of frozen dinners, entrees, pizzas, and similar consumer packaged products in cartons the ingredient statement may be placed on the front riser panel: Provided, That the words “see ingredients” followed immediately by an arrow is placed on the principal display panel immediately above the location of such statement without intervening print or designs.
(3) The ingredient statement may be placed on the 20 percent panel adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container.
(4) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter.
(g)(1) The name or trade name of the person that prepared the product may appear as the name of the manufacturer or packer without qualification on the label. Otherwise the name of the distributor of the product shall be shown with a phrase such as “Prepared for * * *”. The place of business of the manufacturer, packer, or distributor shall be shown on the label by city, State, and postal ZIP code when such business is listed in a telephone or city directory, and if not listed in such directory, then the place of business shall be shown by street address, city, State, and postal ZIP code.
(2) The name and place of business of the manufacturer, packer, or distributor may be shown:
(i) On the principal display panel, or
(ii) On the 20 percent panel adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container, or
(iii) On the front riser panel of frozen food cartons, or
(iv) On the information panel.
(h)(1) The statement of net quantity of contents shall appear on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph.
(2) The statement as it is shown on a label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall be as provided in § 317.19. The statement shall not include any term qualifying a unit of weight, measure, or count such as “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “minimum,” or words of similar importance.
(3) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel in lines generally parallel to the base: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph (h). In any case, the statement may appear in more than one line. The terms “net weight” or “net wt.” shall be used when stating the net quantity of contents in terms of weight, and the term “net contents” or “content” when stating the net quantity of contents in terms of fluid measure.
(4) Except as provided in § 317.7, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semisolid viscous or a mixture of solid and liquid. For example, a declaration of
(5) On packages containing 1 pound or 1 pint and less than 4 pounds or 1 gallon, the statement shall be expressed in ounces or in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart, except that on random weight packages the statement shall be expressed in terms of pounds and decimal fractions of the pound, for packages over 1 pound, and for packages which do not exceed 1 pound the statement may be in decimal fractions of the pound in lieu of ounces. Paragraph (h)(9) of this section permits certain exceptions from the provisions of this paragraph for margarine packages, random weight consumer size packages, and packages of less than
(6) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform of all packages of substantially the same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on packages, the principal display panel of which has an area of 5 square inches or less;
(ii) Not less than one-eighth inch in height on packages, the principal display panel of which has an area of more than 5 but not more than 25 square inches;
(iii) Not less than three-sixteenths inch in height on packages, the principal display panel of which has an area of more than 25 but not more than 100 square inches;
(iv) Not less than one-quarter inch in height on packages, the principal display panel of which has an area of more than 100 but not more than 400 square inches.
(v) Not less than one-half inch in height on packages, the principal display panel of which has an area of more than 400 square inches.
(7) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). Heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards.
(8) The statement shall appear as a distinct item on the principal display panel and shall be separated by a space at least equal to the height of the lettering used in the statement from other printed label information appearing above or below the statement and by a space at least equal to twice the width of the letter “N” of the style of type used in the quantity of contents statement from other printed label information appearing to the left or right of the statement. It shall not include any term qualifying a unit of weight, measure, or count such as, “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “Minimum” or words of similar import.
(9) The following exemptions from the requirements contained in this paragraph (h) are hereby established:
(i) Individually wrapped, random weight consumer size packages shipped in bulk containers (as specified in paragraph (h)(11) of this section) and meat products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined under § 317.19 need not bear a net weight statement when shipped from an official establishment, provided that a net weight shipping statement which meets the requirements of paragraph (h)(2) of this section is applied to their shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement on random weight consumer size packages for retail sale shall be exempt from the type size and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.
(ii) Individually wrapped and labeled packages of less than
(iii) Individually wrapped and labeled packages of less than
(iv) Margarine in 1 pound rectangular packages (except packages containing whipped or soft margarine or packages that contain more than four sticks) is exempt from the requirements of paragraph (h)(3) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds, if the statement appears as “1 pound” or “one pound” in a conspicuous manner on the principal display panel.
(v) Sliced shingle packed bacon in rectangular packages is exempt from the requirements of paragraph (h)(3) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel if the statement appears in a conspicuous manner on the principal display panel.
(10) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of the net quantity of each such serving.
(11) As used in this section, a “random weight consumer size package” is one which is one of a lot, shipment or delivery of packages of the same product with varying weights and with no fixed weight pattern.
(12) On a multiunit retail package, a statement of the net quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and in parentheses, the total net quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces. For the purposes of this section, “multiunit retail package” means a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multiunit retail package but capable of being individually sold in full compliance with all requirements of the regulations in this part. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph if the labeling of each individual unit complies with the requirements of paragraphs (h) (2), (3), (6), and (8) of this section.
(i) The official establishment number of the official establishment in which the product was processed under inspection shall be placed as follows:
(1) Within the official inspection legend in the form required by part 312 of this subchapter; or
(2) Outside the official inspection legend elsewhere on the exterior of the container or its labeling, e.g., the lid of a can, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition and accompanied by the prefix “EST”; or
(3) Off the exterior of the container, e.g., on a metal clip used to close casings or bags, or on the back of a paper label of a canned product, or on other packaging or labeling material in the container, e.g., on aluminum pans and trays placed within containers, when a statement of its location is printed contiguous to the official inspection legend, such as “EST. No. on Metal Clip” or “Est. No. on Pan”, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition; or
(4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix “EST”.
(j) Labels of any product within any of the following paragraphs shall show the information required by such paragraph for such product:
(1) A label for product which is an imitation of another food shall bear the word “imitation” immediately preceding the name of the food imitated and in the same size and style of lettering as in that name and immediately thereafter the word “ingredients:” and the names of the ingredients arranged in the order of their predominance.
(2) If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations (21 CFR part 125) established pursuant to sections 403, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
(3) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of a meat food product, as permitted in part 318 of this subchapter, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as may be applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring so added as an ingredient in the formula of the meat food product.
(4) When any other artificial flavoring is permitted under part 318 of this subchapter to be added to a product, the ingredient statement shall identify it as “Artificial Flavoring.”
(5) When artificial coloring is added to edible fats as permitted under part 318 of this subchapter such substance shall be declared on the label in a prominent manner and contiguous to the name of the product by the words “Artificially colored” or “Artificial coloring added” or “With added artificial coloring.” When natural coloring such as annatto is added to edible fats as permitted under part 318 of this subchapter, such substance shall be declared on the label in the same manner by a phrase such as “Colored with annatto.”
(6) When product is placed in a casing to which artificial coloring is applied as permitted under part 318 of this subchapter, there shall appear on the label, in a prominent manner and contiguous to the name of the product, the words, “Artificially colored.”
(7) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, there shall appear on the label, in a prominent manner and contiguous to the name of product, the words “Artificially colored.”
(8) When a casing is colored prior to its use as a covering for product and the color is not transferred to the product enclosed in the casing, no reference to color need appear on the label but no such casing may be used if it is misleading or deceptive with respect to color, quality, or kind of product, or otherwise.
(9) Product which bears or contains any other artificial coloring, as permitted under part 318 of this subchapter, shall bear a label stating that fact on the immediate container or if there is none, on the product.
(10) When an antioxidant is added to product as permitted under part 318 of this subchapter, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement identifying the officially approved specific antioxidant by its common name or abbreviation thereof and the purpose for which it is added, such as, “BHA, BHT, and Propylgallate added to help protect flavor.”
(11) Containers of meat packed in borax or other preservative for export to a foreign country which permits the use of such preservative shall, at the time of packing, be marked “for export,” followed on the next line by the words “packed in preservative,” or such equivalent statement as may be approved for this purpose by the Administrator and directly beneath this there shall appear the word “establishment” or abbreviation thereof, followed by the number of the establishment at which the product is packed. The complete statement shall be applied in a conspicuous location and in letters not less than 1 inch in height.
(12) Containers of other product packed in, bearing, or containing any chemical preservative shall bear a label stating that fact.
(13)(i) On the label of any “Mechanically Separated (Species)” described in § 319.5(a) of this subchapter, the name of such product shall be followed immediately by the phrase “for processing” unless such product has a protein content of not less than 14 percent and a fat content of not more than 30 percent.
(ii) When any “Mechanically Separated (Species)” described in § 319.5 of this subchapter is used as an ingredient in the preparation of a meat food product and such “Mechanically Separated (Species)” contributes 20 mg or more of calcium to a serving of such meat food product, the label of such meat food product shall state the calcium content of such meat food product, determined and expressed as the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and (e), as part of any nutrition information included on such label, or if such meat food product does not bear nutrition labeling information, as part of a prominent statement in immediate conjunction with the list of ingredients, as follows: “A ______ serving contains ____% of the U.S. RDA of calcium”, with the blanks to be filled in, respectively, with the quantity of such product that constitutes a serving and the amount of calcium provided by such serving: Provided, That, calcium content need not be stated where (a) the percent of the U.S. RDA of calcium to be declared would not differ from the percent of the U.S. RDA that would be declared if the meat food product contained only hand deboned ingredients or (b) the calcium content of a serving of the meat food product would be 20 percent of the U.S. RDA or more if the meat food product contained only hand deboned ingredients.
(k) Packaged products which require special handling to maintain their wholesome condition shall have prominently displayed on the principal display panel of the label the statement: “Keep Refrigerated,” “Keep Frozen,” “Perishable Keep Under Refrigeration,” or such similar statement as the Administrator may approve in specific cases. Products that are distributed frozen during distribution and thawed prior to or during display for sale at retail shall bear the statement on the shipping container: “Keep Frozen.” The consumer-size containers for such products shall bear the statement “Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated.” For all perishable canned products the statement shall be shown in upper case letters one-fourth inch in height for containers having a net weight of 3 pounds or less, and for containers having a net weight over 3 pounds, the statement shall be in upper case letters at least one-half inch in height.
(l) Safe handling instructions shall be provided for: All meat and meat products of cattle, swine, sheep, goat, horse, other equine that do not meet the requirements contained in § 318.17, or that have not undergone other processing that would render them ready-to-eat; and all comminuted meat patties not heat processed in a manner that conforms to the time and temperature combinations in the Table for Permitted Heat-Processing Temperature/Time Combinations For Fully-Cooked Patties in § 318.23, except as exempted under paragraph (l)(4) of this section.
(1)(i) Safe handling instructions shall accompany every meat or meat product, specified in this paragraph (l) destined for household consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall be in lettering no smaller than one-sixteenth of an inch in size and shall be prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(ii) The safe handling information shall be presented on the label under the heading “Safe Handling Instructions” which shall be set in type size larger than the print size of the rationale statement and handling statements as discussed in paragraphs (l)(2) and (l)(3) of this section. The safe handling information shall be set off by a border and shall be one color type printed on a single color contrasting background whenever practical.
(2) The labels of the meat and meat products specified in this paragraph (l) shall include the following rationale statement as part of the safe handling instructions, “This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements.
(3) Meat and meat products, specified in this paragraph (l), shall bear the labeling statements:
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. (Any portion of this statement that is in conflict with the product's specific handling instructions, may be omitted, e.g., instructions to cook without thawing.) (A graphic illustration of a refrigerator shall be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry. (A graphic illustration of soapy hands under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall be displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or discard. (A graphic illustration of a thermometer shall be displayed next to the statement.)
(4) Meat or meat products intended for further processing at another official establishment are exempt from the requirements prescribed in paragraphs (l)(1) through (l)(3) of this section.
(m)(1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions:
(i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used.
(ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel.
(iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.
(2) (i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel.
(ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes.
(a) The Administrator may approve and authorize the use of abbreviations of marks of inspection under the regulations in this subchapter. Such abbreviations shall have the same force and effect as the respective marks for which they are authorized abbreviations.
(b) Except for the purposes of preparing and submitting a sample or samples of the same to the Administrator for approval, no brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any marking device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, without the written authority therefor of the Administrator. However, when any such sample label, or other marking device, is approved by the Administrator, additional supplies of the approved label, or marking device, may be made for use in accordance with the regulations in this subchapter, without further approval by the Administrator. The provisions of this paragraph apply only to labels, or other marking devices, bearing or containing an official inspection legend shown in § 312.2(b), § 312.3(a) (only the legend appropriate for horse meat food products) or § 312.3(b) (only the legend appropriate for other (nonhorse) equine meat food products), or any abbreviations, copy or representation thereof.
(c) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a brand or other marking device containing an official inspection legend, or simulation thereof, shown in § 312.2(a), § 312.3(a) (only the legend appropriate for horse carcasses and parts of horse carcasses), § 312.3(b) (only the legend appropriate for other equine (nonhorse) carcasses and parts of other (nonhorse) equine carcasses) or § 312.7(a).
(1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the brand or other marking device, bearing a certificate serial number and a letterhead and the seal of the United States Department of Agriculture. The certificate authorizes the making of only the brands or other marking devices of the type and quantity listed on the certificate.
(2) After signing the certificate, the Program employee and the establishment shall each keep a copy, and the remaining two copies shall be given to the brand or other marking device manufacturer.
(3) The manufacturer of the brands or other marking devices shall engrave or otherwise mark each brand or other marking device with a permanent identifying serial number unique to it. The manufacturer shall list on each of the two copies of the certificate given to the manufacturer the number of each brand or other marking device authorized by the certificate. The manufacturer shall retain one copy of the certificate for the manufacturer's records and return the remaining copy with the brands or other marking devices to the Program employee whose name and address are given on the certificate as the recipient.
(4) In order that all such brands or other marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such brand or other marking device which does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such brand or other marking device with a permanent identifying number.
Labels shall be used only on products for which they are approved, and only if they have been approved for such products in accordance with § 317.3: Provided, That existing stocks of labels approved prior to the effective date of this section and the quantity of which has been identified to the circuit supervisor as being in storage on said date at the official establishment or other identified warehouse for the account of the operator of the official establishment may be used until such stocks are exhausted, but not later than 1 year after the effective date of this section unless such labels conform to all the requirements of this part and part 319 of this subchapter. The Administrator may upon the show of good cause grant individual extension of time as he deems necessary.
Labels to be affixed to packages of products for foreign commerce may be printed in a foreign language and may show the statement of the quantity of contents in accordance with the usage of the country to which exported and other deviations from the form of labeling required under this part may be approved for such product by the Administrator in specific cases: Provided,
(a) That the proposed labeling accords to the specifications of the foreign purchaser,
(b) That it is not in conflict with the laws of the country to which the product is intended for export, and
(c) That the outside container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of this subchapter apply. The inspection legend and the establishment number shall in all cases appear in English but in addition, may appear literally translated in a foreign language.
(a) No product or any of its wrappers, packaging, or other containers shall bear any false or misleading marking, label, or other labeling and no statement, word, picture, design, or device which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling. No product shall be wholly or partly enclosed in any wrapper, packaging, or other container that is so made, formed, or filled as to be misleading.
(b) The labels and containers of product shall comply with the following provisions, as applicable:
(1) Establishments may only use statements, words, pictures, designs, or devices on the label having geographical significance with reference to a locality other than where the animal from which the product was derived was born, raised, slaughtered, and processed if the statements, words, pictures, designs, or devices are qualified by the word “style,” “type,” or “brand,” as the case may be, in the same size and style of lettering as in the geographical statement, word, picture, design, or device, and accompanied with a prominent qualifying statement identifying the country, State, Territory, or locality, using terms appropriate to effect the qualification. When the word “style” or “type” is used, there must be a recognized style or type of product identified with and peculiar to the area represented by the geographical statement, word, picture, design, or device and the product must possess the characteristics of such style or type, and the word “brand” shall not be used in such a way as to be false or misleading: Provided, That a geographical statement, word, picture, design, or device which has come into general usage as a trade name and which has been approved by the Administrator as being a generic statement, word, picture, design, or device may be used without the qualifications provided for in this paragraph. The terms “frankfurter,” “vienna,” “bologna,” “lebanon bologna,” “braunschweiger,” “thuringer,” “genoa,” “leona,” “berliner,” “holstein,” “goteborg,” “milan,” “polish,” “italian,” and their modifications, as applied to sausages, the terms “brunswick” and “irish” as applied to stews and the term “boston” as applied to pork shoulder butts need not be accompanied with the word “style,” “type,” or “brand,” or a statement identifying the locality in which the product is prepared.
(2) Such terms as “farm” or “country” shall not be used on labels in connection with products unless such products are actually prepared on the farm or in the country: Provided, That if the product is prepared in the same way as on the farm or in the country these terms, if qualified by the word “style” in the same size and style of lettering, may be used: Provided further, That the term “farm” may be used as part of a brand designation when qualified by the word “brand” in the same size and style of lettering, and followed with a statement identifying the locality in which the product is prepared: And Provided further, That the provisions of this paragraph shall not apply to products prepared in accordance with § 319.106 of this subchapter. Sausage containing cereal shall not be labeled “farm style” or “country style,” and lard not rendered in an open kettle shall not be designated as “farm style” or “country style.”
(3) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not relieve any establishment from the requirement that its label shall not be misleading in any particular.
(4) The term “spring lamb” or “genuine spring lamb” is applicable only to carcasses of new-crop lambs slaughtered during the period beginning in March and terminating not beyond the close of the week containing the first Monday in October.
(5)(i) Coverings shall not be of such color, design, or kind as to be misleading with respect to color, quality, or kind of product to which they are applied. For example, transparent or semitransparent coverings for such articles as sliced bacon or fresh (uncooked) meat and meat food products shall not bear lines or other designs of red or other color which give a false impression of leanness of the product. Transparent or semitransparent wrappers, casings, or coverings for use in packaging cured, cured and smoked, or cured and cooked sausage products, and sliced ready-to-eat meat food products may be color tinted or bear red designs on 50 percent of such wrapper or covering: Provided, That the transparent or semitransparent portion of the principal display panel is free of color tinting and red designs: And provided further, That the principal display panel provides at least 20 percent unobstructed clear space, consolidated in one area so that the true nature and color of the product is visible to the consumer.
(ii) Packages for sliced bacon that have a transparent opening shall be designed to expose, for viewing, the cut surface of a representative slice. Packages for sliced bacon which meet the following specifications will be accepted as meeting the requirements of this subparagraph provided the enclosed bacon is positioned so that the cut surface of the representative slice can be visually examined:
(a) For shingle-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice, and this window shall be at least 1
(b) For stack-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice and be at least 1
(6) The word “fresh” shall not be used on labels to designate product which contains any sodium nitrate, sodium nitrite, potassium nitrate, or potassium nitrite, or which has been salted for preservation.
(7)(i) No ingredient shall be designated on the label as a spice, flavoring, or coloring unless it is a spice, flavoring, or coloring, as the case may be. An ingredient that is both a spice and a coloring, or both a flavoring and a coloring, shall be designated as “spice and coloring”, or “flavoring and coloring”, as the case may be, unless such ingredient is designated by its common or usual name.
(ii) Any ingredient not designated in § 317.2(f)(1)(i) of this part whose function is flavoring, either in whole or in part, must be designated by its common or usual name. Those ingredients which are of livestock and poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived.
(8) As used on labels of product, the term “gelatin” shall mean (i) the jelly prepared in official establishments by cooking pork skins, tendons, or connective tissue from inspected and passed product, and (ii) dry commercial gelatin or the jelly resulting from its use.
(9) Product (other than canned product) labeled with the term “loaf” as part of its name:
(i) If distributed from the official establishment in consumer size containers may be in any shape;
(ii) If distributed in a container of a size larger than that sold intact at retail the product shall be prepared in rectangular form, or as in paragraph (b)(9)(iii) of this section;
(iii) If labeled as an “Old Fashioned Loaf” shall be prepared in a traditional form, such as rectangular with rounded top or circular with flat bottom and rounded top.
(10) The term “baked” shall apply only to product which has been cooked by the direct action of dry heat and for a sufficient time to permit the product to assume the characteristics of a baked article, such as the formation of a brown crust on the surface, rendering out of surface fat, and the caramelization of the sugar if applied. Baked loaves shall be heated to a temperature of at least 160 °F. and baked pork cuts shall be heated to an internal temperature of at least 170 °F.
(11) When products such as loaves are browned by dipping in hot edible oil or by a flame, the label shall state such fact, e.g., by the words “Browned in Hot Cottonseed Oil” or “Browned by a Flame,” as the case may be, appearing as part of the product name.
(12) The term “meat” and the names of particular kinds of meat, such as beef, veal, mutton, lamb, and pork, shall not be used in such manner as to be false or misleading.
(13) The word “ham,” without any prefix indicating the species of animal from which derived, shall be used in labeling only in connection with the hind legs of swine. Ham shanks as such or ham shank meat as such or the trimmings accruing in the trimming and shaping of hams shall not be labeled “ham” or “ham meat” without qualification. When used in connection with a chopped product the term “ham” or “ham meat” shall not include the skin.
(14) The terms “shankless” and “hockless” shall apply only to hams and pork shoulders from which the shank or hock has been completely removed, thus eliminating the entire tibia and fibula, or radius and ulna, respectively, together with the overlying muscle, skin, and other tissue.
(15) Such terms as “meat extract” or “extract of beef” without qualification shall not be used on labels in connection with products prepared from organs or other parts of the carcass, other than fresh meat. Extracts prepared from any parts of the carcass other than fresh meat may be properly labeled as extracts with the true name of the parts from which prepared. In the case of extract in fluid form, the word “fluid” shall also appear on the label, as, for example, “fluid extract of beef.”
(16) [Reserved]
(17) When any product is enclosed in a container along with a packing substance such as brine, vinegar, or agar jelly, a declaration of the packing substance shall be printed prominently on the label as part of the name of the product, as for example, “frankfurts packed in brine,” “lamb tongue packed in vinegar,” or “beef tongue packed in agar jelly,” as the case may be. The packing substance shall not be used in such a manner as will result in the container being so filled as to be misleading.
(18) “Leaf lard” is lard prepared from fresh leaf fat.
(19) When lard or hardened lard is mixed with rendered pork fat or hardened rendered pork fat, the mixture shall be designated as “rendered pork fat” or “hardened rendered pork fat,” as the case may be.
(20) Oil, stearin, or stock obtained from beef or mutton fats rendered at a temperature above 170 °F. shall not be designated as “oleo oil,” “oleo stearin,” or “oleo stock,” respectively.
(21) When not more than 20 percent of beef fat, mutton fat, oleo stearin, vegetable stearin, or hardened vegetable fat is mixed with lard or with rendered pork fat, there shall appear on the label, contiguous to and in the same size and style of lettering as the name of the product, the words “beef fat added,” “mutton fat added,” “oleo stearin added,” “vegetable stearin added,” or “hardened vegetable fat added,” as the case may be. If more than 20 percent is added, the product name shall refer to the particular animal fat or fats used, such as, “Lard and Beef Fat.” The designation “vegetable fat” is applicable to vegetable oil, vegetable stearin, or a combination of such oil and stearin, whereas the designations “vegetable oil” and “vegetable stearin” shall be applicable only to the oil and the stearin respectively, when used in meat food products.
(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar products, shall be labeled to show that the bones remain in the product, if such is the case. The designation “semi-boneless” shall not be used if less than 50 percent of the total weight of bones has been removed.
(23) When monoglycerides, diglycerides, and/or polyglycerol esters of fatty acids are added to rendered animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and contiguous to the name of the product a statement such as “With Monoglycerides and Diglycerides Added,” or “With Diglycerides and Monoglycerides,” or “With Polyglycerol Esters of Fatty Acids” as the case may be.
(24) Section 407 of the Federal Food, Drug, and Cosmetic Act contains provisions with respect to colored margarine or colored oleomargarine (21 U.S.C. 347) which are set forth herein as footnote.
(b) No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—
(1) Such oleomargarine or margarine is packaged,
(2) The net weight of the contents of any package sold in a retail establishment is one pound or less,
(3) There appears on the label of the package (A) The word ‘oleomargarine’ or ‘margarine’ in type or lettering at least as large as any other type or lettering on such label, and (B) A full and accurate statement of all the ingredients contained in such oleomargarine, or margarine, and
(4) Each part of the contents of the package is contained in a wrapper which bears the word ‘oleomargarine’ or ‘margarine’ in type or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this Act.
(c) No person shall possess in a form ready for serving colored oleomargarine or colored margarine at a public eating place unless a notice that oleomargarine or margarine is served is displayed prominently and conspicuously in such place and in such manner as to render it likely to be read and understood by the ordinary individual being served in such eating place or is printed or is otherwise set forth on the menu in type or lettering not smaller than that normally used to designate the serving of other food items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made therefor, unless (1) each separate serving bears or is accompanied by labeling identifying it as oleomargarine or margarine, or (2) each separate serving thereof is triangular in shape.
(d) Colored oleomargarine or colored margarine when served with meals at a public eating place shall at the time of such service be exempt from the labeling requirements of section 343 of this Act (except subsection (a) and (f) of section 343 of this title) if it complies with the requirements of subsection (b) of this section.
(e) For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade containing more than one and six tenths degrees of yellow or of yellow and red collectively, but with an excess of yellow over red, measured in terms of Lovibond tintometer scale or its equivalent” (21 U.S.C. 347).
(25) When approved proteolytic enzymes as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with [approved enzyme],” to indicate the use of such enzymes. Any other approved substance which may be used in the solution shall also be included in the statement.
When approved inorganic chlorides as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts there shall appear on the label in a prominent manner, contiguous to the product name, the statement, “Tenderized with (names of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be in the solution shall also be included in the statement.
(26) When dimethylpolysiloxan is added as an antifoaming agent to rendered fats, its presence shall be declared on the label contiguous to the name of the product. Such declaration shall read “Dimethylpolysiloxan Added.”
(27) When pizzas are formulated with crust containing calcium propionate or sodium propionate, there shall appear on the label contiguous to the name of the product the statement “________ added to retard spoilage of crust” preceded by the name of the preservative.
(28) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of this subchapter, shall be marked or labeled with a statement disclosing such treatment and the purpose thereof, such as “dipped in a potassium sorbate solution to retard mold growth.”
(29) Meat of goats shall be identified as goat meat or chevon.
(30) The term “Chitterlings” shall apply to the large intestines of swine, or young bovine animals when preceded with the word “Calf” or “Veal.” Meat food products that contain chitterlings or calf or veal chitterlings, in accordance with § 318.6(b)(8) of this subchapter shall be identified with product names that refer to such ingredients, as for instance, “Chitterling Loaf,” “Chitterling Pie,” or “Calf Chitterlings and Gravy,” and shall be packed in containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact and bearing such other information as is required by this part.
(31) Products that contain blood from livestock as permitted by part 318 of this subchapter shall be labeled with a name that includes the term “blood,” and the specific kind of blood shall be declared in the ingredient statement, e.g., “Swine blood,” in the manner required by this part.
(32) A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:
(i) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading.
(ii) Immediately adjacent to the calendar date there must be a phrase explaining the meaning of the date, in terms of “packing” date, “sell by” date, or “use before” date, with or without a further qualifying phrase, e.g., “For Maximum Freshness” or “For Best Quality.”
(33) [Reserved]
(34) The terms “All,” “Pure,” “100%,” and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient.
(35) When agar-agar is used in canned jellied meat food products, as permitted in part 318 of this subchapter, there shall appear on the label in a prominent manner, contiguous to the product name, a statement to indicate the use of agar-agar.
(36) When sodium alginate, calcium carbonate, and lactic acid and calcium carbonate (or glucono delta-lactone) are used together in a dry binding matrix in restructured, formed meat food products, as permitted in part 318 of this subchapter, there shall appear on the label contiguous to the product name, a statement to indicate the use of sodium alginate, calcium carbonate and lactic acid and calcium carbonate (or glucono delta-lactone).
(37) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with part 320 of this chapter.
(38) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement.
(39) When transglutaminase enzyme is used to bind pieces of meat to form a cut of meat, or to reform a piece of meat from a multiple cuts, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Beef Tenderloin” or “Reformed and Shaped Beef Tenderloin.”
(40) A country of origin statement on the label of any meat “covered commodity” as defined in 7 CFR Part 65, Subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400.
The immediate containers of any equine products shall be labeled to show the kinds of animals from which derived when the products are sold, transported, offered for sale or transportation or received for transportation in commerce.
(a) No official inspection legend or other official mark which has been previously used shall be used again for the identification of any product, except as provided for in paragraph (b) of this section.
(b) All stencils, marks, labels, or other labeling on previously used containers, whether relating to any product or otherwise, shall be removed or obliterated before such containers are used for any product, unless such labeling correctly indicates the product to be packed therein and such containers are refilled under the supervision of a Program employee.
(a) No person shall in any official establishment apply or affix, or cause to be applied or affixed, any label to any product prepared or received in such establishment, or to any container thereof, or fill any container at such an establishment, except in compliance with the regulations in this subchapter.
(b) No covering or other container shall be filled, in whole or in part, at any official establishment with any product unless it has been inspected and passed in compliance with the regulations in this subchapter, is not adulterated, and is strictly in accordance with the statements on the label, and such filling is done under the supervision of a Program employee.
(c) No person shall remove, or cause to be removed from an official establishment any product bearing a label unless such label is in compliance with the regulations in this subchapter, or any product not bearing a label required by such regulations.
When it is claimed by an official establishment that any of its products which bore labels bearing official marks has been transported to a location other than an official establishment, and it is desired to relabel the product because the labels have become mutilated or otherwise damaged, a request for relabeling the product shall be sent to the Administrator, accompanied with a statement of the reasons therefor. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with labels bearing any official marks shall be done under the supervision of a Program inspector. The official establishment shall reimburse the Program, in accordance with the regulations of the Department, for any cost involved in supervising the relabeling of such product.
Labels, wrappers, and containers bearing any official marks, with or without the establishment number, may be transported from one official establishment to any other official establishment provided such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subchapter.
Products that are custom prepared under § 303.1(a)(2) of this subchapter must be packaged immediately after preparation and must be labeled (in lieu of information otherwise required by this part 317) with the words “Not For Sale” in lettering not less than three-eighth inch in height. Such exempted custom prepared products or their containers may bear additional labeling provided such labeling is not false or misleading.
(a) With respect to sections 1(n) (7), (9), and (12) of the Act and § 317.2, any substance mixed with another substance to cure a product must be identified in the ingredients statement on the label of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any product, must be identified on the label of the product by listing each such ingredient in accordance with the provisions of § 317.2.
(b) Any product, such as bacon and pepperoni, which is required to be labeled by a common or usual name or descriptive name in accordance with § 317.2(c)(1) and to which nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and labeled with such common or usual name or descriptive name when immediately preceded with the term “Uncured” as part of the product name in the same size and style of lettering as the product name, provided that the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate or nitrite, or both.
(c)(1) Products described in paragraph (b) of this section or § 319.2 of this subchapter, which contain no nitrate or nitrite shall bear the statement “No Nitrate or Nitrite Added.” This statement shall be adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name.
(2) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall bear, adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name, the statement “Not Preserved—Keep Refrigerated Below 40 °F. At All Times” unless they have been thermally processed to F
(3) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall not be subject to the labeling requirements of paragraphs (b) and (c) of this section if they contain an amount of salt sufficient to achieve a brine concentration of 10 percent or more.
(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for their intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).
(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.
(c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.
(d) The Department will monitor the use of packaging material in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information tm designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective, and approval to continue using the specified packaging material in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health.
(f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health.
(a) Nutrition labeling must be provided for all meat and meat food products intended for human consumption and offered for sale, except single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and are not major cuts of single-ingredient, raw meat products identified in § 317.344, unless the product is exempted under § 317.400 . Nutrition labeling must be provided for the major cuts of single-ingredient, raw meat products identified in § 317.344, either in accordance with the provisions of § 317.309 for nutrition labels, or in accordance with the provisions of § 317.345 for point-of-purchase materials, except as exempted under § 317.400. For all other products for which nutrition labeling is required, including ground or chopped meat products described in § 317.301, nutrition labeling must be provided in accordance with the provisions of § 317.309, except as exempted under § 317.400.
(b) Nutrition labeling may be provided for single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and that are not major cuts of single-ingredient, raw meat products identified in § 317.344, either in accordance with the provisions of § 317.309 for nutrition labels, or in accordance with the provisions of § 317.345 for point-of-purchase materials.
(a) Nutrition labels must be provided for all ground or chopped products (livestock species) and hamburger with or without added seasonings (including, but not limited to, ground beef, ground beef patties, ground sirloin, ground pork, and ground lamb) that are intended for human consumption and offered for sale, in accordance with the provisions of § 317.309, except as exempted under § 317.400.
(b) [Reserved]
(a) Nutrition information on a label of a packaged meat or meat food product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section.
(b) Nutrition information for gift packs may be shown at a location other than on the product label, provided that the labels for these products bear no nutrition claim. In lieu of on the product label, nutrition information may be provided by alternate means such as product label inserts.
(c) Meat or meat food products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered.
The label of any package of a meat or meat food product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 317.2(h)(10).
(a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section.
(b)(1) The term “serving” or “serving size” means an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the product. When the product is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply” (Reference Amount(s)) that appear in § 317.312(b) using the procedures described in this paragraph (b). For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ______ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the Reference Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims.
(3) The declaration of nutrient and food component content shall be on the basis of the product “as packaged” for all products, except that single-ingredient, raw products that are not ground or chopped meat products described in § 317.301 may be declared on the basis of the product “as consumed”. For single-ingredient, raw products that are not ground or chopped meat products described in § 317.301, if data are based on the product ‘as consumed,’ the data must be presented in accordance with § 317.345(d). In addition to the required declaration on the basis of “as packaged” for products other than single-ingredient, raw products that are not ground or chopped meat products described in § 317.301, the declaration may also be made on the basis of “as consumed,” provided that preparation and cooking instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, and individually packaged products within a multi-serving package), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the serving size shall be the number of whole units that most closely approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent of the Reference Amount, the manufacturer may declare one unit or two units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or milliliter) or larger and are individual units within a multi-serving package, if a unit contains more than 150 percent but less than 200 percent of the Reference Amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product as determined in § 317.312(c).
(vii) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided for consumption (e.g., pizza), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g. pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption, the serving size shall be the fractional slice of the ready-to-eat product (e.g.,
(6) For nondiscrete bulk products (e.g., whole roast beef, marinated beef tenderloin, large can of chili), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., roast beef and gravy), the serving size shall be the amount in household measure that most closely approximates the Reference Amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product determined in § 317.312(c).
(7) For labeling purposes, the term “common household measure” or “common household unit” means cup, tablespoon, teaspoon, piece, slice, fraction (e.g.,
(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate. Cups shall be expressed in
(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece, slice, tray, jar, or fraction are not applicable, ounces may be used. Ounce measurements shall be expressed in 0.5-ounce increments most closely approximating the Reference Amount with rounding indicated by the use of the term “about” (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be used for single-serving containers and for individually packaged products within multi-serving containers (e.g., can, box, package, meal, or dinner). A description of the individual unit shall be used for other products in discrete units (e.g., chop, slice, link, or patty).
(v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., pizza kit), the fraction or portion of the package may be used.
(vi) For products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g., ham with a glaze packet), the nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in § 317.312(b) and the procedures described in this section, falls exactly half way between two serving sizes (e.g., 2.5 tbsp), manufacturers shall round the serving size up to the next incremental size.
(8) A product that is packaged and sold individually and that contains less than 200 percent of the applicable Reference Amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving, except for products that have Reference Amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the Reference Amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable Reference Amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.
(9) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(8) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to paragraph (b)(11) of this section. However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single-servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments.
(iii) In addition, serving size may be declared in ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity equivalent to the metric quantity should be expressed in 0.1-oz increments.
(iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term “about” (e.g., about 2 servings; about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size (e.g., pickled pigs feet), the manufacturer may state the typical number of servings per container (e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare “varied” for the number of servings per container provided the nutrition information is based on the Reference Amount expressed in ounces. The manufacturer may provide the typical number of servings in parenthesis following the “varied” statement (e.g., varied (approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package.
(v) For packages containing several individually packaged multi-serving units, the number of servings shall be determined by multiplying the number of individual multi-serving units in the total package by the number of servings in each individual unit. The declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, including those that have been previously frozen.
(11) The declaration of nutrient and food component content shall be on the basis of product as packaged or purchased with the exception of single-ingredient, raw products that are not ground or chopped meat products described in § 317.301 and products that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed. Declaration of the nutrient and food component content of products that are packed in liquid which is not customarily consumed shall be based on the drained solids.
(12) The serving size for meal-type products and main-dish products as defined in § 317.313(l) and § 317.313(m) in single-serving containers will be the entire edible content of the package. Serving size for meal-type products and main-dish products in multi-serve containers will be based on the reference amount applicable to the product in § 317.312(b) if the product is listed in § 317.312(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 317.312(b) will be based on the reference amount according to § 317.312(c), (d), and (e).
(13) Another column of figures may be used to declare the nutrient and food component information in the same format as required by § 317.309(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit.
(14) If a product consists of assortments of meat or meat food products (e.g., variety packs) in the same package, nutrient content shall be expressed on the entire package contents or on each individual product.
(15) If a product is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare the nutrient contents on the basis of the product as consumed for the product alone (e.g., a cream soup mix may be labeled with one set of Daily Values for the dry mix (per serving), and another set for the serving of the final soup when prepared (e.g., per serving of cream soup mix and 1 cup of vitamin D fortified whole milk)): Provided, That the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in labeling of a meat or meat food product shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraph (f) or (g) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraph (d) or (e) of this section.
(1) “Calories, total,” “Total calories,” or “Calories”: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parenthesis immediately following the statement of the caloric content.
(i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given in Table 13, page 25, “Energy Value of Foods—Basis and Derivation,” by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), which is incorporated by reference. Table 13 of the “Energy Value of Foods—Basis and Derivation,” Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of 21 CFR, or by other means, as appropriate.
(ii) “Calories from fat”: A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section per serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving and amounts less than 5 calories may be expressed as zero. This statement shall be declared as provided in paragraph (d)(5) of this section.
(iii) “Calories from saturated fat” or “Calories from saturated” (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section per serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories from fat as provided in paragraph (d)(5) of this section.
(2) “Fat, total” or “Total fat”: A statement of the number of grams of total fat per serving defined as total lipid fatty acids and expressed as triglycerides. Amounts shall be expressed to the nearest 0.5 (
(i) “Saturated fat” or “Saturated”: A statement of the number of grams of saturated fat per serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat per serving if no claims are made about fat or cholesterol content, and if “calories from saturated fat” is not declared. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(A) “Stearic Acid” (VOLUNTARY): A statement of the number of grams of stearic acid per serving may be declared voluntarily, except that when a claim is made about stearic acid, label declaration shall be required. Stearic acid content shall be indented under saturated fat and expressed to the nearest 0.5 (
(B) [Reserved]
(ii) “Polyunsaturated fat” or “Polyunsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat per serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(iii) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat per serving defined as cis-monounsaturated fatty acids may be declared voluntarily, except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(3) “Cholesterol”: A statement of the cholesterol content per serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams of cholesterol per serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. If the product contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as “less than 5 milligrams.”
(4) “Sodium”: A statement of the number of milligrams of sodium per serving expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.
(5) “Potassium” (VOLUNTARY): A statement of the number of milligrams of potassium per serving may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.
(6) “Carbohydrate, total” or “Total carbohydrate”: A statement of the number of grams of total carbohydrate per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, or, if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the product. This calculation method is described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 2 and 3, which is incorporated by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.)
(i) “Dietary fiber”: A statement of the number of grams of total dietary fiber per serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required, or, alternatively, the statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(A) “Soluble fiber” (VOLUNTARY): A statement of the number of grams of soluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(ii) “Sugars”: A statement of the number of grams of sugars per serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars per serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(iii) “Sugar alcohol” (VOLUNTARY): A statement of the number of grams of sugar alcohols per serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the product, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term “sugar alcohol,” the name of the specific sugar alcohol (e.g., “xylitol”) present in the product may be used in the nutrition label, provided that only one sugar alcohol is present in the product. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less then 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(iv) “Other carbohydrate” (VOLUNTARY): A statement of the number of grams of other carbohydrate per serving may be declared voluntarily. Other carbohydrate shall be defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(7) “Protein”: A statement of the number of grams of protein per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in products represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a product represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as percent of Daily Value. When the protein quality in a product as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a product represented or purported to be for infants, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by appropriate methods of analysis in accordance with § 317.309(h), except when the procedure for a specific food requires another factor.
(i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be for infants or children under 4 years of age. When such a declaration is provided, it shall be placed on the label adjacent to the statement of grams of protein and aligned under the column headed “Percent Daily Value,” and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the product is represented or purported to be for infants and the protein quality value is less than 40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for products represented or purported to be for adults and children 1 or more years of age is equal to the actual amount of protein (grams) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8 in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990, which is incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” as published by the Food and Agriculture Organization of the United Nations/World Health Organization, is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700. For products represented or purported to be for infants, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject product's protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d) through (g) of this section, products represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For products represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on products represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other products shall use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the RDI shall include vitamin A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and the vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and declared only in the ingredients statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Amounts of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).” Alternatively, if vitamin A, vitamin C, calcium, or iron is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a significant source of ______ (listing the vitamins or minerals omitted)” is placed at the bottom of the table of nutrient values.
(iv) The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:
(v) The following synonyms may be added in parenthesis immediately following the name of the nutrient or dietary component:
(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent of Daily Value of vitamin A in the product (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)”). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the following DRV's are established for the following food components based on the reference caloric intake of 2,000 calories:
| Food component | Unit of measurement | DRV |
|---|---|---|
| Fat | grams (g) | 65 |
| Saturated fatty acids | do | 20 |
| Cholesterol | milligrams (mg) | 300 |
| Total carbohydrate | grams (g) | 300 |
| Fiber | do | 25 |
| Sodium | milligrams (mg) | 2,400 |
| Potassium | do | 3,500 |
| Protein | grams (g) | 50 |
(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on products in the following format, except on products on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those products on which the simplified format is permitted to be used as provided for in paragraph (f) of this section, on products for infants and children less than 4 years of age as provided for in § 317.400(c), and on products in packages that have a total surface area available to bear labeling of 40 or less square inches as provided for in paragraph (g) of this section.
(i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of text) except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section, and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and (d)(8) of this section shall be in type size no smaller than 8 point. Except for the heading “Nutrition Facts,” the information required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other information contained within the nutrition label shall be in type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall also be in type no smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) of this section (i.e., “Nutrition Facts,” “Amount per Serving,” and “% Daily Value*”), the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, and Protein), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted by bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall separate “Amount Per Serving” from the calorie statements required in paragraph (d)(5) of this section and shall separate each nutrient and its corresponding percent of Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent of Daily Value above and below it.
(2) The information shall be presented under the identifying heading of “Nutrition Facts” which shall be set in a type size larger than all other print size in the nutrition label and, except for labels presented according to the format provided for in paragraph (d)(11) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the heading. Such information shall include:
(i) “Serving Size”: A statement of the serving size as specified in paragraph (b)(9) of this section.
(ii) “Servings Per Container”: The number of servings per container, except that this statement is not required on single-serving containers as defined in paragraph (b)(8) of this section or on single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301.
(4) A subheading “Amount Per Serving” shall be separated from serving size information by a bar.
(5) Information on calories shall immediately follow the heading “Amount Per Serving” and shall be declared in one line, leaving sufficient space between the declaration of “Calories” and “Calories from fat” to allow clear differentiation, or, if “Calories from saturated fat” is declared, in a column with total “Calories” at the top, followed by “Calories from fat” (indented), and “Calories from saturated fat” (indented).
(6) The column heading “% Daily Value,” followed by an asterisk (e.g., “% Daily Value*”), shall be separated from information on calories by a bar. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the left of, and below, this column heading. The column headings “Percent Daily Value,” “Percent DV,” or “% DV” may be substituted for “% Daily Value.”
(7) Except as provided for in paragraph (g) of this section, and except as permitted by § 317.400(d)(2), nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label, except vitamins and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a “g” for grams or “mg” for milligrams.
(ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading “% Daily Value” established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, Iron 4%) or may be listed in two columns, except that when more than four vitamins and minerals are declared, they may be declared vertically with percentages listed under the column headed “% Daily Value.”
(9) A footnote, preceded by an asterisk, shall be placed beneath the list of vitamins and minerals and shall be separated from that list by a hairline.
(i) The footnote shall state: Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.
| Calories: | 2,000 | 2,500 | |
|---|---|---|---|
| Total fat | Less than | 65 g | 80 g |
| Saturated fat | Less than | 20 g | 25 g |
| Cholesterol | Less than | 300 mg | 300 mg |
| Sodium | Less than | 2,400 mg | 2,400 mg |
| Total carbohydrate | 300 g | 375 g | |
| Dietary fiber | 25 g | 30 g |
(ii) If the percent of Daily Value is given for protein in the Percent of Daily Value column as provided in paragraph (d)(7)(ii) of this section, protein shall be listed under dietary fiber, and a value of 50 g shall be inserted on the same line in the column headed “2,000” and value of 65 g in the column headed “2,500.”
(iii) If potassium is declared in the column described in paragraph (d)(7)(i) of this section, potassium shall be listed under sodium and the DRV established in paragraph (c)(9) of this section shall be inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat, carbohydrate, and protein may be presented beneath the information required in paragraph (d)(9), separated from that information by a hairline. This information may be presented horizontally (i.e., “Calories per gram: Fat 9, Carbohydrate 4, Protein 4”) or vertically in columns.
(11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in paragraph (d)(9) of this section, the information required in paragraph (d)(9) may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not adequate to accommodate any remaining vitamins and minerals to be declared or the information required in paragraph (d)(9) of this section, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
(iii) If there is not sufficient continuous vertical space (i.e., approximately 3 inches) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron, the nutrition label may be presented in a tabular display in which the footnote required by paragraph (d)(9) of the section is given to the far right of the label, and additional vitamins and minerals beyond the four that are required (i.e., vitamin A, vitamin C, calcium, and iron) are arrayed horizontally following declarations of the required vitamins and minerals.
(12) The following sample label illustrates the provisions of paragraph (d) of this section:
(13)(i) Nutrition labeling on the outer label of packages of meat or meat food products that contain two or more products in the same packages (e.g., variety packs) or of packages that are used interchangeably for the same type of food (e.g., meat salad containers) may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified to the right of the “Nutrition Facts” title, and both the quantitative amount by weight (i.e., g/mg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the nutrition information may be presented in a separate nutrition label for each language or in one nutrition label with the information in the second language following that in English. Numeric characters that are identical in both languages need not be repeated (e.g., “Protein/Proteinas 2 g”). All required information must be included in both languages.
(e) Nutrition information may be presented for two or more forms of the same product (e.g., both “raw” and “cooked”) or for common combinations of foods as provided for in paragraph (b) of this section, or for different units (e.g., per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDI's are established (e.g., both infants and children less than 4 years of age) as provided for in paragraph (c)(8)(i) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that:
(1) Following the subheading of “Amount Per Serving,” there shall be two or more column headings accurately describing the forms of the same product (e.g., “raw” and “roasted”), the combinations of foods, the units, or the RDI groups that are being declared. The column representing the product as packaged and according to the label serving size based on the Reference Amount in § 317.312(b) shall be to the left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the same product, for combinations of foods, or for different units, total calories and calories from fat (and calories from saturated fat, when declared) shall be listed in a column and indented as specified in paragraph (d)(5) of this section with quantitative amounts declared in columns aligned under the column headings set forth in paragraph (e)(1) of this section.
(3) Quantitative information by weight required in paragraph (d)(7)(i) of this section shall be specified for the form of the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, and according to the label serving size based on the Reference Amount in § 317.312(b).
(i) Quantitative information by weight may be included for other forms of the product represented by the additional column(s) either immediately adjacent to the required quantitative information by weight for the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, and according to the label serving size based on the Reference Amount in § 317.312(b) or as a footnote.
(A) If such additional quantitative information is given immediately adjacent to the required quantitative information, it shall be declared for all nutrients listed and placed immediately following and differentiated from the required quantitative information (e.g., separated by a comma). Such information shall not be put in a separate column.
(B) If such additional quantitative information is given in a footnote, it shall be declared in the same order as the nutrients are listed in the nutrition label. The additional quantitative information may state the total nutrient content of the product identified in the second column or the nutrient amounts added to the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, for only those nutrients that are present in different amounts than the amounts declared in the required quantitative information. The footnote shall clearly identify which amounts are declared. Any subcomponents declared shall be listed parenthetically after principal components (e.g.,
(ii) Total fat and its quantitative amount by weight shall be followed by an asterisk (or other symbol) (e.g., “Total fat (2 g)*”) referring to another asterisk (or symbol) at the bottom of the nutrition label identifying the form(s) of the product for which quantitative information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this section shall be presented under the subheading “% DAILY VALUE” and in columns directly under the column headings set forth in paragraph (e)(1) of this section.
(5) The following sample label illustrates the provisions of paragraph (e) of this section:
(f)(1) Nutrition information may be presented in a simplified format as set forth herein when any required nutrients, other than the core nutrients (i.e., calories, total fat, sodium, total carbohydrate, and protein), are present in insignificant amounts. An insignificant amount shall be defined as that amount that may be rounded to zero in nutrition labeling, except that for total carbohydrate, dietary fiber, sugars and protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the following nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and protein;
(ii) Any of the following that are present in more than insignificant amounts: Calories from fat, saturated fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in more than insignificant amounts may be voluntarily declared as part of the simplified format.
(4) Any required nutrient, other than a core nutrient, that is present in an insignificant amount may be omitted from the tabular listing, provided that the following statement is included at the bottom of the nutrition label, “Not a significant source of ________.” The blank shall be filled in with the appropriate nutrient or food component. Alternatively, amounts of vitamins and minerals present in insignificant amounts may be declared by the use of an asterisk (or symbol) that is placed at the bottom of the table of nutrient values and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).”
(5) Except as provided for in paragraph (g) of this section and in § 317.400(c) and (d), nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section, except that the footnote required in paragraph (d)(9) of this section is not required. When the footnote is omitted, an asterisk shall be placed at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”
(g) Foods in packages that have a total surface area available to bear labeling of 40 or less square inches may modify the requirements of paragraphs (c) through (f) of this section and § 317.302(a) by one or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular or linear (i.e., string) fashion, rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Nutrition information may be given in a linear fashion only if the package shape or size will not accommodate a tabular display.
(ii) When nutrition information is given in a linear display, the nutrition information shall be set off in a box by the use of a hairline. The percent Daily Value is separated from the quantitative amount declaration by the use of parenthesis, and all nutrients, both principal components and subcomponents, are treated similarly. Bolding is required only on the title “Nutrition Facts” and is allowed for nutrient names for “Calories,” “Total fat,” “Cholesterol,” “Sodium,” “Total carbohydrate,” and “Protein.”
(2) Using any of the following abbreviations:
(3) Omitting the footnote required in paragraph (d)(9) of this section and placing another asterisk at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”
(4) Presenting the required nutrition information on any other label panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units that are from one production shift. Alternatively, a collection of consumer units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each from a production lot. Alternatively, the sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each randomly chosen to be representative of a production lot. In each case, the units may be individually analyzed and the results of the analyses averaged, or the units would be composited and the composite analyzed. In both cases, the results, whether an average or a single result from a composite, will be considered by the Agency to be the nutrient content of a composite. All analyses shall be performed by appropriate methods and procedures used by the Department for each nutrient in accordance with the “Chemistry Laboratory Guidebook,” or, if no USDA method is available and appropriate for the nutrient, by appropriate methods for the nutrient in accordance with the 1990 edition of the “Official Methods of Analysis” of the AOAC International, formerly Association of Official Analytical Chemists, 15th ed., which is incorporated by reference, unless a particular method of analysis is specified in § 317.309(c), or, if no USDA, AOAC, or specified method is available and appropriate, by other reliable and appropriate analytical procedures as so determined by the Agency. The “Official Methods of Analysis” is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added, which would make the total amount of such nutrient subject to Class I requirements.
(4) A product with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) unless it meets the following requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.
(5) A product with a label declaration of calories, sugars, total fat, saturated fat, cholesterol, or sodium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls above this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.
(6) The amount of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium may vary over labeled amounts within good manufacturing practice. The amount of calories, sugars, total fat, saturated fat, cholesterol, or sodium may vary under labeled amounts within good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the label statement of serving size.
(8) The management of the establishment must maintain records to support the validity of nutrient declarations contained on product labels. Such records shall be made available to the inspector or any duly authorized representative of the Agency upon request.
(9) The compliance provisions set forth in paragraph (h) (1) through (8) of this section shall not apply to single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, including those that have been previously frozen, when nutrition labeling is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference as provided in § 317.345(e) and (f).
(a) The general principles followed in arriving at the reference amounts customarily consumed per eating occasion (Reference Amount(s)), as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These Reference Amounts are based on data set forth in appropriate national food consumption surveys.
(2) The Reference Amounts are calculated for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. Such Reference Amounts are to be used only when the product is specially formulated or processed for use by an infant or by a child under 4 years of age.
(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating occasion, the mean, median, and mode of the consumed amount per eating occasion were considered.
(5) When survey data were insufficient, FSIS took various other sources of information on serving sizes of food into consideration. These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the Reference Amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the product (e.g., a mixed dish measurable with a cup as a main dish and not as a side dish).
(8) The Reference Amounts for products that are consumed as an ingredient of other products, but that may also be consumed in the form in which they are purchased (e.g., ground beef), are based on use in the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform Reference Amount.
(b) The following Product Categories and Reference Amounts shall be used as the basis for determining serving sizes for specific products:
Table 1—Reference Amounts Customarily Consumed per Eating Occasion—Infant and Toddler Foods 1 2 3
| Product category | Reference amount |
|---|---|
| Infant & Toddler Foods: | |
| Dinner Dry Mix | 15 g |
| Dinner, ready-to-serve, strained type | 60 g |
| Dinner, soups, ready-to-serve junior type | 110 g |
| Dinner, stew or soup ready-to-serve toddlers | 170 g |
| Plain meats and meat sticks, ready-to-serve | 55 g |
1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture.
2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost ready-to-serve form of the product (i.e., heat and serve). If not listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form.
3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation.
Table 2—Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply 1 2 3 4 5
| Product category | Reference amount | Reference amount |
|---|---|---|
| Ready-to-serve | Ready-to-cook | |
| Egg mixtures, (western style omelet, souffle, egg foo young | 110 g | n/a. |
| Lard, margarine, shortening | 1 tbsp | n/a. |
| Salad and potato toppers; e.g., bacon bits | 7 g | n/a. |
| Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) | 15 g | 54 g = bacon. 30 g = breakfast strips. |
| Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio of less than 2:1; e.g., pepperoni | 30 g | n/a. |
| Snacks; e.g., meat snack food sticks | 30 g | n/a. |
| Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crumbles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings | 55 g | n/a. |
| Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet | 55 g | n/a. 75 g = uncooked sausage. |
| Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pureed adult foods | 85 g | 114 g. |
| Canned meats, canned beef, canned pork. 4 | 55 g | n/a. |
| Entrees with sauce, barbecued meats in sauce | 140 g | n/a. |
| Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada | 140 g (plus 55 g for products with sauce toppings) | n/a. |
| Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta | 1 cup | n/a. |
| Salads—pasta or potato, potato salad with bacon, macaroni and meat salad | 140 g | n/a. |
| Salads—all other meat, salads, ham salad | 100 g | n/a. |
| Soups—all varieties | 245 g | n/a. |
| Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with meatballs | 125 g | n/a. |
| Minor main entree sauce; e.g., pizza sauce with meat, gravy |
| n/a. |
| Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat. | ||
| As reconstituted: | ||
| Amount to make one Reference Amount of the final dish; e.g., | ||
| Gravy |
| n/a. |
| Major main entree type sauce | 125 g | n/a. |
| Soup | 245 g | n/a. |
| Entree measurable with a cup | 1 cup | n/a. |
1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-78 and the 1987-88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture.
2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation.
3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount.
4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed.
5 Pizza sauce is part of the pizza and is not considered to be sauce topping.
(c) For products that have no Reference Amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., lunch meat with cheese and crackers), the Reference Amount for the combined product shall be determined using the following rules:
(1) For bulk products, the Reference Amount for the combined product shall be the Reference Amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients.
(2) For products where the ingredient represented as the main ingredient is one or more discrete units, the Reference Amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the Reference Amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients.
(3) If the Reference Amounts are in compatible units, they shall be summed (e.g., ingredients in equal volumes such as tablespoons). If the Reference Amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., grams of one ingredient plus gram weight of tablespoons of a second ingredient).
(d) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a Reference Amount for the product in the prepared form, then the Reference Amount for the unprepared product shall be determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the Reference Amount for the prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the Reference Amount for the prepared product as established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or altered product as defined in § 317.313(d), such as a “low calorie” version, shall be the same as for the product for which it is offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e) of this section shall be used in determining whether a product meets the criteria for nutritional claims. If the serving size declared on the product label differs from the Reference Amount, and the product meets the criteria for the claim only on the basis of the Reference Amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the Reference Amount as it appears in paragraph (b) of this section followed, in parentheses, by the amount in common household measure if the Reference Amount is expressed in measures other than common household measures.
(g) The Administrator, on his or her own initiative or on behalf of any interested person who has submitted a labeling application, may issue a proposal to establish or amend a Product Category or Reference Amount identified in paragraph (b) of this section.
(1) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.
(2) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.
(3) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.
(4) Data accompanying the labeling application, such as food consumption data, shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.
(5) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.
(6) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.
(7) Labeling applications for a new Reference Amount and/or Product Category shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 317.312 with respect to Reference Amount and/or Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label, using the format established by regulation;
(iv) A description of the form in which the product will be marketed;
(v) The intended dietary uses of the product with the major use identified (e.g., ham as a luncheon meat);
(vi) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;
(vii) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);
(viii) The names of the most closely-related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);
(ix) The suggested Reference Amount (the amount of edible portion of food as consumed, excluding bone, skin or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested Reference Amount. In determining the Reference Amount, general principles and factors in paragraph (a) of this section should be followed.
(x) The suggested Reference Amount shall be expressed in metric units. Reference Amounts for foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density such as mixed dishes measurable with a cup.
(A) In expressing the Reference Amount in grams, the following general rules shall be followed:
(1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment.
(2) For quantities less than 10 grams, exact gram weights shall be used.
(B) [Reserved]
(xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information:
(A) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the Reference Amount for the parent category to warrant a separate Reference Amount. Data must include sample size, and the mean, standard deviation, median, and modal consumed amount per eating occasion for the product identified in the labeling application and for other products in the category. All data must be derived from the same survey data.
(B) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the product identified in the labeling application from the rest of the products in the category.
(xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed.
(A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.
(B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.
(C) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.
(D) The methodology used to collect or process data including study design, sampling procedures, materials used (e.g., questionnaire, interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse, should be fully documented.
(xiii) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule.
(8) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(9) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(10) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed Reference Amount and/or Product Category is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the
(i) If the Reference Amount and/or Product Category is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the Reference Amount and/or Product Category on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of an answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(ii) If the Reference Amount and/or Product Category is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(a) This section applies to meat or meat food products that are intended for human consumption and that are offered for sale.
(b) A claim which, expressly or by implication, characterizes the level of a nutrient (nutrient content claim) of the type required in nutrition labeling pursuant to § 317.309, may not be made on a label or in labeling of that product unless the claim is made in accordance with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the product, e.g., “low sodium” or “contains 100 calories.”
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or
(ii) Suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”).
(3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on products intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in subpart B of this part.
(4) Reasonable variations in the spelling of the terms defined in applicable provisions in this subpart and their synonyms are permitted provided these variations are not misleading (e.g., “hi” or “lo”).
(c) Information that is required or permitted by § 317.309 to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims.
(d) A “substitute” product is one that may be used interchangeably with another product that it resembles, i.e., that it is organoleptically, physically, and functionally (including shelf life) similar to, and that it is not nutritionally inferior to unless it is labeled as an “imitation.”
(1) If there is a difference in performance characteristics that materially limits the use of the product, the product may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim as defined in paragraph (j)(2)(iii) of this section, informing the consumer of such difference (e.g., “not recommended for frying”).
(2) This disclaimer shall be in easily legible print or type and in a size no less than that required by § 317.2(h) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than
(e)(1) Because the use of a “free” or “low” claim before the name of a product implies that the product differs from other products of the same type by virtue of its having a lower amount of the nutrient, only products that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the product, remove the nutrient from the product, or not include the nutrient in the product, may bear such a claim (e.g., “low sodium beef noodle soup”).
(2) Any claim for the absence of a nutrient in a product, or that a product is low in a nutrient when the product has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the product inherently meets the criteria and shall clearly refer to all products of that type and not merely to the particular brand to which the labeling attaches (e.g., “lard, a sodium free food”).
(f) A nutrient content claim shall be in type size and style no larger than two times that of the statement of identity and shall not be unduly prominent in type style compared to the statement of identity.
(g) Labeling information required in §§ 317.313, 317.354, 317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not otherwise specified, is required to be in letters and/or numbers no less than
(h) [Reserved]
(i) Except as provided in § 317.309 or in paragraph (q)(3) of this section, the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is consistent with a definition for a claim, as provided in subpart B of this part, for the nutrient that the label addresses. Such a claim might be, “less than 10 g of fat per serving;”
(2) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is not consistent with such a definition, but the label carries a disclaimer adjacent to the statement that the product is not “low” in or a “good source” of the nutrient, such as “only 200 milligrams (mg) sodium per serving, not a low sodium product.” The disclaimer must be in easily legible print or type and in a size no less than required by § 317.2(h) for the net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than
(3) The statement does not in any way implicitly characterize the level of the nutrient in the product and it is not false or misleading in any respect (e.g., “100 calories” or “5 grams of fat”), in which case no disclaimer is required.
(4) “Percent fat free” claims are not authorized by this paragraph. Such claims shall comply with § 317.362(b)(6).
(j) A product may bear a statement that compares the level of a nutrient in the product with the level of a nutrient in a reference product. These statements shall be known as “relative claims” and include “light,” “reduced,” “less” (or “fewer”), and “more” claims.
(1) To bear a relative claim about the level of a nutrient, the amount of that nutrient in the product must be compared to an amount of nutrient in an appropriate reference product as specified in this paragraph (j).
(i)(A) For “less” (or “fewer”) and “more” claims, the reference product may be a dissimilar product within a product category that can generally be substituted for one another in the diet or a similar product.
(B) For “light,” “reduced,” and “added” claims, the reference product shall be a similar product, and
(ii)(A) For “light” claims, the reference product shall be representative of the type of product that includes the product that bears the claim. The nutrient value for the reference product shall be representative of a broad base of products of that type; e.g., a value in a representative, valid data base; an average value determined from the top three national (or regional) brands, a market basket norm; or, where its nutrient value is representative of the product type, a market leader. Firms using such a reference nutrient value as a basis for a claim, are required to provide specific information upon which the nutrient value was derived, on request, to consumers and appropriate regulatory officials.
(B) For relative claims other than “light,” including “less” and “more” claims, the reference product may be the same as that provided for “light” in paragraph (j)(1)(ii)(A) of this section or it may be the manufacturer's regular product, or that of another manufacturer, that has been offered for sale to the public on a regular basis for a substantial period of time in the same geographic area by the same business entity or by one entitled to use its trade name, provided the name of the competitor is not used on the labeling of the product. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting labeling is internally consistent (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information, and the declaration of the percentage of nutrient by which the product has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference product and the percent (or fraction) of the amount of the nutrient in the reference product by which the nutrient has been modified, (e.g., “50 percent less fat than ‘reference product’ ” or “
(ii) This information shall be immediately adjacent to the most prominent claim in easily legible boldface print or type, in distinct contrast to other printed or graphic matter, that is no less than that required by § 317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the referral statement shall be no less than one-half the size of the claim, but no smaller than
(iii) The determination of which use of the claim is in the most prominent location on the label or labeling will be made based on the following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving size with that in the reference product; and
(B) This statement shall appear adjacent to the most prominent claim or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the requirement for a “low” claim for that nutrient.
(k) The term “modified” may be used in the statement of identity of a product that bears a relative claim that complies with the requirements of this part, followed immediately by the name of the nutrient whose content has been altered (e.g., “modified fat ‘product’ ”). This statement of identity must be immediately followed by the comparative statement such as “contains 35 percent less fat than ‘reference product’ ” The label or labeling must also bear the information required by paragraph (j)(2) of this section in the manner prescribed.
(l) For purposes of making a claim, a “meal-type” product will be defined as a product that:
(1) Makes a major contribution to the diet by:
(i) Weighing at least 10 ounces per labeled serving; and
(ii) Containing not less than three 40 gram portions of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in the form commonly understood to be, a breakfast, lunch, dinner, meal, or entre. Such representations may be made by statements, photographs, or vignettes.
(m) For purposes of making a claim, a main-dish product will be defined as a food that:
(1) Makes a major contribution to the meal by:
(i) Weighing at least 6 ounces per labeled serving; and
(ii) Containing not less than 40 grams of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (m)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four food groups in paragraph (m)(l)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(3) Is represented as, or is in a form commonly understood to be, a main dish (e.g., not a beverage or dessert). Such representations may be made by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with § 317.309, shall be provided for any food for which a nutrient content claim is made.
(o) Compliance with requirements for nutrient content claims shall be in accordance with § 317.309(h).
(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in § 317.312(b) through (e) shall be used in determining whether a product meets the criteria for a nutrient content claim. If the serving size declared on the product label differs from the reference amount customarily consumed, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by § 317.312(f) (e.g., “very low sodium, 35 mg or less per 55 grams”).
(2) The criteria for the claim shall be immediately adjacent to the most prominent claim in easily legible print or type and in a size that is no less than that required by § 317.2(h) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the criteria statement shall be no less than one-half the size of the claim but no smaller than
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation and that appear as part of a brand name that was in use prior to November 27, 1991, may continue to be used as part of that brand name, provided they are not false or misleading under section 1(n) of the Act (21 U.S.C. 601(n)(1)).
(2) [Reserved]
(3) A statement that describes the percentage of a vitamin or mineral in the food, including foods intended specifically for use by infants and children less than 2 years of age, in relation to a Reference Daily Intake (RDI) as defined in § 317.309 may be made on the label or in the labeling of a food without a regulation authorizing such a claim for a specific vitamin or mineral.
(4) The requirements of this section do not apply to infant formulas and medical foods, as described in 21 CFR 101.13(q)(4).
(5) [Reserved]
(6) Nutrient content claims that were part of the name of a product that was subject to a standard of identity as of November 27, 1991, are not subject to the requirements of paragraph (b) of this section whether or not they meet the definition of the descriptive term.
(7) Implied nutrient content claims may be used as part of a brand name, provided that the use of the claim has been authorized by FSIS. Labeling applications requesting approval of such a claim may be submitted pursuant to § 317.369.
The major cuts of single-ingredient, raw meat products are: Beef chuck blade roast, beef loin top loin steak, beef rib roast large end, beef round eye round steak, beef round top round steak, beef round tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef round bottom round steak, beef brisket (whole, flat half, or point half), beef rib steak small end, beef loin tenderloin steak, pork loin chop, pork loin country style ribs, pork loin top loin chop boneless, pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin roast, pork shoulder blade steak, pork loin top roast boneless, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, veal shoulder blade steak, veal rib roast, veal loin chop, and veal cutlets.
(a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified in § 317.344, including those that have been previously frozen, is required, either on their label or at their point-of-purchase, unless exempted under § 317.400. If nutrition information is presented on the label, it must be provided in accordance with § 317.309. If nutrition information is presented at the point-of-purchase, it must be provided in accordance with the provisions of this section.
(2) Nutrition information on single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and are not major cuts of single-ingredient, raw meat products identified in § 317.344, including those that have been previously frozen, may be provided at their point-of-purchase in accordance with the provisions of this section or on their label, in accordance with the provisions of § 317.309.
(3) A retailer may provide nutrition information at the point-of-purchase by various methods, such as by posting a sign or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. If a nutrition claim is made on point-of-purchase materials, all of the format and content requirements of § 317.309 apply. However, if only nutrition information—and not a nutrition claim—is supplied on point-of-purchase materials, the requirements of § 317.309 apply, provided, however:
(i) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in § 317.309(c)(8)) and footnote required by § 317.309(d)(9) may be omitted; and
(ii) The point-of-purchase materials are not subject to any of the format requirements.
(b) [Reserved]
(c) For the point-of-purchase materials, the declaration of nutrition information may be presented in a simplified format as specified in § 317.309(f).
(d) The nutrition label data for products covered in paragraphs (a)(1) and (a)(2) must be based on either the raw or cooked edible portions of meat cuts with external cover fat at trim levels reflecting current marketing practices. If data are based on cooked portions, the methods used to cook the products must be specified and for products covered in paragraphs (a)(1) and (a)(2) must be those which do not add nutrients from other ingredients such as flour, breading, and salt. Additional nutritional data may be presented on an optional basis for the raw or cooked edible portions of the separable lean of meat cuts.
(e) Nutrient data that are the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference, may be used for nutrition labeling of single-ingredient, raw meat products, including those that have been previously frozen. These data may be composite data that reflect different quality grades of beef or other variables affecting nutrient content. Alternatively, data that reflect specific grades or other variables may be used, except that if data are used on labels attached to a product which is labeled as to grade of meat or other variables, the data must represent the product in the package when such data are contained in the representative data base. When data are used on labels attached to a product, the data must represent the edible meat tissues present in the package.
(f) If the nutrition information is provided in accordance with paragraph (e) of this section, a nutrition label or labeling will not be subject to the Agency compliance review under § 317.309(h), unless a nutrition claim is made on the basis of the representative data base values.
(g) Retailers may use data bases that they believe reflect the nutrient content of single-ingredient, raw meat products, including those that have been previously frozen; however, such labeling shall be subject to the compliance procedures of paragraph (e) of this section and the requirements specified in this subpart for the mandatory nutrition labeling program.
(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a product in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV) established for that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and
(3) The product for which the claim is made is labeled in accordance with § 317.309.
(b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § 317.313(m) provided that:
(i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of broccoli in this meal is high in vitamin C”).
(c) “Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label or in labeling of products, except meal-type products as described in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § 317.313(m) provided that:
(i) The product contains a food that meets the definition of “good source” in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of sweet potatoes in this meal is a good source of fiber”).
(d) Fiber claims. (1) If a nutrient content claim is made with respect to the level of dietary fiber, i.e., that the product is high in fiber, a good source of fiber, or that the product contains “more” fiber, and the product is not “low” in total fat as defined in § 317.362(b)(2) or, in the case of a meal-type product or a main-dish product, is not “low” in total fat as defined in § 317.362(b)(3), then the labeling shall disclose the level of total fat per labeled serving size (e.g., “contains 12 grams (g) of fat per serving”); and
(2) The disclosure shall appear in immediate proximity to such claim and be in a type size no less than one-half the size of the claim.
(e) “More” claims. (1) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in a product, except meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that:
(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber than ‘reference product’ ”); and
(B) Quantitative information comparing the level of the nutrient in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 1 g per serving; ‘this product’ contains 4 g per serving”).
(2) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that:
(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber per 3 ounces (oz) than does ‘reference product’ ”), and
(B) Quantitative information comparing the level of the nutrient in the meal-type product or a main-dish product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 2 g per 3 oz; ‘this product’ contains 5 g per 3 oz”).
(a) General requirements. A claim using the terms “light” or “lite” to describe a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and
(3) The product for which the claim is made is labeled in accordance with § 317.309.
(b) “Light” claims. The terms “light” or “lite” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), without further qualification, provided that:
(1) If the product derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or
(2) If the product derives less than 50 percent of its calories from fat:
(i) The number of calories is reduced by at least one-third (33
(ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the appropriate reference product as described in § 317.313(j)(1); and
(3) As required in § 317.313(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim (e.g., “
(ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—200 calories, 4 grams (g) fat; regular ‘reference product’—300 calories, 8 g fat per serving”); and
(iii) If the labeled product contains less than 40 calories or less than 3 g fat per reference amount customarily consumed, the percentage reduction for that nutrient need not be declared.
(4) A “light” claim may not be made on a product for which the reference product meets the definition of “low fat” and “low calorie.”
(c)(1)(i) A product for which the reference product contains 40 calories or less and 3 g fat or less per reference amount customarily consumed may use the terms “light” or “lite” without further qualification if it is reduced by 50 percent or more in sodium content compared to the reference product; and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim (e.g., “50 percent less sodium than the market leader”); and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—500 milligrams (mg) sodium per serving; regular ‘reference product’—1,000 mg sodium per serving”).
(2)(i) A product for which the reference product contains more than 40 calories or more than 3 g fat per reference amount customarily consumed may use the terms “light in sodium” or “lite in sodium” if it is reduced by 50 percent or more in sodium content compared to the reference product, provided that “light” or “lite” is presented in immediate proximity with “in sodium” and the entire term is presented in uniform type size, style, color, and prominence; and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim (e.g., “50 percent less sodium than the market leader”); and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., or “lite ‘this product’—170 mg sodium per serving; regular ‘reference product’—350 mg per serving”).
(3) Except for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), a “light in sodium” claim may not be made on a product for which the reference product meets the definition of “low in sodium.”
(d)(1) The terms “light” or “lite” may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product meets the definition of:
(A) “Low in calories” as defined in § 317.360(b)(3); or
(B) “Low in fat” as defined in § 317.362(b)(3); and
(ii)(A) A statement appears on the principal display panel that explains whether “light” is used to mean “low fat,” “low calories,” or both (e.g., “Light Delight, a low fat meal”); and
(B) The accompanying statement is no less than one-half the type size of the “light” or “lite” claim.
(2)(i) The terms “light in sodium” or “lite in sodium” may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that the product meets the definition of “low in sodium” as defined in § 317.361(b)(5)(i); and
(ii) “Light” or “lite” and “in sodium” are presented in uniform type size, style, color, and prominence.
(3) The term “light” or “lite” may be used in the brand name of a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content compared to the reference product;
(ii) A statement specifically stating that the product is “light in sodium” or “lite in sodium” appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the product name; and
(iii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information.
(e) Except as provided in paragraphs (b) through (d) of this section, the terms “light” or “lite” may not be used to refer to a product that is not reduced in fat by 50 percent, or, if applicable, in calories by
(1) It describes some physical or organoleptic attribute of the product such as texture or color and the information (e.g., “light in color” or “light in texture”) so stated, clearly conveys the nature of the product; and
(2) The attribute (e.g., “color” or “texture”) is in the same style, color, and at least one-half the type size as the word “light” and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word “light” has been associated, through common use, with a particular product to reflect a physical or organoleptic attribute to the point where it has become part of the statement of identity, such use of the term “light” shall not be considered a nutrient content claim subject to the requirements in this part.
(g) The term “lightly salted” may be used on a product to which has been added 50 percent less sodium than is normally added to the reference product as described in § 317.313(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not “low in sodium” as defined in § 317.361(b)(4), the statement “not a low sodium food,” shall appear adjacent to the nutrition information and the information required to accompany a relative claim shall appear on the label or labeling as specified in § 317.313(j)(2).
(a) General requirements. A claim about the calorie or sugar content of a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and
(3) The product for which the claim is made is labeled in accordance with § 317.309.
(b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does not provide more than 40 calories per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and does not provide more than 40 calories per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 120 calories or less per 100 g of product; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the calorie content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches.
(4) The terms “reduced calorie,” “reduced in calories,” “calorie reduced,” “fewer calories,” “lower calorie,” or “lower in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., lower calorie ‘product’—“33
(B) Quantitative information comparing the level of calories in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 150 to 100 calories per serving”).
(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent fewer calories per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “calorie reduced ‘product’, 25% less calories per ounce (oz) (or 3 oz) than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of calories in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 110 calories per 3 oz to 80 calories per 3 oz”).
(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”
(c) Sugar content claims. (1) Terms such as “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” or “dietarily insignificant source of sugar” may reasonably be expected to be regarded by consumers as terms that represent that the product contains no sugars or sweeteners, e.g., “sugar free,” or “no sugar,” as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (c)(2) of this section, a product may not be labeled with such terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in § 317.309(c)(6)(ii), per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is generally understood by consumers to contain sugars unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietarily insignificant amount of sugar;” and
(iii)(A) It is labeled “low calorie” or “reduced calorie” or bears a relative claim of special dietary usefulness labeled in compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this section; or
(B) Such term is immediately accompanied, each time it is used, by either the statement “not a reduced calorie product,” “not a low calorie product,” or “not for weight control.”
(2) The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if:
(i) No amount of sugars, as defined in § 317.309(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount present in the ingredients by some means such as the use of enzymes, except where the intended functional effect of the process is not to increase the sugars content of a product, and a functionally insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes normally contains added sugars; and
(v) The product bears a statement that the product is not “low calorie” or “calorie reduced” (unless the product meets the requirements for a “low” or “reduced calorie” product) and that directs consumers' attention to the nutrition panel for further information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual statement that a product, including products intended specifically for infants and children less than 2 years of age, is unsweetened or contains no added sweeteners in the case of a product that contains apparent substantial inherent sugar content, e.g., juices.
(4) The terms “reduced sugar,” “reduced in sugar,” “sugar reduced,” “less sugar,” “lower sugar,” or “lower in sugar” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less sugars per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “this product contains 25 percent less sugar than our regular product”); and
(B) Quantitative information comparing the level of the sugar in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been lowered from 8 g to 6 g per serving”).
(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less sugars per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sugar ‘product’—25% less sugar than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz”).
(a) General requirements. A claim about the level of sodium in a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and
(3) The product for which the claim is made is labeled in accordance with § 317.309.
(b) Sodium content claims. (1) The terms “sodium free,” “free of sodium,” “no sodium,” “zero sodium,” “without sodium,” “trivial source of sodium,” “negligible source of sodium,” or “dietarily insignificant source of sodium” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 5 mg of sodium per labeled serving size;
(ii) The product contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium”; and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “very low sodium” or “very low in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and contains 35 mg or less sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 35 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 35 mg or less of sodium per 100 g of product; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “low sodium,” “low in sodium,” “little sodium,” “contains a small amount of sodium,” or “low source of sodium” may be used on the label and in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp and contains 140 mg or less sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 140 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 140 mg or less sodium per 100 g of product; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(6) The terms “reduced sodium,” “reduced in sodium,” “sodium reduced,” “less sodium,” “lower sodium,” or “lower in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less sodium per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’, 50 percent less sodium than regular ‘product’ ”); and
(B) Quantitative information comparing the level of sodium in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been lowered from 300 to 150 mg per serving”).
(iii) Claims described in paragraph (b)(6) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low sodium.”
(7) The terms defined in paragraph (b)(6) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less sodium per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’—30% less sodium per 3 oz than our ‘regular product’ ”); and
(B) Quantitative information comparing the level of sodium in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been reduced from 220 mg per 3 oz to 150 mg per 3 oz”).
(iii) Claims described in paragraph (b)(7) of this section may not be made on the label or in labeling of products if the nutrient content of the reference product meets the definition for “low sodium.”
(c) The term “salt” is not synonymous with “sodium.” Salt refers to sodium chloride. However, references to salt content such as “unsalted,” “no salt,” “no salt added” are potentially misleading.
(1) The term “salt free” may be used on the label or in labeling of products only if the product is “sodium free” as defined in paragraph (b)(1) of this section.
(2) The terms “unsalted,” “without added salt,” and “no salt added” may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is normally processed with salt; and
(iii) If the product is not sodium free, the statement, “not a sodium free product” or “not for control of sodium in the diet” appears adjacent to the nutrition information of the product bearing the claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual statement that a product intended specifically for infants and children less than 2 years of age is unsalted, provided such statement refers to the taste of the product and is not false or otherwise misleading.
(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of products if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and
(3) The product for which the claim is made is labeled in accordance with § 317.309.
(b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “nonfat,” “trivial source of fat,” “negligible source of fat,” or “dietarily insignificant source of fat” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of fat per labeled serving size;
(ii) The product contains no added ingredient that is a fat or is generally understood by consumers to contain fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat”; and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label and in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 3 g or less of fat per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 3 g or less of total fat per 100 g of product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced fat,” “reduced in fat,” “fat reduced,” “less fat,” “lower fat,” or “lower in fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less fat per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat—50 percent less fat than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fat content has been reduced from 8 g to 4 g per serving”).
(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less fat per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat ‘product’, 33 percent less fat per 3 oz than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent such claim or to the nutrition information (e.g., “fat content has been reduced from 8 g per 3 oz to 5 g per 3 oz”).
(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”
(6) The term “______ percent fat free” may be used on the label or in labeling of products, provided that:
(i) The product meets the criteria for “low fat” in paragraph (b)(2) or (b)(3) of this section;
(ii) The percent declared and the words “fat free” are in uniform type size; and
(iii) A “100 percent fat free” claim may be made only on products that meet the criteria for “fat free” in paragraph (b)(1) of this section, that contain less than 0.5 g of fat per 100 g, and that contain no added fat.
(iv) A synonym for “______ percent fat free” is “______ percent lean.”
(c) Fatty acid content claims. (1) The terms “saturated fat free,” “free of saturated fat,” “no saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of saturated fat,” “negligible source of saturated fat,” or “dietarily insignificant source of saturated fat” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per labeled serving size;
(ii) The product contains no ingredient that is generally understood by consumers to contain saturated fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of saturated fat,” “adds a negligible amount of saturated fat,” or “adds a dietarily insignificant amount of saturated fat;” and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low in saturated fat,” “low saturated fat,” “contains a small amount of saturated fat,” “low source of saturated fat,” or “a little saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains 1 g or less of saturated fat per reference amount customarily consumed and not more than 15 percent of calories from saturated fat; and
(ii) If the product meets these conditions without benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (c)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced saturated fat,” “reduced in saturated fat,” “saturated fat reduced,” “less saturated fat,” “lower saturated fat,” or “lower in saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less saturated fat per reference amount customarily consumed than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’, contains 50 percent less saturated fat than the national average for ‘product’ ”); and
(B) Quantitative information comparing the level of saturated fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat reduced from 3 g to 1.5 g per serving”).
(iii) Claims described in paragraph (c)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”
(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains at least 25 percent less saturated fat per 100 g of product than an appropriate reference product as described in § 317.313(j)(1); and
(ii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’,” “50 percent less saturated fat than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of saturated fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz”).
(iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”
(d) Cholesterol content claims. (1) The terms “cholesterol free,” “free of cholesterol,” “zero cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of cholesterol,” “negligible source of cholesterol,” or “dietarily insignificant source of cholesterol” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of cholesterol,” “adds a negligible amount of cholesterol,” or “adds a dietarily insignificant amount of cholesterol”;
(iii) The product contains 2 g or less of saturated fat per reference amount customarily consumed or, in the case of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), 2 g or less of saturated fat per labeled serving size; and
(iv) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches; or
(v) If the product meets these conditions only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol was reduced are declared in immediate proximity to the most prominent such claim (e.g., “cholesterol free ‘product’, contains 100 percent less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “contains no cholesterol compared with 30 mg in one serving of ‘reference product’ ”).
(2) The terms “low in cholesterol,” “low cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” or “little cholesterol” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i)(A) If the product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed.
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “low cholesterol ‘product’, contains 85 percent less cholesterol than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 30 mg to 5 mg per serving”).
(3) The terms defined in paragraph (d)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of product;
(ii) The product contains 2 g or less of saturated fat per 100 g of product; and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced cholesterol,” “reduced in cholesterol,” “cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in cholesterol” may be used on the label or in labeling of products or products that substitute for those products as specified in § 317.313(d), excluding meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that:
(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;
(ii) The product contains 2 g or less of saturated fat per reference amount customarily consumed; and
(iii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25 percent less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 55 mg to 30 mg per serving”).
(iv) Claims described in paragraph (d)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”
(5) The terms defined in paragraph (d)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l) and main-dish product as defined in § 317.313(m), provided that:
(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in § 317.313(j)(1) and for which it substitutes as described in § 317.313(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of product; and
(iii) As required in § 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25% less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”
(e) “Lean” and “Extra Lean” claims. (1) The term “lean” may be used on the label or in labeling of a product, provided that the product contains less than 10 g of fat, 4.5 g or less of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m).
(2) The term “extra lean” may be used on the label or in labeling of a product, provided that the product contains less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m).
(f) A statement of the lean percentage may be used on the label or in labeling of ground or chopped meat products described in § 317.301 when the product does not meet the criteria for “low fat,” defined in § 317.362(b)(2), provided that a statement of the fat percentage is contiguous to and in lettering of the same color, size, type, and on the same color background, as the statement of the lean percentage.
(a) The term “healthy,” or any other derivative of the term “health,” may be used on the labeling of any meat or meat food product, provided that the product is labeled in accordance with § 317.309 and § 317.313.
(b)(1) The product shall meet the requirements for “low fat” and “low saturated fat,” as defined in § 317.362, except that single-ingredient, raw products may meet the total fat and saturated fat criteria for “extra lean” in § 317.362.
(2) The product shall not contain more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:
(i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean”in § 317.362.
(3) The product shall not contain more than 480 mg of sodium per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:
(i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 oz per serving (container), shall not contain more than 600 mg of sodium per labeled serving size;
(ii) The requirements of this paragraph (b)(3) do not apply to single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference Daily Intake or Daily Reference Value as defined in § 317.309 for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition, except that:
(i) A main-dish product, as defined in § 317.313(m), and including main-dish products that weigh less than 10 oz per serving (container), shall meet the level for two of the nutrients per labeled serving size; and
(ii) A meal-type product, as defined in § 317.313(l), shall meet the level for three of the nutrients per labeled serving size.
(a) This section pertains to labeling applications for claims, express or implied, that characterize the level of any nutrient required to be on the label or in labeling of product by this subpart.
(b) Labeling applications included in this section are:
(1) Labeling applications for a new (heretofore unauthorized) nutrient content claim,
(2) Labeling applications for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient, and
(3) Labeling applications for the use of an implied claim in a brand name.
(c) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.
(d) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.
(e) If nonclinical laboratory studies accompany a labeling application, the applicant shall include, with respect to each nonclinical study included with the application, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
(f) If clinical investigations accompany a labeling application, the applicant shall include, with respect to each clinical investigation included with the application, either a statement that the investigation was conducted in compliance with the requirements for institutional review set forth in part 56 of chapter 1, title 21, or was not subject to such requirements in accordance with § 56.194 or § 56.105, and that it was conducted in compliance with the requirements for informed consents set forth in part 50 of chapter 1, title 21.
(g) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.
(h) The data specified under this section to accompany a labeling application shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.
(i) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.
(j) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.
(k)(1) Labeling applications for a new nutrient content claim shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250.
The undersigned, __________, submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the claim and its proposed use).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the nutrient content claim and the nutrient that the term is intended to characterize with respect to the level of such nutrient. The statement shall address why the use of the term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify the level at which the nutrient must be present or what other conditions concerning the product must be met for the appropriate use of the term in labels or labeling, as well as any factors that would make the use of the term inappropriate.
(ii) A detailed explanation supported by any necessary data of why use of the food component characterized by the claim is of importance in human nutrition by virtue of its presence or absence at the levels that such claim would describe. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, and scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.
(iii) Analytical data that demonstrates the amount of the nutrient that is present in the products for which the claim is intended. The assays should be performed on representative samples in accordance with 317.309(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular food. The validation data shall include a statistical analysis of the analytical and product variability.
(iv) A detailed analysis of the potential effect of the use of the proposed claim on food consumption, and any corresponding changes in nutrient intake. The analysis shall specifically address the intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is intended for a specific group within the population, the analysis shall specifically address the dietary practices of such group, and shall include data sufficient to demonstrate that the dietary analysis is representative of such group.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the
(i) If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(l)(1) Labeling applications for a synonymous term shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the synonymous term and its proposed use in a nutrient content claim that is consistent with an existing term that has been defined under subpart B of part 317).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the synonymous term, the existing term defined by a regulation with which the synonymous term is claimed to be consistent, and the nutrient that the term is intended to characterize the level of. The statement shall address why the use of the synonymous term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify whether any limitations not applicable to the use of the defined term are intended to apply to the use of the synonymous term.
(ii) A detailed explanation supported by any necessary data of why use of the proposed term is requested, including whether the existing defined term is inadequate for the purpose of effectively characterizing the level of a nutrient. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed, and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed synonymous term is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed synonymous term.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the claim is approved, the Agency shall notify the applicant, in writing, and shall publish in the
(m)(1) Labeling applications for the use of an implied nutrient content claim in a brand name shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 317.369 with respect to (statement of the implied nutrient content claim and its proposed use in a brand name).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the implied nutrient content claim, the nutrient the claim is intended to characterize, the corresponding term for characterizing the level of such nutrient as defined by a regulation, and the brand name of which the implied claim is intended to be a part. The statement shall address why the use of the brand-name as proposed will not be misleading. The statement shall provide examples of the types of products on which the brand name will appear. It shall also include data showing that the actual level of the nutrient in the food would qualify the label of the product to bear the corresponding term defined by regulation. Assay methods used to determine the level of a nutrient shall meet the requirements stated under labeling application format in paragraph (k)(1)(iii) of this section.
(ii) A detailed explanation supported by any necessary data of why use of the proposed brand name is requested. This explanation shall also state what nutritional benefit to the public will derive from use of the brand name as proposed. If the branded product is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group and scientific data sufficient for such purpose.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed implied nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish a notice of the labeling application in the
(i) If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(a) General requirements. Any product that purports to be or is represented for special dietary use because of usefulness in reducing body weight shall bear:
(1) Nutrition labeling in conformity with § 317.309 of this subpart, unless exempt under that section, and
(2) A conspicuous statement of the basis upon which the product claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any product subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.
(2) A special dietary product may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the product under the applicable law and regulations of this chapter. Any product that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener; e.g., “Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).”
(c) “Low calorie” foods. A product purporting to be “low calorie” must comply with the criteria set forth for such foods in § 317.360.
(d) “Reduced calorie” foods and other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such foods in § 317.360(b) (4) and (5).
(e) “Label terms suggesting usefulness as low calorie or reduced calorie foods”. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if the claim is not false or misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative calorie claim in compliance with the applicable provisions in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term “diet” that clearly shows that the product is offered solely for a dietary use other than regulating body weight, e.g., “for low sodium diets.”
(3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement or other product that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on foods.
(f) “Sugar free” and “no added sugar”. Criteria for the use of the terms “sugar free” and “no added sugar” are provided for in § 317.360(c).
(a) The following meat or meat food products are exempt from nutrition labeling:
(1) Food products produced by small businesses, other than the major cuts of single-ingredient, raw meat products identified in § 317.344 produced by small businesses, provided that the labels for these products bear no nutrition claims or nutrition information, and ground or chopped products described in § 317.301 produced by small businesses that bear a statement of the lean percentage and fat percentage on the label or in labeling in accordance with § 317.362(f), provided that labels or labeling for these products bear no other nutrition claims or nutrition information,
(i) A food product, for the purposes of the small business exemption, is defined as a formulation, not including distinct flavors which do not significantly alter the nutritional profile, sold in any size package in commerce.
(ii) For purposes of this paragraph, a small business is any single-plant facility, including a single retail store, or multi-plant company/firm, including a multi-retail store operation, that employs 500 or fewer people and produces no more than the following amounts of pounds of the product qualifying the firm for exemption from this subpart:
(A) During the first year of implementation of nutrition labeling, from July 1994 to July 1995, 250,000 pounds or less,
(B) During the second year of implementation of nutrition labeling, from July 1995 to July 1996, 175,000 pounds or less, and
(C) During the third year of implementation and subsequent years thereafter, 100,000 pounds or less.
(iii) For purposes of this paragraph, calculation of the amount of pounds shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years or where products have been produced for less than 2 years, reasonable estimates must indicate that the annual pounds produced will not exceed the amounts specified.
(2) Products intended for further processing, provided that the labels for these products bear no nutrition claim or nutrition information,
(3) Products that are not for sale to consumers, provided that the labels for these products bear no nutrition claims or nutrition information,
(4) Products in small packages that are individually wrapped packages of less than
(5) Products custom slaughtered or prepared,
(6) Products intended for export, and
(7) The following products prepared and served or sold at retail provided that the labels or the labeling of these products bear no nutrition claims or nutrition information:
(i) Ready-to-eat products that are packaged or portioned at a retail store or similar retail-type establishment, provided, however, that this exemption does not apply to ready-to-eat ground or chopped meat products described in § 317.301 that are packaged or portioned at a retail establishment, unless the establishment qualifies for an exemption under (a)(1);
(ii) Multi-ingredient products (e.g., sausage) processed at a retail store or similar retail-type establishment, provided, however, that this exemption does not apply to multi-ingredient ground or chopped meat products described in § 317.301 that are processed at a retail establishment, unless the establishment qualifies for an exemption under (a)(1); and
(iii) Products that are ground or chopped at an individual customer's request.
(b) Restaurant menus generally do not constitute labeling or fall within the scope of these regulations.
(c)(1) Foods represented to be specifically for infants and children less than 2 years of age shall bear nutrition labeling as provided in paragraph (c)(2) of this section, except such labeling shall not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
(2) Foods represented or purported to be specifically for infants and children less than 4 years of age shall bear nutrition labeling except that:
(i) Such labeling shall not include declarations of percent of Daily Value for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber;
(ii) Nutrient names and quantitative amounts by weight shall be presented in two separate columns;
(iii) The heading “Percent Daily Value” required in § 317.309(d)(6) shall be placed immediately below the quantitative information by weight for protein;
(iv) The percent of the Daily Value for protein, vitamins, and minerals shall be listed immediately below the heading “Percent Daily Value”; and
(v) Such labeling shall not include the footnote specified in § 317.309(d)(9).
(d)(1) Products in packages that have a total surface area available to bear labeling of less than 12 square inches are exempt from nutrition labeling, provided that the labeling for these products bear no nutrition claims or other nutrition information, except that this exemption does not apply to the major cuts of single-ingredient, raw meat products identified in § 317.344. The manufacturer, packer, or distributor shall provide, on the label of packages that qualify for and use this exemption, an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., “For nutrition information call 1-800-123-4567”).
(2) When such products bear nutrition labeling, either voluntarily or because nutrition claims or other nutrition information is provided, all required information shall be in a type size no smaller than 6 point or all upper case type of
(a) Except as otherwise provided in paragraphs (g) and (h) of this section or § 318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with § 318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under § 318.3, until it has been reinspected by the inspector.
(b) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been (1) previously inspected and passed and is identified as such in accordance with the requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the regulations thereunder, and has not been prepared other than in an establishment inspected under said Act, or (2) has been inspected and passed and is identified as such in accordance with the requirements of a State law.
(c) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this part or part 317 of this subchapter, and a list of ingredients in the article if composed of two or more ingredients: Provided, That in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper.
(d) To ensure the safe use of preparations used in hog scalding water or in the denuding of tripe, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.
(e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.
(f) [Reserved]
(g) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in § 318.12(a).
(h)(1) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of paragraph 23(a) of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of § 303.1(a)(2) of this subchapter.
(2) Meat, meat byproducts, and meat food products bearing official marks showing that they were inspected and passed under State inspection in any State not designated under section 301(c) of the Act may be received by official establishments for storage and distribution solely in intrastate commerce. The presence of such State inspected products must not create any unsanitary condition or otherwise result in adulteration of any products at the official establishment or interfere with the conduct of inspection under this subchapter. In addition, such State inspected products must be stored separately and apart from the federally inspected products in the official establishment.
(i) The operator of the official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question.
(j) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Administrator to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of this regulation. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified.
(a) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a Program employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in this subchapter.
(b) All products, whether fresh, cured, or otherwise prepared, even though previously inspected and passed, shall be reinspected by Program employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of the regulations in this subchapter are complied with.
(c) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The circuit supervisor shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator.
(d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the area supervisor.
Every official establishment shall designate, with the approval of the circuit supervisor, a dock or place at which products and other articles subject to reinspection under § 318.2 shall be received, and such products and articles shall be received only at such dock or place.
(a) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by Program employees unless such preparation is conducted as a custom operation exempted from inspection under § 303.1(a)(2) of this subchapter in any official establishment or consists of operations that are exempted from inspection under § 303.1(d) of this subchapter and are conducted in a retail store in an establishment subject to inspection only because the State or Territory in which the establishment is located is designated under paragraph 301(c) of the Act. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.
(b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to assure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter. The effectiveness of such measures will be subject to review by the Department.
(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:
(1) A letter to the Administrator from the establishment owner of operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control system requires it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.
(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be responsible for the quality control system.
(3) A list identifying those parts and sections of the Federal meat inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the quality control system will serve to maintain compliance with the applicable regulations.
(4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters or limits which will be used, and the points at which corrective action will occur and the nature of such corrective action—ranging from least to most severe: Provided, That, subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator.
(d) [Reserved]
(e) Evaluation and Approval of Total Plant Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system will be approved and plans will be made for implementation under departmental supervision.
(2) In any situation where the system is found by the Administrator to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Administrator, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding.
(3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control system to assure compliance with the requirements of the Act and regulations thereunder. The Secretary shall continue to provide the Federal inspection necessary to carry out his responsibilities under the Act.
(f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section may only use, as a part of any label, the following logo.
(g) Termination of Total Plant Quality Control. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator.
(2) The approval of a total plant quality control system may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:
(i) If adulterated or misbranded meat food product is found by the Administrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. In those instances where there is conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of approval shall remain in effect pending the final determination of the proceeding.
(ii) If the establishment fails to comply with the quality control system or program to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of quality control approval shall remain in effect pending the final determination of the proceeding.
(3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date.
(h)(1) Operating Schedule Under Total Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permission will be granted provided that:
(i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year.
(ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection.
(iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector.
(2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in § 318.4(h)(1) have been or will be met.
(3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspection services at the discretion of the circuit supervisor and charged for such services.
(a)(1) Care shall be taken to assure that product is not adulterated when placed in freezers. If there is doubt as to the soundness of any frozen product, the inspector will require the defrosting and reinspection of a sufficient quantity thereof to determine its actual condition.
(2) Frozen product may be defrosted in water or pickle in a manner and with the use of facilities which are acceptable to the inspector. Before such product is defrosted, a careful examination shall be made to determine its condition. If necessary, this examination shall include defrosting of representative samples by means other than in water or pickle.
(b) Product, such as pork tenderloins, brains, sweetbreads, stew, or chop suey, shall not be packed in hermetically sealed metal or glass containers, unless subsequently heat processed or otherwise treated to preserve the product in a manner approved by the Administrator in specific cases.
(c) Care shall be taken to remove bones and parts of bones from product which is intended for chopping.
(d) Heads for use in the preparation of meat food products shall be split and the bodies of the teeth, the turbinated and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.
(e) Kidneys for use in the preparation of meat food products shall first be freely sectioned and then thoroughly soaked and washed. All detached kidneys, including beef kidneys with detached kidney fat, shall be inspected before being used in or shipped from the official establishment.
(f) Cattle paunches and hog stomachs for use in the preparation of meat food products shall be thoroughly cleaned on all surfaces and parts immediately after being emptied of their contents, which shall follow promptly their removal from the carcasses.
(g) Clotted blood shall be removed from hog hearts before they are shipped from the official establishment or used in the preparation of meat food products.
(h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog bungs, hog middles, and hog stomachs which are to be used as containers of any meat food product shall be presented for inspection, turned with the fat surface exposed.
(i) Portions of casings which show infection with Oesophagostomum or other nodule-producing parasite, and weasands infected with the larvae of Hypoderma lineatum, shall be rejected, except that when the infestation is slight and the nodules and larvae are removed, the casing or weasand may be passed.
(a) All ingredients and other articles used in the preparation of any product shall be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated. Official establishments shall furnish inspectors accurate information on all procedures involved in product preparation including product composition and any changes in such procedures essential for inspectional control of the product.
(b)(1) The only animal casings that may be used as containers of product are those from sheep, swine, or goats. Casings from cattle may be used as containers of products. However, if casings from cattle are derived from the small intestine, the small intestine must comply with the requirements in 9 CFR 310.22(d). Establishments that use casings derived from the small intestine of cattle as containers for products must demonstrate, through documentation, that the small intestine from which the casing was derived complies with the requirements in 9 CFR 310.22(d).
(2) Casings for products shall be carefully inspected by Program employees. Only those casings which have been carefully washed and thoroughly flushed with clean water immediately before stuffing and are suitable for containers, are clean, and are passed on such inspection shall be used, except that preflushed animal casings packed in salt or salt and glycerine solution or other approved medium may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed before use.
(3) Hog and sheep casings intended for use as containers of product may be treated by soaking in or applying thereto sound, fresh pineapple juice or papain or bromelin or pancreatic extract to permit the enzymes contained in these substances to act on the casings to make them less resistant. The casings shall be handled in a clean and sanitary manner throughout and the treatment shall be followed by washing and flushing the casings with water sufficiently to effectively remove the substance used and terminate the enzymatic action.
(4) On account of the invariable presence of bone splinters, detached spinal cords shall not be used in the preparation of edible product other than for rendering where they constitute a suitable raw material. Detached spinal cords from cattle 30 months of age and older shall not be used as raw materials for edible rendering.
(5) Testicles if handled as an edible product may be shipped from the official establishment as such, but they shall not be used as an ingredient of a meat food product.
(6) Tonsils shall be removed and shall not be used as ingredients of meat food products.
(7) Blood from livestock prepared in accordance with § 310.20 of this subchapter may be used as an ingredient of a meat food product for which a standard is prescribed in part 319 of this subchapter, if permitted by such standard, and may be used in any meat food product for which no such standard is prescribed in part 319 of this subchapter if it is a common and usual ingredient of such product.
(8) Intestines shall not be used as ingredients in any meat food product for which a standard is prescribed in part 319 of this subchapter and shall not be used in other products unless the products are labeled in accordance with § 317.8(b)(3) of this subchapter. When small intestine from cattle is used in a meat food product or for edible rendering, it must comply with the requirements in 9 CFR 310.22(d).
(9) Poultry products and egg products (other than shell eggs) which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when identified as having been inspected and passed for wholesomeness by the Department under the regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to be sound and otherwise acceptable when presented for use. Poultry products and egg products (other than shell eggs) which have not been so inspected and passed for wholesomeness shall not be used in the preparation of such meat food products.
(10) Dry milk products which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when produced in a plant approved by the Department under the regulations in 7 CFR part 58, and when found to be sound and otherwise acceptable when presented for use. Dry milk products prepared in a plant not so approved shall not be used in the preparation of such meat food products.
(11) [Reserved]
(12) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of level permitted in § 318.16.
(13) Use of “Mechanically Separated (Kind of Poultry),” as defined in § 381.173 of this chapter, in the preparation of meat food products shall accord with § 381.174 and all other applicable provisions of this subchapter.
(a) Preservatives and other substances not permitted in domestic product under the regulations in this subchapter may be used in the preparation and packing of product intended for export provided the product (1) accords to the specifications or directions of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; and (3) is labeled on the outside container to show that it is intended for export, and is otherwise labeled as required by this subchapter for such export product.
(b) The preparation and packing of export product as provided for in paragraph (a) of this section shall be done in a manner acceptable to the inspector in charge so that the identity of the export product is maintained conclusively and the preparation of domestic product is adequately protected. The preservatives and other substances not permitted in domestic product shall be stored in a room or compartment separate from areas used to store other supplies and shall be held under Program lock. Use of the preservatives or other substances shall be under the direct supervision of a Program employee.
(c) The packing of all articles under paragraph (a) of this section shall be conducted under the direct supervision of a Program employee.
(d) No article prepared or packed for export under paragraph (a) of this section shall be sold or offered for sale for domestic use or consumption, but unless exported shall be destroyed for food purposes under the direct supervision of a Program employee.
(e) The contents of the container of any article prepared or packed for export under paragraph (a) of this section shall not be removed, in whole or in part, from such container prior to exportation, except under the supervision of a Program employee. If such contents are removed prior to exportation, then the article shall be either repacked, in accordance with the provisions of paragraphs (b) and (c) of this section, or destroyed for food purposes under the direct supervision of a Program employee.
(f) Permission must be obtained from the Administrator before meats packed in borax are shipped from one official establishment to another or to an unofficial establishment for storage, except such meat prepared for the account of Federal agencies.
(g) At all times, the identity of meat to which borax has been added shall be effectively maintained. In no case shall such meat, nor any trimmings or fat derived from such meat, whether unwashed or washed, or otherwise treated, be diverted to domestic use.
(h) Salt used for bulking meat previously packed in borax may not again be used in an edible products department other than in connection with the packing of meat in borax. Only metal equipment should be used for handling such meat. Particularly effective cleansing will be required if wooden equipment such as trucks, washing vats, etc., is used. Boxes from which boraxed meat has been removed may be used for repacking meat in borax, but their use as containers for other meat will be dependent upon the effective removal of all traces of borax.
(i) The following instructions pertain to export cured pork packed in borax for the account of Federal agencies. The meat may be packed in borax in a room in which there is borax-free meat, provided proper care is taken to see that the borax-free meat is not affected by the borax. Under the same condition, meat packed in borax may be received, unpacked, defrosted, soaked, washed, smoked, and repacked in a room where there is other meat. However, meat originally packed in borax shall at all times be subject to the restrictions of meat so packed, even though repacked without borax. After packing or repacking, borax packed meat may be stored in a room with meat not packed in borax, provided a reasonable degree of separation is maintained between the two classes of product.
Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Program, for examination, as often as may be deemed necessary for the efficient conduct of the inspection.
(a) Official establishments may manufacture pet food or similar uninspected, inedible products in areas where edible products also are produced, provided that the manufacture of uninspected, inedible products does not:
(1) Adulterate edible products;
(2) Create insanitary conditions in the official establishment whereby edible products may be adulterated; or
(3) Prevent or interfere with inspection or other program tasks performed by FSIS personnel in the official establishment.
(b) Pet food and similar uninspected, inedible products must be distinguished from edible products so as to avoid their distribution as human food. Pet food or similar uninspected, inedible products must be labeled or otherwise identified in accordance with § 325.11(d) of this subchapter.
Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of § 318.1.
(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.
(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator
(c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:
(1) Separate and condemn all product in damaged or extensively rusted containers.
(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:
(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator,
(ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly.
(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.
(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers.
When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a “U.S. retained” tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.
(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act.
(b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.
(c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator.
(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards:
(1) Lethality. A 6.5-log
(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log
(b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule.
(c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.
Material to be processed into “Mechanically Separated (Species)” shall be so processed within 1 hour from the time it is cut or separated from carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 °F. (4 °C.) or less, or held indefinitely at 0 °F. (−18 °C.) or less. “Mechanically Separated (Species)” shall, directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 °F. (4 °C.) or less or indefinitely at 0 °F. (−18 °C.) or less.
(a) Definitions. For the purposes of this section:
(1) A product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in § 319.104 or the chart in § 319.105.
(2) A Product Group or a Group means one of the following:
Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations.
Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations.
Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III.
Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit into Group I, Group II, or Group III shall be placed in this Group.
(3) A lot is that product from one production shift.
(4) A production rate is frequency of production, expressed in days per week.
(5) Protein fat free percentage, protein fat free content, PFF percentage, PFF content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.
(b) Normal Compliance Procedures. The Department shall collect samples of cured pork products and analyze them for their PFF content. Analyses shall be conducted in accordance with the “Official Methods of Analysis of the Association of Official Analytical Chemists §§ 950.46, and 928.08 (Chapter 39).
1. Laboratory results for percent meat protein and fat will be reported to the second decimal place (hundredths).
2. PFF and Sample Values for charting purposes will be calculated from the reported laboratory results to the second decimal place. Rounding of calculations to reach two decimal places will be done by the following rule:
All values of five-thousandths (0.005) or more will be rounded up to the next highest hundredth. All values of less than five-thousandths (0.005) will be dropped.
3. For compliance with the Absolute Minimum PFF requirements, the PFF will be rounded to the first decimal place (tenths). Rounding of calculations to reach one decimal place will be done by the following rule:
All PFF values of five-hundredths (0.05) or more will be rounded up to the next highest tenth. All PFF values of less than five-hundredths (0.05) will be dropped.
4. For product disposition (pass-fail of a minimum PFF standard for retained product) the average PFF calculation will be rounded to the first decimal place. Individual PFF Values will be calculated to the nearest hundredth as in (2) above. The average, however, will be rounded to the nearest tenth as in (3) above.
(1) Criteria to determine sampling frequency of Product Groups. For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows:
(i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.
(ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91.
(iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference.
(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value.
(v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values.
(vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than −1.40 (e.g., −1.39, −1.14, 0, 0.50, etc.) and shall be daily when the Group Value is −1.40 or less (e.g., −1.40, −1.45, −1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is −1.65 or greater (e.g., −1.63, −1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c).
(2) Criteria for U.S. retention or administrative detention of cured pork products for further analysis. Cured prok products shall be U.S. retained, or administratively detained, as appropriate, when prescribed by paragraphs (b)(2) (i) or (ii) of this section as follows:
(i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of § 319.104 or § 319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be U.S. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there U.S. retained. Any subsequently produced lots of like product and any lots of like product for which production dates cannot be established shall be U.S. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such U.S. retained product shall be in accordance with paragraph (c) of this section.
(ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be U.S. retained shall be as follows:
(A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of § 319.104 and § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.
(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of this section by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section to find the standardized difference.
(C) Use the lesser of 1.65 and the standardized difference as the Sample Value.
(D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be ignored in determining future Product Values.
(E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is −1.65 or less (e.g., −1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be U.S. retained and further evaluated under paragraph (c) of this section. Except for release of individual lot pursuant to paragraph (c)(1), subsequently produced lots of like product shall continue to be U.S. retained until discontinued pursuant to paragraph (c)(2) of this section.
(c) Compliance procedure during product retention. When a product lot is U.S. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section.
(1) A product lot which is U.S. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met:
(i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by § 319.104 or § 319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain.
(ii) The lot of the product is relabeled to conform to the provisions of § 319.104 or § 319.105, under the supervision of a program employee.
(iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of U.S. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section.
(2) The PFF content of three randomly selected samples from each U.S. retained lot shall be used to maintain the Product Value described in paragraph (c)(2)(ii). The manner and effect of such maintenance shall be as follows: (i) Find the average PFF content of the three samples.
(ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirements.
(iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference.
(iv) Use the lesser of 1.30 and the standardized difference as the Sample Value.
(v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (c)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values.
(vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a U.S. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section. Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew.
(vii) When U.S. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section.
(3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing a product from its Product Group, provided product lots are being U.S. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first U.S. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being U.S. retained, the product shall again be considered with its Group.
(d) Adulterated and misbranded products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)).
(e) Quality control. Cured pork products bearing on their labeling the statement “X% of Weight is Added Ingredients” shall be prepared only under a quality control system or program in accordance with § 318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under § 318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided in plant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect.
Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein.
(a) For purposes of this section, the following definitions apply.
(1) Cooked sausage. Cooked sausage is any product described in § 319.140 and §§ 319.180-319.182 of this chapter.
(2) Group 1 Protein-Contributing Ingredients. Ingredients of livestock or poultry origin from muscle tissue which is skeletal or which is found in the edible organs, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing; meat byproducts; mechanically separated (species); and poultry products; except those ingredients processed by hydrolysis, extraction, concentrating or drying.
(3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup 1 protein-contributing ingredients processed by hydrolysis, extraction, concentrating, or drying, or any other ingredient which contributes protein.
(b) The amount of added water in cooked sausage is calculated by:
(1) Determining by laboratory analysis the total percentage of water contained in the cooked sausage; and
(2) Determining by laboratory analysis the total percentage of protein contained in the cooked sausage; and
(3) Calculating the percentage of protein in the cooked sausage contributed by the Group 2 protein-contributing ingredients; and
(4) Subtracting one pecent from the total percentage of protein calculated in (b)(3)); and
(5) Subtracting the remaining percentage of protein calculated in (b)(3) from the total protein content determined in (b)(2); and
(6) Calculating the percentage of indigenous water in the cooked sausage by multiplying the percentage of protein determined in (b)(5) by 4, (This amount is the percentage of water attributable to Group 1 protein-contributing ingredients and one percent of Group 2 protein-contributing ingredients in a cooked sausage.); and
(7) Subtracting the percentage of water calculated in (b)(6) from the total percentage of water determined in (b)(1). (This amount is the percentage of added water in a cooked sausage.)
(a) Definitions. For purposes of this section, the following definitions shall apply:
(1) Patty. A shaped and formed, comminuted, flattened cake of meat food product.
(2) Comminuted. A processing term describing the reduction in size of pieces of meat, including chopping, flaking, grinding, or mincing, but not including chunking or sectioning.
(3) Partially-cooked patties. Meat patties that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.
(4) Char-marked patties. Meat patties that have been marked by a heat source and that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.
(b) Heat-processing procedures for fully-cooked patties. (1) Official establishments which manufacture fully-cooked patties shall use one of the following heat-processing procedures:
Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties
| Minimum internal temperature at the center of each patty
(Degrees) | Minimum holding time after required internal temperature is reached
(Time) | ||
|---|---|---|---|
| Fahrenheit | Or centigrade | Minutes | Or seconds |
| 151 | 66.1 | .68 | 41 |
| 152 | 66.7 | .54 | 32 |
| 153 | 67.2 | .43 | 26 |
| 154 | 67.8 | .34 | 20 |
| 155 | 68.3 | .27 | 16 |
| 156 | 68.9 | .22 | 13 |
| 157 (and up) | 69.4 (and up) | .17 | 10 |
(2) The official establishment shall measure the holding time and temperature of at least one fully-cooked patty from each production line each hour of production to assure control of the heat process. The temperature measuring device shall be accurate within 1 degree F.
(3) Requirements for handling heating deviations. (i) If for any reason a heating deviation has occurred, the official establishment shall investigate and identify the cause; take steps to assure that the deviation will not recur; and place on file in the official establishment, available to any duly authorized FSIS program employee, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence.
(ii) In addition, in the case of a heating deviation, the official establishment may reprocess the affected product, using one of the methods in paragraph (b)(1) in this section; use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics; or relabel the affected product as a partially-cooked patty product, if it meets the stabilization requirements in paragraph (c) of this section.
(c) Stabilization. (1) Fully cooked, partially cooked, and char-marked meat patties must be produced using processes ensuring no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log
(2) For each meat patty product produced using a stabilization process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule.
(3) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.
(4) Partially cooked patties must bear the labeling statement “Partially cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement must be adjacent to the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(5) Char-marked patties must bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement shall be adjacent to the product name, at least one-half the size of the largest letter in the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in § 310.22 of this subchapter, using advances in mechanical meat/bone separation machinery (i.e., AMR systems) that, in accordance with this section, recover meat—
(1) Without significant incorporation of bone solids or bone marrow as measured by the presence of calcium and iron in excess of the requirements in this section, and
(2) Without the presence of any brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).
(b) Process control. As a prerequisite to labeling or using product as meat derived by the mechanical separation of skeletal muscle tissue from livestock bones, the operator of an establishment must develop, implement, and maintain procedures that ensure that the establishment's production process is in control.
(1) The production process is not in control if the skulls entering the AMR system contain any brain or trigeminal ganglia tissue, if the vertebral column bones entering the AMR system contain any spinal cord, if the recovered product fails otherwise under any provision of paragraph (c)(1), if the product is not properly labeled under the provisions of paragraph (c)(2), or if the spent bone materials are not properly handled under the provisions of paragraph (c)(3) of this section.
(2) The establishment must document its production process controls in writing. The program must be designed to ensure the on-going effectiveness of the process controls. If the establishment processes cattle, the program must be in its HACCP plan, its Sanitation SOP, or other prerequisite program. The program shall describe the on-going verification activities that will be performed, including the observation of the bones entering the AMR system for brain, trigeminal ganglia, and spinal cord; the testing of the product exiting the AMR system for bone solids, bone marrow, spinal cord, and DRG as prescribed in paragraph (c)(1) of this section; the use of the product and spent bone materials exiting the AMR system; and the frequency with which these activities will be performed.
(3) The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process.
(4) The establishment shall make available to inspection program personnel the documentation described in paragraphs (b)(2) and (b)(3) of this section and any other data generated using these procedures.
(c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances:
(i) Bone solids. The product's calcium content, measured by individual samples and rounded to the nearest 10th, is more than 130.0 mg per 100 g.
(ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g.
(iii) Brain or trigeminal ganglia. Skulls that enter the AMR system have tissues of brain or trigeminal ganglia.
(iv) Spinal cord. Vertebral column bones that enter the AMR system have tissues of spinal cord, or the product that exits the AMR system contains spinal cord.
(v) DRG. The product that exits the AMR system contains DRG.
(2) If product that may not be labeled or used as “meat” under this section meets the requirements of § 319.5 of this subchapter, it may bear the name “Mechanically Separated (Species)” except as follows:
(i) If skulls or vertebral column bones of cattle younger than 30 months of age that enter the AMR system have tissues of brain, trigeminal ganglia, or spinal cord, the product that exits the AMR system shall not be used as an ingredient of a meat food product.
(ii) If product that exits the AMR system contains spinal cord or DRG from bones of cattle younger than 30 months of age, it shall not be used as an ingredient of a meat food product.
(iii) If product derived from any bones of cattle of any age does not comply with (c)(1)(i) or (ii), it may bear a common or usual name that is not false or misleading, except that the product may not bear the name “Mechanically Separated (Beef).”
(3) Spent skulls or vertebral column bone materials from cattle younger than 30 months of age that exit the AMR system shall not be used as an ingredient of a meat food product.
(a) Labels for products for which standards of identity or composition are prescribed in this part shall show the appropriate product name, an ingredient statement, and other label information in accordance with the special provisions, if any, in this part, and otherwise in accordance with the general labeling provisions in part 317 of this subchapter, and such products shall be prepared in accordance with the special provisions, if any, in this part and otherwise in accordance with the general provisions in this subchapter. Any product for which there is a common or usual name must consist of ingredients and be prepared by the use of procedures common or usual to such products insofar as specific ingredients or procedures are not prescribed or prohibited by the provisions of this subchapter.
(b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of meat products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients.
Any product, such as frankfurters and corned beef, for which there is a standard in this part and to which nitrate or nitrite is permitted or required to be added, may be prepared without nitrate or nitrite and labeled with such standard name when immediately preceded with the term “Uncured” in the same size and style of lettering as the rest of such standard name: Provided, That the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate and nitrite: And provided further, That labeling for such product complies with the provisions of § 317.17(c) of this subchapter.
(a) Mechanically Separated (Species) is any finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of livestock carcasses and parts of carcasses and meeting the other provisions of this paragraph. Examples of such product are “Mechanically Separated Beef”, “Mechanically Separated Veal”, “Mechanically Separated Pork”, and “Mechanically Separated Lamb”. At least 98 percent of the bone particles present in such product shall have a maximum size no greater than 0.5 millimeter in their greatest dimension and there shall be no bone particles larger than 0.85 millimeter in their greatest dimension. The product resulting from the separating process shall not have a calcium content exceeding 0.75 percent, as a measure of a bone solids content of not more than 3 percent, and shall have a minimum PER of 2.5 (except as modified in paragraph (e)(1) of this section). Such product also shall have a protein content of not less than 14 percent and a fat content of not more than 30 percent, or it shall be deemed to be product for processing. Such product failing to meet the bone particle size, calcium, or PER requirements of this paragraph shall only be used in producing animal fats. Where such product meets the bone particle size, calcium, and PER requirements of this paragraph, it may also be used in the formulation of meat food products in accordance with § 319.6.
(b) Mechanically Separated (Beef) is inedible and prohibited for use as human food.
(c)-(d) [Reserved]
(e)(1) An essential amino acid content of at least 33 percent of the total amino acids presents in “Mechanically Separated (Species)” shall be accepted as evidence of compliance with the protein quality requirement set forth in paragraph (a) of this section. For purposes of this paragraph, essential amino acid content includes isoleucine, leucine, lysine, methionine, phenylalanine, threonine, and valine content, and the total amino acids present include isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine, tyrosine, arginine, histidine, alanine, aspartic acid, glutamic acid, glycine, proline, serine, and hydroxyproline content.
(2) Analytical methods used by establishments in verifying the fat, protein, and calcium content of product consisting of or containing Mechanically Separated (Species) shall be among those listed in “Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC),” 16th edition, 1995, §§ 960.39, 976.21, 928.08 (Chapter 39), and 940.33 (Chapter 45), which is incorporated by reference, or, if no AOAC method is available, in the “Chemistry Laboratory Guidebook,” U.S. Department of Agriculture, Washington, D.C., March 1986 edition, sections 6.011-6.013, Revised June 1987 (pages 6-35 through 6-65), or by appropriate methods validated by scientific bodies in collaborative trials. The “Official Methods of Analysis of the Association of Official Analytical Chemists,” Chapter 39 and Chapter 45, subsection 45.2.06 (AOAC Official Method 940.33), 16th edition, 1995, are incorporated by reference with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.
(a) Meat food products required to be prepared from one species shall not contain Mechanically Separated (Species) of any other species.
(b) Mechanically Separated (Species) described in § 319.5 that has a protein content of not less than 14 percent and a fat content of not more than 30 percent may constitute up to 20 percent of the livestock and poultry product portion of any meat food product except those listed in paragraph (d) of this section.
(c) Mechanically Separated (Species) for processing described in § 319.5 may constitute up to 20 percent of the livestock and poultry product portion of any meat food product that is subject to a definition and standard of identity or composition in part 319 which establishes a maximum limit on the fat content of such meat food product except those listed in paragraph (d) of this section.
(d) Mechanically Separated (Species) and Mechanically Separated (Species) for processing described in § 319.5 shall not be used in baby, junior, or toddler foods, ground beef, hamburger, fabricated steaks (§ 319.15 (a), (b), and (d)), barbecued meats (§ 319.80), roast beef-parboiled and steam roasted (§ 319.81), corned (cured) beef cuts (§§ 319.100-319.103), certain cured pork products (§§ 319.104 (a)-(e) and 319.106), tripe with milk (§ 319.308), lima beans with ham and similar products (§ 319.310), beef with gravy and gravy with beef (§ 319.313), and meat pies (§ 319.500).
(a) Description. The meat food products prescribed by this general definition and standard of identity are those products that substitute, in accordance with § 317.313(d), for a standardized product defined in this part and use the name of that standardized product in their statements of identity, but that do not comply with the established standard because of a compositional deviation that results from reduction of a constituent that is described by an expressed nutrient content claim that has been defined by regulation in part 317, subpart B, of this subchapter. The expressed nutrient content claim shall comply with the requirements of § 317.313 of this subchapter and with the requirements of part 317, subpart B, of this subchapter which define the particular nutrient content claim that is used. The meat food product shall comply with the relevant standard in this part in all other respects, except as provided in paragraphs (b) and (c) of this section.
(b) Performance characteristics. The performance characteristics, such as physical properties, functional properties, and shelf-life, of the meat food product shall be similar to those of the standardized meat food product produced under this part. If there is a significant difference in a performance characteristic that materially limits the use of the product compared to the use of the standardized product defined in this part, the label shall include a statement in accordance with § 317.313(d)(1) and (2) of this subchapter that informs the consumer of such differences (e.g., if appropriate, “not recommended for frozen storage” or “not suitable for roller grilling”). Deviations from the ingredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim, while maintaining similar performance characteristics.
(c) Ingredients used in substitute products. (1) Ingredients used in the product shall be those ingredients provided for in the standard as defined in this part, except that safe and suitable ingredients permitted for use in meat food products as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, may be used at the minimum level necessary to improve texture and prevent syneresis, so that the substitute product is not inferior in performance characteristics from the standardized product defined in this part for which it is a substitute.
(2) An ingredient that is specifically required by the standard prescribed in this part shall not be replaced or exchanged with a similar ingredient from another source, for example, turnip chunks shall not replace potatoes in corned beef hash.
(3) An ingredient that is specifically prohibited from use in any meat food product by this part shall not be added to the substitute meat food product under this section.
(4) Unless otherwise specified in this part, a substitute meat food product must meet all other requirements of the applicable standards of identity or composition.
(5) Water and fat-replacers (e.g., binders), in combination, may be added to replace fat in accordance with paragraph (c) of this section.
(6) Textured vegetable protein may be used by itself or in combination with other binders and water as a fat replacer in accordance with paragraph (c) of this section.
(d) Nomenclature. The name of a substitute meat food product that complies with all parts of this section is the appropriate expressed nutrient content claim and the applicable standardized term.
(e) Label declaration. (1) Each of the ingredients used in the substitute meat food product shall be declared on the label as required by this section and part 317 of this subchapter.
(2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in this part, shall be identified as such with an asterisk in the ingredients statement. The statement “*Ingredients not in regular ________” (the blank shall be filled in with the name of the traditional standardized product) or “**Ingredients in excess of amounts permitted in regular ________” (the blank shall be filled in with the name of the traditional standardized product), or both, as appropriate, shall immediately follow the ingredients statement in the same type and size.
(a) Chopped beef, ground beef. “Chopped Beef” or “Ground Beef” shall consist of chopped fresh and/or frozen beef with or without seasoning and without the addition of beef fat as such, shall not contain more than 30 percent fat, and shall not contain added water, phosphates, binders, or extenders. When beef cheek meat (trimmed beef cheeks) is used in the preparation of chopped or ground beef, the amount of such cheek meat shall be limited to 25 percent; and if in excess of natural proportions, its presence shall be declared on the label, in the ingredient statement required by § 317.2 of this subchapter, if any, and otherwise contiguous to the name of the product.
(b) Hamburger. “Hamburger” shall consist of chopped fresh and/or frozen beef with or without the addition of beef fat as such and/or seasoning, shall not contain more than 30 percent fat, and shall not contain added water, phosphates, binders, or extenders. Beef cheek meat (trimmed beef cheeks) may be used in the preparation of hamburger only in accordance with the conditions prescribed in paragraph (a) of this section.
(c) Beef patties. “Beef Patties” shall consist of chopped fresh and/or frozen beef with or without the addition of beef fat as such and/or seasonings. Binders or extenders, Mechanically Separated (Species) used in accordance with § 319.6, and/or partially defatted beef fatty tissue may be used without added water or with added water only in amounts such that the product characteristics are essentially that of a meat pattie.
(d) Fabricated steak. Fabricated beef steaks, veal steaks, beef and veal steaks, or veal and beef steaks, and similar products, such as those labeled “Beef Steak, Chopped, Shaped, Frozen,” “Minute Steak, Formed, Wafer Sliced, Frozen,” “Veal Steaks, Beef Added, Chopped—Molded—Cubed—Frozen, Hydrolyzed Plant Protein, and Flavoring” shall be prepared by comminuting and forming the product from fresh and/or frozen meat, with or without added fat, of the species indicated on the label. Such products shall not contain more than 30 percent fat and shall not contain added water or extenders. Transglutaminase enzyme at levels of up to 65 ppm may be used as a binder. Beef cheek meat (trimmed beef cheeks) may be used in the preparation of fabricated beef steaks only in accordance with the conditions prescribed in paragraph (a) of this section.
(e) Partially defatted beef fatty tissue. “Partially Defatted Beef Fatty Tissue” is a beef byproduct derived from the low temperature rendering (not exceeding 120 °F.) of fresh beef fatty tissue. Such product shall have a pinkish color and a fresh odor and appearance.
(a) Partially defatted pork fatty tissue. “Partially Defatted Pork Fatty Tissue” is a pork byproduct derived from the low temperature rendering (not exceeding 120 °F.) of fresh pork fatty tissue, exclusive of skin. Such product shall have a pinkish color and a fresh odor and appearance.
Barbecued meats, such as product labeled “Beef Barbecue” or “Barbecued Pork,” shall be cooked by the direct action of dry heat resulting from the burning of hard wood or the hot coals therefrom for a sufficient period to assume the usual characteristics of a barbecued article, which include the formation of a brown crust on the surface and the rendering of surface fat. The product may be basted with a sauce during the cooking process. The weight of barbecued meat shall not exceed 70 percent of the weight of the fresh uncooked meat.
“Roast Beef Parboiled and Steam Roasted” shall be prepared so that the weight of the finished product, excluding salt and flavoring material, shall not exceed 70 percent of the fresh beef weight. Transglutaminase enzyme at levels of up to 65 ppm may be used as a binder in such product. Beef cheek meat and beef head meat from which the overlying glandular and connective tissues have been removed, and beef heart meat, exclusive of the heart cap may be used individually or collectively to the extent of 5 percent of the meat ingredients in the preparation of canned product labeled “Roast Beef Parboiled and Steam Roasted.” When beef cheek meat, beef head meat, or beef heart meat is used in the preparation of this product, its presence shall be reflected in the statement of ingredients required by part 317 of this subchapter.
“Corned Beef” shall be prepared from beef briskets, navels, clods, middle ribs, rounds, rumps, or similar cuts using one or a combination of the curing ingredients specified in a regulation permitting that use in this subchapter or 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B. Canned product labeled “Corned Beef” shall be prepared so that the weight of the finished product, excluding cure, salt, and flavoring material, shall not exceed 70 percent of the fresh beef weight. Corned beef other than canned shall be cured in pieces weighing not less than 1 pound, and if cooked, its weight shall not exceed the weight of the fresh uncured beef. Beef cheek meat, beef head meat and beef heart meat may be used to the extent of 5 percent of the meat ingredient in preparation of this product when trimmed as specified in § 319.81. When beef cheek meat, beef head meat, or beef heart meat is used in preparation of this product, its presence shall be reflected in the statement of ingredients required by part 317 of this subchapter. The application of curing solution to beef cuts, other than briskets, which are intended for bulk corned beef shall not result in an increase in the weight of the finished cured product of more than 10 percent over the weight of the fresh uncured meat.
In preparing “Corned Beef Brisket,” the application of curing solution to the beef brisket shall not result in an increase in the weight of the finished cured product of more than 20 percent over the weight of the fresh uncured brisket. If the product is cooked, the weight of the finished product shall not exceed the weight of the fresh uncured brisket.
In preparing “Corned Beef Round” and other corned beef cuts, except “Corned Beef Briskets,” the curing solution shall be applied to pieces of beef weighing not less than one pound and such application shall not result in an increased weight of the cured beef product of more than 10 percent over the weight of the fresh uncured beef cut. If the product is cooked, the weight of the finished product shall not exceed the weight of the fresh uncured beef cut.
In preparing “Cured Beef Tongue,” the application of curing solution to the fresh beef tongue shall not result in an increase in the weight of the cured beef tongue of more than 10 percent over the weight of the fresh uncured beef tongue.
(a) Cured pork products, including hams, shoulders, picnics, butts and loins, shall comply with the minimum meat Protein Fat Free (PFF) percentage requirements set forth in the following chart:
| Type of cured pork product | Minimum meat PFF percentage 1 | Product name and qualifying statements |
|---|---|---|
| Cooked ham, loin 2 | 20.5 | (Common and usual). |
| 18.5 | (Common and usual) with natural juices. | |
| 17.0 | (Common and usual) water added. | |
| <17.0 | (Common and usual) and water product—X% of weight is added ingredients. 3 | |
| Cooked shoulder, butt, picnic 2 | 20.0 | (Common and usual). |
| 18.0 | (Common and usual) with natural juices. | |
| 16.5 | (Common and usual) water added. | |
| <16.5 | (Common and usual) and water product—X% of weight is added ingredients. 3 | |
| Uncooked cured ham, loin | 18.0 | Uncooked (common and usual). |
| <18.0 | Uncooked (common and usual) and water product—X% of weight is added ingredients. 3 | |
| Uncooked cured shoulder, butt, picnic | 17.5 | Uncooked (common and usual). |
| <17.5 | Uncooked (common and usual) and water product—X% of weight is added ingredients. 3 |
1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw unprocessed pork expressed as a percent of the non-fat portion of the finished product; and compliance shall be determined under § 318.19 of this subchapter for domestic cured pork product and § 327.23 of this subchapter for imported cured pork product.
2 The term “cooked” is not appropriate for use on labels of cured pork products heated only for the purpose of destruction of possible live trichinae.
3 Processors may immediately follow this qualifying statement with a list of the ingredients in descending order of predominance rather than having the traditional ingredients statement. In any case, the maximum percent of added substances in the finished product on a total weight percentage basis would be inserted as the X value; e.g., Ham and Water Product—20% of Weight is Added Ingredients.
(b) Cured pork products for which there is a qualifying statement required in paragraph (a) of this section shall bear that statement as part of the product name in lettering not less than
(c) Cured pork product prepared pursuant to this section shall be subject to the compliance procedures in § 318.19 of this subchapter.
(d) The binders provided for use in cured pork products in a regulation in this subchapter, in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B, may be used singly in those cured pork products labeled as “Ham Water Added,” “Ham and Water Product-X% of Weight is Added Ingredients,” and “Ham with Natural Juices.” In addition to the binders referred to in the preceding sentence, the following substances are permitted for use as binders and may be used singly in those cured pork products labeled as “Ham Water Added,” “Ham and Water Product-X% of Weight is Added Ingredients,” and “Ham with Natural Juices”: pork collagen at up to 3.5% of the product formulation. Unless their use is provided for in a regulation in this subchapter, in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B, or in this paragraph, these binders are not permitted to be used in combination with another such binder listed for use in cured pork products. When any such substance is added to these products, the substance shall be declared in the ingredients statement by its common or usual name in order of predominance.
(a) Finely divided (chopped, ground, flaked, chipped) cured ham products such as “Ham patties,” “Chopped ham,” “Pressed ham,” and “Spiced ham” shall comply with minimum meat Protein Fat Free (PFF) percentage requirements set forth in the following chart:
| Type of cured pork product | Minimum meat PFF percentage 1 | Product name and
qualifying statements |
|---|---|---|
| “Ham Patties,” “Chopped Ham,” “Pressed Ham,” and “Spiced Ham” | 19.5 | (Common and usual). |
| “Ham Patties,” “Chopped Ham,” “Pressed Ham,” and “Spiced Ham” | 17.5 | (Common and usual) with natural juices. |
| “Ham Patties,” “Chopped Ham,” “Pressed Ham,” and “Spiced Ham” | 16.0 | (Common and usual) water added. |
| “Ham Patties,” “Chopped Ham,” “Pressed Ham,” and “Spiced Ham” | <16.0 | (Common and usual) and water product—(x)% of weight is added ingredients. 2 |
1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw, unprocessed pork expressed as a percent of the nonfat portion of the finished product; and compliance shall be determined under section 318.19 of this subchapter.
2 Processors may immediately follow this qualifying statement with a list of the ingredients in descending order of predominance rather than having the traditional ingredients statement. In any case, the maximum percent of added substances in the finished product on a total weight percentage basis would be inserted as the X value; e.g., Ham and Water Product—20% of Weight is Added Ingredients.
(b) Cured pork products prepared under this section except “Ham patties” may contain finely chopped ham shank meat to the extent of 25 percent over that normally present in boneless ham. Mechanically Separated (Species) Product may be used in accordance with § 319.6.
(c) Cured pork product prepared pursuant to this section shall be subject to the compliance procedures in § 318.19 of this subchapter, and those cured pork products prepared under this section for which there is a qualifying statement required shall comply with the requirements of § 319.104(b) of this subchapter.
(d) In addition to the other requirements of this section, “Ham Patties” may not contain more than 35 percent fat, by analysis.
(a) “Country Ham,” “Country Style Ham,” or “Dry Cured Ham,” and “Country Pork Shoulder,” “Country Style Pork Shoulder,” or “Dry Cured Pork Shoulder.” are the uncooked, cured, dried, smoked or unsmoked meat food products made respectively from a single piece of meat conforming to the definition of “ham,” as specified in § 317.8(b)(13) of this subchapter, or from a single piece of meat from a pork shoulder. They are prepared in accordance with paragraph (c) of this section by the dry application of salt (NaCl), or by the dry application of salt (NaCl) and one or more of the optional ingredients as specified in paragraph (d) of this section. They may not be injected with curing solutions nor placed in curing solutions.
(b)(1) The entire exterior of the ham or pork shoulder shall be coated by the dry application of salt or by the dry application of salt combined with other ingredients as permitted in paragraph (d) of this section.
(2) Additional salt, or salt mixed with other permitted ingredients, may be reapplied to the product as necessary to insure complete penetration.
(3) When sodium or potassium nitrate, or sodium or potassium nitrite, or a combination thereof, is used, the application of salt shall be in sufficient quantity to insure that the finished product has an internal salt content of at least 4 percent.
(4) When no sodium nitrate, potassium nitrate, sodium nitrite, potassium nitrite or a combination thereof is used, the application of salt shall be in sufficient quantity to insure that the finished product has a brine concentration of not less than 10 percent or a water activity of not more than 0.92.
(5) [Reserved]
(6) [Reserved]
(7) The weight of the finished hams and pork shoulders covered in this section shall be at least 18 percent less than the fresh uncured weight of the article.
(c) The optional ingredients for products covered in this section are:
(1) Nutritive sweeteners, spices, seasonings and flavorings.
(2) Sodium or potassium nitrate and sodium or potassium nitrite if used as prescribed in this section and in accordance with a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.
The weight of cured pork bellies ready for slicing and labeling as “Bacon” shall not exceed the weight of the fresh uncured pork bellies.
Except as otherwise provided in this section, or under the Poultry Products Inspection Act with respect to products consisting partly of poultry, sausage is the coarse or finely comminuted meat food product prepared from one or more kinds of meat or meat and meat byproducts, containing various amounts of water as provided for elsewhere in this part, and usually seasoned with condimented proportions of condimental substances, and frequently cured. Certain sausage as provided for elsewhere in this part may contain binders and extenders as provided in a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B. In addition to the binders and extenders referred to in the preceding sentence, the following two substances may also be used as binders in those sausages in which the use of such class of substances is permitted: pork collagen at up to 3.5% of the product formulation and transglutaminase enzyme at up to 65 ppm of the product formulation. Sausage may not contain phosphates except that phosphates listed in a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B may be used in cooked sausage. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of sausage which is not cooked in an amount not to exceed 3 percent of the total ingredients in the formula. Cooked sausages such as Polish sausage, cotto salami, braunschweiger, liver sausage, and similar cooked sausage products may contain no more than 10 percent of added water in the finished product. Sausage may contain Mechanically Separated (Species) used in accordance with § 319.6.
“Fresh Pork Sausage” is sausage prepared with fresh pork or frozen pork or both, but not including pork byproducts, and may contain Mechanically Separated (Species) in accordance with § 319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.
“Fresh Beef Sausage” is sausage prepared with fresh beef or frozen beef, or both, but not including beef byproducts, and may contain Mechanically Separated (Species) used in accordance with § 319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 30 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.
“Breakfast sausage” is sausage prepared with fresh and/or frozen meat; or fresh and/or frozen meat and meat byproducts, and may contain Mechanically Separated (Species) in accordance with § 319.6, and may be seasoned with condimental substances as permitted in part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used. Binders or extenders may be added as provided in § 319.140 of this part.
“Whole Hog Sausage” is sausage prepared with fresh and/or frozen meat from swine in such proportions as are normal to a single animal, and may include any Mechanically Separated (Species) produced from the animal and used in accordance with § 319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.
(a) Italian sausage products are cured or uncured sausages containing at least 85 percent meat, or combination of meat and fat, with the total fat content constituting not more than 35 percent of the finished product. Such products shall be prepared in accordance with the provisions of paragraph (a) (1), (2) or (3) of this section, and shall contain salt, pepper, and either fennel or anise, or a combination of fennel and anise. Such products may contain any or all of the optional ingredients listed in paragraph (b) of this section.
(1) “Italian Sausage” shall be prepared with fresh or frozen pork, or pork and pork fat, and may contain Mechanically Separated (Species) in accordance with § 319.6.
(2) “Italian Sausage with Beef,” “Italian Sausage with Veal,” or “Italian Sausage with Beef and Veal,” shall be prepared so that fresh or frozen pork constitutes the major portion of the meat content requirement of this paragraph. Mechanically Separated (Species) may be used in accordance with § 319.6.
(3) “Italian Beef Sausage” or “Kosher Italian Beef Sausage” shall be prepared with fresh or frozen beef or beef and beef fat. “Italian Veal Sausage” or “Kosher Italian Veal Sausage” shall be prepared with fresh or frozen veal or veal and veal fat. Mechanically Separated (Species) may be used in accordance with § 319.6.
(4) Italian sausage products made in conformance with the provisions of paragraphs (a) (1), (2), and (3) of this section, and with paragraphs (b) and (c) of this section, may contain sodium nitrite or potassium nitrite in amounts not to exceed those allowed in a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B, provided that such products are labeled with the word “cured” in the product name, such as “Cured Italian Sausage.” The word “cured” shall be displayed on the product label in the same size and style of lettering as other words in the product name.
(b) Optional ingredients permitted in Italian sausage products include:
(1) Spices (including paprika) and flavorings.
(2) Water or ice to facilitate chopping or mixing, but not to exceed 3 percent of the total weight of all ingredients including the water.
(3) Red or green peppers, or both.
(4) Dehydrated or fresh onions, garlic, and parsley.
(5) Sugar, dextrose, corn syrup, corn syrup solids, and glucose syrup.
(6) Monosodium glutamate and antioxidants in accordance with the chart of substances a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B.
(c) If Italian sausage products are cooked or smoked, determination of compliance with the provisions of paragraphs (a) and (b) of this section shall be based on the uncooked or unsmoked product. The product before cooking or smoking shall contain no more than 3 percent water as specified in paragraph (b)(2) of this section. Product which is cooked shall be labeled with the word “cooked” in the product name, such as “Cooked Italian Sausage” or “Cooked Cured Italian Sausage.” Product which is smoked shall be labeled with the word “smoked” in the product name, such as “Smoked Italian Sausage” or “Smoked Cured Italian Sausage.” The words “cooked” and “smoked” shall be displayed on the product label in the same size and style of lettering as other words in the product name.
“Smoked Pork Sausage” is pork sausage that is smoked with hardwood or other approved nonresinous materials. It may be seasoned with condimental substances as permitted in part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water, or ice may be used in an amount not to exceed 3 percent of the total ingredients used.
(a) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages are comminuted, semisolid sausages prepared from one or more kinds of raw skeletal muscle meat or raw skeletal muscle meat and raw or cooked poultry meat, and seasoned and cured, using one or more of the curing agents in accordance with a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B. They may or may not be smoked. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve the curing ingredients but the sausage shall contain no more than 40 percent of a combination of fat and added water. These sausage products may contain only phosphates approved under part 318 of this chapter. Such products may contain raw or cooked poultry meat and/or Mechanically Separated (Kind of Poultry) without skin and without kidneys and sex glands used in accordance with § 381.174, not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and Mechanically Separated (Species) used in accordance with § 319.6. Such poultry meat ingredients shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of § 381.118 of this chapter.
(b) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages that are labeled with the phrase “with byproducts” or “with variety meats” in the product name are comminuted, semisolid sausages consisting of not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts, or not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts and raw or cooked poultry products; and seasoned and cured, using one or more of the curing ingredients in accordance with a regulation permitting that use in this subchapter or in 9 CFR chapter III, subchapter E, or in 21 CFR chapter I, subchapter A or subchapter B. They may or may not be smoked. Partially defatted pork fatty tissue or partially defatted beef fatty tissue, or a combination of both, may be used in an amount not exceeding 15 percent of the meat and meat byproducts or meat, meat byproducts, and poultry products ingredients. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing to dissolve the curing and seasoning ingredients, the sausage shall contain no more than 40 percent of a combination of fat and added water. These sausage products may contain only phosphates approved under part 318 of this chapter. These sausage products may contain poultry products and/or Mechanically Separated (Kind of Poultry) used in accordance with § 381.174, individually or in combination, not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and may contain Mechanically Separated (Species) used in accordance with § 319.6. Such poultry products shall not contain kidneys or sex glands. The amount of poultry skin present in the sausage must not exceed the natural proportion of skin present on the whole carcass of the kind of poultry used in the sausage, as specified in § 381.117(d) of this chapter. The poultry products used in the sausage shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of § 381.118 of this chapter. Meat byproducts used in the sausage shall be designated individually in the ingredient statement on the label for such sausage in accordance with § 317.2 of this chapter.
(c) A cooked sausage as defined in paragraph (a) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst. When such sausage products are prepared with meat from a single species of cattle, sheep, swine, or goats they shall be labeled with the term designating the particular species in conjunction with the generic name, e.g., “Beef Frankfurter,” and when such sausage products are prepared in part with Mechanically Separated (Species) in accordance with § 319.6, they shall be labeled in accordance with § 317.2(j)(13) of this subchapter.
(d) A cooked sausage as defined in paragraph (b) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst, in conjunction with the phrase “with byproducts” or “with variety meats” with such supplemental phrase shown in a prominent manner directly contiguous to the generic name and in the same color on an identical background.
(e) Binders and extenders as provided in § 319.140 of this part may be used in cooked sausage that otherwise comply with paragraph (a) or (b) of this section. When any such substance is added to these products, the substance shall be declared in the ingredients statement by its common or usual name in order of predominance.
(f) Cooked sausages shall not be labeled with terms such as “All Meat” or “All (Species),” or otherwise to indicate they do not contain nonmeat ingredients or are prepared only from meat.
(g) For the purposes of this section: Poultry meat means deboned chicken meat or turkey meat, or both, without skin or added fat; poultry products mean chicken or turkey, or chicken meat or turkey meat as defined in § 381.118 of this chapter, or poultry byproducts as defined in § 381.1 of this chapter; and meat byproducts (or variety meats), mean pork stomachs or snouts; beef, veal, lamb, or goat tripe; beef, veal, lamb, goat, or pork hearts, tongues, fat, lips, weasands, and spleens; and partially defatted pork fatty tissue, or partially defatted beef fatty tissue.
“Cheesefurters” and similar products are products in casings which resemble frankfurters except that they contain sufficient cheese to give definite characteristics to the finished article. They may contain binders and extenders as provided in § 424.21(c) of subchapter E. Limits on use as provided in § 424.21 are intended to be exclusive of the cheese constituent. When any such substance is added to these products, the substance shall be designated in the ingredients statement by its common or usual name in order of predominance. These products shall contain no more than 40 percent of a combination of fat and added water, and no more than 30 percent fat and shall comply with the other provisions for cooked sausages that are in this subchapter.
(a) “Braunschweiger” is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 percent pork, beef, and/or veal livers computed on the weight of the fresh livers. It may also contain pork and/or beef fat. Mechanically Separated (Species) may be used in accordance with § 319.6. Binders and extenders may be used as permitted in § 319.140. The product may have a smoked taste characteristic, which may be imparted by use of smoked meats, smoke flavoring or smoking. If prepared from components of a single species, the product name may reflect the species, e.g., “Beef Braunschweiger.” Braunschweiger may also be labeled as any of the following: “Braunschweiger—A Liver Sausage,” “Braunschweiger—A Liverwurst,” or “Braunschweiger (Liver Sausage)” or “Braunschweiger (Liverwurst).”
(b) “Liver Sausage” or “Liverwurst” is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 percent pork, beef, veal, sheep, and/or goat livers computed on the weight of the fresh livers. It may also contain pork and/or beef byproducts. Mechanically Separated (Species) may be used in accordance with § 319.6. Binders and extenders maybe used as permitted in § 319.140. If prepared from components of a single species, the product name may reflect that species, e.g., “Pork Liver Sausage.”
“Luncheon Meat” is a cured, cooked meat food product made from comminuted meat. Mechanically Separated (Species) may be used in accordance with § 319.6. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of luncheon meat in an amount not to exceed 3 percent of the total ingredients.
“Meat Loaf” is a cooked meat food product in loaf form made from comminuted meat. Mechanically Separated (Species) may be used in accordance with § 319.6. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.
“Scrapple” shall contain not less than 40 percent meat and/or meat byproducts computed on the basis of the fresh weight, exclusive of bone. Mechanically Separated (Species) may be used in accordance with § 319.6. The meal or flour used may be derived from grain and/or soybeans.
(a) Bockwurst is an uncured, comminuted meat food product which may or may not be cooked. It contains meat, milk or water or a combination thereof, eggs, vegetables, and any of the optional ingredients listed in paragraph (b) of this section; and is prepared in accordance with the provisions of paragraphs (a)(1), (2), (3), and (4) of this section.
(1) Meat shall constitute not less than 70 percent of the total weight of the product and shall consist of pork or a mixture of pork and veal, pork and beef, or pork, veal, and beef. Such meat shall be fresh or fresh frozen meat. Pork may be omitted when the specie or species of meat used in the product is identified in the product name (e.g., Veal Bockwurst, Beef Bockwurst, or Beef and Veal Bockwurst). Mechanically Separated (Species) may be used in accordance with § 319.6.
(2) The “milk” may be fresh whole milk, dried milk, nonfat dry milk, calcium reduced dried skim milk, enzyme (rennet) treated calcium reduced dried skim milk and calcium lactate, or any combination thereof.
(3) “Eggs” refer to whole eggs that are fresh, frozen, or dried.
(4) “Vegetables” refer to onions, chives, parsley, and leeks, alone or in any combination.
(b) Bockwurst may contain one or more of the following optional ingredients:
(1) Pork fat.
(2) Celery, fresh or dehydrated.
(3) Spices, flavorings.
(4) Salt.
(5) Egg whites, fresh, frozen, or dried.
(6) Corn syrup solids, corn syrup, or glucose syrup with a maximum limit of 2 percent individually or collectively, calculated on a dry basis. The maximum quantities of such ingredients shall be computed on the basis of the total weight of the ingredients.
(7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein hydrolysate, and monosodium glutamate.
(8) Sugars (sucrose and dextrose).
(9) Binders and extenders may be added as provided in § 424.21(c) of subchapter E. When any such substance is added to bockwurst, the substance shall be designated in the ingredients statement by its common or usual name in order of predominance.
(c) If bockwurst is cooked or partially cooked, the composition of the raw mix from which it is prepared shall be used in determining whether it meets the requirements of this section.
“Chili con carne” shall contain not less than 40 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6. Head meat, cheek meat, and heart meat exclusive of the heart cap may be used to the extent of 25 percent of the meat ingredients under specific declaration on the label. The mixture may contain binders and extenders as provided in § 424.21(c) of subchapter E.
Chili con carne with beans shall contain not less than 25 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6. Head meat, cheek meat, or heart meat exclusive of the heart cap may be used to the extent of 25 percent of the meat ingredients, and its presence shall be reflected in the statement of ingredients required by part 317 of this subchapter. The mixture may contain binders and extenders as provided in § 424.21(c) of subchapter E.
“Hash” shall contain not less than 35 percent of meat computed on the weight of the cooked and trimmed meat. The weight of the cooked meat used in this calculation shall not exceed 70 percent of the weight of the uncooked fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6.
(a) “Corned Beef Hash” is the semi-solid food product in the form of a compact mass which is prepared with beef, potatoes, curing agents, seasonings, and any of the optional ingredients listed in paragraph (b) of this section, in accordance with the provisions of paragraphs (a) (1), (2), (3) and (4) of this section and the provisions of paragraph (c) of this section.
(1) Either fresh beef, cured beef, or canned corned beef or a mixture of two or more of these ingredients, may be used, and the finished product shall contain not less than 35 percent of beef computed on the weight of the cooked and trimmed beef. The weight of the cooked meat used in this calculation shall not exceed 70 percent of the weight of the uncooked fresh meat.
(2) “Potatoes” refers to fresh potatoes, dehydrated potatoes, cooked dehydrated potatoes, or a mixture of two or more of these ingredients.
(3) The curing agents that may be used are salt, sodium nitrate, sodium nitrite, potassium nitrate, or potassium nitrite, or a combination of two or more of these ingredients. When sodium nitrate, or sodium nitrite, potassium nitrate, or potassium nitrite is used it shall be used in amounts not exceeding those specified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.
(4) The seasonings that may be used, singly or in combination, are salt, sugar (sucrose or dextrose), spice, and flavoring, including essential oils, oleoresins, and other spice extractives.
(b) Corned beef hash may contain one or more of the following optional ingredients:
(1) Beef cheek meat and beef head meat from which the overlying glandular and connective tissues have been removed, and beef heart meat, exclusive of the heart cap, may be used individually or collectively to the extent of 5 percent of the meat ingredients;
(2) Onions, including fresh onions, dehydrated onions, or onion powder;
(3) Garlic, including fresh garlic, dehydrated garlic, or garlic powder;
(4) Water;
(5) Beef broth or beef stock;
(6) Monosodium glutamate;
(7) Hydrolyzed plant protein;
(8) Beef fat;
(9) Mechanically Separated (Species) when derived from carcasses of cattle may be used in accordance with § 319.6.
(c) The finished product shall not contain more than 15 percent fat nor more than 72 percent moisture.
(d)(1) When any ingredient specified in paragraph (b)(1) of this section is used, the label shall bear the following applicable statement: “Beef cheek meat constitutes 5 percent of the meat ingredient,” or “Beef head meat constitutes 5 percent of the meat ingredient,” or “Beef heart meat constitutes 5 percent of the meat ingredient.” When two or more of the ingredients are used, the words “Constitutes 5 percent of meat ingredient” need only appear once.
(2) Whenever the words “corned beef hash” are featured on the label so conspicuously as to identify the contents, the statements prescribed in paragraph (d)(1) of this section shall immediately and conspicuously precede or follow such name without intervening written, printed, or other graphic matter.
Meat stews such as “Beef Stew” or “Lamb Stew” shall contain not less than 25 percent of meat of the species named on the label, computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6.
“Tamales” shall be prepared with at least 25 percent meat computed on the weight of the uncooked fresh meat in relation to all ingredients of the tamales. When tamales are packed in sauce or gravy, the name of the product shall include a prominent reference to the sauce or gravy; for example, “Tamales With Sauce” or “Tamales With Gravy.” Product labeled “Tamales With Sauce” or “Tamales With Gravy” shall contain not less than 20 percent meat, computed on the weight of the uncooked fresh meat in relation to the total ingredients making up the tamales and sauce or the tamales and gravy. Mechanically Separated (Species) may be used in accordance with § 319.6.
“Spaghetti with Meatballs and Sauce” and “Spaghetti with Meat and Sauce,” and similar products shall contain not less than 12 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6. The presence of the sauce or gravy constituent shall be declared prominently on the label as part of the name of the product. Meatballs may be prepared with farinaceous material and with other binders and extenders as provided in § 424.21(c) of subchapter E.
“Spaghetti Sauce with Meat” shall contain not less than 6 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with § 319.6.
“Beans with Frankfurters in Sauce,” “Sauerkraut with Wieners and Juice,” and similar products shall contain not less than 20 percent frankfurters or wieners computed on the weight of the smoked and cooked sausage prior to its inclusion with the beans or sauerkraut.
“Lima Beans with Ham in Sauce,” “Beans with Ham in Sauce,” “Beans with Bacon in Sauce,” and similar products shall contain not less than 12 percent ham or bacon computed on the weight of the smoked ham or bacon prior to its inclusion with the beans and sauce.
“Chow Mein Vegetables with Meat” and “Chop Suey Vegetables with Meat” shall contain not less than 12 percent meat computed on the weight of the uncooked fresh meat prior to its inclusion with the other ingredients. Mechanically Separated (Species) may be used in accordance with § 319.6.
“Pork with Barbecue Sauce” and “Beef with Barbecue Sauce” shall consist of not less than 50 percent cooked meat of the species specified on the label. Mechanically Separated (Pork) may be used in accordance with § 319.6.
“Beef with Gravy” and “Gravy with Beef” shall not be made with beef which, in the aggregate for each lot contains more than 30 percent trimmable fat, that is, fat which can be removed by thorough, practicable trimming and sorting.
Meat pies such as “Beef Pie,” “Veal Pie,” and “Pork Pie” shall contain meat of the species specified on the label, in an amount not less than 25 percent of all ingredients including crust and shall be computed on the basis of the fresh uncooked meat.
(a) Margarine or oleomargarine is the food in plastic form or liquid emulsion, containing not less than 80 percent fat determined by the method prescribed under § 938.06 (Chapter 33) of the “Indirect Methods” in “Official Methods of Analysis of the Association of Official Analytical Chemists”, 15th edition, 1990.
(1) Edible fats and oils or mixtures of these, whose origin is vegetable or rendered animal fats from cattle, sheep, swine or goats.
(2)(i) Water; milk; milk products including, but not limited to, the liquid, condensed, or dry form of whey, reduced lactose whey, reduced minerals whey, or whey protein concentrate, non-lactose-containing whey components, casein, or caseinate; or other suitable edible protein, including albumin, vegetable proteins, or soy protein isolate; or any mixture of two or more of the articles designated in this subparagraph, in amounts not greater than reasonably required to accomplish the desired effect.
(ii) The articles designated in this subparagraph shall be pasteurized and then may be subjected to the action of harmless bacterial starters. One or more of the articles designated in this subparagraph is intimately mixed with the edible fat or oil ingredients, or both, to form a solidified or liquid emulsion.
(3) Vitamin A in such quantity that the finished margarine or oleomargarine contains not less than 15,000 International Units (IU) of ViTamin A per pound or 33,000 IU per kilogram.
(b)(1) Vitamin D in such quantity that the finished margarine or oleomargarine contains not less than 1,500 IU of Vitamin D per pound or 3,300 IU per kilogram.
(2) Salt (sodium chloride); or potassium chloride for dietary margarine or oleomargarine.
(3) Nutritive carbohydrate sweeteners.
(4) Emulsifiers identified in a regulation permitting that use in this subchapter or a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, within these maximum amounts in percent by weight of the finished food: Mono- and diglycerides of fatty acids esterified with any or all of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts, 0.5 percent; such mono- and diglycerides in combination with the sodium sulfoacetate derivatives thereof, 0.5 percent; polyglycerol esters of fatty acids, 0.5 percent; 1,2-propylene glycol esters of fatty acids, 2 percent; lecithin, 0.5 percent.
(5) Preservatives identified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, within these maximum amounts in percent by weight of the finished food: Sorbic acid, benzoic acid and their sodium, potassium, and calcium salts, individually, 0.1 percent, or in combination, 0.2 percent, expressed as the acids; calcium disodium EDTA, 0.0075 percent; stearyl citrate, 0.15 percent; isopropyl citrate mixture, 0.02 percent.
(6) Antioxidants identified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, within these maximum amounts in percent by weight of the finished food: propyl, octyl and dodecyl gallates, BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), ascorbyl palmitate, ascorbyl stearate, all individually or in combination, 0.02 percent. Instead of these antioxidants, TBHQ (tertiary butylhydroquinone), alone or in combination only with BHT and/or BHA, with a maximum 0.02 percent by weight of the fat and oil content.
(7) Coloring agents identified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Parts 73, 74, 81, or 82, in amounts sufficient for purpose.
(8) Flavoring substances in amounts sufficient for purpose.
(9) Acidulants identified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, in amounts sufficient for purpose: adipic acid; citric and lactic acids and their potassium and sodium salts; phosphoric acid; L-tartaric acid and its sodium and sodium-potassium salts; and hydrochloric acid.
(10) Alkalizers identified in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, in amounts sufficient for purpose: potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate, and sodium hydroxide.
(11) For the purposes of this section, the term “milk” unqualified means milk from cows. If any milk other than cow's milk is used in whole or in part, the animal source shall be identified in conjunction with the word “milk” in the ingredient statement.
Shortening prepared with a mixture of meat fats and vegetable oils may be identified either as “Shortening Prepared with Meat Fats and Vegetable Oils” or “Shortening Prepared with Vegetable Oils and Meat Fats” depending on the predominance of the fat and oils used, or the product may be labeled “Shortening” when accompanied by an ingredient statement with ingredients listed in descending order of predominance.
(a) Lard is the fat rendered from clean and sound edible tissues from swine. The tissues may be fresh, frozen, cooked, or prepared by other processes approved by the Administrator in specific cases, upon his determination that the use of such processes will not result in the adulteration or misbranding of the lard. The tissues shall be reasonably free from blood, and shall not include stomachs, livers, spleens, kidneys, and brains, or settlings and skimmings. “Leaf Lard” is lard prepared from fresh leaf (abdominal) fat.
(b) Lard (when properly labeled) may be hardened by the use of lard stearin or hydrogenated lard or both and may contain refined lard and deodorized lard, but the labels of such lard shall state such facts, as applicable.
(c) Products labeled “Lard” or “Leaf Lard” must have the following identity and quality characteristics to insure good color, odor, and taste of finished product:
| (1) Color | White when solid, Maximum 3.0 red units in a 5
|
| (2) Odor and taste | Characteristic and free from foreign odors and flavors. |
| (3) Free fatty acid | Maximum 0.5 percent (as oleic) or 1.0 acid value, as milligrams KOH per gram of sample. |
| (4) Peroxide value | Maximum 5.0 (as milliequivalents of peroxide per kilogram fat). |
| (5) Moisture and volatile matter | Maximum 0.2 percent. |
| (6) Insoluble impurities | By appearance of liquid, fat or maximum 0.05 percent. |
(d) Product found upon inspection not to have the characteristics specified in paragraph (c) of this section but found to be otherwise sound and in compliance with paragraph (a) of this section may be further processed for the purpose of achieving such characteristics.
“Rendered Animal Fat,” or any mixture of fats containing edible rendered animal fat, shall contain no added water, except that “Puff Pastry Shortening” may contain not more than 10 percent of water.
Meat extract (e.g., “Beef Extract”) shall contain not more than 25 percent of moisture.
Fluid extract of meat (e.g., “Fluid Extract of Beef”) shall contain not more than 50 percent of moisture.
(a) “Deviled Ham” is a semiplastic cured meat food product made from finely comminuted ham and containing condiments. Mechanically Separated (Species) may be used in accordance with § 319.6. Deviled ham may contain added ham fat: Provided, That the total fat content shall not exceed 35 percent of the finished product. The moisture content of deviled ham shall not exceed that of the fresh unprocessed meat.
(b) The moisture content of “Deviled Tongue” and similar products shall not exceed that of the fresh, unprocessed meat.
“Potted Meat Food Product” and “Deviled Meat Food Product” shall not contain cereal, vegetable flour, nonfat dry milk, or similar substances. The amount of water added to potted meat food product and deviled meat food product shall be limited to that necessary to replace moisture lost during processing.
“Ham Spread,” “Tongue Spread,” and similar products shall contain not less than 50 percent of the meat ingredient named, computed on the weight of the fresh meat. Other meat and fat may be used to give the desired spreading consistency provided it does not detract from the character of the spreads named. Mechanically Separated (Species) may be used in accordance with § 319.6.
The amount of batter and breading used as a coating for breaded product shall not exceed 30 percent of the weight of the finished breaded product.
Meat food products characterized and labeled as liver products such as liver loaf, liver cheese, liver spread, liver mush, liver paste, and liver pudding shall contain not less than 30 percent of pork, beef, sheep, or goat livers computed on the fresh weight of the livers.
(a) Every person (including every firm or corporation) within any of the classes specified in paragraph (a) (1), (2), or (3) of this section is required by the Act to keep records which will fully and correctly disclose all transactions involved in his or its business subject to the Act:
(1) Any person that engages, for commerce, in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food;
(2) Any person that engages in the business of buying or selling (as a meat broker, wholesaler, or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such animals;
(3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter.
(b) The required records are:
(1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any livestock or carcass, part thereof, meat or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act:
(i) The name or description of the livestock or article;
(ii) The net weight of the livestock or article;
(iii) The number of outside containers (if any);
(iv) The name and address of the buyer of livestock or article sold by such person, and the name and address of the seller of livestock or articles purchased by such person;
(v) The name and address of the consignee or receiver (if other than the buyer);
(vi) The method of shipment;
(vii) The date of shipment; and
(viii) The name and address of the carrier.
(ix) In the case of a person belonging to the class specified in paragraph (a)(1), and engaged, for commerce, in the business of slaughtering any swine for use as human or animal food, the name and address (including the city and state, or the township, county, and state) of each person from whom the person belonging to the class so specified purchased or otherwise obtained each swine, and the telephone number, if available, of the person from whom the swine were purchased or otherwise obtained, and all serial numbers and other approved means of identification appearing on all test swine selected at antemortem inspection by FSIS representatives for residue testing.
(2) Shipper's certificates and permits required to be kept by shippers and carriers of articles under part 325 of this subchapter.
(3) A record of seal numbers required to be kept by consignees of inedible products shipped under unofficial seals under § 325.11(b) or (e) of this subchapter, and a record of new consignees of inedible products diverted under § 325.11(e) of this subchapter.
(4)(i) In the case of raw ground beef products, official establishments and retail stores are required to keep records that fully disclose:
(A) The establishment numbers of the establishments supplying the materials used to prepare each lot of raw ground beef product;
(B) All supplier lot numbers and production dates;
(C) The names of the supplied materials, including beef components and any materials carried over from one production lot to the next;
(D) The date and time each lot of raw ground beef product is produced; and
(E) The date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized.
(ii) Official establishments and retail stores covered by this part that prepare ground beef products that are ground at an individual customer's request must keep records that comply with paragraph (b)(4)(i) of this section.
(iii) For the purposes of this section of the regulations, a lot is the amount of ground raw beef produced during particular dates and times, following clean up and until the next clean up, during which the same source materials are used.
(5) Guaranties provided by suppliers of packaging materials under § 317.24.
(6) Records of canning as required by part 431 of this chapter.
(7) Records of nutrition labeling as required by subpart B, part 317, of this subchapter.
(8) Records as required in § 318.23(b) and (c).
(9) Records documenting the development, implementation, and maintenance of procedures for the control of the production process using advanced meat/bone separation machinery and meat recovery systems as required by § 318.24 of this subchapter.
(10) Records of labeling, product formulas, processing procedures, and any additional documentation needed to show that the labels are consistent with the Federal meat and poultry regulations and policies on labeling, as prescribed in § 412.1 of this chapter.
(a) Except as provided in paragraph (b) of this section, any person engaged in any business described in § 320.1 and required by this part to keep records must maintain such records at the place where such business is conducted, except that if such person conducts such business at multiple locations, he may maintain such records at his headquarters' office. When not in actual use, all such records must be kept in a safe place at the prescribed location in accordance with good commercial practices.
(b) Records required to kept under § 320.1(b)(4) must be kept at the location where the raw beef was ground.
(a) Except as provided in paragraphs (b) and (c) of this section, every record required to be maintained under this part must be retained for a period of 2 years after December 31 of the year in which the transaction to which the record relates has occurred and for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such records under this part.
(b) Records of canning as required in subpart G of part 318 of this chapter, must be retained as required in § 318.307(e); except that records required by § 318.302(b) and (c) must be retained as required by those sections.
(c) Records required to be maintained under § 320.1(b)(4) must be retained for one year.
Representatives of the Secretary afforded access to a business specified in § 320.1 of this part (see § 300.6(b)(2) of this chapter) also must be afforded any necessary facilities (other than reproduction equipment) for the examination and copying of records and for the examination and sampling of inventory.
(a) Except as provided in paragraph (c) of this section, every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer, or engages in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, or any livestock, whether intended for human food or other purposes, or engages in business as a public warehouseman storing any such articles in or for commerce, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any such livestock that died otherwise than by slaughter, shall register with the Administrator, giving such information as is required, including his name, and the address of each place of business at which, and all trade names under which he conducts such business, by filing with the Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, a form containing such information within 90 days after the effective date hereof or after such later date as he begins to engage in such business if not engaged therein upon said effective date. All information submitted shall be current and correct. The registration form shall be obtained from Evaluation and Enforcement Division, Office of Program Evaluation, Enforcement, and Review, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, or by calling the District Office.
(b) Whenever any change is made in the name of, or address of any place of business at which, or any trade name under which a registrant conducts his business, he shall report such change in writing to the Administrator within 15 days after making the change.
(c) The registration requirements prescribed in this section shall not apply to persons conducting any of the businesses specified in this section only at an official establishment.
(a) The operator of each official establishment shall furnish to Program employees accurate information as to all matters needed by them for making their daily reports of the amount of products prepared or handled in the departments of the establishment to which they are assigned and such reports concerning sanitation, mandatory microbiological testing, and other aspects of the operations of the establishment and the conduct of inspection, as may be required by the Administrator in special cases.
(b) The operator of each official establishment shall report quarterly the number of pounds of meat and meat food product produced at that establishment. The report shall be made on a form furnished by the Administrator and shall be submitted to an inspector at the establishment. Each report shall cover a calendar quarter and shall be filed within 15 days after the end of each quarter.
(c) The operator of each official establishment shall also make such other reports as the Administrator may from time to time require under the Act.
Whenever the consignee of any product which bears an official inspection legend refuses to accept delivery of such product on the grounds that it is adulterated or misbranded, the consignee shall notify the Inspector in Charge, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, of the kind, quantity, source, and present location of the product and the respects in which it is alleged to be adulterated or misbranded, and it will be a violation of the Act for any person to sell or transport, or offer for sale or transportation, or receive for transportation, in commerce, any such product which is capable of use as human food and is adulterated or misbranded at the time of such sale, transportation, offer, or receipt: Provided, however, That any such allegedly adulterated or misbranded product may be transported to the official establishment from which it had been transported, in accordance with § 325.10 of this subchapter.
(a) The Administrator is authorized under paragraph (a) of section 301 of the Act, when he determines it would effectuate the purposes of the Act, to cooperate with any State (including Puerto Rico) or any organized Territory in developing and administering the meat inspection program of such jurisdiction with a view to assuring that it imposes and enforces requirements at least equal to those under Titles I and IV of the Act, with respect to establishments at which products are prepared for use as human food solely for distribution within such jurisdiction, and with respect to the products of such establishments. Such cooperation is authorized if the jurisdiction has enacted a law imposing mandatory ante-mortem and post-mortem inspection, reinspection, and sanitation requirements at least equal to the Federal requirements with respect to all or certain classes of persons engaged in slaughtering livestock or otherwise preparing products solely for distribution within such jurisdiction.
(b) The Administrator is also authorized under paragraph (a) of section 301 of the Act to cooperate with any State (including Puerto Rico) or any organized Territory in developing and administering programs under the laws of such jurisdiction containing authorities at least equal to those in Title II of the Act (relating to records; registration of specified classes of operators; dead, dying, disabled, or diseased livestock; and products not intended for human food), when he determines that such cooperation would effectuate the purposes of the Act.
(c) Such cooperation may include advisory assistance, technical and laboratory assistance and training, and financial aid. The Federal contribution to any State (or Territory) may not exceed 50 percent of the estimated total cost of the cooperative State (or Territorial) program. A cooperative program under this section is called a State-Federal program.
Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize employees and facilities of any State in carrying out Federal functions under the Federal Meat Inspection Act. A cooperative program for this purpose is called a Federal-State program.
(a) The Administrator is authorized under 21 U.S.C. 683(b) to coordinate with States that have meat inspection programs as provided in § 321.1 of this part to select certain establishments operating under these programs to participate in a cooperative program to ship carcasses, parts of carcasses, meat, and meat food products in interstate commerce. A cooperative program for this purpose is called a “cooperative interstate shipment program.”
(b) Establishments selected to participate in a cooperative interstate shipment program described in this section must receive inspection services from designated State personnel that have been trained in the enforcement of the Act. If the designated personnel determine that the carcasses, parts of carcasses, meat, and meat food products prepared in establishments selected to participate in the cooperative interstate shipment program comply with all requirements under the Act, these items will bear an official Federal mark of inspection and may be shipped in interstate commerce. The Administrator will assign an FSIS “selected establishment coordinator,” who will be an FSIS employee, to each State that participates in a cooperative interstate shipment program to provide Federal oversight of the program and enforcement of the program's requirements. The Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this section will be at least 60 percent of eligible State costs. Eligible State costs are those costs that a State has justified and FSIS has approved as necessary for the State to provide inspection services to selected establishments in the State.
(c) Part 332 of this subchapter prescribes conditions under which States and establishments may participate in the cooperative interstate shipment program.
(d) The Administrator will terminate a cooperative interstate shipment agreement with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Act and the implementing regulations in this chapter.
(a) When authorized by inspection personnel, establishment personnel must mark the outside container of any inspected and passed product for export, the securely enclosed pallet within the consignment, or closed means of conveyance transporting the consignment, with a mark that contains a unique identifier that links the consignment to the export certificate or an official mark as described in § 312.8 of this chapter. Ship stores, small quantities exclusively for the personal use of the consignee and not for sale or distribution, and shipments by and for the U.S. Armed Forces, are exempt from the requirements of this section.
(b) When authorized by inspection personnel, establishments must mark each tank car of inspected and passed lard or similar edible product, and each door of each railroad car or other closed means of conveyance, containing inspected and passed loose product shipped directly to a foreign country, with an export inspection mark as shown in § 312.8 of this subchapter.
(a) Exporters must apply for export certification of inspected and passed products shipped to any foreign country. Exporters may apply for an export certificate using a paper or electronic application. FSIS will assess exporters that submit an electronic application the charge in § 350.7(e) of this chapter.
(b) FSIS will issue only one certificate for each consignment, except in the case of error in the certificate or loss of the certificate originally issued. A request for a replacement certificate, except in the case of a lost certificate, must be accompanied by the original certificate. The new certificate will carry the following statement: “Issued in replacement of ______”, with the numbers of the certificates that have been superseded.
(c) FSIS will deliver a copy of the certificate to the exporter. The exporter may furnish the copy of the certificate to the consignee for purposes of affecting the entry of product into the foreign country of destination.
(d) FSIS will retain a copy of the certificate.
(e) Exporters may request inspection personnel to issue certificates for export consignments of product of official establishments not under their supervision, provided the consignments are first identified as having been “U.S. inspected and passed,” are found to be neither adulterated nor misbranded, and are marked as required by § 322.1.
When inspected and passed products for export are transferred from tank cars to other containers on vessels, such transfer shall be done in accordance with the provisions of part 350 of subchapter B of this chapter.
No clearance shall be given to any vessel having on board any product destined to any foreign country, and no person operating any vessel, and no railroad or other carrier, shall receive for transportation or transport from the United States to any foreign country, any products, unless and until an official export certificate covering the same has been issued and delivered as provided in this part; except in the case of inspected and passed ship stores and not more than 50 pounds of inspected and passed product for the exclusive personal use of the consignee and not for sale or distribution, and except for exempted product eligible for exportation under the provisions of the Act and the regulations in this subchapter and inedible product that is not capable of use as human food and is eligible for exportation under other provisions of said regulations.
No tallow, stearin, oleo oil, or the rendered fat derived from the carcasses of livestock, that has not been inspected and passed, and so marked in compliance with the regulations in this subchapter shall be exported, unless the product has been denatured as required by § 314.5 or § 325.13 of this subchapter or identified and marked as prescribed by § 325.11 of this subchapter.
(a) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any product which is capable of use as human food unless the product and its container, if any, bear the official inspection legend as required under parts 316 and 317 of this subchapter or such product is exempted from the requirement of inspection under part 303 of this subchapter.
(b)(1) No carrier shall transport or receive for transportation in commerce (including transportation in the course of importation) and no person shall offer for transportation any carcass, part thereof, meat or meat food product until a certificate, if required for such transportation by this part, is made and furnished to the carrier in one of the forms prescribed in this part.
(2) Product imported into the United States may be transported and offerred or received for transportation if such product is conveyed in railroad cars, trucks or other means of conveyance, prior to inspection, to an authorized place of inspection, as provided in § 327.6 of this part.
(c) No person, engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, meat or meat food products capable of use as human food, or importing such articles, shall transport, offer for transportation, or receive for transportation in commerce or in any State designated under section 301(c) of the Act, any such meat or meat food product which is capable of use as human food and is not wrapped, packaged, or otherwise enclosed to prevent adulteration by airborne contaminants, unless the railroad car, truck, or other means of conveyance in which the product is contained or transported is completely enclosed with tight fitting doors or other covers for all openings. In all cases, the means of conveyance shall be reasonably free of foreign matter (such as dust, dirt, rust, or other articles or residues), and free of chemical residues, so that product placed therein will not become adulterated. Any cleaning compound, lye, soda solution, or other chemical used in cleaning the means of conveyance must be thoroughly removed from the means of conveyance prior to its use. Such means of conveyance onto which product is loaded, being loaded, or intended to be loaded, shall be subject to inspection by an inspector at any official establishment. The decision whether or not to inspect a means of conveyance in a specific case, and the type and extent of such inspection shall be at the Program's discretion and shall be adequate to determine if product in such conveyance is, or when moved could become, adulterated. Circumstances of transport that can be reasonably anticipated shall be considered in making said determination. These include, but are not limited to, weather conditions, duration and distance of trip, nature of product covering, and effect of restowage at stops en route. Any means of conveyance found upon such inspection to be in such condition that product placed therein could become adulterated shall not be used until such condition which could cause adulteration is corrected. Product placed in any means of conveyance that is found by the inspector to be in such condition that the product may have become adulterated shall be removed from the means of conveyance and handled in accordance with § 318.2(d) of this subchapter.
(a) For the purposes of this subchapter, the United States parcel post shall be deemed a carrier, and the provisions of this subchapter relating to transportation by carrier shall apply, so far as they may be applicable, to transportation by parcel post.
(b) For the purposes of this subchapter, the operator of every ferry shall be deemed a carrier, and the provisions of this subchapter relating to transportation by carrier shall apply to transportation by ferry of any products loaded on a truck or other vehicle, or otherwise moved by such ferry.
When any shipment of any product is offered to any carrier for transportation within the United States as a part of an export movement, the same certificate shall be required as if the shipment were destined to a point within the United States.
(a) Any product which has been inspected and passed may be transported from one official establishment to another for further processing without each article being marked with the official inspection legend, if it is so transported in a railroad car, motortruck, or other means of conveyance which is sealed by a Program employee with an official seal of the Department prescribed in § 312.5(a) of this subchapter. Unless 25 percent or more of the contents of each car or other means of conveyance consists of product not marked with the inspection legend, transportation will not be permitted under this paragraph.
(b) When articles are offered for transportation under paragraph (a) of this section, the initial carrier shall require, and the shipper shall make in duplicate and deliver to the carrier, one copy of a certificate in the following form:
I hereby certify that the following described product has been U.S. inspected and passed by the U.S. Department of Agriculture; and that it is not marked “U.S. inspected and passed,” but has been placed in the means of conveyance specified above under the supervision of an employee of the Meat and Poultry Inspection Programs of said Department, and the means of conveyance has been sealed by him with official U.S. Government seals Nos. ____ and ____.
(c) The signature of the shipper or his agent shall be written in full. This certificate may be stamped upon or incorporated in any form ordinarily used in the transportation of product. Certificates in this form or copies thereof need not be forwarded to any official or office of the Department. The original of the certificate required by this section shall be retained by the carrier and a copy shall be retained by the shipper in accordance with part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with part 320 of this subchapter.
Cattle and sheep paunches which have been made clean and from which the mucous membrane has not been removed may be transported from one official establishment to another official establishment for further processing, only under an official seal of the Department as prescribed in § 312.5(a) of this subchapter.
(a) Products passed for cooking, and beef that is to be refrigerated to destroy cysticerci, may be shipped loose from one official establishment to any other official establishment, for further handling in accordance with part 318 of this subchapter, in railroad cars, trucks, or other means of conveyance sealed with the official seal of the Department as prescribed in § 325.16: Provided, That in the case of railroad cars, the receiving establishment has railroad facilities for unloading the products directly into the establishment.
(b) When such restricted product is shipped from one official establishment to another official establishment in the same railroad car or other means of conveyance with other product, such restricted product shall be packed in individual closed containers as hereinafter provided. Containers shall be sealed by firmly applying a pressure sensitive tape around each container in two directions and stamping the intersection of the tape with the marking device described in § 312.2(a) of this subchapter for use on burlap, muslin, etc. (2
(c) When products are offered for transportation under this section, the initial carrier shall require and the shipper shall make in duplicate and deliver to the carrier one copy of a certificate in the form set out in § 325.5(b). Certificates in this form or copies thereof need not be forwarded to any official or office of the Department, but the original of the certificate shall be retained by the carrier and a copy shall be retained by the shipper in accordance with part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with part 320 of this subchapter.
(a) Lungs or lung lobes, other than those condemned under § 310.16(b) of this subchapter, that are prepared at any official establishment, may be sold, transported, offered for sale or transportation, or received for transportation from the establishment, in commerce or otherwise, without denaturing as prescribed in § 314.1 or § 314.3 of this subchapter: Provided:
(1) The lungs or lung lobes are sold, transported, or offered for sale or transportation to, or received for transportation by: An animal food manufacturer for use in manufacturing animal food; a zoo, mink farm, or other establishment for use as animal food without further processing; a warehouse in the United States for storage and subsequent movement to such a manufacturer or establishment in the United States, or from one warehouse to another for the account of and subsequent movement to such a manufacturer or establishment, or for export, for nonhuman food purposes.
(2) The boxes or other containers used for shipping the undenatured lungs or lung lobes are closed with nylon filament tape, metallic on nonmetallic straps, round wire, or other similar materials that securely effect closure of such containers, and the containers are permanently identified in at least 2-inch (5 cm) high lettering with the statement “(Species) Lungs—Not Intended for Human Food.” In lieu of securely closing the immediate container with any of the above materials, a 1-inch (2.5 cm) wide bright orange band, imprinted around the length and width of the container may be used.
(3) The name and place of business of the packer or distributor shall be shown on the immediate container of the product. In addition, the country of origin shall be shown on the immediate container of imported lungs or lung lobes.
(b) Lungs or lung lobes, other than those condemned under a State law or regulation at least equal to § 310.16(b) of this subchapter, that are prepared at any State inspected establishment may be sold, transported, offered for sale, or transportation or received for transportation from that establishment, in commerce, without denaturing as prescribed under section 201 of the Act, provided the State law or regulations permit such disposition and provided there is compliance with the provisions of paragraph (a) of this section.
(c) Foreign establishments shall be eligible to export lungs or lung lobes, other than those condemned for reasons set forth in § 310.16(b) of this subchapter, to the United States from such foreign country under this section, only if such establishments are certified and approved for export of products to the United States under part 327 of this subchapter, and such product complies with the applicable regulations for preventing the introduction into the United States of diseases (9 CFR 94), in addition to the requirements of paragraph (a) of this section.
(d) All such lungs or lung lobes, if intended for animal food, are subject to the Federal Food, Drug, and Cosmetic Act.
(a) When it is claimed that any inspected and passed product, marked with an inspection legend, has become adulterated or misbranded after it has been transported from an official establishment, such product may be transported in commerce to an official establishment after oral permission is obtained from the area supervisor of the area in which that offical establishment is located. The transportation of the product may be to the official establishment from which it had been transported or to another official establishment designated by the person desiring to handle the product. The transportation shall be authorized only for the purpose of officially determining if the product has become adulterated or misbranded and making the appropriate disposition. The area supervisor shall make a record of the authorization and such other information which will effectively identify the shipment and shall provide a copy of the record to the inspector at the establishment receiving the product. The shipper shall be furnished a copy of the authorization record upon request.
(b) Upon the arrival of the shipment at the official establishment, a careful inspection shall be made of the product by a Program inspector, and if it is found that the article is not adulterated, the same may be received into the establishment; but if the article is found to be adulterated, it shall at once be stamped “U.S. inspected and condemned” and disposed of in accordance with part 314 of this subchapter, and if it is found to be misbranded, it shall be handled in accordance with § 318.2(d) of this subchapter: Provided, That when a product is found to be affected with one of the correctable conditions specified in § 318.2(d) of this subchapter, in respect to which rehandling is permitted, it may be transported from the official establishment to another official establishment for such rehandling as is necessary to assure that the product is not adulterated or misbranded when finally released. The transportation of such a product from an official establishment shall be done in a manner prescribed in each specific case by the Administrator.
(a) Except as provided in § 325.8 and § 325.10, no carcass, part of a carcass, rendered grease, tallow, or other fat derived from the carcasses of livestock, or other meat food product, that has not been inspected and passed at an official establishment under the provisions of this subchapter and is not exempted from such inspection, and no carcass, part of a carcass, fat or other meat food product that is adulterated or misbranded, shall be offered for transportation in commerce by any person unless it is handled in accordance with paragraph (b), (c), (d), or (e) of this section or is denatured or otherwise identified as prescribed in § 325.13, § 314.1, § 314.3, § 314.9, § 314.10, or § 314.11 of this subchapter.
(b) Inedible rendered animal fats from official or other establishments in the United States having the physical characteristics of a meat food product fit for human food may be transported in commerce without denaturing, if the following conditions are met:
(1) Such inedible rendered fat shall not be bought, sold, transported, or offered for sale or offered for transportation in commerce, or imported, except by rendering companies, dealers, brokers, or others who obtain a numbered permit for such activities from the Regional Director.
(2) Such inedible rendered animal fat may be so distributed only if consigned to a domestic manufacturer of technical articles other than for human food or to an export terminal for exportation or storage for exportation as an inedible article, and provided, in the case of such fat consigned to a domestic manufacturer, the product is for use solely by the consignee for manufacturing purposes of nonhuman food articles and may not be further sold or shipped without first receiving approval of the Regional Director: And provided further, That such fat intended for export and stored at a terminal point prior to export will be subject to review by Program employees to assure that it is exported as inedible.
(3) When transported in commerce, or imported, such inedible rendered fat shall be marked conspicuously with the words “technical animal fat not intended for human food” on the ends of the shipping containers, in letters not less than 2 inches high; in the case of shipping containers such as drums, tierces, barrels, and half barrels, and not less than 4 inches high in the case of tank cars and trucks. All shipping containers shall have both ends painted with a durable paint, if necessary, to provide a contrasting background for the required marking.
(4) Such inedible rendered fat shall be transported only in sealed shipping containers bearing unofficial seals applied by the shipper, which shall include the identification number assigned by said Director for the permit holder. The number shall appear on the bill of lading or other transportation documents for the shipment. The consignees in the United States must retain the seals in their records as prescribed in part 320 of this subchapter.
(5) Any diversion or effort to divert inedible rendered fat contrary to the provisions of this paragraph (b) or other violation of the provisions of this section may result in the revocation of the permit for shipment of technical animal fat at the discretion of the Administrator.
(c) Inedible rendered animal fat derived from condemned or other inedible materials at official or other establishments in the United States may be transported in commerce if mixed with low grade offal or other materials which render the fat readily distinguishable from an article of human food, and if the outside container bears the word “inedible.”
(d)(1) Except as provided in paragraphs (d)(2), (3), and (4) of this section, or in §§ 314.10 and 314.11 of this subchapter, no animal food prepared, in whole or in part, from materials derived from the carcasses of livestock in an official establishment or elsewhere, shall be bought, sold, transported, offered for sale or transportation, or received for transportation, in commerce, or imported, unless:
(i) It is properly identified as animal food;
(ii) It is not represented as being a human food; and
(iii) It has been denatured as prescribed in § 325.13(a)(2) so as to be readily distinguishable from an article of human food.
(2) Notwithstanding the provisions of paragraph (d)(1) of this section, an animal food that consists of less than 5 percent of parts or products of the carcasses of livestock and that is not represented by labeling or appearance or otherwise as being a human food or as a product of the meat food industry need not be denatured in accordance with § 325.13(a)(2).
(3) Notwithstanding the provisions of paragraph (d)(1) of this section, animal food packed in hermetically sealed, retort processed, conventional retail-size containers, and retail-size packages of semi-moist animal food need not be denatured in accordance with § 325.13(a)(2) if the name of the article clearly conveys the article's intended use for animal food and appeared on the label in a conspicuous manner.
(i) Except as provided in paragraph (ii) of paragraph (d)(3), the name of the article must be stated on the label as “Animal Food,” “Pet Food,” or “(name of species) Food” (e.g., “Dog Food” or “Cat Food”). To be considered conspicuous, the name of the article, wherever it appears on the label, must be in letters at least twice as high, wide, and thick as the letters indicating the presence in the article of any ingredients derived from the carcasses of livestock.
(ii) Notwithstanding the provisons of paragraph (i) of this paragraph (d)(3), the article's name may be stated on the label to show that it is or contains livestock-source material and that the article is for animals; e.g., “Horsemeat for Pets” or “Beef Stew for Dogs”: Provided, That the entire name of the article is stated, wherever it appears on the label, as an individual, contiguous unit, whether stated on a single line or more than one line, and the letters denoting the article's intended use for animal food are at least as high, wide, and thick as the letters indicating the presence of material derived from any livestock carcass. However, when the label bears on its principal display panel a vignette which pictures, in clearly recognizable form and size, one or more animals of the species for which the article's name indicates the article is intended, the letters used to state the article's intended use shall be at least one-half as high, wide, and thick as the letters used in the article's name or other letters indicating the presence of material derived from any livestock carcass, but shall not be less than
(iii) Letters used to denote the intended use of the article must contrast as markedly with their background as the letters indicating the presence in the article of livestock carcass-source material contrast with their background.
(4) The requirements of this part do not apply to livestock or poultry feeds manufactured from processed livestock byproducts (such as meat meal tankage, meat and bone meal, blood meal, and feed grade animal fat), or to processed dry animal food.
(e) Except for inedible rendered animal fats and lungs or lung lobes, inedible products (including condemned products only if condemned for causes specified in § 314.11 of this subchapter) which were prepared at any official establishment, or at any State inspected establishment in any State not designated under section 301(c) of the Act, and which have the physical characteristics of a product fit for human food, may be transported from an official establishment or in commerce, without denaturing as required by this subchapter, if the following conditions are met:
(1) The shipper must have obtained a numbered permit for such activity from the appropriate Regional Director, as identified in § 301.2 of this subchapter. Such permit may be obtained upon written application to the appropriate Regional Director and his determination that the proposed transportation would be authorized under this paragraph (e). The application shall state the name and address of the applicant, a description of the type of his business operations, and the purpose of making such application.
(2) Such inedible products may be transported under this paragraph (e) only if consigned to a manufacturer in the United States of articles other than for human food and if the product is for use solely by the consignee for manufacturing articles not for human food. Such products may not be transported in commerce to any consignee other than the one to which they were originally shipped unless prior notice of the diversion is given to the appropriate Regional Director and a record identifying the new consignee is maintained by the shipper as required by § 320.1 of this subchapter.
(3) When transported from an official establishment or in commerce under this paragraph (e), the outside container of such inedible products shall be marked conspicuously with the words “Inedible—Not Intended for Human Food” in letters not less than 2 inches high, in the case of containers, such as cartons, drums, tierces, barrels, and half barrels, and not less than 4 inches high in the case of tank cars and trucks used to transport such products not in other containers.
(4) Such inedible products shall be transported from an official establishment or in commerce under this paragraph (e) only in railroad cars, trucks, or containers which bear unofficial seals applied by the shipper, which shall include the identification number assigned to the permit holder and an individual seal serial number assigned by the shipper; and the product so transported shall be accompanied by an invoice or bill of lading specifying the permit holder's identification number. The consignee in the United States must retain a record of the identification and serial numbers shown on the seals in his records as prescribed in part 320 of this subchapter.
(5) Any diversion, or effort to divert, undenatured, inedible product contrary to the provisions of this paragraph (e) or other violation of the provisions of this section may result in the revocation of the permit for shipment of inedible products under this paragraph (e), at the discretion of the Administrator.
(a) Carcasses, parts thereof, meat and meat food products (other than rendered animal fats) that have been treated in accordance with the provisions of this paragraph shall be considered denatured for the purposes of the regulations in this part, except as otherwise provided in part 314 of this subchapter for articles condemned at official establishments.
(1) The following agents are prescribed for denaturing carcasses, parts thereof, meat or meat food products which are affected with any condition that would result in their condemnation and disposal under part 314 of this subchapter if they were at an official establishment: Crude carbolic acid; cresylic disinfectant; a formula consisting of 1 part FD&C green No. 3 coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or other proprietary substance approved by the Administrator in specific cases.
(2) Except as provided in paragraphs (a)(3), (4), and (5) of this section, the following agents are prescribed for denaturing other carcasses, parts thereof, meat and meat food products, for which denaturing is required by this part: FD&C green No. 3 coloring; FD&C blue No. 1 coloring; FD&C blue No. 2 coloring; finely powdered charcoal; or other proprietary substance approved by the Administrator in specific cases.
(3) Tripe may be denatured by dipping it in a 6 percent solution of tannic acid for 1 minute followed by immersion in a water bath, then immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 5 coloring;
(4) Meat may be denatured by dipping it in a solution of 0.0625 percent tannic acid, followed by immersion in a water bath, then dipping it in a solution of 0.0625 percent ferric acid; and
(5) When meat, meat byproducts, or meat food products are in ground form, 4 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 5 mesh in the standards issued by the U.S. Bureau of Standards or 6 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 8 mesh in said Standards, uniformly incorporated with the product may be used in lieu of the agents prescribed in paragraph (a)(2) of this section.
(6) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sectioning will not be necessary.) The application of any of the denaturing agents listed in paragraph (a)(1) or (2) of this section to the outer surface of molds or blocks of boneless meat, meat byproducts, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all of the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.
(7) Carcasses (other than viscera), parts thereof, cuts of meat, and unground pieces of meat darkened by charcoal or other black dyes shall be deemed to be denatured pursuant to this section only if they contain at least that degree of darkness depicted by diagram 1 of the Meat Denaturing Guide (MP Form 91).
(b) Inedible rendered animal fats shall be denatured by thoroughly mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any proprietary denaturing agent approved for the purpose by the Administrator in specific cases. The charcoal shall be used in no less quantity than 100 parts per million and shall be of such character that it will remain suspended indefinitely in the liquid fat. Sufficient of the chosen identifying agents shall be used to give the rendered fat so distinctive a color, odor, or taste that it cannot be confused with an article of human food.
All original certificates delivered to a carrier in accordance with this part shall be filed separate and apart from all its other papers and records or identified in such a manner as to be readily checked by Department employees. Every certificate required to be maintained under this part shall be retained for a period of 2 years after December 31 of the year in which the transaction has occurred.
(a) All waybills, transfer bills, running slips, conductor's cards, or other papers accompanying a shipment, in the course of importation or otherwise in commerce, of any product shall have embodied therein, stamped thereon, or attached thereto a signed statement which shall be evidence to connecting carriers that the proper shipper's certificate, as required by § 325.5, § 325.6, or § 325.7, is on file with the initial carrier. No connecting carrier shall receive for transportation or transport in the course of importation or otherwise in commerce any product unless the waybill, transfer bill, running slip, conductor's card, or other papers accompanying the same includes the signed statement in the following form:
(b) Signatures of agents to statements required under this section shall be written in full.
(a) The official seals required by this part shall be those prescribed in § 312.5(a) of this subchapter.
(b) Except as provided in § 325.18(b), official seal affixed under this part shall be affixed or broken only by Program employees, and no person other than a Program employee shall affix, detach, break, change, or tamper with any such seal in any way whatever. Commission of any such acts contrary to this regulation is a criminal offense.
Unloading any product from an officially sealed railroad car, truck, or other means of conveyance containing any unmarked product or loading any product or any other commodity in the means of conveyance while en route from one official establishment to another official establishment is not permitted, except that product transported under § 325.5 from one official establishment to another for further processing may be unloaded and stored in transit at any approved warehouse which is operated under the identification service provided under the regulations in part 350 of subchapter B of this chapter and which has railroad facilities or a receiving dock for unloading the product directly into such warehouse: Provided, That the product is stored in rooms which are of such size and type as will not result in adulteration or misbranding of the product: And provided further, That the product is transported to and from such warehouse, and under official seal as provided in § 325.5 and stored in such rooms at such warehouse.
(a) Shipments of inspected and passed product that bear the inspection legend may be diverted from the original destination without a reinspection of the articles, provided the waybills, transfer bills, running slips, conductor's card, or other papers accompanying the shipments are marked, stamped, or have attached thereto signed statements in accordance with § 325.15.
(b) In case of wreck or similar extraordinary emergency, the Department seals on a railroad car or other means of conveyance containing any inspected and passed product may be broken by the carrier, and if necessary, the articles may be reloaded into another means of conveyance, or the shipment may be diverted from the original destination, without another shipper's certificate; but in all such cases the carrier shall immediately report the facts by telephone or telegraph to the Regional Director in the area in which the emergency occurs. Such report shall include the following information:
(1) Nature of the emergency.
(2) Place where seals were broken.
(3) Original points of shipment and destination.
(4) Number and initial of the original car or truck.
(5) Number and initials of the car or truck into which the articles are reloaded.
(6) New destination of the shipment.
(7) Kind and amount of articles.
The provisions of this part do not apply:
(a) To specimens of product sent to or by the Department of Agriculture or divisions thereof in Washington, DC, or elsewhere, for laboratory examination, exhibition purposes, or other official use;
(b) To material released for educational, research and other nonfood purposes, as prescribed in § 314.9 of this subchapter;
(c) To glands and organs for use in preparing pharmaceutical, organotherapeutic, or technical products and not used for human food, as described in § 318.1(g) of this subchapter;
(d) To material or specimens of product for laboratory examination, research, or other nonhuman food purposes, when authorized by the Administrator, and under conditions prescribed by him in specific cases; and
(e) To articles that are naturally inedible by humans, such as hoofs, horns, and hides in their natural state.
No person engaged in the business of buying, selling, or transporting in commerce, or importing any dead, dying, disabled or diseased animals or parts of the carcasses of any animals that died otherwise than by slaughter shall:
(a) Buy, sell, transport, or offer for sale or transportation, in commerce, or import any dead livestock if its hide or skin has been removed;
(b) Sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any livestock that died otherwise than by slaughter, unless such livestock and parts are consigned and delivered, without avoidable delay, to establishments of animal food manufacturers, renderers, or collection stations that are registered as required by part 320 of this subchapter, or to official establishments that operate under Federal inspection, or to establishments that operate under a State or Territorial inspection system approved by the Secretary as one that imposes requirements at least equal to the Federal requirements for purposes of paragraph 301(c) of the Act;
(c) Buy in commerce or import any dead, dying, disabled, or diseased livestock or parts of the carcasses of any livestock that died otherwise than by slaughter, unless he is an animal food manufacturer or renderer and is registered as required by part 320 of this subchapter, or is the operator of an establishment inspected as required by paragraph (b) of this section and such livestock or parts of carcasses are to be delivered to establishments eligible to receive them under paragraph (b) of this section;
(d) Unload en route to any establishment eligible to receive them under paragraph (b) of this section, any dead, dying, disabled, or diseased livestock or parts of the carcasses of any livestock that died otherwise than by slaughter, which are transported in commerce or imported by any such person: Provided, That any such dead, dying, disabled, or diseased livestock, or parts of carcasses may be unloaded from a means of conveyance en route where necessary in case of a wreck or otherwise extraordinary emergency, and may be reloaded into another means of conveyance; but in all such cases, the carrier shall immediately report the facts by telegraph or telephone to the Compliance Staff, Meat and Poultry Inspection Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(e) Load into any means of conveyance containing any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any livestock that died otherwise than by slaughter, while in the course of importation or other transportation in commerce any livestock or parts of carcasses not within the foregoing description or any other products or other commodities.
All vehicles and other means of conveyance used by persons subject to § 325.20 for transporting in commerce or importing, any dead, dying, disabled, and diseased livestock or parts of carcasses of livestock that died otherwise than by slaughter shall be leak-proof and so constructed and equipped as to permit thorough cleaning and sanitizing. The means of conveyance so used in conveying such livestock, or parts thereof, shall be cleaned and disinfected prior to use in the transportation of any product intended for use as human food. The cleaning procedure shall include the complete removal from the means of conveyance of any fluid, parts, or product of such dead, dying, disabled, or diseased livestock and the thorough application of a disinfectant to the interior surfaces of the cargo space. Substances permitted for such use are:
(a) “Liquified phenol” (U.S.P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to 1 gallon of water.
(b) “Cresylic disinfectant” in the proportion of not less than 4 fluid ounces to 1 gallon of water; and such other disinfectants as are approved by the Administrator in specific cases. The use of “cresylic disinfectant” is permitted subject to the conditions prescribed in § 71.10(b) of this title.
(a) When used in this part, the following terms are defined to mean:
(1) Import (imported). To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.
(2) Offer(ed) for entry. The point at which the importer presents the imported product for reinspection.
(3) Entry (entered). The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 327.26.
(b) The provisions of this part shall apply to products derived from cattle, sheep, swine, goats, horses, mules, and other equines, if capable of use as human food. Compliance with the conditions for importation of products under this part does not excuse the need for compliance with applicable requirements under other laws, including the provisions in parts 94, 95, and 96 of chapter I of this title.
(a)(1) Whenever it shall be determined by the Administrator that the system of meat inspection maintained by any foreign country, with respect to establishments preparing products in such country for export to the United States, insures compliance of such establishments and their products with requirements equivalent to all the inspection, building construction standards, and all other provisions of the Act and the regulations in this subchapter which are applied to official establishments in the United States, and their products, and that reliance can be placed upon certificates required under this part from authorities of such foreign country, notice of that fact will be given in accordance with paragraph (b) of this section. Thereafter, products prepared in such establishments which are certified and approved in accordance with paragraph (a)(3) of this section, shall be eligible so far as this subchapter is concerned for importation into the United States from such foreign country after applicable requirements of this subchapter have been met.
(2) The determination of acceptability of a foreign meat inspection system for purposes of this section shall be based on an evaluation of the foreign program in accordance with the following requirements and procedures:
(i) The system shall have a program organized and administered by the national government of the foreign country. The system as implemented must provide standards equivalent to those of the Federal system of meat inspection in the United States with respect to:
(A) Organizational structure and staffing, so as to insure uniform enforcement of the requisite laws and regulations in all establishments throughout the system at which products are prepared for export to the United States;
(B) Ultimate control and supervision by the national government over the official activities of all employees or licensees of the system;
(C) The assignment of competent, qualified inspectors;
(D) Authority and responsibility of national inspection officials to enforce the requisite laws and regulations governing meat inspection and to certify or refuse to certify products intended for export;
(E) Adequate administrative and technical support;
(F) The inspection, sanitation, quality, species verification, and residue standards applied to products produced in the United States.
(G) Other requirements of adequate inspection service as required by the regulations in this subchapter.
(ii) The legal authority for the system and the regulations thereunder shall impose requirements equivalent to those governing the system of meat inspection organized and maintained in the United States with respect to:
(A) Ante-mortem inspection of animals for slaughter and inspection of methods of slaughtering and handling in connection with slaughtering which shall be performed by veterinarians or by other employees or licensees of the system under the direct supervision of the veterinarians;
(B) Post-mortem inspection of carcasses and parts thereof at time of slaughter, performed by veterinarians or other employees or licensees of the system under the direct supervision of veterinarians;
(C) Official controls by the national government over establishment construction, facilities, and equipment;
(D) Direct and continuous official supervision of slaughtering and preparation of product, by the assignment of inspectors to establishments certified under paragraph (a)(3) of this section, to assure that adulterated or misbranded product is not prepared for export to the United States;
(E) Complete separation of establishments certified under subparagraph (3) of this paragraph from establishments not certified and the maintenance of a single standard of inspection and sanitation throughout all certified establishments;
(F) Requirements for sanitation at certified establishments and for sanitary handling of product;
(G) Official controls over condemned material until destroyed or removed and thereafter excluded from the establishment;
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as set forth in part 417 of this chapter.
(I) Other matters for which requirements are contained in the Act or regulations in this subchapter.
(iii) Countries desiring to establish eligibility for importation of product into the United States may request a determination of eligibility by presenting copies of the laws and regulations on which the foreign meat inspection system is based and such other information as the Administrator may require with respect to matters enumerated in paragraphs (a)(2) (i) and (ii) of this section. Determination of eligibility is based on a study of the documents and other information presented and an initial review of the system in operation by a representative of the Department using the criteria listed in paragraphs (a)(2) (i) and (ii) of this section. Maintenance of eligibility of a country for importation of products into the United States depends on the results of periodic reviews of the foreign meat inspection system in operation by a representative of the Department, and the timely submission of such documents and other information related to the conduct of the foreign inspection system, including information required by paragraph (e) of section 20 of the Act, as the Administrator may find pertinent to and necessary for the determinations required by this section of the regulations.
(iv) The foreign inspection system must maintain a program to assure that the requirements referred to in this section, equivalent to those of the Federal system of meat inspection in the United States, are being met. The program as implemented must provide for the following:
(A) Periodic supervisory visits by a representative of the foreign inspection system to each establishment certified in accordance with paragraph (a)(3) of this section to ensure that requirements referred to in paragraphs (a)(2)(ii)(A) through (H) of this section are being met: Provided, That such visits are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States;
(B) Written reports prepared by the representative of the foreign inspection system who has conducted a supervisory visit, documenting his or her findings with respect to the requirements referred to in (A) through (H) of paragraph (a)(2)(ii) of this section, copies of which shall be made available to the representative of the Department at the time of that representative's review upon request by that representative to a responsible foreign meat inspection official: Provided, That such reports are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States; and
(C) Random sampling of internal organs and fat of carcasses at the point of slaughter and the testing of such organs and fat, for such residues having been identified by the exporting country's meat inspection authorities or by this Agency as potential contaminants, in accordance with sampling and analytical techniques approved by the Administrator: Provided, That such testing is required only on samples taken from carcasses from which meat or meat food products intended for importation into the United States are produced.
(3) Only those establishments that are determined and certified to the Agency by a responsible official of the foreign meat inspection system as fully meeting the requirements of paragraphs (a)(2)(i) and (ii) of this section are eligible to have their products imported into the United States. Establishment eligibility is subject to review by the Agency (including observations of the establishments by Program representatives at times prearranged with the foreign meat inspection system officials). Foreign establishment certifications must be renewed annually. Notwithstanding certification by a foreign official, the Administrator may terminate the eligibility of any foreign establishment for the importation of its products into the United States if it does not comply with the requirements listed in paragraphs (a)(2)(i) and (ii) of this section, or if current establishment information cannot be obtained. The Administrator will provide reasonable notice to the foreign government of the proposed termination of any foreign establishment, unless a delay in terminating its eligibility could result in the importation of adulterated or misbranded product.
(i) For a new establishment, or any establishment for which information from last year's electronic certification or paper certificate has changed, the certification or certificate must contain: The date; the foreign country; the foreign establishment's name, address, and foreign establishment number; the foreign official's title and signature (for paper certificates only); the type of operations conducted at the establishment (e.g., slaughter, processing, storage, exporting warehouse); and the establishment's eligibility status (e.g., new or relisted (if previously delisted)). Slaughter and processing establishment certifications must address the species and type of products produced at the establishment (e.g., the process category).
(ii) If the establishment information provided on the preceding year's electronic foreign establishment certification or paper certificate, as required in paragraph (a)(3)(i) of this section, has not changed, the certification or certificate must contain: The date, the foreign country, the foreign establishment's name, and the foreign official's title and signature (for paper certificates only).
(4) Meat and meat food products from foreign countries not deemed eligible in accordance with paragraph (b) of this section are not eligible for importation into the United States, except as provided by § 327.16 or § 327.17. Eligibility of any foreign country under this section may be withdrawn whenever the Administrator determines that the system of meat inspection maintained by such foreign country does not assure compliance with requirements equivalent to all the inspection, building construction standards, and other requirements of the Act and the regulations in this subchapter as applied to official establishments in the United States; or that reliance cannot be placed upon certificates required under this part from authorities of such foreign country; or that, for lack of current information concerning the system of meat inspection being maintained by such foreign country, such foreign country should be required to reestablish its eligibility.
(b) A list of countries eligible to export specific process categories of meat and meat food products is maintained at http://www.fsis.usda.gov/importlibrary. Meat and meat food products from listed countries must be accompanied by foreign inspection certificates of the country of origin, as required by § 327.4, and are eligible under the regulations in this subchapter for entry into the United States after inspection and marking as required by the applicable provisions of this part. Fresh, chilled, or frozen or other product from countries in which rinderpest, foot-and-mouth disease or African swine fever exist, as provided in part 94 of this title, are ineligible for importation into the United States.
(a) No product offered for importation from any foreign country shall be admitted into the United States if it is adulterated or misbranded or does not comply with all the requirements of this subchapter that would apply to it if it were a domestic product.
(b) No cooked or partially cooked meat or meat trimmings, either in separable pieces or molded into larger forms, shall be permitted entry except under the following conditions:
(1) A complete procedure for preparing and handling the product in the foreign country and en route to the United States shall be submitted by the exporter or his authorized agent to the Administrator and determined by the Administrator to be adequate to assure that the product will not be adulterated or misbranded at the time of offer for entry.
(2) A system acceptable to the Administrator (upon his determination that the system will provide a reliable indication of the kinds and numbers of microorganisms present) for the microbiological testing of the finished product shall be installed by the processor, the product is subjected to such testing, and the results thereof are furnished to the Administrator and are acceptable to him as showing that the product has been prepared and handled in a sanitary manner.
(c) [Reserved]
(a) Except as provided in § 327.16, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.
(b) An official of the foreign government must certify that any product described on any official certificate was produced in accordance with the regulatory requirements in § 327.2.
(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment, and be available to import inspection personnel.
(d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue inspection certificates for products imported to the United States.
(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign establishment number;
(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;
(4) The product's description, including the process category, the product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or identification mark on the units;
(8) The net weight of each lot; and
(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.
(a) Applicants must submit an import inspection application, to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 327.16 and 327.17.
(a)(1) Except as provided in §§ 327.16 and 327.17, all products offered for entry from any foreign country shall be reinspected by a Program inspector before they shall be allowed entry into the United States.
(2) Every lot of product shall routinely be given visual inspection by a Program import inspector for appearance and condition, and checked for certification and label compliance.
(3) The electronic inspection system shall be consulted for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.
(4) When the inspector deems it necessary, the inspector may sample and inspect lots not designated by the electronic inspection system.
(b) All products, required by this part to be inspected, shall be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section. Such approved official import inspection establishments will be listed in the Directory of Meat and Poultry Inspection Program Establishments, Circuits and Officials, published by the Food Safety and Inspection Service. The listing will categorize the kind or kinds of product
(c) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application shall be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and shall include all information called for by that form.
(d) Approval for Federal import inspection shall be in accordance with part 304 of this subchapter.
(e) Owners or operators of official import inspection establishments must furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 304.2, 307.1, 307.2(b), (d), (f), (h), (k), and (l), and part 416 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments.
(f) The Administrator is authorized to approve any establishment as an official import inspection establishment provided that an application has been filed and drawings have been submitted in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(g) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may also be withdrawn in accordance with section 401 of the Act and applicable rules of practice.
(h) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment.
(i) A sampling inspection shall be made, as provided in paragraph (a) of this section, of foreign chilled fresh or frozen fresh meat, including defrosting if necessary to determine its condition. Inspection standards for foreign chilled fresh or frozen fresh meat shall be the same as those used for domestic chilled fresh or frozen fresh meat. (See § 327.21)
(j) Imported canned products are required to be sound, healthful, properly labeled, wholesome, and otherwise not adulterated at the time the products are offered for importation into the United States. Provided other requirements of this part are met, the determination of the acceptability of the product and the condition of the containers shall be based on the results of an examination of a statistical sample drawn from the consignment as provided in paragraph (a) of this section. If the inspector determines, on the basis of the sample examination, that the product does not meet the requirements of the Act and regulations thereunder, the consignment shall be refused entry. However, a consignment rejected for container defects but otherwise acceptable may be reoffered for inspection under the following conditions:
(1) If the defective containers are not indicative of an unsafe and unstable product as determined by the Administrator;
(2) If the number and kinds of container defects found in the original sample do not exceed the limits specified for this purpose in FSIS guidelines; and
(3) If the defective containers in the consignment have been sorted out and exported or destroyed under the supervision of an inspector.
(k) Program inspectors or Customs officers at border or seaboard ports shall report the sealing of cars, trucks, or other means of conveyance, and the sealing or identification of containers of foreign product on Form MP-410 to Program area supervisors at points where such product is to be inspected.
(l) Representative samples of canned product designated by the Administrator in instructions to inspectors shall be incubated under supervision of such inspectors in accordance with § 318.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of this subchapter. The importers or his/her agent shall provide the necessary incubation facilities in accordance with § 318.309(d)(1)(i) of this subchapter.
(m) Sampling plans and acceptance levels as prescribed in paragraphs (j) and (l) of this section may be obtained, upon request, from International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(a) No product required by this part to be inspected shall be moved, prior to inspection from any port, or, if arriving by water from the wharf where first unloaded, to any place other than the place designated by, or in accordance with, this part as the place where the same shall be inspected.
(b) No product required by this part to be inspected shall be conveyed, prior to inspection, from any port, or, if arriving by water, from the wharf where first unloaded, in any manner other than in compliance with this part.
(c) No product required by this part to be inspected shall be delivered to the consignee or his agent prior to inspection, unless the consignee shall furnish a bond, in form prescribed by the Secretary of the Treasury, conditioned that the product shall be returned, if demanded, to the collector of the port where the same is offered for clearance through the customs.
(d) The consignee or his agent shall provide such assistance as Program inspectors may require for the handling and marking of product offered for entry.
Compartments of steamships, sailing vessels, railroad cars, and other means of conveyance transporting any product to the United States, and all trucks, chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any product offered for importation into the United States, shall be maintained in a sanitary condition.
Burlap shall not be used as a wrapping for foreign meat unless the meat is first wrapped with a good grade of paper or cloth of a kind which will prevent contamination with lint or other foreign material.
(a) Program inspectors may take, without cost to the United States, for laboratory examination, samples of any product which is subject to analysis, from each consignment offered for importation, except that such samples shall not be taken of any product offered for importation under § 327.16.
(b) Except for product offered for entry from Canada, the outside containers of all products offered for entry from any foreign country and accompanied with a foreign inspection certificate as required by this part, which, upon reinspection by import inspectors are found not to be adulterated or misbranded and are otherwise eligible for entry into the United States under this part, or the products themselves if not in containers, shall be marked with the official inspection legend prescribed in § 327.26 of this part. Except for Canadian product, all other products so marked, in compliance with this part, shall be entered into the United States, insofar as such entry is regulated under the Act.
(c) Product which is inspected and rejected shall be marked “U.S. Refused Entry” as shown in § 327.26(c). Such marks shall be applied to the shipping container or the product itself if not in a container.
(d) The inspection legend may be placed on containers of product before completion of official import inspection if the containers are being inspected by an import inspector who reports directly to an Import Field Office Supervisor; the product is not required to be held at the establishment pending the receipt of laboratory test results; and a written procedure for controlled stamping, submitted by the import establishment and approved by the Director, Import Inspection Division, is on file at the import inspection facility where the inspection is to be performed.
(1) The written procedure for controlled pre-stamping should be in the form of a letter and shall include the following:
(i) That stamping under this part will be limited to those lots of product which can be inspected on the day that certificates for the product are examined;
(ii) That all product which has been pre-stamped will be stored in the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and
(iv) That the establishment will maintain a daily stamping log containing the following information for each lot of product: the date of inspection, the country of origin, the foreign establishment number, the product name, the number of units, the shipping container marks, and the MP-410 number covering the product to be inspected. The daily stamping log must be retained by the establishment in accordance with the requirements of § 320.3.
(2) An official import establishment's controlled pre-stamping privilege may be cancelled orally or in writing by the inspector or other Agency employee who is supervising its enforcement whenever the employee finds that the official import establishment has failed to comply with the provisions of this part or any conditions imposed pursuant thereto. If the cancellation is oral, the decision or action and the reasons therefor will be confirmed in writing, as promptly as circumstances allow. Any person whose controlled pre-stamping privilege has been cancelled may appeal the decision or action in accordance with 9 CFR 500.9. The appeal must state all of the facts and reasons upon which the person relies to show that the controlled pre-stamping privilege was wrongfully cancelled.
In order that importers may be assured that samples of foreign products collected for laboratory examination are to be used exclusively for that purpose, official receipts shall be issued and delivered to importers, or their agents, by inspectors for all samples of foreign products collected. The official receipt shall be prepared in duplicate, over the signature of the inspector who collects the samples, and shall show the name of the importer, country of origin, quantity and kind of product collected, date of collection, and that the sample was collected for laboratory examination. The duplicate copy of the receipt shall be retained by the inspectors as their office record.
(a) Samples of foreign canned or packaged products bearing on their immediate containers trade labels which have not been approved under § 317.3 of this subchapter shall be collected and forwarded to the laboratory by the Program inspector for examination, and the products shall be held pending receipt of the report of the laboratory findings and the results of the examination of trade labels and the marks on shipping containers.
(b) Foreign canned or packaged products bearing trade labels and other markings which have been approved under § 317.3 of this subchapter shall be inspected for soundness and checked for net weight. Samples may be collected for laboratory examination, but the products may be released under customs' bond pending the report of laboratory findings.
(c) Samples shall be taken from foreign canned products or packaged products as required by § 327.6 (a) and (j) of this part.
(a)(1) Program inspectors shall report their findings as to any product which has been inspected in accordance with this part, to the Director of Customs at the original port of entry where the same is offered for clearance through Customs inspection.
(2) When product has been identified as “U.S. refused entry, ” the inspector shall request the Director of Customs to refuse admission to such product and to direct that it be exported by the owner or consignee within the time specified in this section, unless the owner or consignee, within the specified time, causes it to be destroyed by disposing of it under the supervision of a Program employee so that the product can no longer be used as human food, or by converting it to animal food uses, if permitted by the Food and Drug Administration. The owner or consignee of the refused entry product shall not transfer legal title to such product, except to a foreign consignee for direct and immediate exportation, or to an end user, e.g., an animal food manufacturer or a renderer, for destruction for human food purposes. “Refused entry” product must be delivered to and used by the manufacturer or renderer within the 45-day time limit. Even if such title is illegally transferred, the subsequent purchaser will still be required to export the product or have it destroyed as specified in the notice under paragraph (a)(5) of this section.
(3) No lot of product which has been refused entry may be subdivided during disposition pursuant to paragraph (a)(2) of this section, except that removal and destruction of any damaged or otherwise unsound product from a lot destined for reexportation is permitted under supervision of USDA prior to exportation. Additionally, such refused entry lot may not be shipped for export from any port other than that through which the product came into the United States, without the expressed consent of the Administrator based on full information concerning the product's disposition, including the name of the vessel and the date of export. For the purposes of this paragraph, the term “lot” shall refer to that product indentified on MP Form 410 in the original request for inspection for importation pursuant to § 327.5.
(4) Product which has been refused entry solely because of misbranding, in lieu of exportation or destruction pursuant to paragraph (a)(2) of this section, may be brought into compliance with the requirements of this part, under supervision of an authorized representative of the Administrator.
(5) The owner or consignee shall have 45 days after notice is given by FSIS to the Director of Customs at the original port of entry to take the action required in paragraph (a)(2) of this section for “refused entry” product. Extension beyond the 45-day period may be granted by the Administrator when extreme circumstances warrant it; e.g., a dock workers' strike or an unforeseeable vessel delay.
(6) If the owner or consignee fails to take the required action within the time specified under paragraph (a)(5) of this section, the Department will take such action as may be necessary to effectuate its order to have the product destroyed for human food purposes. The Department shall seek court costs and fees, storage, and proper expense in the appropriate legal forum.
(7) No product which has been refused entry and exported to another country pursuant to paragraph (a)(2) of this section may be returned to the United States under any circumstance. Any such product so returned to the United States shall be subject to administrative detention in accordance with section 402 of the Act and seizure and condemnation in accordance with section 403 of the Act.
(b) Upon the request of the Director of Customs at the port where a product is offered for clearance through the customs, the consignee of the product shall, at the consignee's own expense, immediately return to the Director any product which has been delivered to consignee under § 327.7 and subsequently designated “U.S. Refused Entry” or found in any respect not to comply with the requirements in this part.
(c) All charges for storage, cartage, and labor with respect to any product which was imported contrary to the Act shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against such product and any other product thereafter imported by or for such owner or consignee.
(a) Product which is offered for importation, and which is susceptible of marking, shall, whether or not enclosed in an immediate container, bear the name of the country of origin, preceded by the words “product of”; the establishment number assigned by the foreign meat inspection system and certified to the Program; and such other markings as are necessary for compliance with part 316 of this subchapter. When such markings are imprints of stamps or brands made with branding ink, such ink shall be harmless and shall create permanent imprints. In case the name of the country of origin appears as part of an official mark of the national foreign government and such name is prominently and legibly displayed, the words “product of” may be omitted.
(b) In addition to the marking of products required under paragraph (a) of this section, the immediate container of any product offered for importation:
(1) Shall bear a label showing in accordance with § 317.2 of this subchapter all information required by that section (except that the establishment number assigned by the foreign meat inspection system and certified to the Program and the official inspection mark of the foreign meat inspection system shall be shown instead of the official inspection legend of the United States) and in addition the name of the country of origin preceded by the words “product of,” immediately under the name or descriptive designation of the product as required by § 317.2: Provided, That such establishment number may be omitted from a label lithographed directly on a can if said number is lithographed or embossed elsewhere on the can; and
(2) Shall, if such immediate container is a sealed metal container, have the establishment number assigned by the foreign meat inspection authority and certified by the Program embossed or lithographed on the sealed metal container, and such establishment number shall not be covered or obscured by any label or other means.
(c) All marks and other labeling for use on or with immediate containers, as well as private brands on carcasses or parts of carcasses, must be approved by the Food Safety and Inspection Service in accordance with part 412 of this chapter before products bearing such marks, labeling, or brands will be entered into the United States. The marks of inspection of foreign systems embossed on metal containers or branded on carcasses or parts thereof need not be submitted to the Food Safety and Inspection Service for approval, and such marks of inspection put on stencils, box dies, labels, and brands may be used on such immediate containers as tierces, barrels, drums, boxes, crates, and large-size fiberboard containers of foreign products without such marks of inspection being submitted for approval, provided the markings made by such articles are applicable to the product and are not false or misleading.
(a) The outside container in which any immediate container of foreign product is shipped to the United States shall bear, in English, in a prominent and legible manner:
(1) The name or descriptive designation of the product in accordance with § 317.2 of this subchapter;
(2) The name of the country of origin; and
(3) The establishment number assigned by the foreign meat inspection system and certified to the Program.
(b) All labeling used with an outside container of foreign product must be approved in accordance with part 317 of this subchapter.
(c) Except for product offered for entry from Canada, all outside containers of products which have been inspected and passed in accordance with this part shall be marked by a Program import inspector or under a Program import inspector's supervision with the official import meat inspection mark prescribed in § 327.26.
Any product in a quantity of 50 pounds or less which was purchased by the importer outside the United States for his/her own consumption, is eligible to be imported into the United States from any country without compliance with the provisions in other sections of this part but subject to applicable requirements under other laws, including the regulations in part 94 of this title. However, Program employees may inspect any product imported under this section to determine whether it is within the class eligible to be imported under this paragraph.
U.S. inspected and passed and so marked products exported to and returned from foreign countries will be admitted into the United States without compliance with this part upon notification to and approval of the Deputy Administrator, International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, in specific cases.
(a) All products, after entry into the United States, shall be deemed and treated as domestic products and shall be subject to the applicable provisions of the Act and the regulations in this subchapter and the applicable requirements under the Federal Food, Drug and Cosmetic Act, except that products imported under § 327.16 are required to comply only with the requirements of that Act and § 327.16 of this subchapter.
(b) Products entered in accordance with this part may, subject to the provisions of part 318 of this subchapter, be taken into official establishments and be mixed with or added to any product in such establishments which has been inspected and passed therein.
(c) Imported product which has been inspected, passed, and marked under this part may be transported in the course of importation or subsequently in commerce only upon compliance with part 325 of this subchapter.
The provisions in this part do not apply to specimens of products for laboratory examination, research, or similar purposes when authorized importation by the Administrator under conditions specified by him in specific cases, including requirements of denaturing or other identification to deter their use for human food. Authorization will not be given for the importation of any products contrary to the provisions of part 94 of this chapter.
No inedible grease, inedible tallow, or other inedible rendered fat shall be imported into the United States unless it has been first denatured as prescribed in § 327.25 of this part and the containers marked as prescribed by § 316.15 of this subchapter or unless it is identified and handled as prescribed by § 325.11 (b) or (c) of this subchapter.
(a) Definitions; sampling; standards. (1) Frozen boneless manufacturing meat is meat, frozen in the fresh state from cattle, sheep, swine, goats, horses, mules, or other equines that has all bone removed and is cut into pieces or trimmings, frozen into a compact block of any shape and suitable for slicing or chopping in the manufacturing of meat food products. As used in this section, the term “frozen” includes “chilled fresh,” and “lot” means any amount of frozen boneless manufacturing meat of one species, similarly packaged, shipped from one establishment, and offered for import inspection under one or more foreign inspection certificates.
(2) Imported frozen boneless manufacturing meat shall be sampled as required by § 327.6(a) of this part, and the samples defrosted for inspection. The Program import inspector, or in the case of Canadian product subject to procedures described in § 327.5(d)(1), the Canadian representative will select from a lot the appropriate number of cartons specified by the table of sampling plans. The total sample for inspection will consist of the necessary number of 12-pound units drawn from these cartons. The 12-pound units selected will be completely defrosted and examined.
(b) Lots refused entry. Reinspection (including resampling) will be provided for any lot of frozen boneless manufacturing meat which was refused entry under this section on the basis of the original evaluation of the sample thereof, upon appeal from the inspector's initial decision.
(a) Definitions. For the purposes of this section:
(1) A Product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in § 319.104 or § 319.105 of this subchapter.
(2) A Product Group or a Group means one of the following:
(i) Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product that fits into the Group shall be placed in this Group regardless of any other considerations.
(ii) Group II, consisting of cured pork products which have been water cooked. Any product that does not fit into Group I but does fit into Group II shall be placed into Group II regardless of any other considerations.
(iii) Group III, consisting of boneless, smokehouse heated cured pork products. Any boneless product that does not fit into Group I or II shall be placed in Group III.
(iv) Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product and does not fit into Group I, II, or III shall be placed in this Group.
(3) Protein Fat-Free Percentage, Protein Fat-Free Content, PFF Percentage, PFF Content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.
(4) A PFF Standardized Difference is the PFF of the sample minus the minimum PFF requirement, set forth in § 319.104 and § 319.105 of this subchapter, for the product being analyzed, divided by the Appropriate Standard Deviation for the product group.
(5) The Absolute Minimum PFF Requirement is that no laboratory result of an individual sample for PFF content be below the applicable minimum requirement of § 319.104 or § 319.105 of this subchapter by 2.3 or more percentage points for a Group I or II product or 2.7 or more percentage points for a Group III or IV product.
(6) A PFF Standardized Arithmetic Average of the Country's Products is the arithmetic average of PFF Standardized Differences from either 36 or 100 consecutively sampled lots of product entering the United States from a given producing country.
(7) A PFF Standardized Weighted Average of the Country's Products is an estimate of the average of the PFF Standardized Differences from either 36 or 100 consecutively sampled lots, adjusted for the size of the lot, of different types of cured pork product entering the United States from a given producing country. A Standardized Weighted Average is computed by multiplying the PFF Standardized Difference calculated for each lot by the number of pounds of product in each lot, adding those results together, and dividing the sum by the total weight of product from all the lots making up the average.
(8) The Appropriate Standard Deviation is based on within lot variability. That assigned to Groups I and II = 0.75 percent PFF and that assigned to Groups III and IV = 0.91 percent PFF.
(9) A Lot is all product of one type from one establishment presented by an importer as the unit for inspection at the Port of Entry.
(b) Normal monitoring procedures. Except for product imported from Canada, the Department shall collect sample(s) of cured pork product on a random basis from lots offered for entry at the Port of Entry and, after analyzing the sample for fat and indigenous protein content, calculate the PFF percentage. The product shall not be held pending laboratory results during the monitoring phase. The PFF percentage for each sample shall be considered along with the cumulative results of prior samples to assess the effectiveness of a country's overall compliance program and to determine the course of action for subsequent lots of product.
(1) Factors determining whether a country's inspection system is functioning adequately:
(i) The PFF percentage for each sample must not be below the minimum PFF requirement by 2.3 percentage points for cured pork products in Groups I and II or 2.7 percentage points for cured pork products in Groups III and IV.
(ii) Both of the PFF Standardized Averages, Arithmetic and Weighted, for the last 100 consecutive lots of all cured pork products from the country must be equal to or greater than zero. The count for the 100 consecutive lots starts with the lots arriving from that country after April 15, 1985.
(iii) Both of the PFF Standardized Averages, Arithmetic and Weighted, for the last 36 consecutive lots of all cured pork products from the country must be above the lowest 5 percent of the Normal distribution. This minimum value is minus 0.28 (−0.28) for the Arithmetic Average and depends on the production volume for the Weighted Average.
(2) Actions when calculations indicate that processing procedures in a country are out-of-compliance:
(i) If the PFF level of a sample taken during normal monitoring procedures is found to be as low as the Absolute Minimum PFF Requirement, the country of origin shall be notified; the lot involved shall be retained if still available in an official establishment or subject to detention or other actions pursuant to the Act; and all subsequently presented lots of that cured pork product from the same foreign establishment shall be held under retention until the provisions of paragraph (c) are satisfied.
(ii) If either of the PFF Standardized Averages, Arithmetic or Weighted, for the last 100 consecutive lots falls below zero or either of the PFF Standardized Averages for the last 36 consecutive lots falls below the upper 95 percent of the Normal distribution, all available cured pork product from the foreign country shall be subject to administrative retention and all subsequently presented lots of cured pork product from the foreign country shall be held under retention until the provisions of paragraph (c) are satisfied. The country of origin shall be notified, and shall be subject to other actions pursuant to the Act.
(c) Retention. When lots of cured pork product are under retention they shall be refused entry and reexported in accordance with § 327.13 of this subchapter unless they can be released in accordance with the provisions of paragraph (c)(1), establishments may be returned to normal monitoring procedures in accordance with paragraph (c)(2), and countries may be returned to normal monitoring procedures in accordance with paragraph (c)(3).
(1) If a lot is subject to retention procedures under this section, the Department shall collect five randomly selected sample units from each lot and determine the PFF of each sample unit. The lot may be released into commerce if:
(i) The average PFF percentage of the five randomly selected sample units is equal to or greater than the applicable minimum PFF percentage required by § 319.104 or § 319.105 of this subchapter, or
(ii) The product is relabeled under the supervision of a program employee so that it conforms to the provisions of § 319.104 or § 319.105 of this subchapter.
(2) If product from a foreign establishment is subject to retention procedures under this section, the foreign establishment may be returned to normal monitoring procedures when:
(i) Ten consecutively presented lots of that cured pork product from that establishment have been sampled as provided in paragraph (c)(1) of this section and the average of each set of five sample units representing each lot have been found to be equal to or greater than the required minimum PFF percentage; and
(ii) The PFF percentage of each sample unit (50 in all) is above the Absolute Minimum PFF Percentage.
(3) If a country is subject to retention procedures under this section, the country shall be returned to normal monitoring procedures when:
(i) Twenty-five consecutively presented lots of cured pork product have been sampled as required in paragraph (c)(1) of this section and the average of each set of five sample units representing each lot have been found to be equal to or greater than the required minimum PFF percentage; and
(ii) The PFF percentage of each sample unit (125 in all) is above the Absolute Minimum PFF Percentage; and
(iii) Both of the PFF Standardized Averages for 36 consecutive lots are in the required percentage of the Normal distribution; and
(iv) Both of the PFF Standardized Averages for 100 consecutive lots are zero or higher.
(4) The sample units collected under retention procedures as provided in paragraph (c)(2) of this section will not be included in the PFF standardized averages for 36 and 100 consecutive lots.
(d) Adulterated and Misbranded Products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)).
(e) Activities requiring additional inspectional supervision, such as relabeling, shall be at the importer's expense. In addition, if the importer wishes, he or she may have samples analyzed at an accredited laboratory.
Any appeal of a decision or action of any program employee will be made to his/her immediate supervisor having responsibility over the subject matter of the appeal in accordance with 9 CFR 500.9.
(a) Carcasses, parts thereof, meat and meat food products (other than rendered animal fats) that have been treated in accordance with the provisions of this section shall be considered denatured for the purposes of the regulations in this part, except as otherwise provided in part 314 of this subchapter for articles condemned at official establishments or at official import inspection establishments.
(1) The following agents are prescribed for denaturing carcasses, parts thereof, meat or meat food products which are affected with any condition that would result in their condemnation and disposal under part 314 of this subchapter if they were at an official establishment or at an official import inspection establishment: Crude carbolic acid; cresylic disinfectant; a formula consisting of 1 part FD&C green No. 3 coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or other proprietary substance approved by the Administrator in specific cases.
(2) Meat may be denatured by dipping it in a solution of 0.0625 percent tannic acid, followed by immersion in a water bath, then dipping it in a solution of 0.0625 percent ferric acid; and except as provided in paragraphs (a) (3) and (5) of this section, the following agents are prescribed for denaturing other carcasses, parts thereof, meat and meat food products, for which denaturing is required by this part: FD&C green No. 3 coloring; FD&C blue No. 1 coloring; FD&C blue No. 2 coloring; finely powdered charcoal; or other proprietary substance approved by the Administrator in specific cases.
(3) Tripe may be denatured by dipping it in a 6 percent solution of tannic acid for 1 minute followed by immersion in a water bath, then immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 5 coloring.
(4) When meat, meat byproducts, or meat food products are in ground form, 4 percent by weight of coarsely ground hard done, which shall be in pieces no smaller than the opening size specified for No. 5 mesh in the standards issued by the U.S. Bureau of Standards or 6 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 8 mesh in said Standards, uniformly incorporated with the product, may be used in lieu of the agents prescribed in paragraph (a)(2) of this section.
(5) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sectioning will not be necessary.) The application of any of the denaturing agents listed in paragraph (a) (1) or (2) of this section to the outer surface of molds or blocks or boneless meat, meat by-products, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.
(b) Inedible rendered animal fats shall be denatured by thoroughly mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any proprietary denaturing agent approved for the purpose by the Administrator in specific cases. The charcoal shall be used in no less quantity than 100 parts per million and shall be of such character that it will remain suspended indefinitely in the liquid fat. Sufficient of the chosen identifying agents shall be used to give the rendered fat so distinctive a color, odor, or taste that it cannot be confused with an article of human food.
(a) When import inspections are performed in official import inspection establishments, the official inspection legend to be applied to imported meat and meat food products shall be in the appropriate form
For application to cattle, sheep, swine, and goat carcasses, primal parts, and cuts, not in containers.
For application to outside containers of meat and meat food products prepared from cattle, sheep, swine, and goats.
For application to horse carcasses, primal parts, and cuts, not in containers.
For application to outside containers of horsemeat food products.
For application to mule and other (nonhorse) equine carcasses, primal parts, and cuts, not in containers.
For application to outside containers of equine meat food products.
(b) Except for product offered for entry from Canada, when import inspections are performed in official establishments the official inspection legend to be applied to meat and meat food products offered for entry shall be the appropriate form as specified in §§ 312.2 and 312.3 of this subchapter.
(c) When products are refused entry into the United States, the official mark to be applied to the products refused entry shall be in the following form:
(d) Devices for applying “United States Refused Entry” marks shall be furnished to Program inspectors by the Department.
(e) The ordering and manufacture of brands containing official inspection legends shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations.
Any carcass, part of a carcass, meat or meat food product of livestock, or article exempted from the definition of meat food product, or any dead, dying, disabled, or diseased livestock is subject to detention for a period not to exceed 20 days when found by any authorized representative of the Secretary upon any premises where it is held for the purposes of, or during or after distribution in, commerce or it is otherwise subject to Title I or II of the Act, and there is reason to believe that:
(a) Any such article is adulterated or misbranded and is capable of use as human food; or
(b) Any such article has not been inspected, in violation of the provisions of Title I of the Act, any other Federal law, or the laws of any State or Territory, or the District of Columbia; or
(c) Any such article or livestock has been or is intended to be, distributed in violation of the provisions of Title I of the Act, any other Federal law, or the laws of any State or Territory, or the District of Columbia.
An authorized representative of the Secretary shall detain any article or livestock to be detained under this part, by affixing an official “U.S. Detained” tag (FSIS Form 8400-2) to such article or livestock.
(a) When any article or livestock is detained under this part, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the article or livestock detained, and
(2) Promptly furnish a copy of a completed “Notice of Detention” (FSIS Form 8080-1) to the immediate custodian of the detained article or livestock.
(b) If the owner of the detained article or livestock, or the owner's agent, is not the immediate custodian at the time of detention and if the owner, or owner's agent, can be ascertained and notified, an authorized representative of the Secretary shall furnish a copy of the completed “Notice of Detention” to the owner or the owner's agent. Such copy shall be served, as soon as possible, by delivering the notification to the owner, or the owner's agent, or by certifying and mailing the notification to the owner, or the owner's agent, at his or her last known residence or principal office or place of business.
Within 48 hours after the detention of any livestock or article pursuant to this part, an authorized representative of the Secretary shall give oral or written notification of such detention to any Federal authorities not connected with the Program, and any State or other governmental authorities, having jurisdiction over such livestock or article. In the event notification is given orally, it shall be confirmed in writing, as promptly as circumstances permit.
(a) No article or livestock detained in accordance with the provisions in this part shall be moved by any person from the place at which it is located when so detained, until released by an authorized representative of the Secretary: Provided, That any such article or livestock may be moved from the place at which it is located when so detained, for refrigeration, freezing, or storage purposes if such movement has been approved by an authorized representative of the Secretary: And provided further, That the article or livestock so moved will be detained by an authorized representative of the Secretary after such movement until such time as the detention is terminated.
(b) Upon terminating the detention of such article or livestock, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the released article or livestock, and
(2) Furnish copies of a completed “Notice of Termination of Detention” (FSIS Form 8400-1) to the persons notified when the article or livestock was detained. The notice shall be served by either delivering the notice to such persons or by certifying and mailing the notice to such persons at their last known residences or principal offices or places of business.
(c) All official marks may be required by such representative to be removed from such article or livestock before it is released unless it appears to the satisfaction of the representative that the article or livestock is eligible to retain such marks.
Any carcass, part of a carcass, meat or meat food product, or any dead, dying, disabled, or diseased livestock, that is being transported in commerce or is otherwise subject to Title I or II of the Act, or is held for sale in the United States after such transportation, is subject to seizure and condemnation, in a judicial proceeding pursuant to section 403 of the Act if such article or livestock:
(a) Is or has been prepared, sold, transported, or otherwise distributed or offered or received for distribution in violation of the Act, or
(b) Is capable of use as human food and is adulterated or misbranded, or
(c) In any other way is in violation of the Act.
Any article or livestock subject to seizure and condemnation under this part shall be liable to be proceeded against and seized and condemned, and disposed of, at any time, on an appropriate pleading in any United States district court, or other proper court specified in section 404 of the Act, within the jurisdiction of which the article or livestock is found.
The provisions of this part relating to seizure, condemnation and disposition of articles or livestock do not derogate from authority for condemnation or seizure conferred by other provisions of the Act, or other laws.
The Act contains criminal provisions with respect to numerous offenses specified in the Act, including but not limited to bribery of Program employees, receipt of gifts by Program employees, and forcible assaults on, or other interference with, Program employees while engaged in, or on account of, the performance of their official duties under the Act.
For purposes of this part, the term “State” means any State (including the Commonwealth of Puerto Rico) or organized Territory.
The provisions of the regulations in this subchapter apply to operations and transactions wholly within each State designated under paragraph 301(c) of the Act, except as otherwise provided in this section. (The provisions of the regulations apply in all respects to operations and transactions in or for commerce.)
(a) Each establishment located in such a designated State shall be granted inspection required under § 302.1(a)(2) of this subchapter only if it is found, upon a combined evaluation of its premises, facilities, and operating procedures, to be capable of producing products that are not adulterated or misbranded.
(b) Section 305.2 of this subchapter will apply to establishments required to have inspection under § 302.1(a)(2) of this subchapter, except that existing interconnections between official and unofficial establishments will be permitted if it is determined in specific cases that the interconnections are such that transfer of inedible product into the official establishment would be difficult or unusual, and any such transfers are strictly prohibited, except as permitted under other provisions of this subchapter. It is essential that separation of facilities be maintained to the extent necessary to assure that inedible product does not enter the official establishment contrary to the regulations in this subchapter.
(c) Sections 416.2(c), (d), (e), (f), and (h) of this chapter shall apply to such establishments.
(d) Section 314.2 of this subchapter shall apply to such establishments, except that a separate room or compartment need not be provided for inedible products if they can be handled so that they do not create insanitary conditions in any room or compartment used for edible products or otherwise render any edible products adulterated and do not interfere with the conduct of inspection. For example, intestines, paunch contents, feet, and hides might be accumulated on the kill floor in clean, watertight drums with close fitting covers if there is sufficient space to store them out of the way until the close of the day's operation.
(e) Sections 316.7, 317.3, and 412.1 of this chapter apply to such establishments, except as provided in this paragraph (e).
(1) The operator of each such establishment will, prior to the inauguration of inspection, identify all labeling and marking devices in use, or proposed for use, (upon the date of inauguration of inspection) to the Front Line Supervisor of the circuit in which the establishment is located. Temporary approval, pending formal approval under §§ 316.7, 317.3, and 412.1 of this chapter, will be granted by the Front Line Supervisor for labeling and marking devices that he determines are neither false nor misleading, provided the official inspection legend bearing the official establishment number is applied to the principal display panel of each label, either by a mechanical printing device or a self-destructive pressure sensitive sticker, and provided the label shows the true product name, an accurate ingredient statement, the name and address of the manufacturer, packer, or distributor, and any other features required by section 1(n) of the Act.
(2) The circuit supervisor will forward one copy of each item of labeling and a description of each marking device for which he has granted temporary approval to the Washington, DC, office of the Labeling and Packaging Staff and will retain one copy in a temporary approval file for the establishment.
(3) The operator of the official establishment shall promptly forward a copy of each item of labeling and a description of each marking device for which temporary approval has been granted by the Front Line Supervisor (showing any modifications required by the Front Line Supervisor) to the FSIS Labeling and Program Delivery Staff, accompanied by the formula and details of preparation and packaging for each product. Within 90 days after inauguration of inspection, all labeling material and marking devices temporarily approved by the Front Line Supervisor must receive approval as required by §§ 316.7, 317.3, and 412.1 of this chapter, or their use must be discontinued.
(4) The circuit supervisor will also review all shipping containers to insure that they do not have any false or misleading labeling and are otherwise not misbranded. Modifications of unacceptable information on labeling material by the use of self-destructive pressure sensitive tape or by blocking out with an ink stamp will be authorized on a temporary basis to permit the maximum allowable use of all labeling materials on hand. All unacceptable labeling material which is not modified to comply with the requirements of this subchapter must be destroyed or removed from the official establishment.
(f) Sections 320.1, 320.2, 320.3, 320.4, 320.5, 325.20, and 325.21 apply to operations and transactions not in or for commerce in a State designated under paragraph 301(c) only if the State is also designated under section 205 of the Act and if such provisions are applicable.
(g) Section 321.1(a) of this subchapter will not apply to States designated under paragraph 301(c) of the Act.
(h) Parts 322 and 327 and § 325.3 of this subchapter relating to exports and imports do not apply to operations and transactions solely in or for intrastate commerce.
(i) Part 325 of this subchapter will apply to establishments required to have inspection under § 302.1(a)(2) of this subchapter and to operations and transactions solely in or for intrastate commerce, except as provided in paragraphs (h) and (j) of this section.
(j) Sections 325.4, 325.15, and 325.1(b) of this subchapter will not apply to require a certificate, or evidence thereof, for the distribution solely within any designated State of products that are U.S. inspected and passed and so marked.
Upon the effective date of designation of a State under paragraph 301(c) of the Act, no products can be prepared within the State unless they are prepared under inspection pursuant to the regulations in this subchapter or are exempted from the requirement of inspection under § 303.1 of this subchapter, and no unexempted products which were prepared without any inspection can lawfully be distributed within the State. For a period of 90 days from the effective date of such designation, products which were prepared and inspected and passed under the supervision of a responsible State or local inspection agency can be distributed solely within the State, provided they are not adulterated or misbranded, except that the official inspection legend is not required. Within the 90-day period, products that have been inspected by the State or local inspection agency may be further prepared and otherwise handled in official establishments required to have inspection under § 302.1(a)(2) of this subchapter or at establishments exempted from the requirements of such inspection under § 303.1 of this subchapter, and may be distributed as provided in this section but otherwise shall be handled in accordance with § 305.4 of this subchapter. Such products shall not bear any [Federal] official inspection legends. After said 90-day period, only federally inspected and passed products may be distributed within the designated State, except as provided in § 303.1 of this subchapter.
(a) An establishment preparing products solely for distribution within any State shall be designated as one producing adulterated products which would clearly endanger the public health, if:
(1) Any meat or meat food product prepared at the establishment is adulterated in any of the following respects:
(i) It bears or contains a pesticide chemical, food additive, or color additive, that is “unsafe” within the meaning of sections 408, 409, or 706 of the Federal Food, Drug, and Cosmetic Act or was intentionally subjected to radiation in a manner not permitted under section 409 of said Act; or if it bears or contains any other added poisonous or added deleterious substance which may render it injurious to health or make it unfit for human food; or
(ii) It consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, or unwholesome or otherwise unfit for human food (for example, it was prepared from meat or other ingredients exhibiting spoilage characteristics; or it is, or was prepared from, a carcass affected with a disease transmissible to humans and its condemnation would be required under part 309 or 310 of the Federal Meat Inspection regulations (9 CFR parts 309, 310) at federally inspected establishments; or
(iii) It has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health (for example if insects or vermin are not effectively controlled at the establishments, or insanitary water is used in preparing meat or meat food products for human food); or
(iv) It is, in whole or in part, the product of an animal that died otherwise than by slaughter; or
(v) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; and
(2) Such adulterated articles are intended to be or are distributed from the establishment while capable of use as human food.
(b) When any such establishment is identified by a Program Inspector as one producing adulterated product, which would clearly endanger public health under the criteria in paragraph (a) of this section, the following procedure will be followed:
(1) The Program Inspector will informally advise the operator of the establishment concerning the deficiencies found by him and report his findings to the appropriate Regional Director for the Program. When it is determined by the Regional Director that any establishment preparing products solely for distribution within any State is producing adulterated products for distribution within such State which would clearly endanger the public health, written notification thereof will be issued to the appropriate State officials, including the Governor of the State and the appropriate Advisory Committee, for effective action under State or local law to prevent such endangering of the public health. Such written notification shall clearly specify the deficiencies deemed to result in the production of adulterated products and shall specify a reasonable time for such action under State or local law.
(2) If effective action is not taken under State or local law within the specified time, written notification shall be issued by the Regional Director to the operator of the establishment, specifying the deficiencies involved and allowing him ten days to present his views or make the necessary corrections, and notifying him that failure to correct such deficiencies may result in designation of the establishment and operator thereof as subject to the provisions of titles I and IV of the Act as though engaged in commerce.
(3) Thereafter the Program Inspector shall survey the establishment and designate it if he determines, in consultation with the Regional Director, that it is producing adulterated products, which would clearly endanger the public health, and formal notice of such designation will be issued to the operator of the establishment by the Regional Director.
(c) Products on hand at the time of designation of an establishment under this section are subject to detention, seizure and condemnation in accordance with part 329 of this subchapter: Provided, That products that have been federally inspected and so identified and that have not been further prepared at any nonfederally inspected establishment may be released for distribution if the products appear to be not adulterated or misbranded at the time of such release.
(d) No establishment designated under this section can lawfully prepare any products unless it first obtains inspection or qualifies for exemption under § 303.1 of this subchapter. All of the provisions of the regulations shall apply to establishments designated under this section, except that the exceptions provided for in § 331.3 of this part shall apply to such establishments.
Cooperative interstate shipment program. A cooperative meat inspection program described in § 321.3 of this subchapter.
Cooperative State meat inspection program. A cooperative State-Federal meat inspection program described in § 321.1 of this subchapter.
Designated personnel. State inspection personnel that have been trained in the enforcement of the Act and any additional State program requirements in order to provide inspection services to selected establishments.
Interstate commerce. “Interstate commerce” has the same meaning as “commerce” under § 301.2 of this subchapter.
Selected establishment. An establishment operating under a State cooperative meat inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program.
This part prescribes the conditions under which States that administer cooperative State meat inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program.
(a) An establishment that operates under a cooperative State meat inspection program may apply to participate in a cooperative interstate shipment program under this part if:
(1) The establishment employs on average no more than 25 employees based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer than 35 employees as of June 18, 2008. If selected to participate in a cooperative interstate shipment program, an establishment under this paragraph must employ on average no more than 25 employees as of July 1, 2014, or it must transition to become an official establishment as provided in § 332.11 of this part.
(b) An establishment that has 25 or fewer employees based on the following standards is considered to have 25 or fewer employees on average for purposes of this part.
(1) All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis whose duties involve handling the meat or meat food products prepared by the establishment are counted when calculating the total number of employees.
(2) All individuals employed by the establishment from a temporary employee agency, professional employee organization, or leasing concern whose duties involve handling the meat or meat food products prepared by the establishment are counted when calculating the total number of employees.
(3) The average number of employees is calculated for each of the pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-time employees.
(5) If the establishment has not been in business for 12 months, the average number of employees is calculated for each of the pay periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered employees unless their duties involve handling the meat or meat food products prepared by the establishment.
(7) The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average (except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as provided in § 321.2 of this subchapter as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18, 2008, but that were re-organized on a later date by the person that controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State meat inspection that employed more than 35 employees as of June 18, 2008, that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under § 332.11 of this part;
(7) Establishments that are in violation of the Act;
(8) Establishments located in States without a cooperative State meat inspection program; and
(9) Establishments located in a State whose agreement for a cooperative interstate shipment program was terminated by the Administrator as provided in § 321.3(d) of this subchapter.
(d) An establishment that meets the conditions in paragraph (a) of this section and that is not an ineligible establishment under paragraph (c) of this section may apply for selection into a cooperative interstate shipment program through the State in which the establishment is located.
(a) State participation in a cooperative interstate shipment program under this part is limited to States that have implemented cooperative State meat inspection programs.
(b) To request an agreement for a cooperative interstate shipment program under this part, a State must submit a written request to the Administrator through the FSIS District Office for the FSIS District in which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be selected for the program that the State recommends for initial selection into the program, if any;
(2) Demonstrate that the State is able to provide the necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program established under this part; and
(3) Agree that, if the State enters into an agreement with FSIS for a cooperative interstate shipment program, the State will:
(i) Provide FSIS with access to the results of all laboratory analyses conducted on product samples from selected establishments in the State;
(ii) Notify the selected establishment coordinator for the State of the results of any laboratory analyses that indicate that a product prepared in a selected establishment may be adulterated or may otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments.
(c) If the Administrator determines that a State that has submitted a request to participate in a cooperative interstate shipment program qualifies to enter into a cooperative agreement for such a program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments located in the State.
(d) After the Administrator and a State have signed an agreement for a cooperative interstate shipment program as provided in paragraph (c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment coordinator for the State and
(2) Coordinate with the State to select establishments to participate in the program as provided in § 332.5(b) of this part.
(a) An establishment operating under a cooperative State meat inspection program will qualify for selection into a cooperative interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the program;
(2) Has the appropriate number of employees under § 332.3(a) of this part;
(3) Is not ineligible to participate in a cooperative interstate shipment program under § 332.3(c) of this part;
(4) Is in compliance with all requirements under the cooperative State meat inspection program; and
(5) Is in compliance with all requirements under the Act and the implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an establishment that meets the conditions in paragraph (a) of this section must be selected by the Administrator, in coordination with the State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative interstate shipment program as provided in paragraph (b) of this section, the State is to assign the establishment an official number that reflects the establishment's participation in the cooperative interstate shipment program and advise the FSIS selected establishment coordinator for the State of the official number assigned to each selected establishment in the State. The official number assigned to every selected establishment must contain a suffix, e.g., “SE,” that identifies the establishment as a selected establishment and that identifies the State, e.g., “SETX,” for “selected establishment Texas.”
(d) Failure of the State to comply with paragraph (c) of this section will disqualify the State from participation in the cooperative interstate shipment program.
(a) A cooperative interstate shipment program will commence when the Administrator, in coordination with the State, has selected establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee.
(c) Carcasses, parts of carcasses, meat, and meat food products prepared in a selected establishment and inspected and passed by designated State personnel must bear an official Federal mark, stamp, tag, or label of inspection in the appropriate form prescribed in part 312 of this subchapter that includes the information specified in § 332.5(c) of this part.
(d) Carcasses, parts of carcasses, meat, and meat food products prepared in a selected establishment that comply with the conditions in paragraph (c) of this section may be distributed in interstate commerce.
(a) The FSIS selected establishment coordinator for a State that has entered into an agreement for a cooperative interstate shipment program will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the Act and the implementing regulations in this chapter. The frequency with which the SEC will visit selected establishments under the SEC's jurisdiction will be based on factors that include, but are not limited to, the complexity of the operations conducted at the selected establishment, the establishment's schedule of operations, and the establishment's performance under the cooperative interstate shipment program. If necessary, the selected establishment coordinator, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a selected establishment on behalf of the selected establishment coordinator.
(b) The selected establishment coordinator, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from designated personnel, and that these establishments are eligible, and remain eligible, to participate in a cooperative interstate shipment program. The selected establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and continues to employ, 25 or fewer employees, on average, as required under § 332.3(a) of this part, unless the establishment is transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing inspection services to selected establishments in a manner that complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that the State staffing levels for each selected establishments are appropriate to carry out the required inspection activities; and
(4) Assessing each selected establishment's compliance with the Act and implementing regulations under this chapter.
(c) If the selected establishment coordinator determines that designated personnel are providing inspection services to selected establishments in the State in a manner that is inconsistent with the Act and the implementing regulations in this chapter, the Administrator will provide an opportunity for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the selected establishment coordinator. If the State fails to develop a corrective action plan, or the selected establishment coordinator for the State determines that the corrective action plan is inadequate, the Administrator will terminate the agreement for the cooperative interstate shipment program as provided in § 321.3(d) of this chapter.
(a) The selected establishment coordinator will prepare a report on a quarterly basis that describes the status of each selected establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section will:
(1) Include the selected establishment coordinator's assessment of the performance of the designated personnel in conducting inspection activities at selected establishments and
(2) Identify those selected establishments that the selected establishment coordinator has verified are in compliance with the Act and implementing regulations in this chapter, those that have been deselected under § 332.10 of this part, and those that are transitioning to become official establishments under § 332.11 of this part.
(c) The selected establishment coordinator is to submit the quarterly report to the Administrator through the District Manager for the State where the selected establishments identified in the report are located.
(a) To facilitate oversight and enforcement of this part, selected establishments operating under a cooperative interstate shipment program must, upon request, give the FSIS selected establishment coordinator or other FSIS officials access to all establishment records required under the Act and the implementing regulations in this chapter. The Administrator may deselect any selected establishment that refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any appropriate enforcement action provided for in part 500 of this chapter if they determine that a selected establishment under their jurisdiction is operating in a manner that is inconsistent with the Act and the implementing regulations in this chapter. Selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any of the reasons specified in § 500.3 or § 500.4 of this chapter, FSIS will:
(1) Provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or
(2) Move to deselect the establishment as provided in § 332.10 of this part.
(d) The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis. In making this decision, FSIS, in consultation with the State where the selected establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
(a) The Administrator will deselect a selected establishment that becomes ineligible to participate in a cooperative interstate shipment program for any reason listed under § 332.3(c) of this part.
(b) An establishment that has been deselected must transition to become an official establishment as provided in § 332.11 of this part.
(a) If an establishment is deselected from a cooperative interstate shipment program as provided in § 332.10 of this part, FSIS, in coordination with the State where the establishment is located, will develop and implement a plan to transition the establishment to become an official establishment. Except that an establishment that was deselected from a cooperative interstate shipment program because it is located in a State whose agreement for such a program was terminated may either transition to become an official establishment or transition to become a State-inspected establishment under the cooperative State meat inspection program.
(b) An establishment that has been deselected from a cooperative interstate shipment program and successfully transitioned to become an official establishment may withdraw from the Federal inspection program and resume operations under the cooperative State meat inspection program after operating as an official establishment in full compliance with the Act for a year.
(a) Transition grants are funds that a State participating in a cooperative interstate shipment program under this part may apply for to reimburse selected establishments in the State for the cost to train one individual in the seven HACCP principles for meat or poultry processing as required under § 417.7 of this chapter and associated training in the development of sanitation standard operating procedures required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment program that receives a transition grant must use grant funds to reimburse the training costs of one employee per each selected establishment in the State. Any other use of such funds is prohibited.
A selected establishment may conduct operations under the cooperative State meat inspection program if the establishment implements and maintains written procedures for complete physical separation of product and process for each operation by time or space.
A selected establishment that is in full compliance with the requirements in this part may voluntarily end its participation in a cooperative interstate shipment program and operate under the cooperative State meat inspection program. Establishments that voluntarily end their participation in the cooperative may re-apply for the program after operating under the cooperative State meat inspection program for one year.
(a) Except as provided in paragraphs (a)(1) through (5) of this section, before any violation of the Federal Meat Inspection Act is reported to the Department of Justice by the Secretary for criminal prosecution the Secretary must give reasonable notice to the suspected violator that the Secretary intends to report the violation for prosecution and give the suspected violator an opportunity to present the violator's views to the Secretary with respect to such proceeding.
(1) Notice and opportunity need not be provided if the Secretary has any reason to believe that providing such notice and opportunity could result in the alteration or destruction of evidence, or where disclosure could result in injury to persons or property.
(2) Notice and opportunity need not be provided if the Secretary has any reason to believe that providing such notice and opportunity could result in flight of a suspected violator to avoid prosecution.
(3) Notice and opportunity need not be provided if the Secretary has any reason to believe that providing such notice and opportunity could result in compromising special investigative techniques, such as undercover or other covert operations.
(4) Notice and opportunity need not be provided when the impending criminal referral involves suspicion of bribery and related offenses, or clandestine slaughtering and/or processing operations.
(5) Notice and opportunity need not be provided when the impending referral is part of an investigation involving non-Act violations, and the Act and non-Act violations are jointly referred for prosecution.
(b) A notice of opportunity to present views will be sent by registered or certified mail, summarize the violations that constitute the basis of the contemplated prosecution, and describe the procedures for presentation of views. Any information given by a respondent, orally or in writing, shall become part of the Department's official record concerning the matter. The Department is under no obligation to disclose evidence to the suspected violator.
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.
For the purposes of the regulations in this part, unless the context otherwise requires, the following terms shall be construed, respectively, to mean:
(a) Department. The United States Department of Agriculture.
(b) Service. The Food Safety and Inspection Service of the Department.
(c) Administrator. The Administrator of the Service or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
(d) [Reserved]
(e) Inspector. Any officer or employee of the Department authorized to perform any duties under the regulations in this part.
(f) Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other organized group of any of the foregoing.
(g) Federally inspected and passed. Inspected and passed under the Meat Inspection Act, as amended (21 U.S.C. 71 et seq.) or under the provisions in paragraphs 306 (b) and (c) of the Tariff Act of 1930 (19 U.S.C. 1306 (b) and (c)).
(h) Official establishment. An establishment operated under Federal meat inspection pursuant to the Meat Inspection Act, as amended (21 U.S.C. 71 et seq.).
(i) Food article. Any article of human food derived wholly or in part from meat, meat byproducts, or meat food products, which is not subject to the Federal meat inspection laws, and animal casings, for which the mark of Federal meat inspection is requested: Provided, That such articles and casings are derived from federally inspected and passed carcasses.
(j) [Reserved]
(k) Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or may hereafter be delegated, to act in his stead in connection with the function involved.
Upon application in accordance with § 350.5 the following types of service may be furnished under the regulations in this part:
(a) Identification service. (1) Meat or other product that is federally inspected and passed at an official establishment, or upon importation, under the meat inspection laws, is officially marked to identify it as federally inspected and passed. In order to facilitate the division of such meat or other product into smaller portions or its combination into larger units and still maintain its identity as product which has been federally inspected and passed and so marked, inspectors may supervise the handling of the product and mark such portions or units with the marks of Federal inspection when they determine that the identity has been maintained.
(2) At the time service is furnished product must be sound, wholesome and fit for human food. The service will be available only on premises other than those of an official establishment. The sanitation of the plant or area where service is furnished must comply with applicable provisions of part 416, §§ 416.1 through 416.6 of this chapter.
(3) The mark of inspection shall be applied only under the immediate supervision of an inspector.
(4) The service will be available for products moved in tank cars and tank trucks from an official establishment or from a location operating under this service only if such tank cars or tank trucks bear a label before leaving such official establishment or such other location, in accordance with 9 CFR §§ 316.14 and 317.2.
(b) Certification service. At the request of a purchaser, supplier, exporter, or others, inspectors may make certification regarding livestock products for human food purposes (including casings), to be exported, as meeting conditions or standards that are not imposed or are in addition to those imposed by the regulations in parts 301 through 331 of this chapter and the laws under which such regulations were issued.
(c) Food inspection service. An inspection and certification service for wholesomeness relating to the manufacture of a food article may be furnished upon application. All applicable provisions of this chapter shall apply to the preparation, labeling and certification of the food article prepared under this food inspection service.
(d) [Reserved]
Any person who desires to receive service under the regulations in this part for meat or other product eligible therefor under such regulations may make application for service to the Administrator, upon an application form which will be furnished by the Administrator upon request.
(a) If any person has applied for service for meat or other product not eligible therefor under the regulations in this part, or has failed to make proper application for service or to pay fees and charges due for service furnished or to be furnished to him under the regulations in this part, or if the service cannot be furnished to any person applying therefor because of lack of available inspectors or other administrative reasons, the service may be denied to such person by the Administrator until the condition justifying such denial is corrected.
(b) Service under the regulations in this part may also be denied to any person by the Secretary for such period as he may deem proper, if it is determined, after opportunity for hearing before a proper official in the Department, that such person has been responsible for any willful misrepresentation to the Department concerning any meat or other product for which service has been requested under the regulations, in this part, or that such person has been responsible for the use without authority, or the imitation, of any marks or certificates of Federal meat inspection on or with respect to any meat or other product, or has otherwise been responsible for any fraudulent or deceptive practice with respect to such service, or that such person has interfered with or obstructed any inspector in the performance of his duties under the regulations in this part, or attempted to do so. When the Administrator determines that the public interest so requires, he may deny or withdraw service provided for in this part, without a hearing, pending final determination of the matter. The applicant or recipient of service involved shall be notified of the Administrator's decision to deny or suspend service and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. The Administrator's decision to deny or suspend the service shall be effective upon such oral or written notification, whichever is earlier, to the applicant or recipient of service. If such notification is oral, the Administrator shall confirm such decision and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient of service, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)). In other cases prior to the institution of proceedings for denial of service under this paragraph, the facts or conduct which may warrant such action shall be called to the attention of the person involved, in writing, and he shall be given an opportunity to demonstrate or achieve compliance with all applicable requirements.
(a) Fees and charges for service under the regulations in this part shall be paid by the applicant for the service in accordance with this section, and, if required by the Administrator, the fees and charges shall be paid in advance.
(b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the Treasurer of the United States and shall be remitted promptly to the Administrator upon furnishing to the applicant of a statement as to the amount due.
(c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs. Such fees shall cover the costs of the service and shall be charged for the time required to render such services. Where appropriate, this time will include, but will not be limited to, the time required for travel of the inspector or inspectors in connection therewith during the regularly scheduled administrative workweek.
(d) Charges may also be made to cover the cost of travel and other expenses incurred by the Service in connection with the furnishing of the service.
(e) Exporters that submit electronic export certificate applications will be charged a fee per application submitted.
(f) For each calendar year, FSIS will calculate the electronic export certificate application fee, using the following formula: Labor Costs (Technical Support Cost + Export Library Maintenance Cost) + Information Technology Costs (On-going operations Cost + Maintenance Cost + eAuthentication Cost), divided by the number of export applications.
(g) FSIS will publish notice of the electronic export certificate application fee annually in the
The rules of practice of the Department of Agriculture in subpart H of part I, subtitle A, title 7 of the Code of Federal Regulations, are the rules of practice applicable to adjudicatory, administrative proceedings under the regulations in this part (9 CFR part 350).
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.
When used in this part, unless the context otherwise requires:
(a) Department means the United States Department of Agriculture.
(b) Program means the Meat and Poultry Inspection Program of the Food Safety and Inspection Service of the Department.
(c) Administrator means the Administrator of the Food Safety and Inspection Service of the Department, or any officer or employee of the Department to whom authority has heretofore been delegated or may hereafter be delegated to act in his stead.
(d) Circuit supervisor means an employee of the Program assigned to supervise and perform official work in a circuit. Such employee is assigned by and reports directly to the Administrator or person designated by him.
(e) Inspector means an employee of the Program or a cooperating State.
(f) Circuit means one or more inspected plants assigned to a circuit supervisor.
(g) Recognized State means any State not designated under section 301(c) of the Act.
(h) Cooperating State means any State cooperating under § 351.7 in administration of the regulations in this part.
(i) Inspection means ante-mortem and post-mortem inspection by Program inspectors or inspectors of a Meat Inspection Service of a recognized State.
(j) Animals means cattle, sheep, swine, goats, horses, mules and other equines.
(k) Technical animal fat means animal fat eligible for exportation, or storage for exportation, in accordance with § 325.11 of this chapter.
(l) Certified technical animal fat means technical animal fat certified for export or storage for export under the regulations in this part.
(m) Tallow means technical animal fat with a minimum titre of 40 °C.
(n) Certified plant means any plant or storage facility preparing or storing certified technical animal fat for export, or for transfer to another certified plant or storage facility for ultimate export, and at which certification service is provided under the regulations in this part.
(o) Inspected and Passed means inspected and passed under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or the meat inspection laws of a recognized State.
(a) Certification, in the form set forth in paragraph (b), is available under the regulations in this part for specific lots of technical animal fat for export, if the fat was rendered from materials derived from carcasses, or parts of carcasses, that had been inspected and passed and came from animals that did not die otherwise than by slaughter under inspection. The certification will be made by a Program employee when he determines, upon the basis of examinations made by him or other inspectors, as provided in § 351.14, and information obtained by him or them from the exporter or other sources, as provided in the regulations in this part, that the technical animal fat is eligible for certification under this section and therefore the statements to be certified are correct. The service will be available upon a voluntary fee basis in accordance with said regulations.
(b)(1) The form of Certificate for Export of Technical Animal Fats is as follows:
(2) Certified technical animal fat may be described on the certificate as “technical animal fat”; or if it is tallow, it may be described on the certificate as “Tallow” and the description may include the statement “titre not less than 40 °C.”
Application for certification service under the regulations in this part may be made to the Administrator by the operator of any rendering plant or storage facility at which technical animal fat is prepared or stored for export. In case of a change of ownership or change of location, a new application shall be made. Applications shall be made on forms
(a) To be eligible for certification service under the regulations in this part, the operator of a rendering plant must demonstrate that:
(1) He operates a rendering plant which will receive materials derived from inspected and passed carcasses, or parts of carcasses, of animals that did not die otherwise than by slaughter under inspection, (i.e., not “dead animals”); and such source materials will be rendered at the plant into technical animal fat eligible for export, or storage for export, in accordance with the regulations in this part;
(2) The source materials and the rendered technical animal fat described in paragraph (a)(1) will be identified and kept separated at all times from other products; and
(3) He will comply with the applicable regulations in this part.
(b) To be eligible for certification service under the regulations in this part, the operator of a storage facility must demonstrate that:
(1) He operates a storage facility that will receive for storage certified technical animal fat shipped directly from a certified rendering plant for storage for export and he will keep such shipments identified and separated from other products that are not certified, and he will receive such fat only if it is accompanied by MP Form 85, as required by § 351.17.
(2) He will comply with the applicable regulations in this part.
(c) Each applicant for certification service must file with the Administrator, with the application for service, a written description of the procedures to be used for receiving, identifying, processing, storing, and otherwise handling technical animal fat, and materials for use in the preparation thereof, at the plant or storage facility involved, and for shipping technical animal fat from the plant or facility and storing and exporting such technical animal fat, and a written description of the shipping, receiving, and inventory records maintained for technical animal fat.
(d) The Administrator will determine, on the basis of all information available to him, whether the arrangements at the plant or storage facility are such as will assure that certifications of technical animal fat will be correct, and, if so, will grant the application for certification service. An applicant will be given an opportunity to present his views prior to refusal of the service.
The Administrator will assign a certified technical animal fat plant number to each plant granted service. Such number shall be preceded by the letter “C” and be used to identify all certified technical animal fat prepared or stored by the plant.
(a) The regulations in this part shall be administered by the circuit supervisor for the jurisdiction in which is located the certified plant or plants for which application for certification service is made, and such assistants as may be necessary will be assigned by the Administrator.
(b) The Administrator may enter into a cooperative agreement with any recognized State for the conduct by State employees of any surveys, examinations, and other activities involved in the administration of the regulations in this part. However, certifications under these regulations may be issued only by Program employees, as provided in § 351.3.
Applicants for the certification service shall pay the Department for salary costs at the rates specified in §§ 391.2 and 391.3 respectively for base time, and for overtime, travel, and per diem allowances at rates currently allowed by the Federal Travel Regulations, and other expenses incidental to the initial survey of the rendering plants or storage facilities for which certification service is requested.
(a) The fees to be charged and collected by the Administrator for examination shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays, as provided for in § 351.14; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs and which are required to determine the eligibility of any technical animal fat for certification under the regulations in this Part. Such fees shall be charged for the time required to render such service, including, but not limited to, the time required for the travel of the inspector or inspectors in connection therewith.
(b) Charges may also be made to cover the actual cost of travel and per diem allowance at rates currently allowed by the General Services Administration, and other expenses incurred by the Department in connection with such examinations and laboratory service.
(a) Facilities for the preparation, identification, and storage of the technical animal fat to be certified shall be furnished and maintained by the certified plant in accordance with this section.
(b) The operator of the certified plant shall provide at the plant, rooms, compartments, and equipment needed to maintain the identity of certified technical animal fats and materials used in their preparation, and separation of such articles from other products. Such rooms, compartments, and equipment shall be conspicuously marked with the phrase “Certified Technical Animal Fat” whenever they contain these fats.
(a) All technical animal fat to be offered for certification under this part and materials to be used in the preparation of such fat, and all certified technical animal fat, shall be identified and kept separate from other products from the time of receipt at a certified plant and throughout processing or handling at such plant. All wrappers and packaging shall be removed from the source materials to the fullest extent practicable before the materials are rendered at the plant.
(b) If a plant's operations are within the provisions of § 351.14(b)(3), all equipment shall be cleaned before it is used for receiving, preparation, or storage of certified technical animal fats or material to be used in preparation of such fats. Such cleaning shall be done in such manner as to prevent contamination of such certified fats or source material with materials that are unacceptable under § 351.3.
The operator of each certified plant shall inform the circuit supervisor, in advance, when the plant's work schedule will include preparing technical animal fats for certification and identify the approximate days and hours when operations will begin and end.
For the purpose of administering the regulations in this part, inspectors shall have access at all times by day or night to every part of a certified plant.
(a) All processes used in the preparation of certified technical animal fats at any certified plant shall be subject to supervision by an inspector. Certified plants shall not prepare any technical animal fat for certification under the regulations in this part, except in accordance with such regulations.
(b) Supervision, ranging from full-time coverage of an entire process to one or more reviews per month, to determine a plant's compliance with the regulations in this part will be maintained. A circuit supervisor may increase the frequency of reviews whenever he deems necessary to assure the validity of certifications under the regulations in this part. Usual coverage of individual rendering plants will be as follows:
(1) Coverage shall be at least once a month if the plant consistently handles only raw materials acceptable under § 351.3 for the preparation of certified technical animal fat and the plant operator, in writing, certifies that he is maintaining this procedure.
(2) Coverage shall be at least once a week if the plant consistently handles some raw materials that are acceptable, and some that are unacceptable, under § 351.3, for the preparation of certified technical animal fat, uses separate equipment for processing, and uses separate rooms, compartments, and equipment for receiving and storing the respective types of raw materials and technical animal fats, and the plant operator, in writing, certifies that he is maintaining this complete physical separation procedure.
(3) Coverage shall be fulltime during receiving of raw materials and their preparation into certified technical animal fat, if the plant handles some raw materials that are acceptable, and some that are unacceptable, under § 351.3, for the preparation of certified technical animal fat, and uses the same rooms, compartments, and equipment, with only time separation between receiving, processing, and storing the respective types of raw materials and technical animal fats.
Inspectors shall report to the circuit supervisor any apparent violations of the regulations in this part or the Federal Meat Inspection Act or regulations thereunder (subchapter A of this chapter) which occur at certified plants, or elsewhere, within their knowledge. The circuit supervisor shall report such actions to the Administrator through appropriate channels.
No certified plant shall export any certified technical animal fat unless the shipment is accompanied by a certificate issued under § 351.3.
Certified technical animal fats being exported directly from a certified plant or transferred between certified plants for storage for export are subject to the requirements of § 325.11 of this chapter. In addition, such shipments between certified plants shall be accompanied by MP Form 85 (Declaration to Accompany Technical Animal Fats Between Certified Technical Animal Fat Plants)
(a) The form of certification set forth in § 351.3 and the term “Certified Technical Animal Fat” are official identifications for purposes of the Agricultural Marketing Act of 1946, as amended, and shall not be falsely made, issued, altered, forged, or counterfeited, or used for purpose of misrepresentation or deception.
(b) No container which bears or is to bear any designation as certified technical animal fat shall be filled in whole or in part, except with technical animal fats which have been certified and identified in compliance with this part.
If an inspector has reason to believe that a lot of technical animal fat is ineligible for certification under § 351.3, or any materials to be used in a lot of technical animal fat would make the technical animal fat ineligible for such certification, certification of the lot shall be withheld pending final determination by the circuit supervisor. The operator of the plant shall be afforded an opportunity to demonstrate the eligibility of the lot for certification before the final determination is made.
(a) After opportunity for hearing has been accorded the operator of a certified plant, the certification service, provided for in this part, may be withdrawn from such plant in accordance with the applicable rules of practice, if it is determined that:
(1) The operator, or his employee or agent:
(i) Has made any willful misrepresentation or engaged in any fraudulent or deceptive practice in connection with the service;
(ii) Has interfered with or obstructed any Program employee or other inspector in the performance of his duties, under the regulations in this part, by intimidation, threats, or other improper means; or
(iii) Has violated section 203(h) of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1622(h)), or any regulation in this part; or
(2) Facilities or procedures at the certified plant do not conform to the arrangements approved by the Administrator under § 351.5.
(b) Pending final determination of the matter, the Administrator may summarily suspend the certification service at any certified plant when he has reason to believe that there is cause for withdrawal of the service under paragraph (a). The operator of the certified plant shall be notified of the Administrator's decision to suspend summarily the certification service at such plant and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. The Administrator's decision to suspend summarily the certification service shall be effective upon such oral or written notification, whichever is earlier, to the operator of the certified plant. If such notification is oral, the Administrator shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the operator of the certified plant, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)).
(c) The rules of practice of the Department of Agriculture in subpart H of part I, subtitle A, title 7 of the Code of Federal Regulations, are the rules of practice applicable to adjudicatory, administrative proceedings under the regulations in this part (9 CFR part 351).
Any person receiving inspection service may, if dissatisfied with any decision of an inspector relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.
(a) Each day a certified plant prepares, receives, or ships certified technical animal fat or receives material for use in such product, the operator of the plant shall prepare records identifying the kinds and quantities of such materials and technical animal fats received, the number of pounds of certified technical animal fat prepared or shipped, and an up-to-date inventory of certified technical animal fats in storage. The operator of each certified plant shall include in the records required by this section all MP Forms 85 which he receives with shipments of certified technical animal fat from any other certified plant. These records shall be maintained by the operator of each certified plant and made available to an inspector, upon request, for examination and copying, for a period of 1 year after the date of the transaction involved.
(b) The operator of each certified plant shall provide such relevant information as any inspector may request to enable him to determine whether any technical animal fats are eligible for certification and whether the plant is eligible for certification service under the regulations in this part.
The definitions in § 301.2, not otherwise defined in this part, are incorporated into this part. In addition to those definitions, the following definitions will be applicable to the regulations in this part.
(a) Act means the applicable provisions of the Agricultural Marketing Act of 1946, as amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).
(b) Acceptable means suitable for the purpose intended and acceptable to the Food Safety and Inspection Service.
(c) Antelope means any of various ruminant deerlike mammals (family Bovidae) chiefly of Africa and southwest Asia that have a slender lean build and usually horns directed upward and backward.
(d) Applicant means any interested party who requests any inspection service.
(e) Bison (Bison bison), commonly known as the American bison or buffalo, is a species of the genus Bison native to North America. Bison includes catalo or cattalo.
(f) Buffalo refers to a subtribe Bubalina of the tribe Bovini within the subfamily Bovinae that includes the water buffalo (Bubalus bubalis) and Cape buffalo (Syncerus caffer).
(g) Catalo or Cattalo means any hybrid animal with bison (Bison bison) appearance resulting from direct crossbreeding of bison (Bison bison) and cattle (Bos taurus).
(h) Condition means any condition, including, but not limited to, the state of preservation, cleanliness, or soundness of any product or the processing, handling, or packaging which may affect such product.
(i) Condition and wholesomeness means the condition of any product, its healthfulness and fitness for human food.
(j) Deer refers to the any farm-raised species of the family Cervidae.
(k) Exotic animal means any reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak.
(l) Elk (Cervus canadensis) refers to one of the largest species within the family Cervidae. It is native to North America and in high mountains of Central Asia.
(m) Exotic animal inspection service means the personnel who are engaged in the administration, application, and direction of exotic animal inspection programs and services pursuant to the regulations in this part.
(n) Exotic animal producer means any interested party that engages in the raising and/or marketing of an exotic animal for commercial purposes.
(o) Field ante-mortem inspection means the ante-mortem inspection of an exotic animal away from the official exotic animal establishment's premises.
(p) Field designated area means any designated area on the applicant's premises, approved by the Regional Director, where field ante-mortem inspection is to be performed.
(q) Identify means to apply official identification to products or containers.
(r) Inspection means any inspection by an inspector to determine, in accordance with regulations in this part, (1) the condition and wholesomeness of an exotic animal, or (2) the condition and wholesomeness of edible product of an exotic animal at any state of the preparation or packaging in the official plant where inspected and certified, or (3) the condition and wholesomeness of any previously inspected and certified product of an exotic animal if such product has not lost its identity as an inspected and certified product.
(s) Interested party means any person financially interested in a transaction involving any inspection.
(t) Official exotic animal establishment means any slaughtering, cutting, boning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this part.
(u) Official device means a stamping appliance, branding device, stencil printed label, or any other mechanically or manually operated tool that is approved by the Administrator for the purpose of applying any official mark or other identification to any product or packaging material.
(v) Official identification means any symbol, stamp, label or seal indicating that the product has been officially inspected and/or indicating the condition of the product approved and authorized by the Administrator to be affixed to any product, or affixed to or printed on the packaging material of any product.
(w) Program means the Voluntary Exotic Animal Inspection Program of the Food Safety and Inspection Service.
(x) Reindeer (Rangifer tarandus), commonly referred to as caribou, is a species within the family Cervidae with circumpolar distribution, native to Arctic, sub-Arctic, tundra, boreal, and mountainous regions of northern Europe, Siberia, and North America.
(y) Transport vehicle means any vehicle used to transport an exotic animal.
(z) Veterinarian means an authorized veterinarian of the Program employed by the Department or any cooperating State who is authorized by the Secretary to do any work or perform any duty in connection with the Program.
(aa) Water buffalo (Bubalus bubalis), commonly known as the domestic water buffalo or Asian water buffalo, is a large bovid originating in the Indian subcontinent, Southeast Asia, and China.
(bb) Yak (Bos grunniens) means a long-haired bovid animal originally found throughout the Himalaya region of southern Central Asia and the Tibetan Plateau.
Upon application, in accordance with §§ 352.3, 352.4, and 352.5, the following type of service may be furnished under the regulations in this part:
(a) Voluntary Inspection Service. An inspection and certification service for wholesomeness relating to the slaughter and processing of exotic animals and the processing of exotic animal products. All provisions of this part shall apply to the slaughter of exotic animals, and the preparation, labeling, and certification of the exotic animal meat and exotic animal products processed under this exotic animal inspection service.
(b) Only exotic animals which have had ante-mortem inspection as described under this part and which are processed in official exotic animal establishments in accordance with this part may be marked inspected and passed.
(c) Exotic animals, exotic animal meat and meat food products shall be handled in an official exotic animal establishment to ensure separation and identity of the exotic animal or exotic animal meat and meat food products until they are shipped from the official exotic animal establishment to prevent commingling with other species.
(a) Any person desiring to process an exotic animal, exotic animal carcasses, exotic animal meat and meat food products in an establishment under exotic animal inspection service must receive approval of such establishment and facilities as an official exotic animal establishment prior to the rendition of such service. An application for inspection service to be rendered in an official exotic animal establishment shall be approved in accordance with the provisions contained in §§ 304.1 and 304.2 of subchapter A of this chapter.
(b) Initial survey. When an application has been filed for exotic animal inspection service, the Regional Director or designee, shall examine the establishment, premises, and facilities.
Any exotic animal producer desiring field ante-mortem exotic animal inspection service must receive approval of the field ante-mortem designated area from the Regional Director or designee prior to the rendition of such service. An application seeking approval of the designated area for ante-mortem inspection shall be obtained from the Regional Director, and completed and submitted to the Regional Director.
(a) An initial application for field ante-mortem exotic animal inspection service shall be made by an official exotic animal establishment to the Regional Director. Subsequent requests shall be made by the official exotic animal establishment on behalf of an exotic animal producer to the Regional Director in one of the following manners: (1) telephone, (2) telegraph, (3) mail, or (4) in person as determined by the Regional Director.
(b) Upon receipt of the completed application, the Regional Director or designee shall examine the field ante-mortem designated area and facilities for approval of the designated area.
(c) All fees involved for the approval of the designated area, including but not limited to any travel, per diem costs, and time required to perform such approval services, shall be paid directly by the applicant to the Regional Director.
(a) Fees and charges for service under the regulations in this part shall be paid by the applicant for the service in accordance with this section.
(b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the “Treasurer of the United States” and shall be remitted promptly to the Regional Director upon furnishing to the applicant a statement as to the amount due.
(c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs. Such fees shall cover the costs of the service and shall be charged for the time required to render such service, including, but not limited to, the time required for the travel of the inspector or inspectors in connection therewith during the regularly scheduled administrative workweek.
(d) Charges may also be made to cover other expenses incurred by the Service in connection with the furnishing of the service.
(e) Fees and charges for any inspection pursuant to a cooperative agreement with any State shall be paid in accordance with the terms of such cooperative agreement.
(a) For miscellaneous reasons. An application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person, without a hearing by the appropriate Regional Director: (1) for administrative reasons such as the nonavailability of personnel to perform the service; (2) for the failure of payment for service; (3) in case the application or request relates to exotic animals or exotic animal products which are not eligible for service under this part; (4) for failure to maintain the designated area or the plant in a state of repair approved by the Service; (5) for the use of operating procedures which are not in accordance with the regulations of this part; (6) for alterations of buildings, facilities, or equipment which cannot be approved under the regulations in this part. Notice of such rejection, denial, or withdrawal, and the reasons therefore, shall promptly be given to the person involved. The applicant or recipient shall be notified of such decision to reject an application or request for service or to deny or withdraw the benefits of the service, and the reasons therefor, in writing in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. Such decision shall be effective upon such oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the person making such decision shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)).
(b) For disciplinary reasons—Basis for denial or withdrawal. An application or request for service may be denied, or the benefits of the service may be withdrawn from, any person or entity who, or whose officer, employee or agent in the scope of his employment or agency: (1) Has willfully made any misrepresentation or has committed any other fraudulent or deceptive practice in connection with any application or request for service under this part; (2) has given or attempted to give, as a loan or for any other purpose, any money, favor or other thing of value, to any employee or agent of the Department or a cooperating State authorized to perform any function under this part; (3) has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee or agent of the Department or cooperating State in the performance of his or her duties under this part by intimidation, threats, assaults, abuse, or any other improper means; (4) has knowingly represented that any exotic animal carcass, or exotic animal product, has been officially inspected and passed by an authorized inspector under this part, when it had not, in fact, been so inspected; (5) has been convicted of more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged good, or fraud in connection with transactions in food, or any felony; Provided, an application or a request for service made in the name of a person or entity otherwise eligible for service under the regulations may be denied, or the benefits of the service may be withdrawn, from such a person or entity in case the service is or would be performed at a location operated by a person or entity, from whom the benefits of the service are currently being denied or have been withdrawn under this part; or by a person or entity having an officer, director, partner, manager or substantial investor from whom the benefits of service under this part are currently being denied or have been withdrawn under this part, and who has any authority with respect to the location where service is or would be performed; or in case the service is or would be performed with respect to any exotic animal or exotic animal product in which any person or entity, from whom the benefits of service are currently being denied or have been withdrawn under this part, has contract or other financial interest.
(c) Procedure. (1) An application or request for service may be denied or benefits of the service may be withdrawn by the Secretary, as provided by paragraph (b) of this section, after notice and opportunity for hearing before a designated official of the Department. The Administrator may suspend service under this paragraph without hearing, pending final determination of the matter, when he determines that the public health, interest or safety so requires. The applicant or recipient shall be notified of the Administrator's decision to suspend service, and the reasons therefor, in writing or orally. The Administrator's decision to suspend service under this part shall be effective upon such an oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the Administrator shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient in the manner prescribed in 1.147(b) of Departmental rules of practice (7 CFR 1.147(b)).
(2) The written notification specified in paragraph (c) of this section, which shall constitute the complaint in the proceeding, shall briefly set forth the reason for the denial or withdrawal of service, including allegations of fact which constitute a basis for the action. After the complaint is served upon the respondent, as provided in § 1.147(b) of Departmental rules of practice (7 CFR 1.147(b)), the proceeding shall thereafter be conducted in accordance with rules of practice which shall be adopted for the proceeding.
Wording and form of inspection mark. This wording shall be contained within a triangle in the form and arrangement shown in this section. The establishment number of the official establishment shall be included in the triangle unless it appears elsewhere on the packaging material. Ordering and manufacture of the triangle brand shall be in accordance with the provisions in 9 CFR 317.3(c) of the Federal meat inspection regulations. The Administrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation shall be applied, under the supervision of the inspector, to the inspected and passed edible product, packaging material, immediate container or shipping container. When the inspection mark or approved abbreviation is used on packaging material, immediate container or shipping container, it shall be printed on such material or container or on a label to be affixed to the packaging material or container. The name and address of the packer or distributor of such product shall be printed on the packaging material or label. The inspection marks may be stenciled on the container, and when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or rubber stamp. The name and address of the packer or distributor, if prominently shown elsewhere on the packaging material or container, may be omitted from insert labels which bear an official identification if the applicable establishment number is shown. All labels intended for use on inspected and passed exotic animal products must be approved in accordance with Part 412 of this chapter.
(a) The inspection mark to be applied to inspected and passed carcasses and parts of carcasses of an exotic animal, and products as therefrom approved by the Administrator, shall be in the form and arrangement as indicated in the example below.
(1) For application to exotic animal carcasses, primal parts and cuts therefrom, exotic animal livers, exotic animal tongues, and exotic animal hearts.
(2) For application to exotic animal calf carcasses.
(3) For application to exotic animal tails.
(4) For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.
(b) The official inspection mark to be shown on all labels.
(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.
(3) The official inspection legend described in paragraph (b)(1) of this section shall also be used on shipping containers, bond labels, artificial casings, and other articles with the approval of the Administrator.
(c) Any brand, stamp, label or other device approved by the Administrator and bearing any official mark prescribed in paragraph (a) or (b) of this section shall be an official device for purposes of the Act.
The official exotic animal establishment on behalf of the applicant shall notify the Regional Director or designee, in advance, of the hours when such inspection is desired. Inspection personnel shall have access at all times to every part of any field ante-mortem inspection area and/or official exotic animal establishment to which they are assigned.
Reports of the work of inspection carried on within the field ante-mortem inspection area of an exotic animal producer's premises and/or official exotic animal establishment shall be forwarded to the Administrator by the ante-mortem inspector. The applicant for such inspection shall furnish to the Administrator such information as may be required on forms provided by the Administrator.
An ante-mortem inspection of an exotic animal shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made on the day of slaughter of an exotic animal, in one of the following listed ways or as determined by the Administrator. Humane handling of an exotic animal during ante-mortem inspection shall be in accordance with the provisions contained in 9 CFR 313.2. Immediately after the animal is stunned or killed, it shall be shackled, hoisted, stuck and bled.
(a) To be performed on an exotic animal in the field in a designated area of an exotic animal producer's premises.
(1) Reindeer, elk, deer, antelope, bison and water buffalo are eligible for field ante-mortem inspection. The field ante-mortem designated area must be approved by the Regional Director or designee prior to rendition of the service.
(2) Any person who desires to receive field ante-mortem inspection must provide:
(i) Notification from an official exotic animal establishment to the Regional Director or designee.
(ii) A field ante-mortem designated area.
(iii) A stunning/slaughtering area which is in a condition that minimizes the possibility of soiling the animal when stunned/slaughtered and bled as determined by the inspector.
(iv) A transport vehicle that is as sanitary as practicable as determined by the inspector.
(3) The ante-mortem inspector shall determine the acceptableness and safety of performing field ante-mortem inspection. If, in the opinion of the ante-mortem inspector, an unsafe circumstance exists at the time of field ante-mortem inspection, the service shall be denied.
(4) An exotic animal that, in the ante-mortem inspector's opinion, does not pass ante-mortem inspection must be withheld from slaughter.
(5) Stunning to render the animal unconscious shall be in accordance with 9 CFR 313.15 or 313.16.
(6) All stunned/slaughtered and bled exotic animals shall be tagged with a “U.S. Suspect” tag in an ear by the ante-mortem inspector or designee prior to loading on the transport vehicle.
(7) The transport of intact exotic animal carcasses to an official exotic animal establishment for post-mortem inspection shall be as expedient as possible, and must be within the same day as field slaughter.
(8) Ante-mortem cards (Form MP 402-2) shall be filled out by the ante-mortem inspector. One copy is to be retained by the ante-mortem inspector. The other copy shall accompany the transport vehicle to the official exotic animal establishment and shall be delivered to the post-mortem veterinarian.
(9) The ante-mortem inspector shall supervise all phases of field ante-mortem inspection.
(b) To be performed on exotic animals that are inside of the transport vehicle at an official exotic animal establishment.
(1) Reindeer, elk, deer, antelope, bison, and water buffalo are eligible for transport vehicle inspection.
(2) The ante-mortem inspector shall remain outside the transport vehicle while performing ante-mortem inspection.
(3) The person requesting transport vehicle inspection must provide a transport vehicle that is as sanitary as practicable and that would safely and thoroughly permit the inspection of an exotic animal from outside of the transport vehicle as determined by the inspector.
(4) The ante-mortem inspector shall determine the adequacy and safety of performing ante-mortem inspection. If, in the ante-mortem inspector's opinion, the transport vehicle is not adequate or safe to perform ante-mortem inspection, the service shall be denied.
(c) To be performed in pens at official exotic animal establishments. The inspection shall be conducted in accordance with the provisions contained in 9 CFR part 309.
(a) Post-mortem inspection of reindeer, elk, deer, antelope, bison and water buffalo shall be conducted in accordance with the provisions contained in 9 CFR part 310 or as determined by the Administrator.
(b) The post-mortem examination of field ante-mortem-inspected exotic animals must occur in the shortest length of time practicable and on the day that field ante-mortem inspection is performed to minimize the changes in the carcass which can affect the post-mortem examination, disposition and wholesomeness of the carcass and its parts.
(c) The post-mortem veterinarian shall inspect and make the disposition of all incoming “U.S. Suspect” tagged exotic animals.
This shall be conducted in accordance with the provisions contained in 9 CFR part 311.
This shall be conducted in accordance with the provisions contained in 9 CFR part 314.
This shall be conducted in accordance with the provisions contained in 9 CFR 318.1, 318.2, and 318.3.
This shall be conducted or maintained in accordance with the provisions contained in 9 CFR 320.1 through 320.7.
This shall be conducted in accordance with the provisions contained in 9 CFR 322.1 through 322.5.
This shall be conducted in accordance with the provisions contained in §§ 325.1 through 325.21.
Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize employees and facilities of States in carrying out Federal functions.
Unless the context otherwise requires, the following terms shall have the following meaning:
(a) Act means the applicable provisions of the Agricultural Marketing Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.) or any other act of Congress conferring like authority.
(b) Acceptable means suitable for the purpose intended and acceptable to the Service.
(c) Administrator means the Administrator of the Food Safety and Inspection Service of the Department or any other officer or employee of the Department to whom there has heretofore been delegated, or to whom there may hereafter be delegated the authority to act in his stead.
(d) Applicant means any interested party who requests any inspection service.
(e) Area supervisor means any employee of the Department in charge of rabbit inspection service in a designated geographical area.
(f) Carcass means any rabbit carcass.
(g) Circuit supervisor or technical supervisor means the officer in charge of the rabbit inspection service in a circuit consisting of a group of stations within an area.
(h) Class means any subdivision of a product based on essential physical characteristics that differentiate between major groups of the same kind.
(i) Condition means any condition, including, but not being limited to, the state of preservation, cleanliness, or soundness, of any product or the processing, handling, or packaging which may affect such product.
(j) Condition and wholesomeness means the condition of any product, its healthfulness and fitness for human food.
(k) Department means the United States Department of Agriculture.
(l) Edible product means any product derived from ready-to-cook domestic rabbits.
(m) Giblets means the liver from which the bile sac has been removed and the heart from which the pericardial sac has been removed.
(n) Holiday or legal holiday shall mean the legal public holidays specified by the Congress in paragraph (a) of section 6103, Title 5, of the United States Code.
(o) Identify means to apply official identification to products or to containers thereof.
(p) Inspected and certified or certified means, with respect to any product, that it has undergone an inspection and was found, at the time of such inspection, to be sound, wholesome, and fit for human food.
(q) Inspection, inspection service, or inspection of products for condition and wholesomeness means any inspection by an inspector to determine, in accordance with the regulations in this part, (1) the condition and wholesomeness of rabbits, or (2) the condition and wholesomeness of any edible product at any state of the preparation or packaging thereof in the official plant where inspected and certified, or (3) the condition and wholesomeness of any previously inspected and certified product if such product has not lost its identity as an inspected and certified product.
(r) Inspection certificate means a statement, either written or printed, issued by an inspector, pursuant to the regulations in this part, relative to the condition and wholesomeness of products.
(s) Inspector means any person who is licensed by the Secretary to investigate and certify, in accordance with the regulations in this part, the condition and wholesomeness of products. An inspector is an employee of the Department or of a State; he may be a graduate veterinarian or a layman.
(t) Interested party means any person financially interested in a transaction involving any inspection.
(u) National supervisor means (1) the officer in charge of the rabbit inspection service of the Food Safety and Inspection Service, and (2) other officers or employees of the Department designated by the officer in charge of the rabbit inspection service of the Food Safety and Inspection Service.
(v) Official plant means one or more buildings or parts thereof, comprising a single plant in which the facilities and methods of operation therein have been approved by the Administrator as suitable and adequate for operation under inspection service and in which inspection is carried on in accordance with the regulations in this part.
(w) Person means any individual, partnership, association, business trust, corporation, or any organized group of persons, whether incorporated or not.
(x) Potable water means water that has been approved by the State health authority as safe for drinking and suitable for food processing.
(y) Product means ready-to-cook cooked rabbits, or edible products derived therefrom.
(z) Rabbit means any domesticated rabbit, whether live or dead.
(aa) Rabbit inspection service means the personnel who are engaged in the administration, application, and direction of rabbit inspection programs and services pursuant to the regulations in this part.
(bb) Ready-to-cook domestic rabbit means any rabbit which has been slaughtered for human food, from which the head, blood, skin, feet, and inedible viscera have been removed, that is ready to cook without need of further processing. Ready-to-cook rabbit also means any cut-up or disjointed portion of rabbit or any edible part thereof, as described in this paragraph.
(cc) Regulations means the provisions of this entire part as may be in effect at the time inspection is performed.
(dd) Secretary means the Secretary of the Department, or any other officer or employee of the Department to whom there has heretofore been delegated, or to whom there may hereafter be delegated, the authority to act in his stead.
(ee) Service means the Food Safety and Inspection Service of the Department.
(ff) Station supervisor means any authorized individual who is designated to supervise rabbit inspection service in a large official plant or in a group of several small plants.
Subsection 203(h) of the Agricultural Marketing Act of 1946, as amended by Pub. L. 272, 84th Congress, provides criminal penalties for various specified offenses relating to official certificates, memoranda, marks or other identifications, and devices for making such marks or identifications, issued or authorized under section 203 of said Act, and certain misrepresentations concerning the inspection of agricultural products under said section. For the purposes of said subsection and the provisions in this part, the terms listed in this section shall have the respective meanings specified:
(a) Official certificate means any form of certification, either written or printed, used under this part to certify with respect to the inspection or class or condition of products.
(b) Official memorandum means any initial record of findings made by an authorized person in the process of inspecting or sampling, pursuant to this part, any processing or plant operation report made by an authorized person in connection with inspecting or sampling under this part, and any report made by an authorized person of services performed pursuant to this part.
(c) Official mark means the inspection mark, and any other mark, or any variations in such marks, approved by the Administrator and authorized to be affixed to any product, or affixed to or printed on the packaging material of any product, stating that the product was inspected, or indicating the condition of the product, or for the purpose of maintaining the identity of products inspected under this part, including, but not limited to, that set forth in § 354.65.
(d) Official identification means any symbol, stamp, label, or seal indicating that the product has been officially inspected and/or indicating the class or condition of the product approved by the Administrator and authorized to be affixed to any product, or affixed to or printed on the packaging material of any product.
(e) Official device means a stamping appliance, branding device, stencil, printed label, or any other mechanically or manually operated tool that is approved by the Administrator for the purpose of applying any official mark or other identification to any product or the packaging material thereof.
The Administrator shall perform, for and under the supervision of the Secretary, such duties as are prescribed in the regulations in this part and as the Secretary may require in the administration of the regulations in this part. The Administrator is authorized to waive for limited periods any particular provisions of the regulations to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements and, at the same time, to assure full compliance with the spirit and intent of the regulations. The Food Safety and Inspection Service and its officers and employees shall not be liable in damages through acts of commission or omission in the administration of this part.
Any inspection service in accordance with the regulations in this part shall be for condition and wholesomeness.
(a) Only rabbits which are processed in official plants in accordance with the regulations in this part may be inspected.
(b) All rabbits that are eviscerated in an official plant where inspection service is maintained shall be inspected for condition and wholesomeness and no dressed rabbits or uninspected products shall be brought into such official plant.
All inspection service shall be subject to supervision at all times by the station supervisor, circuit supervisor, area supervisor, and national supervisor. Such service shall be rendered where the facilities and conditions are satisfactory for the conduct of the service and the requisite inspectors are available.
The Administrator is authorized to waive the provisions of § 354.12 which pertain to the entry of uninspected edible products into official plants in specific instances where rabbits are to be brought into compliance with a law under the provisions of a court order. Such rabbits shall be handled in an official plant in accordance with such procedures as the Administrator may prescribe to insure proper segregation and identity of the rabbits or rabbit products until they are shipped from the official plant.
(a) Any person who is a Federal or State employee or the employee of a local jurisdiction possessing proper qualifications as determined by an examination for competency, and who is to perform inspection service under this part may be licensed or otherwise authorized by the Secretary as an inspector.
(b) All licenses issued by the Secretary shall be countersigned by the officer in charge of the rabbit inspection service of the Animal and Plant Health Inspection Service or any other designated officer of such Service.
Pending final action by the Secretary, any person authorized to countersign a license to perform inspection service may, whenever he deems such action necessary to assure that any inspection service is properly performed, suspend any license to perform inspection service issued pursuant to this part, by giving notice of such suspension to the respective licensee, accompanied by a statement of the reasons therefor. Within 7 days after the receipt of the aforesaid notice and statement of reasons, the licensee may file an appeal in writing, with the Secretary, supported by any argument or evidence that he may wish to offer as to why his license should not be further suspended or revoked. After the expiration of the aforesaid 7-day period and consideration of such argument and evidence, the Secretary will take such action as he deems appropriate with respect to such suspension or revocation. When no appeal is filed within the prescribed 7 days, the license to perform inspection service is revoked.
Each license which is suspended, or revoked, or has expired shall promptly be surrendered by the licensee to his immediate superior. Upon termination of the services of a licensed inspector, the licensee shall promptly surrender his license to his immediate superior.
Each inspector shall have in his possession at all times, and present upon request while on duty, the means of identification furnished by the Department to such person.
No inspector shall render service on any product in which he is financially interested.
All inspectors are forbidden, during the period of their respective appointments or licenses, to take an active part in political management or in political campaigns. Political activity in city, county, State, or national elections, whether primary or regular, or in behalf of any party or candidate, or any measure to be voted upon, is prohibited. This applies to all appointees, including, but not being limited to, temporary and cooperative employees and employees on leave of absence with or without pay. Willful violation of §§ 354.20 to 354.25 will constitute grounds for dismissal in the case of appointees and revocation of licenses in the case of licensees.
Inspection operating schedules for services performed pursuant to § 354.107 shall be requested in writing and be approved by the Administrator. Normal operating schedules for a full week consist of a continuous 8-hour period per day (excluding not to exceed 1 hour for lunch), 5 consecutive days per week, within the period of Monday through Saturday, for each shift required. Less than 8-hour schedules may be requested and will be approved if an inspector is available. Sundays may not be approved in any tour of duty. Clock hours of daily operations need not be specified in the request, although as a condition of continued approval, the hours of operation shall be reasonably uniform from day to day. Inspectors are to be notified by management 1 day in advance of any change in the hours inspection service is requested.
An application for inspection service may be made by any interested person, including, but not being limited to, the United States, any State, county, municipality, or common carrier, and any authorized agent of the foregoing.
(a) On a fee basis. An application for any inspection service on a fee basis may be made in any office of inspection or with any inspector at or nearest the place where the service is desired. Such application may be made orally (in person or by telephone), in writing, or by telegraph. If the application for inspection service is made orally, the office of inspection or the inspector with whom the application is made, or the Administrator, may require that the application be confirmed in writing.
(b) On a resident inspection basis. An application for resident inspection service must be made in writing on forms approved by the Administrator and filed with the Administrator. Such forms may be obtained at the national, area, or State inspection office. In making application, the applicant agrees to comply with the terms and conditions of the regulations (including, but not being limited to, such instructions governing inspection of products as may be issued from time to time by the Administrator). No member of or delegate to Congress or Resident Commissioner shall be admitted to any benefit that may arise from such service unless derived through service rendered a corporation for its general benefit.
An application for inspection service shall be regarded as filed only when made pursuant to the regulations in this part.
Proof of the authority of any person applying for inspection service may be required at the discretion of the Administrator.
Any person desiring to process and pack products in a plant under inspection service must receive approval of such plant and facilities as an official plant prior to the rendition of such service. An application for inspection service to be rendered in an official plant shall be approved according to the following procedure:
(a) Initial survey. When application has been filed for inspection service as aforesaid, the area supervisor, or his assistant, shall examine the plant, premises, and facilities and shall specify any additional facilities required for the service. Appeals with respect to any such specification may be made to the national supervisor.
(b) Drawings and specifications to be furnished in advance of construction or alterations.
(1) Four copies of drawings or blueprints showing the features specified herein shall be submitted to the Administrator. The drawings or blueprints shall be legible, made with sharp, clear lines, and properly drawn to scale, and shall consist of floor plans and a plot plan.
(2) The plot plan shall show such features as the limits of the plant's premises, locations in outline of buildings on the premises, one point of the compass, and roadways and railroads serving the plant.
(3) The floor plan shall show all space to be included in the official plant. If rooms or compartments shown on the drawings or blueprints are not to be included as part of the official plant, this shall be clearly indicated thereon.
(4) The sheets of paper on which drawings or blueprints are made shall not exceed a size 34″ × 44″. The drawings other than of the plot plan shall be made to a scale of
(c) Features required to be shown on floor plan. The following features shall be shown on the floor plan:
(1) The principal pieces of equipment drawn to scale in the proper locations.
(2) The name of the firm and the address of the plant by street and street number, or by other means properly identifying the location of the plant.
(3) One point of the compass.
(4) The doors and openings for passageways, designating those which are self-closing or permanently closed.
(5) All floor drain openings and gutter drains.
(6) Lavatories in toilet and processing rooms (lavatories which are other than hand-operated shall be so designated on the drawings or blueprints).
(7) All steam and hot and cold water outlets for cleanup purposes.
(8) Ice-making and storage facilities.
(9) The point at which live rabbits are hung on the conveyor line, the point at which the ready-to-cook rabbits are removed, and any intermediate transfer points.
(10) The routes of the edible and inedible products.
(11) The location of fresh air inlets, exhaust fans, and hoods.
(d) Specifications. Specifications covering the following items shall accompany the drawings:
(1) Height of ceilings.
(2) Type of ceilings—open or closed.
(3) Finish of ceilings; for example—cement plaster, metal, marine plywood, cement, asbestos board, etc.
(4) Finish of walls; for example—cement plaster, glazed tile, glaze brick, glass blocks, etc.
(5) Screens—indicate whether all outside openings are screened or provided with other suitable devices against entrance of flies or other insects.
(6) Finish of floors—concrete, brick, mastic material, etc.
(7) Drainage—indicate the amount of slope of floors to the drains in processing rooms, coolers, toilets, and refuse rooms, and give description of trapping and venting of drainage lines and of floor drain openings. Indicate size of drainage lines and whether house drainage lines and toilet soil lines are separate to a point outside of buildings.
(8) Heating—indicate type.
(9) Water supply—indicate whether public or private water supply, or both, and specify in terms of gallons of water available per minute for the processing needs of the plant. Also indicate whether or not a nonpotable water supply is used for any purpose in the plant and, if so, specify such uses.
(10) Hot water facilities—specify facilities such as boilers, storage tanks, mixing valves, etc., and indicate the size and number of boilers and storage tanks.
(11) Specify number of men and number of women who will use each toilet room.
(12) Sewage disposal—indicate whether city sewer, cesspool, sedimentation tank, etc.
(13) Approximate rate of production—indicate hourly rate of slaughter and evisceration for rabbits.
(e) Rooms and compartments which must be included in the official plant. The official plant shall include employees' toilet and dressing rooms, office space for the inspectors, storerooms for supplies, refuse rooms, and rooms, compartments, or passageways where rabbits or any ingredients to be used in the preparation of products under inspection will be handled or kept. It also may include other rooms or compartments located in the buildings comprising the official plant.
(f) Changes in drawings or blueprints. When changes are proposed in areas for which drawings or blueprints have been previously approved, one of the following types of revised drawings or blueprints shall be submitted for review and consideration.
(1) A completely revised sheet or sheets showing proposed alterations or additions, or
(2) Approved pasters of the proposed changes which may be affixed to the affected areas on the previously approved drawings or blueprints in a manner not obscuring essential data. Paster drawings and blueprints shall be prepared to the same scale and presented on a background similar to that of the originally approved drawing or blueprint.
(g) Final survey and plant approval. Prior to the inauguration of the inspection service, a final survey of the plant and premises shall be made by the area supervisor or his assistant to determine if the plant is constructed and facilities are installed in accordance with the approved drawings and the regulations in this part. The plant may be approved by the Administrator only when these requirements have been met, except that conditional approval for a specified limited time may be granted only under emergency conditions of restricted availability of facilities and construction materials, provided practices suitable to the Administrator are employed to effect adequate sanitary conditions in the plant.
Any application for inspection service may be rejected by the Administrator:
(a) Whenever the applicant fails to meet the requirements of the regulations prescribing the conditions under which the service is made available;
(b) Whenever the product is owned by or located on the premises of a person currently denied the benefits of the Act;
(c) Where any individual holding office or a responsible position with or having a substantial financial interest or share in the applicant is currently denied the benefits of the Act or was responsible in whole or in part for the current denial of the benefits of the Act to any person;
(d) Where the Administrator determines that the application is an attempt on the part of a person currently denied the benefits of the Act to obtain inspection service;
(e) Whenever the applicant, after an initial survey has been made in accordance with § 354.34(a), fails to bring the plant, facilities, and operating procedures into compliance with the regulations within a reasonable period of time; or
(f) Notwithstanding any prior approval whenever, before inauguration of service, the applicant fails to fulfill commitments concerning the inauguration of the service. Each such applicant shall be promptly notified by registered mail of the reasons for the rejection. A written petition for reconsideration of such rejection may be filed by the applicant with the Administrator if postmarked or delivered within 10 days after the receipt of notice of the rejection. Such petition shall state specifically the errors alleged to have been made by the Administrator in rejecting the application. Within 20 days following the receipt of such a petition for reconsideration, the Administrator shall approve the application or notify the applicant by registered mail of the reasons for the rejection thereof.
Any application for inspection service may be withdrawn by the applicant at any time before the service is performed upon payment, by the applicant, of all expenses incurred by the Service in connection with such application.
(a) Any plant approval given pursuant to the regulations in this part may be suspended by the Administrator for:
(1) Failure to maintain plant and equipment in a satisfactory state of repair;
(2) The use of operating procedures which are not in accordance with the regulations in this part; or
(3) Alterations of buildings, facilities, or equipment which cannot be approved in accordance with the regulations in this part.
(b) During such period of suspension, inspection service shall not be rendered. However, the other provisions of the regulations pertaining to providing service on a resident basis will remain in effect unless such service is terminated in accordance with the provisions of this part. If the plant facilities or methods of operation are not brought into compliance within a reasonable period of time, to be specified by the Administrator, the service shall be terminated. Upon termination of inspection service in an official plant pursuant to the regulations in this part, the plant approval shall also become terminated, and all labels, seals, tags or packaging material bearing official identification shall, under the supervision of a person designated by the Service, either be destroyed, or the official identification completely obliterated, or sealed in a manner acceptable to the Service.
(a) The acts or practices set forth in §§ 354.46 through 354.51 or the causing thereof may be deemed sufficient cause, for the debarment, by the Secretary, of any person, including any agents, officers, subsidiaries, or affiliates of such person, from any or all benefits of the Act for a specified period after notice and opportunity for hearing has been afforded.
(b) Whenever the Administrator has reason to believe that any person or his employee, agent, or representative has flagrantly or repeatedly committed any of the acts or practices specified in §§ 354.46 to 354.51, he may, without hearing, direct that the benefits of the Act be denied such person, including any agents, officers, subsidiaries, or affiliates of such person, pending investigation and hearing, and shall give notice thereof to any such person in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)). The Administrator's decision to deny the benefits of the Act to any such person, including any agents, officers, subsidiaries, or affiliates of such person, shall be effective upon service of such notice. A written petition for reconsideration of such interim denial may be filed with the Administrator by any person so denied the benefits of the Act within 10 days after notice of the interim denial. Such petition shall state specifically the errors alleged to have been made by the Administrator in denying the benefits of the Act pending investigation and hearing. Within 20 days following the receipt of such petition for reconsideration, the Administrator shall reinstate the benefits of the Act or notify the petitioner of the reasons for continued interim denial.
Any willful misrepresentation or any deceptive or fraudulent act or practice made or committed by any person in connection with:
(a) The making or filing of any application for any inspection service;
(b) The making of the product accessible for inspection;
(c) The making, issuing, or using, or attempting to issue or use any inspection certificate, symbol, stamp, label, seal or identification, authorized pursuant to the regulations in this part;
(d) The use of the terms “U.S. Inspected” or “Government Inspected”, or any term of similar import in the labeling or advertising of any product.
Using or attempting to use a form which simulates, in whole or in part, any certificate, symbol, stamp, label, seal or identification authorized to be issued or used under the regulations in this part.
Any willful violation of the regulations in this part or the Act.
Any interference with or obstruction or any attempted interference or obstruction of or assault upon any inspector or employee of the Service in the performance of his duties. The giving or offering directly or indirectly of any money, loan, gift, or anything of value to an employee of the Service or the making or offering of any contribution to or in any way supplementing the salary, compensation, or expenses of an employee of the Service, or the offering or entering into a private contract or agreement with an employee of the Service for any services to be rendered while employed by the Service.
The existence of any of the conditions set forth in § 354.35 constituting a basis for the rejection of an application for inspection service.
Compliance with the regulations in this part shall not excuse failure to comply with any other Federal or any State or municipal applicable laws or regulations.
All labels intended for use on inspected and passed rabbit products which bear any official identification must be approved in accordance with part 412 of this chapter.
The Administrator is authorized to prescribe and approve the form of the inspection mark that may be used.
(a) Wording and form of inspection mark. Except as otherwise authorized, the inspection mark permitted to be used with respect to inspected and certified edible products shall include wording as follows: “Inspected for Wholesomeness by U.S. Department of Agriculture.” This wording shall be contained within a circle in the form and arrangement shown in § 354.65. The appropriate plant number of the official plant shall be included in the circle unless it appears elsewhere on the packaging material. The Administrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation thereof, as the case may be, may be applied to the inspected and certified edible product or to the packaging material of such product. When the inspection mark, or the approved abbreviation thereof, is used on packaging material, it shall be printed on such material or on a label to be affixed to the packaging material and the name of the packer or distributor of such product shall be printed on the packaging material or label, as the case may be, except that on shipping containers and containers for institutional packs, the inspection marks may be stenciled on the container and, when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or a rubber stamp. Notwithstanding the foregoing, the name and address of the packer or distributor, if appropriately shown elsewhere on the packaging material, may be omitted from insert labels which bear an official identification if the applicable plant number is shown.
(b) Wording on labels. Each trade label to be approved for use pursuant to §§ 354.60 to 354.64 with respect to any inspected and certified edible product shall bear the true name of the edible product, the name and address of the packer or distributor thereof, and in prominent letters and figures of uniform size, the inspection mark, as aforesaid, and the label shall also bear, in such manner as may be prescribed or approved by the Administrator, the plant number, if any, of the official plant in which such product was inspected and certified. The class of the rabbits shall be shown on the label. The appropriate designation “young”, “mature”, or “old” may be used as a prefix to the word “rabbit” in lieu of the class name.
(c) Labels in foreign languages. Any trade label to be affixed to a container of any edible products for foreign commerce may be printed in a foreign language. However, the inspection mark shall appear on the label in English, but, in addition, may be literally translated into such foreign language. Each such trade label which is to be printed in a foreign language must be approved pursuant to §§ 354.60 to 354.64.
(d) Unauthorized use or disposition of approved labels. (1) Labels approved for use pursuant to §§ 354.60 to 354.64 shall be used only for the purpose for which approved and shall not otherwise be disposed of from the plant for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labels or labels bearing official identification may result in cancellation of the approval and denial of the use of labels bearing official identification or denial of the benefits of the Act pursuant to the provisions of § 354.60.
(2) The use of simulations or imitations of any official identification by any person is prohibited.
(e) Rescindment of approved labels. Once a year, or more often if requested, each applicant shall submit to the Administrator a list in triplicate of approved labels that have become obsolete, accompanied with a statement that such approvals are no longer desired. The approvals shall be identified by the date of approval and the name of product or other designation showing the class of material.
The form prescribed in § 354.65 is subject to the requirements of §§ 354.60 to 354.64, Identifying and Marking Products.
The inspection mark approved for use on inspected and certified edible products shall be contained within a circle and include the following wording: “Inspected for Wholesomeness by U.S. Department of Agriculture.” The form and arrangement of such wording shall be as indicated in the example below. The plant number of the official plant shall be set forth if it does not appear on the packaging material.
No inspector shall authorize the use of official identification for any inspected product unless he has on file evidence that such official identification or packaging material bearing such official identification has been approved in accordance with the provisions of §§ 354.60 to 354.64.
(a) No official identification or any abbreviation, copy, or representation thereof may be affixed to or placed on or caused to be affixed to or placed on any product or container thereof except by an inspector or under the supervision of an inspector. All such products shall have been inspected and certified. The inspector shall have supervision over the use and handling of all material bearing any official identification.
(b) Each container of inspected and certified products to be shipped from one official plant to another official plant for further processing shall be marked for identification and shall show the following information:
(1) The name of the inspected and certified products in the container;
(2) The name and address of the packer or distributor of such products;
(3) The net weight of the container;
(4) The inspection mark permitted to be used pursuant to the regulations in this part unless the containers are sealed or otherwise identified in such manner as may be approved by the Administrator; and
(5) The plant number of the official plant where the products were packed.
No container which bears or may bear any official identification or any abbreviation or copy or representation thereof may be filled in whole or in part except with edible products which were inspected and certified and are, at the time of such filing, sound, wholesome, and fit for human food. All such filling of containers shall be under the supervision of an inspector.
An inspector may use such labels, devices, and methods as may be approved by the Administrator for the identification of:
(a) Products which are held for further examination, and
(b) All equipment and utensils which are to be held for proper cleaning.
Inspection of products shall be rendered pursuant to the regulations in this part and under such conditions and in accordance with such methods as may be prescribed or approved by the Administrator.
Each product for which inspection service is requested shall be so arranged so as to permit adequate determination of its class, quantity, and condition as the circumstances may warrant.
The inspector who is to perform the inspection in an official plant shall be informed, in advance, by the applicant of the hours when such inspection is desired. Inspectors shall have access at all times to every part of any official plant to which they are assigned.
Reports of the work of inspection carried on within official plants shall be forwarded to the Administrator by the inspector in such manner as may be specified by the Administrator.
When inspection service is performed within an official plant, the applicant for such inspection shall furnish to the inspector rendering such service such information as may be required for the purposes of §§ 354.90 to 354.92.
Each inspector shall report, in the manner prescribed by the Administrator, all violations of and noncompliance with the Act and the regulations in this part of which he has knowledge.
(a) Fees and charges for any inspection shall be paid by the applicant for the service in accordance with the applicable provisions of §§ 354.100 to 354.110, both inclusive. If so required by the inspector, such fees and charges shall be paid in advance.
(b) Fees and charges for any inspection service shall, unless otherwise required pursuant to paragraph (c) of this section, be paid by check, draft, or money order payable to the Food Safety and Inspection Service and remitted promptly to the Service.
(c) Fees and charges for any inspection pursuant to a cooperative agreement with any State or person shall be paid in accordance with the terms of such cooperative agreement.
(a) Unless otherwise provided in this part, the fees to be charged and collected for any service performed, in accordance with this part, on a fee basis shall be based on the applicable rates specified in this section.
(b) The charges for inspection service will be based on the time required to perform such services. The hourly rates shall be as specified in §§ 391.2 and 391.3 respectively for base time and for overtime or holiday work.
(c) Charges for certain laboratory analysis or laboratory examination of rabbits under this part related to inspection service shall be at the rate specified in § 391.4 for that part which is not covered under the base time, overtime, and/or holiday costs.
Additional copies, other than those provided for in §§ 354.141, 354.142, and 354.143, of any inspection certificates may be supplied to any interested party upon payment of a fee of $2.00 for each set of five or fewer copies.
Charges are to be made to cover the cost of travel and other expenses incurred by the Service in connection with rendering inspection service. Such charges shall include the costs of transportation, per diem, and any other expenses.
The charges for inspection of rabbits and products thereof shall be those provided for in § 354.101(b) and specified by hourly rates in §§ 391.2 and 391.3 when the inspection service is performed on a continuous year-round resident basis and the services of an inspector or inspectors are required 4 or more hours per day. When the services of an inspector are required on an intermittent basis, the charges shall be those provided for in § 354.101(b) and specified by hourly rates in §§ 391.2 and 391.3 plus the travel expense and other charges provided for in § 354.106.
Fees or charges to be made to an applicant for any inspection service which differ from those listed in §§ 354.100 through 354.107 shall be provided for by a cooperative agreement.
Fees for inspection under a cooperative agreement with any State or person shall be disposed of in accordance with the terms of such agreement. Such portion of the fees collected under a cooperative agreement as may be due the United States shall be remitted to the Service.
Unless otherwise specified in the regulations in this part or by the Administrator, products which are to be further processed under inspection in an official plant shall be prepared and handled in such official plant under the supervision of an inspector.
An ante-mortem inspection of rabbits shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made of rabbits on the day of slaughter in any official plant processing rabbits under inspection pursuant to the regulations in this part.
Rabbits found in a dying condition on premises of an official plant shall be immediately destroyed and, together with any rabbits found dead on such premises, shall be disposed of in accordance with § 354.132. Rabbits plainly showing, on ante-mortem inspection, any disease or condition, that under §§ 354.129 to 354.131, inclusive, would cause condemnation of their carcasses on post-mortem inspection, shall be condemned. Rabbits which, on ante-mortem inspection, are condemned shall not be dressed, nor shall they be conveyed into any department of the plant where rabbit products are prepared or held. Rabbits which have been condemned on ante-mortem inspection and have been killed shall, under the supervision of an inspector of the Inspection Service, receive treatment as provided in § 354.132.
All rabbits which, on ante-mortem inspection, do not plainly show, but are suspected of being affected with any disease or condition that under §§ 354.129 to 354.131, inclusive, may cause condemnation in whole or in part on post-mortem inspection, shall be segregated from the other rabbits and held for separate slaughter, evisceration, and post-mortem inspection. The inspector shall be notified when such segregated lots are presented for post-mortem inspection and inspection of such rabbits shall be conducted separately. Such procedure for the correlation of ante-mortem and post-mortem findings by the inspector, as may be prescribed or approved by the Administrator, shall be carried out.
If live rabbits, which are affected by any contagious disease which is transmissible to man, are brought into an official establishment, such rabbits shall be segregated. The slaughtering of such rabbits shall be deferred and they shall be dealt with in one of the following ways:
(a) If it is determined by a veterinary inspector that further handling of the rabbits will not create a health hazard, the lot shall be subject to ante-mortem and post-mortem inspection pursuant to the regulations in this part.
(b) If it is determined by a veterinary inspector that further handling of the rabbits will not create a health hazard, such rabbits may be released for treatment under the control of an appropriate State or Federal agency. If the circumstances are such that release for treatment is impracticable, a careful rabbit-by-rabbit ante-mortem inspection shall be made, and all rabbits found to be, or which are suspected of being, affected with the contagious disease transmissible to man shall be condemned.
No viscera or any part thereof shall be removed from any rabbits which are to be processed under inspection in any official plant, except at the time of evisceration and inspection. Each carcass to be eviscerated shall be opened so as to expose the organs and the body cavity for proper examination by the inspector and shall be prepared immediately after inspection as ready-to-cook rabbit.
Each carcass, including all parts thereof, in which there is any lesion of disease or other condition, which might render such carcass or any part thereof unfit for human food, and with respect to which a final decision cannot be made on first examination by the inspector, shall be held for further examination. The identity of each such carcass, including all parts thereof, shall be maintained until a final examination has been completed.
Each carcass, or any part thereof, which is found to be unsound, unwholesome, or otherwise unfit for human food shall be condemned by the inspector and shall receive such treatment, under the supervision of the inspector, as will prevent its use for human food and preclude dissemination of disease through consumption by animals.
Each carcass and all parts and organs thereof which are found by the inspector to be sound, wholesome, and fit for human food shall be certified as provided in this part.
The carcasses or parts of carcasses of all rabbits inspected at an official establishment and found at the time of post-mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this part, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or condition and to designate at just what stage a disease process results in an unwholesome product, the decision as to the disposal of all carcasses, parts, or organs not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the laboratory for diagnosis.
(a) Carcasses of rabbits affected with or showing lesions of any of the following named diseases or conditions shall be condemned: Tularemia, anthrax, hemorrhagic septicemia, pyemia, septicemia, leukemia, acute enteritis, peritonitis, sarcomatosis, metritis, necrobacillosis (Smorl's Disease), tuberculosis, emaciation, streptobacillary pseudotuberculosis, and advanced stages of snuffles. Rabbits from pathological laboratories shall be condemned.
(b) Any organ or part of a rabbit carcass affected with a tumor shall be condemned and when there is evidence that the general condition of the rabbit has been affected by the size, position, or nature of the tumor, the whole carcass shall be condemned. In cases of malignant neoplasms involving any internal organ to a marked extent, or affecting the muscles, skeleton, or body lymph glands, even primarily, the whole carcass shall be condemned.
(c) Carcasses of rabbits showing any disease such as generalized melanosis, pseudoleukemia, and the like, which systemically affect the rabbit, shall be condemned.
(d) Any organ or part of a carcass which is badly bruised or which is affected by an abscess, or a suppurating sore, shall be condemned. Parts or carcasses which are contaminated by pus shall be condemned.
(e) Carcasses of rabbits contaminated by volatile oils, paints, poisons, gases, or other substances which affect the wholesomeness of the carcass shall be condemned.
(f) All carcasses of rabbits so infected that consumption of the meat or meat food products thereof may give rise to meat poisoning shall be condemned. This includes all carcasses showing signs of any of the following diseases: Acute inflammation of the lungs, pleura, pericardium, peritoneum or meninges; septicemia or pyemia, whether traumatic, or without evident cause; gangrenous or severe hemorrhagic enteritis or gastritis; polyarthritis and acute nephritis. Immediately after the slaughter of any rabbit so infected, the infected premises and implements used shall be thoroughly sanitized. The part or parts of any carcass coming into contact with the carcass or any part of the carcass of any rabbit covered by this section other than those affected with acute inflammation of the lungs, pleura, pericardium, peritoneum or meninges, shall be condemned.
(g) Carcasses showing any degree of icterus with a parenchymatous degeneration of organs, the result of infection or intoxication, and those which, as a result of a pathological condition, show an intense yellow or greenish-yellow discoloration without evidence of infection or intoxication shall be condemned.
(h) Carcasses of rabbits affected with mange or scab in advanced stages, or showing emaciation or extension of the inflammation to the flesh, shall be condemned. When the diseased condition is slight, the carcass may be passed for food after removal and condemnation of the affected parts.
(i) In the disposal of carcasses and parts of carcasses showing evidence of infestation with parasites not transmissible to man, the following general rules shall govern: If the lesions are localized in such manner and are of such character that the parasites and the lesions caused by them may be radically removed, the non-affected portion of the carcass, or part of the carcass, may be certified for food after the removal and condemnation of the affected portions. Where a part of a carcass shows numerous lesions caused by parasites, or the character of the infestation is such that complete extirpation of the parasites and lesions is difficult and uncertainly accomplished, or if the parasitic infestation or invasion renders the organ or part in any way unfit for food, the affected organ or part shall be condemned. Where parasites are found to be distributed in a carcass in such a manner or to be of such a character that their removal and the removal of the lesions caused by them are impracticable, no part of the carcass shall be certified for food and the entire carcass shall be condemned. Carcasses infested with a hydatid cyst or cysts (Echinococcus granulosis), transmissible to dogs and from dogs to man, shall in all cases be condemned regardless of the degree of infestation.
(j) Carcasses of rabbits showing such degree of emaciation or anemic condition as would render the meat unwholesome, and carcasses which show a slimy degeneration of the fat or a serious infiltration of the muscles shall be condemned.
Carcasses of rabbits deleteriously affected by post-mortem changes shall be disposed of as follows:
(a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned.
(b) [Reserved]
(c) Carcasses affected by types of post-mortem change which are superficial in nature may be certified for food after removal and condemnation of affected parts.
All condemned carcasses, or parts of carcasses, shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service: (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishment.)
(a) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat for a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection, by means of pipes or otherwise, between tanks containing inedible products and those containing edible products.
(b) Incineration or complete destruction by burning.
(c) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of:
(1) Crude carbolic acid,
(2) Kerosene, fuel oil, or used crank case oil,
(3) Any phenolic disinfectant conforming to commercial standards CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or solution, or
(4) Any other substance that the Administrator approves which will decharacterize the carcasses or parts to the extent necessary to accomplish the purposes of this section.
(a) Any inspected and certified edible product may be brought into an official plant only if the container of such product is marked for identification in the manner prescribed in § 354.71(b) and the product is reinspected by an inspector at the time it is brought into such plant. Upon reinspection, if any such product or portion thereof is found to be unsound, unwholesome, or otherwise unfit for human food, such product, or portion thereof, shall be condemned and shall receive treatment as provided in § 354.127.
(b) Any product which is prepared under inspection in an official plant shall be inspected in such plant as often as the inspector deems it necessary in order to ascertain whether such product is sound, wholesome, and fit for human food at the time such product leaves such plant. Upon any such inspection, if any such product or portion thereof is found to be unsound, unwholesome, or otherwise unfit for human food, such product or portion thereof shall be condemned and shall receive treatment as provided in § 354.127.
(c) All substances and ingredients used in the manufacture or preparation of any edible product shall be clean, sound, wholesome, and fit for human food. Liquid and frozen egg products used in the preparation of any edible product shall have been prepared under continuous inspection of the Department.
Any person receiving inspection service may, if dissatisfied with any decision of an inspector relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.
Each inspection certificate issued pursuant to the regulations in this part shall be approved by the Administrator as to form, and:
(a) Each rabbit inspection certificate shall show the class or classes of rabbits, the quantity of product contained in the respective lot, and all pertinent information concerning the condition and wholesomeness thereof;
(b) Each food product inspection certificate shall show the names of the edible products covered by such certificate, the quantity of each such product, such shipping marks as are necessary to identify such products, and all pertinent information concerning the condition and wholesomeness thereof;
(c) Each export certificate shall show the respective names of the exporter and the consignee, the destination, the shipping marks, the numbers of the export stamps attached to the edible products to be exported and covered by the certificate, and the names of such products and the total net weight thereof.
(a) Upon the request of an interested party, any inspector is authorized to issue a rabbit inspection certificate with respect to any lot of rabbits inspected by him. Each certificate shall be signed by the inspector who made the inspection covered by the certificate, and if more than one inspector participated in the inspection of the lot of rabbits, each such inspector shall sign the certificate with respect to such lot.
(b) The original and a copy of each inspection certificate, issued pursuant to §§ 354.140 to 354.144, and not to exceed two additional copies thereof if requested by the applicant prior to issuance, shall, immediately upon issuance, be delivered or mailed to the applicant or person designated by him. One copy shall be filed in the office of the area supervisor serving the area in which the inspection was performed, and the remaining copies shall be disposed of in such manner as the Administrator may approve. Additional copies of any such certificate may be furnished to any interested party as provided in § 354.105.
(a) Upon the request of an interested party, any inspector is authorized to issue a food product inspection certificate with respect to any inspected and certified edible product after suitable examination of the product has been made by the inspector.
(b) The original of each food product inspection certificate, and not to exceed two copies thereof, if requested, shall, immediately upon issuance, be delivered or mailed to the applicant or person designated by him. Another copy shall be filed in the office of the regional supervisor serving the area in which such certificate was issued, and one copy shall be forwarded to the Administrator. The last named two copies shall be retained until otherwise ordered by the Administrator.
(a) Upon the request of an exporter, any inspector is authorized to issue an export certificate with respect to the shipment to any foreign country of any inspected and certified edible product after suitable examination of the product has been made by the inspector.
(b) Each export certificate shall be issued in quintuplicate; the original shall be delivered to the exporter who requested such certificate, and the duplicate copy shall be delivered to the agent of the railroad or other carrier transporting such products from the United States. The triplicate copy of such export certificate shall be forwarded to the Administrator; the quadruplicate copy shall be filed in the office of the regional supervisor serving the area in which such export certificate was issued, and the memorandum copy shall be retained by the inspector for filing. The last named three copies shall be retained until otherwise ordered by the Administrator.
Upon the request of an applicant, all or part of the contents of any inspection certificate issued to such applicant may be telephoned or telegraphed to him, or to any person designated by him, at his expense.
Any rabbit inspection system may be deemed to be acceptable to the Administrator which:
(a) Is conducted under the authority of laws, ordinances, or similar enactments of the State, county, city, or other political subdivision in which is located the official plant at which the ready-to-cook rabbits are prepared and
(b) Imposes at least the requirements set forth in § 354.161: Provided, That no such inspection shall be deemed acceptable to the Administrator with respect to any official plant in which ready-to-cook rabbits are prepared if he finds at any time that such requirements are not adequately enforced.
(a) The inspection shall be conducted by an inspector who is a qualified veterinarian or under the supervision of a qualified veterinarian. All such inspectors shall be employed by the State, county, city, or other political subdivision in which the official plant is located.
(b) The inspection shall include post-mortem examination of each rabbit carcass during the evisceration operation.
(c) All carcasses which show evidence of disease or any other condition which may render them unwholesome or unfit for food shall be condemned and shall be destroyed for food purposes under the supervision of an inspector. Each carcass and part thereof which has been inspected and passed or containers of carcasses or parts thereof shall bear the identifying inspection symbol of the official inspection system and the marking devices or labels shall be in the custody of the inspector at all times.
A qualified veterinary supervisor of the rabbit inspection service shall investigate the manner of operation of the inspection system to determine the adequacy of the post-mortem examination and the compliance with the requirements contained in §§ 354.160 to 354.162 prior to approving the official plant for the inspection of ready-to-cook rabbits. This supervisor, as well as any official graders who may be stationed in the official plant, shall periodically observe the inspection operations in the official plant to determine that the requirements of §§ 354.160 to 354.162 are being met.
The provisions of §§ 354.210 to 354.247 shall apply with respect to inspection service in all official plants. The table set forth in § 354.247 indicates some of the types of material which may be used in the construction of equipment, utensils, and facilities for use in the plant.
The buildings shall be of sound construction and kept in good repair, and shall be of such construction as to prevent the entrance or harboring of vermin.
(a) Outside openings. (1) The doors, windows, skylights, and other outside openings of the plant, except receiving rooms and live rabbit holding rooms, shall be protected by properly fitted screens or other suitable devices against the entrance of flies and other insects.
(2) Outside doors, except in receiving rooms and live rabbit holding rooms, shall be self-closing and so hung that not over
Rooms and compartments used for edible products shall be separate and distinct from inedible products departments and from rooms where rabbits are slaughtered and skinned. Separate rooms shall be provided when required for conducting processing operations in a sanitary manner, and all rooms shall be of sufficient size to permit the installation of the necessary equipment for processing operations and the conduct of such operations in a sanitary manner.
(a) Rooms for separate operation. The official plant should have separate rooms for each of the following operations depending upon the various types of operations conducted, but, in no case, shall the receiving or holding of live rabbits or killing operations be permitted in rooms in which eviscerating operations are performed:
(1) The receiving and feeding of live rabbits.
(2) Killing and skinning operations.
(3) Eviscerating, chilling, and packing operations for ready-to-cook rabbits.
(4) Inedible products departments.
(5) Refuse room.
(b) Rooms for holding carcasses for further inspection. Rooms and compartments in which carcasses or parts thereof are held for further inspection shall be in such number and such location as the needs of the inspection in the plant may require. They shall be equipped with locks and keys and the keys shall not leave the custody of the inspector in charge of the plant. All such rooms and compartments shall be marked conspicuously with the word “retained” in letters not less than 2 inches high.
(c) Coolers and freezers. Coolers and freezers of adequate size and capacity shall be provided to reduce the internal temperature of ready-to-cook rabbits prepared and otherwise handled in the plant to 36 °F. within 24 hours unless other cooling facilities are available.
(d) Refuse rooms. Refuse rooms shall be entirely separate from other rooms in the plant, and shall have tight fitting doors and be properly ventilated.
(e) Storage and supply rooms. The storage and supply rooms shall be in good repair, kept dry, and maintained in a sanitary condition.
(f) Boiler room. The boiler room shall be a separate room, if necessary, to prevent its being a source of dirt and objectionable odors entering any room where ready-to-cook rabbits are prepared, processed, handled, and stored.
(g) Inspector's office. Furnished office space, including, but not being limited to, light, heat, and janitor service shall be provided rent free in the official plant for the exclusive use for official purposes of the inspector and the Administration. The room or rooms set apart for this purpose must meet with the approval of the regional supervisor and be conveniently located, properly ventilated, and provided with lockers or cabinets suitable for the protection and storage of supplies and with facilities suitable for inspectors to change clothing.
(h) Toilet rooms. Toilet rooms opening directly into rooms where rabbit products are exposed shall have self-closing doors and shall be ventilated to the outside of the building.
(a) Floors. All floors in rooms where exposed products are prepared or handled shall be constructed of or finished with materials impervious to moisture, so they can be readily and thoroughly cleaned. The floors in killing, ice cooling, ice packing, eviscerating, cooking, boning, and cannery rooms shall be graded for complete runoff with no standing water.
(b) Walls, posts, partitions, doors. All walls, posts, partitions, and doors in rooms where exposed products are prepared or handled shall be smooth and constructed of materials impervious to moisture to a height of 6 feet above the floor to enable thorough cleaning. All surfaces above this height must be smooth and finished with moisture-resistant material.
(c) Ceilings. Ceilings must be moisture-resistant in rooms where exposed products are prepared or handled, and finished and sealed to prevent collection of dirt or dust that might sift through flooring above or fall from collecting surfaces on equipment or exposed product.
There shall be an efficient drainage and plumbing system for the plant and premises.
(a) Drains and gutters. All drains and gutters shall be properly installed with approved traps and vents. The drainage and plumbing system must permit the quick runoff of all water from plant buildings, and surface water around the plant and on the premises, and all such water shall be disposed of in such a manner as to prevent a nuisance or health hazard.
(b) Sewage and plant wastes. (1) The sewerage system shall have adequate slope and capacity to remove readily all waste from the various processing operations and to minimize, and if possible to prevent, stoppage and surcharging of the system.
(2) Grease traps which are connected with the sewerage system shall be suitably located but not near any edible products department or in any area where products are unloaded from or loaded into vehicles. To facilitate cleaning, such traps shall have inclined bottoms and be provided with suitable covers.
(3) Toilet soil lines shall be separate from house drainage lines to a point outside the buildings unless they are positively trapped to prevent backing up. Drainage from toilet bowls and urinals shall not be discharged into a grease catch basin.
(4) All floor drains shall be equipped with traps, constructed so as to minimize clogging, and the plumbing shall be so installed as to prevent sewerage from backing up and from flooding the floor.
(5) Floor drainage lines should be of metal and at least 4 inches in diameter and open into main drains of at least 6 inches in diameter and shall be properly vented to outside air.
(6) Where refrigerators are equipped with drains, such drains should be properly trapped and should discharge through an air gap into the sewer system. All new installations, and all replacements, or refrigerators equipped with drains shall meet these requirements.
The water supply shall be ample, clean, and potable with adequate facilities for its distribution in the plant and its protection against contamination and pollution.
(a) Hot water at a temperature not less than 180 °F. shall be available for sanitation purposes.
(b) Hose connections with steam and water mixing valves or hot water hose connections shall be provided at convenient locations throughout the plant for cleaning purposes.
(c) The refuse rooms shall be provided with adequate facilities for washing refuse cans and other equipment in the rooms; the rooms, cans, and equipment shall be cleaned after each day's use.
Modern lavatory accommodations and properly located facilities for cleaning utensils and hands shall be provided.
(a) Adequate lavatory and toilet accommodations, including, but not being limited to, running hot water and cold water, soap, and towels, shall be provided. Such accommodations shall be in or near toilet and locker rooms and also at such other places in the plant as may be essential to the cleanliness of all personnel handling products.
(b) Sufficient metal containers shall be provided for used towels and other wastes.
(c) An adequate number of hand washing facilities serving areas where dressed rabbits and edible products are prepared shall be operated by other than hand-operated controls, or shall be of a continuous flow type which provides an adequate flow of water for washing hands.
(d) Durable signs shall be posted conspicuously in each toilet room and locker room directing employees to wash their hands before returning to work.
(e) Toilet facilities shall be provided according to the following formula:
| Persons of same sex | Toilet bowls required |
|---|---|
| 1 to 15, inclusive | 1 |
| 16 to 35, inclusive | 2 |
| 36 to 55, inclusive | 1 3 |
| 56 to 80, inclusive | 1 4 |
| For each additional 30 persons in excess of 80 | 1 1 |
1 Urinals may be substituted for toilet bowls but only to the extent of
There shall be ample light, either natural or artificial or both, of good quality and well distributed, and sufficient ventilation for all rooms and compartments to insure sanitary conditions.
(a) All rooms in which rabbits are killed, eviscerated, or otherwise processed shall have at least 30 foot candles of light intensity on all working surfaces except that at the inspection stations such light intensity shall be of 50 foot candles. In all other rooms, there shall be provided at least 5 foot candles of light intensity when measured at distance of 30 inches from the floor.
(b) All rooms shall be adequately ventilated to eliminate objectionable odors and minimize moisture condensation.
Equipment and utensils used for the preparation, processing, or other handling of any product in the plant shall be suitable for the purpose intended and shall be of such material and construction as will facilitate their thorough cleaning and insure cleanliness in the preparation and handling of products.
(a) Live rabbit holding pens shall be so constructed as to allow satisfactory ante-mortem examination and to permit proper cleaning.
(b) Metal refuse containers shall be provided, and such containers shall be kept covered.
(c) Insofar as it is practical, equipment and utensils shall be made of metal or other impervious material. Trucks and receptacles used for handling inedible products shall be of similar construction and shall be conspicuously and distinctly marked and shall not be used for handling any edible products.
(d) Chilling vats or tanks used for chilling ready-to-cook rabbits shall be made of metal or other hard-surfaced impervious material.
(e) Where grading bins are used for ready-to-cook rabbits, they shall be of sufficient number and capacity to handle the grading adequately without the use of makeshift bins and all ready-to-cook rabbits shall be kept off the floor. Grading bins may be made of metal or enameled wood and shall be constructed and maintained in such a manner as to allow easy and thorough cleaning. All replacements of such bins shall, however, be of metal.
(f) Except as otherwise provided herein, all equipment and utensils used in the killing, skinning, eviscerating, chilling, and packing rooms shall be of metal or other impervious material and constructed so as to permit proper and complete cleaning.
(g) Conveyors: (1) Conveyors used in the preparation of ready-to-cook rabbits shall be of metal or other acceptable material and of such construction as to permit thorough and ready cleaning and easy identification of viscera with its carcass.
(2) Overhead conveyors shall be so constructed and maintained that they do not allow grease, oil, or dirt to accumulate on the drop chain or shackle, which shall be of noncorrosive metal.
(3) Nonmetallic belt-type conveyors used in moving edible products shall be of water-proof composition.
(h) Inspection, eviscerating, and cutting tables shall be made of metal and have coved corners and be so constructed and placed to permit thorough cleaning.
(i) In plants where no conveyors are used, each carcass shall be eviscerated in an individual metal tray of seamless construction.
(j) Water spray washing equipment shall be used for washing carcasses inside and out.
(k) Watertight metal receptacles shall be used for entrails and other waste resulting from preparation of ready-to-cook rabbits.
(l) Watertight trucks and receptacles for holding or handling diseased carcasses and diseased parts of carcasses shall be so constructed as to be readily and thoroughly cleaned; such trucks and receptacles shall be marked in a conspicuous manner with the word “condemned” in letters not less than 2 inches high and, when required by the inspector in charge, shall be equipped with facilities for locking and sealing.
(m) Freezing rooms should be adequately equipped to freeze ready-to-cook rabbits solid in less than 48 hours. Ready-to-cook rabbits should be frozen at temperatures of −10 °F. to −40 °F. and should be stored at 0 °F. or below, with the temperature maintained as constant as possible. Freezing room should be equipped with floor racks or pallets and fans to insure air circulation.
(n) Cooling racks should be made of metal and be readily accessible for thorough washing and cleaning. All replacements of cooling racks shall be made of metal.
(o) Trucks and receptacles in which carcasses or parts thereof are held for further inspection shall be in such number and such location as the needs of the inspection in the plant may require. They shall be equipped for locking by means of lock and key and the key shall not leave the custody of the inspector in charge of the plant. Such trucks and receptacles shall be marked conspicuously with the word “retained” in letters not less than 2 inches high.
All equipment shall be so placed as to be readily accessible for all processing and cleaning operations.
Equipment and utensils used in the official plant shall not be used outside the official plant except under such conditions as may be prescribed or approved by the national supervisor, and equipment used in the preparation of any article (including, but not being limited to, animal food) from inedible material shall not be used outside of the inedible products department except under such conditions as may be prescribed or approved by the national supervisor.
The premises shall be kept free from refuse, waste materials, and all other sources of objectionable odors and conditions.
Rooms, compartments, or other parts of the official plant shall be kept clean and in sanitary condition.
(a) All blood, offal, rabbits or parts of rabbits too severely damaged to be salvaged and all discarded containers and other materials shall be completely disposed of daily.
(b) All windows, doors, and light fixtures in the official plant shall be kept clean.
(c) All docks and rooms shall be kept clean and free from debris and unused equipment and utensils.
(d) Live rabbit receiving docks and receiving rooms shall be of such construction as readily to permit their thorough cleaning, and such docks and rooms should be kept clean at all times.
(e) Floors in live rabbit holding rooms shall be cleaned with such regularity as may be necessary to maintain them in a sanitary condition.
(f) The killing and skinning room shall be kept clean and free from offensive odors at all times.
(g) The walls, floors, and all equipment and utensils used in the killing and skinning room shall be thoroughly washed and cleaned after each day's operation.
(h) The floor in the killing and skinning rooms shall be cleaned frequently during killing and skinning operations and be kept reasonably free from accumulated blood, offal, water, and dirt.
(i) All equipment in the toilet room and locker room, as well as the room itself, shall be kept clean, sanitary, and in good repair.
(j) Cooler and freezer rooms shall be free from objectionable odors of any kind and shall be maintained in a sanitary condition (including, but not being limited to, the prevention of drippings from refrigerating coils onto products).
Equipment and utensils used for preparing or otherwise handling any product shall be kept clean and in a sanitary condition and in good repair.
(a) Pens shall be cleaned regularly and the manure removed from the plant daily.
(b) All equipment and utensils used in the killing and skinning rooms shall be thoroughly washed and cleaned after each day's operation. The eviscerating, chilling, and packing room and equipment and utensils used therein shall be maintained in a clean and sanitary condition.
(c) Graders' and packers' gloves and grading bins shall be washed daily and used only for grading or packing, as the case may be.
(d) All crates or pens used for transporting live rabbits to the plant shall be cleaned regularly.
(e) Chilling vats or tanks, if practicable, shall be emptied after each use. They shall be thoroughly cleaned once daily and, after each cleaning operation, they shall be sanitized with such compounds or by such methods as may be approved or prescribed by the Administrator.
(f) When synchronized overhead conveyors and tray conveyors are used, the trays shall be completely washed and sanitized after being automatically emptied of inedible viscera.
(g) When a conveyor tray operation is used, each carcass shall be eviscerated in an individual metal tray of seamless construction, and such trays shall be completely washed and sanitized after each use.
(h) Tables, shelves, bins, trays, pans, knives, and all other tools and equipment used in the preparation of ready-to-cook rabbits shall be kept clean and sanitary at all times. Cleaned equipment and utensils shall be drained on racks and shall not be nested.
(i) Drums, cans, tanks, vats, and other receptacles used to hold or transport ready-to-cook rabbits shall be kept in a clean and sanitary condition.
Operations and procedures involving the preparation, storing, or handling of any product shall be strictly in accord with clean and sanitary methods.
(a) There shall be no handling or storing of materials which create an objectionable condition in rooms, compartments, or other places in the plant where any product is prepared, stored, or otherwise handled.
(b) Blood from the killing operation shall be confined to a relatively small area and kept from being splashed about the room.
(c) In the final washing, the carcass shall be passed through a system of sprays providing an abundant supply of fresh clean water.
(d) The floors in the eviscerating room shall be kept clean and reasonably dry during eviscerating operations and free of all refuse.
(e) Conveyors shall be operated at such speeds as will permit a sanitary eviscerating operation and will permit adequate inspection for condition and wholesomeness.
(f) Mechanized packaging equipment shall be maintained in good sanitary condition.
(g) All offal resulting from the eviscerating operation shall be removed as often as necessary to prevent the development of a nuisance.
(h) Paper and other material used for lining containers in which products are packaged shall be of such kinds as do not tear readily during use, but remain intact when moistened by the product. Wooden containers to be used for packaging ready-to-cook rabbits shall be fully lined except when the individual carcasses to be packaged therein are fully wrapped.
(i) Protective coverings shall be used for the product in the plant and as it is distributed from the plant, as will afford adequate protection for the product against contamination by any foreign substance (including, but not being limited to, dust, dirt, and insects), considering the means intended to be employed in transporting the product from the plant.
(j) Refuse may be moved directly to loading docks only for prompt removal.
(k) Cleanliness and hygiene of personnel: (1) All employees coming in contact with exposed edible products or edible products handling equipment shall wear clean garments and should wear caps or hair nets, and shall keep their hands clean at all times while thus engaged.
(2) Hands of employees handling edible products or edible products handling equipment shall be free of infected cuts, boils, and open sores at all times while thus engaged.
(3) Every person, after each use of toilet or change of garments, shall wash his hands thoroughly before returning to duties that require the handling of edible products or containers therefor or edible products handling equipment.
(4) Neither smoking nor chewing of tobacco shall be permitted in any room where exposed edible products are prepared, processed, or otherwise handled.
Temperatures and procedures which are necessary for cooling and freezing of rabbits in accordance with sound commercial practice shall be maintained in the coolers and freezers, and chilling temperatures and procedures shall also be in accordance with sound commercial practice.
(a) Cooling. Immediately after evisceration and washing of the carcass, it shall be placed in a cooling tank containing running cold tap water to remove the animal heat from the carcass. Carcasses shall not be allowed to remain in the cooling tank for longer than 1 hour.
(b) Air chilling. Immediately after the initial water chilling, the carcasses shall be placed in cooling racks and thereupon placed in a refrigerated cooler with moderate air movements and a temperature which will reduce the internal temperature of the carcasses to from 36 °F. to 40 °F., both inclusive, within 24 hours.
(c) Freezing. (1) When ready-to-cook rabbits are packaged in bulk or shipping containers, the carcasses should be individually wrapped or packaged in water-vapor resistant cartons or the containers should be lined with heavy water-vapor resistant paper so as to assure adequate overlapping of the lining to completely surround the carcasses and to permit unsealed closure or sealing in such a manner that water-vapor loss from the product is considerably retarded or prevented. The rabbit carcasses should receive an initial rapid freezing under such packaging, temperature, air circulation, and stacking conditions which will result in freezing the carcasses solid in less than 48 hours.
(2) Frozen ready-to-cook rabbits shall be held under conditions which will maintain the product in a solidly frozen state with temperature maintained as constant as possible.
(d) Refrigeration. Immediately after packaging, all ready-to-cook rabbits, other than those which are shipped from the plant in a refrigerated carrier, should be moved into the freezer, except that a period not exceeding 72 hours will be permitted for transportation and temporary holding before placing in the freezer provided such rabbits are held at not above 36 °F.
Every practicable precaution shall be taken to exclude flies, rats, mice, and other vermin from the official plant. Dogs, cats, and other pets shall be excluded from rooms where edible products are processed, handled, or stored.
No person affected with any communicable disease (including, but not being limited to, tuberculosis) in a transmissible stage shall be permitted in any room or compartment where exposed or unpacked edible products are prepared, processed, or otherwise handled.
| Equipment, utensils, and facilities | Iron | Stainless steel and monel metal | Aluminum | Galvanized iron |
|---|---|---|---|---|
| Holding pens | A | A | A | A |
| Overhead conveyors | A | A | A | A |
| Conveyor track | A | A | A | |
| Shackles | A | A | ||
| Shackle chain | A | A | A | |
| Eviscerating pans | A | A | A | |
| Inspection table | A | A | A | |
| Inside and outside washer | A | A | A | |
| Cooling tanks and racks | A | A | A | |
| Utensils for handling edible products | A | A | A | |
| Framework (of equipment) | A |
Key: A—Acceptable.
The rules of practice of the Department of Agriculture in subpart H of part I, subtitle A, title 7 of the Code of Federal Regulations, are the rules of practice applicable to adjudicatory, administrative proceedings under the regulations in this part (9 CFR part 354).
The definitions in § 381.1 are incorporated in this part except for the definitions excluded in § 362.2(a). In addition to those definitions, the following definitions will be applicable to the regulations in this part.
(a) Act. “Act” means the Agricultural Marketing Act of 1946, as amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).
(b) Inspector. “Inspector” means any officer or employee of the Department authorized to perform any duties under the regulations in this part.
(c) Person. “Person” means any individual, corporation, company, association, firm, partnership, society, or joint stock company, or other organized business unit.
(d) Poultry. “Poultry” means any migratory water fowl or game bird, whether dead or alive.
(e) Poultry Product. “Poultry product” means any poultry carcass or part thereof; or any human food product which is made wholly or in part from the carcass of any domesticated bird (as defined in § 381.1(b) of this chapter) and is excepted from the inspection requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.).
Upon application, in accordance with § 362.3, the following types of service may be furnished under the regulations in this part:
(a) Inspection service. An inspection and certification service for wholesomeness relating to the slaughter and processing of poultry and the processing of poultry products. All provisions of Part 381, Part 412, and §§ 416.1 through 416.6 of this chapter shall apply to the slaughter of poultry, and the preparation, labeling, and certification of the poultry and poultry products processed under this poultry inspection service except for the following provisions: the definitions of “Act,” “animal food manufacturer,” “Inspection Service,” “inspector,” “Inspector in Charge,” “poultry,” “poultry product,” “poultry food product,” “poultry products broker,” “renderer,” and “U.S. Refused Entry” in §§ 381.1 b), 381.3 (a), 381.6, 381.10, 381.13 through 381.17, 381.21, 381.29, 381.39 through 381.42, 381.175(a)(2) and (3), 381.179, 381.185 through 381.187, 381.192, and 381.195 through 381.225.
(b) Export certification service. At the request of any person intending to export any slaughtered poultry or poultry product, inspectors may make certification regarding products for human food purposes, to be exported, as meeting conditions or standards that are not imposed or are in addition to those imposed by the regulations in this chapter and the laws under which such regulations were issued.
(c) Identification Service. (1) Poultry or other product that is federally inspected and passed at an official establishment, or upon importation, under the Poultry Products Inspection Act, is officially marked to identify it as federally inspected and passed. In order to facilitate the division of such poultry or other product into smaller portions or its combination into larger units and still maintain its identify as product which has been federally inspected and passed and so marked, inspectors may supervise the handling and weighing of the product and mark such portions and units with the official mark of inspection when they determine that identify has been maintained.
(2) At the time service is furnished, product must be sound, wholesome, and fit for human food. The service will be available only on premises other than those of an official establishment. The sanitation of the place or area where service is furnished must comply with provisions of §§ 416.1 through 416.6 of this chapter.
(3) The mark of inspection shall be applied only under the immediate supervision of an inspector.
(4) This service does not cover further cutting and processing of products. These activities must take place at an official establishment.
(5) The registration and recordkeeping requirements enumerated in Part 381, subpart Q, of this chapter shall apply to persons requesting voluntary identification service under this paragraph (c).
Any person who desires to receive service under the regulations in this part for poultry or other product eligible therefor under such regulations may make application for service to the Administrator, upon an application form which will be furnished by the Administrator upon request to the Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application must include all the information called for by that form. In case of change of name, ownership, management, or location, a new application shall be made.
(a) For disciplinary reasons—(1) Bases for denial or withdrawal. An application or request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person who, or whose employee or agent in the scope of his employment or agency, (i) has willfully made any misrepresentation or has committed any other fraudulent or deceptive practice in connection with any application or request for service under the regulations in this chapter; (ii) has given or attempted to give, as a loan or for any other purpose, any money, favor, or other thing of value, to any employee of the Department authorized to perform any function under the regulations in this chapter; (iii) has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee of the Department in the performance of his duties under the regulations in this chapter by intimidation, threats, assaults, abuse, or any other improper means; (iv) has knowingly falsely made, issued, altered, forged, or counterfeited any official certificate, memorandum, mark, or other identification, or device for making any such mark or identification authorized or issued under this chapter; (v) has knowingly uttered, published, or used as true any such falsely made, issued, altered, forged, or counterfeited certificate, memorandum, mark, identification, or device; (vi) has knowingly obtained or retained possession of any such falsely made, issued, altered, forged, or counterfeited certificate, memorandum, mark, identification, or device, or of any carcass or poultry or product bearing any such falsely made, issued, altered, forged or counterfeited certificate, memorandum, mark, or identification; (vii) has knowingly represented that any carcass, poultry, or product has been officially inspected and passed (by an authorized inspector) under this chapter, when it had not in fact been so inspected; (viii) has, within the previous ten years, been convicted of any felony or more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged food, or fraud in connection with transactions in food, or any felony indicating a lack of the integrity needed for the conduct of operations affecting the public health; (ix) has in any manner not specified in this paragraph violated subsection 203(h) of the Act:
Provided, That paragraph (a)(1)(vi) of this section shall not be deemed to be violated if the person in possession of any item mentioned therein notifies the inspector without delay that he has possession of such item and, in the case of an official device, surrenders it to the inspector, and, in the case of any other item, surrenders it to the inspector or destroys it or brings it into compliance with the regulations by obliterating or removing the violative features under supervision of the inspector; And provided further, That an application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from any person who operates an establishment for which he has made application for service if, with the knowledge of such operator, any other person conducting any operations in such establishment has committed any of the offenses specified in paragraphs (a)(1) (i) through (ix) of this section after such application was made. Moreover, an application or a request for service made in the name of a person otherwise eligible for service under the regulations may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, such a person (a) in case the service is or would be performed at an establishment operated (1) by a corporation, partnership, or other person from whom the benefits of the service are currently being withheld under this chapter, or (2) by a corporation, partnership, or other person having an officer, director, partner, or substantial investor from whom the benefits of service under this chapter are currently being withheld and who has any authority with respect to the establishment where service is or would be performed, or (b) in case the service is or would be performed with respect to any poultry or product in which any corporation, partnership, or other person within (a)(1) of this section has a contract or other financial interest.
(2) Procedure. An application or request for service may be rejected, or benefits of the service may be otherwise denied to or withdrawn by the Secretary, as provided by this paragraph, after notice and opportunity for hearing before a proper official of the Department. The Administrator may reject an application or request for service or deny or withdraw service under this paragraph without hearing, pending final determination of the matter, when he determines that the public interest so requires. The operator or applicant of such plant shall be notified of the Administrator's decision to reject the application or request for service or to deny or withdraw such service, and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. The Administrator's decision to reject an application or request for service or to deny or withdraw the benefits of service under the Act shall be effective upon such oral or written notification, whichever is earlier, to the operator or applicant of such plant. If such notification is oral, the Administrator shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the operator or applicant of such plant in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)).
(b) For correctable cause—(1) Basis for denial or withdrawal. An application or request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person whose establishment does not meet the requirements as to premises, facilities, and equipment, and the operation thereof, prescribed in the regulations to prevent the distribution of adulterated poultry or poultry products, or who has not received approval of labeling and containers to be used at the establishment as required by the regulations.
(2) Procedure. An application or request for service may be rejected, or benefits of the service may be otherwise denied to or withdrawn by the Secretary, as provided by this paragraph, after notice and opportunity for hearing before a proper official of the Department. The Administrator may reject an application or request for service or deny or withdraw service under this paragraph without hearing, pending final determination of the matter, when he determines that the public interest so requires. The operator or applicant of such plant shall be notified of the Administrator's decision to reject the application or request for service or to deny or withdraw such service, and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. The Administrator's decision to reject an application or request for service or to deny or withdraw the benefits of service under the Act shall be effective upon such oral or written notification, whichever is earlier, to the operator or applicant of such plant. If such notification is oral, the Administrator shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the operator or applicant of such plant in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)).
(c) For miscellaneous reasons. An application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person, without a hearing, by the official in charge of the appropriate regional office, with the concurrence of the Regional Director (1) for administrative reasons such as the nonavailability of personnel to perform the service; (2) for the failure to pay for service; (3) in case the application or request relates to birds or products which are not eligible for service under this part 362; or (4) in case the person is a partnership, corporation, or other person from whom the benefits of the service are currently being withheld under paragraph (a) of this section. Notice of such rejection, denial, or withdrawal, and the reasons therefor, shall promptly be given to the person involved. The operator or applicant of such plant shall be notified of such decisions to reject an application or request for service or to deny or withdraw the benefits of the service, and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. Such decision shall be effective upon such oral or written notification, whichever is earlier, to the operator or applicant of such plant. If such notification is oral, the person making such decision shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the operator or applicant of such plant in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)).
(d) Scope and applicability of rules of practice. The rules of practice of the Department of Agriculture in subpart H of part I, subtitle A, title 7 of the Code of Federal Regulations, are the rules of practice applicable to adjudicatory, administrative proceedings under the regulations in this part (9 CFR part 362).
(a) Fees and charges for service under the regulations in this part shall be paid by the applicant for the service in accordance with this section, and, if required by the Administrator, the fees and charges shall be paid in advance.
(b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the Treasurer of the United States and shall be remitted promptly to the Administrator upon furnishing to the applicant a statement as to the amount due.
(c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs. Such fees shall cover the costs of the services and shall be charged for the time required to render such service, including, but not limited to, the time required for the travel of the inspector or inspectors in connection therewith during the regularly scheduled administrative workweek.
(d) Charges may also be made to cover the cost of travel and other expenses incurred by the Service in connection with the furnishing of the service.
(e) Exporters that submit electronic export certificate applications will be charged a fee per application submitted.
(f) For each calendar year, FSIS will calculate the electronic export certificate application fee, using the following formula: Labor Costs (Technical Support Cost + Export Library Maintenance Cost) + Information Technology Costs (On-going operations Cost + Maintenance Cost + eAuthentication Cost), divided by the number of export applications.
(g) FSIS will publish notice of the electronic export certificate application fee annually in the
(a) For the purposes of the regulations in this part, unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa.
(b) For the purposes of such regulations, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:
Acceptable. “Acceptable” means suitable for the purpose intended and acceptable to the Administrator.
Act. “Act” means the Poultry Products Inspection Act (71 Stat. 441, as amended by the Wholesome Poultry Products Act, 82 Stat. 791; 21 U.S.C. 451 et seq.).
Adulterated. “Adulterated” applies to any poultry product under one or more of the following circumstances:
(i) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(ii)(a) If it bears or contains (by reason of administration of any substance to the live poultry or otherwise) any added poisonous or added deleterious substance (other than one which is a pesticide chemical in or on a raw agricultural commodity; a food additive; or a color additive) which may, in the judgment of the Administrator, make such article unfit for human food;
(b) If it is, in whole or part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
(c) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
(d) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act:
(iii) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;
(iv) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(v) If it is, in whole or in part, the product of any poultry which has died otherwise than by slaughter;
(vi) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(vii) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act; or
(viii) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from carcasses or parts or products of the carcass of poultry, except that the term animal food as used herein does not include (i) processed dry animal food or (ii) livestock or poultry feeds manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate).
Animal food manufacturer. “Animal Food Manufacturer” means any person engaged in the business of manufacturing or processing animal food.
Applicant. “Applicant” means any person who requests inspection service, exemption, or other authorization under the regulations.
Biological residue. “Biological Residue” means any substance, including metabolites, remaining in poultry at the time of slaughter or in any of its tissues after slaughter, as the result of treatment or exposure of the live poultry to a pesticide, organic compound, metallic or other inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other agent that leaves a residue.
Capable of use as human food. The term “capable of use as human food” applies to any carcass, or part or product of a carcass of any poultry, unless it is denatured or otherwise identified as required by the regulations, or it is naturally inedible by humans.
Carcass. This term means all parts, including viscera, of any slaughtered poultry.
Commerce. “Commerce” means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia.
Consumer package. “Consumer package” means any container in which a poultry product is enclosed for the purpose of display and sale to household consumers.
Container. The term “container” includes any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover.
Edible. This term means that an article is intended for use as human food.
Egg Products Inspection Act. “Egg Products Inspection Act” means the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21 U.S.C. 1031 et seq.).
Federal Food, Drug, and Cosmetic Act. “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and acts amendatory thereof or supplementary thereto (21 U.S.C. 301 et seq.).
Federal Meat Inspection Act. “Federal Meat Inspection Act” means the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq.).
Free from protruding pinfeathers. “Free from protruding pinfeathers” means that the carcass is free from protruding pinfeathers which are visible to an inspector during an examination of the carcass at normal operating speeds. However, a carcass may be considered as being free from protruding pinfeathers if it has a generally clean appearance (especially on the breast), and if not more than an occasional protruding pinfeather is in evidence during a more careful examination of the carcass.
Giblets. “Giblets” means the liver from which the bile sac has been removed, the heart from which the pericardial sac has been removed, and the gizzard from which the lining and contents have been removed: Provided, That each such organ has been properly trimmed and washed.
Immediate container. “Immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed.
Inedible. This term means any carcass or any part of a carcass that is either naturally inedible by humans or is rendered unfit for human food by reason of adulteration or denaturing.
Inspected for wholesomeness. This term means that the poultry product so identified has been inspected and was found at the time of such inspection to be not adulterated.
Inspection. “Inspection” means any inspection required by the regulations to determine whether any poultry or poultry products comply with the requirements of the Act and the regulations.
Label. This term applies to any display of written, printed, or graphic matter upon any article or the immediate container (not including package liners) of any article.
Labeling. This term applies to all labels and other written, printed, or graphic matter (i) upon any article or any of its containers or wrappers, or (ii) accompanying such article.
Misbranded. This term applies to any poultry product under one or more of the following circumstances:
(i) If its labeling is false or misleading in any particular;
(ii) If it is offered for sale under the name of another food;
(iii) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated;
(iv) If its container is so made, formed, or filled as to be misleading;
(v) If in a package or other container, unless it bears a label showing:
(a) The name and place of business of the manufacturer, packer, or distributor; and
(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in § 381.121(a) with respect to the quantity of contents;
(vi) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(vii) If it purports to be or is represented as a food for which a definition and standard of identity or composition is prescribed by the regulations in subpart P of this part unless:
(a) It conforms to such definition and standard, and
(b) Its label bears the name of the food specified in the definition and standard, and insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.
(viii) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the Secretary,
(ix) If it is not subject to the provisions of paragraph (b)(vii) of this section, unless its label bears:
(a) The common or usual name of the food, if any there be, and
(b) In case it is fabricated from two or more ingredients, the common or usual name of each ingredient, except as otherwise provided in § 381.118(c);
(x) If it purports to be or is represented for special dietary uses, unless the label bears such information concerning its vitamin, mineral, and other dietary properties as is required by § 381.124;
(xi) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided in § 381.119, or
(xii) If it fails to bear, directly thereon or on its containers, when required by § 381.123, the official inspection legend and the official establishment number of the establishment where the product was processed; and unrestricted by any of the foregoing; such other information as the Administrator may require in the regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.
Nonfood compounds. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of poultry or poultry products, excluding labeling and packaging materials as covered in subpart N of this part.
Official certificate. This term means any certificate prescribed in subpart M of this part relating to poultry or poultry products.
Official device. This term means any label or other device prescribed in subpart M of this part for use in applying any official mark.
Official establishment. “Official establishment” means any establishment as determined by the Administrator at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained pursuant to the regulations.
Official import inspection establishment. This term means any establishment, other than an official establishment as defined in this definition where inspections are authorized to be conducted as prescribed in § 381.199.
Official inspection legend. This term means the official inspection mark prescribed in § 381.96 or the official poultry identification mark prescribed in § 381.97, showing that an article was inspected for wholesomeness and passed in accordance with the Act.
Official mark. This term means any symbol prescribed in subpart M of this part to identify the status of any article or poultry under the Act.
Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for poultry products.
Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for the purposes of the Act and the regulations as under the Federal Food, Drug, and Cosmetic Act.
Poultry. “Poultry” means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about thirty days of age), whether live or dead.
Poultry product. (i) This term means any poultry carcass or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15. Except where the context requires otherwise (e.g., in paragraph (b)(42) of this section), this term is limited to articles capable of use as human food.
(ii) Poultry food product. This term means any product capable of use as human food which is made in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15.
Poultry products broker. “Poultry products broker” means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person.
Process. Process used as a verb means to conduct any operation or combination of operations, whereby poultry is slaughtered, eviscerated, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed. The term “process” does not refer to freezing of poultry products, except when freezing is incidental to operations otherwise classed as “processing” under this paragraph.
Process authority. A person or organization with expert knowledge in poultry production process control and relevant regulations.
Process schedule. A written description of processing procedures, consisting of any number of specific, distinct, and ordered operations directly under control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production.
Ready-to-cook poultry. “Ready-to-cook poultry” means any slaughtered poultry free from protruding pinfeathers and vestigial feathers (hair or down), from which the head, feet, crop, oil gland, trachea, esophagus, entrails, and lungs have been removed, and from which the mature reproductive organs and kidneys may have been removed, and with or without the giblets, and which is suitable for cooking without need of further processing. Ready-to-cook poultry also means any cut-up or disjointed portion of poultry or other parts of poultry, such as reproductive organs, head, or feet that are suitable for cooking without need of further processing.
Regulations. “Regulations” means the provisions of this entire part.
Renderer. “Renderer” means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption pursuant to the regulations.
Shipping container. “Shipping container” means any container used or intended for use in packaging the product packed in an immediate container.
Slaughter. “Slaughter” means the act of killing poultry for human food.
State. Except as otherwise provided in § 381.220 “State” means any State of the United States and the Commonwealth of Puerto Rico.
Supervision. This term means the controls, as prescribed in instructions to Inspection Service employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations in this part.
Territory. The term “territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.
United States. This term means the States, the District of Columbia, and the territories of the United States.
U.S. Condemned. This term means that the poultry carcass, or part or product of a poultry carcass, so identified was inspected and found to be adulterated and is condemned.
U.S. Detained. This term is applicable to poultry, poultry products, and other articles which are held in official custody in accordance with section 19 of the Act and § 381.210, pending disposal as provided in said section 19.
U.S. Refused Entry. This term means that the slaughtered poultry or other poultry product so identified was presented for inspection for entry into the United States and was found not to comply with the requirements of the Act.
U.S. Rejected. This term means that the equipment or facility so identified is prohibited from being used in the processing of any poultry or poultry product until such equipment or facility is found by an inspector to be sanitary and otherwise eligible for use under the regulations.
U.S. Retained. This term means that the poultry or carcass, or part or product of a carcass, of poultry so identified is held at an official establishment by the inspection service for further determination as to its disposal.
(c) For the purposes of the standard for cooked, smoked sausage (§ 319.180 of this chapter), the term “poultry byproduct” means the skin, fat, gizzard, heart, or liver, or any combination thereof, of any poultry.
(a) [Reserved]
(b) The Administrator may in specific classes of cases waive for limited periods any provisions of the regulations in order to permit appropriate and necessary action in the event of a public health emergency or to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements: Provided, That such waivers of the provisions of the regulations are not in conflict with the purposes or provisions of the Act.
(c) Pursuant to section 6 of the Act, the Administrator believes that, in establishments processing poultry products at which inspection under the Act and regulations is required, the frequency with which and the manner in which poultry products made from poultry previously slaughtered and eviscerated in official establishments are reinspected by Inspection Service employees should be based on considerations relevant to effective regulation of poultry products and protection of the health and welfare of consumers. In order to test procedures for use in making such determinations and, in particular, for determining whether and, if so, to what extent the intensity of inspection coverage exceeds that which should be deemed necessary pursuant to section 6 of the Act, the Administrator is initiating experimentation of a new system of inspection for reviewing the performance of establishments and for designing the supervision and other conditions and methods of inspection coverage. For the period of such experimentation, the Administrator shall identify establishments for review, and the frequency and the manner of inspection by Inspection Service employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.
(d) The determinations referred to in paragraph (c) of this section shall be made by the Inspection Service and shall reflect evaluations of the performance and the characteristics of such establishments.
(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:
(i) The history of compliance with applicable regulatory requirements by the person operating such establishment or by anyone responsibly connected with the business operating such establishment, as “responsibly connected” is defined in section 18(a) of the Act,
(ii) The competence of the person operating such establishment, as indicated by:
(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,
(B) Demonstrated ability to apply such knowledge in a timely and consistent manner, and
(C) Commitment to correcting deficiencies noted by Inspection Service employees and otherwise assuring compliance with applicable regulatory requirements, and
(iii) The procedures used in such establishment to control the production process, environment, and resulting product in order to assure and monitor compliance with the requirements of the Act and the rules and regulations promulgated thereunder.
(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:
(i) The complexity of the processing operation(s) conducted at such establishment,
(ii) The frequency with which each such operation is conducted at such establishment,
(iii) The volume of product resulting from each such operation at such establishment,
(iv) Whether and to what extent slaughter and evisceration operations also are conducted at such establishment,
(v) What, if any, food products not regulated under this Act or the Federal Meat Inspection Act also are processed at such establishment, and
(vi) The size of such establishment.
(e)(1) For the period of experimentation described in paragraph (c) of this section, the frequency of inspection by Inspection Service employees of operations other than slaughter and evisceration may be reduced in an establishment in which the procedures referred to therein are being tested if and only if the evaluation of the performance of such establishment described in paragraph (d)(1) indicates that there are:
(i) No instances, documented in records compiled no earlier than 10 years before, of substantial and recent noncompliance with applicable regulatory requirements (taking into account both the nature and frequency of any such noncompliance), and
(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.
(2)(i) The frequency of Federal inspection and other conditions and methods of inspection coverage in any establishment in which the frequency of Federal inspection is reduced shall be based on:
(A) The evaluation of the characteristics of such establishment described in paragraph (d)(2) of this section,
(B) The significance of potential public health consequences of noncompliance, and
(C) The availability of Inspection Service employees.
(ii) To the extent that frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this part, the Administrator will waive such provisions for the period of experimentation, in accordance with paragraph (b) of this section.
Inspection of poultry products shall be rendered pursuant to the regulations and under such conditions and in accordance with such methods as may be prescribed or approved by the Administrator.
Publications under the Act and the regulations shall be made in the
Inspection under the regulations is required at:
(a) Every establishment, except as provided in § 381.10 (a) and (b) or § 381.11, in which any poultry is slaughtered for transportation or sale in commerce, or in which any poultry products are wholly or in part, processed for transportation or sale in commerce, as articles intended for use as human food;
(b) Every establishment, except as provided in § 381.10 (a) and (b), (c), or (d), or § 381.11, within any State or organized territory which is designated pursuant to section 5(c) of the Act, at which any poultry is slaughtered or any poultry products are processed, for use as human food solely for distribution within such jurisdiction; and
(c) Except as provided in § 381.10 (a) and (b), or (c), or § 381.11, every establishment designated by the Administrator pursuant to section 5(c) of the Act as one producing adulterated poultry products which would clearly endanger the public health.
All poultry and poultry products processed in an official establishment shall be inspected, handled, processed, marked, and labeled as required by the regulations.
(a) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry products shall not apply to:
(1) Any retail dealer with respect to poultry products sold in commerce directly to consumers in an individual retail store, if the only processing operation performed by such retail dealer is the cutting up of poultry products on the premises where such sales to consumers are made: Provided, That such operation is conducted under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products sold in commerce are derived from poultry inspected and passed under the Act and such poultry products are not adulterated or misbranded at the time of sale (except that the official inspection legend shall not be used). (For the purposes of this subparagraph, a retail dealer is any person who sells poultry products directly to consumers as defined in paragraph (d)(2)(vi) of this section and whose sales of poultry products to household consumers constitute, in terms of dollar value, at least 75 percent of his total sales of poultry products.)
(2) The slaughter of poultry, and the processing of poultry products, by any person in any territory not organized with a legislative body, solely for distribution within such territory: Provided, That such poultry is sound and healthy and is slaughtered under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products are not adulterated or misbranded when so distributed (except that the official inspection legend shall not be used).
(3) The slaughtering by any person of poultry of his own raising, and the processing by him and transportation in commerce of the poultry products exclusively for use by him and members of his household and his nonpaying guests and employees: Provided, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food, and the shipping containers of such poultry products bear the producer's name and address and the statement “Exempted—P.L. 90-492.”
(4) The custom slaughter by any person of poultry delivered by the owner thereof for such slaughter, and the processing by such slaughterer and transportation in commerce of the poultry products exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and the employees: Provided, That such custom slaughterer does not engage in the business of buying or selling any poultry products capable of use as human food: And provided further, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean and fit for human food, and the shipping containers of such poultry products bear the owner's name and address and the statement “Exempted—P.L. 90-492.”
(5) The slaughtering of sound and healthy poultry and processing of poultry products therefrom in any State or territory or the District of Columbia by any poultry producer on his own premises with respect to poultry raised on his premises, and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when so distributed; (ii) such poultry products when so distributed, bear (in lieu of labeling that would otherwise be required) the producer's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such producer and distributor do not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (5) or (6) of this section; and (iv) neither such producer or distributor slaughters or processes the products of more poultry than allowed by paragraph (b) of this section.
(6) The slaughtering of sound and healthy poultry or the processing of poultry products of such poultry in any State or territory or the District of Columbia by any poultry producer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boardinghouses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when distributed by such processor; (ii) such poultry products when so distributed bear (in lieu of labeling that would otherwise be required) the processor's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such processor does not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (6) or (5) of this section; and (iv) such processor does not exceed the volume limitation prescribed in paragraph (b) of this section.
(7) The operations and products of small enterprises (including poultry producers) not exempted under paragraphs (a) (1) through (6) of this section that are engaged in any State or territory or the District of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such jurisdiction; Provided, That (i) such poultry is sound and healthy when slaughtered and is slaughtered and/or cut up and handled under such sanitary standards, practices and procedures as result in the preparation of poultry products that are not adulterated when so distributed; and (ii) when so distributed, such poultry products are not misbranded (except that the official inspection legend shall not be used).
(b) No person qualifies for any exemption specified in paragraph (a)(5), (6), or (7) of this section if, in the current calendar year, such person:
(1) Slaughters or processes the products of more than 20,000 poultry, or
(2) Slaughters or processes poultry products at a facility used for slaughtering or processing poultry products by any other person, except when the Administrator grants such exemption after determining, upon review of a person's application, that such an exemption will not impair effectuating the purposes of the Act.
(c) The provisions of the Act and the regulations do not apply to any poultry producer with respect to poultry, of his own raising on his own farm, which he slaughters if:
(1) Such producer slaughters not more than 1,000 poultry during the calendar year for which this exemption is being determined;
(2) Such poultry producer does not engage in buying or selling poultry products other than those produced from poultry raised on his own farm; and
(3) None of such poultry moves in “commerce” (as defined in § 381.1).
(d)(1) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar-retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments.
(2) For the purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at retail stores and restaurants include any processing of poultry products except canning of poultry products and except slaughtering of poultry unless such slaughtering is conducted at a retail store with respect to live poultry purchased by the consumer at the retail store and processed by the retail store operator in accordance with the consumer's instructions.
(ii) A normal retail quantity is any quantity of a poultry product purchased by a household consumer from a retail supplier that in the aggregate does not exceed 75 pounds. A normal retail quantity sold by a retail supplier to other than a household consumer is any quantity that in the aggregate does not exceed 150 pounds.
(iii) A retail store is any place of business where:
(a) The sales of poultry products are made to consumers only;
(b) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Administrator. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $500. Notice of the adjusted dollar limitation will be published in the
(c) Only federally or State inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;
(d) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and
(e) The processing of poultry products for sale is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Poultry products are processed only for sale or service in meals or as entrees directly to individual consumers at such establishments;
(2) Only federally inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;
(3) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and
(4) The processing of poultry products is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.
(b) The definition of a restaurant includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meets the requirements of this paragraph.
(c) For purposes of this paragraph, operations conducted as a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares poultry products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirement of this paragraph: Provided, That the requirements of §§ 381.175 through 381.178 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its poultry products are rendered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator's determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.
(v) A similar retail-type establishment is any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as prescribed in paragraph (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.
(vi) A consumer is any household consumer, hotel, or restaurant, or similar institution as determined by the Administrator in specific cases.
(3) Whenever any complaint is received by the Administrator from any person alleging that any retail establishment or restaurant claiming exemption under this paragraph (d) in any State or organized territory designated under both sections 5(c) and 11 of the Act as a jurisdiction that does not have or is not exercising adequate authority with respect to recordkeeping requirements, has been operated in violation of the conditions prescribed in this paragraph (d) for such exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail establishment or restaurant and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator determines that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail establishment or restaurant would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of his total monthly purchases and of his total monthly sales of poultry and poultry products. Such records shall separately show total sales to household consumers and total sales to other consumers, and shall be maintained for the period prescribed in § 381.177. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this subparagraph.
(4) The adulteration and misbranding provisions of the Act and the regulations other than the requirement of the official inspection legend, apply to articles which are exempted from inspection under this paragraph (d).
(e)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to poultry pizzas containing poultry product ingredients which were prepared, inspected, and passed in a cured or cooked form as ready-to-eat (i.e., no further cooking or other preparation is needed) in compliance with the requirements of the Act and these regulations; and the poultry pizzas are to be served in public or private nonprofit institutions, provided that the poultry pizzas are ready to eat (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to the receiving institution by employees of the preparing firm, receiving institution, or a food service management company contracted to conduct food service at the public or private nonprofit institution, without intervening transfer or storage.
(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the provisions of Chapters 2 through 8, except sections 2-102 (a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-203, and 6-105, Part IV, of the Food and Drug Administration's Food Service Sanitation Manual (1976 Recommendations), DHEW Publication No. (FDA) 78-2081, which is incorporated by reference, shall apply to the facilities and operations of businesses claiming this exemption. (These materials are incorporated as they exist on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(3) Facilities and operations of businesses claiming this exemption shall also conform to the following requirements:
(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing and sanitizing of utensils and equipment, a sink with not fewer than three compartments shall be provided and used. Sink compartments shall be large enough to permit the accommodation of the equipment and utensils, and each compartment of the sink shall be supplied with hot and cold potable running water. Fixed equipment and utensils and equipment too large to be cleaned in sink compartments shall be washed manually or cleaned through pressure spray methods.
(B) Drain boards or easily movable dish tables of adequate size shall be provided for proper handling of soiled utensils prior to washing and for cleaned utensils following sanitizing and shall be located so as not to interfere with the proper use of the dishwashing facilities.
(C) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil.
(D) Except for fixed equipment and utensils too large to be cleaned in sink compartments, manual washing, rinsing and sanitizing shall be conducted in the following sequence:
(1) Sinks shall be cleaned prior to use.
(2) Equipment and utensils shall be thoroughly washed in the first compartment with a hot detergent solution that is kept clean.
(3) Equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment.
(4) Equipment and utensils shall be sanitized in the third compartment according to one of the methods prescribed in paragraph (e)(3)(i)(E) (1) through (4) of this section.
(E) The food-contact surfaces of all equipment and utensils shall be sanitized by:
(1) Immersion for at least
(2) Immersion for at least 1 minute in a clean solution containing at least 50 parts per million of available chlorine as a hypochlorite and at a temperature of at least 75 °F; or
(3) Immersion for at least 1 minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and at a temperature of at least 75 °F; or
(4) Immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 that will provide the equivalent bactericidal effect of a solution containing at least 50 parts per million of available chlorine as a hypochlorite at a temperature of at least 75 °F for 1 minute; or
(5) Treatment with steam free from materials or additives other than those specified in 21 CFR 173.310 in the case of equipment too large to sanitize by immersion, but in which steam can be confined; or
(6) Rinsing, spraying, or swabbing with a chemical sanitizing solution of at least twice the strength required for that particular sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in the case of equipment too large to sanitize by immersion.
(F) When hot water is used for sanitizing, the following facilities shall be provided and used:
(1) An integral heating device or fixture installed in, on, or under the sanitizing compartment of the sink capable of maintaining the water at a temperature of at least 170 °F; and
(2) A numerically scaled indicating thermometer, accurate to ±3 °F, convenient to the sink for frequent checks of water temperature; and
(3) Dish baskets of such size and design to permit complete immersion of the tableware, kitchenware, and equipment in the hot water.
(G) When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted under 21 CFR 178.1010 and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.
(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils. These machines and devices shall be properly installed and maintained in good repair. Machines and devices shall be operated in accordance with manufacturers' instructions, and utensils and equipment placed in the machine shall be exposed to all dishwashing cycles. Automatic detergent dispensers, wetting agent dispensers, and liquid sanitizer injectors, if any, shall be properly installed and maintained.
(B) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than 15 nor more than 25 pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A
(C) Machine or water line mounted numerically scaled indicating thermometers, accurate to ±3 °F, shall be provided to indicate the temperature of the water in each tank of the machine and the temperature of the final rinse water as it enters the manifold.
(D) Rinse water tanks shall be protected by baffles, curtains, or other effective means to minimize the entry of wash water into the rinse water. Conveyors in dishwashing machines shall be accurately timed to assure proper exposure times in wash and rinse cycles in accordance with manufacturers' specifications attached to the machines.
(E) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of easily movable dishtables for the storage of clean utensils following sanitization.
(F) Equipment and utensils shall be flushed or scraped and, when necessary, soaked to remove gross food particles and soil prior to being washed in a dishwashing machine unless a prewashcycle is a part of the dishwashing machine operation. Equipment and utensils shall be placed in racks, trays, or baskets, or on conveyors, in a way that food-contact surfaces are exposed to the unobstructed application of detergent wash and clean rinse waters and that permits free draining.
(G) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washers) using chemicals for sanitization may be used: Provided, That,
(1) The temperature of the wash water shall not be less than 120 °F.
(2) The wash water shall be kept clean.
(3) Chemicals added for sanitization purposes shall be automatically dispensed.
(4) Utensils and equipment shall be exposed to the final chemical sanitizing rinse in accordance with manufacturers' specifications for time and concentration.
(5) The chemical sanitizing rinse water temperature shall be not less than 75 °F nor less than the temperature specified by the machine's manufacturer.
(6) Chemical sanitizers used shall meet the requirements of 21 CFR 178.1010.
(7) A test kit or other device that accurately measures the parts per million concentration of the solution shall be available and used.
(H) Machines using hot water for sanitizing may be used provided that wash water and pumped rinse water shall be kept clean and water shall be maintained at not less than the following temperatures:
(1) Single-tank, stationary-rack, dual-temperature machine:
(2) Single-tank, stationary-rack, single-temperature machine:
(3) Single-tank, conveyor machine:
(4) Multitank, conveyor machine:
(5) Single-tank, pot, pan, and utensil washer (either stationary or moving-rack):
(I) All dishwashing machines shall be thoroughly cleaned at least once a day or more often when necessary to maintain them in a satisfactory operating condition.
(iii) Steam. Steam used in contact with food or food-contact surfaces shall be free from any materials or additives other than those specified in 21 CFR 173.310.
(4) For purposes of this paragraph, the term “private nonprofit institution” means “a corporation, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals, no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation, and which does not participate in, or intervene in (including the publishing or distribution of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”
(5) The Administrator may withdraw or modify the exemption set forth in § 381.10(e)(1) for a particular establishment when he or she determines that such action is necessary to ensure food safety and public health. Before such action is taken, the owner or operator of the particular establishment shall be notified, in writing, of the reasons for the proposed action and shall be given an opportunity to respond, in writing, to the Administrator within 20 days after notification of the proposed action. The written notification shall be served on the owner or operator of the establishment in the manner prescribed in section 1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). In those instances where there is conflict of any material fact, the owner or operator of the establishment, upon request, shall be afforded an opportunity for a hearing with respect to the disputed fact, in accordance with rules of practice which shall be adopted for the proceeding. However, such withdrawal or modification shall become effective pending final determination in the proceeding when the Administrator determines that an imminent threat to food safety or public health exists, and that such action is, therefore, necessary to protect the public health, interest or safety. Such withdrawal or modification shall be effective upon oral or written notification, whichever is earlier, to the owner or operator of the particular establishment as promptly as circumstances permit. In the event of oral notification, written confirmation shall be given to the owner or operator of the establishment as promptly as circumstances permit. This withdrawal or modification shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(6) The adulteration and misbranding provisions of the Act and the regulations apply to articles which are exempted from inspection under § 381.10(e).
(a) Any person who slaughters, processes, or otherwise handles poultry or poultry products which have been or are to be processed as required by recognized religious dietary laws may apply for exemption from specific provisions of the Act or regulations which are in conflict with such religious dietary laws. Any person desiring such an exemption shall apply in writing to the Meat and Poultry Inspection Program, Food Safety and Inspection Service, Department of Agriculture, Washington, DC 20250, setting forth the specific provisions of the Act and the regulations from which exemption is sought and setting forth the provisions of the religious dietary laws in support of the requested exemption. In addition, the applicant for such an exemption shall submit a statement from the clerical official having jurisdiction over the enforcement of the religious dietary laws with respect to the poultry or poultry products involved, which identifies the requirements of such laws pertaining to the slaughter of the poultry and the processing or other handling of the poultry products involved, and certifies that such requirements are in conflict with specific provisions of the Act and regulations from which the exemption is sought.
(b) The Administrator, upon a determination that an exemption should be granted, will grant such exemption to the extent necessary to avoid conflict with the religious requirements while still effectuating the purposes of the Act. He may impose such conditions as to sanitary standards, practices, and procedures in granting such exemption as he deems necessary to effectuate the purposes of the Act. Any person who processes poultry or poultry products under exemption from certain requirements as provided in this section shall be subject to all of the other applicable provisions of the Act and the regulations. Processing plants shall meet the sanitary requirements set forth in this part and unless exempted from inspection under the provisions of this subpart, shall be required to qualify for inspection and operate as official establishments. Slaughtered poultry which is prepared under an exemption authorizing the sale of noneviscerated poultry in commerce shall be individually identified with a label approved by the Administrator which identifies the clerical official under whose supervision the poultry was slaughtered.
Whenever a slaughterer or processor is granted an exemption under § 381.11 with respect to the slaughtering or processing of any poultry or poultry products under this part, under specified conditions, the sale, offer for sale, transportation and other handling in commerce by any person of such poultry and poultry products in accordance with such conditions is hereby authorized, except as restricted by the Act.
(a) The Administrator may, by order, in accordance with the applicable rules of practice suspend or terminate any exemption under § 381.10(a) with respect to any person whenever he finds that such action will aid in effectuating the purposes of the Act. Failure to comply with the conditions of the exemption, including, but not limited to, failure to process poultry and poultry products under clean and sanitary conditions may result in termination of an exemption, in addition to any other penalties provided by law.
(b) Except as provided in § 381.10(c), the Administrator may extend the requirements of the Act to any establishment in any State or organized territory at which poultry products are processed for distribution solely within such jurisdiction if he determines in accordance with the provisions of subparagraph 5(c)(1) of the Act that the establishment is producing adulterated poultry products which would clearly endanger the public health.
Inspectors of the Inspection Service are authorized to make inspections in accordance with law to ascertain whether any of the provisions of the Act or the regulations applying to producers, retailers, or other persons purporting to be exempted from any requirements under this subpart have been violated.
The following articles contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry. Therefore said articles are exempted from the definition of “poultry product” and the requirements of the Act and the regulations applicable to poultry products, if they comply with the conditions specified in this section.
(a) Any human food product (in a consumer package) not provided for in paragraph (c) of this section, if:
(1) It contains less than 2 percent cooked poultry meat (deboned white or dark poultry meat, or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173;
(2) It contains less than 10 percent of cooked poultry skins, giblets, or fat, separately, and less than 10 percent of cooked poultry skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1) of this section) or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, in any combination;
(3) The poultry ingredients used in the product were prepared under inspection as defined in § 381.1, or were inspected under a foreign inspection system approved under § 381.196(b) and imported in compliance with the Act and the regulations;
(4) The immediate container of the product bears a label which shows the name of the product in accordance with this section; and
(5) The product is not represented as a poultry product. The aforesaid percentages of ingredients shall be computed on the basis of the moist, deboned, cooked poultry in the ready-to-serve product when prepared according to the serving directions on the consumer package.
(b) Any human food product (in an institutional pack), not provided for in paragraph (c) of this section, if:
(1) It is prepared for sale only to institutional users, such as hotels, restaurants, and boardinghouses, for use as a soup base or flavoring;
(2) It contains less than 15 percent cooked poultry meat (deboned white or dark poultry meat or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, computed on the basis of the moist deboned, cooked poultry meat and/or “Mechanically Separated (Kind of Poultry)” in such product; and
(3) It complies with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.
(c) Bouillon cubes, poultry broths, gravies, sauces, seasonings, and flavorings if:
(1) They contain poultry meat and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173 or poultry fat only in condimental quantities;
(2) They comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects; and
(3) In the case of poultry broth, it will not be used in the processing of any poultry product in any official establishment.
(d) Fat capsules and sandwiches containing poultry products if they comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.
(e) Products of the types specified in this section except those specified in paragraphs (c) and (d) of this section will be deemed to be represented as poultry products if the kind name of the poultry (chicken, turkey, etc.) is used in the product name of the product without appropriate qualification. For example, a consumer-packaged noodle soup product containing less than 2 percent chicken meat on a ready-to-serve basis may not be labeled “Chicken Noodle Soup” but, when appropriate, could be labeled as “Chicken Flavored Noodle Soup.” Products exempted under this section are subject to the requirements of the Federal Food, Drug, and Cosmetic Act.
The operator of each establishment of the kind required by § 381.6 to have inspection shall make application to the Administrator for inspection service. In cases of change of name, ownership, or location, a new application shall be made.
Every application for inspection at any establishment shall be made by the operator on a form furnished by the Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, and shall include all information called for by that form, including the name of any subsidiary corporation that will prepare any poultry product or conduct any other operation at the establishment for which inspection is requested. The applicant for inspection will be held responsible for compliance by all its subsidiaries with the requirements of the regulations at such establishments if inspection is granted. Processing of poultry products and other operations at the establishment for which inspection is granted may be conducted only by the applicant, except that such a subsidiary of the grantee, may conduct such operations at such establishment.
Any person applying for inspection service may be required at the discretion of the Administrator to demonstrate that the operator of the establishment authorized him to do so.
(a) Before inspection is granted, FSIS shall survey the establishment to determine if the construction and facilities of the establishment are in accordance with the regulations. FSIS will grant inspection, subject to § 381.21, when these requirements are met.
(b) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the establishment, including the limits of the establishment's premises, to which the grant pertains.
(a) Any application for inspection in accordance with this part may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(b)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters of the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended, to provide the Administrator with a certification as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless such certification has been obtained, or is waived because of failure or refusal of the State, interstate agency, or the Administrator of the Environmental Protection Agency to act on a request for certification within 1 year after receipt of such request. Further, upon receipt of an application for inspection and a certification as required by subsection 21(b) of the Federal Water Pollution Control Act, the Administrator (as defined in § 381.1) is required by paragraph (2) of said subsection to notify the Administrator of the Environmental Protection Agency for proceedings in accordance with that paragraph. No grant of inspection can be made until the requirements of said paragraph (2) have been met.
(2) However, certification under subsection 21(b) of the Federal Water Pollution Control Act is not initially required in connection with an application for inspection granted after April 3, 1970, for facilities existing or under construction on April 3, 1970, although certification for such facilities is required to be obtained within the 3-year period immediately following April 3, 1970. Failure to obtain such certification or to meet the other requirements of subsection 21(b) prior to April 3, 1973, will result in the termination of inspection at such facilities on that date.
(3) Further, any application for inspection pending on April 3, 1970, and granted within 1 year thereafter shall not require certification for 1 year following the grant of inspection but such grant of inspection shall terminate at the end of 1 year after its issuance unless prior thereto such certification has been obtained and the other requirements of subsection 21(b) are met.
(4) In the case of any activity which will affect water quality but for which there are no applicable water quality standards, no certification is required prior to the grant of inspection but such grant will be conditioned upon a requirement of compliance with the purpose of the Federal Water Pollution Control Act as provided in paragraph 21(b)(9) of said Act.
(a) Before being granted Federal inspection, an official establishment or an official import inspection establishment, must have developed written Sanitation Standard Operating Procedures, as required by part 416 of this chapter, and written recall procedures as required by part 418 of this chapter.
(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, in accordance with §§ 417.2 and 417.4 of this chapter. A conditional grant of inspection shall be issued for a period not to exceed 90 days, during which period the establishment must validate its HACCP plan.
(c) Before producing new product for distribution in commerce, an establishment shall have conducted a hazard analysis and developed a HACCP plan applicable to that product in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP plan, in accordance with § 417.4 of this chapter.
An official establishment number shall be assigned to each establishment granted inspection service. Such number shall be used to identify all containers of inspected poultry products prepared in the establishment. An establishment shall not have more than one establishment number.
Each official establishment shall be separate and distinct from any other official establishment and from any unofficial establishment except an establishment preparing meat products under the Federal Meat Inspection Act or under State meat inspection. Further, doorways, or other openings, may be permitted between establishments at the discretion of the Administrator and under such conditions as he may prescribe.
The inspector in charge or his supervisor shall, upon or prior to the inauguration of service, inform the operator of the establishment of the requirements of the regulations. If the establishment at the time service is inaugurated contains any poultry product which has not been inspected and marked in compliance with the regulations, its identity shall be maintained, and it shall not be represented or dealt with as a product which has been inspected. Such products may not be shipped in commerce unless such products are eligible for such shipment under an exemption from inspection under subpart C and comply with all requirements of said subpart.
Each inspector, agent, representative, or employee of the Inspection Service shall report, in the manner prescribed by the Administrator, all violations of the Act and noncompliance with the regulations of which he has knowledge.
[See § 300.6 of this chapter regarding access to establishments and other places of business.]
Each inspector will be furnished with a numbered official inspection badge, which shall remain in his or her possession at all times, and which shall be worn in such manner and at such times as the Administrator may prescribe.
(a) No inspector shall inspect any poultry or poultry product in which he, his spouse, minor child, partner, organization in which he is serving as officer, director, trustee, partner, or employee, or any person with whom he is negotiating or has any arrangement concerning prospective employment, is financially interested.
(b) All inspectors are subject to statutory restrictions with respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
(c) Violation of the provisions of paragraph (a) of this section or the provisions of applicable statutes referenced in paragraph (b) of this section will constitute grounds for dismissal in the case of appointees and for revocation of licenses in the case of licensees.
(d) Inspectors are subject to all applicable provisions of law and regulations and instructions of the Department and the Food Safety and Inspection Service and other authority concerning employee responsibilities and conduct. The setting forth of certain prohibitions in this part in no way limits the applicability of such general or other regulations or instructions.
Any person receiving inspection service may, if dissatisfied with any decision or action of an inspector or other Agency employee relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.
(a) Inspector's Office. Office space, including, but not being limited to furnishings, light, heat, and janitor service, shall be provided rent free in the official establishment, for the use of Government personnel for official purposes. The room or space set apart for this purpose must meet the approval of the Inspection Service and be conveniently located, properly ventilated, and provided with lockers or file cabinets suitable for the protection and storage of supplies and with facilities suitable for inspectors to change clothing. At the discretion of the Administrator, small plants requiring the services of less than one full-time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Each official establishment shall provide commercial laundry service for inspectors' outer work clothing, or disposable outer work garments designed for one-time use, or uniform rental service garments which are laundered by the rental service.
(b) Facilities for ante mortem inspection. A suspect pen is required for adequate ratite inspection.
(c) Facilities for the Streamlined Inspection System (SIS). The following requirements for lines operating under SIS are in addition to the normal requirements to obtain a grant of inspection. The requirements for SIS in § 381.76(b) also apply.
(1) The following provisions shall apply to every inspection station:
(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (c)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 4 feet along the conveyor line for the inspector, and 4 feet for the establishment helper. A total of at least 8 feet along the conveyor line shall be supplied for one inspection station and 16 feet for two-inspection stations.
(iii) Selectors or “kickouts” shall be installed in establishments with two inspection stations on a line so each inspector will receive birds on 12-inch centers with no intervening birds to impede inspection. The selector must move the bird to the edge of the trough for the inspector and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid swinging when entering the inspection station.
(iv) Each inspector's station shall have a platform that is slip-resistant and can be safely accessed by the inspector. The platform shall be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform shall be a minimum length of 4 feet and have a minimum width of 2 feet; the platform shall be designed with a 42-inch high rail on the back side and with
(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(vi) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.
(vii) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index value of 85 where the birds are inspected to facilitate inspection.
(viii) Online handrinsing facilities with a continuous flow of water must be provided for and within easy reach of each inspector and each establishment helper. The hand-contact element must be rinsed automatically with a sufficient volume of water to remove all fat, tissue, debris, and other extraneous material from the hand contact element after each use. Both hot and cold running water shall be available at each inspection station on the eviscerating line and shall be delivered through a suitable mixing device controlled by the inspector. Alternatively, water for hand washing shall be delivered to such inspection stations at a minimum temperature of 65 degrees F.
(ix) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.
(x) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to prechill and postchill reinspection stations:
(i) Floor space shall consist of a minimum of 3 feet along each conveyor line and after each chiller to allow carcasses to be removed for evaluation. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.
(iii) A table, at least 2 feet wide, 2 feet deep, and 3 feet high designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(iv) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index of 85 on the table surface shall be provided.
(v) A separate clip board holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and shall be within easy access of persons working at the stations.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(d) Facilities for the New Line Speed (NELS) inspection system. The following requirements for lines operating under the NELS inspection system are in addition to the normal requirements to obtain a grant of inspection and to the requirements for NELS in § 381.76 (b) and (c).
(1) The following provisions shall apply to every inspection station:
(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (d)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 6 feet along the conveyor line for the establishment employee presenting the birds, 4 feet for the inspector, and 4 feet for the establishment helper. A total of at least 42 feet along the conveyor line shall be supplied for three inspection stations.
(iii) Selectors or “kickouts” shall be installed so the three inspection stations will receive birds on 18-inch centers with no intervening birds to impede inspection. The selector must move the bird to the end of the trough for the presenter, inspector, and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid splashing the mirror (paragraph (d)(1)(vii) of this section) and swinging when entering the inspection station. Guide bars shall not extend in front of the inspection station mirror to avoid obstructing the inspector's view.
(iv) Each inspector's station shall have an easily and rapidly adjustable platform, with a minimum of 14 inches of vertical adjustment, which covers the entire length of the station (4 feet) and has a minimum width of 2 feet. The platform shall be designed with a 42-inch high rail on the back side and with
(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(vi) A trough shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.
(vii) A distortion-free mirror, at least 3 feet wide and 2 feet high, shall be mounted at each inspection station so that it can be adjusted between 5 and 15 inches behind the shackles, tilt up and down, tilt from side to side, and be raised and lowered. The mirror shall be positioned in relation to the inspection platform so that the inspector can position himself/herself opposite it 8 to 12 inches from the downstream edge. The mirror must be maintained abrasion free.
(viii) A minimum of 200-footcandles of shadow-free lighting with minimum color rendering index value of 85
(ix) “One-line” handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment presenter and helper.
(x) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.
(xi) Each inspection station shall be provided with receptacle for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection station:
(i) Floor space shall consist of 6 feet along the conveyor line. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.
(iii) A table, at least 3 feet wide and 2 feet deep, shall be provided for reinspecting the sample birds.
(iv) A minimum of 200-footcandles of shows free lighting with a minimum color rendering index of 85
(v) A separate clip board holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and shall be within easy reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(e) Facilities for the New Turkey Inspection (NTI) System. The following requirements for lines operating under the NTI System are in addition to the normal requirements to obtain a grant of inspection and to the requirements for the NTI System in § 381.76 (b) and (c).
(1) The following provisions apply to every inspection station:
(i) The conveyor line must be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (e)(1)(iii) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 8 feet along the conveyor line; at least 4 feet for the inspector, and at least 4 feet for the establishment helper.
(iii) The inspector's station shall have an easily and rapidly adjustable platform with a minimum width of 2 feet which covers the entire length of the station (4 feet). The platform must adjust vertically a minimum of 14 inches, and must have a 42-inch rail on the back side and
(iv) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(v) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be wide enough to prevent trimmings, drippage, and debris from accumulation on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to prevent contamination of carcasses by splash.
(vi) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85
(vii) On-line handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment helper.
(viii) Hangback racks shall be provided for and within easy reach of the establishment helper.
(ix) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection station:
(i) Floor space shall consist of a minimum of 3 feet along the conveyor line so carcasses can be removed from each line for evaluation. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.
(iii) A table at least 3 feet wide and 2 feet deep designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(iv) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85
(v) A clipboard holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and within easy reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at this station.
(f) Facilities for post-mortem inspection under the New Poultry Inspection System. The following facilities requirements apply to establishments operating under the New Poultry Inspection System and are in addition to the requirements for obtaining a grant of inspection.
(1) The following provisions apply to the online carcass inspection station:
(i) On each production line, at a point before the chiller and after the establishment has completed all sorting, trimming, and reprocessing activities necessary to comply with § 381.76(b)(6)(ii), at least 4 feet of floor space along the conveyor line must be provided for one online carcass inspection station.
(ii) The conveyor line must be level for the entire length of the online carcass inspection station. The vertical distance from the bottom of the shackles to the top of the platform (paragraph (f)(1)(iii) of this section) must not be less than 60 inches.
(iii) Each online carcass inspection station must have a platform that is slip-resistant and can be safely accessed by the inspector. The platform must be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform must be a minimum length of 4 feet and have a minimum width of 2 feet. The platform must be designed with a 42-inch high rail on the back side and with
(iv) Conveyor line stop/start switches must be located within easy reach of the online carcass inspector.
(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85 must be provided where the birds are inspected to facilitate online carcass inspection.
(vi) Hand rinsing facilities must be provided for use by and within easy reach of the online carcass inspector. The hand rinsing facilities must have a continuous flow of water or be capable of being immediately activated and deactivated in a hands-free manner, must minimize any splash effect, and must otherwise operate in a sanitary manner that prevents contamination of carcasses and inspector clothing. The hand rinsing facilities must provide water at a temperature between 65 and 120 degrees Fahrenheit.
(vii) A separate clipboard holder for holding recording sheets must be provided for and within easy reach of the online carcass inspector.
(viii) Receptacles for condemned carcasses and parts that comply with the performance standards in § 416.3(c) of this chapter must be provided at each online carcass inspection station.
(ix) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the online carcass inspector.
(x) A buzzer shall be located within easy reach of the online carcass inspector to be used by the carcass inspector to alert the inspector-in-charge, offline inspectors, or establishment management of conditions that require their attention.
(2) The following provisions apply to pre-chill and post-chill offline verification inspection stations:
(i) One or more offline verification inspection stations must be located at the end of the line or lines prior to the chiller. One or more offline verification inspection stations must also be located after the chiller or chillers. The Agency will determine the total number of offline verification inspection stations needed in establishments having more than one processing line or more than one chiller.
(ii) Floor space for all offline verification inspection stations must consist of a minimum of 3 feet along each conveyor line and after each chiller, as applicable, to allow carcasses to be removed for evaluation by the verification inspector. The space must be level and protected from all traffic and overhead obstructions.
(iii) At the pre-chill location, the vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.
(iv) At each offline verification inspection station, a table designed to be readily cleanable and drainable must be provided for offline verification inspectors to conduct offline verification activities. At turkey slaughter establishments, the table must be at least 3 feet wide, 2 feet deep, and 3 feet high. At all other poultry slaughter establishments, the table must be at least 2 feet wide, 2 feet deep, and 3 feet high
(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface must be provided.
(vi) The establishment must provide a separate clipboard holder for holding recording sheets; or alternatively, the establishment may provide electronic means for the offline verification inspector to record inspection results.
(vii) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the offline verification inspector.
(viii) Hand washing facilities must be provided within easy access of all offline verification inspection stations.
(3) [Reserved]
(4) A trough or other similar drainage facility must extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splashing.
(a) No operations requiring inspection shall be conducted except under the supervision of an Inspection Service employee. All eviscerating of poultry and further processing shall be done with reasonable speed, considering the official establishment's facilities.
(b) A shift is a regularly scheduled operating period, exclusive of mealtime. One lunch period is the only official authorized interruption in the inspector's tour of duty once it begins. Lunch periods may be 30 minutes, 45 minutes, or in any case may not exceed one hour in duration. Once established, the lunch period must remain relatively constant as to time and duration. Lunch periods for inspectors shall not, except as provided herein, occur prior to 4 hours after the beginning of scheduled operations nor later than 5 hours after operations begin. In plants where a company rest break of not less than 30 minutes is regularly observed, approximately midpoint between start of work and the lunch period, and the inspector is allowed this time to meet his personal needs, the lunch period may be scheduled as long as 5
(c) Official establishments, importers, and exporters shall be provided inspection service, without charge, up to 8 hours per shift during the basic workweek subject to the provisions of § 381.38: Provided, That any additional shifts meet requirements as determined by the Administrator or his designee. The basic workweek shall consist of 5 consecutive 8-hour days within the administrative workweek Sunday through Saturday, except that, when possible, the Department shall schedule the basic workweek so as to consist of 5 consecutive 8-hour days Monday through Friday. The 8-hour day excludes the lunch period but shall include activities deemed necessary by the Agency to fully carry out an inspection program, including the time for FSIS inspection program personnel to put on required gear, pick up required forms and walk to a work station; and the time for FSIS inspection program personnel to return from a work station, drop off required forms, and remove required gear; and to conduct duties scheduled by FSIS, including administrative duties. The Department may depart from the basic workweek in those cases where maintaining such a schedule would seriously handicap the Department in carrying out its functions. These provisions are applicable to all official establishments except in certain cases as provided in § 381.145(h) of this subchapter.
(d)(1) Each official establishment shall submit a work schedule to the area supervisor for approval. In consideration of whether the approval of an establishment work schedule shall be given, the area supervisor shall take in account the efficient and effective use of inspection personnel. The work schedule must specify the workweek, daily clock hours of operation, and lunch periods for all departments of the establishment requiring inspection.
(2) Establishments shall maintain consistent work schedules. Any request by an establishment for a change in its work schedule involving changes in the workweek or an addition or elimination of shifts shall be submitted to the area supervisor at least 2 weeks in advance of the proposed change. Frequent requests for change shall not be approved: Provided, however, Minor deviations from a daily operating schedule may be approved by the inspector in charge if such request is received on the day preceding the day of change.
(3) Requests for inspection service outside an approved work schedule shall be made as early in the day as possible for overtime work to be performed within that same workday; or made prior to the end of the day's operation when such a request will result in overtime service at the start of the following day: Provided, That an inspector may be recalled to his assignment after the completion of his daily tour of duty under the provisions of § 381.39(b).
(a) The management of an official establishment, an importer, or an exporter shall reimburse the Program, at the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday specified in paragraph (b) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.
(b) Holidays for Federal employees shall be New Year's Day, January 1; Birthday of Martin Luther King, Jr., the third Monday in January; Washington's Birthday, the third Monday in February; Memorial Day, the last Monday in May; Independence Day, July 4; Labor Day, the first Monday in September; Columbus Day, the second Monday in October; Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in November; Christmas Day, December 25. When any of the above-listed holidays falls outside the basic workweek, the nearest workday within that week shall be the holiday.
(a) Each recipient of overtime or holiday inspection service, or both, shall be billed as provided for in § 381.38(a) and at the rate specified in § 391.3, in increments of quarter hours. For billing purposes, 8 or more minutes shall be considered a full quarter hour. Billing will be for each quarter hour of service rendered by each Inspection Service employee.
(b) Official establishments, importers, or exporters requesting and receiving the services of an Inspection Service employee after he has completed his day's assignment and left the premises, or called back to duty during any overtime or holiday period, shall be billed for a minimum of 2 hours overtime or holiday inspection service at the established rate.
(c) Bills are payable upon receipt and become delinquent 30 days from the date of the bill. Overtime or holiday inspection will not be performed for anyone having a delinquent account.
Each establishment that participates in the New Poultry Inspection System (NPIS) shall submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers, and that the program includes the following elements:
(a) Policies to encourage early reporting of symptoms of injuries and illnesses, and assurance that it has no policies or programs in place that would discourage the reporting of injuries and illnesses.
(b) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms.
(c) Monitoring on a regular and routine basis of injury and illness logs, as well as nurse or medical office logs, workers' compensation data, and any other injury or illness information available.
Should a court of competent jurisdiction hold any provision of this part 381, subpart H to be invalid, such action shall not affect any other provision of this part 381.
(a) Operations and procedures involving the processing, other handling, or storing of any poultry product must be strictly in accord with clean and sanitary practices and must be conducted in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry products that are not adulterated.
(b) Poultry must be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Blood from the killing operation must be confined to a relatively small area.
(c) When thawing frozen ready-to-cook poultry in water, the establishment must use methods that prevent adulteration of, or net weight gain by, the poultry.
(d) The water used in washing the poultry must be permitted to drain freely from the body cavity.
(e) Detached ova may be collected for human food and handled only in accordance with 9 CFR 590.44 and may leave the establishment only to be moved to an official egg product processing plant for processing. Ova from condemned carcasses must be condemned and treated as required in § 381.95.
(f) Procedures for controlling visible fecal contamination. Official poultry slaughter establishments must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with visible fecal material do not enter the chiller. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
(g) Procedures for controlling contamination throughout the slaughter and dressing operation. Official poultry slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. At a minimum, these procedures must include sampling and analysis for microbial organisms in accordance with the sampling location and frequency requirements in paragraphs (g)(1) and (2) of this section to monitor their ability to maintain process control.
(1) Sampling locations. Establishments, except for very small establishments operating under Traditional Inspection or very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the pre-chill and post-chill points in the process. Very small establishments operating under Traditional Inspection and very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the post-chill point in the process.
(i) Very small establishments are establishments with fewer than 10 employees or annual sales of less than $2.5 million.
(ii) Very low volume establishments annually slaughter no more than 440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, or 60,000 squabs.
(2) Sampling frequency. (i) Establishments, except for very low volume establishments as defined in paragraph (g)(1)(ii) of this section, must, at a minimum, collect and analyze samples at a frequency proportional to the establishment's volume of production at the following rates:
(A) Chickens. Once per 22,000 carcasses, but a minimum of once during each week of operation.
(B) Turkeys, ducks, geese, guineas, and squabs. Once per 3,000 carcasses, but at a minimum once each week of operation.
(ii) Very low volume establishments as defined in paragraph (g)(1)(ii) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, a very low volume establishment can demonstrate that it is effectively maintaining process control, it may modify its sampling plan.
(iii) Establishments must sample at a frequency that is adequate to monitor their ability to maintain process control for enteric pathogens. Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (h) of this section.
(h) Recordkeeping requirements. Official poultry slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under paragraph (g) of this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS.
(a) General. Temperatures and procedures that are necessary for chilling and freezing ready-to-cook poultry, including all edible portions thereof, must be in accordance with operating procedures that ensure the prompt removal of the animal heat, preserve the condition and wholesomeness of the poultry, and assure that the products are not adulterated.
(b) Chilling performance standards, except for ratites. (1)(i) Each official poultry slaughter establishment must ensure that all poultry carcasses, parts, and giblets are chilled immediately after slaughter operations so that there is no outgrowth of pathogens, unless such poultry is to be frozen or cooked immediately at the official establishment.
(ii) Previously chilled poultry carcasses and major portions must be kept chilled so that there is no outgrowth of the pathogens, unless such poultry is to be packed and frozen immediately at the official establishment.
(2) After product has been chilled, the establishment must prevent the outgrowth of pathogens on the product as long as the product remains at the establishment.
(3) The establishment must develop, implement, and maintain written procedures for chilling that address, at a minimum, the potential for pathogen outgrowth, the conditions affecting carcass chilling, and when its chilling process is completed. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program.
(c) Ice and water chilling. (1) Only ice produced from potable water may be used for ice and water chilling, except that water and ice used for chilling may be reused in accordance with § 416.2(g). The ice must be handled and stored in a sanitary manner.
(2)(i) Poultry chilling equipment must be operated in a manner consistent with meeting the applicable pathogen reduction performance standards for raw poultry products as set forth in § 381.94 and the provisions of the establishment's HACCP plan.
(ii) Major portions of poultry carcasses, as defined in § 381.170(b)(22), may be chilled in water and ice.
(d) Water absorption and retention. (1) Poultry washing, chilling, and draining practices and procedures must be such as will minimize water absorption and retention at time of packaging.
(2) The establishment must provide scales, weights, identification devices, and other supplies necessary to conduct water tests.
(e) Air chilling. Air chilling is the method of chilling raw poultry carcasses and parts predominately with air. An antimicrobial intervention may be applied with water at the beginning of the chilling process, provided that its use does not result in any net pick-up of water or moisture during the chilling process. The initial antimicrobial intervention may result in some temperature reduction of the product, provided that the majority of temperature removal is accomplished exclusively by chilled air.
(f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled with descriptive terms such as “fresh frozen,” “quick frozen” or “frozen fresh” or any other term implying a rapid change from a fresh state to a frozen state shall be placed into a freezer within 48 hours after initial chilling in accordance with paragraph (b) of this section. During this period, if such poultry is not immediately placed into a freezer after chilling and packaging, it shall be held at 36 °F. or lower.
(2) Ready-to-cook poultry shall be frozen in a manner so as to bring the internal temperature of the birds at the center of the package to 0 °F. or below within 72 hours from the time of entering the freezer. Such procedures shall not apply to raw poultry product described in § 381.129(b)(6)(i) of this subchapter.
(3) Upon written request, and under such conditions as may be prescribed by the Administrator, in specific cases, ready-to-cook poultry which is to be frozen immediately may be moved from the official establishment prior to freezing: Provided, That the plant and freezer are so located and such necessary arrangements are made that the Inspection Service will have access to the freezing room and adequate opportunity to determine compliance with the time and temperature requirements specified in paragraph (f)(2) of this section.
(4) Warm packaged ready-to-cook poultry which is to be chilled by immediate entry into a freezer within the official establishment shall within 2 hours from time of slaughter be placed in a plate freezer or a freezer with a functioning circulating air system where a temperature of −10 °F. or lower is maintained.
(5) Frozen poultry shall be held under conditions which will maintain the product in a solidly frozen state with temperature maintained as constant as possible under good commercial practice.
The maximum number of birds to be inspected by each inspector per minute under the traditional inspection procedure for the different young chicken and squab slaughter line configurations are specified in the following table. These maximum rates will not be exceeded. The inspector in charge will be responsible for reducing production line rates where in the inspector's judgment the prescribed inspection procedure cannot be adequately performed within the time available, either because the birds are not presented by the official establishment in such a manner that the carcasses, including both internal and external surfaces and all organs, are readily accessible for inspection, or because the health conditions of a particular flock dictate a need for a more extended inspection procedure. The standards in 381.170(a) of this part specify which classes of birds constitute young chickens and squabs. Section 381.76(b) specifies when either the traditional inspection procedure or the modified traditional inspection procedure can or must be used.
Maximum Production Line Rates—Chickens and Squabs-Traditional Inspection Procedures
| Line configuration 1 | Number of inspection stations | Birds per inspector per minute |
|---|---|---|
| 6-1 | 1 | 25 |
| 12-1 | 2 | 23 |
| 12-2 | 2 | 21 |
| 18-1 | 3 | 19 |
| 18-2 | 3 | 19 |
| 18-3 | 3 | 18 |
| 24-1 | 4 | 16
|
| 24-2 | 4 | 16 |
| 24-4 | 4 | 15
|
1 Birds are suspended on the slaughter line at 6-inch intervals. The first number indicates the interval in inches between the birds that each inspector examines. The second number indicates how many of the birds presented, the inspector is to inspect, i.e., “1” means inspect every bird. “4” means inspect every fourth bird, etc.
(a) The maximum inspection rates for one inspector New Turkey Inspection (NTI-1 and NTI-1 Modified) and two inspectors New Turkey Inspection (NTI-2 and NTI-2 Modified) are listed in the table below. The line speeds for NTI-1 and NTI-2 are for lines using standard 9-inch shackles on 12-inch centers with birds hung on every shackle and opened with J-type or Bar-type opening cuts. The line speeds for NTI-1 Modified and NTI-2 Modified are for Bar-type cut turkey lines using a shackle with a 4-inch by 4-inch selector (or kickout), a 45 degree bend of the lower 2 inches, an extended central loop portion of the shackle that lowers the abdominal cavity opening of the carcasses to an angle of 30 degrees from the vertical in direct alignment with the inspector's view, and a width of 10.5 inches. Maximum rates for those establishments having varying configurations will be established by the Administrator but will not exceed those in the table. Neither the rates in the table nor those established for establishments with varying configurations shall be exceeded under any circumstances.
(b) There are two categories of turkeys for determining inspection rates, “light turkeys” and “heavy turkeys”. Light turkeys are all turkeys weighing less than 16 pounds. Heavy turkeys are all turkeys weighing 16 pounds or more. The weights refer to the bird at the point of post-mortem inspection, with blood, feathers and feet removed.
(c) The inspector in charge may reduce inspection line rates when in his/her judgment the prescribed inspection procedure cannot be adequately performed within the time available because the health conditions of a particular flock or other factors, including the manner in which birds are being presented to the inspector for inspection and the level of contamination among the birds on the line, dictate a need for a more extended inspection.
Maximum Turkey Inspection Rates
| Inspection system | Line configuration | Number of inspectors | Birds/minute | |||
|---|---|---|---|---|---|---|
| J-Type | Bar-Type | |||||
| (<16#)
light | (>16#)
1
heavy | (<16#)
light | (>16#)
1
heavy | |||
| NTI-1 | 12-1 | 1 | 32 | 30 | 25 | 21 |
| NTI-2 | 2 24-2 | 2 | 51 | 41 | 45 | 35 |
| NTI-1 Modified | 12-1 | 1 | — | — | 32 | 30 |
| NTI-2 Modified | 2 24-2 | 2 | — | — | 51 | 41 |
1 This weight refers to the bird at the point of post-mortem inspection without blood or feet.
2 The turkeys are suspended on the slaughter line at 12-inch intervals with two inspectors each looking at alternating birds at 24-inch intervals.
(a) The maximum line speed for young chicken slaughter establishments that operate under the New Poultry Inspection System is 140 birds per minute.
(b) The maximum line speed for turkey slaughter establishments that operate under the New Poultry Inspection System is 55 birds per minute.
(c) Notwithstanding paragraphs (a) and (b) of this section, establishments that operate under the New Poultry Inspection System must reduce their line speed as directed by inspectors-in-charge. Inspectors-in-charge are authorized to direct establishments to operate at a reduced line speed when in their judgment a carcass-by-carcass inspection cannot be adequately performed within the time available due to the manner in which the birds are presented to the online carcass inspector, the health conditions of a particular flock, or factors that may indicate a loss of process control.
(d) Establishments operating under the line speed limits authorized in this section shall comply with all other applicable requirements of the laws, including, but not limited to, 29 U.S.C. 654(a).
(a) An ante mortem inspection of poultry shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made of poultry on the day of slaughter in any official establishment.
(b) The examination and inspection of ratites will be on the day of slaughter, except:
(1) When it is necessary for humane reasons to slaughter an injured animal at night or on a Sunday or holiday, and the FSIS veterinary medical officer cannot be obtained; or
(2) In low volume establishments, when ante mortem inspection cannot be done on the day of slaughter, and the birds to be slaughtered have received ante mortem inspection in the last 24 hours, provided the establishment has an identification and control system over birds that have received ante mortem inspection.
(a) Birds plainly showing on ante mortem inspection any disease or condition, that under §§ 381.80 to 381.93, inclusive, would cause condemnation of their carcasses on post mortem inspection, shall be condemned. Birds which on ante mortem inspection are condemned shall not be dressed, nor shall they be conveyed into any department of the official establishment where poultry products are prepared or held. Poultry which has been condemned on ante mortem inspection and has been killed or died otherwise shall under the supervision of an inspector of the Inspection Service, be disposed of as provided in § 381.95.
(b) Dead-on-arrival ratites and ratites condemned on ante mortem inspection will be tagged “U.S. Condemned” by an establishment employee under FSIS supervision and disposed of by one of the methods prescribed in § 381.95.
(c) All seriously crippled ratites and non-ambulatory ratites, commonly termed “downers,” shall be identified as “U.S. Suspects.”
(d) Ratites exhibiting signs of drug or chemical poisoning shall be withheld from slaughter.
(e) Ratites identified as “U.S. Suspects” or “U.S. Condemned” may be set aside for treatment. The “U.S. Suspect” or “U.S. Condemned” identification device will be removed by an establishment employee under FSIS supervision following treatment if the bird is found to be free of disease. Such a bird found to have recovered from the condition for which it was treated may be released for slaughter or for purposes other than slaughter, provided that in the latter instance permission is first obtained from the local, State, or Federal sanitary official having jurisdiction over movement of such birds.
(f) When it is necessary for humane reasons to slaughter an injured ratite at night or Sunday or a holiday, and the Agency veterinary medical officer cannot be obtained, the carcass and all parts shall be kept for inspection, with the head and all viscera except the gastrointestinal tract held by the natural attachment. If all parts are not so kept for inspection, the carcass shall be condemned. If on inspection of a carcass slaughtered in the absence of an inspector, any lesion or other evidence is found indicating that the bird was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante mortem inspection, or if there is lacking evidence of the condition that rendered emergency slaughter necessary, the carcass shall be condemned. Ratites that are sick, dying, or that have been treated with a drug or chemical and presented for slaughter before the required withdrawal period, are not covered by emergency slaughter provisions.
(a) All birds, except ratites, that on ante mortem inspection do not plainly show, but are suspected of being affected with, any disease or condition that under §§ 381.80 to 381.93 of this Part may cause condemnation in whole or in part on post mortem inspection, shall be segregated from the other poultry and held for separate slaughter, evisceration, and post mortem inspection. The inspector shall be notified when such segregated lots are presented for post mortem inspection, and inspection of such birds shall be conducted separately. Such procedure for the correlation of ante mortem and post mortem findings by the inspector, as may be prescribed or approved by the Administrator, shall be carried out.
(b) All ratites showing symptoms of disease will be segregated, individually tagged as “U.S. Suspects” by establishment personnel under FSIS supervision with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Suspect,” and held for further examination by an FSIS veterinarian. Depending upon the findings of the veterinarian's examination, these birds will either be passed for regular slaughter, slaughtered as suspects, withheld from slaughter, or condemned on ante mortem. Those ratites affected with conditions that would be readily detected on post mortem inspection need not be individually tagged on ante mortem inspection with the “U.S. Suspect” tag provided that such ratites are segregated and otherwise handled as “U.S. Suspects.” All ratites identified as “U.S. Condemned” shall be tagged by establishment personnel, under FSIS supervision, with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Condemned.”
If live poultry, which is affected by any contagious disease which is transmissible to man, is brought into an official establishment, such poultry shall be segregated. The slaughtering of such poultry shall be deferred and the poultry shall be dealt with in one of the following ways:
(a) If it is determined by a veterinary inspector that further handling of the poultry will not create a health hazard, the lot shall be slaughtered separately, subject to ante mortem and post mortem inspection pursuant to the regulations.
(b) If it is determined by a veterinary inspector that further handling of the poultry will create a health hazard, such poultry may be released for treatment under the control of an appropriate State or Federal agency. If the circumstances are such that release for treatment is impracticable, a careful bird-by-bird ante mortem inspection shall be made, and all birds found to be, or which are suspected of being, affected with a contagious disease transmissible to man shall be condemned.
When any poultry at an official establishment is suspected of having been treated with or exposed to any substance that may impart a biological residue that would make their edible tissues adulterated, they shall, at the option of the operator of the establishment, be processed at the establishment and the carcasses and all parts thereof retained under U.S. Retained tags, pending final disposition in accordance with § 381.80, of this part, and other provisions in subpart K; or they shall be slaughtered at the establishment and buried or incinerated in a manner satisfactory to the inspector. Alternatively, such poultry may be returned to the grower, if further holding is likely to result in their not being adulterated by reason of any residue. The Inspection Service will notify the other Federal and State agencies concerned of such action. To aid in determining the amount of residue present in the poultry, officials of the Inspection Service may permit the slaughter of any such poultry for the purpose of collecting tissues for analysis of the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of poultry.
(a) No poultry used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless the operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Inspection Service, or the Veterinary Biologics unit of Veterinary Services, Animal and Plant Health Inspection Service of the Department or the Environmental Protection Agency, or the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such poultry being adulterated, and the Administrator has approved such slaughter.
(a) A post-mortem inspection shall be made on a bird-by-bird basis on all poultry eviscerated in every official establishment. Each carcass, or all parts comprising such carcass, must be examined by an inspector, except for parts that are not needed for inspection purposes and are not intended for human food and are condemned. Each carcass eviscerated shall be prepared as ready-to-cook poultry.
(b)(1) There are six systems of post-mortem inspection: the New Poultry Inspection System (NPIS), which may be used for young chickens and turkeys; the Streamlined Inspection System (SIS) and the New Line Speed Inspection System (NELS), both of which may be used only for broilers and cornish game hens; the New Turkey Inspection (NTI) System, which may be used only for turkeys; Traditional Inspection, which may be used for all poultry, except for ratites; and Ratite Inspection.
(i) The SIS shall be used only for broilers and cornish game hens if:
(a) The Administrator determines that SIS will increase inspector efficiency; or
(b) The operator requests SIS and the Administrator determines that the system will result in no loss of inspection efficiency.
(ii) The NELS Inspection System shall be used only for broilers and cornish game hens if:
(a) The operator requests the NELS Inspection System, and
(b) The Administrator determines that the establishment has the intent and capability to operate at line speeds greater than 70 birds per minute, and meets all the facility requirements in § 381.36(d).
(iii) The NTI System shall be used only for turkeys if:
(a) The operator requests it, and
(b) The Administrator determines that the establishment meets all the facility requirements in § 381.36(e).
(iv) The NPIS may be used for young chickens and turkeys if the official establishment requests to use it and meets or agrees to meet the requirements of paragraph (b)(6) of this section and the Administrator approves the establishment's request. The Administrator may permit establishments that slaughter classes of poultry other than young chickens and turkeys to operate under the New Poultry Inspection System under a waiver from the provisions of the regulations as provided in § 381.3(b).
(v) Traditional Inspection shall be used for turkeys when neither the NTI System nor the NPIS is used. For other classes of poultry, Traditional Inspection shall be used when SIS, NELS, and the NPIS are not used.
(2) Official establishments that operate under Traditional Inspection, SIS, NELS, NTI, or Ratite Inspection must meet the following requirements:
(i) No viscera or any part thereof may be removed from any poultry processed in any official establishment, except at the time of post-mortem inspection, unless its identity with the rest of the carcass is maintained in a manner satisfactory to the inspector until such inspection is made.
(ii) Each carcass to be eviscerated must be opened so as to expose the organs and the body cavity for proper examination by the inspector.
(iii) If a carcass is frozen, it must be thoroughly thawed before being opened for examination by an inspector.
(3) The following requirements are applicable to SIS:
(i) Definitions. For purposes of this paragraph, the following definitions shall apply:
(a) Cumulative sum (CUSUM). A statistical concept used by the establishment and monitored by the inspector whereby compliance is determined based on sample results collected over a period of time. For purposes of determining compliance with the finished product standards, the CUSUM is equal to the sum of prior test results plus the weighted result of the current test minus the tolerance, with the condition that the resulting CUSUM cannot go below zero.
(b) Tolerance number. A weighted measure that equates to product being produced at a national product quality level. See Table 2.
(c) Action number. A level reached by the CUSUM where the process is out of control and product action is required by the establishment or the inspector. See Table 2.
(d) “Start number”. A value halfway between zero and the action number. The start number is used to determine the starting CUSUM for the first subgroup of a shift and to reset the CUSUM value if the CUSUM is equal to or greater than the action number. See Table 2.
(e) Subgroup. A 10-bird sample collected before product enters the chiller and after product leaves the chiller.
(f) Subgroup absolute limit. The tolerance number plus 5. See Table 2.
(g) Prechill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system.
(h) Postchill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected as the product leaves the chilling system.
(i) Rework. Reprocessing the product to correct the condition or conditions causing the nonconformances listed in Table 1.
(ii) General. (a) Under SIS, one inspector inspects the outside, inside, and viscera of each bird. There may be two inspectors on one processing line, each inspecting every other bird. For the establishment to run its processing line(s) at maximum speed, optimal conditions must be maintained so that inspection may be conducted efficiently. The inspector in charge determines the speed at which each processing line may be operated to permit inspection. A variety of conditions may affect this determination including the health of each flock and the manner in which birds are being presented to the inspector for inspection.
(b) SIS may be performed by one inspector (SIS-1) or two inspectors (SIS-2). SIS-1 requires that the establishment provide one inspection station for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-1 is 35 birds per minute. SIS-2 requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-2 is 70 birds per minute.
(c) Under all inspection systems, including SIS, inspectors conduct post-mortem inspection and look for a number of conditions, as specified elsewhere in this subpart, which may indicate adulteration. Adulterated product is condemned and destroyed, except that carcasses and parts which may be made unadulterated by reprocessing (reworking) may be so reprocessed under the supervision of an inspector and reinspected. Under SIS, inspectors also reinspect product by sampling finished birds (both before and after chilling) for nonconformances with finished product standards (see Table 1). If such nonconformances are present at certain statistical levels, it may indicate process difficulties requiring corrective action by the establishment. If the establishment does not take adequate corrective action, the inspector shall initiate corrective actions such as conducting closer post-mortem inspections and requiring reprocessing and reinspection of previously processed carcasses and parts. Thus, SIS is conducted in two phases—a post-mortem inspection phase and a reinspection phase. The following paragraphs describe the inspection requirements (not addressed elsewhere in this subpart) under each.
(iii) Post-mortem inspection. (a) Facilities: Each inspection station must comply with the facility requirements in § 381.36(c).
(b) Presentation: Each inspector shall be flanked by an establishment employee assigned to be the inspector's helper. The one inspector on the SIS-1 line shall be presented every bird. Each inspector on the SIS-2 line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented.
(c) Disposition: The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to trim and reinspection. Carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after all giblets are harvested and prior to reinspection.
(iv) Reinspection. (a) Facilities: Reinspection stations are required at both the prechill and postchill locations. The Agency will determine the number of stations needed in those establishments having more than one processing line or more than one chiller. One or more prechill reinspection stations shall be conveniently located at the end of the line or lines prior to chilling. One or more postchill stations must be conveniently located at the end of the chiller or chillers. The prechill and postchill reinspection stations must meet the following provisions:
(1) Floor space shall consist of 3 feet along each conveyor line. The space shall be level and protected from all traffic and overhead obstructions.
(2) A table at least 2 feet wide and 2 feet deep and 3 feet in height designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(3) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface.
(4) A separate clip board holder shall be provided for holding the recording sheets.
(5) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(b) Disposition: An inspector shall monitor the establishment's application of the Finished Product Standards program and shall take corrective action including retaining product to prevent adulterated product from leaving the establishment when the inspector determines that the establishment has failed to apply the program as prescribed in paragraph (b)(3)(iv)(c) of this section).
(c) Finished Product Standards: Finished Product Standards (FPS) are criteria applied to processed birds before and after chill to ensure that the product being produced is consistently wholesome and unadulterated. These criteria consist of nonconformances (listed in Table 1), the incidence of which is determined from 10 bird subgroup samples, reduced to a CUSUM number, and measured against the standards (Table 2). The standards are applied to permit the Agency to estimate when the production process is in control and when it is out of control. The establishment is responsible for maintaining FPS which, in turn, is monitored by the inspector. FPS is applied in two separate parts. The first is called prechill testing. It is designed to ensure that the slaughter and evisceration procedures are in control. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system. The second part of the FPS is called postchill testing. It is designed to monitor the production through the chill system to ensure that it meets the postchill FPS. This test is independent of the prechill test. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples as they exit the chilling system. When the system is operating within compliance, the establishment applies the FPS to product samples at the prechill reinspection station. Testing time and time between tests are such that birds represented by the test are still within the chiller. If an out-of-compliance condition is found, the product leaving the chiller is segregated for rework and retested before it may proceed into commerce. A second 10 bird subgroup sample of the birds is taken after they leave the chiller to ensure that the product meets the postchill FPS. Since the product is closer to the end of processing, the controls on releasing reworked product are stricter than controls under prechill testing, again to ensure that no adulterated product enters into commerce.
(d) Prechill testing. The prechill FPS have been divided into processing and trim categories. The processing category is designed to monitor the output of the dressing and evisceration procedures. The trim category monitors the establishment's ability to remove unwholesome lesions and conditions from inspected and passed carcasses. Each category is monitored independently of the other category using a separate CUSUM for each category.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall:
(A) Randomly select and record subgroup sampling times for each production unit of time before product reaches the prechill reinspection station on the production line. In no case shall the time between tests exceed 1 hour of production time.
(B) Conduct a 10-bird subgroup test at a random time on each poultry slaughter line. These times are preselected by the establishment and available to the inspector prior to the start of the shift/day's operations. All 10 samples of the subgroup shall be collected at the random time.
(C) Obtain the weighted value of each nonconformance by multiplying the number recorded for each nonconformance by the “factor” in Table 1, sum the total of all the nonconformances, and calculate the CUSUM value for that test.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for monitoring subgroup tests for each half-shift on the evisceration line. In establishments that have multiple evisceration lines on a production shift, monitor all lines of product at the random times.
(B) Collect the subgroup samples to be monitored at preselected times. All 10 samples of the subgroup shall be collected at the random time selected in paragraph (b)(3)(iv)(d)(1)(ii)(A) of this section.
(C) Conduct the 10-bird monitoring subgroup test.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5 (T + 5), the establishment shall determine if any of the immediate past 5 plant prechill subgroups for that category (processing or trim) resulted in a CUSUM above the start number.
(i) If all of the past 5 plant prechill subgroups are at or below the start number, the establishment shall immediately conduct a retest subgroup on that category of prechill to determine sample validity. If retest subgroup total equals tolerance or less, the establishment resumes random time testing. If the retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section. In either case, the prechill retest results will be used to calculate CUSUM.
(ii) If any of the past 5 plant prechill subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section.
(3) Actions to be taken when a trimmable lesion/condition is found. If either inspection or plant monitoring finds any trimmable lesion or condition as specified in item B(7) of Table 1 during a prechill subgroup test, the establishment shall immediately conduct an additional prechill subgroup test for the same trimmable lesion/condition category. This is a requirement on the subgroup testing for the prechill trim nonconformance that is in addition to the CUSUM test described in paragraph (b)(3)(iv)(d)(1) of this section.
(i) If no additional item in the same category is found on retest, the establishment shall resume random time sampling.
(ii) If an additional item in the same category is found on retest, the establishment shall proceed as if CUSUM reaches the action number and shall initiate corrective action set forth in paragraph (b)(3)(iv)(d)(4) of this section for this category only.
(4) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Immediately notify the inspector in charge and the production supervisor responsible for the affected evisceration line.
(B) Suspend random time prechill testing of the affected nonconformance category (processing or trim). Suspend random time postchill subgroup testing when the processing category is the affected nonconformance category.
(C) Conduct subgroup retests on carcasses leaving the chill system. Apply the prechill criteria in Table 1 (A) or (B), depending upon which category caused the action, and apply prechill Finished Product Standards as listed in Table 2 to determine product compliance. In no case shall the time between retests exceed 30 minutes of production time. Apply prechill standard criteria at the postchill location after notifying the establishment's production supervisor. If any of these subgroup retests on product leaving the chill system result in a subgroup total exceeding tolerance, identify for rework subsequent product at the postchill location. All noncomplying product will be brought into compliance prior to release into commerce. Product from the chiller will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) Conduct additional subgroup tests at the prechill reinspection station to determine the adequacy of production corrective action. If the prechill tests results in a subgroup total exceeding the tolerance, notify the production supervisor. The number of additional tests at the postchill reinspection station using prechill standards is increased as required to include the product in the chiller represented by this additional prechill test.
(E) After two consecutive additional prechill subgroup tests result in subgroup totals equal to or less than tolerance:
—Resume random time prechill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(d)(1) of this section.
—Identify product entering the chill system that will mark the end of the retest action upon arrival at the postchill sampling location. Such identification may include tagging or empty space in chillers, depending upon the establishment's identification method.
—Once all product identified as needing retesting has arrived at the postchill sampling location, random time postchill FPS testing resumes.
—If two consecutive additional prechill subgroup tests demonstrate process control with subgroup totals equal to or less than tolerance, but they do not cause CUSUM to fall to the start line or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions by making spot-check observations to ensure that all program requirements are met.
(e) Postchill testing. Postchill subgroups shall be collected after the product leaves the chiller but before the product is divided into separate processes. Each bird sampled shall be observed and its conformance measured against the postchill criteria. The subgroup nonconformance weights shall be totaled and the CUSUM calculated by subtracting the tolerance from the sum of the subgroup total and the starting CUSUM.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall conduct a 10-bird subgroup test for each chiller system at a randomly selected time of production. In no case shall the time between tests exceed 2 hours of production time.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for postchill monitoring.
(B) Monitor each chill system twice per shift.
(C) Conduct subgroup tests at preselected random times.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5(T + 5), the establishment shall determine if any of the last 5 postchill monitoring subgroups resulted in a CUSUM above the start number.
(i) If all of the past 5 postchill monitoring subgroups resulted in a CUSUM at or below the start number, the establishment shall immediately retest a subgroup to determine sample validity. If this retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(ii) If any of the past 5 postchill monitoring subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(3) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Notify the inspector in charge and the production supervisor responsible for product in the chiller.
(B) Suspend random time postchill subgroup testing.
(C) Immediately conduct an additional postchill subgroup test. If the retest subgroup total exceeds tolerance, the establishment shall identify subsequent product for rework. Product will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) After two consecutive additional postchill subgroup tests results in subgroup totals equal to or less than tolerance:
—Resume random time postchill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(e)(1) of this section.
—If the two consecutive additional postchill subgroup totals equal to or less than tolerance do not cause CUSUM to fall to the start number or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions to ensure that program requirements are met.
(v) When the prechill or postchill product has been identified as having been produced when the process was not in control, additional online subgroup testing by the establishment is required to determine its conformance to the standard. If any of the additional plant subgroup testing results in a subgroup total exceeding tolerance, offline product corrective actions must take place. The responsibilities of the establishment and the inspector change depending on the CUSUM.
All corrective actions such as identifying affected product, segregating product, and maintaining control through rework actions are the establishment's responsibility. Corrective actions by the inspector depends upon the establishment's ability to control rework of affected product. If the establishment fails in its responsibilities, the inspector will identify, segregate, and retain affected product to prevent adulterated product from reaching consumers.
(a) Offline product. The establishment shall identify the affected product so that it may be segregated and accumulated offline for rework. The inspector shall spot check the establishment's identification, segregation, and control of reworked product to ensure that program requirements are met.
(b) Reworked product. Reworked product must be tested by the establishment with a randomly selected subgroup test of the accumulated reworked lot. Before product is released, the random subgroup test must result in a subgroup total equal to or less than tolerance. If the subgroup test of a reworked lot results in a subgroup total exceeding tolerance, the lot must be reworked again before another subgroup is selected. The following actions are required.
(1) Establishment Actions. The establishment shall:
(i) Select the random subgroup from throughout the lot only after the total lot has been reworked.
(ii) Conduct the subgroup test using the same criteria (prechill or postchill) that resulted in the rework action.
(iii) Release the lot if the reworked subgroup test resulted in a subgroup total equal to or less than tolerance.
(iv) Identify and control the lot to be reworked if the reworked subgroup total again exceeds tolerance.
(2) Inspector Actions: The inspector shall spot check the rework procedure to ensure that plant monitoring and production meet the requirements of the program.
(vi) After the 10 bird subgroup tests are completed, the prechill and postchill processing nonconformances shall be corrected on all bird samples prior to returning the samples to the product flow. Samples with trim nonconformances shall be returned to the trim station for correction prior to their return to the product flow.
Table 1—Definitions of Nonconformances
| A Processing Nonconformances |
| 1 Extraneous material ≤
|
| —Include any specks, tiny smears, or stains of material that measure
|
| Examples: Ingesta, unattached feathers, grease, bile remnants, and/or whole gall bladder or spleen, embryonic yolk, etc. |
| —Factor is one. |
| —1 to 5 = 1 defect: 6 to 10 = 2 defects; 11 or more = 3 defects. A maximum of three incidents per carcass. |
| 2 Extraneous material >
|
| —The same material as line 1, but measuring >
|
| —Factor is one. |
| —A maximum of three incidents per carcass. |
| 3 Extraneous material >1″ |
| —The same material as lines 1 to 2, but measuring greater than one inch. |
| —Factor is two. |
| —A maximum of two incidents per carcass. |
| 4 Oil glands remnant—less than two whole glands |
| —Recognizable fragment(s) of one or both oil glands equals one incident. |
| —Factor is one. |
| —Maximum of one incident per carcass. |
| 5 Oil glands—two whole glands |
| —Both whole oil glands with no missing fragments equals one incident. If the oil glands are cut, but no fragment is removed, consider them to be whole. But if even a small fragment is removed, use line 4. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 6 Lung ≥
|
| —Any portion less than a whole lung, and equal to or greater than
|
| —Factor is one. |
| —A maximum of two incidents per carcass. |
| 7 Lung—whole |
| —Each whole lung equals one incident. |
| —Factor is two. |
| —A maximum of two incidents per carcass. |
| 8 Intestine |
| —Any identifiable portion of the terminal portion of the intestinal tract with a lumen (closed circle) present, or split piece of intestine large enough to be closed to form a lumen. |
| —Factor is five. |
| —A maximum of one incident per carcass. |
| 9 Cloaca |
| —Any identifiable portion of the terminal portion of the intestinal tract with mucosal lining. |
| —Factor is five. |
| —A maximum of one incident per carcass. |
| 10 Bursa of Fabricius |
| —A whole rosebud, or identifiable portion with two or more mucosal folds. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 11 Esophagus |
| —Any portion of the esophagus with identifiable mocosal lining. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 12 Crop—partial—with mucosa |
| —Any portion of the crop that includes the mucosal lining. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 13 Crop—whole |
| —Any complete crop. |
| —Factor is five. |
| —A maximum of one incident per carcass. |
| 14 Trachea ≤1″ |
| —Identifiable portion of trachea less than or equal to one inch long. |
| —Factor is one. |
| —A maximum of one incident per carcass. |
| 15 Trachea >1″ |
| —Identifiable portion of trachea greater than one inch. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 16 Hair ≥
|
| —Hair which is one-fourth inch long or longer measured from the top of the follicle to the end of the hair. 26 or more hairs equal one incident. |
| —Factor is one. |
| —A maximum of one incident per carcass. |
| 17 Feather and/or Pinfeathers ≤1″ |
| —Attached feathers or protruding pinfeathers less than or equal to one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15 per carcass as two incidents, and 16 or more as three incidents. |
| —Factor is one. |
| —A maximum of three incidents per carcass. |
| 18 Feathers >1″ |
| —Attached feathers longer than one inch. Scored 1 to 3 per carcass as one incident 4 to 6 per carcass as two incidents, and 7 or more as three incidents. |
| —Factor is one. |
| —A maximum of three incidents per carcass. |
| 19 Long Shank—both condyles covered |
| —If the complete tibiotarsal joint is covered, it equals one incident. |
| —Factor is two. |
| —A maximum of two incidents per carcass. |
| B Trim nonconformances |
| 1 Breast blister |
| —Inflammatory tissue, fluid, or pus between the skin and keel must be trimmed if membrane “slips” or if firm nodule is greater than
|
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 2 Breast blister—partially trimmed |
| —All inflammatory tissue, including that which adheres tightly to the keel bone, must be removed. |
| —Factor is two. |
| —A maximum of one incident per carcass. |
| 3 Bruise
|
| —Blood clumps or clots in the superficial layers of tissue, skin, muscle or loose subcutaneous tissue may be slit and the blood completely washed out. When the bruise extends into the deeper layers of muscle, the affected tissue must be removed. Very small bruises less than
|
| —Factor is one. |
| —A maximum of five incidents per carcass. |
| 4 Bruise >1″ |
| —Same criteria as in line three, but greater than one inch in greatest dimension. |
| —Factor is two. |
| —A maximum of three incidents per carcass. |
| 5 Bruise black/green
|
| —Bruises
|
| —Factor is two. |
| —A maximum of three incidents per carcass. |
| 6 Bruise Black/green >1″ |
| —Same as line 5, but measuring greater that 1″ in greatest dimension. |
| —Factor is five. |
| —A maximum of two incidents per carcass. |
| 7 Trimmable lesions/Condition |
| —A trimmable tumor or identifiable portion of a tumor on any part of the carcass. |
| —Trimmable Synovitis/airsacculitis (saddle/frog) lesions that have not been removed. |
| —Lesion/condition subject to removal following an approved cleanout process. Examples: airsacculitis, salpingitis, nephritis, spleen, or liver conditions requiring removal of the kidneys. |
| Note: All establishments shall develop and maintain a permanent marking system that identifies carcasses with removable lesions/conditions on the inside surfaces. When removable lesions/conditions are identified inside the carcass by the inspector, the helper will be notified to apply the permanent mark. When removable inside lesions/conditions are found on a subgroup sample without the permanent mark, the error is not recorded in line 7. The affected carcass(s) will be hungback for IIC disposition and corrective action. |
| —Factor is five. |
| —A maximum of one incident per carcass. |
| 8 Failure to complete task as indicated by marking system. |
| Example: Synovitis, airsacculitis, inflammatory process, contamination, etc. |
| —The helper, under the inspector's direction, will apply a mark to the carcass, indicating to the trimmer(s) that specific action must be taken on that carcass. When airsac and kidney cleanout, or synovitis part removal, or carcass removal from the line is not completed, or only partially completed, this occurrence is recorded as one defect. |
| —Factor is five. It will also be recorded as a line 7 defect for a total factor of 10. |
| —A maximum of one incident per carcass. |
| 9 Compound fracture |
| —Any bone fracture (i.e., leg or wing) that has caused an opening through the skin. May be accompanied with a bruise, but not always. Do not count the bruise in line 3 or 4 if it is associated with the compound fracture. |
| —Factor is two. |
| —A maximum of three incidents per carcass. |
| 10 Wingtip compound fracture |
| —Same criteria as line 9, but only for wingtips. |
| Note: Bruises not associated with the fracture should be recorded in the appropriate lines. |
| —Factor is one. |
| —A maximum of two incidents per carcass. |
| 11 Untrimmed short hock |
| —When no cartilage of the hock surface is present and no tendons are attached to the bone. |
| —Factor is two. |
| —A maximum of two incidents per carcass. |
| 12 Sores, scabs, inflammatory process, etc. ≤
|
| —Any defects such as sores, abscesses, scabs, wounds, dermatitis, inflammatory process, that measure less than or equal to
|
| —Factor is two. |
| —A maximum of two incidents per carcass. |
| 13 Sores, scabs, inflammatory process, etc. >
|
| —Same as line 12, but greatest dimension is greater than
|
| —Factor is five. |
| —A maximum of one incident per carcass. |
| 14 External mutilation |
| —Mutilation to the skin and/or muscle that is caused by the slaughter, dressing or eviscerating processes. Skinned elbows (bucked wings) do not trim require unless affected wing joint capsule is also opened. |
| —Factor is one. |
| —A maximum of three incidents per carcass. |
| C Postchill nonconformances—(Designed to monitor those nonconformances added to product during the chilling process) |
| 1 Extraneous material ≤
|
| —Include specks, grease, or unidentifiable foreign material that measure
|
| —Example: Ingesta, grease, or unidentifiable foreign material. |
| —Factor is one. |
| —3 to 7 = 1 defect; 8 to 12 = 2 defects; 13 or more = 3 defects. A maximum of three incidents per carcass. |
| 2 Extraneous material >
|
| —This includes ingesta, grease, or unidentifiable foreign material measureing >
|
| —Factor is one. |
| —A maximum of three incidents per carcass. |
| 3 Extraneous material >1″ |
| —The same material as line 2, but measuring greater than one inch. |
| —Factor is two. |
| —A maximum of two incidents per carcass. |
Table 2—Finished Product Standards
| SIS | |
|---|---|
| Prechill Processing Nonconformance | |
| Tolerance number (T) | 25 |
| Subgroup Absolute Limit (T + 5) | 30 |
| Action number | 22 |
| Start number | 11 |
| Prechill Trim Nonconformance | |
| Tolerance number (T) | 12 |
| Subgroup Absolute Limit (T + 5) | 17 |
| Action number | 15 |
| Start number | 8 |
| Postchill Nonconformance | |
| Tolerance number (T) | 5 |
| Subgroup Absolute Limit (T + 5) | 10 |
| Action number | 10 |
| Start number | 5 |
(4) The following requirements are also applicable to NELS inspection:
(i) Inspection under NELS is conducted in two phases, as post-mortem inspection phase and a reinspection phase.
(a) Post-mortem inspection. The establishment shall provide three inspection stations on each eviscerating line in compliance with the facility requirements § 381.36(d)(1). The three inspectors shall inspect the inside, viscera, and outside of all birds presented. Each inspector shall be flanked by two establishment employees—the presenter and the helper. The presenter shall ensure that the bird is properly eviscerated and presented for inspection and the viscera uniformly trailing or leading. The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Poultry carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming or birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after giblet harvest and prior to reinspection.
(b) A reinspection station shall be located at the end of each line. This station shall comply with the facility requirements in § 381.36(d)(2). The inspector shall ensure that the establishment has performed the indicated trimming of carcasses passed subject to reinspection by visually monitoring, checking data, or gathering samples at the station or at other critical points on the line.
(ii)-(iii) [Reserved]
(iv) The maximum inspection rate for NELS shall be 91 birds per minute per eviscerating line.
(5) The following requirements are also applicable to the NTI System:
(i) Inspection under the NTI System is conducted in two phases, a post-mortem inspection phase and a reinspection phase. The NTI-1 Inspection System requires that the establishment provide one inspection station for each line and adequate reinspection facilitiates so carcasses can be removed from each line for evaluation. The NTI-2 Inspection System requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation.
(a) Post-mortem inspection. Each inspection station must comply with the facility requirements in § 381.36(e)(1). Each inspector shall be flanked by and establishment employee assigned to be the inspector's helper. The one inspector on an NTI-1 Inspection System shall be presented every bird. Each inspector on an NTI-2 Inspection System line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented. The inspector shall determine which bird shall be salvaged, reprocessed, condemned, retained for disposition by a veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Turkey carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after the giblet harvest and prior to reinspection.
(b) Reinspection. A reinspection station shall be located at the end of the lines. This station shall comply with the facility requirements in § 381.36(e)(2). The inspector shall ensure that establishments have performed the indicated trimming of each carcass passed subject to reinspection by visually monitoring, checking data, and/or sampling product at the reinspection station and, if necessary, at other points, critical to the wholesomeness of product, on the eviscerating line.
(ii)-(iii) [Reserved]
(6) The following requirements are applicable to the NPIS:
(i) Facilities. The establishment must comply with the facilities requirements in § 381.36(f).
(ii) Carcass sorting and disposition. (A) The establishment must conduct carcass with associated viscera sorting activities, dispose of carcasses and parts exhibiting condemnable conditions, and conduct appropriate trimming and reprocessing activities before carcasses are presented to the online carcass inspector.
(B) Any carcasses removed from the line for reprocessing activities or salvage must be returned to the line before the online carcass inspection station. The establishment must include in its written HACCP plan, or sanitation SOP, or other prerequisite program a process by which parts, other than parts identified as “major portions” as defined in § 381.170(b)(22), are available for inspection offline after reprocessing or salvage.
(C) The establishment must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with septicemic and toxemic conditions do not enter the chiller. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program. These procedures must cover, at a minimum, establishment sorting activities required under paragraph (b)(6)(ii) of this section.
(D) The establishment must maintain records to document that the products resulting from its slaughter operation meet the definition of ready-to-cook poultry in § 381.1. These records are subject to review and evaluation by FSIS personnel.
(iii) Presentation for online carcass inspection. To ensure the online carcass inspector may properly inspect every carcass, the establishment must present carcasses as follows:
(A) Each carcass, except carcasses and parts identified as “major portions” under 9 CFR 381.179(b)(22), must be held by a single shackle;
(B) Both hocks of each carcass must be held by the shackle;
(C) The back side of the carcass must be faced toward the inspector;
(D) There must be minimal carcass swinging motion;
(E) The establishment must ensure that it can sufficiently identify viscera and parts corresponding with each carcass inspected by the online carcass inspector so that if the carcass inspector condemns a carcass all corresponding viscera and parts are also condemned.
Each carcass, including all parts thereof, in which there is any lesion of disease, or other condition which might render such carcass or any part thereof adulterated and with respect to which a final decision cannot be made on first examination by the inspector, shall be held for further examination. The identity of each such carcass, including all parts thereof, shall be maintained until a final examination has been completed.
(a) At the time of any inspection under this subpart each carcass, or any part thereof, which is found to be adulterated shall be condemned, except that any such articles which may be made not adulterated by reprocessing, need not be so condemned if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated.
(b) When a lot of poultry suspected of containing biological residues is inspected in an official establishment, all carcasses and any parts of carcasses in such lot which are condemned shall be kept separate from all other condemned carcasses or parts.
Each carcass and all organs and other parts of carcasses which are found to be not adulterated shall be passed for human food.
(a) The carcasses or parts of carcasses of all poultry inspected at an official establishment and found at the time of post mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this subpart, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or conditions and to designate at just what stage a disease process results in an adulterated article, the decision as to the disposal of all carcasses, organs or other parts not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the Inspection Service laboratory for diagnosis.
(b) All carcasses, organs, or other parts of carcasses of poultry shall be condemned if it is determined on the basis of a sound statistical sample that they are adulterated because of the presence of any biological residues.
Carcasses of poultry affected with tuberculosis shall be condemned.
Carcasses of poultry showing evidence of any septicemic or toxemic disease, or showing evidence of an abnormal physiologic state, shall be condemned.
Carcasses of poultry with evidence of extensive involvement of the air sacs with airsacculitis or those showing airsacculitis along with systemic changes shall be condemned. Less affected carcasses may be passed for food after complete removal and condemnation of all affected tissues including the exudate.
Carcasses of poultry showing evidence of any disease which is characterized by the presence, in the meat or other edible parts of the carcass, or organisms or toxins dangerous to the consumer, shall be condemned.
Any organ or other part of a carcass which is affected by an inflammatory process shall be condemned and, if there is evidence of general systemic disturbance, the whole carcass shall be condemned.
(a) Tumors, including those possibly caused by avian leukosis complex, may be trimmed from any affected organ or other part of a carcass where there is no evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor. Trimmed carcasses otherwise found to be not adulterated shall be passed as human food.
(b) Any organ or other part of a carcass which is affected by a tumor where there is evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor, must be condemned.
Organs or other parts of carcasses which are found to be infested with parasites, or which show lesions of such infestation shall be condemned and, if the whole carcass is affected, the whole carcass shall be condemned.
Any part of a carcass which is badly bruised shall be condemned and, if the whole carcass is affected as a result of the bruise, the whole carcass shall be condemned. Parts of a carcass which show only slight reddening from a bruise may be passed for food.
Carcasses of poultry showing evidence of having died from causes other than slaughter shall be condemned.
(a) Carcasses of poultry contaminated by volatile oils, paints, poisons, gases, scald vat water in the air sac system, or other substances which render the carcasses adulterated shall be condemned. Any organ or other part of a carcass which has been accidentally multilated in the course of processing shall be condemned, and if the whole carcass is affected, the whole carcass shall be condemned.
(b) Any carcass of poultry accidentally contaminated during slaughter with digestive tract contents need not be condemned if promptly reprocessed under the supervision of an inspector and thereafter found not to be adulterated. Contaminated surfaces that are cut must be removed only by trimming. Contaminated inner surfaces that are not cut may be cleaned by trimming alone or may be re-processed as provided in subparagraph (b)(1) or (2) of this section.
(1) Online reprocessing. Poultry carcasses accidentally contaminated with digestive tract contents may be cleaned by applying an online reprocessing antimicrobial intervention to all carcasses after evisceration and before the carcasses enter the chiller if the parameters for use of the antimicrobial intervention system have been approved by the Administrator. Establishments must incorporate procedures for the use of any online reprocessing antimicrobial intervention system into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
(2) Offline reprocessing. Contaminated inner surfaces that are not cut may be cleaned at an approved reprocessing station away from the main processing line by any method that will remove the contamination, such as vacuuming, washing, and trimming, singly or in combination. All visible specks of contamination must be removed, and if the inner surfaces are reprocessed other than solely by trimming, all surfaces of the carcass must be treated with chlorinated water containing 20 ppm to 50 ppm available chlorine or another approved antimicrobial substance in accordance with the parameters approved by the Administrator. Establishments must incorporate procedures for the use of any offline reprocessing into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
Carcasses of poultry which have been overscalded, resulting in a cooked appearance of the flesh, shall be condemned.
Carcasses of poultry deleteriously affected by post mortem changes shall be disposed of as follows:
(a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned.
(b) Any part of a carcass which is green struck shall be condemned and, if the carcass is so extensively affected that removal of affected parts is impracticable, the whole carcass shall be condemned.
(c) Carcasses affected by types of post mortem change which are superficial in nature may be passed for human food after removal and condemnation of the affected parts.
(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters ratites shall test for Escherichia coli Biotype I (E. coli). Establishments that slaughter ratites and livestock, shall test the type of ratites or livestock slaughtered in the greatest number. The establishment shall:
(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and
(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.
(2) Sampling requirements. (i) Written procedures. Each establishment that slaughters ratites shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request.
(ii) Sample collection. The establishment must collect samples from whole ratites at the end of the chilling process. Samples from ratites may be collected by sponging the carcass on the back and thigh or samples can be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird.
(iii) Sampling frequency. Establishments that slaughter ratites, except very low volume ratite establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the establishment's volume of production at the following rate: 1 sample per 3,000 carcasses, but at a minimum one sample each week of operation.
(iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with § 417.2(b) of this chapter may substitute an alternative frequency for the frequency of sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls.
(v) Sampling in very low volume ratite establishments. (A) Very low volume ratite establishments annually slaughter no more than 6,000 ratites. Very low volume ratite establishments that slaughter ratites in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June of the following year or until 13 samples have been collected, whichever comes first.
(B) Upon the establishment's meeting the requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or by FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the three tube Most Probable Number (MPN) method and agreeing with the 95 percent upper and lower confidence limit of the appropriate MPN index.
(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of colony forming units (CFU)/ml of rinse fluid. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.
(5) Establishments shall evaluate E. coli test results using statistical process control techniques.
(6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.
(7) Failure to test and record. Inspection will be suspended in accordance with rules of practice that will be adopted for such proceeding, upon a finding by FSIS that one or more provisions of paragraphs (a) (1) through (4) of this section have not been complied with and written notice of same has been provided to the establishment.
(b) [Reserved]
All condemned carcasses, or condemned parts of carcasses, or other condemned poultry products, except those condemned for biological residues shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service. (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishment.)
(a) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat, for a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. (Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection by means of pipes, or otherwise, between tanks containing inedible products and those containing edible products.)
(b) Incineration or complete destruction by burning.
(c) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of:
(1) Crude carbolic acid,
(2) Kerosene, fuel oil, or used crankcase oil, or
(3) Any phenolic disinfectant conforming to commercial standards CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or solution.
(d) Any other substance or method that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section.
(e) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (b) of this section or by burying under the supervision of an inspector.
Except as otherwise provided in this subpart, the official inspection legend required to be used with respect to inspected and passed poultry products shall include wording as follows: “Inspected for wholesomeness by U.S. Department of Agriculture.” This wording shall be contained within a circle. The form and arrangement of such wording shall be exactly as indicated in the example in Figure 1, except that the appropriate official establishment number shall be shown, and if the establishment number appears elsewhere on the labeling material in the manner prescribed in § 381.123(b), it may be omitted from the inspection mark. The administrator may approve the use of abbreviations of such inspection mark; and such approved abbreviations shall have the same force and effect as the inspection mark. The official inspection legend, or the approved abbreviation thereof, shall be printed on consumer packages and other immediate containers of inspected and passed poultry products, or on labels to be securely affixed to such containers of such products and may be printed or stenciled thereon, but shall not be applied by rubber stamping. When applied by a stencil, the legend shall not be less than 4 inches in diameter. An official brand must be applied to inspected and passed carcasses and parts of ratites that are shipped unpacked.
The official mark for use in sealing means of conveyance used in transporting poultry products under any requirement in this part shall be the inscription and a serial number as shown below, and any seals approved by the Administrator for applying such mark shall be an official device.
The official marks for use in post-mortem inspection and identification of adulterated products, insanitary equipment and facilities are:
(a) A paper tag (a portion of Form MP-35) bearing the legend “U.S. Retained” for use on poultry or poultry products under this section.
(b) A paper tag (another portion of Form C&MS 510) bearing the legend “U.S. Rejected” for use on equipment, utensils, rooms and compartments under this section.
The detention tag prescribed in § 381.211 is an official device.
The term “U.S. Condemned” as shown below is an official mark and the devices used by the Department for applying such mark are official devices.
Upon request by the operator of the establishment, the inspector in charge shall issue a poultry condemnation certificate (Form MP-514-1), showing the total number of poultry in the lot and the numbers condemned and the reasons for such condemnations.
The official poultry condemnation certificate authorized by this subpart is a paper certificate (Form MP-514-1), for signature by an inspector, bearing the legend
The export inspection mark required in § 381.105 must be either a mark that contains a unique identifier that links the consignment to the export certificate or an official mark with the following form:
When authorized by inspection personnel, establishments must mark the outside container of any inspected and passed product for export, the securely enclosed pallet within the consignment, or closed means of conveyance transporting the consignment, with a mark that contains a unique identifier that links the consignment to the export certificate or an official mark as described in § 381.104. Ship stores, small quantities exclusively for the personal use of the consignee and not for sale or distribution, and shipments by and for the U.S. Armed Forces, are exempt from the requirements of this section.
(a) Exporters must apply for export certification of inspected and passed products to any foreign country. Exporters may apply for an export certificate using a paper or electronic application. FSIS will assess exporters that submit an electronic application the charge in § 362.5(e) of this chapter.
(b) FSIS will issue only one certificate for each consignment, except in the case of error in the certificate or loss of the certificate originally issued. A request for a replacement certificate, except in the case of a lost certificate, must be accompanied by the original certificate. The new certificate will carry the following statement: “Issued in replacement of ______”, with the numbers of the certificates that have been superseded.
(c) FSIS will deliver a copy of the certificate to the person who requested such certificate or his agent. Such persons may duplicate the certificate as required in connection with the exportation of the product.
(d) FSIS will retain a copy of the certificate.
(e) Exporters may request inspection personnel to issue certificates for export consignments of product of official establishments not under their supervision, provided the consignments are first identified as having been “U.S. inspected and passed,” are found to be neither adulterated nor misbranded, and are marked as required by § 381.105.
When export certificates are required by any foreign country for poultry products exported to such country, the Administrator shall in specific cases prescribe or approve the form of export certificate to be used and the methods and procedures he deems appropriate with respect to the processing of such products, in order to comply with requirements specified by the foreign country regarding the export products. Inspectors shall satisfy themselves that all such requirements are met before issuing such an export certificate. It shall be the responsibility of the exporter to provide any unofficial documentation needed to meet the foreign requirements, before the export certificate will be issued. Such certificates may also cover articles exempted from definition as a poultry product under § 381.15 if they have been inspected and are certified under the regulations in part 362 of this chapter.
(a) Upon the request of an interested party, any veterinary inspector is authorized to issue an official poultry inspection certificate with respect to any lot of slaughtered poultry inspected by him. At any official establishment each such certificate shall be signed by the inspector who made the inspection covered by the certificate, and if more than one inspector participated in the inspection of the lot of poultry, each such inspector shall sign the certificate with respect to such lot. If the inspection of a lot covered by a certificate was made by a food inspector, such certificate shall also be signed by the inspector in charge when such inspection was made. Any inspector is authorized to issue a poultry inspection certificate with respect to any other poultry product inspected by him.
(b) The original and one copy of each poultry inspection certificate shall be issued to the applicant who requested such certificate, and one copy shall be retained by the inspector for filing. The inspector who issues any inspection certificate is authorized to furnish an additional copy of such certificate upon the request of an interested party. The person who sold the live poultry involved to the official establishment is an interested party for purposes of this section.
(a) The official poultry inspection certificate authorized by this subpart is a paper certificate (Form MP-505) for signature by an inspector, bearing the legend
(b) The certificate also bears a serial number such as “B 3208” and shows the respective name and address of the applicant, the shipper or seller and the receiver or buyer and the net weight in pounds of amount passed, amount rejected or condemned, type of poultry, lot number and class, and such other information as the Administrator may prescribe or approve in specific cases.
Erasures or alterations not initialed by the issuing inspector shall not be permitted on any official certificate or any copy thereof. All certificates rendered useless through clerical error or otherwise and all certificates canceled for whatever cause shall be voided and initialed, and one copy shall be retained in the inspector's file; and the original and all other copies shall be forwarded to the appropriate program supervisor.
All certificates shall be so executed that the data entered thereon will appear in the proper spaces on each copy of the certificate.
The official mark for use in sealing containers of samples submitted under any requirements in this part and section 11(b) of the Poultry Products Inspection Act shall bear the designation “Sample Seal” accompanied by the official USDA logo as shown below. Any seal approved by the Administrator for applying such mark shall be deemed an official device for purposes of the Act. Such device shall be supplied to inspectors, compliance officers, and other designated Agency officials by the United States Department of Agriculture.
Except as may be authorized in specific cases by the Administrator with respect to shipment of poultry products between official establishments, each shipping container and each immediate container of any inspected and passed poultry product shall at the time it leaves the official establishment bear a label which contains information, and has been approved, in accordance with this subpart.
(a) Each label for use on immediate containers for inspected and passed poultry products shall bear on the principal display panel (except as otherwise permitted in the regulations), the items of information required by this subpart. Such items of information shall be in distinctly legible form. Except as provided in § 381.128, all words, statements and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend.
(b) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by the regulations with clarity and conspicuousness and without being obscured by design or vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The area that is to bear the principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area of which is the product of the height times the width of that side.
(2) In the case of a cylindrical or nearly cylindrical container:
(i) An area on the side of the container that is 40 percent of the product of the height of the container times the circumference, or
(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, That there is, immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in §§ 381.118, 381.122, and 381.123. Such panel shall be known as the “20 percent panel” and such information may be shown on that panel in lieu of showing it on the principal display panel as provided in this § 381.116.
(3) In the case of a container of any other shape, 40 percent of the total surface of the container.
(c) (1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions:
(i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used.
(ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel.
(iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.
(2) (i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel.
(ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes.
(a) The label shall show the name of the product, which, in the case of a poultry product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in subpart P, shall be the name of the food specified in the standard, and in the case of any other poultry product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation.
(b) The name of the product required to be shown on labels for fresh or frozen raw whole carcasses of poultry shall be in either of the following forms: The name of the kind (such as chicken, turkey, or duck) preceded by the qualifying term “young” or “mature” or “old”, whichever is appropriate; or the appropriate class name as described in § 381.170(a). The name of the kind may be used in addition to the class name, but the name of the kind alone without the qualifying age or class term is not acceptable as the name of the product, except that the name “chicken” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen cut-up young chickens, or a half of a young chicken, and the name “duckling” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen young ducks. The class name may be appropriately modified by changing the word form, such as using the term “roasting chicken”, rather than “roaster.” The appropriate names for cut-up parts are set forth in § 381.170(b). When naming parts cut from young poultry, the identity of both the kind of poultry and the name of the part shall be included in the product name. The product name for parts or portions cut from mature poultry shall include, along with the part or portion name, the class name or the qualifying term “mature.” The name of the product for cooked or heat processed poultry products shall include the kind name of the poultry from which the product was prepared but need not include the class name or the qualifying term “mature.”
(c) Poultry products containing light and dark chicken or turkey meat in quantities other than the natural proportions, as indicated in Table 1 in this paragraph, must have a qualifying statement in conjunction with the name of the product indicating, as shown in Table 1, the types of meat actually used, except that when the product contains less than 10 percent cooked deboned poultry meat or is processed in such a manner that the character of the light and dark meat is not distinguishable, the qualifying statement will not be required, unless the product bears a label referring to the light or dark meat content. In the latter case, the qualifying statement is required if the light and dark meat are not present in natural proportions. The qualifying statement must be in type at least one-half the size and of equal boldness as the name of the product; e.g., Boned Turkey (Dark Meat).
Table 1
| Label terminology | Percent light meat | Percent dark meat |
|---|---|---|
| Natural proportions | 50-65 | 50-35 |
| Light or white meat | 100 | 0 |
| Dark meat | 0 | 100 |
| Light and dark meat | 51-65 | 49-35 |
| Dark and light meat | 35-49 | 65-51 |
| Mostly white meat | 66 or more | 34 or less |
| Mostly dark meat | 34 or less | 66 or more |
(d) Boneless poultry products shall be labeled in a manner that accurately describes their actual form and composition. The product name shall specify the form of the product (e.g., emulsified, finely chopped, etc.), and the kind name of the poultry, and if the product does not consist of natural proportions of skin and fat, as they occur in the whole carcass, shall also include terminology that describes the actual composition. If the product is cooked, it shall be so labeled. For the purpose of this paragraph, natural proportions of skin, as found on a whole chicken or turkey carcass, will be considered to be as follows:
| Percent | ||
|---|---|---|
| Raw | Cooked | |
| Chicken | 20 | 25 |
| Turkey | 15 | 20 |
(e) On the label of any “Mechanically Separated (Kind of Poultry) “ described in § 381.173, the name of such product shall be followed immediately by the phrase: “with excess skin” unless such product is made from poultry product that does not include skin in excess of the natural proportion of skin present on the whole carcass, as specified in paragraph (d) of this section. Appropriate terminology on the label shall indicate if heat treatment has been used in the preparation of the product. The labeling information described in this paragraph shall be identified on the label before the product leaves the establishment at which it is manufactured.
(f) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with subpart Q of this part.
(g) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement.
(h) The product name for a raw poultry product that contains added solution and does not meet a standard of identity in this part must contain a descriptive designation that includes:
(1) The percentage of added solution (total weight of the solution ingredients divided by the weight of the raw poultry without solution or any other added ingredients multiplied by 100). The percentage of added solution must appear as a number (such as, 15, 20, 30) and the percent symbol (%). The percentage of added solution may be declared by the words “containing” or “contains” (such as, “contains 15% added solution of water and salt,” or “containing 15% added solution of water and teriyaki sauce”).
(2) The common or usual name of all individual ingredients or multi-ingredient components in the solution listed in descending order of predominance by weight.
(3) When the descriptive designation includes all ingredients in the solution, a separate ingredients statement is not required on the label. When the descriptive designation includes multi-ingredient components and the ingredients of the component are not declared in the product name, all ingredients in the product must be declared in a separate ingredients statement on the label as required in § 381.118.
(4) The product name and the descriptive designation must be printed in a single easy-to-read type style and color and must appear on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third (
(5) The word “enhanced” cannot be used in the product name.
(a)(1) The label shall show a statement of the ingredients in the poultry product if the product is fabricated from two or more ingredients. Such ingredients shall be listed by their common or usual names in the order of their descending proportions, except as prescribed in paragraph (a)(2) of this section.
(2)(i) Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as “Contains __________ percent or less of __________ ,” or “Less than __________ percent of __________ .” The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may also be utilized when an ingredients statement contains a listing of ingredients by individual components. Each component listing may utilize the required quantifying statement at the end of each component ingredients listing.
(ii) Such ingredients may be adjusted in the product formulation without a change being made in the ingredients statement on the labeling, provided that the adjusted amount complies with subpart P of this part and § 424.21(c) of subchapter E, and does not exceed the amount shown in the quantifying statement. Any such adjustments to the formulation shall be provided to the inspector-in-charge.
(b) For the purpose of this paragraph, the term “chicken meat,” unless modified by an appropriate adjective, is construed to mean deboned white and dark meat; whereas the term “chicken” may include other edible parts such as skin and fat not in excess of their natural proportions, in addition to the chicken meat. If the term “chicken meat” is listed and the product also contains skin, giblets, or fat, it is necessary to list each such ingredient. Similar principles shall be followed in listing ingredients of poultry products processed from other kinds of poultry.
(c) The terms spice, natural flavor, natural flavoring, flavor or flavoring may be used in the following manner:
(1) The term “spice” means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10, and 184.
(2) The term “natural flavor,” “natural flavoring,” “flavor” or “flavoring” means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 172.510. The term natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powdered onion, powdered garlic, and powdered celery.
(i) Natural flavor, natural flavoring, flavor or flavoring as described in paragraph (c)(1) and (2) of this section, which are also colors shall be designated as “natural flavor and coloring,” “natural flavoring and coloring,” “flavor and coloring” or “flavoring and coloring” unless designated by their common or usual name.
(ii) Any ingredient not designated in paragraphs (c) (1) and (2) of this section whose function is flavoring, either in whole or in part, must be designated by its common or usual name. Those ingredients which are of livestock or poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived.
(d) On containers of frozen dinners, entrees, and pizzas, and similarly packaged products in cartons, the ingredient statement may be placed on the front riser panel: Provided, That the words “see ingredients,” followed immediately by an arrow pointing to the front riser panel, are placed on the principal display panel immediately above the location of such statement, without intervening printing or designs.
(e) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter.
(f) Establishments may interchange the identity of two kinds of poultry (e.g., chicken and turkey, chicken meat and turkey meat) used in a product formulation without changing the product's ingredient statement or product name under the following conditions:
(1)(i) The two kinds of poultry used must comprise at least 70 percent by weight of the poultry and the poultry ingredients [e.g. giblets, skin or fat in excess of natural proportions, or mechanically separated (kind)] used; and,
(ii) Neither of the two kinds of poultry used can be less than 30 percent by weight of the total poultry and poultry ingredients used;
(2) The word “and” in lieu of a comma must be shown between the declaration of the two kinds of poultry in the ingredients statement and in the product name.
(a) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of any poultry product, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring added as an ingredient in the formula of the poultry product.
(b) Any poultry product which bears or contains any artificial flavoring other than an artificial smoke flavoring or a smoke flavoring, or bears or contains any artificial coloring shall bear a statement stating that fact on the immediate container or, if there is none, on the product.
When an antioxidant is added to a poultry product, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement showing the name of the antioxidant and the purpose for which it is added, such as “BHA added to help protect the flavor.” Immediate containers of poultry products packed in, bearing, or containing any chemical preservative shall bear a label stating that fact and naming the additive and the purpose of its use. Immediate containers of poultry products packed in, bearing or containing any other chemical additive shall bear a label naming the additive and the purpose of its use when required by the Administrator in specific cases. When approved proteolytic enzymes as permitted in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement “Tenderized with [approved enzyme],” to indicate the use of such enzymes. Any other approved substance which may be used in the solution shall also be included in the statement. When approved inorganic chlorides as permitted in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with (name of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be used in the solution shall also be included in the statement.
(a) The label shall bear a statement of the quantity of contents in terms of weight or measures as provided in paragraph (c)(5) of this section. However, the Administrator may approve the use of labels for certain types of consumer packages which do not bear a statement of the net weight that would otherwise be required under this subparagraph: Provided, That the shipping container bears a statement “Net weight to be marked on consumer packages prior to display and sale”: And provided further, That the total net weight of the contents of the shipping container is marked on such container: And provided further, That the shipping container bears a statement “Tare weight of consumer package” and in close proximity thereto, the actual tare weight (weight of packaging material), weighed to the nearest one-eighth ounce or less, of the individual consumer package in the shipping container. The above-specified statements may be added to approved shipping container labels upon approval by the inspector in charge.
(b) When a poultry product and a nonpoultry product are separately wrapped and are placed in a single immediate container bearing the same name of both products, the net weight on such immediate container may be the total net weight of the products, or such immediate container may show the net weights of the poultry product and the nonpoultry product separately. Notwithstanding the other provisions of this paragraph, the label on consumer size retail packages of stuffed poultry and other stuffed poultry products must show the total net weight of the poultry product, and in close proximity thereto, a statement specifying the minimum weight of the poultry in the product.
(c)(1) The statement of net quantity of contents shall appear (except as otherwise permitted under this paragraph (c)), on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type, in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph (c). An unused tare weight, as defined in section 381.121b of this subchapter, may be printed adjacent to the statement of net quantity of contents when the product is packaged totally with impervious packaging material and is packed with a usable medium.
(2) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel, in lines generally parallel to the base: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph. The declaration may appear in more than one line.
(3) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on containers, the principal display panel of which has an area of 5 square inches or less;
(ii) Not less than one-eighth inch in height on containers, the principal display panel of which has an area of more than 5 but not more than 25 square inches;
(iii) Not less than three-sixteenth inch in height on containers, the principal display panel of which has an area of more than 25 but not more than 100 square inches;
(iv) Not less than one-quarter inch in height on containers, the principal display panel of which has an area of more than 100 but not more than 400 square inches;
(v) Not less than one-half inch in height on containers, the principal display panel of which has an area of more than 400 square inches.
(vi) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). This height standard pertains to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards.
(4) The statement shall appear as a distinct item on the principal display panel and shall be separated, from other label information appearing to the left or right of the statement, by a space at least equal in width to twice the width of the letter “N” of the style of type used in the quantity of contents statement and shall be separated from other label information appearing above or below the statement by a space at least equal in height to the height of the lettering used in the statement.
(5) The terms “net weight” or “net wt.” shall be used when stating the net quantity of contents in terms of weight, and the term “net contents” or “contents” when stating the net quantity of contents in terms of fluid measure. Except as provided in § 381.128, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semi-solid, viscous, or a mixture of solid and liquid. On packages containing less than 1 pound or 1 pint, the statement shall be expressed in ounces or fractions of a pint, respectively. On packages containing 1 pound or 1 pint or more, and less than 4 pounds or 1 gallon, the statement shall be expressed in ounces or in pounds with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fraction of the pint or quart. For example, a declaration of three-fourths pound avoirdupois weight shall be expressed as “Net Wt. 12 oz.”; a declaration of 1
(6) The statement as it is shown on a label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall be as provided in section 381.121b of this subchapter. The statement shall not include any term qualifying a unit of weight, measure, or count such as “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “minimum,” or words of similar importance except as provided in paragraph (b) of this section.
(7) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of the net quantity of each such serving.
(8) On a multiunit retail package, a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and, in parentheses, the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces. “A multiunit retail package” is a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multiunit retail package but capable of being sold individually. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph (c) (8) if the labeling of each individual unit complies with the requirements of this paragraph (c).
(9) The following exemptions from the requirements contained in this section are hereby established:
(i) Individually wrapped, random weight consumer size packages of poultry products (as specified in paragraph (c)(10) of this section) and poultry products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined in NBS handbook 133, section 3.18.2, need not bear a net weight statement when shipped from an official establishment provided a net weight shipping statement which meets the requirements of paragraph (c)(6) of this section is applied to the shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size and placement requirements of this paragraph if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement of random weight consumer size packages for retail sale shall be exempt from the type size and placement requirements of this paragraph if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.
(ii) Individually wrapped and labeled packages of less than
(iii) Individually wrapped and labeled packages of less than
(10) As used in this section a “random weight consumer size package” is one of a lot, shipment or delivery of packages of the same product, with varying weights and with no fixed weight pattern.
The name and address, including zip code, of the manufacturer, packer, or distributor shall be shown on the label and if only the name and address of the distributor is shown, it shall be qualified by such term as “packed for,” “distributed by,” or “distributors.” The name and place of business of the manufacturer, packer, or distributor may be shown on the principal display panel, on the 20-percent panel of the principal display panel reserved for required information, on the front riser panel of frozen food cartons, or on the information panel.
The immediate container of every inspected and passed poultry product shall bear:
(a) The official inspection legend; and
(b) The official establishment number of the official establishment in which the product was processed under inspection and placed as follows:
(1) Within the official inspection legend in the form required by subpart M of this part; or
(2) Outside the official inspection legend elsewhere on the exterior of the container or its labeling, e.g., the lid of a can, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition and accompanied by the prefix “P”; or
(3) Off the exterior of the container, e.g., on a metal clip used to close casings or bags, or on the back of a paper label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans and trays placed within containers, when a statement of its location is printed contiguous to the official inspection legend, such as “Plant No. on Package Closure” or “Plant No. on Pan”, if shown in a prominent and legible manner in a size sufficient to ensure easy visibility and recognition; or
(4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix “P”.
If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations (21 CFR part 125) established pursuant to sections 403 and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
(a) Packaged products which require special handling to maintain their wholesome condition shall have prominently displayed on the principal display panel of the label the statement: “Keep Refrigerated,” “Keep Frozen,” “Keep Refrigerated or Frozen,” “Perishable—Keep Under Refrigeration,” or such similar statement as the Administrator may approve in specific cases. The immediate containers for products that are frozen during distribution and intended to be thawed prior to or during display for sale shall bear the statement “Shipped/Stored and Handled Frozen for Your Protection, Keep Refrigerated or Freeze.” For all canned perishable products, the statement shall be shown in upper case letters one-fourth inch in height for containers having a net weight of 3 pounds or less, and for containers having a net weight over 3 pounds, the statement shall be shown in letters one-half inch in height.
(b) Safe handling instructions shall be provided for all poultry products not processed in accordance with the provisions of § 381.150(a) or that have not undergone other processing that would render them ready-to-eat, except as exempted under paragraph (b)(4) of this section.
(1) (i) Safe handling instructions shall accompany the poultry products, specified in this paragraph (b), destined for household consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall be in lettering no smaller than one-sixteenth of an inch in size and shall be prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(ii) The safe handling information shall be presented on the label under the heading “Safe Handling Instructions” which shall be set in type size larger than the print size of the rationale statement and handling statements as discussed in paragraphs (b)(2) and (b)(3) of this section. The safe handling information shall be set off by a border and shall be one color type printed on a single color contrasting background whenever practical.
(2) (i) The labels of the poultry products, specified in this paragraph (b) and prepared from inspected and passed poultry, shall include the following rationale statement as part of the safe handling instructions, “This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements.
(ii) The labels of the poultry products, specified in this paragraph (b) and prepared pursuant to § 381.10(a) (2), (5), (6), and (7), shall include the following rationale statement as part of the safe handling instructions, “Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements.
(3) Poultry products, specified in this paragraph (b), shall bear the labeling statements.
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. (Any portion of this statement that is in conflict with the product's specific handling instructions may be omitted, e.g., instructions to cook without thawing.) (A graphic illustration of a refrigerator shall be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry. (A graphic illustration of soapy hands under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall be displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or discard. (A graphic illustration of a thermometer shall be displayed next to the statement.)
(4) Poultry products intended for further processing at another official establishment are exempt from the requirements prescribed in paragraphs (b)(1) through (b)(3) of this section.
(a) Either the immediate container or the shipping container of all poultry food products shall be plainly and permanently marked by code or otherwise with the date of packing. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2).
(b) The immediate container for dressed poultry shall be marked with a lot number which shall be the number of the day of the year on which the poultry was slaughtered or a coded number.
(c) All canned products shall be plainly and permanently marked, by code or otherwise, on the containers, with the identity of the contents and date of canning, except that canned products packed in glass containers are not required to be marked with the date of canning if such information appears on the shipping container. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2).
(d) If any marking is by code, the inspector in charge shall be informed as to its meaning.
(a) Each label for use on a shipping container for inspected and passed poultry products shall bear, in distinctly legible form, the following information:
(1) The official inspection legend.
(2) The official establishment number of the official establishment in which the poultry product was inspected, either within the official inspection mark, or elsewhere on the container clearly visible and in proximity to the official inspection mark.
Any label to be affixed to a container of any dressed poultry or other poultry product for foreign commerce may be printed in a foreign language. However, the official inspection legend and establishment number shall appear on the label in English, but in addition, may be literally translated into such foreign language. Each such label shall be subject to the applicable provisions of §§ 381.115 to 381.141, inclusive. Deviations from the form of labeling required under the regulations may be approved by the Administrator in specific cases and such modified labeling may be used for poultry products to be exported: Provided, (a) That the proposed labeling accords to the specifications of the foreign purchaser, (b) that it is not in conflict with the Act or the laws of the country to which it is intended for export, and (c) that the outside of the shipping container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of the regulations shall apply.
(a) No poultry product subject to the Act shall have any false or misleading labeling or any container that is so made, formed, or filled as to be misleading. However, established trade names and other labeling and containers which are not false or misleading and which are approved by the Administrator in the regulations or in specific cases are permitted.
(b) No statement, word, picture, design, or device which is false or misleading in any particular or conveys any false impression or gives any false indication of origin, identity, or quality, shall appear on any label. For example:
(1) Official grade designations such as the letter grades A, B, and C may be used in labeling individual carcasses of poultry or containers of poultry products only if such articles have been graded by a licensed grader of the Federal or Federal-State poultry grading service and found to qualify for the indicated grade.
(2) Statements, words, pictures, designs, or devices having geographical significance with reference to a particular locality must be made in accordance with § 317.8(b)(1) of this chapter.
(3) “Fresh frozen”, “quick frozen”, “frozen fresh”, and terms of similar import apply only to ready-to-cook poultry processed in accordance with § 381.66(f)(1). Ready-to-cook poultry handled in any other manner and dressed poultry may be labeled “frozen” only if it is frozen in accordance with § 381.66(f)(2) under Department supervision and is in fact in a frozen state. “Individually quick frozen (Kind)” and terms of similar import are applicable only to poultry products that are frozen as stated on the label and whose component parts can be easily separated at time of packing.
(4) Poultry products labeled with a term quoted in any paragraph of § 381.170(b) shall comply with the specifications in the applicable paragraph. However, parts of poultry may be cut in any manner the processor desires as long as the labeling appropriately reflects the contents of the container of such poultry.
(5) The terms “All,” “Pure,” “100%,” and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient.
(6)(i) A raw poultry product whose internal temperature has ever been below 26 °F may not bear a label declaration of “fresh.” A raw poultry product bearing a label declaration of “fresh” but whose internal temperature has ever been below 26 °F is mislabeled. The temperature of individual packages of raw poultry product within an official establishment may deviate below the 26 °F standard by 1 degree (i.e., have a temperature of 25 °F) and still be labeled “fresh.” The temperature of individual packages of raw poultry product outside an official establishment may deviate below the 26 °F standard by 2 degrees (i.e., have a temperature of 24 °F) and still be labeled “fresh.” The average temperature of poultry product lots of each specific product type must be 26 °F. Product described in this paragraph is not subject to the freezing procedures required in § 381.66(f)(2) of this subchapter.
(ii) Raw poultry product whose internal temperature has ever been at or below 0°F must be labeled with the descriptive term “frozen,” except when such labeling duplicates or conflicts with the labeling requirements in § 381.125 of this subchapter. The word “previously” may be placed next to the term “frozen” on an optional basis. The descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the descriptive term is affixed to the label, it must be prominently affixed to the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Product described in this paragraph is subject to the freezing procedures required in § 381.66(f)(2) of this subchapter.
(iii) Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, is not required to bear any specific descriptive term. Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, may bear labeling with an optional, descriptive term, provided the optional, descriptive term does not cause the raw poultry product to become misbranded. If used, an optional, descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the optional, descriptive term is affixed to the label, it must be prominently affixed on the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(iv) Handling and relabeling of products. (A) Except as provided under paragraph (b)(6)(iii)(C) of this section, when any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, such product may be transported in commerce to an official establishment after oral permission is obtained from the Area Supervisor of the area in which that official establishment is located. The transportation of the product may be to the official establishment from which it had been transported or to another official establishment designated by the person desiring to handle the product. The transportation shall be authorized only for the purpose of the relabeling of the product. The Area Supervisor shall record the authorization and other information necessary to identify the product and shall provide a copy of the record to the inspector at the establishment receiving the product. The shipper shall be furnished a copy of the authorization record upon request.
(B) Upon the arrival of the shipment at the official establishment, a careful inspection shall be made of the product by the inspector, and if it is found that the product is not adulterated, it may be received into the establishment; but if the product is found to be adulterated, it shall at once be condemned and disposed of in accordance with § 381.95 of this subchapter. Wholesome product will be relabeled in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate.
(C) When any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, the owner may transport the product in commerce to a retail entity for relabeling in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate, or to other end users, such as hotels, restaurants or similar institutions; or, relabel the product in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate if the product is already at a retail entity. A hotel, restaurant or similar institution is not required to relabel product misbranded under this subpart; Provided, That the product is prepared in meals or as entrees only for sale or service directly to individual consumers at such institutions, and that the mark of inspection is removed or obliterated. Oral permission shall be obtained from the Area Officer-in-Charge of the Compliance Program for the area in which the product is located prior to such transportation or relabeling. The Area Officer-in-Charge shall record the authorization and other information necessary to identify the product, and shall furnish a copy of the authorization record upon request. Before being offered for sale at a retail entity, such product shall be relabeled.
(v) Ready-to-cook chicken may bear the claim “air chilled” or “air chilling” on its label only if the product was chilled under a process that meets the definition of air chilling in § 381.66(e).
(c) A calendar date may be shown on labeling when declared in accordance with the provisions of this paragraph:
(1) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading.
(2) Immediately adjacent to the calendar date will be a phrase explaining the meaning of such date in terms of “packing” date, “sell by” date, or “use before” date, with or without a further qualifying phrase, e.g., “For Maximum Freshness” or “For Best Quality.”
(d) When sodium alginate, calcium carbonate, lactic acid, and calcium lactate are used together in a dry binding matrix in ground or formed poultry products, as permitted in § 424.21(c) of subchapter E, there shall appear on the label contiguous to the product name a statement to indicate the use of sodium alginate, calcium carbonate, lactic acid, and calcium lactate.
(e) When transglutaminase enzyme is used to bind pieces of poultry to form a cut of poultry, or to reform a piece of poultry from a multiple cuts of poultry, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Turkey Thigh Roast” or “Reformed and Shaped Chicken Breast.”
(f) A country of origin statement on the label of any poultry product “covered commodity” as defined in 7 CFR part 65, subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400.
If the Administrator has reason to believe that any marking or other labeling or the size or form of any container in use or proposed for use with respect to any article subject to the Act is false or misleading in any particular, he may direct that the use of the article be withheld unless it is modified in such manner as the Administrator may prescribe so that it will not be false or misleading. If the person using or proposing to use the labeling or container does not accept the determination of the Administrator, he may request a hearing, but the use of the labeling or container shall, if the Administrator so directs, be withheld pending hearing and final determination by the Secretary in accordance with applicable rules of practice. Any such determination with respect to the matter by the Secretary shall be conclusive unless, within 30 days after the receipt of notice of such final determination, the person adversely affected thereby appeals to the U.S. Court of Appeals for the Circuit in which he has his principal place of business, or to the U.S. Court of Appeals for the District of Columbia Circuit. The provisions of section 204 of the Packers and Stockyards Act of 1921, as amended, shall be applicable to appeals taken under this section.
(a) Except for the purposes of preparing and submitting a sample or samples of the same to the Administrator for approval, no brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any marking device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, without the written authority therefor of the Administrator. However, when any such sample label, or other marking device, is approved by the Administrator, additional supplies of the approved label, or marking device, may be made for use in accordance with the regulations in this subchapter, without further approval by the Administrator. The provisions of this paragraph do not apply to marking devices containing the official inspection legend shown in Figure 5 of § 381.102.
(b) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a marking device containing the official inspection legend shown in Figure 5 of § 381.102 or any simulation of that legend.
(1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the marking device, bearing a certificate serial number and a letterhead and the seal of the United States Department of Agriculture. The certificate authorizes the making of only the devices of the type and quantity listed on the certificate.
(2) After signing the certificate, the Program employee and the establishment shall each keep a copy, and the remaining two copies shall be given to the marking device manufacturer.
(3) The manufacturer of the marking devices shall engrave or otherwise mark each marking device with a permanent identifying serial number unique to it. The manufacturer shall list on each of the two copies of the certificate given to the manufacturer the number of each marking device authorized by the certificate. The manufacturer shall retain one copy of the certificate for the manufacturer's records and return the remaining copy with the marking devices to the Program employee whose name and address are given on the certificate as the recipient.
(4) In order that all such marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such marking device that does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such marking device with a permanent identifying number.
Copies of each label submitted for approval, shall when the Administrator requires in any specific case, be accompanied by a statement showing, by their common or usual names, the kinds and percentages of the ingredients comprising the poultry product and by a statement indicating the method or preparation of the product with respect to which the label is to be used. Approximate percentages may be given in cases where the percentages of ingredients may vary from time to time, if the limits of variation are stated.
(a) No official inspection legend or any abbreviation or other simulation thereof may be affixed to or placed on or caused to be affixed to or placed on any poultry product or container thereof, except by an inspector or under the supervision of an inspector or other person authorized by the Administrator, and no container bearing any such legend shall be filled except under such supervision.
(b) No official inspection legend shall be used on any poultry product or other article which does not qualify for such mark under the regulations.
No inspector shall authorize the use of any device bearing any official inspection legend unless he or she has on file evidence that such device has been approved in accordance with the provisions of this subpart.
(a) Labeling and devices approved for use pursuant to § 381.115 shall be used only for the purpose for which approved, and shall not be disposed of from the official establishment for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labeling or devices bearing official inspection marks is prohibited and may result in cancellation of the approval.
(b) Labeling and containers bearing any official inspection marks, with or without the official establishment number, may be transported from one official establishment to any other official establishment, only if such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. Approved labeling and containers may be moved without restriction under this part between official establishments operated by the same person if such labeling and containers are approved for use at all such establishments. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subpart.
(a) Every person who receives any poultry product in containers which bear any official inspection legend shall remove or deface such legend or destroy the containers upon removal of such articles from the containers.
(b) No person shall alter, detach, deface, or destroy any official identifications prescribed in subpart M that were applied pursuant to the regulations, unless he is authorized to do so by an inspector or this section; and no person shall fail to use any such official identification when required by this part.
When it is claimed by the operator of an official establishment that some of its labeled poultry product, which has been transported to a location other than an official establishment, is in need of relabeling because the labeling has become mutilated or damaged, or for some other reason needs relabeling, the requests for relabeling the poultry product shall be sent to the Administrator and accompanied with a statement of the reasons therefor and the quantity of labeling required. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with official labels shall be done under the supervision of an inspector pursuant to the regulations in part 362 of this chapter. The establishment shall reimburse the Inspection Service for any cost involved in supervising the relabeling of such product as provided in said regulations.
(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for the intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).
(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.
(c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.
(d) The Department will monitor the use of packaging materials in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information to designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective and approval to continue using the specified packaging material in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with the FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health.
(f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health.
(a) No poultry product (including poultry broth for use in any poultry product in any official establishment) may be brought into any official establishment unless it has been processed in the United States only in an official establishment or imported from a foreign country eligible to export such poultry and poultry products to the United States under § 381.196(b), and inspected and passed, in accordance with the regulations; and unless the container of such product is marked so as to identify the product as so inspected and passed, in accordance with § 381.115 or § 381.205, except that poultry products inspected and passed and identified as such under the laws of an “at least equal” State or territory listed in § 381.187 may be brought into any official establishment solely for storage and distribution therefrom without repackaging, relabeling, or processing in such establishment. No carcass, part thereof, meat or meat food product of cattle, sheep, swine, goats, or equines may be brought into an official establishment unless it has been prepared in the United States only in an official meat packing establishment, or imported, and inspected and passed, in accordance with the Federal Meat Inspection Act, and the regulations under such Act (Subchapter A of this chapter) and is properly marked as so inspected and passed; or has been inspected and passed and is identified as such in accordance with the requirements of the law and regulations of a State not designated under section 301(c) of the Act; or is present in the official establishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act (Subchapter A of this chapter) or the law and regulations of a State not so designated. However, such exempted articles may enter only under conditions approved by the Administrator in specific cases, including but not limited to, complete separation of inspected poultry products and processing and other operations with respect thereto from the exempted articles and operations with respect thereto, complete cleanup of facilities and equipment between processing of inspected poultry products and the exempted articles and no commingling of inspected and exempted articles in receiving, holding or storage areas.
(b) All poultry products and all carcasses, parts thereof, meat and meat food products of cattle, sheep, swine, goats, or equines which enter any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment. All poultry products, and all carcasses, parts thereof, meat and meat food products of such animals, which are processed or otherwise handled at any official establishment shall be subject to examination by an inspector at the official establishment in such manner and at such times as may be deemed necessary by the inspector in charge to assure compliance with the regulations. Upon such examination, if any such article or portion thereof is found to be adulterated, such article or portion shall, in the case of poultry products, be condemned and disposed of as prescribed in § 381.95, unless by reprocessing they may be made not adulterated, and shall, in the case of such other articles be disposed of according to applicable law.
(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing poultry product who has a total plant quality control system or plan for controlling such products, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:
(1) A letter to the Administrator from the establishment owner or operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control systems require it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.
(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of a small establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will also be responsible for the quality control system.
(3) A list identifying those subparts and sections of the poultry products inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the system will serve to maintain compliance with the applicable regulations.
(4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters of limits which will be used and the points at which corrective action will occur, and the nature of such corrective action—ranging from the least to most severe: Provided, That subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator.
(d)-(e) [Reserved]
(f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section may only use, as a part of any label, the following logo.
(g) Termination of Quality Control Systems. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator.
(2) The approval of a total plant quality control system or a quality control system for irradiation facilities may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:
(i) If adulterated or misbranded poultry product is found by the Adminstrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, to resolve the conflict, The Administrator's termination of approval shall remain in effect pending the final determination of the proceeding.
(ii) If the establishment fails to comply with the quality control system to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, to resolve the conflict. The Administrator's termination of quality control approval shall remain in effect pending the final determination of the proceeding.
(3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date.
(4) If approval of a quality control system for irradiation facilities, as specified in section 381.149 of this subpart, has been terminated in accordance with the provisions of this section, a request for approval of the same or a modified quality control system will be evaluated by the Administrator upon receipt.
(h)(1) Operating Schedule Under Total Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permissions will be granted provided that:
(i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year.
(ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection.
(iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector.
(2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in § 381.145(h)(1) have been or will be met.
(3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspectiom services at the discretion of the circuit supervisor and charged for such services.
(i) To ensure the safe use of preparations used in poultry scald water, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B or 9 CFR Chapter III, Subchapter A or Subchapter E.
Inspectors may take, without cost to the Department, such samples as are necessary of any poultry product, or other article for use as an ingredient of any poultry product, at any official establishment to determine whether it complies with the requirements of the regulations.
Procedures with respect to processing of frozen ready-to-heat-and-eat poultry products or stuffed ready-to-roast poultry shall be in accordance with sound operating practices and carried out in a manner which will assure freedom from adulteration of the products. Products to be frozen shall be moved into the freezer promptly under such supervision by an inspector as is necessary to assure preservation of the products by prompt and efficient freezing. Adequate freezing facilities shall be provided within the official establishment where products to be frozen are prepared, except that, upon written request, and under such conditions as may be prescribed by the Administrator in specific cases, such products may be moved from the official establishment prior to freezing: Provided, That the official establishment and freezer are so located and the necessary arrangements are made so that the Inspection Service will have access to the freezing room and adequate opportunity to determine that the products are being properly handled and frozen.
(a) Fully cooked poultry products must be produced using processes ensuring that the products meet the following performance standards:
(1) Lethality. A 7-log
(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log
(b) Partially cooked poultry breakfast strips must be produced using processes ensuring that the products meet the performance standard listed in paragraph (a)(2) of this section. Labeling for these products must comply with § 381.125. In addition, the statement “Partially Cooked: For Safety, Cook Until Well Done” must appear on the principal display panel in letters no smaller than
(c) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in § 381.1(b). Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule.
(d) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.
(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all poultry products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.
(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator
(c) Hermetically sealed containers of poultry product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:
(1) Separate and condemn all poultry products in damaged or extensively rusted containers.
(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:
(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator,
(ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly.
(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.
(4) The identity of the canned poultry product shall be maintained throughout all stages of the rehandling operations, to insure correct labeling of containers.
(a) Official establishments may manufacture pet food or similar uninspected, inedible products in areas where edible products also are produced, provided that the manufacture of uninspected, inedible products does not:
(1) Adulterate edible products;
(2) Create insanitary conditions in the official establishment whereby edible products may be adulterated; or
(3) Prevent or interfere with inspection or other program tasks performed by FSIS personnel in the official establishment.
(b) The immediate container of uninspected, inedible products manufactured in an official establishment shall be conspicuously labeled so as to distinguish them from human food in accordance with § 381.193 of this subchapter.
(a) Authorization to establish specifications. (1) The Administrator is authorized to establish specifications or definitions and standards of identity or composition, covering the principal constituents of any poultry product with respect to which a specified name of the product or other labeling terminology may be used, whenever he determines such action is necessary to prevent sale of the product under false or misleading labeling. Further, the Administrator is authorized to prescribe definitions and standards of identity or composition for poultry products whenever he determines such action is otherwise necessary for the protection of the public. The requirements of this subpart are hereby found to be necessary for these purposes and standards are hereby established as set forth in this subpart.
(2) Where cooked poultry meat is specified in this subpart as an ingredient of poultry products, this means poultry meat derived from poultry processed, cooked, and cooled in a manner approved by the Administrator in specific cases without use of liquid or moisture in direct contact with the poultry meat following the cooking and cooling of the poultry.
(3) If, following cooking and cooling of poultry meat to be used in poultry products, liquid or moisture is used in direct contact with such poultry meat and the percentage of solids, excluding salt, in the poultry meat is found to be below 34 percent when such poultry meat is tested by acceptable methods, the percentage of poultry meat required by this section for any poultry product shall be increased in proportion to the deficiency, or the meat shall be so processed as to raise the solids content, excluding salt, to 34 percent. The official establishment shall furnish adequate facilities for such testing.
(b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of poultry products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients.
Poultry products with labeling terminology as set forth in Table I shall comply with the specifications for percent light meat and percent dark meat set forth in said table.
Table I
| Label terminology | Percent light meat | Percent dark meat |
|---|---|---|
| Natural proportions | 50-65 | 50-35. |
| Light or white meat | 100 | 0. |
| Dark meat | 0 | 100. |
| Light and dark meat | 51-65 | 49-35. |
| Dark and light meat | 35-49 | 65-51. |
| Mostly white meat | 66 or more | 34 or less. |
| Mostly dark meat | 34 or less | 66 or more. |
(a) Canned boned poultry shall, unless otherwise specified in this section, be prepared from cooked deboned poultry meat and may contain skin and fat not in excess of natural whole carcass proportions. Gelatin, stabilizers, or similar solidifying or emulsifying agents shall not be added to product labeled “Boned (Kind)—Solid Pack,” but may be added in quantities not in excess of a total of 0.5 percent of the total ingredients in the preparation of other canned boned poultry products and in such cases the common name of the substance shall be included in the name of the product, e.g., “Boned Chicken with Broth—Gelatin Added.”
(b) Canned boned poultry, except poultry within paragraph (c) of this section, shall meet the requirements set forth in Table II. The percentages in Table II shall be calculated on the basis of the total ingredients used in the preparation of the product.
(c) Canned boned poultry with natural juices (Boned (Kind) with natural juices) shall be prepared from either raw boned poultry or a mixture of raw boned poultry and cooked boned poultry and shall have no liquid added during the preparation of the product.
(d) Canned shredded poultry (Shredded Kind), consists of poultry meat reduced to a shredded appearance, from the kind of poultry indicated, with meat, skin, and fat not in excess of the natural whole carcass proportions. Canned shredded poultry from specific parts may include skin or fat in excess of the proportions normally found on a whole carcass, but not in excess of the proportions of skin and fat normal to the particular part or parts; and such product shall be labeled in accordance with § 381.117(d).
(e) Canned boned poultry shall be prepared as set forth in Table II, items 1, 2, 3, or 4, whichever is applicable.
Table II
| Product name | Minimum percent cooked, deboned poultry meat of kind indicated, with skin, fat, and seasoning | Maximum percent liquid that may be added 1 |
|---|---|---|
| 1. Boned (Kind)—solid pack | 95 | 5 |
| 2. Boned (Kind) | 90 | 10 |
| 3. Boned (Kind) with broth 2 | 80 | 20 |
| 4. Boned (Kind) (____) percent broth 2 3 | 50 | 50 |
1 Liquid may be in the form of, but is not limited to, broth or extractives.
2 Alternatively, product may be prepared from raw boned poultry in combination with cooked boned poultry so long as the product complies with the specified standard.
3 Total amount of liquid added shall be included in the name of the product; e.g., “Boned Chicken with 25 percent broth.”
(f) Poultry products intended for infant or geriatric use and represented as having a “high meat” content shall contain not less than 18.75 percent cooked, deboned poultry meat of the kind indicated, with seasoning.
Table IIa
| Product name | Minimum percent cooked, deboned, poultry meat of kind indicated, with seasoning | Maximum percent liquid that may be added 1 |
|---|---|---|
| 1. Strained or chopped (Kind) with broth 2 3 | 43 | 57 |
| 2. High meat dinner 3 | 18.75 |
1 Liquid may be in the form of, but not limited to, broth or extractives.
2 Alternatively, product may be prepared from raw boned poultry meat in combination with cooked bone poultry meat so long as the product complies with the specified standard.
3 Label must indicate in some manner that product is for infant or geriatric servings.
Poultry dinners (frozen) and pies shall meet the requirements set forth in Table III of this section and the percentage or weight specified therein shall be calculated on the basis of total ingredients used in the preparation of the poultry product.
Table III
| Minimum cooked deboned poultry meat of kind indicated | Minimum raw deboned poultry meat of kind indicated | |||
|---|---|---|---|---|
| Percent | Weight | Percent | Weight | |
| (Kind) Pies | 14 | or 1
| 25 | or 2 oz. per 8-oz. pie. 1 |
| (Kind) Dinners | 18 | or 2 oz. 2 3 | ||
1 14 percent or 1
2 Excluding weight of appetizers, desserts, etc.
3 18 percent or 2 oz., whichever is greater. A minimum of 45 percent, or 5 ounces per dinner, whichever is greater, of cooked poultry including bone and breading may be used in lieu of minimum 18 percent or 2 ounces of cooked deboned poultry meat and the cooked poultry including bone and breading shall not contain more than 30 percent breading.
(a) Binders or extenders may be added in accordance with a regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the binders referred to in the preceding sentence, the following substances are permitted for use as binders in poultry rolls: transglutaminase enzyme at up to 65 ppm. When binding agents are added in excess of 3 percent for cooked rolls and 2 percent for raw rolls, the common name of the agent or the term “Binders Added” shall be included in the name of the product; e.g., “Turkey Roll-Gelatin Added.”
(b) With respect to heat processed rolls, 2 percent or less liquid based on the weight of the finished product without liquid may remain with or be returned to product labeled as “(Kind) Roll.”
(c) Heat processed rolls which have more than 2 percent liquid remaining with or returned to the product shall be labeled as “(Kind) Roll with Natural Juices.” If more than 2 percent of any liquid other than natural cookout juices is added, the product must be labeled to indicate that fact; e.g., “Turkey Roll with Broth.” Liquid shall not be returned or added to product within this paragraph graph in excess of the amount normally cooked out during preparation.
Such product consists of 100 percent poultry of the kind indicated, with skin and fat not in excess of natural proportions. Product containing fillers or binders shall be named “(Kind) Patties.”
Such product consists of poultry meat of the kind indicated, stuffed with butter which may be seasoned and the product may be wrapped in sufficient skin to cover the meat. It may be dipped in batter, fried, and frozen.
Such product consists of a boneless slice or strip of poultry meat of the kind indicated.
Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry source heat, e.g., oven roasted or oven baked.
Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry heat and basted with a seasoned sauce.
Such product consists of ready-to-cook poultry of the kind indicated that has been cooked by the action of moist heat in a barbecue sauce.
“Breaded” is a term applicable to any poultry product which is coated with breading or a batter and breading in an amount not to exceed 30 percent of the weight of the finished breaded product.
Poultry dishes and specialty items listed in Table IV of this paragraph shall meet the requirements set forth in said table, irrespective of the type of packaging, and the percentages in Table IV shall be calculated on a ready-to-serve basis, except that soup bases in institutional packs which are prepared for sale to institutional users shall have a minimum of 15 percent cooked deboned poultry meat based on the weight of the soup base product.
Table IV
| Product name 1 | Minimum percent cooked deboned poultry meat of kind indicated | Minimum percent cooked poultry of kind indicated, indicating bone |
|---|---|---|
| (Kind) Ravioli | 2 | |
| (Kind) Soup | 2 | |
| Chop Suey with (Kind) | 2 | |
| (Kind) Chop Suey | 4 | |
| (Kind) Chow Mein without noodles | 4 | |
| (Kind) Tamales | 6 | |
| Noodles or Dumplings with (Kind) 2 | 6 | |
| (Kind) Stew | 12 | |
| (Kind) Fricassee of Wings | 40 | |
| (Kind) Noodles or Dumplings 2 | 15 | 30 |
| (Kind) with Vegetables | 15 | |
| Gravy with sliced (Kind) | 15 | |
| (Kind) Tetrazzini | 15 | |
| (Kind) chili with beans | 17 | |
| Creamed (Kind) | 20 | |
| (Kind) Cacciatore | 20 | 40 |
| (Kind) Fricassee | 20 | 40 |
| (Kind) A-La-King | 20 | |
| (Kind) croquettes | 25 | |
| Slice (Kind) with Gravy and Dressing | 25 | |
| (Kind) Salad 3 | 25 | |
| (Kind) chili | 28 | |
| (Kind) Hash | 30 | |
| Sliced (Kind) with Gravy | 35 | |
| Minced (Kind) Barbecue | 40 |
1 The product name may contain other appropriate descriptive terms such as “noodle”; e.g., “Chicken Noodle Soup.”
2 This standard also applies to products named (Kind) with rice or similar starches.
3 The 25 percent-standard listed includes poultry meat plus proportions of skin and fat natural to the poultry used.
The poultry products listed in Table V shall have not more than the percent of skin specified in the table, when raw and when cooked.
Table V
| Product name | Percent skin | |
|---|---|---|
| Raw | Cooked | |
| Boneless Turkey Breast | ||
| or | ||
| Boneless Turkey Breast Roll | 14 | |
| Boneless Turkey Thigh | ||
| or | ||
| Boneless Turkey Thigh Roll | 8 | |
| Boneless Turkey | ||
| or | ||
| Turkey Roll | 15 | |
| Boneless Chicken Breast | ||
| or | ||
| Boneless Chicken Breast Roll | 18 | 20 |
| Boneless Chicken | ||
| or | ||
| Chicken Roll | 20 | 25 |
(a) The following standards specify the various classes of the specified kinds of poultry and the requirements for each class:
(1) Chickens—(i) Rock Cornish game hen or Cornish game hen. A “Rock Cornish game hen” or “Cornish game hen” is a young, immature chicken (less than 5 weeks of age), of either sex, with a ready-to-cook carcass weight of not more than 2 pounds.
(ii) Broiler or fryer. A “broiler” or “fryer” is a young chicken (less than 10 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and flexible breastbone cartilage.
(iii) Roaster or roasting chicken. A “roaster” or “roasting chicken” is a young chicken (less than 12 weeks of age), of either sex, with a ready-to-cook carcass weight of 5.5 pounds or more, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is somewhat less flexible than that of a broiler or fryer.
(iv) Capon. A “capon” is a surgically neutered male chicken (less than 4 months of age) that is tender-meated with soft, pliable, smooth-textured skin.
(v) Hen, fowl, baking chicken, or stewing chicken. A “hen,” “fowl,” “baking chicken,” or “stewing chicken” is an adult female chicken (more than 10 months of age) with meat less tender than that of a roaster or roasting chicken and a nonflexible breastbone tip.
(vi) Cock or rooster. A “cock” or “rooster” is an adult male chicken with coarse skin, toughened and darkened meat, and a nonflexible breastbone tip.
(2) Turkeys—(i) Fryer-roaster turkey. A “fryer-roaster turkey” is an immature turkey (less than 12 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin, and flexible breastbone cartilage.
(ii) Young turkey. A “young turkey” is a turkey (less than 8 months of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is less flexible than that of a fryer-roaster turkey.
(iii) Yearling turkey. A “yearling turkey” is a turkey (less than 15 months of age), of either sex, that is reasonably tender-meated with reasonably smooth-textured skin.
(iv) Mature or old (hen or tom) turkey. A “mature turkey” or “old turkey” is an adult turkey (more than 15 months of age), of either sex, with coarse skin and toughened flesh. Sex designation is optional.
(3) Ducks—(i) Duckling. A “duckling” is a young duck (less than 8 weeks of age), of either sex, that is tender-meated and has a soft bill and soft windpipe.
(ii) Roaster duck. A “roaster duck” is a young duck (less than 16 weeks of age), of either sex, that is tender-meated and has a bill that is not completely hardened and a windpipe that is easily dented.
(iii) Mature duck or old duck. A “mature duck” or an “old duck” is an adult duck (more than 6 months of age), of either sex, with toughened flesh, a hardened bill, and a hardened windpipe.
(4) Geese—(i) Young goose. A “young goose” is an immature goose, of either sex, that is tender-meated and has a windpipe that is easily dented.
(ii) Mature goose or old goose. A “mature goose” or “old goose” is an adult goose, of either sex, that has toughened flesh and a hardened windpipe.
(5) Guineas—(i) Young guinea. A “young guinea” is an immature guinea, of either sex, that is tender-meated and has a flexible breastbone cartilage.
(ii) Mature guinea or old guinea. A “mature guinea” or “old guinea” is an adult guinea, of either sex, that has toughened flesh and a non-flexible breastbone.
(b) The following standards specify the requirements for the specified cuts of poultry:
(1) “Breasts” shall be separated from the back at the shoulder joint and by a cut running backward and downward from that point along the junction of the vertebral and sternal ribs. The ribs may be removed from the breasts, and the breasts may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as e.g., “chicken breasts.” Neck skin shall not be included with the breasts, except that “turkey breasts” may include neck skin up to the whisker.
(2) “Breasts with ribs” shall be separated from the back at the junction of the vertebral ribs and back. Breasts with ribs may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as “breasts with ribs.” Neck skin shall not be included, except that “turkey breasts with ribs” may include neck skin up to the whisker.
(3) “Wishbones” (Pulley Bones), with covering muscle and skin tissue, shall be severed from the breast approximately halfway between the end of the wishbone (hypocledium) and front point of the breastbone (cranial process of the sternal crest) to a point where the wishbone joins the shoulder. Neck skin shall not be included with the wishbone.
(4) “Drumsticks” shall be separated from the thigh by a cut through the knee joint (femorotibial and patellar joint) and from the hock joint (tarsal joint).
(5) “Thighs” shall be disjointed at the hip joint and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included.
(6) “(Kind) legs” shall be the poultry product which includes the thigh and the drumstick, i.e., the whole leg, and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included.
(7) “Wings” shall include the entire wing with all muscle and skin tissue intact, except that the wingtip may be removed.
(8) “Backs” shall include the pelvic bones and all the vertebrae posterior to the shoulder joint. The meat shall not be peeled from the pelvic bones. The vertebral ribs and/or scapula may be removed or included without affecting the appropriateness of the name. Skin shall be substantially intact.
(9) “Stripped backs” shall include the vertebrae from the shoulder joint to the tail, and include the pelvic bones. The meat may be stripped off of the pelvic bones.
(10) “Necks”, with or without neck skin, shall be separated from the carcass at the shoulder joint.
(11) “Halves” are prepared by making a full-length back and breast split of an eviscerated poultry carcass so as to produce approximately equal right and left sides.
(12) “Quarters” consist of the entire eviscerated poultry carcass, which has been cut into four equal parts, but excluding the neck.
(13) “Breast quarter” consists of half a breast with the wing and a portion of the back attached.
(14) “Breast quarter without wing” consists of a front quarter of a poultry carcass, from which the wing has been removed.
(15) “Leg quarter” consists of a poultry thigh and drumstick, with a portion of the back attached.
(16) “Thigh with back portion” consists of a poultry thigh with back portion attached.
(17) “Legs with pelvic bone” consists of a poultry leg with adhering meat and skin and pelvic bone.
(18) “Wing drummette” consists of the humerus of a poultry wing with adhering skin and meat attached.
(19) “Wing portion” consists of a poultry wing except that the drummette has been removed.
(20) “Cut-up Poultry” is any cut-up or disjointed portion of poultry or any edible part thereof, as described in this section.
(21) “Giblets” consist of approximately equal numbers of hearts, gizzards, and livers, as determined on a count basis.
(22) “Major portions” of eviscerated poultry carcasses are either carcasses from which parts may be missing, or the front or rear portions of transversely-split carcasses.
(a) “Turkey Ham” shall be fabricated from boneless, turkey thigh meat with skin and the surface fat attached to the skin removed. The thighs shall be that cut of poultry described in § 381.170(b)(5) of this part.
(b) The product may or may not be smoked, and shall be cured using one or more of the approved curing agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. The product may also contain cure accelerators, phosphates, and flavoring agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B; common salt, sugars, spices, spice extractives, dehydrated garlic, and dehydrated onions; and water for purpose of dissolving and dispersing the substances specified above.
(c) The cooked finished product weight shall be no more than the original weight of the turkey thigh meat used prior to curing.
(d) The product name on the label shall show the word “Turkey” in the same size, style, color, and with the same background as the word “Ham” and shall precede and be adjacent to it.
(e) The product name shall be qualified with the statement “Cured Turkey Thigh Meat.” The qualifying statement shall be contiguous to the product name, without intervening type or designs, shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name.
(f) If the product is fabricated from pieces of turkey thigh meat that result from the cutting through the muscle (as opposed the whole thighs intact or whole thighs with some incidental separation of muscle tissue during removal of the bone), the product name shall be further qualified by a descriptive statement. The product name of product fabricated from such pieces of turkey thigh meat equivalent in size to a one-half inch cube or greater shall be further qualified to specify that the product is “Chunked and Formed.” The product name of product fabricated from such pieces of turkey thigh meat smaller than the equivalent of a one-half inch cube shall be further qualified to specify that the product is “Ground and Formed” or “Chopped and Formed” as appropriate. The qualifying statement shall immediately follow and be contiguous to the statement required in paragraph (e) of this section, and shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name.
(a) Description. The poultry products prescribed by this general definition and standard of identity are those products that substitute, in accordance with § 381.413(d), for a standardized product defined in this subpart and use the name of that standardized product in their statements of identity, but that do not comply with the established standard because of a compositional deviation that results from reduction of a constituent that is described by an expressed nutrient content claim that has been defined by regulation in this subpart. The expressed nutrient content claim shall comply with the requirements of § 381.413 and with the requirements in subpart Y of this part which define the particular nutrient content claim that is used. The poultry product shall comply with the relevant standard in this part in all other respects, except as provided in paragraphs (b) and (c) of this section.
(b) Performance characteristics. The performance characteristics, such as physical properties, functional properties, and shelf-life, of the poultry product shall be similar to those of the standardized poultry product produced under subpart P of this part. If there is a significant difference in a performance characteristic that materially limits the use of the product compared to the use of the standardized product defined in subpart P of this part, the label shall include a statement in accordance with § 381.413(d)(1) and (2) of this part, that informs the consumer of such differences (e.g., if appropriate, “not recommended for frozen storage” or “not suitable for roller grilling”). Deviations from the ingredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim, while maintaining similar performance characteristics.
(c) Ingredients used in substitute products. (1) Ingredients used in the product shall be those ingredients provided for in the standard as defined in subpart P of this part, except that safe and suitable ingredients permitted for use in poultry products as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, may be used at the minimum level necessary to improve texture and prevent syneresis, so that the substitute product is not inferior in performance characteristics from the standardized product defined in subpart P of this part for which it is a substitute.
(2) An ingredient that is specifically required by the standard prescribed in subpart P of this part shall not be replaced or exchanged with a similar ingredient from another source, for example, extruded turnips shall not replace noodles in poultry with noodles.
(3) An ingredient that is specifically prohibited from use in any poultry product by subpart P of this part shall not be added to the substitute poultry product under this section.
(4) Unless otherwise specified in this part, a substitute poultry product must meet all other requirements of the applicable standards of identity or composition.
(5) Water and fat-replacers (e.g., binders), in combination, may be added to replace fat in accordance with paragraph (c) of this section.
(6) Textured vegetable protein may be used by itself or in combination with other binders and water as a fat replacer in accordance with paragraph (c) of this section.
(d) Nomenclature. The name of a substitute poultry product that complies with this section is the appropriate expressed nutrient content claim and the applicable standardized term.
(e) Label declaration. (1) Each of the ingredients used in the substitute poultry product shall be declared on the label as required by this section and subpart N of this part.
(2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in subpart P of this part, shall be identified as such with an asterisk in the ingredients statement. The statement “*Ingredients not in regular __________” (the blank shall be filled in with the name of the traditional standardized product) or “**Ingredients in excess of amounts permitted in regular __________” (the blank shall be filled in with the name of the traditional standardized product), or both, as appropriate, shall immediately follow the ingredients statement in the same type and size.
(a) “Mechanically Separated (Kind of Poultry)” is any product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle and other tissue of poultry carcasses and parts of carcasses that has a paste-like form and consistency, that may or may not contain skin with attached fat and meeting the other provisions of this section. Examples of such product are “Mechanically Separated Chicken” and “Mechanically Separated Turkey.”
(b) “Mechanically Separated (Kind of Poultry)” shall not have a bone solids content of more than 1 percent. At least 98 percent of the bone particles present in “Mechanically Separated (Kind of Poultry) “ shall have a maximum size no greater than 1.5 mm (millimeter) in their greatest dimension and there shall be no bone particles larger than 2.0 mm in their greatest dimension.
(c) “Mechanically Separated (Kind of Poultry)” shall not have a calcium content exceeding 0.235 percent when made from mature chickens or from turkeys as defined in § 381.170(a)(l)(vi) and (vii) and (a)(2), respectively, or 0.175 percent when made from other poultry, based on the weight of product that has not been heat treated, as a measure of a bone solids content of not more than 1 percent.
(d) “Mechanically Separated (Kind of Poultry)” may be used in the formulation of poultry products in accordance with § 381.174 and meat food products in accordance with subchapter A of this chapter.
(e) Product resulting from the mechanical separation process that fails to meet the bone particle size or calcium content requirements for “Mechanically Separated (Kind of Poultry)” shall be used only in producing poultry extractives, including fats, stocks, and broths and labeled as “Mechanically Separated (Kind of Poultry) for Further Processing.”
(a) A poultry product required to be prepared from a particular kind of poultry (e.g., chicken) shall not contain “Mechanically Separated (Kind of Poultry)” described in § 381.173, that is made from any other kind of poultry (e.g., Mechanically Separated Turkey).
(b) “Mechanically Separated (Kind of Poultry)” described in § 381.173 may be used in the formulation of any poultry or meat food product, provided such use conforms with any applicable requirements of the definitions and standards of identity or composition in this subchapter or part 319 of this chapter, and provided that it is identified as “Mechanically Separated (Kind of Poultry).”
(a) Every person within any of the classes specified in paragraph (a) (1), (2), or (3) of this section is required by the Act to keep such records as are properly necessary for the effective enforcement of the Act:
(1) Any person that engages in the business of slaughtering any poultry or processing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any poultry, for commerce, for use as human food or animal food;
(2) Any person that engages in the business of buying or selling (as a poultry products broker, wholesaler, or otherwise) or transporting, in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any poultry;
(3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter.
(b) The required records are:
(1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any poultry or poultry carcass, or part or product of a poultry carcass, is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act.
(i) The name or description of the poultry or other articles;
(ii) The net weight of the poultry or other articles;
(iii) The number of outside containers;
(iv) The name and address of the buyer of the poultry or other articles sold by such person, and the name and address of the seller of the poultry or other articles purchased by such person;
(v) The name and address of the consignee or receiver (if other than the buyer);
(vi) The method of shipment;
(vii) The date of shipment; and
(viii) The name and address of the carrier.
(2) Guaranties provided by suppliers of packaging materials under § 381.144.
(3) Records of canning as required by part 431 of this chapter.
(4) Records of irradiation as required by sections 381.149 of this part.
(5) Records of nutrition labeling as required by subpart Y of this part.
(6) Records of all labeling, along with the product formula, processing procedures, and any additional documentation needed to support that the labels are consistent with the Federal meat and poultry regulations and policies on labeling, as prescribed in § 412.1 of this chapter.
Every person engaged in any business described in § 381.175(a) shall maintain the records required by § 381.175 at the place of business where such business is conducted, except that, if such person conducts such business at multiple locations, he may maintain such records at his headquarters' office. When not in actual use, all such records shall be kept in a safe place at the prescribed location in accordance with good commercial practices.
(a) Every record required to be maintained under this subpart shall be retained for a period not to exceed 2 years after December 31 of the year in which the transaction to which the record relates has occurred, and for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such record under this subpart.
(b) Records of canning as required by subpart X of this part 381, subchapter C, 9 CFR chapter III, shall be retained as required in § 381.307; except that records required by § 381.302 (b) and (c) shall be retained as required by those sections.
Representatives of the Secretary afforded access to a business specified in § 381.175 of this part (see § 300.6(b)(2) of this chapter) also must be afforded any necessary facilities (other than reproduction equipment) for the examination and copying of records and the examination and sampling of inventory.
(a) Except as provided in paragraph (c) of this section, every person that engages in business, in or for commerce, as a poultry products broker, renderer, or animal food manufacturer, or engages in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any poultry, whether intended for human food or other purposes, or engages in the business as a public warehouseman storing any such articles in or for commerce, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, shall register with the Administrator, giving such information as is required, including his name, and the address of each place of business at which, and all trade names under which he conducts such business. Such persons shall register under this section by filing with the Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, a form containing such information, within 90 days after the effective date hereof or after such later date as he begins to engage in such business if not engaged therein upon said effective date. All information submitted shall be current and correct. The registration form shall be obtained from District Enforcement Operations, Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or by calling the District Office.
(b) Whenever any change is made in the name of, or address of any place of business at which, or any trade name under which a registrant conducts his business, he shall report such change in writing to the Administrator within 15 days after making the change.
(c) The registration requirements prescribed in this section shall not apply to persons conducting any of the businesses specified in this section only at an official establishment.
(a) The operator of each official establishment shall furnish to Program employees accurate information as to all matters needed by them for making their daily reports of the amount of products prepared or handled in the departments of the establishment to which they are assigned and such reports concerning sanitation, mandatory microbiological testing, and other aspects of the operations of the establishment and the conduct of inspection thereat, as may be required by the Administrator in special cases.
(b) The operator of each official establishment shall also make such other reports as the Administrator may from time to time require under the Act.
Whenever the consignee of any poultry product which bears an official inspection legend refuses to accept delivery of such product on the grounds that it is adulterated or misbranded, the consignee shall notify the appropriate program supervisor, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, of the kind, quantity, source and present location of the product and the respects in which it is alleged to be adulterated or misbranded, and it will be a violation of the Act for any person to sell or transport, or offer for sale or transportation or receive for transportation, in commerce, any such product which is capable of use as human food and is in fact adulterated or misbranded at the time of such sale, transportation, offer, or receipt: Provided, That any such allegedly adulterated or misbranded product may be transported to any official establishment for reinspection.
Reports of the inspection work carried on within official establishments shall be forwarded to the Administrator by the inspector in charge in such a manner as may be specified by the Administrator.
(a) The Administrator is authorized, under paragraph (a) of section 5 of the Act, when he determines it would effectuate the purposes of the Act, to cooperate with any State (including Puerto Rico) or any organized territory in developing and administering the poultry product inspection program of such jurisdiction, with a view to assuring that it imposes and enforces requirements at least equal to those under sections 2 through 4, 6 through 10, and 12 through 22 of the Act, with respect to establishments at which poultry are slaughtered or poultry products are processed for use as human food, solely for distribution within such jurisdiction, and with respect to the poultry products of such establishments. Such cooperation is authorized if the jurisdiction has enacted a mandatory law imposing ante mortem and post mortem inspection, reinspection, and sanitation requirements (at least equal to those under the Federal Act), with respect to all or certain classes of persons engaged in slaughtering poultry or otherwise processing poultry products for use as human food solely for distribution within such jurisdiction.
(b) The Administrator is also authorized under paragraph (a) of section 5 of the Act, to cooperate with any State (including Puerto Rico) or any organized territory in developing and administering programs under the laws of such jurisdiction containing authorities at least equal to those provided in section 11 of the Act (relating to records; registration of specified classes of operators; dead, dying, disabled, or diseased poultry; and products not intended for human food) when he determines that such cooperation would effectuate the purposes of the Act.
(c) Such cooperation may include advisory assistance, technical and laboratory assistance and training, and financial aid. The Federal contribution to any State (or territory) for any year shall not exceed 50 percent of the estimated total cost of the cooperative State (or territorial) program. A cooperative program under this section is called a State-Federal program.
Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized under stated conditions to utilize employees and facilities of any State in carrying out Federal functions under the Poultry Products Inspection Act. A cooperative program for this purpose is called a Federal-State program. Under paragraph (a) of section 5 of the Poultry Products Inspection Act, the Administrator is also authorized to conduct examinations, investigations, and inspections under the Act through any officer or employee of any State or territory or the District of Columbia commissioned by him for such purpose.
(a) The Administrator is authorized under 21 U.S.C. 472(b) to coordinate with States that have poultry products inspection programs as provided in § 381.185 of this subpart to select certain establishments operating under these programs to participate in a cooperative program to ship poultry products in interstate commerce. A cooperative program for this purpose is called a “cooperative interstate shipment program.”
(b) Establishments selected to participate in a cooperative interstate shipment program described in this section must receive inspection services from designated State personnel that have been trained in the enforcement of the Act. If the designated personnel determine that the poultry products prepared in establishments selected to participate in the cooperative interstate shipment program comply with all requirements under the Act, these items will bear an official Federal mark of inspection and may be shipped in interstate commerce. The Administrator will assign an FSIS “selected establishment coordinator,” who will be an FSIS employee, to each State that participates in a cooperative interstate shipment program to provide Federal oversight of the program and enforcement of the program's requirements. The Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this section will be at least 60 percent of eligible State costs. Eligible State costs are those costs that a State has justified and FSIS has approved as necessary for the State to provide inspection services to selected establishments in the State.
(c) Subpart Z, of this part 381 prescribes conditions under which States and establishments may participate in the cooperative interstate shipment program.
(d) The Administrator will terminate a cooperative interstate shipment agreement with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Act and the implementing regulations in this chapter.
The provisions of this subpart do not apply:
(a) To dead, dying, disabled or diseased poultry and specimens of undenatured, uninspected or adulterated carcasses, parts, or products of poultry sent to or by the Department of Agriculture or divisions thereof in Washington, DC, or elsewhere, for laboratory examination, exhibition purposes, or other official use;
(b) To dead, dying, disabled or diseased poultry and specimens of undenatured, uninspected or adulterated carcasses, parts, or products of poultry thereof for educational, research, or other nonfood purposes shipped under permit issued by the inspector in charge upon his determination that collection and movement thereof will not interfere with inspection or sanitary conditions at the establishment, and the specimens are for nonfood purposes. The person desiring such specimens shall make a written application to the inspector in charge for such permit on Form MP-112 and shall obtain permission from the operator of the official establishment to obtain the specimens. Permits shall be issued for a period not longer than one year. The permit may be revoked by the inspector in charge if he determines after notice and opportunity to present views is afforded to the permittee that any such specimens were not used as stated in the application, or if the collection or handling of the specimens interferes with inspection or the maintenance of sanitary conditions in the establishment. The specimens referred to in this paragraph shall be collected and handled only at such time and place and in such manner as not to interfere with the inspection or to cause any objectionable condition and shall be identified as inedible when they leave the establishment.
(c) To parts of poultry carcasses that are naturally inedible by humans, such as entrails and feathers in their natural state.
(a) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce or from any official establishment, any slaughtered poultry from which the blood, feathers, feet, head, or viscera have not been removed in accordance with the regulations.
(b)(1) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any slaughtered poultry or other poultry product which is capable of use as human food and is adulterated or fails to bear an official inspection legend or is otherwise misbranded at the time of such sale, transportation, offer or receipt, except as otherwise provided in this paragraph (b) and subpart C or T.
(2)(i) Poultry heads and feet that are collected and handled at an official establishment in an acceptable manner may be shipped from the official establishment directly for export as human food, if they have been examined and found to be suitable for such purpose, by an inspector and are labeled as prescribed in this paragraph.
(ii) The containers of all such products shall bear a label showing: (A) The name of the products; (B) the name and address of the packer or distributor, and, when the name of the distributor is shown, it shall be qualified by such terms as “packed for,” “distributed by,” or “distributors”; and (C) the official establishment number of the establishment where packed.
(iii) Such products shall not bear the official inspection legend.
(3)(i) Poultry heads and feet that are collected and handled at an official establishment in an acceptable manner may be shipped from the official establishment and in commerce directly to another official establishment for processing before export, provided the receiving establishment maintains records that:
(A) Identify the source of the incoming undenatured poultry product;
(B) Identify the location of the product at all times during processing and preparation for export; and
(C) Contain a written certification from an official of the receiving establishment that the undenatured poultry product intended for export has not been, and will not be, commingled with any product intended for consumption in the United States.
(ii) The receiving establishment may only ship the undenatured poultry product intended for export in accordance with the inspection and labeling requirements of paragraph (b)(2) of this section.
(c) No person, engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, poultry products capable of use as human food, or importing such articles, shall transport, offer for transportation, or receive for transportation, in commerce or in any State designated under § 381.221, any poultry product which is capable of use as human food and is not wrapped, packaged, or otherwise enclosed to prevent adulteration by airborne contaminants, unless the railroad car, truck, or other means of conveyance in which the product is contained or transported is completely enclosed with tight fitting doors or other covers for all openings. In all cases, the means of conveyance shall be reasonably free of foreign matter (such as dust, dirt, rust, or other articles or residues), and free of chemical residues, so that product placed therein will not become adulterated. Any cleaning compound, lye, soda solution, or other chemical used in cleaning the means of conveyance must be thoroughly removed from the means of conveyance prior to its use. Such means of conveyance onto which product is loaded, being loaded, or intended to be loaded, shall be subject to inspection by an inspector at any official establishment. The decision whether or not to inspect a means of conveyance in a specific case, and the type and extent of such inspection shall be at the Inspection Service's discretion and shall be adequate to determine if poultry product in such conveyance is, or when moved could become, adulterated.
For the purpose of facilitating the distribution in commerce of inspected poultry products to small lot buyers (such as small restaurants), distributors or jobbers may remove inspected and passed non-consumer-packaged poultry carcasses or consumer-packaged poultry products from shipping containers or immediate containers, other than consumer packages, and place them into other containers which do not bear an official inspection mark: Provided, That the individual non-consumer-packaged carcasses bear the official inspection legend and the official establishment number of the establishment that processed the articles; and the consumer-packaged articles are fully labeled in accordance with subpart N: And provided further, That the other container is marked with the name and address of the distributor or jobber and bears the statement “The poultry product contained herein was inspected by the U.S.D.A.” in the case of poultry products processed in the United States, or the statement “The poultry products contained herein have been approved for importation under P.P.I.A.” in the case of imported poultry products.
No carrier shall be subject to the penalties of the Act, other than the penalties for violation of section 11, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier, of poultry or poultry products, owned by another person, unless the carrier has knowledge, or is in possession of facts which would cause a reasonable person to believe that such poultry or poultry products were not inspected or marked in accordance with the provisions of the Act or where otherwise not eligible for transportation under the Act, or unless the carrier refuses to furnish on request of a representative of the Secretary, the name and address of the person from whom he received such poultry or poultry products, and copies of all documents, if any there be, pertaining to the delivery of the poultry or poultry products to such carrier.
(a) Except as provided in paragraph (b) of this section, poultry carcasses, and parts and products thereof, that are not intended for use as human food may, after they have been denatured as prescribed in § 381.95, be bought, sold, transported, offered for sale or transportation, or received for transportation, in commerce, or imported, even though they do not comply with all the provisions of the regulations, provided they are marked “Not fit for human food.” These requirements do not apply to parts of poultry carcasses that are naturally inedible by humans, such as entrails.
(b)(1) Except as provided in paragraphs (b) (2), (3), and (4) of this section, no animal food processed, in whole or in part, from materials derived from the carcasses of poultry in an official establishment or elsewhere, shall be bought, sold, transported, offered for sale or transportation, or received for transportation in commerce, or imported, unless:
(i) It is properly identified as animal food;
(ii) It is not represented as being a human food; and
(iii) It has been denatured as prescribed in § 381.95 so as to be readily distinguishable from an article of human food.
(2) Notwithstanding the provisions of paragraph (b)(1) of this section, an animal food that consists of less than 5 percent of parts or products of the carcasses of poultry and that is not represented by labeling or appearance or otherwise as being a human food or as a product of the poultry industry need not be denatured in accordance with § 381.95.
(3) Notwithstanding the provisions of paragraph (b)(1) of this section, animal food packed in hermetically sealed, retort processed, conventional retail-size containers, and retail-size packages of semi-moist animal food need not be denatured in accordance with § 381.95 if the name of the article clearly conveys the article's intended use for animal food and appears on the label in a conspicuous manner.
(i) Except as provided in paragraph (ii) of paragraph (b)(3) of this section, the name of the article must be stated on the label as “Animal Food,” “Pet Food,” or “(name of species) Food” (e.g., “Dog Food” or “Cat Food”). To be considered conspicuous, the name of the article, wherever it appears on the label, must be stated in letters at least twice as high, wide, and thick as the letters indicating the presence in the article of any ingredients derived from carcasses of poultry.
(ii) Notwithstanding the provisions of paragraph (i) of paragraph (b)(3) of this section, the article's name may be stated on the label to show that it is or contains poultry carcass-source material and that the article is for animals; e.g., “Chicken for Pets” or “Turkey Dinner for Cats”: Provided, That the entire name of the article is stated, wherever it appears on the label, as an individual, contiguous unit, whether stated on a single line or more than one line, and the letters denoting the article's intended use for animal food are at least as high, wide, and thick as the letters indicating the presence of material derived from any poultry carcass. However, when the label bears on its principal display panel a vignette which pictures, in clearly recognizable form and size, one or more animals of the species for which the article's name indicates the article is intended, the letters used to state the article's intended use shall be at least one-half as high, wide, and thick as the letters used in the article's name or other letters indicating the presence of material derived from any poultry carcass, but shall not be less than
(iii) Letters used to denote the intended use of the article must contrast as markedly with their background as the letters indicating the presence in the article of poultry carcass-source material contrast with their background.
(4) The requirements of this part do not apply to livestock or poultry feed manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate), or to processed dry animal food.
No person engaged in the business of buying, selling, or transporting in commerce, or importing any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter shall:
(a) Sell, transport, offer for sale or transportation or receive for transportation, in commerce, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, unless such poultry and parts are consigned and delivered, without avoidable delay, to establishments of animal food manufacturers, renderers, or collection stations that are registered as required by § 381.179, or to official establishments that operate under Federal inspection, or to establishments that operate under a State or Territorial inspection system approved by the Secretary as one that imposes requirements at least equal to the Federal requirements for purposes of section 5(c) of the Act.
(b) Buy in commerce or import any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter, unless he is an animal food manufacturer or renderer and is registered as required by § 381.179, or is the operator of an establishment inspected as required by paragraph (a) of this section and such poultry or parts of carcasses are to be delivered to establishments eligible to receive them under paragraph (a) of this section.
(c) Unload en route to any establishment eligible to receive them under paragraph (a) of this section, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter, which are transported in commerce or imported by any such person: Provided, That any such dead, dying, disabled, or diseased poultry, or parts of carcasses may be unloaded from a means of conveyance en route where necessary in case of a wreck or otherwise extraordinary emergency, and may be reloaded into another means of conveyance; but in all such cases, the carrier shall immediately report the facts by telegraph or telephone to the Director, Compliance Staff, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(a) When used in this part, the following terms are defined to mean:
(1) Import (imported). To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.
(2) Offer(ed) for entry. The point at which the importer presents the imported product for reinspection.
(3) Entry (entered). The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 381.204.
(b) No slaughtered poultry, or parts or products thereof, shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, adulterated, or unfit for human food and they also comply with the regulations prescribed in this subpart to assure that they comply with the standards provided for in the Act: Provided, That the provisions of this subpart apply to such articles only if they are capable of use as human food.
(c) Except as provided in § 381.207, slaughtered poultry and other poultry products may be imported only if they were processed solely in countries found eligible to export poultry products to the United States under § 381.196(b). Slaughtered poultry may be imported only if it qualifies as ready-to-cook poultry.
(a)(1) Whenever it shall be determined by the Administrator that the system of poultry inspection maintained by any foreign country, with respect to establishments preparing products in such country for export to the United States, insures compliance of such establishments and their poultry products, with requirements equivalent to all the provisions of the Act and the regulations in this part which are applied to official establishments in the United States, and their poultry products, and that reliance can be placed upon certificates required under this subpart from authorities of such foreign country, notice of that fact will be given in accordance with paragraph (b) of this section. Thereafter, poultry products processed in such establishments which are certified and approved in accordance with paragraph (a)(3) of this section shall be eligible, so far as the regulations in this part are concerned, for importation into the United States from such foreign country after applicable requirements of this part have been met.
(2) The determination of acceptability of a foreign poultry inspection system for purposes of this section shall be based on an evaluation of the foreign program in accordance with the following requirements and procedures:
(i) The system shall have a program organized and administered by the national government of the foreign country. The system as implemented must provide standards equivalent to those of the Federal system of poultry inspection in the United States with respect to:
(A) Organizational structure and staffing, so as to insure uniform enforcement of the requisite laws and regulations in all establishments throughout the system at which poultry products are processed for export to the United States;
(B) Ultimate control and supervision by the national government over the official activities of all employees or licensees of the system;
(C) The assignment of competent, qualified inspectors;
(D) Authority and responsibility of national inspection officials to enforce the requisite laws and regulations governing poultry inspection and to certify or refuse to certify poultry products intended for export;
(E) Adequate administrative and technical support;
(F) The inspection, sanitation, quality, species verification, and residue standards applied to products produced in the United States.
(G) Other requirements of adequate inspection service as required by the regulations.
(ii) The legal authority for the system and the regulations thereunder shall impose requirements equivalent to those governing the system of poultry inspection organized and maintained in the United States with respect to:
(A) Ante mortem inspection of poultry for slaughter, which shall be performed by veterinarians or by other employees or licensees of the system under the direct supervision of veterinarians;
(B) Post mortem inspection of carcasses and parts thereof at time of slaughter, performed by veterinarians or other employees or licensees of the system under the direct supervision of veterinarians;
(C) Official controls by the national government over establishment construction, facilities, and equipment;
(D) Direct and continuous official supervision of slaughtering of poultry and processing of poultry products, by the assignment of inspectors to establishments certified under paragraph (a)(3) of this section to assure that adulterated or misbranded poultry products are not processed for export to the United States;
(E) Complete separation of establishments certified under subparagraph (3) of this paragraph from establishments not certified, and the maintenance of a single standard of inspection and sanitation throughout all certified establishments;
(F) Requirements for sanitation at certified establishments and for sanitary handling of poultry products;
(G) Official controls over condemned material until destroyed or removed and thereafter excluded from the establishment;
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as set forth in part 417 of this chapter.
(I) Other matters for which requirements are contained in the Act or the regulations in this part.
(iii) Countries desiring to establish eligibility for importation of poultry products into the United States may request a determination of eligibility by presenting copies of the laws and regulations on which the foreign poultry inspection system is based and such other information as the Administrator may require with respect to matters enumerated in paragraphs (a)(2) (i) and (ii). Determination of eligibility is based on a study of the documents and other information presented and an initial review of the system in operation by a representative of the Department using the criteria listed in paragraphs (a)(2) (i) and (ii) of this section. Maintenance of eligibility of a country for importation of poultry products into the United States depends on the results of periodic reviews of the foreign poultry inspection system in operation by a representative of the Department, and the timely submission of such documents and other information related to the conduct of the foreign inspection system as the Administrator may find pertinent to and necessary for the determinations required by this section.
(iv) The foreign inspection system must maintain a program to assure that the requirements referred to in this section, equivalent to those applicable to the Federal system in the United States, are being met. The program as implemented must provide for the following:
(A) Periodic supervisory visits by a representative of the foreign inspection system to each establishment certified in accordance with paragraph (a)(3) of this section to ensure that requirements referred to in paragraphs (a)(2)(ii)(A) through (H) of this section are being met: Provided, That such visits are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States;
(B) Written reports prepared by the representative of the foreign inspection system who has conducted a supervisory visit, documenting his or her findings with respect to the requirements referred to in paragraphs (a)(2)(ii)(A) through (a)(2)(ii)(H) of this section, copies of which shall be made available to the representative of the Department at the time of the representative's review upon request by that representative to a responsible foreign inspection official: Provided, that such reports are not required during a period when the establishment is not operating or not engaged in producing products for exportation to the United States.
(C) Random sampling and testing at the point of slaughter of carcasses, including internal organs and fat, for residues identified by the exporting country's inspection authorities or by this Agency as potential contaminants, in accordance with sampling and analytical techniques approved by the Administrator: Provided, that such testing is required only on samples taken of carcasses from which poultry or poultry products intended for importation into the United States are produced.
(3) Only those establishments that are determined and certified to the Agency by a responsible official of the foreign meat inspection system as fully meeting the requirements of paragraphs (a)(2)(i) and (ii) of this section are eligible to have their products imported into the United States. Establishment eligibility is subject to review by the Agency (including observations of the establishments by Program representatives at times prearranged with the foreign meat inspection system officials). Foreign establishment certifications must be renewed annually. Notwithstanding certification by a foreign official, the Administrator may terminate the eligibility of any foreign establishment for the importation of its products into the United States if it does not comply with the requirements listed in paragraphs (a)(2)(i) and (ii) of this section, or if current establishment information cannot be obtained. The Administrator will provide reasonable notice to the foreign government of the proposed termination of any foreign establishment, unless a delay in terminating its eligibility could result in the importation of adulterated or misbranded product.
(i) For a new establishment or any establishment for which information from last year's electronic certification or paper certificate has changed, the certification or certificate must contain: The date; the foreign country; the foreign establishment's name, address, and foreign establishment number; the foreign official's title; the foreign official's signature (for paper certificates only); the type of operation(s) conducted at the establishment (e.g., slaughter, processing, storage, exporting warehouse); and the establishment's eligibility status (e.g., new or relisted (if previously delisted)). Slaughter and processing establishment certifications must address the species and type of products produced at the establishment (e.g., the process category).
(ii) If the establishment information provided on the preceding year's electronic foreign establishment certification or paper certificate, as required in paragraph (a)(3)(i) of this section, has not changed, the certification or certificate must contain: The date, the foreign country, the foreign establishment's name, the foreign official's title and signature (for paper certificates only).
(4) Poultry products from foreign countries not deemed eligible in accordance with paragraph (b) of this section may not be imported into the United States, except as provided by §§ 381.207 and 381.209. Eligibility of any foreign country under this section may be withdrawn whenever the Administrator determines that the system of poultry inspection maintained by such foreign country does not assure compliance with requirements equivalent to all the requirements of the Act and the regulations as applied to official establishments in the United States; or that reliance cannot be placed upon certificates required under this subpart from authorities of such foreign country; or that, for lack of current information concerning the system of poultry inspection being maintained by such foreign country, such foreign country should be required to reestablish its eligibility.
(b) A list of countries eligible to export specific process categories of poultry products to the United States is maintained at http://www.fsis.usda.gov/importlibrary. Such products from listed countries must be accompanied by inspection certificates of the country of origin, as required by § 381.197, and are eligible under the regulations in this subpart for entry into the United States, after inspection and marking as required by the applicable provisions of this subpart.
(a) Except as provided in §§ 381.207 and 381.209, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.
(b) An official of the foreign government must certify that any product described on any official certificate was produced in accordance with the regulatory requirements in § 381.196.
(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment, and be available to import inspection personnel.
(d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; and bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue inspection certificates for products imported to the United States.
(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign establishment number;
(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;
(4) The product's description, including the process category, the product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or identification mark on the units;
(8) The net weight of each lot; and
(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.
(a) Applicants must submit an import inspection application to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 381.207 and 381.209.
(a)(1) Except as provided in § 381.209 and paragraph (c) of this section, all slaughtered poultry and poultry products offered for entry from any foreign country shall be reinspected by a Program import inspector before they shall be allowed entry into the United States.
(2) Every lot of product shall routinely be given visual inspection for appearance and condition, and checked for certification and label compliance.
(3) The electronic inspection system shall be consulted for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.
(4) When the inspector deems it necessary, the inspector may sample and inspect lots not designated by the electronic inspection system.
(b) Inspectors may take, without cost to the United States, from each consignment of poultry products offered for entry, such samples of the products as are deemed necessary to determine the eligibility of the products for entry into the commerce of the United States.
(c) Poultry products imported under § 381.207 shall not be sampled and inspected under this section unless there is reason for suspecting the presence therein of a substance in violation of that section, and in such case they shall be sampled and inspected in accordance with paragraph (a) of this section.
(d) In addition to the provisions specified in paragraphs (a), (b), and (c) of this section, the following requirements apply to imported canned product.
(1) Imported canned products are required to be sound, healthful, properly labeled, wholesome, and otherwise not adulterated at the time the products are offered for importation into the United States. Provided other requirements of this part are met, the determination of the acceptability of the product and the condition of the containers shall be based on the results of an examination of a statistical sample drawn from the consignment as provided in paragraph (a) of this section. If the inspector determines, on the basis of the sample examination, that the product does not meet the requirements of the Act and regulations thereunder, the consignment shall be refused entry. However, a consignment rejected for container defects but otherwise acceptable may be reoffered for inspection under the following conditions:
(i) If the defective containers are not indicative of an unsafe or unstable product as determined by the Administrator;
(ii) If the number and kinds of container defects found in the original sample do not exceed the limits specified for this purpose in FSIS guidelines; and
(iii) If the defective containers in the consignment have been sorted out and exported or destroyed under the supervision of an inspector.
(2) Representative samples of canned product designated by the Administrator in instructions to inspectors shall be incubated under the supervision of such inspectors in accordance with § 381.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and (d)(1)(viii) of this subchapter. The importer or his/her agent shall provide the necessary incubation facilities in accordance with § 381.309(d)(1)(i) of this subchapter.
(3) Sampling plans and acceptance levels as prescribed in paragraphs (d)(1) and (d)(2) of this section may be obtained, upon request, from International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(e) All products, required by this part to be inspected, shall be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section. Such approved official import inspection establishments will be listed in the Meat, Poultry and Egg Product Inspection Directory, published by the Food Safety and Inspection Service. The listing will categorize the kind or kinds of product which may be inspected at each official import inspection establishment, based on the adequacy of the facilities for making such inspections and handling such products in a sanitary manner.
(f) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application shall be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and shall include all information called for by that form.
(g) Approval for Federal import inspection shall be in accordance with subpart D of this part.
(h) Owners or operators of establishments at which import inspections of product are to be made shall furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 381.21 and 381.36, and part 416 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments.
(i) The Administrator is authorized to approve any establishment as an official import inspection establishment provided that an application has been filed and drawings have been submitted in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(j) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may also be withdrawn in accordance with section 401 of the Act and applicable rules of practice.
(k) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment.
(a) No slaughtered poultry or other poultry product required by this subpart to be inspected shall be released from customs custody prior to inspection, but such product may be delivered to the consignee, or his agent, prior to inspection, if the consignee shall furnish a bond, in form prescribed by the Secretary of the Treasury, conditioned that the product shall be returned, if demanded, to the collector of the port where the same is offered for clearance through the customs.
(b) Except as provided in paragraph (a) of this section, no product required by this subpart to be inspected shall be moved, prior to inspection, from the port of arrival where first unloaded, and if arriving by water, from the wharf where first unloaded at such port, to any place other than the place designated in accordance with this subpart as the place where the same shall be inspected; and no product shall be conveyed in any manner other than in compliance with this subpart.
(c) The consignee, or his agent, shall furnish such facilities and shall provide such assistance for handling and marking poultry products offered for entry as the inspector may require.
Compartments of steamships, railroad cars, and other means of conveyance transporting any poultry product to the United States, and all chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any poultry product offered for entry into the United States, shall be maintained in a sanitary condition.
(a)(1) Program inspectors shall report their findings as to any product which has been inspected in accordance with this part, to the Director of Customs at the original port of entry.
(2) When product has been identified as “U.S. refused entry,” the inspector shall request the Director of Customs to refuse admission to such product and to direct that it be exported by the owner or consignee within the time specified in this section, unless the owner or consignee, within the specified time, causes it to be destroyed by disposing of it under the supervision of a Program employee so that the product can no longer be used as human food, or by converting it to animal food uses, if permitted by the Food and Drug Administration. The owner or consignee of the refused entry product shall not transfer legal title to such product, except to a foreign consignee for direct and immediate exportation, or an end user, e.g., an animal food manufacturer or a renderer, for destruction for human food purposes. “Refused entry” product must be delivered to and used by the manufacturer or renderer within the 45-day time limit. Even if such title is illegally transferred, the subsequent purchaser will still be required to export the product or have it destroyed as specified in the notice under paragraph (a)(4) of this section.
(3) No lot of product which has been refused entry may be subdivided during disposition pursuant to paragraph (a)(2) of this section, except that removal and destruction of any damaged or otherwise unsound product from a lot destined for reexportation is permitted under supervision of USDA prior to exportation. Additionally, such refused entry lot may not be shipped for export from any port other than that through which the product came into the United States without the expressed consent of the Administrator, based on full information concerning the product's disposition, including the name of the vessel and the date of export. For the purposes of this paragraph, the term “lot” shall refer to that product identified on MP Form 410 in the original request for inspection for importation pursuant to § 381.198.
(4) The owner or consignee shall have 45 days after notice is given by FSIS to the Director of Customs at the original port of entry to take the action required in paragraph (a)(2) of this section for “refused entry” product. Extension beyond the 45-day period may be granted by the Administrator when extreme circumstances warrant it; e.g., a dock workers' strike or an unforeseeable vessel delay.
(5) If the owner or consignee fails to take the required action within the time specified under paragraph (a)(4) of this section, the Department will take such actions as may be necessary to effectuate its order to have the product destroyed for human food purposes. The Department shall seek court costs and fees, storage, and proper expenses in the appropriate forum.
(6) No product which has been refused entry and exported to another country pursuant to paragraph (a)(2) of this section may be returned to the United States under any circumstance. Any such product so returned to the United States shall be subject to administrative detention in accordance with section 19 of the Act, and seizure and condemnation in accordance with section 20 of the Act.
(b) Upon the request of the Director of Customs at the port where a product is offered for clearance through the customs, the consignee of the product shall, at the consignee's own expense, immediately return to the Director any product which has been delivered to consignee under this subpart and subsequently designated “U.S. Refused Entry” or found in any request not to comply with the requirements in this subpart.
(c) Except as provided in § 381.200(a) or (b), no person shall remove or cause to be removed from any place designated as the place of inspection, any poultry product which the regulations in this subpart require to be marked in any way, unless the same has been clearly and legibly marked in compliance with this subpart.
(d) Any person receiving inspection service may, if dissatisfied with any decision or action of an inspector or other Agency employee relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9. The poultry or poultry products involved in any appeal must be identified by U.S. retained tags and segregated in a manner approved by the inspector or other Agency employee pending completion of an appeal inspection.
(e) All condemned carcasses, or condemned parts of carcasses, or other condemned poultry products, except those condemned for biological residues, shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service. (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishments.)
(1) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat, a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. (Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection by means of pipes, or otherwise, between tanks containing inedible products and those containing edible products.)
(2) Incineration or complete destruction by burning.
(3) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of:
(i) Crude carbolic acid,
(ii) Kerosene, fuel oil, or used crankcase oil, or
(iii) Any phenolic disinfectant conforming to commercial standards CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or solution.
(4) Any other substances or method that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section.
(5) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (e)(2) of this section or by burying under the supervision of an inspector.
All charges for storage, cartage, and labor with respect to any product offered for entry which is refused entry pursuant to the regulations shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any other products offered for entry thereafter by or for such owner or consignee.
(a) Except for products offered for entry from Canada, poultry products which upon reinspection are found to be acceptable for entry into the United States shall be marked with the official inspection legend shown in paragraph (b) of this section. Such inspection legend shall be placed upon such products only after completion of official import inspection and product acceptance.
(b) The official mark for marking poultry products offered for entry as “U.S. inspected and passed” shall be in the following form, and any device approved by the Administrator for applying such mark shall be an official device.
(c) When products are refused entry into the United States, the official mark to be applied to the products refused entry shall be in the following form:
(d) The import warning notice prescribed in § 381.200(c) is an official mark.
(e) The ordering and manufacture of brands shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations.
(f) The inspection legend may be placed on containers of product before completion of official import inspection if the containers are being inspected by an import inspector who reports to an Import Field Office Supervisor, the product is not required to be held at the establishment pending the receipt of laboratory test results; and a written procedure for controlled stamping, submitted by the import establishment and approved by the Director, Import Inspection Division, is on file at the import inspection facility where the inspection is to be performed.
(1) The written procedure for controlled pre-stamping should be in the form of a letter and shall include the following:
(i) That stamping under this subpart will be limited to those lots of product which can be inspected on the day that certificates for the product are examined;
(ii) That all products which have been pre-stamped will be stored in the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and
(iv) That the establishment will maintain a daily stamping log containing the following information for each lot of product: the date of inspection, the country of origin, the foreign establishment number, the product name, the number of units, the shipping container marks, and the MP-410 number covering the product to be inspected. The daily stamping log must be retained by the establishment in accordance with the requirements of § 381.177.
(2) An official import establishment's controlled pre-stamping privilege may be cancelled orally or in writing by the inspector or other Agency employee who is supervising its enforcement whenever the employee finds that the official import establishment has failed to comply with the provisions of this part or any conditions imposed pursuant thereto. If the cancellation is oral, the decision or action and the reasons therefor will be confirmed in writing, as promptly as circumstances allow. Any person whose controlled pre-stamping privilege has been cancelled may appeal the decision or action in accordance with 9 CFR 500.9. The appeal must state all of the facts and reasons upon which the person relies to show that the controlled pre-stamping privilege was wrongfully cancelled.
(a) Immediate containers of poultry products imported into the United States shall bear a label printed in English showing in accordance with subpart N of this part all information required by that section (except that the inspection mark and establishment number assigned by the foreign poultry inspection system and certified to the Inspection Service shall be shown instead of the official dressed poultry identification mark or other official inspection legend, and official establishment number); and in addition the label shall show the name of the country of origin preceded by the words “Product of,” which statement shall appear immediately under the name of the product.
(b) The labels shall not be false or misleading in any respect.
(c) All marks and other labeling for use on or with immediate containers must be approved for use by the Food Safety and Inspection Service in accordance with part 412 of this chapter before products bearing such marks and other labeling will be permitted for entry into the United States.
Shipping containers of imported poultry products are required to bear in a prominent and legible manner the name of the product, the name of the country of origin, the foreign inspection system establishment number of the establishment in which the product was processed, and the inspection mark of the country of origin. Labeling on shipping containers shall be examined at the time of inspection in the United States and if found to be false or misleading, the product shall be refused entry. All labeling used with a shipping container of imported poultry products must be approved in accordance with subpart N of this part.
Any poultry product (other than one which is forbidden entry by other Federal law or regulation) from any country in quantities of less than 50 pounds net weight, exclusively for the personal use of the consignee, or for display or laboratory analysis by the consignee, and not for sale or distribution; which is sound, healthful, wholesome, and fit for human food, and which is not adulterated and contains no substance not permitted by the Act or regulations, may be imported into the United States without a foreign inspection certificate, and such product is not required to be inspected upon arrival in the United States and may be shipped to the consignee without further restriction under this part, except as provided in § 381.199(c): And provided, That the Department may with respect to any specific importation, require that the consignee certify that such product is exclusively for the personal use of said consignee, or for display or laboratory analysis by said consignee, and not for sale or distribution.
(a) All poultry products, after entry into the United States in compliance with this subpart, shall be deemed and treated and, except as provided in § 381.207, shall be handled and transported as domestic products, and shall be subject to the applicable provisions of this part and to the provisions of the Poultry Products Inspection Act and the Federal Food, Drug, and Cosmetic Act.
(b) Poultry products entered in accordance with this subpart may, subject to the provisions of the regulations, be taken into official establishments and be mixed with or added to poultry products that are inspected and passed or exempted from inspection in such establishments.
(c) Imported poultry products which have been inspected, passed, and marked under this subpart may be transported in commerce, only upon compliance with the applicable regulations.
Poultry products which have been inspected and passed by the U.S. Department of Agriculture and are so marked, and are returned from foreign countries, may be imported if they are not adulterated or misbranded at the time of such return. Such products are exempted from further requirements under this part. Such returned shipments shall be reported to the Administrator by letter prior to arrival at the United States port of entry.
Any poultry carcass, or part thereof; or any product made wholly or in part from any poultry carcass or part thereof; or any dead, dying, disabled, or diseased poultry is subject to detention for a period not to exceed 20 days when found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in commerce or otherwise subject to the Act, and there is reason to believe that any such poultry or other article is adulterated or misbranded and is capable of use as human food or has not been inspected, in violation of the provisions of the Act, any other Federal law, or the laws of any State or territory, or the District of Columbia; or that it has been or is intended to be distributed in violation of the provisions of the Act, any other Federal law, or the laws of any State or territory, or the District of Columbia.
An authorized representative of the Secretary shall detain any poultry or other article to be detained under this subpart, by affixing an official “U.S. Detained” tag (FSIS Form 8400-2) to such article.
(a) When any poultry or other article is detained under this subpart, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the poultry or other article detained, and
(2) Promptly furnish a copy of a completed “Notice of Detention” (FSIS Form 8080-1) to the immediate custodian of the detained poultry or other article.
(b) If the owner of the detained poultry or other article, or the owner's agent, is not the immediate custodian at the time of detention and if the owner, or owner's agent, can be ascertained and notified, an authorized representative of the Secretary shall furnish a copy of the completed “Notice of Detention” to the owner, or the owner's agent. Such copy shall be served, as soon as possible, by delivering the notification to the owner, or the owner's agent, or by certifying and mailing the notification to the owner, or the owner's agent, at his or her last known residence or principal office or place of business.
Within 48 hours after the detention of any poultry or other article pursuant to § 381.211, an authorized representative of the Secretary shall give oral or written notification of such detention to any Federal authorities not connected with the Inspection Service, and any State or other governmental authorities, having jurisdiction over such article. In the event notification is given orally, it shall be confirmed in writing, as promptly as circumstances permit.
(a) No poultry or other article detained in accordance with the provisions in this subpart shall be moved by any person from the place at which it is located when so detained, until released by an authorized representative of the Secretary: Provided, That any such article may be moved from the place at which it is located when so detained, for refrigeration or freezing, or storage purposes if such movement has been approved by an authorized representative of the Secretary and the article so moved will be further detained by an authorized representative of the Secretary after such movement.
(b) Upon terminating the detention of such article, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the released article, and
(2) Furnish copies of a completed “Notice of Termination of Detention” (FSIS Form 8400-1) to the persons notified when the article was detained. The notice shall be served by either delivering the notice to such persons or by certifying and mailing the notice to such persons at their last known residences or principal offices or places of business.
(c) All official marks may be required by such representative to be removed from such article before it is released unless it appears to the satisfaction of the representative that the article is eligible to retain such marks.
Any poultry carcass, or part thereof, or any product made wholly or in part from any poultry carcass or part thereof; except those exempted from the definition of a poultry product in § 381.15, or any dead, dying, disabled, or diseased poultry, that is being transported in commerce or is otherwise subject to the Act, or is held for sale in the United States after such transportation, is subject to seizure and condemnation, in a judicial proceeding pursuant to section 20 of the Act if such poultry or other article:
(a) Is or has been processed, sold, transported, or otherwise distributed or offered or received for distribution in violation of the Act; or
(b) Is capable of use as human food and is adulterated or misbranded; or
(c) In any other way is in violation of the Act.
Any poultry or other article subject to seizure and condemnation under this subpart is liable to be proceeded against and seized and condemned, and disposed of, at any time, on an appropriate pleading in any U.S. district court, or other proper court specified in section 21 of the Act, within the jurisdiction of which the article is found.
The provisions of this subpart relating to detention, seizure, condemnation and disposition of poultry or other articles do not derogate from authority for retention, condemnation, or seizure conferred by other provisions of the Act, or other laws.
The Act contains criminal provisions with respect to numerous offenses specified in the Act, including but not limited to forcible assaults on, or other interference with, any person while engaged in, or on account of the performance of, his official duties under the Act. Criminal provisions with respect to gifts or offers of bribes to such persons and related offenses are contained in the general criminal code (18 U.S.C. 201).
For purposes of this subpart, the term “State” means any State (including the Commonwealth of Puerto Rico) or organized territory.
The provisions of the regulations in this part apply to operations and transactions wholly within each State designated under paragraph 5(c) of the Act, except as otherwise provided in this section. (The provisions of the regulations apply in all respects to operations and transactions in or for commerce.)
(a) Each establishment located in such a designated State, shall be granted inspection required under § 381.6(b) only if it is found, upon a combined evaluation of its premises, facilities, and operating procedures, to be capable of producing products that are not adulterated or misbranded.
(b) Section 381.26 will apply to establishments required to have inspection under § 381.6(b), except that existing interconnections between official and unofficial establishments or between official establishments will be permitted if it is determined in specific cases that the interconnections are such that transfer of inedible poultry product into the official establishment would be difficult or unusual, and any such transfers are strictly prohibited, except as permitted under other provisions of the regulations. It is essential that separation of facilities be maintained to the extent necessary to assure that inedible poultry product does not enter the official establishment contrary to the regulations.
(c) Sections 381.49 and 381.51 shall apply to such establishments, except that separate facilities for men and women workers will not be required when the majority of the workers in the establishment are related by blood or marriage, provided that this will not conflict with municipal or State requirements; and except that separation of toilet soil lines from house drainage lines to a point outside the buildings will not be required in existing construction when positive acting backflow devices are installed.
(d) Subpart N of this part shall apply to such establishments except as provided in this paragraph (d).
(1) The operator of each such establishment shall, prior to the inauguration of inspection, identify all labeling and marking devices in use, or proposed for use (upon the date of inauguration of inspection) to the Front Line Supervisor in which the establishment is located. Temporary approval, pending formal approval under § 412.1 of this chapter, will be granted by the Front Line Supervisor for labeling and marking devices that he determines are neither false nor misleading, provided the official inspection legend bearing the official establishment number is applied to the principal display panel of each label, either by a mechanical printing device or a self-destructive pressure sensitive sticker, and provided the label shows the true product name, an accurate ingredient statement, the name and address of the manufacturer, packer, or distributor, and any other features required by section 4(h) of the Act.
(2) The Front Line Supervisor will forward one copy of each item of labeling and a description of each marking device for which he has granted temporary approval to the FSIS Labeling and Program Delivery Staff and will retain one copy in a temporary approval file for the establishment.
(3) The operator of the official establishment shall promptly forward a copy of each item of labeling and a description of each marking device for which temporary approval has been granted by the Front Line Supervisor (showing any modifications required by the Front Line Supervisor) to the FSIS Labeling and Program Delivery Staff at headquarters, accompanied by the formula and details of preparation and packaging for each product. Within 90 days after inauguration of inspection, all labeling material and marking devices temporarily approved by the Front Line Supervisor must receive approval as required by § 412.1 or their use must be discontinued.
(4) The Front Line Supervisor will also review all shipping containers to ensure that they do not have any false or misleading labeling and are otherwise not misbranded. Modifications of unacceptable information on labeling material by the use of pressure sensitive tape of a type that cannot be removed without visible evidence of such removal, or by blocking out with an ink stamp will be authorized on a temporary basis to permit the maximum allowable use of all labeling materials on hand. All unacceptable labeling material which is not modified to comply with the requirements of the regulations must be destroyed or removed from the official establishment.
(e) Sections 381.175 through 381.179 apply to operations and transactions not in or for commerce in a State designated under paragraph 5(c) only if the State is also designated under section 11 of the Act and if such provisions are applicable.
(f) Section 381.185(a) will not apply to States designated under paragraph 5(c) of the Act.
(g) Provisions of this part relating to exports and imports do not apply to operations and transactions solely in or for intrastate commerce.
Upon the effective date of designation of a State under paragraph 5(c) of the Act, no poultry products can be processed within the State unless they are prepared under inspection pursuant to the regulations or are exempted from the requirement of inspection under § 381.10, and no unexempted poultry products which were processed without any inspection can lawfully be distributed within the State. For a period of 90 days from the effective date of such designation, poultry products which were processed in any State listed in § 381.187 and inspected and passed under the supervision of a responsible State or local inspection agency or exempted from State inspection can be distributed solely within the State, provided they are not adulterated or misbranded, except that the official inspection legend shall not be used. Such products may not enter official establishments. After said 90-day period, only federally inspected and passed products may be distributed within the designated State, except as provided in § 381.10.
(a) An establishment in any State not designated under section 5(c) of the Act that is preparing poultry products solely for distribution within such State shall be designated as one producing adulterated products which would clearly endanger the public health, if:
(1) Any poultry product processed at the establishment is adulterated in any of the following respects:
(i) It bears or contains a pesticide chemical, food additive, or color additive, that is “unsafe” within the meaning of section 408, 409, or 706 of the Federal Food, Drug, and Cosmetic Act or was intentionally subjected to radiation in a manner not permitted under section 409 of said Act; or if it bears or contains any other added poisonous or added deleterious substance which may render it injurious to health or make it unfit for human food; or
(ii) It consists in whole or in part of any filthy, putrid or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food (for example, it was prepared from a poultry carcass or other ingredients exhibiting spoilage characteristics); or it is, or was prepared from, a poultry carcass which would be required to be condemned under subpart K at official establishments; or
(iii) It has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health (for example, if insects or vermin are not effectively controlled at the establishment, or insanitary water is used in preparing poultry products for human food); or
(iv) It is, in whole or in part, the product of poultry that died otherwise than by slaughter; or
(v) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; and
(2) Such adulterated articles are intended to be or are distributed from the establishment while capable of use as human food.
(b) When any such establishment is identified by an inspector as one producing adulterated poultry products which would clearly endanger public health under the criteria in paragraph (a) of this section, the following procedure will be followed:
(1) The inspector will informally advise the operator of the establishment concerning the deficiencies found by him and report his findings to the appropriate Regional Director for the Inspection Service. When it is determined by the Regional Director that any establishment preparing poultry products solely for distribution within any State is producing adulterated poultry products for distribution within such State which would clearly endanger the public health, written notification thereof will be issued to the appropriate State officials, including the Governor of the State and the appropriate Advisory Committee, for effective action under State or local law to prevent such endangering of the public health. Such written notification shall clearly specify the deficiencies deemed to result in the production of adulterated poultry products and shall specify a reasonable time for such action under State or local law.
(2) If effective action is not taken under State or local law within the specified time, written notification shall be issued by the Regional Director to the operator of the establishment, specifying the deficiencies involved and allowing him 10 days to present his views or make the necessary corrections, and notifying him that failure to correct such deficiencies may result in designation of the establishment and operator thereof as subject to the provisions of sections 1 through 4, 6 through 10, and 12 through 22 of the Act as though engaged in commerce.
(3) Thereafter the inspector shall survey the establishment and designate it if he determines, in consultation with the Regional Director, that it is producing adulterated poultry products, which would clearly endanger the public health, and formal notice of such designation will be issued to the operator of the establishment by the Regional Director.
(c) Poultry products on hand at the time of designation of an establishment under this section are subject to retention or detention, and seizure and condemnation in accordance with § 381.145 or subpart U of this part: Provided, That poultry products that have been federally inspected and so identified and that have not been further prepared at any nonfederally inspected establishment may be released for distribution if the products appear to be not adulterated or misbranded at the time of such release.
(d) No establishment designated under this section can lawfully prepare any poultry products unless it first obtains inspection or qualifies for exemption under § 381.10 of this subpart. All other provisions of the regulations shall apply to establishments designated under this section to the same extent and in the same manner as if they were engaged in commerce, except that the exceptions provided for in § 381.222 shall apply to such establishments.
(a) Nutrition labeling must be provided for all poultry products intended for human consumption and offered for sale, except single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and are not major cuts of single-ingredient, raw poultry products identified in § 381.444, unless the product is exempted under § 381.500. Nutrition labeling must be provided for the major cuts of single-ingredient, raw poultry products identified in § 381.444, either in accordance with the provisions of § 381.409 for nutrition labels, or in accordance with the provisions of § 381.445 for point-of-purchase materials, except as exempted under § 381.500. For all other products that require nutrition labeling, including ground or chopped poultry products described in § 381.401, nutrition labeling must be provided in accordance with the provisions of § 381.409, except as exempted under § 381.500.
(b) Nutrition labeling may be provided for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and that are not major cuts of single-ingredient, raw poultry products identified in § 381.444, either in accordance with the provisions of § 381.409 for nutrition labels, or in accordance with the provisions of § 381.445 for point-of-purchase materials.
Nutrition labels must be provided for all ground or chopped poultry (kind) with or without added seasonings (including, but not limited to, ground chicken, ground turkey, and (kind) burgers) that are intended for human consumption and offered for sale, in accordance with the provisions of § 381.409, except as exempted under § 381.500.
(a) Nutrition information on a label of a packaged poultry product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section.
(b) Nutrition information for gift packs may be shown at a location other than on the product label, provided that the labels for these products bear no nutrition claim. In lieu of on the product label, nutrition information may be provided by alternate means such as product label inserts.
(c) Poultry products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered.
The label of any package of a poultry product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 381.121(c)(7).
(a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section.
(b)(1) The term “serving” or “serving size” means an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the product. When the product is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, the serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply” (Reference Amount(s)) that appear in § 381.412(b) using the procedures described in this paragraph (b). For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ______ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the Reference Amounts in § 381.412(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims.
(3) The declaration of nutrient and food component content shall be on the basis of the product “as packaged” for all products, except that single-ingredient, raw products that are not ground or chopped poultry products as described in § 381.401 may be declared on the basis of the product “as consumed.” For single-ingredient, raw products that are not ground or chopped poultry products described in § 381.401, if data are based on the product “as consumed,” the data must be presented in accordance with § 381.445(d). In addition to the required declaration on the basis of “as packaged” for products other than single-ingredient, raw products that are not ground or chopped poultry products as described in § 381.401, the declaration may also be made on the basis of “as consumed,” provided that preparation and cooking instructions are clearly stated.
(4) For products in discrete units (e.g., chicken wings, and individually packaged products within a multi-serving package), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., chicken wings and barbecue sauce), the serving size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the serving size shall be the number of whole units that most closely approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent of the Reference Amount, the manufacturer may declare one unit or two units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or milliliter) or larger and are individual units within a multi-serving package, if a unit contains more than 150 percent but less than 200 percent of the Reference Amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., chicken wings and barbecue sauce), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product as determined in § 381.412(c).
(vii) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided for consumption (e.g., pizza, pan of poultry lasagna), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption, the serving size shall be the fractional slice of the ready-to-eat product (e.g.,
(6) For nondiscrete bulk products (e.g., whole turkey, turkey breast, ground poultry), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., turkey breast and gravy), the serving size shall be the amount in household measure that most closely approximates the Reference Amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product determined in § 381.412(c).
(7) For labeling purposes, the term “common household measure” or “common household unit” means cup, tablespoon, teaspoon, piece, slice, fraction (e.g.,
(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate. Cups shall be expressed in
(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece, slice, tray, jar, or fraction are not applicable, ounces may be used. Ounce measurements shall be expressed in 0.5-ounce increments most closely approximating the Reference Amount with rounding indicated by the use of the term “about” (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be used for single-serving containers and for individually packaged products within multi-serving containers (e.g., can, box, package, meal, or dinner). A description of the individual unit shall be used for other products in discrete units (e.g., wing, slice, link, or patty).
(v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., pizza kit), the fraction or portion of the package may be used.
(vi) For products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g., chicken wings with a glaze packet), the nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in § 381.412(b) and the procedures described in this section, falls exactly half way between two serving sizes (e.g., 2.5 tbsp), manufacturers shall round the serving size up to the next incremental size.
(8) A product that is packaged and sold individually and that contains less than 200 percent of the applicable Reference Amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving, except for products that have Reference Amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the Reference Amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable Reference Amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.
(9) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(8) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to paragraph (b)(11) of this section. However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments.
(iii) In addition, serving size may be declared in ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced chicken roll. The ounce quantity equivalent to the metric quantity should be expressed in 0.1-oz increments.
(iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term “about” (e.g., about 2 servings; about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size, the manufacturer may state the typical number of servings per container (e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare “varied” for the number of servings per container provided the nutrition information is based on the Reference Amount expressed in ounces. The manufacturer may provide the typical number of servings in parenthesis following the “varied” statement (e.g., varied (approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package.
(v) For packages containing several individually packaged multi-serving units, the number of servings shall be determined by multiplying the number of individual multi-serving units in the total package by the number of servings in each individual unit. The declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, including those that have been previously frozen.
(11) The declaration of nutrient and food component content shall be on the basis of product as packaged or purchased with the exception of single-ingredient, raw products that are not ground or chopped poultry products described in § 381.401 and products that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed. Declaration of the nutrient and food component content of products that are packed in liquid which is not customarily consumed shall be based on the drained solids.
(12) The serving size for meal-type products and main-dish products as defined in § 381.413(l) and § 381.413 (m) in single-serve containers will be the entire edible content of the package. Serving size for meal-type products and main-dish products in multi-serve containers will be based on the reference amount applicable to the product in § 381.412(b) if the product is listed in § 381.412(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 381.412(b) will be based on the reference amount according to § 381.412(c), (d), and (e).
(13) Another column of figures may be used to declare the nutrient and food component information in the same format as required by § 381.409(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit.
(14) If a product consists of assortments of poultry products (e.g., variety packs) in the same package, nutrient content shall be expressed on the entire package contents or on each individual product.
(15) If a product is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare the nutrient contents on the basis of the product as consumed for the product alone (e.g., a cream soup mix may be labeled with one set of Daily Values for the dry mix (per serving), and another set for the serving of the final soup when prepared (e.g., per serving of cream soup mix and 1 cup of vitamin D fortified whole milk)): Provided, that the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in labeling of a poultry product shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraph (f) or (g) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraph (d) or (e) of this section.
(1) “Calories, total,” “Total calories,” or “Calories”: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parenthesis immediately following the statement of the caloric content.
(i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given in Table 13, page 25, “Energy Value of Foods—Basis and Derivation,” by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), which is incorporated by reference. Table 13 of the “Energy Value of Foods—Basis and Derivation,” Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of 21 CFR, or by other means, as appropriate.
(ii) “Calories from fat”: A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section per serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving and amounts less than 5 calories may be expressed as zero. This statement shall be declared as provided in paragraph (d)(5) of this section.
(iii) “Calories from saturated fat” or “Calories from saturated” (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section per serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories from fat as provided in paragraph (d)(5) of this section.
(2) “Fat, total” or “Total fat”: A statement of the number of grams of total fat per serving defined as total lipid fatty acids and expressed as triglycerides. Amounts shall be expressed to the nearest 0.5 (
(i) “Saturated fat” or “Saturated”: A statement of the number of grams of saturated fat per serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat per serving if no claims are made about fat or cholesterol content, and if “calories from saturated fat” is not declared. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(A) “Stearic Acid” (VOLUNTARY): A statement of the number of grams of stearic acid per serving may be declared voluntarily, except that when a claim is made about stearic acid, label declaration shall be required. Stearic acid content shall be indented under saturated fat and expressed to the nearest 0.5 (
(B) [Reserved]
(ii) “Polyunsaturated fat” or “Polyunsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat per serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 381.462(b)(1) for a claim for “fat free,” label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(iii) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat per serving defined as cis-monounsaturated fatty acids may be declared voluntarily, except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 381.462(b)(1) for a claim for “fat free,” label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (
(3) “Cholesterol”: A statement of the cholesterol content per serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams of cholesterol per serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. If the product contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as “less than 5 milligrams.”
(4) “Sodium”: A statement of the number of milligrams of sodium per serving expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.
(5) “Potassium” (VOLUNTARY): A statement of the number of milligrams of potassium per serving may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.
(6) “Carbohydrate, total” or “Total carbohydrate”: A statement of the number of grams of total carbohydrate per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, or, if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the product. This calculation method is described in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), pages 2 and 3, which is incorporated by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.).
(i) “Dietary fiber”: A statement of the number of grams of total dietary fiber per serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required, or, alternatively, the statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(A) “Soluble fiber” (VOLUNTARY): A statement of the number of grams of soluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(ii) “Sugars”: A statement of the number of grams of sugars per serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars per serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(iii) “Sugar alcohol” (VOLUNTARY): A statement of the number of grams of sugar alcohols per serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the product, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term “sugar alcohol,” the name of the specific sugar alcohol (e.g., “xylitol”) present in the product may be used in the nutrition label, provided that only one sugar alcohol is present in the product. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(iv) “Other carbohydrate” (VOLUNTARY): A statement of the number of grams of other carbohydrate per serving may be declared voluntarily. Other carbohydrate shall be defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
(7) “Protein”: A statement of the number of grams of protein per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in products represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a product represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as percent of Daily Value. When the protein quality in a product as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a product represented or purported to be for infants, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by appropriate methods of analysis in accordance with § 381.409(h), except when the procedure for a specific food requires another factor.
(i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be for infants or children under 4 years of age. When such a declaration is provided, it shall be placed on the label adjacent to the statement of grams of protein and aligned under the column headed “Percent Daily Value,” and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the product is represented or purported to be for infants and the protein quality value is less than 40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for products represented or purported to be for adults and children 1 or more years of age is equal to the actual amount of protein (grams) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8 in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990, which is incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” as published by the Food and Agriculture Organization of the United Nations/World Health Organization, is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC 20250-3700. For products represented or purported to be for infants, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject product's protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d) through (g) of this section, products represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For products represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on products represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other products shall use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the RDI shall include vitamin A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and the vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and declared only in the ingredients statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Amounts of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).” Alternatively, if vitamin A, vitamin C, calcium, or iron is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a significant source of ________ (listing the vitamins or minerals omitted)” is placed at the bottom of the table of nutrient values.
(iv) The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:
(v) The following synonyms may be added in parenthesis immediately following the name of the nutrient or dietary component:
(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent of Daily Value of vitamin A in the product (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)”). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the following DRV's are established for the following food components based on the reference caloric intake of 2,000 calories:
| Food component | Unit of measurement | DRV |
|---|---|---|
| Fat | grams (g) | 65 |
| Saturated fatty acids | ......do | 20 |
| Cholesterol | milligrams (mg) | 300 |
| Total carbohydrate | grams (g) | 300 |
| Fiber | ......do | 25 |
| Sodium | milligrams (mg) | 2400 |
| Potassium | ......do | 3500 |
| Protein | grams (g) | 50 |
(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on products in the following format, except on products on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those products on which the simplified format is permitted to be used as provided for in paragraph (f) of this section, on products for infants and children less than 4 years of age as provided for in § 381.500(c), and on products in packages that have a total surface area available to bear labeling of 40 or less square inches as provided for in paragraph (g) of this section.
(i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of text) except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section, and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and (d)(8) of this section shall be in type size no smaller than 8 point. Except for the heading “Nutrition Facts,” the information required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other information contained within the nutrition label shall be in type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall also be in type no smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) of this section (i.e., “Nutrition Facts,” “Amount Per Serving,” and “% Daily Value*”), the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, and Protein), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted by bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall separate “Amount Per Serving” from the calorie statements required in paragraph (d)(5) of this section and shall separate each nutrient and its corresponding percent of Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent of Daily Value above and below it.
(2) The information shall be presented under the identifying heading of “Nutrition Facts” which shall be set in a type size larger than all other print size in the nutrition label and, except for labels presented according to the format provided for in paragraph (d)(11) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the heading. Such information shall include:
(i) “Serving Size”: A statement of the serving size as specified in paragraph (b)(9) of this section.
(ii) “Servings Per Container”: The number of servings per container, except that this statement is not required on single-serving containers as defined in paragraph (b)(8) of this section or on single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401.
(4) A subheading “Amount Per Serving” shall be separated from serving size information by a bar.
(5) Information on calories shall immediately follow the heading “Amount Per Serving” and shall be declared in one line, leaving sufficient space between the declaration of “Calories” and “Calories from fat” to allow clear differentiation, or, if “Calories from saturated fat” is declared, in a column with total “Calories” at the top, followed by “Calories from fat” (indented), and “Calories from saturated fat” (indented).
(6) The column heading “% Daily Value,” followed by an asterisk (e.g., “% Daily Value*”), shall be separated from information on calories by a bar. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the left of, and below, this column heading. The column heading “Percent Daily Value,” “Percent DV,” or “% DV” may be substituted for “% Daily Value.”
(7) Except as provided for in paragraph (g) of this section, and except as permitted by § 381.500(d)(2), nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label, except vitamins and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a “g” for grams or “mg” for milligrams.
(ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading “% Daily Value” established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, Iron 4%) or may be listed in two columns, except that when more than four vitamins and minerals are declared, they may be declared vertically with percentages listed under the column headed “% Daily Value.”
(9) A footnote, preceded by an asterisk, shall be placed beneath the list of vitamins and minerals and shall be separated from that list by a hairline.
(i) The footnote shall state: Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.
| Calories | 2,000 | 2,500 | |
|---|---|---|---|
| Total fat | Less than | 65 g | 80 g |
| Saturated fat | Less than | 20 g | 25 g |
| Cholesterol | Less than | 300 mg | 300 mg |
| Sodium | Less than | 2400 mg | 2400 mg |
| Total carbohydrate | 300 g | 375 g | |
| Dietary fiber | 25 g | 30 g |
(ii) If the percent of Daily Value is given for protein in the Percent of Daily Value column as provided in paragraph (d)(7)(ii) of this section, protein shall be listed under dietary fiber, and a value of 50 g shall be inserted on the same line in the column headed “2,000” and value of 65 g in the column headed “2,500.”
(iii) If potassium is declared in the column described in paragraph (d)(7)(i) of this section, potassium shall be listed under sodium and the DRV established in paragraph (c)(9) of this section shall be inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat, carbohydrate, and protein may be presented beneath the information required in paragraph (d)(9), separated from that information by a hairline. This information may be presented horizontally (i.e., “Calories per gram: Fat 9, Carbohydrate 4, Protein 4”) or vertically in columns.
(11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in paragraph (d)(9) of this section, the information required in paragraph (d)(9) may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not adequate to accommodate any remaining vitamins and minerals to be declared or the information required in paragraph (d)(9) of this section, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the percent of Daily Value information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
(iii) If there is not sufficient continuous vertical space (i.e., approximately 3 inches) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron, the nutrition label may be presented in a tabular display in which the footnote required by paragraph (d)(9) of the section is given to the far right of the label, and additional vitamins and minerals beyond the four that are required (i.e., vitamin A, vitamin C, calcium, and iron) are arrayed horizontally following declarations of the required vitamins and minerals.
(12) The following sample label illustrates the provisions of paragraph (d) of this section:
(13)(i) Nutrition labeling on the outer label of packages of poultry products that contain two or more products in the same packages (e.g., variety packs) or of packages that are used interchangeably for the same type of food (e.g., poultry salad containers) may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified to the right of the “Nutrition Facts” title, and both the quantitative amount by weight (i.e., g/mg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the nutrition information may be presented in a separate nutrition label for each language or in one nutrition label with the information in the second language following that in English. Numeric characters that are identical in both languages need not be repeated (e.g., “Protein/Proteinas 2 g”). All required information must be included in both languages.
(e) Nutrition information may be presented for two or more forms of the same product (e.g., both “raw” and “cooked”) or for common combinations of foods as provided for in paragraph (b) of this section, or for different units (e.g., per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDI's are established (e.g., both infants and children less than 4 years of age) as provided for in paragraph (c)(8)(i) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that:
(1) Following the subheading of “Amount Per Serving,” there shall be two or more column headings accurately describing the forms of the same product (e.g., “raw” and “roasted”), the combinations of foods, the units, or the RDI groups that are being declared. The column representing the product as packaged and according to the label serving size based on the Reference Amount in § 381.412(b) shall be to the left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the same product, for combinations of foods, or for different units, total calories and calories from fat (and calories from saturated fat, when declared) shall be listed in a column and indented as specified in paragraph (d)(5) of this section with quantitative amounts declared in columns aligned under the column headings set forth in paragraph (e)(1) of this section.
(3) Quantitative information by weight required in paragraph (d)(7)(i) of this section shall be specified for the form of the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, and according to the label serving size based on the Reference Amount in § 381.412(b).
(i) Quantitative information by weight may be included for other forms of the product represented by the additional column(s) either immediately adjacent to the required quantitative information by weight for the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, and according to the label serving size based on the Reference Amount in § 381.412(b) or as a footnote.
(A) If such additional quantitative information is given immediately adjacent to the required quantitative information, it shall be declared for all nutrients listed and placed immediately following and differentiated from the required quantitative information (e.g., separated by a comma). Such information shall not be put in a separate column.
(B) If such additional quantitative information is given in a footnote, it shall be declared in the same order as the nutrients are listed in the nutrition label. The additional quantitative information may state the total nutrient content of the product identified in the second column or the nutrient amounts added to the product as packaged, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, for only those nutrients that are present in different amounts than the amounts declared in the required quantitative information. The footnote shall clearly identify which amounts are declared. Any subcomponents declared shall be listed parenthetically after principal components (e.g.,
(ii) Total fat and its quantitative amount by weight shall be followed by an asterisk (or other symbol) (e.g., “Total fat (2 g)*”) referring to another asterisk (or symbol) at the bottom of the nutrition label identifying the form(s) of the product for which quantitative information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this section shall be presented under the subheading “% DAILY VALUE” and in columns directly under the column headings set forth in paragraph (e)(1) of this section.
(5) The following sample label illustrates the provisions of paragraph (e) of this section:
(f)(1) Nutrition information may be presented in a simplified format as set forth herein when any required nutrients, other than the core nutrients (i.e., calories, total fat, sodium, total carbohydrate, and protein), are present in insignificant amounts. An insignificant amount shall be defined as that amount that may be rounded to zero in nutrition labeling, except that for total carbohydrate, dietary fiber, sugars and protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the following nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and protein;
(ii) Any of the following that are present in more than insignificant amounts: Calories from fat, saturated fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in more than insignificant amounts may be voluntarily declared as part of the simplified format.
(4) Any required nutrient, other than a core nutrient, that is present in an insignificant amount may be omitted from the tabular listing, provided that the following statement is included at the bottom of the nutrition label, “Not a significant source of ________.” The blank shall be filled in with the appropriate nutrient or food component. Alternatively, amounts of vitamins and minerals present in insignificant amounts may be declared by the use of an asterisk (or symbol) that is placed at the bottom of the table of nutrient values and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).”
(5) Except as provided for in paragraph (g) of this section and in § 381.500(c) and (d), nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section, except that the footnote required in paragraph (d)(9) of this section is not required. When the footnote is omitted, an asterisk shall be placed at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”
(g) Foods in packages that have a total surface area available to bear labeling of 40 or less square inches may modify the requirements of paragraphs (c) through (f) of this section and § 381.402(a) by one or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular or linear (i.e., string) fashion, rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Nutrition information may be given in a linear fashion only if the package shape or size will not accommodate a tabular display.
(ii) When nutrition information is given in a linear display, the nutrition information shall be set off in a box by the use of a hairline. The percent Daily Value is separated from the quantitative amount declaration by the use of parenthesis, and all nutrients, both principal components and subcomponents, are treated similarly. Bolding is required only on the title “Nutrition Facts” and is allowed for nutrient names for “Calories,” “Total fat,” “Cholesterol,” “Sodium,” “Total carbohydrate,” and “Protein.”
(2) Using any of the following abbreviations:
(3) Omitting the footnote required in paragraph (d)(9) of this section and placing another asterisk at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”
(4) Presenting the required information on any other label panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units that are from one production shift. Alternatively, a collection of consumer units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each from a production lot. Alternatively, the sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each randomly chosen to be representative of a production lot. In each case, the units may be individually analyzed and the results of the analyses averaged, or the units would be composited and the composite analyzed. In both cases, the results, whether an average or a single result from a composite, will be considered by the Agency to be the nutrient content of a composite. All analyses shall be performed by appropriate methods and procedures used by the Department for each nutrient in accordance with the “Chemistry Laboratory Guidebook,” or, if no USDA method is available and appropriate for the nutrient, by appropriate methods for the nutrient in accordance with the 1990 edition of the “Official Methods of Analysis” of the AOAC International, formerly Association of Official Analytical Chemists, 15th ed., which is incorporated by reference, unless a particular method of analysis is specified in § 381.409(c), or, if no USDA, AOAC, or specified method is available and appropriate, by other reliable and appropriate analytical procedures as so determined by the Agency. The “Official Methods of Analysis” is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC International, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added, which would make the total amount of such nutrient subject to Class I requirements.
(4) A product with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be deemed to be misbranded under section 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)(4)) unless it meets the following requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.
(5) A product with a label declaration of calories, sugars, total fat, saturated fat, cholesterol, or sodium shall be deemed to be misbranded under section 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)(4)) if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls above this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.
(6) The amount of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium may vary over labeled amounts within good manufacturing practice. The amount of calories, sugars, total fat, saturated fat, cholesterol, or sodium may vary under labeled amounts within good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the label statement of serving size.
(8) The management of the establishment must maintain records to support the validity of nutrient declarations contained on product labels. Such records shall be made available to the inspector or any duly authorized representative of the Agency upon request.
(9) The compliance provisions set forth in paragraph (h)(1) through (8) of this section shall not apply to single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, including those that have been previously frozen, when nutrition labeling is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference, as provided in § 381.445(e) and (f).
(a) The general principles followed in arriving at the reference amounts customarily consumed per eating occasion (Reference Amount(s)), as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These Reference Amounts are based on data set forth in appropriate national food consumption surveys.
(2) The Reference Amounts are calculated for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. Such Reference Amounts are to be used only when the product is specially formulated or processed for use by an infant or by a child under 4 years of age.
(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating occasion, the mean, median, and mode of the consumed amount per eating occasion were considered.
(5) When survey data were insufficient, FSIS took various other sources of information on serving sizes of food into consideration. These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the Reference Amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the product (e.g., a mixed dish measurable with a cup as a main dish and not as a side dish).
(8) The Reference Amounts for products that are consumed as an ingredient of other products, but that may also be consumed in the form in which they are purchased (e.g., ground poultry), are based on use in the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform Reference Amount.
(b) The following Product Categories and Reference Amounts shall be used as the basis for determining serving sizes for specific products:
Table 1—Reference Amounts Customarily Consumed per Eating Occasion—Infant and Toddler Foods 1 2 3
| Product category | Reference amount |
|---|---|
| Infant & Toddler Foods: | |
| Dinner Dry Mix | 15 g |
| Dinner, ready-to-serve, strained type | 60 g |
| Dinner, soups, ready-to-serve junior type | 110 g |
| Dinner, stew or soup ready-to-serve toddlers | 170 g |
| Plain poultry and poultry sticks, ready-to-serve | 55 g |
1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture.
2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost ready-to-serve form of the product (i.e., heat and serve). If not listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form.
3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure most appropriate to their specific product using the procedures established by the regulation.
Table 2—Reference Amounts Customarily Consumed per Eating Occasion—General Food Supply 1 2 3 4 5
| Product category | Reference Amount | Reference Amount |
|---|---|---|
| Ready-to-serve | Ready-to-cook | |
| Egg mixtures, (western style omelet, souffle, egg foo young with poultry) | 110 g | n/a |
| Salad and potato toppers; e.g., poultry bacon bits | 7 g | n/a |
| Bacon; e.g., poultry breakfast strips. | 15 g | 26 g = bacon.
18 g = breakfast strips |
| Dried; e.g., poultry jerky, dried poultry, poultry sausage products with a moisture/protein ratio of less than 2:1 | 30 g | n/a |
| Snacks; e.g., poultry snack food sticks | 30 g | n/a |
| Luncheon products, poultry bologna, poultry Canadian style bacon, poultry crumbles, poultry luncheon loaf, potted poultry products, poultry taco filings | 55 g | n/a |
| Linked poultry sausage products, poultry franks, poultry Polish sausage, smoked or pickled poultry meat, poultry smoked sausage | 55 g | n/a
69 g = uncooked sausage. |
| Entrees without sauce, poultry cuts, ready to cook poultry cuts, including marinated, tenderized, injected cuts of poultry, poultry corn dogs, poultry croquettes, poultry fritters, cured poultry ham products, adult pureed poultry | 85 g | 114g |
| Canned poultry, canned chicken, canned 4 turkey | 55 g | n/a |
| Entrees with sauce, turkey and gravy | 140 g | n/a |
| Mixed dishes NOT measurable with a cup; 5 e.g., poultry burrito, poultry enchiladas, poultry pizza, poultry quiche, all types of poultry sandwiches, cracker and poultry lunch-type packages, poultry gyro, poultry stromboli, poultry frank on a bun, poultry burger on a bun, poultry taco, chicken cordon bleu, poultry calzone, stuffed vegetables with poultry, poultry kabobs | 140 g (plus 55 g for products toppings) | n/a |
| Mixed dishes, measurables with a cup; e.g., poultry casserole, macaroni and cheese with poultry, poultry pot pie, poultry spaghetti with sauce, poultry chili, poultry chili with beans, poultry hash, creamed dried poultry, poultry ravioli in sauce, poultry a la king, poultry stew, poultry goulash, poultry lasagna, poultry-filled pasta | 1 cup | n/a |
| Salads—pasta or potato, potato salad with poultry, macaroni and poultry salad | 140 g | n/a |
| Salads—all other, poultry salads, chicken salad, turkey salad | 100 g | n/a |
| Soups—all varieties | 245 g | n/a |
| Major main entree type sauce; e.g., spaghetti sauce with poultry | 125 g | n/a |
| Minor main entree sauce; e.g., pizza sauce with poultry, gravy |
| n/a |
| Seasoning mixes dry, freeze dry, dehydrated, concentrated soup mixes, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with poultry | ||
| As reconstituted: Amount to make one Reference Amount of the final dish; e.g.— | ||
| Gravy |
| n/a |
| Major main entree type sauce | 125 g | n/a |
| Soup | 245 g | n/a |
| Entree measurable with a cup | 1 cup | n/a |
1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-78 and the 1987-88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture.
2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation.
3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount.
4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed.
5 Pizza sauce is part of the pizza and is not considered to be a sauce topping.
(c) For products that have no Reference Amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., poultry lunch meat with cheese and crackers), the Reference Amount for the combined product shall be determined using the following rules:
(1) For bulk products, the Reference Amount for the combined product shall be the Reference Amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients.
(2) For products where the ingredient represented as the main ingredient is one or more discrete units, the Reference Amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the Reference Amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients.
(3) If the Reference Amounts are in compatible units, they shall be summed (e.g., ingredients in equal volumes such as tablespoons). If the Reference Amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., grams of one ingredient plus gram weight of tablespoons of a second ingredient).
(d) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a Reference Amount for the product in the prepared form, then the Reference Amount for the unprepared product shall be determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the Reference Amount for the prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the Reference Amount for the prepared product as established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or altered product as defined in § 381.413(d), such as a “low calorie” version, shall be the same as for the product for which it is offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e) of this section shall be used in determining whether a product meets the criteria for nutritional claims. If the serving size declared on the product label differs from the Reference Amount, and the product meets the criteria for the claim only on the basis of the Reference Amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the Reference Amount as it appears in paragraph (b) of this section followed, in parenthesis, by the amount in common household measure if the Reference Amount is expressed in measures other than common household measures.
(g) The Administrator, on his or her own initiative or on behalf of any interested person who has submitted a labeling application, may issue a proposal to establish or amend a Product Category or Reference Amount identified in paragraph (b) of this section.
(1) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.
(2) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.
(3) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.
(4) Data accompanying the labeling application, such as food consumption data, shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.
(5) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.
(6) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.
(7) Labeling applications for a new Reference Amount and/or Product Category shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 381.412 with respect to Reference Amount and/or Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label, using the format established by regulation;
(iv) A description of the form in which the product will be marketed;
(v) The intended dietary uses of the product with the major use identified (e.g., turkey as a luncheon meat);
(vi) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;
(vii) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);
(viii) The names of the most closely-related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);
(ix) The suggested Reference Amount (the amount of edible portion of food as consumed, excluding bone, skin or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested Reference Amount. In determining the Reference Amount, general principles and factors in paragraph (a) of this section should be followed.
(x) The suggested Reference Amount shall be expressed in metric units. Reference Amounts for foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density such as mixed dishes measurable with a cup.
(A) In expressing the Reference Amount in grams, the following general rules shall be followed:
(1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment.
(2) For quantities less than 10 grams, exact gram weights shall be used.
(B) [Reserved]
(xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information:
(A) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the Reference Amount for the parent category to warrant a separate Reference Amount. Data must include sample size, and the mean, standard deviation, median, and modal consumed amount per eating occasion for the product identified in the labeling application and for other products in the category. All data must be derived from the same survey data.
(B) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the product identified in the labeling application from the rest of the products in the category.
(xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed.
(A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.
(B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.
(C) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.
(D) The methodology used to collect or process data including study design, sampling procedures, materials used (e.g., questionnaire, interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse, should be fully documented.
(xiii) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule.
(8) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(9) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(10) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed Reference Amount and/or Product Category is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the
(i) If the Reference Amount and/or Product Category is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the Reference Amount and/or Product Category on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia.
(ii) If the Reference Amount and/or Product Category is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(a) This section applies to poultry products that are intended for human consumption and that are offered for sale.
(b) A claim which, expressly or by implication, characterizes the level of a nutrient (nutrient content claim) of the type required in nutrition labeling pursuant to § 381.409, may not be made on a label or in labeling of that product unless the claim is made in accordance with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the product, e.g., “low sodium” or “contains 100 calories.”
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or
(ii) Suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”).
(3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on products intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in subpart Y of this part.
(4) Reasonable variations in the spelling of the terms defined in applicable provisions in this subpart and their synonyms are permitted provided these variations are not misleading (e.g., “hi” or “lo”).
(c) Information that is required or permitted by § 381.409 to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims.
(d) A “substitute” product is one that may be used interchangeably with another product that it resembles, i.e., that it is organoleptically, physically, and functionally (including shelf life) similar to, and that it is not nutritionally inferior to unless it is labeled as an “imitation.”
(1) If there is a difference in performance characteristics that materially limits the use of the product, the product may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim as defined in paragraph (j)(2)(iii) of this section, informing the consumer of such difference (e.g., “not recommended for frying”).
(2) This disclaimer shall be in easily legible print or type and in a size no less than that required by § 381.121(c) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than
(e)(1) Because the use of a “free” or “low” claim before the name of a product implies that the product differs from other products of the same type by virtue of its having a lower amount of the nutrient, only products that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the product, remove the nutrient from the product, or not include the nutrient in the product, may bear such a claim (e.g., “low sodium chicken noodle soup”).
(2) Any claim for the absence of a nutrient in a product, or that a product is low in a nutrient when the product has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the product inherently meets the criteria and shall clearly refer to all products of that type and not merely to the particular brand to which the labeling attaches (e.g., “chicken breast meat, a low sodium food”).
(f) A nutrient content claim shall be in type size and style no larger than two times that of the statement of identity and shall not be unduly prominent in type style compared to the statement of identity.
(g) Labeling information required in §§ 381.413, 381.454, 381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is not otherwise specified, is required to be in letters and/or numbers no less than
(h) [Reserved]
(i) Except as provided in § 381.409 or in paragraph (q)(3) of this section, the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is consistent with a definition for a claim, as provided in subpart Y of this part, for the nutrient that the label addresses. Such a claim might be, “less than 10 g of fat per serving;”
(2) The use of the statement on the product implicitly characterizes the level of the nutrient in the product and is not consistent with such a definition, but the label carries a disclaimer adjacent to the statement that the product is not “low” in or a “good source” of the nutrient, such as “only 200 milligrams (mg) sodium per serving, not a low sodium product.” The disclaimer must be in easily legible print or type and in a size no less than required by § 381.121(c) for the net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than
(3) The statement does not in any way implicitly characterize the level of the nutrient in the product and it is not false or misleading in any respect (e.g., “100 calories” or “5 grams of fat”), in which case no disclaimer is required.
(4) “Percent fat free” claims are not authorized by this paragraph. Such claims shall comply with § 381.462(b)(6).
(j) A product may bear a statement that compares the level of a nutrient in the product with the level of a nutrient in a reference product. These statements shall be known as “relative claims” and include “light,” “reduced,” “less” (or “fewer”), and “more” claims.
(1) To bear a relative claim about the level of a nutrient, the amount of that nutrient in the product must be compared to an amount of nutrient in an appropriate reference product as specified in this paragraph (j).
(i)(A) For “less” (or “fewer”) and “more” claims, the reference product may be a dissimilar product within a product category that can generally be substituted for one another in the diet or a similar product.
(B) For “light,” “reduced,” and “added” claims, the reference product shall be a similar product, and
(ii)(A) For “light” claims, the reference product shall be representative of the type of product that includes the product that bears the claim. The nutrient value for the reference product shall be representative of a broad base of products of that type; e.g., a value in a representative, valid data base; an average value determined from the top three national (or regional) brands, a market basket norm; or, where its nutrient value is representative of the product type, a market leader. Firms using such a reference nutrient value as a basis for a claim, are required to provide specific information upon which the nutrient value was derived, on request, to consumers and appropriate regulatory officials.
(B) For relative claims other than “light,” including “less” and “more” claims, the reference product may be the same as that provided for “light” in paragraph (j)(1)(ii)(A) of this section or it may be the manufacturer's regular product, or that of another manufacturer, that has been offered for sale to the public on a regular basis for a substantial period of time in the same geographic area by the same business entity or by one entitled to use its trade name, provided the name of the competitor is not used on the labeling of the product. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting labeling is internally consistent (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information, and the declaration of the percentage of nutrient by which the product has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference product and the percent (or fraction) of the amount of the nutrient in the reference product by which the nutrient has been modified, (e.g., “50 percent less fat than ‘reference product’ ” or “
(ii) This information shall be immediately adjacent to the most prominent claim in easily legible boldface print or type, in distinct contrast to other printed or graphic matter, that is no less than that required by § 381.121(c) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the referral statement shall be no less than one-half the size of the claim, but no smaller than
(iii) The determination of which use of the claim is in the most prominent location on the label or labeling will be made based on the following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving size with that in the reference product; and
(B) This statement shall appear adjacent to the most prominent claim or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the requirement for a “low” claim for that nutrient.
(k) The term “modified” may be used in the statement of identity of a product that bears a relative claim that complies with the requirements of this part, followed immediately by the name of the nutrient whose content has been altered (e.g., “modified fat ‘product’ ”). This statement of identity must be immediately followed by the comparative statement such as “contains 35 percent less fat than ‘reference product’ ” The label or labeling must also bear the information required by paragraph (j)(2) of this section in the manner prescribed.
(l) For purposes of making a claim, a “meal-type” product will be defined as a product that:
(1) Makes a major contribution to the diet by:
(i) Weighing at least 10 ounces per labeled serving; and
(ii) Containing not less than three 40 gram portions of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in the form commonly understood to be, a breakfast, lunch, dinner, meal, or entrèe. Such representations may be made by statements, photographs, or vignettes.
(m) For purposes of making a claim, a “main-dish” product will be defined as a food that:
(1) Makes a major contribution to the meal by:
(i) Weighing at least 6 ounces per labeled serving; and
(ii) Containing not less than 40 grams of food, or combinations of foods, from two or more of the following four food groups, except as noted in paragraph (m)(1)Iii)(E) of this section.
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four food groups in paragraph (m)(1)(ii)(A) through (D) of this section, that are in the sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a main dish (e.g., not a beverage or a dessert). Such representations may be made by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with § 381.409 shall be provided for any food for which a nutrient content claim is made.
(o) Compliance with requirements for nutrient content claims shall be in accordance with § 381.409(h).
(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in § 381.412(b) through (e) shall be used in determining whether a product meets the criteria for a nutrient content claim. If the serving size declared on the product label differs from the reference amount customarily consumed, and the amount of the nutrient contained in the labeled serving does not meet the maximum or minimum amount criterion in the definition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by § 381.412(f) (e.g., “very low sodium, 35 mg or less per 55 grams”).
(2) The criteria for the claim shall be immediately adjacent to the most prominent claim in easily legible print or type and in a size that is no less than that required by § 381.121(c) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the criteria statement shall be no less than one-half the size of the claim but no smaller than 1/16-inch minimum height, except as permitted by § 381.500(d)(2).
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation and that appear as part of a brand name that was in use prior to November 27, 1991, may continue to be used as part of that brand name, provided they are not false or misleading under section 4(h) of the Act (21 U.S.C. 453(h)(4)).
(2) [Reserved]
(3) A statement that describes the percentage of a vitamin or mineral in the food, including foods intended specifically for use by infants and children less than 2 years of age, in relation to a Reference Daily Intake (RDI) as defined in § 381.409 may be made on the label or in the labeling of a food without a regulation authorizing such a claim for a specific vitamin or mineral.
(4) The requirements of this section do not apply to infant formulas and medical foods, as described in 21 CFR 101.13(q)(4).
(5) [Reserved]
(6) Nutrient content claims that were part of the name of a product that was subject to a standard of identity as of November 27, 1991, are not subject to the requirements of paragraph (b) of this section whether or not they meet the definition of the descriptive term.
(7) Implied nutrient content claims may be used as part of a brand name, provided that the use of the claim has been authorized by FSIS. Labeling applications requesting approval of such a claim may be submitted pursuant to § 381.469.
The major cuts of single-ingredient, raw poultry products are: Whole chicken (without neck and giblets), chicken breast, chicken wing, chicken drumstick, chicken thigh, whole turkey (without necks and giblets; separate nutrient panels for white and dark meat permitted as an option), turkey breast, turkey wing, turkey drumstick, and turkey thigh.
(a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products identified in § 381.444, including those that have been previously frozen, is required, either on their label or at their point-of-purchase, unless exempted under § 381.500. If nutrition information is presented on the label, it must be provided in accordance with the provisions of § 381.409. If nutrition information is presented at the point-of-purchase, it must be provided in accordance with the provisions of this section.
(2) Nutrition information on single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and are not major cuts of single-ingredient, raw poultry products identified in § 381.444, including those that have been previously frozen, may be provided at their point-of-purchase in accordance with the provisions of this section or on their label, in accordance with the provisions of § 381.409.
(3) A retailer may provide nutrition information at the point-of-purchase by various methods, such as by posting a sign or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. If a nutrition claim is made on point-of-purchase materials, all of the format and content requirements of § 381.409 apply. However, if only nutrition information—and not a nutrition claim—is supplied on point-of-purchase materials, the requirements of § 381.409 apply, provided, however:
(i) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in § 381.409(c)(8)) and footnote required by § 381.409(d)(9) may be omitted; and
(ii) The point-of-purchase materials are not subject to any of the format requirements.
(b) [Reserved]
(c) For the point-of-purchase materials, the declaration of nutrition information may be presented in a simplified format as specified in § 381.409(f).
(d) The nutrition label data for products covered in paragraphs (a)(1) and (a)(2) must be based on either raw or cooked edible portions of poultry cuts with skin. If data are based on cooked portions, the methods used to cook the products must be specified and for products covered in paragraphs (a)(1) and (a)(2) must be those which do not add nutrients from other ingredients such as flour, breading, and salt. Additional nutritional data may be presented on an optional basis for the raw or cooked edible portions of the skinless poultry meat.
(e) Nutrient data that are the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference, may be used for nutrition labeling of single-ingredient, raw poultry products, including those that have been previously frozen. These data may be composite data that reflect different classes of turkey or other variables affecting nutrient content. Alternatively, data that reflect specific classes or other variables may be used, except that if data are used on labels attached to a product which is labeled as to class of poultry or other variables, the data must represent the product in the package when such data are contained in the representative data base. When data are used on labels attached to a product, the data must represent the edible poultry tissues present in the package.
(f) If the nutrition information is provided in accordance with paragraph (e) of this section, a nutrition label or labeling will not be subject to the Agency compliance review under § 381.409(h), unless a nutrition claim is made on the basis of the representative data base values.
(g) Retailers may use data bases that they believe reflect the nutrient content of single-ingredient, raw poultry products, including those that have been previously frozen; however, such labeling shall be subject to the compliance procedures of paragraph (e) of this section and the requirements specified in this subpart for the mandatory nutrition labeling program.
(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a product in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV), established for that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that the product contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of broccoli in this meal is high in vitamin C”).
(c) “Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label or in labeling of products, except meal-type products as described in § 381.413(l) and main-dish products as defined in § 317.313(m), provided that the product contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains a food that meets the definition of “good source” in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of sweet potatoes in this meal is a good source of fiber”).
(d) Fiber claims. (1) If a nutrient content claim is made with respect to the level of dietary fiber, i.e., that the product is high in fiber, a good source of fiber, or that the product contains “more” fiber, and the product is not “low” in total fat as defined in § 381.462(b)(2) or, in the case of a meal-type product or in a main-dish product, is not “low” in total fat as defined in § 381.462(b)(3), then the labeling shall disclose the level of total fat per labeled serving size (e.g., “contains 12 grams (g) of fat per serving”); and
(2) The disclosure shall appear in immediate proximity to such claim and be in a type size no less than one-half the size of the claim.
(e) “More” claims. (1) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in a product, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber than ‘reference product’ ”); and
(B) Quantitative information comparing the level of the nutrient in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 1 g per serving; ‘this product’ contains 4 g per serving”).
(2) A relative claim using the terms “more” and “added” may be used on the label or in labeling to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains at least 10 percent more of the RDI or the DRV for protein, vitamins, minerals, dietary fiber, or potassium (expressed as a percent of the Daily Value) per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the nutrient is greater relative to the RDI or DRV are declared in immediate proximity to the most prominent such claim (e.g., “contains 10 percent more of the Daily Value for fiber per 3 ounces (oz) than does ‘reference product’ ”), and
(B) Quantitative information comparing the level of the nutrient in the meal-type product or in a main-dish product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fiber content of ‘reference product’ is 2 g per 3 oz; ‘this product’ contains 5 g per 3 oz”).
(a) General requirements. A claim using the terms “light” or “lite” to describe a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(b) “Light” claims. The terms “light” or “lite” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), without further qualification, provided that:
(1) If the product derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference product as described in § 381.413(j)(1); or
(2) If the product derives less than 50 percent of its calories from fat:
(i) The number of calories is reduced by at least one-third (33
(ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the appropriate reference product as described in § 381.413(j)(1); and
(3) As required in § 381.413(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim (e.g., “
(ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—200 calories, 4 grams (g) fat; regular ‘reference product’—300 calories, 8 g fat per serving”); and
(iii) If the labeled product contains less than 40 calories or less than 3 g fat per reference amount customarily consumed, the percentage reduction for that nutrient need not be declared.
(4) A “light” claim may not be made on a product for which the reference product meets the definition of “low fat” and “low calorie.”
(c)(1)(i) A product for which the reference product contains 40 calories or less and 3 g fat or less per reference amount customarily consumed may use the terms “light” or “lite” without further qualification if it is reduced by 50 percent or more in sodium content compared to the reference product; and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim (e.g., “50 percent less sodium than the market leader”); and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—500 milligrams (mg) sodium per serving; regular ‘reference product’—1,000 mg sodium per serving”).
(2)(i) A product for which the reference product contains more than 40 calories or more than 3 g fat per reference amount customarily consumed may use the terms “light in sodium” or “lite in sodium” if it is reduced by 50 percent or more in sodium content compared to the reference product, provided that “light” or “lite” is presented in immediate proximity with “in sodium” and the entire term is presented in uniform type size, style, color, and prominence; and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim (e.g., “50 percent less sodium than the market leader”); and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., or “lite ‘this product’—170 mg sodium per serving; regular ‘reference product’—350 mg per serving”).
(3) Except for meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), a “light in sodium” claim may not be made on a product for which the reference product meets the definition of “low in sodium.”
(d)(1) The terms “light” or “lite” may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product meets the definition of:
(A) “Low in calories” as defined in § 381.460(b)(3); or
(B) “Low in fat” as defined in § 381.462(b)(3); and
(ii)(A) A statement appears on the principal display panel that explains whether “light” is used to mean “low fat,” “low calories,” or both (e.g., “Light Delight, a low fat meal”); and
(B) The accompanying statement is no less than one-half the type size of the “light” or “lite” claim.
(2)(i) The terms “light in sodium” or “lite in sodium” may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that the product meets the definition of “low in sodium” as defined in § 381.461(b)(5)(i); and
(ii) “Light” or “lite” and “in sodium” are presented in uniform type size, style, color, and prominence.
(3) The terms “light” or “lite” may be used in the brand name of a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content compared to the reference product;
(ii) A statement specifically stating that the product is “light in sodium” or “lite in sodium” appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the product name; and
(iii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium was reduced are declared in immediate proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per labeled serving size with that of the reference product it replaces is declared adjacent to the most prominent claim or to the nutrition information.
(e) Except as provided in paragraphs (b) through (d) of this section, the terms “light” or “lite” may not be used to refer to a product that is not reduced in fat by 50 percent, or, if applicable, in calories by
(1) It describes some physical or organoleptic attribute of the product such as texture or color and the information (e.g., “light in color” or “light in texture”) so stated, clearly conveys the nature of the product; and
(2) The attribute (e.g., “color” or “texture”) is in the same style, color, and at least one-half the type size as the word “light” and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word “light” has been associated, through common use, with a particular product to reflect a physical or organoleptic attribute to the point where it has become part of the statement of identity, such use of the term “light” shall not be considered a nutrient content claim subject to the requirements in this part.
(g) The term “lightly salted” may be used on a product to which has been added 50 percent less sodium than is normally added to the reference product as described in § 381.413(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not “low in sodium” as defined in § 381.461(b)(4), the statement “not a low sodium food,” shall appear adjacent to the nutrition information and the information required to accompany a relative claim shall appear on the label or labeling as specified in § 381.413(j)(2).
(a) General requirements. A claim about the calorie or sugar content of a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 318.413(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does not provide more than 40 calories per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and does not provide more than 40 calories per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 120 calories or less per 100 g of product; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the calorie content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches.
(4) The terms “reduced calorie,” “reduced in calories,” “calorie reduced,” “fewer calories,” “lower calorie,” or “lower in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 318.413(m), provided that:
(i) The product contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., lower calorie ‘product’—“33
(B) Quantitative information comparing the level of calories in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 150 to 100 calories per serving”).
(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent fewer calories per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the calories differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “calorie reduced ‘product’, 25% less calories per ounce (oz) (or 3 oz) than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of calories in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “calorie content has been reduced from 110 calories per 3 oz to 80 calories per 3 oz”).
(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of products if the reference product meets the definition for “low calorie.”
(c) Sugar content claims. (1) Terms such as “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” or “dietarily insignificant source of sugar” may reasonably be expected to be regarded by consumers as terms that represent that the product contains no sugars or sweeteners, e.g., “sugar free,” or “no sugar,” as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (c)(2) of this section, a product may not be labeled with such terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in § 381.409(c)(6)(ii), per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is generally understood by consumers to contain sugars unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietarily insignificant amount of sugar;” and
(iii)(A) It is labeled “low calorie” or “reduced calorie” or bears a relative claim of special dietary usefulness labeled in compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this section; or
(B) Such term is immediately accompanied, each time it is used, by either the statement “not a reduced calorie product,” “not a low calorie product,” or “not for weight control.”
(2) The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if:
(i) No amount of sugars, as defined in § 381.409(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount present in the ingredients by some means such as the use of enzymes, except where the intended functional effect of the process is not to increase the sugars content of a product, and a functionally insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes normally contains added sugars; and
(v) The product bears a statement that the product is not “low calorie” or “calorie reduced” (unless the product meets the requirements for a “low” or “reduced calorie” product) and that directs consumers' attention to the nutrition panel for further information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual statement that a product, including products intended specifically for infants and children less than 2 years of age, is unsweetened or contains no added sweeteners in the case of a product that contains apparent substantial inherent sugar content, e.g., juices.
(4) The terms “reduced sugar,” “reduced in sugar,” “sugar reduced,” “less sugar,” “lower sugar,” or “lower in sugar” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 318.413(m), provided that:
(i) The product contains at least 25 percent less sugars per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “this product contains 25 percent less sugar than our regular product”); and
(B) Quantitative information comparing the level of the sugar in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been lowered from 8 g to 6 g per serving”).
(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less sugars per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sugars differ between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sugar ‘product’—
(B) Quantitative information comparing the level of the nutrient in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz”).
(a) General requirements. A claim about the level of sodium in a product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(b) Sodium content claims. (1) The terms “sodium free,” “free of sodium,” “no sodium,” “zero sodium,” “without sodium,” “trivial source of sodium,” “negligible source of sodium,” or “dietarily insignificant source of sodium” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 5 mg of sodium per labeled serving size;
(ii) The product contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium;” and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “very low sodium” or “very low in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and contains 35 mg or less sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 35 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 35 mg or less of sodium per 100 g of product; and
(ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “low sodium,” “low in sodium,” “little sodium,” “contains a small amount of sodium,” or “low source of sodium” may be used on the label and in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp and contains 140 mg or less sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 140 mg or less sodium per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 140 mg or less sodium per 100 g of product; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(6) The terms “reduced sodium,” “reduced in sodium,” “sodium reduced,” “less sodium,” “lower sodium,” or “lower in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less sodium per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(l); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’, 50 percent less sodium than regular ‘product’ ”); and
(B) Quantitative information comparing the level of sodium in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been lowered from 300 to 150 mg per serving”).
(iii) Claims described in paragraph (b)(6) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low sodium.”
(7) The terms defined in paragraph (b)(6) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less sodium per 100 g of product than an appropriate reference product as described in § 381.413(j)(l); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the sodium differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced sodium ‘product’—30% less sodium per 3 oz than our ‘regular product’ ”); and
(B) Quantitative information comparing the level of sodium in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “sodium content has been reduced from 220 mg per 3 oz to 150 mg per 3 oz”).
(iii) Claims described in paragraph (b)(7) of this section may not be made on the label or in labeling of products if the nutrient content of the reference product meets the definition for “low sodium.”
(c) The term “salt” is not synonymous with “sodium.” Salt refers to sodium chloride. However, references to salt content such as “unsalted,” “no salt,” “no salt added” are potentially misleading.
(1) The term “salt free” may be used on the label or in labeling of products only if the product is “sodium free” as defined in paragraph (b)(1) of this section.
(2) The terms “unsalted,” “without added salt,” and “no salt added” may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is normally processed with salt; and
(iii) If the product is not sodium free, the statement “not a sodium free product” or “not for control of sodium in the diet” appears adjacent to the nutrition information of the product bearing the claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual statement that a product intended specifically for infants and children less than 2 years of age is unsalted, provided such statement refers to the taste of the product and is not false or otherwise misleading.
(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of products if:
(1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “nonfat,” “trivial source of fat,” “negligible source of fat,” or “dietarily insignificant source of fat” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of fat per labeled serving size;
(ii) The product contains no added ingredient that is a fat or is generally understood by consumers to contain fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat”; and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label and in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i)(A) The product has a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and contains 3 g or less of fat per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form).
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 3 g or less of total fat per 100 g of product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced fat,” “reduced in fat,” “fat reduced,” “less fat,” “lower fat,” or “lower in fat” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less fat per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat—50 percent less fat than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “fat content has been reduced from 8 g to 4 g per serving”).
(iii) Claims described in paragraph (b)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”
(5) The terms defined in paragraph (b)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less fat per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced fat ‘product’, 33 percent less fat per 3 oz than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent such claim or to the nutrition information (e.g., “fat content has been reduced from 8 g per 3 oz to 5 g per 3 oz”).
(iii) Claims described in paragraph (b)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low fat.”
(6) The term “____________ percent fat free” may be used on the label or in labeling of products, provided that:
(i) The product meets the criteria for “low fat” in paragraph (b)(2) or (b)(3) of this section;
(ii) The percent declared and the words “fat free” are in uniform type size; and
(iii) A “100 percent fat free” claim may be made only on products that meet the criteria for “fat free” in paragraph (b)(1) of this section, that contain less than 0.5 g of fat per 100 g, and that contain no added fat.
(iv) A synonym for “______ percent fat free” is “______ percent lean.”
(c) Fatty acid content claims. (1) The terms “saturated fat free,” “free of saturated fat,” “no saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of saturated fat,” “negligible source of saturated fat,” or “dietarily insignificant source of saturated fat” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids per labeled serving size;
(ii) The product contains no ingredient that is generally understood by consumers to contain saturated fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of saturated fat,” “adds a negligible amount of saturated fat,” or “adds a dietarily insignificant amount of saturated fat;” and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(2) The terms “low in saturated fat,” “low saturated fat,” “contains a small amount of saturated fat,” “low source of saturated fat,” or “a little saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains 1 g or less of saturated fat per reference amount customarily consumed and not more than 15 percent of calories from saturated fat; and
(ii) If the product meets these conditions without benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (c)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced saturated fat,” “reduced in saturated fat,” “saturated fat reduced,” “less saturated fat,” “lower saturated fat,” or “lower in saturated fat” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less saturated fat per reference amount customarily consumed than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’, contains 50 percent less saturated fat than the national average for ‘product’ ”); and
(B) Quantitative information comparing the level of saturated fat in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat reduced from 3 g to 1.5 g per serving”).
(iii) Claims described in paragraph (c)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”
(5) The terms defined in paragraph (c)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less saturated fat per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the saturated fat differs between the two products are declared in immediate proximity to the most prominent such claim (e.g., “reduced saturated fat ‘product’, 50 percent less saturated fat than our regular ‘product’ ”); and
(B) Quantitative information comparing the level of saturated fat in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz”).
(iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low saturated fat.”
(d) Cholesterol content claims. (1) The terms “cholesterol free,” “free of cholesterol,” “zero cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of cholesterol,” “negligible source of cholesterol,” or “dietarily insignificant source of cholesterol” may be used on the label or in labeling of products, provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally understood by consumers to contain cholesterol, unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of cholesterol,” “adds a negligible amount of cholesterol,” or “adds a dietarily insignificant amount of cholesterol”;
(iii) The product contains 2 g or less of saturated fat per reference amount customarily consumed or, in the case of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), 2 g or less of saturated fat per labeled serving size; and
(iv) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which it attaches; or
(v) If the product meets these conditions only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol was reduced are declared in immediate proximity to the most prominent such claim (e.g., “cholesterol free ‘product’, contains 100 percent less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “contains no cholesterol compared with 30 mg in one serving of ‘reference product’ ”).
(2) The terms “low in cholesterol,” “low cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” or “little cholesterol” may be used on the label or in labeling of products, except meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i)(A) If the product has a reference amount customarily consumed greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients per reference amount customarily consumed, the per-50-g criterion refers to the “as prepared” form); and
(2) The product contains 2 g or less of saturated fat per reference amount customarily consumed.
(ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as a result of special processing, alteration, formulation, or reformulation, the amount of cholesterol is reduced by 25 percent or more from the reference product it replaces as described in § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “low cholesterol ‘product’, contains 85 percent less cholesterol than our regular ‘product”’); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 30 mg to 5 mg per serving”).
(3) The terms defined in paragraph (d)(2) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of product;
(ii) The product contains 2 g or less of saturated fat per 100 g of product; and
(iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches.
(4) The terms “reduced cholesterol,” “reduced in cholesterol,” “cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in cholesterol” may be used on the label or in labeling of products or products that substitute for those products as specified in § 381.413(d), excluding meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m), provided that:
(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;
(ii) The product contains 2 g or less of saturated fat per reference amount customarily consumed; and
(iii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25 percent less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol lowered from 55 mg to 30 mg per serving”).
(iv) Claims described in paragraph (d)(4) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”
(5) The terms defined in paragraph (d)(4) of this section may be used on the label or in labeling of a meal-type product as defined in § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference product it replaces as described in § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of product; and
(iii) As required in § 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or fraction) that the cholesterol has been reduced are declared in immediate proximity to the most prominent such claim (e.g., “25% less cholesterol than ‘reference product’ ”); and
(B) Quantitative information comparing the level of cholesterol in the product per specified weight with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not be made on the label or in labeling of a product if the nutrient content of the reference product meets the definition for “low cholesterol.”
(e) “Lean” and “Extra Lean” claims. (1) The term “lean” may be used on the label or in labeling of a product, provided that the product contains less than 10 g of fat, 4.5 g or less of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m).
(2) The term “extra lean” may be used on the label or in labeling of a product, provided that the product contains less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of cholesterol per 100 g of product and per reference amount customarily consumed for individual foods, and per 100 g of product and per labeled serving size for meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(m).
(f) A statement of the lean percentage may be used on the label or in labeling of ground or chopped poultry products described in § 381.401 when the product does not meet the criteria for “low fat,” defined in § 381.462(b)(2), provided that a statement of the fat percentage is contiguous to and in lettering of the same color, size, type, and on the same color background, as the statement of the lean percentage.
(a) The term “healthy,” or any other derivative of the term “health,” may be used on the labeling of any poultry product, provided that the product is labeled in accordance with § 381.409 and § 381.413.
(b)(1) The product shall meet the requirements for “low fat” and “low saturated fat,” as defined in § 381.462, except that single-ingredient, raw products may meet the total fat and saturated fat criteria for “extra lean” in § 381.462.
(2) The product shall not contain more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:
(i) A main-dish product, as defined in § 381.413(m), and meal-type product, as defined in § 381.413(l), and including meal-type products that weigh more than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean” in § 381.462.
(3) The product shall not contain more than 480 mg of sodium per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 381.409(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that:
(i) A main-dish product, as defined in § 381.413(m), and meal-type product, as defined in § 381.413(l), and including meal-type products that weigh more than 12 oz per serving (container), shall not contain more than 600 mg of sodium per labeled serving size;
(ii) The requirements of this paragraph (b)(3) do not apply to single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference Daily Intake or Daily Reference Value as defined in § 381.409 for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition, except that:
(i) A main-dish product, as defined in § 381.413(m), and including meal-type products that weigh less than 10 oz per serving (container), shall meet the level for two of the nutrients per labeled serving size; and
(ii) A meal-type product, as defined in § 381.413(l), shall meet the level for three of the nutrients per labeled serving size.
(a) This section pertains to labeling applications for claims, express or implied, that characterize the level of any nutrient required to be on the label or in labeling of product by this subpart.
(b) Labeling applications included in this section are:
(1) Labeling applications for a new (heretofore unauthorized) nutrient content claim,
(2) Labeling applications for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient, and
(3) Labeling applications for the use of an implied claim in a brand name.
(c) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.
(d) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.
(e) If nonclinical laboratory studies accompany a labeling application, the applicant shall include, with respect to each nonclinical study included with the application, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
(f) If clinical investigations accompany a labeling application, the applicant shall include, with respect to each clinical investigation included with the application, either a statement that the investigation was conducted in compliance with the requirements for institutional review set forth in part 56 of chapter 1, title 21, or was not subject to such requirements in accordance with § 56.194 or § 56.105, and that it was conducted in compliance with the requirements for informed consents set forth in part 50 of chapter 1, title 21.
(g) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.
(h) The data specified under this section to accompany a labeling application shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.
(i) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.
(j) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.
(k)(1) Labeling applications for a new nutrient content claim shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the claim and its proposed use).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the nutrient content claim and the nutrient that the term is intended to characterize with respect to the level of such nutrient. The statement shall address why the use of the term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify the level at which the nutrient must be present or what other conditions concerning the product must be met for the appropriate use of the term in labels or labeling, as well as any factors that would make the use of the term inappropriate.
(ii) A detailed explanation supported by any necessary data of why use of the food component characterized by the claim is of importance in human nutrition by virtue of its presence or absence at the levels that such claim would describe. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed and why such benefit is not available through the use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, and scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.
(iii) Analytical data that demonstrates the amount of the nutrient that is present in the products for which the claim is intended. The assays should be performed on representative samples in accordance with 381.409(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular food. The validation data shall include a statistical analysis of the analytical and product variability.
(iv) A detailed analysis of the potential effect of the use of the proposed claim on food consumption, and any corresponding changes in nutrient intake. The analysis shall specifically address the intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is intended for a specific group within the population, the above analysis shall specifically address the dietary practices of such group, and shall include data sufficient to demonstrate that the dietary analysis is representative of such group.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the
(i) If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed nutrient content claim.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(l)(1) Labeling applications for a synonymous term shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the synonymous term and its proposed use in a nutrient content claim that is consistent with an existing term that has been defined under subpart Y of part 381).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the synonymous term, the existing term defined by a regulation with which the synonymous term is claimed to be consistent, and the nutrient that the term is intended to characterize the level of. The statement shall address why the use of the synonymous term as proposed will not be misleading. The statement shall provide examples of the nutrient content claim as it will be used on labels or labeling, as well as the types of products on which the claim will be used. The statement shall also specify whether any limitations not applicable to the use of the defined term are intended to apply to the use of the synonymous term.
(ii) A detailed explanation supported by any necessary data of why use of the proposed term is requested, including whether the existing defined term is inadequate for the purpose of effectively characterizing the level of a nutrient. This explanation shall also state what nutritional benefit to the public will derive from use of the claim as proposed, and why such benefit is not available through use of existing terms defined by regulation. If the claim is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group, scientific data sufficient for such purpose, and data and information to the extent necessary to demonstrate that consumers can be expected to understand the meaning of the term under the proposed conditions of use.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed synonymous term is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed synonymous term.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the claim is approved, the Agency shall notify the applicant, in writing, and shall publish in the
(m)(1) Labeling applications for the use of an implied nutrient content claim in a brand name shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:
The undersigned, ____________ submits this labeling application pursuant to 9 CFR 381.469 with respect to (statement of the implied nutrient content claim and its proposed use in a brand name).
Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:
(i) A statement identifying the implied nutrient content claim, the nutrient the claim is intended to characterize, the corresponding term for characterizing the level of such nutrient as defined by a regulation, and the brand name of which the implied claim is intended to be a part. The statement shall address why the use of the brand-name as proposed will not be misleading. The statement shall provide examples of the types of products on which the brand name will appear. It shall also include data showing that the actual level of the nutrient in the food would qualify the label of the product to bear the corresponding term defined by regulation. Assay methods used to determine the level of a nutrient shall meet the requirements stated under labeling application format in paragraph (k)(1)(iii) of this section.
(ii) A detailed explanation supported by any necessary data of why use of the proposed brand name is requested. This explanation shall also state what nutritional benefit to the public will derive from use of the brand name as proposed. If the branded product is intended for a specific group within the population, the analysis shall specifically address nutritional needs of such group and scientific data sufficient for such purpose.
(2) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.
(3) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed implied nutrient content claim is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish a notice of the labeling application in the
(i) If the claim is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the claim on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed implied nutrient content claim.
(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the applicant, in writing, and shall also publish in the
(a) General requirements. Any product that purports to be or is represented for special dietary use because of usefulness in reducing body weight shall bear:
(1) Nutrition labeling in conformity with § 381.409 of this subpart, unless exempt under that section, and
(2) A conspicuous statement of the basis upon which the product claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any product subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.
(2) A special dietary product may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the product under the applicable law and regulations of this chapter. Any product that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener; e.g., “Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).”
(c) “Low calorie” foods. A product purporting to be “low calorie” must comply with the criteria set forth for such foods in § 381.460.
(d) “Reduced calorie” foods and other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such foods in § 387.460(b) (4) and (5).
(e) “Label terms suggesting usefulness as low calorie or reduced calorie foods”. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if the claim is not false or misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative calorie claim in compliance with the applicable provisions in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term “diet” that clearly shows that the product is offered solely for a dietary use other than regulating body weight, e.g., “for low sodium diets.”
(3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement or other product that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on foods.
(f) “Sugar free” and “no added sugar”. Criteria for the use of the terms “sugar free” and “no added sugar” are provided for in § 381.460(c).
(a) The following poultry products are exempt from nutrition labeling:
(1) Food products produced by small businesses other than the major cuts of single-ingredient, raw poultry products identified in § 381.444 produced by small businesses, provided that the labels for these products bear no nutrition claims or nutrition information, and ground or chopped products described in § 381.401 produced by small businesses that bear a statement of the lean percentage and fat percentage on the label or in labeling in accordance with § 381.462(f), provided that labels or labeling for these products bear no other nutrition claims or nutrition information,
(i) A food product, for purposes of the small business exemption, is defined as a formulation, not including distinct flavors which do not significantly alter the nutritional profile, sold in any size package in commerce.
(ii) For purposes of this paragraph, a small business is any single-plant facility, including a single retail store, or multi-plant company/firm, including a multi-retail store operation that employs 500 or fewer people and produces no more than the following amounts of pounds of the product qualifying the firm for exemption from this subpart:
(A) During the first year of implementation of nutrition labeling, from July 1994 to July 1995, 250,000 pounds or less,
(B) During the second year of implementation of nutrition labeling, from July 1995 to July 1996, 175,000 pounds or less, and
(C) During the third year of implementation and subsequent years thereafter, 100,000 pounds or less.
(iii) For purposes of this paragraph, calculation of the amount of pounds shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years or where products have been produced for less than 2 years, reasonable estimates must indicate that the annual pounds produced will not exceed the amounts specified.
(2) Products intended for further processing, provided that the labels for these products bear no nutrition claims or nutrition information,
(3) Products that are not for sale to consumers, provided that the labels for these products bear no nutrition claims or nutrition information,
(4) Products in small packages that are individually wrapped packages of less than
(5) Products custom slaughtered or prepared,
(6) Products intended for export, and
(7) The following products prepared and served or sold at retail provided that the labels or the labeling of these products bear no nutrition claims or nutrition information:
(i) Ready-to-eat products that are packaged or portioned at a retail store or similar retail-type establishment, provided, however, that this exemption does not apply to ready-to-eat ground or chopped poultry products described in § 381.401 that are packaged or portioned at a retail establishment, unless the establishment qualifies for an exemption under (a)(1);
(ii) Multi-ingredient products (e.g. sausage) processed at a retail store or similar retail-type establishment, provided, however, that this exemption does not apply to multi-ingredient ground or chopped poultry products described in § 381.401 that are processed at a retail establishment, unless the establishment qualifies for an exemption under (a)(1); and
(iii) Products that are ground or chopped at an individual customer's request.
(b) Restaurant menus generally do not constitute labeling or fall within the scope of these regulations.
(c)(1) Foods represented to be specifically for infants and children less than 2 years of age shall bear nutrition labeling as provided in paragraph (c)(2) of this section, except such labeling shall not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
(2) Foods represented or purported to be specifically for infants and children less than 4 years of age shall bear nutrition labeling except that:
(i) Such labeling shall not include declarations of percent of Daily Value for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber;
(ii) Nutrient names and quantitative amounts by weight shall be presented in two separate columns;
(iii) The heading “Percent Daily Value” required in § 381.409(d)(6) shall be placed immediately below the quantitative information by weight for protein;
(iv) The percent of the Daily Value for protein, vitamins, and minerals shall be listed immediately below the heading “Percent Daily Value”; and
(v) Such labeling shall not include the footnote specified in § 381.409(d)(9).
(d)(1) Products in packages that have a total surface area available to bear labeling of less than 12 square inches are exempt from nutrition labeling, provided that the labeling for these products bear no nutrition claims or other nutrition information except that this exemption does not apply to the major cuts of single-ingredient, raw poultry products identified in § 381.444. The manufacturer, packer, or distributor shall provide, on the label of packages that qualify for and use this exemption, an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., “For nutrition information call 1-800-123-4567”).
(2) When such products bear nutrition labeling, either voluntarily or because nutrition claims or other nutrition information is provided, all required information shall be in a type size no smaller than 6 point or all upper case type of
Cooperative interstate shipment program. A cooperative poultry products inspection program described in § 381.187 of this part.
Cooperative State poultry products inspection program. A cooperative State-Federal poultry products inspection program described in § 381.185 of this part.
Designated personnel. State inspection personnel that have been trained in the enforcement of the Act and any additional State program requirements in order to provide inspection services to selected establishments.
Interstate commerce. “Interstate commerce” has the same meaning as “commerce” under § 381.1 of this part.
Selected establishment. An establishment operating under a State cooperative poultry products inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program.
This subpart Z prescribes the conditions under which States that administer cooperative State poultry products inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program.
(a) An establishment that operates under a cooperative State poultry products inspection program may apply to participate in a cooperative interstate shipment program under this subpart if:
(1) The establishment employs on average no more than 25 employees based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer than 35 employees as of June 18, 2008. If selected to participate in a cooperative interstate shipment program, an establishment under this paragraph must employ on average no more than 25 employees as of July 1, 2014, or it must transition to become an official establishment as provided in § 381.521 of this subpart.
(b) An establishment that has 25 or fewer employees based on the following standards is considered to have 25 or fewer employees on average for purposes of this subpart.
(1) All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis whose duties involve handling the poultry products prepared by the establishment are counted when calculating the total number of employees.
(2) All individuals employed by the establishment from a temporary employee agency, professional employee organization, or leasing concern whose duties involve handling the poultry products prepared by the establishment are counted when calculating the total number of employees.
(3) The average number of employees is calculated for each of the pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-time employees.
(5) If the establishment has not been in business for 12 months, the average number of employees is calculated for each of the pay periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered employees unless their duties involve handling the poultry products prepared by the establishment.
(7) The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average (except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as provided in § 381.186 of this part as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18, 2008, but that were re-organized on a later date by the person that controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State poultry products inspection program that employed more than 35 employees as of June 18, 2008, that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under § 381.521 of this subpart;
(7) Establishments that are in violation of the Act;
(8) Establishments located in States without a cooperative State poultry products inspection program; and
(9) Establishments located in a State whose agreement for a cooperative interstate shipment program was terminated by the Administrator as provided in § 381.187(d) of this part.
(d) An establishment that meets the conditions in paragraph (a) of this section and that is not an ineligible establishment under paragraph (c) of this section may apply for selection into a cooperative interstate shipment program through the State in which the establishment is located.
(a) State participation in a cooperative interstate shipment program under this subpart is limited to States that have implemented cooperative State poultry products inspection programs.
(b) To request an agreement for a cooperative interstate shipment program under this subpart, a State must submit a written request to the Administrator through the FSIS District Office for the FSIS District in which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be selected for the program that the State recommends for initial selection into the program, if any;
(2) Demonstrate that the State is able to provide the necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program established under this subpart; and
(3) Agree that, if the State enters into an agreement with FSIS for a cooperative interstate shipment program, the State will:
(i) Provide FSIS with access to the results of all laboratory analyses conducted on product samples from selected establishments in the State;
(ii) Notify the selected establishment coordinator for the State of the results of any laboratory analyses that indicate that a product prepared in a selected establishment may be adulterated or may otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments.
(c) If the Administrator determines that a State that has submitted a request to participate in a cooperative interstate shipment program qualifies to enter into a cooperative agreement for such a program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments located in the State.
(d) After the Administrator and a State have signed an agreement for a cooperative interstate shipment program as provided in paragraph (c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment coordinator for the State and
(2) Coordinate with the State to select establishments to participate in the program as provided in § 381.515(b) of this subpart.
(a) An establishment operating under a cooperative State poultry products inspection program will qualify for selection into a cooperative interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the program;
(2) Has the appropriate number of employees under § 381.513(a) of this subpart;
(3) Is not ineligible to participate in a cooperative interstate shipment program under § 381.513(c) of this subpart;
(4) Is in compliance with all requirements under the cooperative State poultry products inspection program; and
(5) Is in compliance with all requirements under the Act and the implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an establishment that meets the conditions in paragraph (a) of this section must be selected by the Administrator, in coordination with the State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative interstate shipment program as provided in paragraph (b) of this section, the State is to assign the establishment an official number that reflects the establishment's participation in the cooperative interstate shipment program and advise the FSIS selected establishment coordinator for the State of the official number assigned to each selected establishment in the State. The official numbers assigned to every selected establishment must contain a suffix, e.g., “SE,” that identifies the establishment as a selected establishment; that includes the letter “P,” which identifies the establishment as a poultry establishment; and that identifies the State, e.g., “SEPND,” for “selected establishment poultry North Dakota.”
(d) Failure of a State to comply with paragraph (c) of this section will disqualify the State from participation in the cooperative interstate shipment program.
(a) A cooperative interstate shipment program will commence when the Administrator, in coordination with the State, has selected establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee.
(c) Poultry products processed in a selected establishment and inspected and passed by designated State personnel must bear an official Federal mark, stamp, tag, or label of inspection in the appropriate form prescribed in subpart M of this part that includes the information specified in § 381.515(c) of this subpart.
(d) Poultry products processed in a selected establishment that comply with the conditions in paragraph (c) of this section may be distributed in interstate commerce.
(a) The FSIS selected establishment coordinator for a State that has entered into an agreement for a cooperative interstate shipment program will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the Act and the implementing regulations in this chapter. The frequency with which the SEC will visit selected establishments under the SEC's jurisdiction will be based on factors that include, but are not limited to, the complexity of the operations conducted at the selected establishment, the establishment's schedule of operations, and the establishment's performance under the cooperative interstate shipment program. If necessary, the selected establishment coordinator, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a selected establishment on behalf of the selected establishment coordinator.
(b) The selected establishment coordinator, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from designated personnel, and that these establishments are eligible, and remain eligible, to participate in a cooperative interstate shipment program. The selected establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and continues to employ, 25 or fewer employees, on average, as required under § 381.513(a) of this part, unless the establishment is transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing inspection services to selected establishments in a manner that complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that the State staffing levels for each selected establishments are appropriate to carry out the required inspection activities; and
(4) Assessing each selected establishment's compliance with the Act and implementing regulations in this chapter.
(c) If the selected establishment coordinator determines that designated personnel are providing inspection services to selected establishments in the State in a manner that is inconsistent with the Acts and the implementing regulations in this chapter, the Administrator will provide an opportunity for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the selected establishment coordinator. If the State fails to develop a corrective action plan, or the selected establishment coordinator for the State determines that the corrective action plan is inadequate, the Administrator will terminate the agreement for the cooperative interstate shipment program as provided in § 381.187(d) of this part.
(a) The selected establishment coordinator will prepare a report on a quarterly basis that describes the status of each selected establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section will:
(1) Include the selected establishment coordinator's assessment of the performance of the designated personnel in conducting inspection activities at selected establishments and
(2) Identify those selected establishment that the selected establishment coordinator has verified are in compliance with the Act and implementing regulations in this chapter, those that have been deselected under § 381.520 of this subpart, and those that are transitioning to become official establishments under § 381.521 of this subpart.
(c) The selected establishment coordinator is to submit the quarterly report to the Administrator through the District Manager for the State where the selected establishments identified in the report are located.
(a) To facilitate oversight and enforcement of this subpart, selected establishments operating under a cooperative interstate shipment program must, upon request, give the FSIS selected establishment coordinator or other FSIS officials access to all establishment records required under the Act and the implementing regulations in this chapter. The Administrator may deselect any selected establishment that refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any appropriate enforcement action provided for in part 500 of this chapter if they determine that a selected establishment under their jurisdiction is operating in manner that is inconsistent with the Act and the implementing regulations in this chapter. Selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any of the reasons specified in § 500.3 or § 500.4 of this chapter, FSIS will:
(1) Provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or
(2) Move to deselect the establishment as provided in § 381.520 of this subpart.
(d) The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis. In making this decision, FSIS, in consultation with the State where the selected establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
(a) The Administrator will deselect a selected establishment that becomes ineligible to participate in a cooperative interstate shipment program for any reason listed under § 381.513(c) of this subpart.
(b) An establishment that has been deselected must transition to become an official establishment as provided in § 381.521 of this subpart.
(a) If an establishment is deselected from a cooperative interstate shipment program as provided in § 381.520 of this subpart, FSIS, in coordination with the State where the establishment is located, will develop and implement a plan to transition the establishment to become an official establishment. Except that an establishment that was deselected from a cooperative interstate shipment program because it is located in a State whose agreement for such a program was terminated may either transition to become an official establishment or transition to become a State-inspected establishment under the cooperative State poultry products inspection program.
(b) An establishment that has been deselected from a cooperative interstate shipment program and successfully transitioned to become an official establishment may withdraw from the Federal inspection program and resume operations under the cooperative State poultry products inspection program after operating as an official establishment in full compliance with the Act for a year.
(a) Transition grants are funds that a State participating in a cooperative interstate shipment program under this subpart may apply for to reimburse selected establishments in the State for the cost to train one individual in the seven HACCP principles for meat or poultry processing as required under § 417.7 of this chapter and associated training in the development of sanitation standard operating procedures required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment program that receives a transition grant must use grant funds to reimburse the training costs of one employee per each selected establishment in the State. Any other use of such funds is prohibited.
A selected establishment may conduct operations under the cooperative State poultry products inspection program if the establishment implements and maintains written procedures for complete physical separation of product and process for each operation by time or space.
A selected establishment that is in full compliance with the requirements in this part may voluntarily end its participation in a cooperative interstate shipment program and operate under the cooperative State poultry products inspection program. Establishments that voluntarily end their participation in the cooperative may re-apply for the program after operating under the cooperative State poultry products inspection program for one year.
This part is issued pursuant to the Freedom of Information Act (FOIA) as amended (5 U.S.C. 552), and in accordance with the directives of the Department of Agriculture regulations in part 1, subpart A, of Title 7. The availability of records, including electronic records created on or after November 1, 1996, of the Food Safety and Inspection Service (FSIS), and the procedures by which the public may request such information, will be governed by the FOIA and by the Department regulations as implemented and supplemented by the regulations in this part.
FSIS rules and regulations relating to its regulatory responsibilities and administrative procedures are published and made available to the public in the
(a) Pursuant to the regulations in 7 CFR 1.4(c), FSIS will maintain and make available for public inspection and copying an index providing identifying information regarding the materials required to be published or made available under the Freedom of Information Act (5 U.S.C. 552(a)(2)). The Agency will make the index available by computer telecommunications by December 31, 1999. Quarterly publication of the index is unnecessary and impractical, since the material is voluminous and does not change often enough to justify the expense of quarterly publication. The Agency will provide copies of any index, upon request, at a cost not to exceed direct cost of duplication.
(b) FSIS is responsible for preparing reference material or a guide for requesting records or information from the Agency. This guide also will include an index of all major information systems and a description of major information and record locator systems.
(c) FSIS will prepare a handbook for obtaining information from the Agency. The handbook will be available on paper and through electronic means, and will discuss how the public can use it to access Agency FOIA annual reports. Similarly, the annual reports will refer to the handbook and how to obtain it.
Facilities for public inspection and copying of the material described in §§ 390.2 and 390.3 of this part will be provided by FSIS pursuant to 7 CFR 1.5(a) in a reading area, on business days between the hours of 8:30 a.m. and 4:30 p.m., upon request to the Freedom of Information Coordinator or designee at the following address:
(a) The FOIA Coordinator of FSIS is authorized to receive requests and to exercise authority under 7 CFR 1.3(a) to—
(1) Make determinations to grant or deny such requests,
(2) Extend the 20-day deadline,
(3) Make discretionary releases of exempt records, except where disclosure is specifically prohibited by Executive Order, statute, and applicable regulations,
(4) Consider expedited processing when appropriate,
(5) Make determinations regarding the charging of fees pursuant to the established schedule, and
(6) Determine the applicability of 7 CFR 1.5 to requests for records.
(b) Requests for FSIS records or information will be made in writing in accordance with 7 CFR 1.5 and submitted to the FSIS Freedom of Information Act Coordinator at the following address:
The submitter will identify each record with reasonable specificity as prescribed in 7 CFR 1.3. All requests to inspect or obtain copies of any record or to obtain a fee waiver must be submitted in writing.
(c) In exercising authority under 7 CFR 1.3(a)(3) to grant and deny requests, the Coordinator or designee will comply with subsection (b) of the Freedom of Information Act (5 U.S.C. 552(b)), as amended, which requires that any reasonably segregated portion of a document will be provided to a person requesting the document after deletion of any portions within the scope of the request for which an exemption is being claimed under the Act. Therefore, unless the disclosable and nondisclosable portions are so inextricably linked that it is not reasonably possible to separate them, the document will be released with the nondisclosable portions deleted. The Coordinator or designee may exercise discretion as limited by 7 CFR l.15 to release the entire document or make only a minimum number of deletions. If portions of a document in electronic format have been redacted, the Agency must indicate, on the released portion of the document, the amount of information that has been deleted from a record, unless that indication would harm an interest protected by an applicable exemption.
Department regulations provide for a schedule of reasonable standard charges for document search and duplication. See 7 CFR 1.17. Fees to be charged are in 7 CFR part 1, subpart A, appendix A.
(a) If the request for information or for a waiver of search or duplication is denied, in whole or in part, the FOIA Coordinator or designee will explain in the letter of response the grounds for any denial of access and offer the requester an opportunity to file an administrative appeal, pursuant to 7 CFR 1.3(a)(4). The appeal should be filed in writing within 45 days of the date of denial (departmental regulations, 7 CFR 1.14) and addressed as follows:
(b) The FSIS Administrator is authorized under 7 CFR 1.3(a)(4) to extend the 20-day deadline, make discretionary releases, and make determinations regarding the charging of fees.
(a) The response to Freedom of Information requests and appeals by officials named in §§ 390.5 and 390.7 of this part shall be governed by and made in accordance with 7 CFR 1.7 and the regulations in this part.
(b) If requests for records and information are received by field offices, the field office will immediately notify the FOIA Coordinator or designee by telephone and transmit the request to the FOIA office. In rare instances, the FOIA Coordinator or designee will authorize a release of the requested records to the field office receiving the request. The request will be considered as having been received on the date of arrival in the office of the Coordinator or designee. Any person whose request for records has been granted may inspect and copy the records (or copies) at the office listed in § 390.4 of this part in accordance with the provisions of that section and with § 390.6. Copies also may be obtained by mail.
(a) The Administrator of the Food Safety and Inspection Service (FSIS), or designee, may authorize the disclosure of distribution lists (records that show where and when product was shipped) obtained from a firm recalling products, or incorporated into agency-prepared records, to State and other Federal government agencies to verify the removal of the recalled product, provided that:
(1) The State agency has provided both a written statement establishing its authority to protect confidential distribution lists from public disclosure and a written commitment not to disclose any information provided by FSIS, without the written permission of the submitter of the information or written confirmation by FSIS that the information no longer has confidential status. Federal government agencies must provide a written commitment not to disclose the information and to refer any request for distribution lists to FSIS for response; and
(2) The Administrator of FSIS or designee determines that disclosure would be in the interest of public health.
(b) This provision does not authorize the disclosure to State or other Federal government agencies of trade secret information, unless otherwise provided by law or pursuant to an express written authorization provided by the submitter of the information.
(c) Information disclosed under this section is not a disclosure of information to the public. Disclosures made under this section do not waive any FOIA exemption protection.
The Administrator of the Food Safety and Inspection Service will make publicly available the names and locations of retail consignees of recalled meat or poultry products that the Agency compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death.
(a) USDA/FSIS-0005, AssuranceNet system of records, is exempt from subsections (c)(3), (d)(1)-(4), (e)(1), (e)(4)(G)-(I), and (f) of the Privacy Act, 5 U.S.C. 552a, to the extent it contains investigatory material compiled for law enforcement purposes in accordance with 5 U.S.C. 552a(k)(2). Exemptions from the particular subsections are justified for the following reasons:
(1) From subsection (c)(3) because the release of the disclosure accounting would permit the subject of an investigation to obtain valuable information concerning the nature of that investigation. This would permit record subjects to impede the investigation, e.g., destroy evidence, intimidate potential witnesses, or flee the area to avoid inquiries or apprehension by law enforcement personnel.
(2) From subsection (d)(1) because the records contained in this system relate to official Federal investigations and matters of law enforcement. Individual access to these records might compromise ongoing or impending investigations, reveal confidential informants, or constitute unwarranted invasions of the personal privacy of third parties who are involved in a certain investigation.
(3) From section (d)(2) because amendment of the records would interfere with ongoing law enforcement proceedings and impose an impossible administrative burden by requiring investigations to be continuously reinvestigated.
(4) From subsections (d)(3) and (4) because these subsections are inapplicable to the extent exemption is claimed from subsections (d)(1) and (2).
(5) From subsection (e)(1) because it is often impossible to determine in advance if investigatory information contained in this system is accurate, relevant, timely and complete, but, in the interests of effective law enforcement, it is necessary to retain this information to aid in establishing patterns of activity and provide investigative leads. Moreover, it would impede the specific investigative process if it were necessary to assure the relevance, accuracy, timeliness, and completeness of all information obtained.
(6) From subsections (e)(4)(G) and (H) since an exemption being claimed for subsection (d) makes these subsections inapplicable.
(7) From subsection (e)(4)(I) because the categories of sources of the records in this system have been published in the
(8) From subsection (f) to the extent that the system is exempt from other specific subsections of the Privacy Act.
(b) [Reserved]
Fees shall be charged by the Agency for certain specified inspection services provided on a holiday, on an overtime basis, and/or which are voluntary inspection services.
(a) For each calendar year, FSIS will calculate the basetime rate for inspection services, per hour per program employee, provided pursuant to §§ 350.7, 351.8, 351.9, 352.5, 354.101, 355.12, and 362.5 of this chapter, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate.
(b) FSIS will calculate the benefits, travel and operating, overhead, and allowance for bad debt rate components of the basetime rate, using the following formulas:
(1) Benefits rate. The quotient of dividing the previous fiscal year's direct benefits costs by the previous fiscal year's total hours (regular, overtime, and holiday), plus the quotient multiplied by the calendar year's percentage cost of living increase. Some examples of direct benefits are health insurance, retirement, life insurance, and Thrift Savings Plan basic and matching contributions.
(2) Travel and operating rate. The quotient of dividing the previous fiscal year's total direct travel and operating costs by the previous fiscal year's total hours (regular, overtime, and holiday), plus the quotient multiplied by the calendar year's percentage of inflation.
(3) Overhead rate. The quotient of dividing the previous fiscal year's indirect costs plus the previous fiscal year's information technology (IT) costs in the Public Health Data Communication Infrastructure System Fund plus the previous fiscal year's Office of Management Program cost in the Reimbursable and Voluntary Funds plus the provision for the operating balance less any Greenbook costs (i.e., costs of USDA support services prorated to the service component for which the fees are charged) that are not related to food inspection, by the previous fiscal year's total hours (regular, overtime, and holiday) worked across all funds, plus the quotient multiplied by the calendar year's percentage of inflation.
(4) Allowance for bad debt rate. Previous fiscal year's allowance for bad debt (for example, debt owed that is not paid in full by plants and establishments that declare bankruptcy) divided by the previous fiscal year's total hours (regular, overtime, and holiday) worked.
(c) The calendar year's cost of living increases and percentage of inflation factors used in the formulas in this section are based on the Office of Management and Budget's Presidential Economic Assumptions.
For each calendar year, FSIS will calculate the overtime and holiday rates, per hour per program employee, provided pursuant to §§ 307.5, 350.7, 351.8, 351.9, 352.5, 354.101, 355.12, 362.5, and 381.38 of this chapter, using the following formulas:
(a) Overtime rate. The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, multiplied by 1.5, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate.
(b) Holiday rate. The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, multiplied by 2, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate.
(c) FSIS will calculate the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt rate using the formulas set forth in § 391.2(b), and the cost of living increases and percentage of inflation factors set forth in § 391.2(c).
(a) For each calendar year, FSIS will calculate the laboratory services rate, per hour per program employee, provided pursuant to §§ 350.7, 351.9, 352.5, 354.101, 355.12, and 362.5 of this chapter, using the following formula: The quotient of dividing the Office of Public Health Science (OPHS) previous fiscal year's regular direct pay by OPHS previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage cost of living increase, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate.
(b) FSIS will calculate the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt rate using the formulas set forth in § 391.2(b), and the cost of living increases and percentage of inflation factors set forth in § 391.2(c).
(a) The annual fee for the accreditation and maintenance of accreditation provided pursuant to § 439.5 of this chapter shall be $5,000 for the first analyte class, $2,900 for the second analyte class, and $2,100 for each additional analyte class.
(b) Laboratories that request special onsite inspections shall pay FSIS the actual cost of reasonable travel and other expenses necessary to perform the unscheduled or non-routine onsite inspections.
This part contains provisions governing the submission of petitions for rulemaking to the Food Safety and Inspection Service (FSIS). The provisions in this part apply to all rulemaking petitions submitted to FSIS, except to the extent that other parts or sections of this chapter prescribe procedures for submitting a request to amend a particular regulation.
For purposes of this part, a “petition” is a written request to issue, amend, or repeal a regulation administered by FSIS. A request to issue, amend, or repeal a document that interprets a regulation administered by FSIS may also be submitted by petition.
To be considered by FSIS, a petition must contain the following information:
(a) The name, address, telephone number, and e-mail address (if available) of the person who is submitting the petition;
(b) A full statement of the action requested by the petitioner, including the exact wording and citation of the existing regulation, if any, and the proposed regulation or amendment requested;
(c) A full statement of the factual and legal basis on which the petitioner relies for the action requested in the petition, including all relevant information and views on which the petitioner relies, as well as information known to the petitioner that is unfavorable to the petitioner's position. The statement should identify the problem that the requested action is intended to address and explain why the requested action is necessary to address the problem.
(a) Information referred to or relied on in support of a petition should be included in full and should not be incorporated by reference. A copy of any article or other source cited in a petition should be submitted with the petition.
(b) Sources of information that are appropriate to use in support of a petition include, but are not limited to:
(1) professional journal articles,
(2) research reports,
(3) official government statistics,
(4) official government reports,
(5) industry data, and
(6) scientific textbooks.
(c) If an original research report is used to support a petition, the information should be presented in a form that would be acceptable for publication in a peer reviewed scientific or technical journal.
(d) If quantitative data are used to support a petition, the presentation of the data should include a complete statistical analysis using conventional statistical methods.
(a) Any interested person may file a petition with FSIS. For purposes of this part, an “interested person” is any individual, partnership, corporation, association, or public or private organization.
(b) To file a petition with FSIS, a person should submit the petition to the FSIS Docket Clerk, Department of Agriculture, Food Safety and Inspection Service, Room 2534 South Building, 1400 Independence Ave., SW., Washington, DC 20250-3700.
(c) Once a petition is submitted in accordance with this part, it will be filed by the FSIS Docket Clerk, stamped with the date of filing, and assigned a petition number. Once a petition has been filed, FSIS will notify the petitioner in writing and provide the petitioner with the number assigned to the petition and the Agency contact for the petition. The petition number should be referenced by the petitioner in all contacts with the Agency regarding the petition.
(d) If a petitioner elects to withdraw a petition submitted in accordance with this part, the petitioner should inform FSIS in writing. Once a petition has been withdrawn, the petitioner may re-submit the petition at any time.
(a) All rulemaking petitions filed with FSIS, along with any documentation submitted in support of a petition, will be available for public inspection in the FSIS docket room and will be posted on the FSIS Web site at http://www.fsis.usda.gov/.
(b) If FSIS cannot readily determine whether information submitted in support of a petition is privileged or confidential business information, FSIS will request that the petitioner submit a written statement that certifies that the petition does not contain confidential information that should not be put on public display. If the petitioner fails to submit the certification within a time specified by FSIS, the Agency will consider the information to be confidential.
(c) If FSIS determines that a petition, or any documentation submitted in support of a petition, contains information that is exempt from public disclosure under the Freedom of Information Act (5 U.S.C. 552 et seq.) or any other applicable laws or regulations, and that the information would provide the basis for granting the petition, FSIS will inform the petitioner in writing. FSIS will provide the petitioner an opportunity to withdraw the petition or supporting documentation, or modify the supporting documentation to permit public disclosure.
(a) Any interested person may submit written comments on a petition filed with FSIS.
(b) Comments on a petition should be submitted within 60 days of the posting date of the petition and should identify the number assigned to the petition to which the comments refer.
(c) FSIS will consider all timely comments on a petition that are submitted in accordance with this section as part of its review of the petition.
(d) All comments on a petition will become part of the petition file and will be available for public inspection in the FSIS docket room and posted on the FSIS Web site at http://www.fsis.usda.gov/.
(e) Any interested person who wishes to suggest an alternative action to the action requested by the petition should submit a separate petition that complies with these regulations and not submit the alternative as a comment on the petition.
(f) If FSIS determines that a comment received on a petition is in fact a request for an alternative action, the Agency will inform the commenter in writing. The Agency will take no further action on the requested alternative action unless the commenter submits an appropriate petition for rulemaking.
(a) A petition will receive expedited review by FSIS if the requested action is intended to enhance the public health by removing or reducing foodborne pathogens or other potential food safety hazards that might be present in or on meat, poultry, or egg products.
(b) For a petition to be considered for expedited review, the petitioner must submit scientific information that demonstrates that the requested action will reduce or remove foodborne pathogens or other potential food safety hazards that are likely to be present in or on meat, poultry, or egg products, and how it will do so.
(c) If FSIS determines that a petition warrants expedited review, FSIS will review the petition ahead of other pending petitions.
Information related to the submission and processing of petitions for rulemaking may be found on the FSIS Web site at http://www.fsis.usda.gov/.
(a) No final label may be used on any product unless the label has been submitted for approval to the FSIS Labeling and Program Delivery Staff, accompanied by FSIS Form 7234-1, Application for Approval of Labels, Marking, and Devices, and approved by such staff, except for generically approved labels authorized for use in § 412.2. The management of the official establishment or establishment certified under a foreign inspection system, in accordance with parts 327 and 381, subpart T, must maintain a copy of all labels used, in accordance with parts 320 and 381, subpart Q, of this chapter. Such records must be made available to any duly authorized representative of the Secretary upon request.
(b) All labels required to be submitted for approval as set forth in paragraph (a) of this section will be submitted to the FSIS Labeling and Program Delivery Staff. A parent company for a corporation may submit only one label application for a product produced in other establishments that are owned by the corporation.
(c) The Food Safety and Inspection Service requires the submission of labeling applications for the following:
(1) Sketch labels as defined in paragraph (d) of this section for products which are produced under a religious exemption;
(2) [Reserved]
(3) Special statements and claims as defined in paragraph (e) of this section and presented in the context of a final label.
(4) Requests for the temporary use of final labels as prescribed in paragraph (f) of this section.
(d) A “sketch” label is the concept of a label. It may be a printer's proof or equivalent that is sufficiently legible to clearly show all labeling features, size, and location. The Food Safety and Inspection Service will accept sketches that are hand drawn or computer generated, or other reasonable facsimiles that clearly reflect and project the final version of the label.
(e) “Special statements and claims” are statements, claims, logos, trademarks, and other symbols on labels as defined in this paragraph (e).
(1) The following are considered special statements and claims:
(i) Those not defined in the Federal meat and poultry products inspection regulations or the Food Standards and Labeling Policy Book;
(ii) “Natural” claims, regardless of whether they are defined in the Food Standards and Labeling Policy Book; and
(iii) Health claims (including graphic representations of hearts), ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims regarding the raising of animals (e.g., “no antibiotics administered”), products labeled as organic (except for those where only individual ingredients are labeled as organic), and instructional or disclaimer statements concerning pathogens (e.g., “for cooking only” or “not tested for E. coli O157:H7”).
(2) The following are not considered special statements and claims:
(i) Allergen statements (e.g., “contains soy”) applied in accordance with the Food Allergen Labeling and Consumer Protection Act;
(ii) Negative claims regarding ingredients not listed in the ingredients statement (e.g., “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”);
(iii) Statements that characterize a product's nutrient content in compliance with Title 9 of the CFR, such as “low fat”; and
(iv) Claims related to geographical significance, such as “German Brand Made in the US,” or those that make a country of origin statement on the label of any meat or poultry product “covered commodity,”
(f)(1) Temporary approval for the use of a final label that may be deemed deficient in some particular may be granted by the FSIS Labeling and Program Delivery Staff. Temporary approvals may be granted for a period not to exceed 180 calendar days, under the following conditions:
(i) The proposed label would not misrepresent the product;
(ii) The use of the label would not present any potential health, safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship; and
(iv) An unfair competitive advantage would not result from the granting of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the FSIS Labeling and Program Delivery Staff provided that the applicant demonstrates that new circumstances, meeting the above criteria, have developed since the original temporary approval was granted.
(a)(1) An official establishment, or an establishment certified under a foreign inspection system in accordance with part 327, or part 381, subpart T of this chapter, is authorized to use generically approved labels, as defined in paragraph (b) of this section, and thus is free to use such labels without submitting them to the Food Safety and Inspection Service for approval, provided the label, in accordance with this section, displays all mandatory features in a prominent manner in compliance with part 317 or part 381, and is not otherwise false or misleading in any particular.
(2) The Food Safety and Inspection Service will select samples of generically approved labels from the records maintained by official establishments and establishments certified under foreign inspection systems, in accordance with part 327 or part 381, subpart T, to determine compliance with label requirements. If the Agency finds that an establishment is using a false or misleading label, it will institute the proceedings prescribed in § 500.8 of this chapter to revoke the approval for the label.
(b) Generically approved labels are labels that bear all applicable mandatory labeling features (i.e., product name, handling statement, ingredients statement, the name and place of business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition labeling) in accordance with Federal regulations and do not bear special statements and claims as defined in § 412.1(e).
(a) The claims “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate single ingredient products derived from animals born, raised, slaughtered, and processed in the United States.
(b)(1) The claims “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate multi-ingredient products if:
(i) All ingredients that are produced under FSIS mandatory inspection or voluntary inspection services in the product are derived from animals born, raised, slaughtered, and processed in the United States;
(ii) All other ingredients in the product are of domestic origin; and
(iii) The preparation and processing steps for the multi-ingredient product have occurred in the United States.
(2) For purposes of this paragraph (b), spices and flavorings need not be of domestic origin for claim use, but all other ingredients of the product must be of domestic origin.
(c) Claims other than “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate the U.S.-origin component of single ingredient and multi-ingredient products' preparation and processing only if the claim includes a description of the preparation and processing steps that occurred in the United States upon which the claim is being made. Such labels must be truthful and not misleading.
(d) Claims may be used under generic approval on labels to designate the U.S. State, Territory, or locality-origin of single ingredient and multi-ingredient products or components of a product's preparation and processing, only if the claim meets the requirements for use of U.S.-origin claims under paragraphs (a) through (c) of this section with regards to the U.S. State, territory, or locality origin.
(e) Display of the U.S. flag, or a U.S. State or territory flag, may be used under generic approval on labels to designate the United States, U.S. State, or U.S. territory origin of single and multi-ingredient products or components of a product's preparation and processing, only if the display of the flag meets the requirements for use of U.S.-origin claims under paragraphs (a) through (d) of this section. For the purposes of the display of a flag that meets the requirements for use of U.S.-origin claims other than “Product of USA” and “Made in the USA” under paragraph (c) or (d) of this section, the display must be accompanied by a description of the preparation and processing steps that occurred in the United States, or in the U.S. State or territory, upon which the claim is being made.
(f) In addition to the requirements in § 412.2, official establishments using and facilities choosing to use labels that bear the claims “Product of USA” or “Made in the USA” to designate products of U.S. origin must maintain records to support the U.S.-origin claim. Examples of the types of documentation that may be maintained to support the U.S.-origin claims “Product of USA” or “Made in the USA” include:
(1) A written description of the controls used in the birthing, raising, slaughter, and processing of the source animals and eggs, and for multi-ingredient products the preparation and processing of all additional ingredients other than spices and flavorings, to ensure that each step complies with paragraphs (a) and (b) of this section.
(2) A written description of the controls used to trace and, as necessary, segregate, from the time of birth through packaging and wholesale or retail distribution, source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products that comply with paragraphs (a) and (b) of this section.
(3) A signed and dated document describing how the product is prepared and processed to support that the claim is not false or misleading.
(g) In addition to the requirements in § 412.2, official establishments using and facilities choosing to use a U.S.-origin label claim other than “Product of USA” or “Made in the USA” to designate the U.S.-origin preparation and processing steps of a product must maintain records to support the qualified U.S.-origin claim. Examples of the types of documentation that may be maintained to support the qualified U.S.-origin claim include:
(1) A written description of the controls used in each applicable preparation and processing step of source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products to demonstrate that the qualified U.S.-origin claim complies with paragraph (c) or (d) of this section. The described controls may include those used to trace and, as necessary, segregate, during each applicable step, source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products that comply with the U.S.-origin claim from those that do not comply.
(2) A signed and dated document describing how the qualified U.S.-origin claim regarding the preparation and processing steps is not false or misleading.
Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.
(a) Grounds and pest control. The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.
(b) Construction. (1) Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good repair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.
(2) Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.
(3) Walls, floors, ceilings, doors, windows, and other outside openings must be constructed and maintained to prevent the entrance of vermin, such as flies, rats, and mice.
(4) Rooms or compartments in which edible product is processed, handled, or stored must be separate and distinct from rooms or compartments in which inedible product is processed, handled, or stored, to the extent necessary to prevent product adulteration and the creation of insanitary conditions.
(c) Light. Lighting of good quality and sufficient intensity to ensure that sanitary conditions are maintained and that product is not adulterated must be provided in areas where food is processed, handled, stored, or examined; where equipment and utensils are cleaned; and in hand-washing areas, dressing and locker rooms, and toilets.
(d) Ventilation. Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.
(e) Plumbing. Plumbing systems must be installed and maintained to:
(1) Carry sufficient quantities of water to required locations throughout the establishment;
(2) Properly convey sewage and liquid disposable waste from the establishment;
(3) Prevent adulteration of product, water supplies, equipment, and utensils and prevent the creation of insanitary conditions throughout the establishment;
(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor;
(5) Prevent back-flow conditions in and cross-connection between piping systems that discharge waste water or sewage and piping systems that carry water for product manufacturing; and
(6) Prevent the backup of sewer gases.
(f) Sewage disposal. Sewage must be disposed into a sewage system separate from all other drainage lines or disposed of through other means sufficient to prevent backup of sewage into areas where product is processed, handled, or stored. When the sewage disposal system is a private system requiring approval by a State or local health authority, the establishment must furnish FSIS with the letter of approval from that authority upon request.
(g) Water supply and water, ice, and solution reuse. (1) A supply of running water that complies with the National Primary Drinking Water regulations (40 CFR part 141), at a suitable temperature and under pressure as needed, must be provided in all areas where required (for processing product, for cleaning rooms and equipment, utensils, and packaging materials, for employee sanitary facilities, etc.). If an establishment uses a municipal water supply, it must make available to FSIS, upon request, a water report, issued under the authority of the State or local health agency, certifying or attesting to the potability of the water supply. If an establishment uses a private well for its water supply, it must make available to FSIS, upon request, documentation certifying the potability of the water supply that has been renewed at least semi-annually.
(2) Water, ice, and solutions (such as brine, liquid smoke, or propylene glycol) used to chill or cook ready-to-eat product may be reused for the same purpose, provided that they are maintained free of pathogenic organisms and fecal coliform organisms and that other physical, chemical, and microbiological contamination have been reduced to prevent adulteration of product.
(3) Water, ice, and solutions used to chill or wash raw product may be reused for the same purpose provided that measures are taken to reduce physical, chemical, and microbiological contamination so as to prevent contamination or adulteration of product. Reuse that which has come into contact with raw product may not be used on ready-to-eat product.
(4) Reconditioned water that has never contained human waste and that has been treated by an onsite advanced wastewater treatment facility may be used on raw product, except in product formulation, and throughout the facility in edible and inedible production areas, provided that measures are taken to ensure that this water meets the criteria prescribed in paragraph (g)(1) of this section. Product, facilities, equipment, and utensils coming in contact with this water must undergo a separate final rinse with non-reconditioned water that meets the criteria prescribed in paragraph (g)(1) of this section.
(5) Any water that has never contained human waste and that is free of pathogenic organisms may be used in edible and inedible product areas, provided it does not contact edible product. For example, such reuse water may be used to move heavy solids, to flush the bottom of open evisceration troughs, or to wash antemortem areas, livestock pens, trucks, poultry cages, picker aprons, picking room floors, and similar areas within the establishment.
(6) Water that does not meet the use conditions of paragraphs (g)(1) through (g)(5) of this section may not be used in areas where edible product is handled or prepared or in any manner that would allow it to adulterate edible product or create insanitary conditions.
(h) Dressing rooms, lavatories, and toilets. (1) Dressing rooms, toilet rooms, and urinals must be sufficient in number, ample in size, conveniently located, and maintained in a sanitary condition and in good repair at all times to ensure cleanliness of all persons handling any product. They must be separate from the rooms and compartments in which products are processed, stored, or handled.
(2) Lavatories with running hot and cold water, soap, and towels, must be placed in or near toilet and urinal rooms and at such other places in the establishment as necessary to ensure cleanliness of all persons handling any product.
(3) Refuse receptacles must be constructed and maintained in a manner that protects against the creation of insanitary conditions and the adulteration of product.
(a) Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adulteration of product during processing, handling, or storage. Equipment and utensils must be maintained in sanitary condition so as not to adulterate product.
(b) Equipment and utensils must not be constructed, located, or operated in a manner that prevents FSIS inspection program employees from inspecting the equipment or utensils to determine whether they are in sanitary condition.
(c) Receptacles used for storing inedible material must be of such material and construction that their use will not result in the adulteration of any edible product or in the creation of insanitary conditions. Such receptacles must not be used for storing any edible product and must bear conspicuous and distinctive marking to identify permitted uses.
(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.
(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.
(c) Cleaning compounds, sanitizing agents, processing aids, and other chemicals used by an establishment must be safe and effective under the conditions of use. Such chemicals must be used, handled, and stored in a manner that will not adulterate product or create insanitary conditions. Documentation substantiating the safety of a chemical's use in a food processing environment must be available to FSIS inspection program employees for review.
(d) Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.
(a) Cleanliness. All persons working in contact with product, food-contact surfaces, and product-packaging materials must adhere to hygienic practices while on duty to prevent adulteration of product and the creation of insanitary conditions.
(b) Clothing. Aprons, frocks, and other outer clothing worn by persons who handle product must be of material that is disposable or readily cleaned. Clean garments must be worn at the start of each working day and garments must be changed during the day as often as necessary to prevent adulteration of product and the creation of insanitary conditions.
(c) Disease control. Any person who has or appears to have an infectious disease, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, must be excluded from any operations which could result in product adulteration and the creation of insanitary conditions until the condition is corrected.
When an FSIS program employee finds that any equipment, utensil, room, or compartment at an official establishment is insanitary or that its use could cause the adulteration of product, he will attach to it a “U.S. Rejected” tag. Equipment, utensils, rooms, or compartments so tagged cannot be used until made acceptable. Only an FSIS program employee may remove a “U.S. Rejected” tag.
Each official establishment shall develop, implement, and maintain written standard operating procedures for sanitation (Sanitation SOP's) in accordance with the requirements of this part.
(a) The Sanitation SOP's shall describe all procedures an official establishment will conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of product(s).
(b) The Sanitation SOP's shall be signed and dated by the individual with overall authority on-site or a higher level official of the establishment. This signature shall signify that the establishment will implement the Sanitation SOP's as specified and will maintain the Sanitation SOP's in accordance with the requirements of this part. The Sanitation SOP's shall be signed and dated upon initially implementing the Sanitation SOP's and upon any modification to the Sanitation SOP's.
(c) Procedures in the Sanitation SOP's that are to be conducted prior to operations shall be identified as such, and shall address, at a minimum, the cleaning of food contact surfaces of facilities, equipment, and utensils.
(d) The Sanitation SOP's shall specify the frequency with which each procedure in the Sanitation SOP's is to be conducted and identify the establishment employee(s) responsible for the implementation and maintenance of such procedure(s).
(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP's before the start of operations.
(b) Each official establishment shall conduct all other procedures in the Sanitation SOP's at the frequencies specified.
(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP's.
Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOP's and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel.
(a) Each official establishment shall take appropriate corrective action(s) when either the establishment or FSIS determines that the establishment's Sanitation SOP's or the procedures specified therein, or the implementation or maintenance of the Sanitation SOP's, may have failed to prevent direct contamination or adulteration of product(s).
(b) Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP's and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP's or the procedures specified therein.
(a) Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP's and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP's as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP's shall authenticate these records with his or her initials and the date.
(b) Records required by this part may be maintained on computers provided the establishment implements appropriate controls to ensure the integrity of the electronic data.
(c) Records required by this part shall be maintained for at least 6 months and made available to FSIS. All such records shall be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.
FSIS shall verify the adequacy and effectiveness of the Sanitation SOP's and the procedures specified therein by determining that they meet the requirements of this part. Such verification may include:
(a) Reviewing the Sanitation SOP's;
(b) Reviewing the daily records documenting the implementation of the Sanitation SOP's and the procedures specified therein and any corrective actions taken or required to be taken;
(c) Direct observation of the implementation of the Sanitation SOP's and the procedures specified therein and any corrective actions taken or required to be taken; and
(d) Direct observation or testing to assess the sanitary conditions in the establishment.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation occurs.
Critical control point. A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit. The maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP plan itself.
Hazard. SEE Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be used to control an identified food safety hazard.
Process-monitoring instrument. An instrument or device used to indicate conditions during processing at a critical control point.
Responsible establishment official. The individual with overall authority on-site or a higher level official of the establishment.
(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.
(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.
(3) Food safety hazards might be expected to arise from the following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Zoonotic diseases;
(vii) Decomposition;
(viii) Parasites;
(ix) Unapproved use of direct or indirect food or color additives; and
(x) Physical hazards.
(b) The HACCP plan. (1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories:
(i) Slaughter—all species.
(ii) Raw product—ground.
(iii) Raw product—not ground.
(iv) Thermally processed—commercially sterile.
(v) Not heat treated—shelf stable.
(vi) Heat treated—shelf stable.
(vii) Fully cooked—not shelf stable.
(viii) Heat treated but not fully cooked—not shelf stable.
(ix) Product with secondary inhibitors—not shelf stable.
(2) A single HACCP plan may encompass multiple products within a single processing category identified in this paragraph, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph (c) of this section are essentially the same, provided that any required features of the plan that are unique to a specific product are clearly delineated in the plan and are observed in practice.
(3) HACCP plans for thermally processed/commercially sterile products do not have to address the food safety hazards associated with microbiological contamination if the product is produced in accordance with the requirements of part 431 of this chapter.
(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:
(1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process.
(2) List the critical control points for each of the identified food safety hazards, including, as appropriate:
(i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and
(ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;
(3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.
(7) List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with § 417.4 of this part.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part.
(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the requirements of this part, may render the products produced under those conditions adulterated.
(a) The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall:
(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform a review to determine the acceptability of the affected product for distribution;
(3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an individual trained in accordance with § 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.
(c) All corrective actions taken in accordance with this section shall be documented in records that are subject to verification in accordance with § 417.4(a)(2)(iii) and the recordkeeping requirements of § 417.5 of this part.
(a) Every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.
(1) Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.
(2) Ongoing verification activities. Ongoing verification activities include, but are not limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part.
(3)(i) Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with § 417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of § 417.2(c) of this part.
(ii) Each establishment must make a record of each reassessment required by paragraph (a)(3)(i) of this section and must document the reasons for any changes to the HACCP plan based on the reassessment, or the reasons for not changing the HACCP plan based on the reassessment. For annual reassessments, if the establishment determines that no changes are needed to its HACCP plan, it is not required to document the basis for this determination.
(b) Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or, the intended use or consumers of the finished product.
(a) The establishment shall maintain the following records documenting the establishment's HACCP plan:
(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation;
(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP's and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.
(3) Records documenting the monitoring of CCP's and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.
(c) Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official.
(d) Records maintained on computers. The use of records maintained on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.
(e) Record retention. (1) Establishments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years.
(2) Off-site storage of records required by paragraph (a)(3) of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee's request.
(f) Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying.
A HACCP system may be found to be inadequate if:
(a) The HACCP plan in operation does not meet the requirements set forth in this part;
(b) Establishment personnel are not performing tasks specified in the HACCP plan;
(c) The establishment fails to take corrective actions, as required by § 417.3 of this part;
(d) HACCP records are not being maintained as required in § 417.5 of this part; or
(e) Adulterated product is produced or shipped.
(a) Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with § 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance with § 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat, poultry, or egg products processing, including a segment on the development of a HACCP plan for a specific product and on record review.
FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include:
(a) Reviewing the HACCP plan;
(b) Reviewing the CCP records;
(c) Reviewing and determining the adequacy of corrective actions taken when a deviation occurs;
(d) Reviewing the critical limits;
(e) Reviewing other records pertaining to the HACCP plan or system;
(f) Direct observation or measurement at a CCP;
(g) Sample collection and analysis to determine the product meets all safety standards; and
(h) On-site observations and record review.
Each official establishment must promptly notify the local FSIS District Office within 24 hours of learning or determining that an adulterated or misbranded meat, meat food, poultry, or poultry product received by or originating from the official establishment has entered commerce, if the official establishment believes or has reason to believe that this has happened. The official establishment must inform the District Office of the type, amount, origin, and destination of the adulterated or misbranded product.
Each official establishment must prepare and maintain written procedures for the recall of any meat, meat food, poultry, or poultry product produced and shipped by the official establishment. These written procedures must specify how the official establishment will decide whether to conduct a product recall, and how the establishment will effect the recall, should it decide that one is necessary.
All records, including records documenting procedures required by this part, must be available for official review and copying.
This part of the regulations prescribes rules for the preparation of meat and the processing of poultry products. The rules in this part further the purposes of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) by, among other things, preventing the adulteration or misbranding of meat and poultry products at official establishments. 9 CFR Chapter III, Subchapter A, Parts 318 and 319, Subpart C of this part, and 21 CFR Chapter I, Subchapter A or Subchapter B, specify rules for the use of certain food ingredients (e.g., food additives and color additives) and sources of radiation that may render meat or poultry products adulterated or misbranded.
(a)(1) General. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, part 318 or part 319 of this chapter, or by the Administrator in specific cases.
(2)(i) Poultry products and poultry broth used in the processing of poultry products shall have been processed in the United States only in an official establishment or imported from a foreign country determined to be eligible to export such products to the United States under § 381.196(b), and have been inspected and passed in accordance with the regulations. Detached ova and offal shall not be used in the processing of any poultry products, except that poultry feet may be processed for use as human food in a manner approved by the Administrator in specific cases and detached ova may be used in the processing of poultry products if the processor demonstrates that such ova comply with the requirements of the Federal Food, Drug, and Cosmetic Act.
(ii) Liquid, frozen, and dried egg products used in the processing of any poultry product shall have been prepared under inspection and be so marked in accordance with the Egg Products Inspection Act.
(3) Carcasses, parts thereof, and products of cattle, sheep, swine, goats, or equines may be used in the processing of poultry products only if they were prepared in the United States in an official meat packing establishment or imported from a foreign country determined to be eligible to export such products to the United States under § 327.2(b), were inspected and passed in accordance with the Federal Meat Inspection Act and the regulations under such Act (subchapter A of this chapter), and are so marked.
(b)(1) Food ingredients and sources of radiation. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR chapter I, subchapter A or subchapter B, shall be listed for such use under this chapter, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter, unless precluded from such use or further restricted in parts 318 or 319, or subparts O and P, of part 381 of this chapter, or unless such use otherwise results in the adulteration or misbranding of meat or poultry products. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR Chapter I, subchapter A or subchapter B, may be listed or approved for such use under this chapter by the Administrator in § 424.21, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter.
(2) No food ingredients or sources of radiation may be used in the preparation of any meat or poultry product, for any purpose, unless the use is listed or approved in 21 CFR chapter I as a direct food additive (21 CFR part 172), a secondary direct food additive (21 CFR part 173), indirect food additive (21 CFR parts 174-178), radiation source (21 CFR part 179), an interim-listed direct food additive (21 CFR part 180), a prior-sanctioned substance (21 CFR part 181), a Generally Recognized As Safe (GRAS) substance (21 CFR parts 182 or 184), or by a regulation in this chapter. Part 319 of this chapter also specifies other food ingredients that are acceptable in preparing specified products.
(3) No food ingredient, the intended use of which is to impart color in any meat or poultry product, shall be used unless such use is approved in 21 CFR chapter I as a color additive (21 CFR Parts 73, 74, 81, and 82) or in a regulation in this chapter.
(4) Petitions to amend 21 CFR chapter I to provide for uses of food additives, or other substances or sources of radiation necessary in the preparation of meat or poultry products, or food ingredients used to impart color to product, should be sent to the Food and Drug Administration, in accordance with the provisions of 21 CFR parts 71 or 171, as appropriate.
(5) Inquiries concerning the regulatory status under the Federal Food, Drug, and Cosmetic Act of any articles intended for use as components of, or in contact with, meat or poultry products, may be addressed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 20204, or the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.
(6) Inquiries concerning the use in specific meat or poultry products of substances that are not affirmed by the Food and Drug Administration as Generally Recognized as Safe (GRAS) or otherwise listed in 21 CFR part 182 or part 184, or of food or color additives listed in 21 CFR regulations for general use in foods or for use in meat, or poultry products, generally, including mixtures of such substances or additives, should be addressed to the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.
(c) The food ingredients specified in the following chart are approved for use in the preparation of meat products, provided they are used for the purposes indicated, within the limit of the amounts stated, and under other conditions specified in this part and Part 317 of this chapter. Part 319 of this chapter specifies other food ingredients that are acceptable in preparing specified meat products. This chart also contains food ingredients that are acceptable for use in poultry products, provided they are used for the purpose indicated, within the limits of the amounts stated and under other conditions specified in this part. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, or by the Administrator in specific cases.
| Class of substance | Substance | Purpose | Products | Amount |
|---|---|---|---|---|
| Acidifiers | Acetic acid | To adjust acidity | Various meat and poultry products 2 | Sufficient for purpose. 3 |
| Citric acid | ......do | ......do | Do. | |
| Glucono delta-lactone | ......do | ......do | Do. | |
| Lactic acid | ......do | ......do | Do. | |
| Phosphoric acid | ......do | ......do | Do. | |
| Tartaric acid | ......do | ......do | Do. | |
| Anti-coagulants | Citric acid | To prevent clotting | Fresh blood of livestock | 0.2 percent with or without water. When water is used to make a solution of citric acid added to the blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used. |
| Sodium citrate | ......do | ......do | Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to livestock blood, not more than 2 parts of water to 1 part of sodium citrate shall be used. | |
| Antifoaming agent | Methyl polysilicone | To retard foaming | Soups (meat and poultry) | 10 ppm. |
| ......do | Rendered fats (meat and poultry) | Do. | ||
| ......do | Curing pickle (meat and poultry) | 50 ppm. | ||
| Antimicrobial Agents | Potassium lactate | To inhibit microbial growth | Various meat and poultry products, except infant formulas and infant food | 4.8% by weight of total formulation. |
| Sodium diacetate | ......do | ......do | 0.25% by weight of total formulation. | |
| Sodium lactate | ......do | ......do | 4.8% by weight of total formulation. | |
| Trisodium phosphate | To reduce microbial levels | Raw, chilled poultry carcasses | 8 to 12 percent; solution to be maintained at 45 °F. to 55 °F. and applied by spraying or dipping carcasses for up to 15 seconds when used in accordance with 21 CFR 182.1778. | |
| Antioxidants and oxygen interceptors | Ascorbyl palmitate | To retard rancidity | Margarine or oleomargarine | 0.02 percent (by wt. of finished product) individually or in combination with other antioxidants approved for use in margarine. |
| Ascorbyl stearate | ||||
| BHA (butylated hydroxyanisole) | ||||
| ......do | Dry sausage | 0.003 based on total weight | 0.006 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. | |
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. | ||
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content. | ||
| BHT (butylated hydroxytoluene) | ......do | Dry sausage | 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. | |
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. | ||
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content. | ||
| Dodecyl gallate | ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. | |
| Glycine | ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat. | |
| Octyl gallate | ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. | |
| Propyl gallate | ......do | Dry sausage | 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. | |
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat. | |
| ......do | Margarine or oleo-margarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. | ||
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content). | ||
| Resin guaiac | ......do | Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent | 0.02 percent in combination with other antioxidants for use in meat. | |
| TBHQ (tertiary butylhydroquinone) | ......do | Dry sausage 0.003 percent based on weight | 0.006 percent in combina-tion only with BHA and/or BHT. | |
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combina-tion only with BHA or BHT. | |
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combin-ation only with BHA and/ or BHT, based on fat content. | |
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combina-tion only with BHA and/or BHT. | |
| ......do | Margarine or oleo-margarine | 0.02 percent alone or in combination only with BHA and/or BHT, based on oil or fat content. | ||
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination only with BHA and/or BHT, based on fat content). | ||
| Tocopherols | ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as “lard” or “rendered pork fat.” | |
| ......do | Dry sausage, semidry sausage, dried meats, uncooked or cooked fresh sausage made with beef and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausages, pregrilled beef patties, and restructured meats | Not to exceed 0.03 percent based on fat content. Not used in combination with other antioxidants. | ||
| ......do | Various poultry products | 0.03 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content). | ||
| Artificial Sweeteners | Saccharin | To sweeten product | Bacon | 0.01 percent. |
| Binders and Extenders | Agar-agar | To stabilize and thicken | Thermally processed canned and jellied meat food products | 0.25 percent of finished product. |
| Algin | To extend and stabilize product | Breading mix; sauces (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| A mixture of sodium alginate, calcium carbonate and calcium lactate/lactic acid (or glucono delta lactone) | To bind meat pieces | Restructured meat food products | Sodium alginate not to exceed 1.0 percent; calcium carbonate not to exceed 0.2 percent; and lactic acid/calcium lactate (or glucono delta-lactone) not to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Mixture ingredients must be added dry. | |
| A mixture of sodium alginate, calcium carbonate, lactic acid, and calcium lactate | To bind poultry pieces | Ground and formed raw or cooked poultry pieces | Sodium alginate not more than 0.8 percent, calcium carbonate not more than 0.15 percent; lactic acid and calcium lactate, in combination, not more than 0.6 percent of product formulation. Added mixture may not exceed 1.55 percent of product at formulation. The mixture must be added in dry form. | |
| Bread | To bind and extend product | Bockwurst | 3.5 percent individually or collectively with other binders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat. | ||
| ......do | Spaghetti with meat balls and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders for use in meat. | ||
| Carboxymethyl cellulose (cellulose gum) | To extend and stabilize product | Baked pies (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| Carrageenan | To extend and stabilize product | Breading mix; sauces (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| To prevent purging of brine solution | Cured pork products as provided in 9 CFR 319.104(d) | Not to exceed 1.5 percent of product formulation; permitted in combination only with soy protein concentrate, combination not to exceed 1.5 percent of product formulation; in accordance with 21 CFR 172.620, 172.623, and 172.626. | ||
| Carrageenan, Locust bean gum, and Xanthan gum blend | ......do | ......do | In combination, not to exceed 0.5 percent of formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695. | |
| Cereal | To bind and extend product | Sausages as provided in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat. | ||
| Dried milk | ......do | Sausages as provided for in 9 CFR Part 319 | 3.5 percent individually or collectively with other binders for use in meat | |
| Dried skim milk, calcium reduced | ......do | Sausages as provided in 9 CFR 9 CFR Part 319 | Do. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat. | ||
| Enzyme (rennet) treated with calcium reduced dried skim milk and calcium lactate | ......do | Sausages as provided for in 9 CFR Part 319 | 3.5 percent total finished product (calcium lactate required at rate of 10 percent of binder.) | |
| ......do | Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 10 percent of binder). | ||
| Enzyme (rennet) treated with sodium caseinate and calcium lactate | ......do | Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 25 percent of binder). | |
| Food starch modified | To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation in “Ham Water Added” and “Ham with Natural Juices” products; not to exceed 3.5 percent of product formulation in “Ham and Water Product—X percent of Weight is Added Ingredients” products; permitted in combination only with soy protein concentrate, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in accordance with 21 CFR 172.892. | |
| Gelatin | To bind and extend product | Various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| Gums, vegetable | ......do | Egg roll (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| Isolated soy protein | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 2 percent. | |
| ......do | Imitation sausages; nonspecific loaves; soups; stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5. | ||
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat. | ||
| To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation, not permitted in combination with other binders approved for use in cured pork products. | ||
| Methyl cellulose | To extend and stabilize product (also carrier) | Meat and vegetable patties; various poultry products | 0.15 percent. | |
| Sodium caseinate | To bind and extend product | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 182.1748 and 21 CFR 172.5. | |
| ......do | Sausages as provided for in 9 CFR Part 319 | 2 percent in accordance with 21 CFR 182.1748. | ||
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748. | ||
| To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products, in accordance with 21 CFR 182.1748. | ||
| To bind and extend product | Various poultry products | 3 percent in cooked product, 2 percent in raw product, in accordance with 21 CFR 172.5 and 182.1748. | ||
| Soy flour | ......do | Sausages as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat. | ||
| Soy protein concentrate | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat. | ||
| To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 3.5 percent of product formulation; permitted in combination only with modified food starch, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in combination only with carrageenan, combination not to exceed 1.5 percent of product formulation. | ||
| Starchy vegetable flour | To bind and extend product | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| Tapioca dextrin | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277. | ||
| ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1277. | ||
| Vegetable starch | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| Wheat gluten | To bind and extend product | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322. | |
| ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat, in accordance with 21 CFR 184.1322. | ||
| ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322. | ||
| ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1322. | ||
| Whey, Dry or dried | To bind or thicken | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1322. | ||
| Whey, Reduced lactose | To bind or thicken | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 172.5. | ||
| ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| Whey, Reduced minerals | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat. | |
| ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 172.5. | ||
| ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat. | ||
| Whey protein concentrate | ......do | Sausage as provided in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c. | |
| ......do | Imitation sausages, nonspecific loaves, soups, stews | Sufficient for purpose in accordance with 21 CFR 184.1979c. | ||
| ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c | ||
| To bind meat pieces | Restructured meat food products, whole muscle meat cuts | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c. | ||
| Xanthan gum | To maintain: uniform viscosity; suspension of particulate matter, emulsion stability; freeze-thaw stability | Meat sauces, gravies or sauces and meats, canned or frozen and/or refrigerated meat salads, canned or frozen meat stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes | Sufficient for purpose in accordance with 21 CFR 172.5. | |
| ......do | Various poultry products, except uncooked products or sausages or other products with a moisture limitation established by Subpart P of Part 381 | Sufficient for purpose | ||
| Bleaching Agent | Hydrogen peroxide | To remove color | Tripe (substance must be removed from product by rinsing with clear water) | Sufficient for purpose. |
| Catalysts (substances must be eliminated during process) | Nickel | To accelerate chemical reaction | Rendered animal fats or a combination of such fats and vegetable fats | Do. |
| Sodium amide | Rearrangement of fatty acid radicals | ......do | Do. | |
| Sodium methoxide | ......do | ......do | ||
| Chilling Media | Salt (NaCl) | To aid in chilling | Raw poultry products | 700 lbs. to 10,000 gallons of water. |
| Coloring Agents (artificial) | Coal tar dyes (FD&C certified) | To color products | Various poultry products | Sufficient for purpose. |
| Color additives listed in 21 CFR Part 74, Subpart A of Part 82, Subpart B (operator must furnish evidence to inspector in charge that color additive has been certified for use in connection with foods by the Food and Drug Administration) | To color casings or rendered fats; marking and branding product | Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) | Sufficient for purpose (may be mixed with approved natural coloring matters or harmless inert material such as common salt and sugar). | |
| Titanium oxide | To whiten | Canned ham salad spread and creamed-type canned meat products. Poultry salads and poultry spreads | 0.5 percent. | |
| Coloring Agents (natural) | Alkanet, annatto, carotene, cochineal, green chlorophyll, saffron and tumeric | To color casings or rendered fats; marking and branding product | Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) | Sufficient for purpose (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar). |
| Annatto, carotene | To color products | Various poultry products | Sufficient for purpose. | |
| Curing accelerators (must be used only in combination with curing agents) | Ascorbic acid | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products | 75 oz to 100 gal pickle at 10 percent pump level;
|
| Citric acid or sodium citrate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products | May be used in cured meat products or in 10 percent solution used to spray surfaces of cured meat cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. May be used in cured poultry products to replace 50 percent of the ascorbic acid or sodium ascorbate that is used. | |
| Erythorbic acid | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products | 75 oz to 100 gal pickle at 10 percent pump level;
| |
| Fumaric acid | ......do | Cured, comminuted meat, poultry or meat and poultry products | 0.065 percent (or 1 oz to 100 lb) of the weight of the meat, poultry or the meat or poultry byproducts before processing. | |
| Glucono delta lactone | ......do | Cured, comminuted meat or meat food product | 8 oz to each 100 lb of meat or meat byproduct. | |
| ......do | Genoa salami | 16 oz to 100 lb of meat (1.0 percent). | ||
| Sodium acid pyrophosphate | ......do | Frankfurters, wieners, vienna, bologna, garlic bologna, knockwurst and similar products | Not to exceed alone or in combination with other curing accelerators for use in meat the following: 8 oz in 100 lb of meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product. | |
| Sodium ascorbate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products | 87.5 oz to 100 gal pickle at 10 percent pump level;
| |
| Sodium erythorbate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food products, cured comminuted poultry or poultry products | 87.5 oz to 100 gal pickle at 10 percent pump level;
| |
| Curing Agents | Sodium or potassium nitrate | Source of nitrite | Cured meat products other than bacon. Nitrates may not be used in baby, junior, and toddler foods. Cured, comminuted poultry or poultry products | 7 lb to 100 gal pickle; 3
|
| Sodium or potassium nitrite (supplies of sodium nitrite and potassium nitrite and mixtures containing them must be kept under the care of a responsible employee of the establishment. The specific nitrite content of such supplies must be known and clearly marked accordingly) | To fix color | Cured meat and poultry products. Nitrites may not be used in baby, junior, or toddler foods | 2 lb to 100 gal pickle at 10 percent pump level; 1 oz to 100 lb meat or poultry product (dry cure);
| |
| Denuding Agents (may be used in combination. Must be removed from tripe by rinsing with potable water.) | Lime (calcium oxide, calcium hydroxide) | To denude mucous membranes | Tripe | Sufficient for purpose. |
| Sodium carbonate | ......do | ......do | Do. | |
| Sodium citrate | ......do | ......do | Do. | |
| Sodium gluconate | ......do | ......do | Do. | |
| Sodium hydroxide | ......do | ......do | Do. | |
| Sodium persulfate | ......do | ......do | Do. | |
| Sodium silicates (ortho, meta, and sesqui) | ......do | ......do | Do. | |
| Trisodium phosphate | ......do | ......do | Do. | |
| Emulsifying Agents | Actylated monoglycerides | To emulsify product | Shortening and various poultry products | Sufficient for purpose. |
| Diacetyl tartaric acid esters of mono-and diglycerides | ......do | ......do | Do. | |
| Glycerol-lacto stearate, oleate, or palmitate | ......do | ......do | Do. | |
| Lecithin | To emulsify product (also as an antioxidant) | Oleomargarine, shortening, various meat and poultry products | 0.5 percent in oleomargarine, use in other products—sufficient amount for emulsification. | |
| Mono and diglycerides (glycerol palmitate, etc.) | To emulsify product | Rendered animal fat or a combination of such fat with vegetable fat; oleomargarine | Sufficient for purpose in lard and shortening; 0.5 percent in oleomargarine. | |
| ......do | Various poultry products | Sufficient for purpose. | ||
| Mono and diglycerides of fatty acids esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate derivatives of these mono and diglycerides | ......do | Margarine or oleomargarine | 0.5 percent. | |
| Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are restricted to those up to and including the decaglycerol esters and otherwise meeting the requirements of § 172.854(a) of the Food Additive Regulations) | ......do | Rendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity of composition; oleomargarine | Sufficient for purpose for rendered animal fat or combination with vegetable fat; 0.5 percent for oleomargarine. | |
| Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) | ......do | Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Rendered poultry fat or a combination of such fat with vegetable fat | 1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 percent. | |
| Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) | ......do | Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Various poultry products | 1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 percent. | |
| 1,2-propylene glycol esters of fatty acids | ......do | Margarine or oleomargarine | 2.0 percent. | |
| Propylene glycol mono and diesters of fats and fatty acids | ......do | Rendered animal or poultry fat or a combination of such fat with vegetable fat | Sufficient for purpose. | |
| Stearyl-2-lactylic acid | ......do | Shortening to be used for cake icings and fillings (meat only) | 3.0 percent. | |
| Stearyl monoglyceridyl citrate | ......do | Shortening | Sufficient for purpose | |
| Film Forming Agents | A mixture consisting of water, sodium alginate, calcium chloride, sodium carboxymethyl-cellulose, and corn syrup solids | To reduce cooler shrinkage and help protect surface | Freshly dressed meat carcasses. Such carcasses must bear a statement “Protected with a film of water, corn syrup solids, sodium alginate, calcium chloride and sodium carboxymethyl-cellulose.” | Formulation may not exceed 1.5 percent of hot carcass weight when applied. Chilled weight may not exceed hot weight. |
| Flavoring Agents; Protectors and Developers | Artificial smoke flavoring | To flavor product | Various (meat and poultry) 2 | Sufficient for purpose. |
| Autolyzed yeast extract | ......do | ......do | Do. | |
| Benzoic acid (sodium, potassium and calcium salts) | To retard flavor reversion | Margarine or oleomargarine | 0.1 percent individually, or if used in combination with other flavoring agents for use in meat or with sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). | |
| Calcium lactate | To protect flavor | Cooked semi-dry and dry products including sausage, imitation sausage, and nonspecific meat food sticks | 0.6 percent in product formulation. | |
| Citric acid | ......do | Various poultry products | Sufficient for purpose. | |
| Flavoring | Chili con carne | Do. | ||
| Corn syrup solids; corn syrup; glucose syrup | To flavor product | Various poultry products, sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham | Do. | |
| Dextrose | ......do | Sausage, ham and cured products | Do. | |
| Diacetyl | ......do | Oleomargarine | Do. | |
| Disodium guanylate | ......do | Various meat and poultry products. 2 | ||
| Disodium inosinate | ......do | ......do | Do. | |
| Harmless bacteria starters of the acidophilus type, lactic acid starter or culture of | To develop flavor | Dry sausage, pork roll, thuringer, lebanon bologna, cervelat, and salami | 0.5 percent. | |
| Harmless lactic acid producing bacteria | To prevent the growth of | Bacon | Sufficient for purpose. | |
| Hydrolyzed plant protein | To flavor product | Various meat and poultry products. 2 | Do. | |
| Isopropyl citrate | To protect flavor | Oleomargarine | 0.02 percent. | |
| Malt syrup | To flavor product | Cured meat products | 2.5 percent. | |
| ......do | Various poultry products | Sufficient for purpose. | ||
| Milk protein hydrolysate | ......do | Various meat and poultry products. 2 | Do. | |
| Monoammonium glutamate | ......do | ......do | Do. | |
| Monosodium glutamate | ......do | ......do | Do. | |
| Potassium lactate | ......do | Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. 2 | Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1639. | |
| Smoke flavoring | To flavor product | Various meat and poultry products | Sufficient for purpose. | |
| Sodium acetate | To flavor products | Various meat and poultry products | Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1721. | |
| Sodium diacetate | ......do | ......do | Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1754. | |
| Sodium lactate | ......do | Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. 2 | Not to exceed 2 percent of formulation in accordance with 21 CFR 184.1768. | |
| Sodium sulfoacetate derivative of mono and diglycerids | ......do | Various meat and poultry products. 2 | 0.5 percent. | |
| Sodium tripolyphosphate | To help protect flavor | “Fresh Beef,” 2 “Beef for further cooking, “Cooked Beef,” Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing | 0.5 percent of total product. | |
| Sodium tripolyphosphate and sodium mixtures, metaphosphate, insoluble; and sodium polyphosphates, glassy | ......do | ......do | Do. | |
| Sorbitol | To flavor, to facilitate the removal of casings from product, and to reduce caramelization and charring | Cooked sausage labeled frankfurter, frank, furter, wiener, and knockwurst; cured pork and pork products, as provided for in 9 CFR Part 319 | Not to exceed 2 percent of the weight of the formula excluding the formula weight of water or ice, when used in accordance with 21 CFR 184.1835. | |
| Starter distillate | To help protect flavor | Oleomargarine | Sufficient for purpose. | |
| Stearyl citrate | ......do | ......do | 0.15 percent. | |
| Sugars (sucrose and dextrose) | To flavor product | Various meat and poultry products | Sufficient for purpose. | |
| Gases | Carbon dioxide liquid | Contact freezing | Various poultry products | Do. |
| Carbon dioxide solid (dry ice) | To cool product | Chopping of meat, packing of product | Sufficient for purpose. | |
| To cool product or facilitate chopping or packaging | Various poultry products | Do. | ||
| Nitrogen | To exclude oxygen from sealed containers | Various meat and poultry products | Do. | |
| Nitrogen, liquid | Contact freezant | ......do | Do. | |
| Hog Scald Agents (must be removed by subsequent cleaning operations) | Caustic soda | To remove hair | Hog carcasses | Sufficient for purpose. |
| Dicotyl sodium sulfosuccinate | ......do | ......do | Do. | |
| Dimethylpolysiloxane | ......do | ......do | Do. | |
| Disodium-calcium ethylenediaminetetra-acetate | ......do | ......do | Do. | |
| Disodium phosphate | ......do | ......do | Do. | |
| Ethylenediaminetetra-acetic acid (sodium salts) | ......do | ......do | Do. | |
| Lime (calcium oxide, calcium hydroxide) | ......do | ......do | Do. | |
| Potassium hydroxide | Do. | |||
| Propylene glycol | ......do | ......do | Do. | |
| Soap (prepared by the reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils) | ......do | ......do | Do. | |
| Sodium acid pyrophosphate | ......do | ......do | Do. | |
| Sodium carbonate | ......do | ......do | Do. | |
| Sodium dodecylbenzene sulfonate | ......do | ......do | Do. | |
| Sodium gluconate | ......do | ......do | Do. | |
| Sodium hexametaphosphate | ......do | ......do | Do. | |
| Sodium lauryl sulfate | ......do | ......do | Do. | |
| Sodium mono and dimethylnaphthalene sulfonate (molecular weight 245-260) | ......do | ......do | Do. | |
| Sodium n-alkylbenzene sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16) | ......do | ......do | Do. | |
| Sodium pyrophosphate | ......do | ......do | Do. | |
| Sodium silicates (ortho, meta, and sesqui) | ......do | ......do | Do. | |
| Sodium sulfate | ......do | ......do | Do. | |
| Sodium tripolyphosphate | ......do | ......do | Do. | |
| Sucrose | ......do | ......do | Do. | |
| Triethanolamine dodecylbenzene sulfonate | ......do | ......do | Do. | |
| Trisodium phosphate | ......do | ......do | Do. | |
| Miscellaneous | Adipic acid | To acidify | Margarine or oleomargarine | Sufficient for purpose. |
| Ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and sodium citrate, singly or in combination | To delay discoloration | Fresh beef cuts, fresh lamb cuts, and fresh pork cuts | Not to exceed, singly or in combination, 500 ppm or 1.8 mg/sq inch of product surface of ascorbic acid (in accordance with 21 CFR 182.3013), erythorbic acid (in accordance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or sodium citrate (in accordance with 21 CFR 182.6751). | |
| Calcium disodium, EDTA (calcium disodium ethylene-diaminetetraacetate | To preserve product and to protect flavor | Margarine or oleomargarine | 75 ppm by weight of the finished oleomargarine or margarine. | |
| Calcium propionate | To retard mold growth | Pizza crust | 0.32 percent alone or in combination based on weight of the flour brace used. | |
| ......do | Fresh pie dough (poultry only) | 0.3 percent of calcium propionate or sodium propionate alone, or in combination, based on weight of flour used. | ||
| Citric acid | To preserve cured color during storage | Cured pork cuts | Not to exceed 30 percent in water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 184.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to product). | |
| Citric acid (sodium and potassium salts) | To acidify | Margarine and oleomargarine | Sufficient for purpose. | |
| d- and dl-alpha-tocopherol | To inhibit nitrosamine formation | Pump-cured bacon | 500 ppm; by injection or surface application. | |
| Dipotassium phosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product. | |
| Disodium phosphate | ......do | ......do | Do. | |
| Glycerine | Humectant | Shelf stable meat snacks | Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320. | |
| Hydrochloric acid | To acidify | Margarine or oleomargarine | Sufficient for purpose. | |
| Lactic acid (sodium and potassium salts) | ......do | ......do | Do. | |
| L-Tartaric acid (sodium and sodium potassium salts) | ......do | ......do | Do. | |
| Monopotassium phosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. | |
| Monosodium phosphate | ......do | ......do | Do. | |
| Phosphoric acid | To acidify | Margarine or oleomargarine | Sufficient for purpose. | |
| Potassium bicarbonate | To alkalize | Margarine or oleomargarine | Sufficient for purpose. | |
| Potassium carbonate | ......do | ......do | Do. | |
| Potassium pyrophosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product. | |
| Potassium sorbate | To retard mold growth | Dry sausage | 10 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing. | |
| Potassium tripolyphosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations | 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product. | |
| Propyl paraben (propyl p-hydroxy-benzoate) | To retard mold growth | Dry sausage | 3.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing. | |
| Silicon dioxide | Processing aid/dispersant | Tocopherol containing bacon curing mixes | At level not to exceed 4.0 percent in the dry mix. | |
| Sodium acid pyrophosphate | To decrease the amount of cooked out juices | Meat food products except where other prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. | |
| Sodium bicarbonate | To neutralize excess acidity, cleaning vegetables | Rendered fats, soups, curing pickle (meat and poultry) | Sufficient for purpose. | |
| To alkalize | Margarine or oleomargarine | Do. | ||
| Sodium carbonate | ......do | ......do | Do. | |
| Sodium citrate buffered with citric acid to a pH of 5.6 | To inhibit the growth of micro-organisms and retain product flavor during storage | Cured and uncured, processed whole muscle meat and poultry food products, e.g., ham, chicken breasts | Not to exceed 1.3 percent of the formulation weight of the product in accordance with 21 CFR 184.1751. | |
| Sodium hydroxide | To alkalize | Margarine or oleomargarine | Sufficient for purpose. | |
| To decrease the amount of cooked out juices | Poultry food products containing phosphates | May be used only in combination with phosphate in a ratio not to exceed one part sodium hydroxide to four parts phosphate. | ||
| ......do | Meat food products containing phosphates | May be used only in combination with phosphates in a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product. | ||
| Sodium metaphosphate, insoluble | ......do | Meat food products except where other prohibited by the meat inspection regulations, and poultry food products except where otherwise prohibited by the poultry products inspection regulations | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. | |
| Sodium polyphosphate, glassy | ......do | ......do | Do. | |
| Sodium proprionate | To retard mold growth | Pizza crust | 0.32 percent alone or in combination based on weight of the flour brace used. | |
| ......do | Fresh pie dough (poultry only) | 0.3 percent of calcium proprionate or sodium proprionate alone, or in combination, based on weight of flour used. | ||
| Sodium pryophosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. | |
| Sodium tripolyphosphate | ......do | ......do | Do. | |
| Sorbic acid (sodium, potassium, and calcium salts) | To preserve product and to retard mold growth | Margarine or oleomargarine | 0.1 percent individually, or if used in combination or with benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). | |
| Tricalcium phosphate | To preserve product color during dehydration process | Mechanically deboned chicken to be dehydrated | Not to exceed 2 percent of the weight of the mechanically deboned chicken prior to dehydration, in accordance with 21 CFR 182.1217. | |
| Poultry scald agents (must be removed by subsequent cleaning operations) | Alpha-hydro-omega-hydroxy-poly (oxyethylene) poly (oxypropylene) (minimum 15 moles) poly (oxyethylene) block copolymer (poloxamer) | To remove feathers | Poultry carcasses | Not to exceed 0.05 percent by weight in scald water. |
| Dimethylpolysiloxane | ......do | ......do | Sufficient for purpose. | |
| Dioctyl sodium sulfosuccinate | ......do | ......do | Do. | |
| Dipotassium phosphate | ......do | ......do | Do. | |
| Ethylenediaminetetra-acetic acid (sodium salts) | ......do | ......do | Do. | |
| Lime (calcium oxide, calcium hydroxide) | ......do | ......do | Do. | |
| Polyoxyethylene (20) sorbitan monooleate | ......do | ......do | Not to exceed 0.0175 percent in scald water. | |
| Potassium hydroxide | ......do | ......do | Sufficient for purpose. | |
| Propylene glycol | ......do | ......do | Do. | |
| Sodium acid phosphate | ......do | ......do | Do. | |
| Sodium acid pyrophosphate | ......do | ......do | Do. | |
| Sodium bicarbonate | ......do | ......do | Do. | |
| Sodium carbonate | ......do | ......do | Do. | |
| Sodium dodecylbenzene-sulfonate | ......do | ......do | Do. | |
| Sodium-2-ethylhexyl sulfate | ......do | ......do | Do. | |
| Sodium hexametaphosphate | ......do | ......do | Do. | |
| Sodium hydroxide | ......do | ......do | Do. | |
| Sodium lauryl sulfate | ......do | ......do | Do. | |
| Sodium phosphate (mono-, di-, tribasic) | ......do | ......do | Do. | |
| Sodium pyrophosphate | ......do | ......do | Do. | |
| Sodium sesquicarbonate | ......do | ......do | Do. | |
| Sodium sulfate | ......do | ......do | Do. | |
| Sodium tripolyphosphate | ......do | ......do | Do. | |
| Tetrasodium pyrophosphate | ......do | ......do | Do. | |
| Proteolytic Enzymes | Aspergillus flavus oryzae group | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. |
| Aspergillus oryzae | ......do | ......do | Do. | |
| Bromelin | ......do | ......do | Do. | |
| Ficin | ......do | ......do | Do. | |
| Papain | ......do | ......do | Do. | |
| Refining Agents (must be eliminated during process of manufacturing) | Acetic acid | To separate fatty acids and glycerol | Rendered fats (meat only) | Sufficient for purpose. |
| Bicarbonate of soda | ......do | ......do | Do. | |
| Carbon (purified charcoal) | To aid in refining of animal fats | ......do | Do. | |
| Caustic soda (sodium hydroxide) | To refine fats | ......do | Do. | |
| Diatomaceous earth; Fuller's earth | ......do | ......do | Do. | |
| Sodium carbonate | ......do | ......do | Do. | |
| Tannic acid | ......do | ......do | Do. | |
| Rendering agents | Tricalcium phosphate | To aid rendering | Animal fats | Do. |
| Trisodium phosphate | ......do | ......do | Do. | |
| Synergists (used in combination with antioxidants) | Citric acid | To increase effectiveness of antioxidants | Any meat product permitted to contain antioxidants as provided for in this part | Not to exceed 0.01 percent based on fat content. |
| ......do | Poultry fats | 0.01 percent alone or in combination with antioxidants in poultry fats. | ||
| Malic acid | ......do | Lard and shortening | 0.01 percent based on total weight in combination with antioxidants for use in meat products only. | |
| ......do | Poultry fats | 0.01 percent alone or in combination with antioxidants in poultry fats. | ||
| Monoglyceride citrate | ......do | Lard, shortening, fresh pork sausage, dried meats and poultry fats | 0.02 percent. | |
| Monoisopropyl citrate | ......do | Lard, shortening, oleomargarine, fresh pork sausage, dried meats | Do. | |
| ......do | Poultry fats | 0.01 percent poultry fats. | ||
| Phosphoric acid | ......do | Lard, shortening, and poultry fats | 0.01 percent. | |
| Tenderizing agents | Aspergillus flavus oryzae group | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. |
| Aspergillus oryzae | ......do | ......do | Not more than 3 percent of a 0.8 molar solution. | |
| Bromelin | ......do | ......do | Do. | |
| Calcium chloride | ......do | ......do | Do. | |
| Magnesium chloride | ......do | ......do | Do. | |
| Papain | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. | |
| Potassium chloride | ......do | ......do | Not more than 3 percent of a 2.0 molar solution. | |
| Potassium, magnesium or calcium chloride | ......do | ......do | A solution of approved inorganic chlorides injected into or applied to raw meats or poultry cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. |
1 [Reserved]
2 Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
3 Provided that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under part 412 of this chapter.
4 Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water.
(a) Under appropriate declaration as required in parts 316 and 317 of this chapter, the following substances may be added to meat:
(1) General. Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids (corn syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other food and color additives specified in the chart in paragraph (c) of this section may be added to meat under conditions, if any, specified in this part or in part 317 of this chapter.
(2) Artificial flavorings. Other harmless artificial flavorings may be added to meat, with the approval of the Administrator in specific cases.
(3) Coloring matter and dyes. Coloring matter and dyes, other than those specified in a regulation permitting that use in this chapter or in 21 CFR Chapter I, Subchapter A and Subchapter B, may be applied to meat mixed with rendered fat, applied to natural and artificial casings, and applied to such casings enclosing products, if approved by the Administrator in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product.
(b) Use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon—(1) Pumped bacon. With respect to bacon injected with curing ingredients and massaged bacon, sodium nitrite shall be used at 120 parts per million (ppm) ingoing or an equivalent amount of potassium nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 ppm of sodium ascorbate or sodium erythorbate.
(i) [Reserved]
(ii) Sodium nitrite may be used at:
(A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; or
(B) A predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and additional sucrose or other similar fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the production of botulinum toxin at a level sufficient for the purpose of preventing the production of botulinum toxin.
(2) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring material. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or estimated skin-free green weight of the bacon bellies.
(3) Bacon made with dry curing materials. With respect to bacon made with dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.
(c) Irradiation of meat food and poultry products.
(1) General requirements. Meat food and poultry products may be treated to reduce foodborne pathogens and to extend product shelf-life by the use of sources of ionizing radiation as identified in 21 CFR 179.26(a). Official establishments must irradiate meat food and poultry products in accordance with 21 CFR 179.26(b), the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, and the provisions of this section.
(2) Dosimetry. Official establishments that irradiate meat food and poultry products must have the following procedures in place:
(i) Laboratory operation procedures for determining the absorbed dose value from the dosimeter.
(ii) Calibration criteria for verifying the accuracy and consistency of any means of measurement (e.g., time clocks and weight scales).
(iii) Calibration and accountability criteria for verifying the traceability and accuracy of dosimeters for the intended purpose, and the verification of calibration at least every 12 months. To confirm traceability, establishments must relate, through documentation, the end point measurement of a dosimeter to recognized standards.
(iv) Procedures for ensuring that the product unit is dose mapped to identify the regions of minimum and maximum absorbed dose and such regions are consistent from one product unit to another of like product.
(v) Procedures for accounting for the total absorbed dose received by the product unit (e.g., partial applications of the absorbed dose within one production lot).
(vi) Procedures for verifying routine dosimetry, i.e., assuring each production lot receives the total absorbed dose. Establishments may either position one dosimeter at the regions of minimum and maximum absorbed dose (or at one region verified to represent such) on at least the first, middle, and last product unit in each production lot or use statistically based validation and dose mapping to determine the number and placement of dosimeters in each production lot.
(vii) Procedures for verifying the relationship of absorbed dose as measured by the dosimeter to time exposure of the product unit to the radiation source.
(viii) Procedures for verifying the integrity of the radiation source and processing procedure. Aside from expected and verified radiation source activity decay for radionuclide sources, the radiation source or processing procedure must not be altered, modified, replenished, or adjusted without repeating dose mapping of product units to redefine the regions of minimum and maximum absorbed dose.
(3) Documentation. Official establishments that irradiate meat food or poultry products must have the following documentation on premises, available to FSIS:
(i) Documentation that the irradiation facility is licensed or possesses gamma radiation sources registered with the Nuclear Regulatory Commission (NRC) or the appropriate State government acting under authority granted by the NRC.
(ii) Documentation that the machine radiation source irradiation facility is registered with the appropriate State government, if applicable.
(iii) Documentation that a worker safety program addressing OSHA regulations (29 CFR chapter XVII) is in place.
(iv) Citations or other documents that relate to incidences in which the establishment was found not to comply with Federal or State agency requirements for irradiation facilities.
(v) A certification by the operator that the irradiation facility personnel will only operate under supervision of a person who has successfully completed a course of instruction for operators of food irradiation facilities.
(vi) A certification by the operator that the key irradiation personnel, who monitor or control daily operations, have been trained in food technology, irradiation processing, and radiation health and safety.
(vii) Guarantees from the suppliers of all food-contact packaging materials that may be subject to irradiation that those materials comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(4) Labeling. (i) The labels on packages of meat food and poultry products irradiated in their entirety, in conformance with this section and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end of this paragraph. Unless the word “Irradiated” is part of the product name, labels also must bear a statement such as “Treated with radiation” or “Treated by irradiation.” The logo must be placed in conjunction with the required statement, if the statement is used. The statement is not required to be more prominent than the declaration of ingredients required under § 317.2(c)(2) of this chapter.
(ii) For meat food or poultry products that have been irradiated in their entirety, but that are not sold in packages, the required logo must be displayed to the purchaser with either the labeling of the bulk container plainly in view or a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. In either case, the information must be prominently and conspicuously displayed to purchasers. Unless the word “Irradiated” is part of the product name, the labeling counter sign, card, or other device also must bear a statement such as “Treated with radiation” or “Treated by irradiation.” The logo must be placed in conjunction with the required statement, if the statement is used.
(iii) The inclusion of an irradiated meat food or poultry product ingredient in any multi-ingredient meat food or poultry product must be reflected in the ingredient statement on the finished product labeling.
(iv) Optional labeling statements about the purpose for radiation processing may be included on the product label in addition to the stated requirements elsewhere in this section, provided that such statements are not false or misleading. Statements that there has been a specific reduction in microbial pathogens must be substantiated by processing documentation.
(a) Substances that conceal damage or inferiority or make products appear better or of greater value. No substance may be used in or on any meat if it conceals damage or inferiority or makes the product appear to be better or of greater value than it is. Therefore:
(1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat, such as chopped and formed steaks or patties; or in any other meat consisting of fresh meat (with or without seasoning).
(2) Paprika or oleoresin paprika may be used in or on chorizo sausage and other meat in which paprika or oleoresin paprika is permitted as an ingredient in a standard of identity or composition in part 319 of this subchapter.
(3) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of sorbic acid shall not be used in cooked sausages or any other meat; sulfurous acid and salts of sulfurous acid shall not be used in or on any meat; and niacin or nicotinamide shall not be used in or on fresh meat product; except that potassium sorbate, propylparaben (propyl p-hydroxybenzoate), and calcium propionate, may be used in or on any product, only as provided in 9 CFR Chapter III.
(b) Nitrates. Nitrates shall not be used in curing bacon.
Antimicrobial agent. A substance in or added to an RTE product that has the effect of reducing or eliminating a microorganism, including a pathogen such as L. monocytogenes, or that has the effect of suppressing or limiting growth of L. monocytogenes in the product throughout the shelf life of the product. Examples of antimicrobial agents added to RTE products are potassium lactate and sodium diacetate.
Antimicrobial process. An operation, such as freezing, applied to an RTE product that has the effect of suppressing or limiting the growth of a microorganism, such as L. monocytogenes, in the product throughout the shelf life of the product.
Deli product. A ready-to-eat meat or poultry product that typically is sliced, either in an official establishment or after distribution from an official establishment, and typically is assembled in a sandwich for consumption.
Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, or wiener, such as a product defined in 9 CFR 319.180 and 319.181.
Lethality treatment. A process, including the application of an antimicrobial agent, that eliminates or reduces the number of pathogenic microorganisms on or in a product to make the product safe for human consumption. Examples of lethality treatments are cooking or the application of an antimicrobial agent or process that eliminates or reduces pathogenic microorganisms.
Post-lethality exposed product. Ready-to-eat product that comes into direct contact with a food contact surface after the lethality treatment in a post-lethality processing environment.
Post-lethality processing environment. The area of an establishment into which product is routed after having been subjected to an initial lethality treatment. The product may be exposed to the environment in this area as a result of slicing, peeling, re-bagging, cooling semi-permeable encased product with a brine solution, or other procedures.
Post-lethality treatment. A lethality treatment that is applied or is effective after post-lethality exposure. It is applied to the final product or sealed package of product in order to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.
Prerequisite program. A procedure or set of procedures that is designed to provide basic environmental or operating conditions necessary for the production of safe, wholesome food. It is called “prerequisite” because it is considered by scientific experts to be prerequisite to a HACCP plan.
Ready-to-eat (RTE) product. A meat or poultry product that is in a form that is edible without additional preparation to achieve food safety and may receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. RTE product is not required to bear a safe-handling instruction (as required for non-RTE products by 9 CFR 317.2(l) and 381.125(b)) or other labeling that directs that the product must be cooked or otherwise treated for safety, and can include frozen meat and poultry products.
(a) Listeria monocytogenes can contaminate RTE products that are exposed to the environment after they have undergone a lethality treatment. L. monocytogenes is a hazard that an establishment producing post-lethality exposed RTE products must control through its HACCP plan or prevent in the processing environment through a Sanitation SOP or other prerequisite program. RTE product is adulterated if it contains L. monocytogenes, or if it comes into direct contact with a food contact surface that is contaminated with L. monocytogenes. Establishments must not release into commerce product that contains L. monocytogenes or that has been in contact with a food contact surface contaminated with L. monocytogenes without first reworking the product using a process that is destructive of L. monocytogenes.
(b) In order to maintain the sanitary conditions necessary to meet this requirement, an establishment producing post-lethality exposed RTE product must comply with the requirements included in one of the three following alternatives:
(1) Alternative 1. Use of a post-lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product and an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes. If an establishment chooses this alternative:
(i) The post-lethality treatment must be included in the establishment's HACCP plan. The antimicrobial agent or process used to suppress or limit the growth of the pathogen must be included in either the establishment's HACCP plan or its Sanitation SOP or other prerequisite program.
(ii) The establishment must validate the effectiveness of the post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The establishment must document, either in its HACCP plan or in its Sanitation SOP or other prerequisite program, that the antimicrobial agent or process, as used, is effective in suppressing or limiting growth of L. monocytogenes.
(2) Alternative 2. Use of either a post-lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product or an antimicrobial agent or process that suppresses or limits growth of L. monocytogenes. If an establishment chooses this alternative:
(i) The post-lethality treatment must be included in the establishment's HACCP plan. The antimicrobial agent or process used to suppress or limit growth of the pathogen must be included in either the establishment's HACCP plan or its Sanitation SOP or other prerequisite program.
(ii) The establishment must validate the effectiveness of a post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The establishment must document in its HACCP plan or in its Sanitation SOP or other prerequisite program that the antimicrobial agent or process, as used, is effective in suppressing or limiting growth of L. monocytogenes.
(iii) If an establishment chooses this alternative and chooses to use only an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes, its sanitation program must:
(A) Provide for testing of food contact surfaces in the post-lethality processing environment to ensure that the surfaces are sanitary and free of L. monocytogenes or of an indicator organism;
(B) Identify the conditions under which the establishment will implement hold-and-test procedures following a positive test of a food-contact surface for an indicator organism;
(C) State the frequency with which testing will be done;
(D) Identify the size and location of the sites that will be sampled; and
(E) Include an explanation of why the testing frequency is sufficient to ensure that effective control of L. monocytogenes or of indicator organisms is maintained.
(iv) An establishment that chooses this alternative and uses a post-lethality treatment of product will likely be subject to more frequent verification testing by FSIS than if it had chosen Alternative 1. An establishment that chooses this alternative and uses an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes will likely be subject to more frequent FSIS verification testing than if it uses a post-lethality treatment.
(3) Alternative 3. Use of sanitation measures only.
(i) If an establishment chooses this alternative, its sanitation program must:
(A) Provide for testing of food contact surfaces in the post-lethality processing environment to ensure that the surfaces are sanitary and free of L. monocytogenes or of an indicator organism;
(B) Identify the conditions under which the establishment will implement hold-and-test procedures following a positive test of a food-contact surface for an indicator organism;
(C) State the frequency with which testing will be done;
(D) Identify the size and location of the sites that will be sampled; and
(E) Include an explanation of why the testing frequency is sufficient to ensure that effective control of L. monocytogenes or of indicator organisms is maintained.
(ii) An establishment producing a deli product or a hotdog product, in addition to meeting the requirements of paragraph (b)(3)(i) of this section, must meet the following requirements:
(A) The establishment must verify that the corrective actions that it takes with respect to sanitation after an initial positive test for L. monocytogenes or an indicator organism on a food contact surface in the post-lethality processing environment are effective by conducting follow-up testing that includes a targeted test of the specific site on the food contact surface area that is the most likely source of contamination by the organism and such additional tests in the surrounding food contact surface area as are necessary to ensure the effectiveness of the corrective actions.
(B) During this follow-up testing, if the establishment obtains a second positive test for an indicator organism, the establishment must hold lots of product that may have become contaminated by contact with the food contact surface until the establishment corrects the problem indicated by the test result.
(C) In order to release into commerce product held under this section, the establishment must sample and test the lots for L. monocytogenes or an indicator organism using a sampling method and frequency that will provide a level of statistical confidence that ensures that each lot is not adulterated with L. monocytogenes. The establishment must document the results of this testing. Alternatively, the establishment may rework the held product using a process that is destructive of L. monocytogenes or the indicator organism.
(iii) An establishment that chooses Alternative 3 is likely to be subject to more frequent verification testing by FSIS than an establishment that has chosen Alternative 1 or 2. An establishment that chooses Alternative 3 and that produces deli meat or hotdog products is likely to be subject to more frequent verification testing than one that does not produce such products.
(c) For all three alternatives in paragraph (b):
(1) Establishments may use verification testing that includes tests for L. monocytogenes or an indicator organism, such as Listeria species, to verify the effectiveness of their sanitation procedures in the post-lethality processing environment.
(2) Sanitation measures for controlling L. monocytogenes and procedures for antimicrobial agents or processes that suppress or limit the growth of the pathogen may be incorporated either in the establishment's HACCP plan or in its Sanitation SOP or other prerequisite program. When these control procedures are incorporated into the Sanitation SOP or prerequisite program, and not as a CCP in the HACCP plan, the establishment must have documentation that supports the decision in its hazard analysis that L. monocytogenes is not a hazard that is reasonably likely to occur.
(3) The establishment must maintain sanitation in the post-lethality processing environment in accordance with part 416.
(4) If L. monocytogenes control measures are included in the HACCP plan, the establishment must validate and verify the effectiveness of measures for controlling L. monocytogenes included in its HACCP plan in accordance with § 417.4.
(5) If L. monocytogenes control measures are included in the Sanitation SOP, the effectiveness of the measures must be evaluated in accordance with § 416.14.
(6) If the measures for addressing L. monocytogenes are addressed in a prerequisite program other than the Sanitation SOP, the establishment must include the program and the results produced by the program in the documentation that the establishment is required to maintain under 9 CFR 417.5.
(7) The establishment must make the verification results that demonstrate the effectiveness of the measures it employs, whether under its HACCP plan or its Sanitation SOP or other prerequisite program, available upon request to FSIS inspection personnel.
(d) [Reserved]
(e) An establishment that controls L. monocytogenes by using a post-lethality treatment or an antimicrobial agent or process that eliminates or reduces, or suppresses or limits the growth of the organism may declare this fact on the product label provided that the establishment has validated the claim.
Abnormal container. A container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled.
Acidified low acid product. A canned product which has been formulated or treated so that every component of the finished product has a pH of 4.6 or lower within 24 hours after the completion of the thermal process unless data are available from the establishment's processing authority demonstrating that a longer time period is safe.
Bleeders. Small orifices on a retort through which steam, other gasses, and condensate are emitted from the retort throughout the entire thermal process.
Canned product. A meat or poultry food product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Unless otherwise specified, the term “product” as used in this part means “canned product.”
Closure technician. The individual(s) identified by the establishment as being trained to perform specific container integrity examinations as required by this part and designated by the establishment to perform such examinations.
Code lot. All production of a particular product in a specific size container marked with a specific container code.
Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heating medium into a closed retort and the start of process timing.
Critical factor. Any characteristic, condition or aspect of a product, container, or procedure that affects the adequacy of the process schedule. Critical factors are established by processing authorities.
Headspace. That portion of a container not occupied by the product.
(1) Gross headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (i.e., the flange of an unsealed can, the top of the double seam on a sealed can, or the top edge of an unsealed jar).
(2) Net headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the inside surface of the lid.
Hermetically sealed containers. Air-tight containers which are designed and intended to protect the contents against the entry of microorganisms during and after thermal processing.
(1) Rigid container. A container, the shape or contour of which, when filled and sealed, is neither affected by the enclosed product nor deformed by external mechanical pressure of up to 10 pounds per square inch gauge (0.7 kg/cm
(2) Semirigid container. A container, the shape or contour of which, when filled and sealed, is not significantly affected by the enclosed product under normal atmospheric temperature and pressure, but can be deformed by external mechanical pressure of less than 10 pounds per square inch gauge (0.7 kg/cm
(3) Flexible container. A container, the shape or contour of which, when filled and sealed, is significantly affected by the enclosed product.
Incubation tests. Tests in which the thermally processed product is kept at a specific temperature for a specified period of time in order to determine if outgrowth of microorganisms occurs.
Initial temperature. The temperature, determined at the initiation of a thermal process cycle, of the contents of the coldest container to be processed.
Low acid product. A canned product in which any component has a pH value above 4.6.
Process schedule. The thermal process and any specified critical factors for a given canned product required to achieve shelf stability.
Process temperature. The minimum temperature(s) of the heating medium to be maintained as specified in the process schedule.
Process time. The intended time(s) a container is to be exposed to the heating medium while the heating medium is at or above the process temperature(s).
Processing authority. The person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this part.
Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program.
Retort. A pressure vessel designed for thermal processing of product packed in hermetically sealed containers.
Seals. Those parts of a semirigid container and lid or of a flexible container that are fused together in order to hermetically close the container.
Shelf stability. The condition achieved by application of heat, sufficient, alone or in combination with other ingredients and/or treatments, to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50 °F or 10 °C) at which the product is intended to be held during distribution and storage. Shelf stability and shelf stable are synonymous with commercial sterility and commercially sterile, respectively.
Thermal process. The heat treatment necessary to achieve shelf stability as determined by the establishment's processing authority. It is quantified in terms of:
(1) Time(s) and temperature(s); or
(2) Minimum product temperature.
Venting. The removal of air from a retort before the start of process timing.
Water activity. The ratio of the water vapor pressure of the product to the vapor pressure of pure water at the same temperature.
(a) Examination and handling of empty containers. (1) Empty containers, closures, and flexible pouch roll stock must be evaluated by the establishment to ensure that they are free of structural defects and damage that may affect product or container integrity. Such an examination should be based on a statistical sampling plan.
(2) All empty containers, closures, and flexible pouch roll stock must be stored, handled, and conveyed in such a manner that will prevent damage that could affect the hermetic condition of the sealed container.
(3) Just before filling, rigid containers must be cleaned to prevent incorporation of foreign matter into the finished product. Closures, semirigid containers, preformed flexible pouches, and flexible pouch roll stock contained in original wrappings do not need to be cleaned before use.
(b) Closure examinations for rigid containers (cans)—(1) Visual examinations. A closure technician must visually examine the double seams formed by each closing machine head. When seam defects (e.g., cutovers, sharpness, knocked down flanges, false seams, droops) are observed, necessary corrective actions, such as adjusting or repairing the closing machine, must be taken. In addition to the double seams, the entire container must be examined for product leakage or obvious defects. A visual examination must be performed on at least one container from each closing machine head, and the observations, along with any corrective actions, must be recorded. Visual examinations must be conducted with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations must be made by the closure technician at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for changes in container size).
(2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head must be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing head must be examined on the packer's end during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, must be promptly recorded by the closure technician. The establishment must have container specification guidelines for double seam integrity on file and available for review by Program employees. A teardown examination of the can maker's end must be performed on at least one container selected from each closing machine during each examination period except when teardown examinations are made on incoming empty containers or when, in the case of self-manufactured containers, the containers are made in the vicinity of the establishment and the container plant records are made available to Program employees. Additional teardown examinations on the packer's end should be made at the beginning of production, immediately following every jam in a closing machine and after closing machine adjustment (including adjustment for a change in container size). The following procedures must be used in teardown examinations of double seams:
(i) Dimensional measurement. One of the following two methods must be employed for dimensional measurements of the double seam.
(A) Micrometer measurement. (1) For cylindrical containers, measure the following dimensions (Figure 1 to § 431.2) at three points approximately 120 degrees apart on the double seam excluding and at least one-half inch from the side seam juncture:
(i) Double seam length—W;
(ii) Double seam thickness—S;
(iii) Body hook length—BH; and
(iv) Cover hook length—CH.
(2) Maximum and minimum values for each dimensional measurement must be recorded by the closure technician.
(B) Seamscope or seam projector. Required measurements of the seam include thickness, body hook, and overlap.
(ii) Seam thickness. Seam thickness must be obtained by micrometer. For cylindrical containers, at least two locations, excluding the side seam juncture, must be used to obtain the required measurements.
(iii) Seam tightness. Regardless of the dimensional measurement method used to measure seam dimensions, at a minimum, the seam(s) examined must be stripped to assess the degree of wrinkling.
(iv) Side seam juncture rating. Regardless of the dimensional measurement method used to measure seam dimensions, the cover hook must be stripped to examine the cover hook droop at the juncture for containers having side seams.
(v) Examination of noncylindrical containers. Examination of noncylindrical containers (e.g., square, rectangular, “D”-shaped, and irregularly-shaped) must be conducted as described in paragraphs (b)(2)(i), (ii), (iii), and (iv) of this section except that the required dimensional measurements must be made on the double seam at the points listed in the establishment's container specification guidelines.
(c) Closure examinations for glass containers—(1) Visual examinations. A closure technician must visually assess the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine must be taken and recorded. In addition to the closures, the entire container must be examined for defects. Visual examinations must be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations must be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).
(2) Closure examinations and tests. Depending upon the container and closure, tests must be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made either before or after thermal processing and at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing machine must be examined during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, must be promptly recorded by the closure technician. The establishment must have specification guidelines for closure integrity on file and available for review by Program employees. Additional closure examinations should be made at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).
(d) Closure examinations for semi-rigid and flexible containers—(1) Heat seals—(i) Visual examinations. A closure technician must visually examine the seals formed by each sealing machine. When sealing defects are observed, necessary corrective actions, such as adjusting or repairing the sealing machine, must be taken and recorded. In addition to examining the heat seals, the entire container must be examined for product leakage or obvious defects. Visual examinations must be performed before and after the thermal processing operation and with sufficient frequency to ensure proper closure. These examinations should be conducted at least in accordance with a statistical sampling plan. All defects noted and corrective actions taken must be promptly recorded.
(ii) Physical tests. Tests determined by the establishment as necessary to assess container integrity must be conducted by the closure technician at a frequency sufficient to ensure proper closure. These tests must be performed after the thermal processing operation and should be made at least every 2 hours of continuous production. The establishment's acceptance guidelines for each test procedure must be on file and available for review by Program employees. Test results along with any necessary corrective actions, such as adjusting or repairing the sealing machine, must be recorded.
(2) Recording. Double seams on semirigid or flexible containers must be examined and the results recorded as provided in paragraph (b) of this section. Any additional measurements specified by the container manufacturer must also be made and recorded.
(e) Container coding. Each container must be marked with a permanent, legible, identifying code mark. The mark must, at a minimum, identify in code the product (unless the product name is lithographed or printed elsewhere on the container) and the day and year the product was packed.
(f) Handling of containers after closure. (1) Containers and closures must be protected from damage which may cause defects that are likely to affect the hermetic condition of the containers. The accumulation of stationary containers on moving conveyors should be minimized to avoid damage to the containers.
(2) The maximum time lapse between closure of containers and initiation of thermal processing must be 2 hours unless data are available from the establishment's processing authority demonstrating that an alternative time period is safe and will not result in product spoilage.
(a) Process schedules. Prior to the processing of canned product for distribution in commerce, an establishment must have a process schedule (as defined in § 431.1) for each canned meat or poultry product to be packed by the establishment.
(b) Source of process schedules. (1) Process schedules used by an establishment must be developed or determined by a processing authority.
(2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements must be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority must amend the process schedule accordingly.
(3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, must be made available by the establishment to the Program employee upon request.
(c) Submittal of process information. (1) Prior to the processing of canned product for distribution in commerce, the establishment must provide the inspector at the establishment with a list of the process schedules (including alternate schedules) along with any additional applicable information, such as the retort come-up operating procedures and critical factors.
(2) Letters or other written communications from a processing authority recommending all process schedules must be maintained on file by the establishment. Upon request by Program employees, the establishment must make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment must provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to establish the process schedule. Once submitted, the process schedules and associated critical factors and the procedures for measuring (including the frequency), controlling, and recording of critical factors must not be changed without the prior written submittal of the revised procedures (including supporting documentation) to the inspector at the establishment.
Critical factors specified in the process schedule must be measured, controlled, and recorded by the establishment to ensure that these factors remain within the limits used to establish the process schedule. Examples of factors that are often critical to process schedule adequacy may include:
(a) General. (1) Maximum fill-in weight or drained weight;
(2) Arrangement of pieces in the container;
(3) Container orientation during thermal processing;
(4) Product formulation;
(5) Particle size;
(6) Maximum thickness for flexible containers, and to some extent semirigid containers, during thermal processing;
(7) Maximum pH;
(8) Percent salt;
(9) Ingoing (or formulated) nitrite level (ppm);
(10) Maximum water activity; and
(11) Product consistency or viscosity.
(b) Continuous rotary and batch agitating retorts. (1) Minimum headspace; and
(2) Retort reel speed.
(c) Hydrostatic retorts. (1) Chain or conveyor speed.
(2) [Reserved]
(d) Steam/air retorts. (1) Steam/air ratio; and
(2) Heating medium flow rate.
(a) Posting of processes. Process schedules (or operating process schedules) for daily production, including minimum initial temperatures and operating procedures for thermal processing equipment, must be posted in a conspicuous place near the thermal processing equipment. Alternatively, such information must be available to the thermal processing system operator and the inspector.
(b) Process indicators and retort traffic control. A system for product traffic control must be established to prevent product from bypassing the thermal processing operation. Each basket, crate, or similar vehicle containing unprocessed product, or at least one visible container in each vehicle, must be plainly and conspicuously marked with a heat sensitive indicator that will visually indicate whether such unit has been thermally processed. Exposed heat sensitive indicators attached to container vehicles must be removed before such vehicles are refilled with unprocessed product. Container loading systems for crateless retorts must be designed to prevent unprocessed product from bypassing the thermal processing operation.
(c) Initial temperature. The initial temperature of the contents of the coldest container to be processed must be determined and recorded by the establishment at the time the processing cycle begins to assure that the temperature of the contents of every container to be processed is not lower than the minimum initial temperature specified in the process schedule. Thermal processing systems which subject the filled and sealed containers to water at any time before process timing begins must be operated to assure that such water will not lower the temperature of the product below the minimum initial temperature specified in the process schedule.
(d) Timing devices. Devices used to time applicable thermal processing operation functions or events, such as process schedule time, come-up time, and retort venting, must be accurate to assure that all such functions or events are achieved. Pocket watches and wrist watches are not considered acceptable timing devices. Analog and digital clocks are considered acceptable. If such clocks do not display seconds, all required timed functions or events must have at least a 1-minute safety factor over the specified thermal processing operation times. Temperature/time recording devices must correspond within 15 minutes to the time of the day recorded on written records required by § 431.7.
(e) Measurement of pH. Unless other methods are approved by the Administrator, potentiometric methods using electronic instruments (pH meters) must be used for making pH determinations when a maximum pH value is specified as a critical factor in a process schedule.
(a) Instruments and controls common to different thermal processing systems—(1) Indicating temperature devices. Each retort must be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, must be used as the reference instrument for indicating the process temperature.
(i) Mercury-in-glass thermometers. A mercury-in-glass thermometer must have divisions that are readable to 1 °F (or 0.5 °C) and whose scale contains not more than 17 °F/inch (or 4.0 °C/cm) of graduated scale. Each mercury-in-glass thermometer must be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test must be maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard must be repaired and tested for accuracy before further use, or replaced.
(ii) Other devices. Temperature-indicating devices, such as resistance temperature detectors, used in lieu of mercury-in-glass thermometers, must meet known, accurate standards for such devices when tested for accuracy. The records of such testing must be available to FSIS program employees.
(2) Temperature/time recording devices. Each thermal processing system must be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy must be equal to or better than 1 °F (or 0.5 °C) at the process temperature. The temperature recording chart should be adjusted to agree with, but must never be higher than, the known accurate indicating temperature device. A means of preventing unauthorized changes in the adjustment must be provided. For example, a lock or a notice from management posted at or near the recording device warning that only authorized persons are permitted to make adjustments, are satisfactory means for preventing unauthorized changes. Air-operated temperature controllers must have adequate filter systems to ensure a supply of clean, dry air. The recorder timing mechanism must be accurate.
(i) Chart-type devices. Devices using charts must be used only with the correct chart. Each chart must have a working scale of not more than 55 °F/inch (or 12 °C/cm.) within a range of 20 °F (or 11 °C) of the process temperature. Chart graduations must not exceed 2 °F degrees (or 1 °C) within a range of 10 °F (or 5 °C) of the process temperature. Multipoint plotting chart-type devices must print temperature readings at intervals that will assure that the parameters of the process time and process temperature have been met. The frequency of recording should not exceed 1-minute intervals.
(ii) Other devices. Temperature/time recording devices or procedures used in lieu of chart-type devices must meet known accurate standards for such devices or procedures when tested for accuracy. Such a device must be accurate enough for ensuring that process time and temperature parameters have been met.
(3) Steam controllers. Each retort must be equipped with an automatic steam controller to maintain the retort temperature. This may be a recording/controlling instrument when combined with a temperature/time recording device.
(4) Air valves. All air lines connected to retorts designed for pressure processing in steam must be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of air into the retort during the process cycle.
(5) Water valves. All retort water lines that are intended to be closed during a process cycle must be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of water into the retort during the process cycle.
(b) Pressure processing in steam—(1) Common to batch still, batch agitating, continuous rotary retorts, and hydrostats—(i) Basic requirements. The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices must be installed either within the retort shell or in external wells attached to the retort. External wells must be connected to the retort through at least a
(ii) Steam inlet. The steam inlet to each retort must be large enough to provide steam for proper operation of the retort, and must enter at a point(s) to facilitate air removal during venting.
(iii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment must have on file documentation that the mufflers do not impede the removal of air from the retort. Such documentation must consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information must be made available to Program employees for review.
(iv) Bleeders. Bleeders, except those for external wells of temperature devices and hydrostatic retorts, must have a
(2) Batch still retorts—(i) Crate supports. Vertical still retorts with bottom steam entry must employ bottom retort crate supports. Baffle plates must not be used in the bottom of retorts.
(ii) Steam spreader. Perforated steam spreaders, if used, must be maintained to ensure they are not blocked or otherwise inoperative. Horizontal still retorts must be equipped with perforated steam spreaders that extend the full length of the retort unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority. Such information must be maintained on file by the establishment and made available to Program employees for review.
(iii) Condensate removal. In retorts having a steam inlet above the level of the lowest container, a bleeder must be installed in the bottom of the retort to remove condensate. The condensate bleeder must be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder must be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems must be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system must be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.
(iv) Stacking equipment—(A) Equipment for holding or stacking containers in retorts. Crates, trays, gondolas, carts, and other vehicles for holding or stacking product containers in the retort must be so constructed to ensure steam circulation during the venting, come-up, and process times. The bottom of each vehicle must have perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) centers or the equivalent unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority and such information is maintained on file by the establishment and made available to Program employees for review.
(B) Divider plates. Whenever one or more divider plates are used between any two layers of containers or placed on the bottom of a retort vehicle, the establishment must have on file documentation that the venting procedure allows the air to be removed from the retort before timing of the thermal process is started. Such documentation must be in the form of heat distribution data or documentation from a processing authority. This information must be made available to Program employees for review.
(v) Vents. (A) Vents must be located in that portion of the retort opposite the steam inlet and must be designed, installed, and operated in such a way that air is removed from the retort before timing of the thermal process is started. Vents must be controlled by a gate, plug cock, or other full-flow valve which must be fully opened to permit rapid removal of air from retorts during the venting period.
(B) Vents must not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold must be controlled by a gate, plug cock, or other full-flow valve and the manifold must be of a size such that the cross-sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge must not be connected to a closed drain without an atmospheric break in the line. A manifold header connecting vents or manifolds from several still retorts must lead to the atmosphere. The manifold header must not be controlled by a valve and must be of a size such that the cross-sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from the maximum number of retorts to be vented simultaneously.
(C) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation must be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information must be maintained on file by the establishment and made available to Program employees for review.
(D) For crateless retort installations, the establishment must have heat distribution data or other documentation from the equipment manufacturer or from a processing authority that demonstrates that the venting procedure used accomplishes the removal of air and condensate. This information must be maintained on file by the establishment and made available to Program employees for review.
(E) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows:
(1) Venting horizontal retorts. (i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.
(ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.
(iii) Venting through water spreaders.
(iv) Venting through a single 2
(2) Venting vertical retorts. (i) Venting through a 1
(ii) Venting through a single 1 inch (2.5 cm) side or top vent.
(3) Batch agitating retorts—(i) Venting and condensate removal. The air in the retort must be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure must be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain must be opened to remove steam condensate from the retort. A bleeder must be installed in the bottom of the retort to remove condensate during retort operation. The condensate bleeder must be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder must be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems must be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system must be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.
(ii) Retort or reel speed timing. The retort or reel speed must be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed must be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer must be determined and recorded at least once per shift by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts must be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.
(4) Continuous rotary retorts—(i) Venting and condensate removal. The air in the retort must be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure must be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain must be opened to remove steam condensate from the retort. A bleeder must be installed in the bottom of the shell to remove condensate during the retort operation. The condensate bleeder must be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder must be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems must be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system must be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.
(ii) Retort speed timing. The rotational speed of the retort must be specified in the process schedule. The speed must be adjusted as specified, and recorded by the establishment when the retort is started, and checked and recorded at intervals not to exceed 4 hours to ensure that the correct retort speed is maintained. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. If a recording tachometer is used, the speed must be manually checked against an accurate stopwatch at least once per shift and the results recorded. A means of preventing unauthorized speed changes on retorts must be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.
(5) Hydrostatic retorts—(i) Basic requirements. The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, indicating temperature devices must be located in the steam dome near the steam/water interface. Where the process schedule specifies maintenance of particular water temperatures in the hydrostatic water legs, at least one indicating temperature device must be located in each hydrostatic water leg so that it can accurately measure water temperature and be easily read. The temperature/time recorder probe must be installed either within the steam dome or in a well attached to the dome. Each probe must have a
(ii) Steam inlet. The steam inlets must be large enough to provide steam for proper operation of the retort.
(iii) Bleeders. Bleeder openings
(iv) Venting. Before the start of processing operations, the retort steam chamber(s) must be vented to ensure removal of air. Heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the air is removed from the retort prior to processing must be kept on file at the establishment and made available to Program employees for review.
(v) Conveyor speed. The conveyor speed must be calculated to obtain the required process time and recorded by the establishment when the retort is started. The speed must be checked and recorded at intervals not to exceed 4 hours to ensure that the correct conveyor speed is maintained. A recording device may be used to provide a continuous record of the conveyor speed. When a recording device is used, the speed must be manually checked against an accurate stopwatch at least once per shift by the establishment. A means of preventing unauthorized speed changes of the conveyor must be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.
(vi) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment must have documentation that the mufflers do not impede the removal of air from the retort. Such documentation must consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information must be maintained on file by the establishment and made available to Program employees for review.
(c) Pressure processing in water—(1) Common to batch still and agitating retorts—(i) Basic requirements. The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section.
(ii) Pressure recording device. Each retort must be equipped with a pressure recording device which may be combined with a pressure controller.
(iii) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority demonstrating uniform heat distribution within the retort must be kept on file at the establishment and made available to Program employees for review.
(iv) Drain valve. A non-clogging, water-tight drain valve must be used. Screens must be installed over all drain openings.
(2) Batch still retorts—(i) Temperature device bulbs and probes. The indicating temperature device bulbs or probes must be located in such a position that they are beneath the surface of the water throughout the process. On horizontal retorts, the indicating temperature device bulb or probe must be inserted directly into the retort shell. In both vertical and horizontal retorts, the indicating temperature device bulb or probe must extend directly into the water a minimum of 2 inches (or 5 cm) without a separable well or sleeve. In vertical retorts equipped with a recorder/controller, the controller probe must be located at the bottom of the retort below the lowest crate rest in such a position that the steam does not strike it directly. In horizontal retorts so equipped, the controller probe must be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for direct steam impingement on the controller probe. Air-operated temperature controllers must have filter systems to ensure a supply of clean, dry air.
(ii) Crate supports. A bottom crate support must be used in vertical retorts. Baffle plates must not be used in the bottom of the retort.
(iii) Stacking equipment. For filled flexible containers and, where applicable, semi-rigid containers, stacking equipment must be designed to ensure that the thickness of the filled containers does not exceed that specified in the process schedule and that the containers do not become displaced and overlap or rest on one another during the thermal process.
(iv) Water level. There must be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). For retorts requiring complete immersion of containers, water must cover the top layer of containers during the entire come-up time and thermal processing periods and should cover the top layer of containers during cooling. For retorts using cascading water or water sprays, the water level must be maintained within the range specified by the retort manufacturer or processing authority during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods must be provided. The retort operator must check and record the water level at intervals to ensure it meets the specified processing parameters.
(v) Air supply and controls. In both horizontal and vertical still retorts, a means must be provided for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry must be controlled by an automatic pressure control unit. A non-return valve must be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure must be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it must be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort must be documented by heat distribution data or other documentation from a processing authority, and such data must be maintained on file by the establishment and made available to Program employees for review.
(vi) Water recirculation. When a water recirculation system is used for heat distribution, the water must be drawn from the bottom of the retort through a suction manifold and discharged through a spreader that extends the length or circumference of the top of the retort. The holes in the water spreader must be uniformly distributed. The suction outlets must be protected with screens to keep debris from entering the recirculation system. The pump must be equipped with a pilot light or a similar device to warn the operator when it is not running, and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort must be documented by heat distribution or other documentation from a processing authority, and such data must be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used, provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.
(vii) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.
(3) Batch agitating retorts—(i) Temperature device bulbs and probes. The indicating temperature device bulb or probe must extend directly into the water without a separable well or sleeve. The recorder/controller probe must be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for steam to directly strike the controller bulb or probe.
(ii) Stacking equipment. All devices used for holding product containers (e.g., crates, trays, divider plates) must be so constructed to allow the water to circulate around the containers during the come-up and thermal process periods.
(iii) Water level. There must be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). Water must completely cover all containers during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods must be provided. The retort operator must check and record the adequacy of the water level with sufficient frequency to ensure it meets the specified processing parameters.
(iv) Air supply and controls. Retorts must be provided with a means for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry must be controlled by an automatic pressure control unit. A non-return valve must be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure must be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it must be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort must be documented by heat distribution data or other documentation from a processing authority, and such data must be maintained on file by the establishment and made available to Program employees for review.
(v) Retort or reel speed timing. The retort or reel speed timing must be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed must be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer must be determined and recorded at least once per shift by the establishment by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts must be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.
(vi) Water recirculation. If a water recirculation system is used for heat distribution, it must be installed in such a manner that water will be drawn from the bottom of the retort through a suction manifold and discharged through a spreader which extends the length of the top of the retort. The holes in the water spreader must be uniformly distributed. The suction outlets must be protected with screens to keep debris from entering the recirculation system. The pump must be equipped with a pilot light or a similar device to warn the operator when it is not running and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort must be documented by heat distribution data or other documentation from a processing authority, and such data must be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.
(vii) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.
(d) Pressure processing with steam/air mixtures in batch retorts—(1) Basic requirements. The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulb sheaths or probes for indicating temperature devices and temperature/time recording devices or controller probes must be inserted directly into the retort shell in such a position that steam does not strike them directly.
(2) Recording pressure controller. A recording pressure controller must be used to control the air inlet and the steam/air mixture outlet.
(3) Circulation of steam/air mixtures. A means must be provided for the circulation of the steam/air mixture to prevent formation of low-temperature pockets. The efficiency of the circulation system must be documented by heat distribution data or other documentation from a processing authority, and such data must be maintained on file by the establishment and made available to Program employees for review. The circulation system must be checked to ensure its proper functioning and must be equipped with a pilot light or a similar device to warn the operator when it is not functioning. Because of the variety of existing designs, reference must be made to the equipment manufacturer for details of installation, operation, and control.
(e) Atmospheric cookers—(1) Temperature/time recording device. Each atmospheric cooker (e.g., hot water bath) must be equipped with at least one temperature/time recording device in accordance with the basic requirements described in paragraph (a)(2) of this section.
(2) Heat distribution. Each atmospheric cooker must be equipped and operated to ensure uniform heat distribution throughout the processing system during the thermal process. Heat distribution data or other documentation from the manufacturer or a processing authority demonstrating uniform heat distribution within the cooker must be kept on file by the establishment and made available to Program employees for review.
(f) Other systems. All other systems not specifically delineated in this section and used for the thermal processing of canned product must be adequate to produce shelf-stable products consistently and uniformly.
(g) Equipment maintenance. (1) Upon installation, all instrumentation and controls must be checked by the establishment for proper functioning and accuracy and, thereafter, at any time their functioning or accuracy is suspect.
(2) At least once a year each thermal processing system must be examined by an individual not directly involved in daily operations to ensure the proper functioning of the system as well as all auxiliary equipment and instrumentation. In addition, each thermal processing system should be examined before the resumption of operation following an extended shutdown.
(3) Air and water valves that are intended to be closed during thermal processing must be checked by the establishment for leaks. Defective valves must be repaired or replaced as needed.
(4) Vent and bleeder mufflers must be checked and maintained or replaced by the establishment to prevent any reduction in bleeder efficiency.
(5) When water spreaders are used for venting, a maintenance schedule must be developed and implemented to assure that the holes are maintained at their original size.
(6) Records must be kept on all maintenance items that could affect the adequacy of the thermal process. Records must include the date and type of maintenance performed and the person conducting the maintenance.
(h) Container cooling and cooling water. (1) Potable water must be used for cooling except as provided for in paragraphs (h)(2) and (3) of this section.
(2) Cooling canal water must be chlorinated or treated with a chemical having a bactericidal effect equivalent to chlorination. There must be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals must be cleaned and replenished with potable water to prevent the buildup of organic matter and other materials.
(3) Container cooling waters that are recycled or reused must be handled in systems that are so designed, operated, and maintained so there is no buildup of microorganisms, organic matter, and other materials in the systems and in the waters. System equipment, such as pipelines, holding tanks and cooling towers, must be constructed and installed so that they can be cleaned and inspected. In addition, the establishment must maintain, and make available to Program employees for review, information on at least the following:
(i) System design and construction;
(ii) System operation including the rates of renewal with fresh, potable water and the means for treating the water so that there is a measurable residual of an acceptable sanitizer, per paragraph (h)(2) of this section, in the water at the point where the water exits the container cooling vessel;
(iii) System maintenance including procedures for the periodic cleaning and sanitizing of the entire system; and
(iv) Water quality standards, such as microbiological, chemical and physical, monitoring procedures including the frequency and site(s) of sampling, and the corrective actions taken when water quality standards are not met.
(i) Post-process handling of containers. Containers must be handled in a manner that will prevent damage to the hermetic seal area. All worn and frayed belting, can retarders, cushions, and the like must be replaced with nonporous materials. To minimize container abrasions, particularly in the seal area, containers should not remain stationary on moving conveyors. All post-process container handling equipment should be kept clean so there is no buildup of microorganisms on surfaces in contact with the containers.
At least the following processing and production information must be recorded by the establishment: Date of production; product name and style; container code; container size and type; and the process schedule, including the minimum initial temperature. Measurements made to satisfy the requirements of § 431.4 regarding the control of critical factors must be recorded. In addition, where applicable, the following information and data must also be recorded:
(a) Processing in steam—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or the number of retort crates per retort load, product initial temperature, time steam on, the time and temperature vent closed, the start of process timing, time steam off, and the actual processing time. The indicating temperature device and the temperature recorder must be read at the same time at least once during process timing and the observed temperatures recorded.
(2) Batch agitating retorts. In addition to recording the information required for batch still steam retorts in paragraph (a)(1) of this section, record the functioning of the condensate bleeder(s) and the retort or reel speed.
(3) Continuous rotary retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent closed, time process temperature reached, the time the first can enters and the time the last can exits the retort. The retort or reel speed must be determined and recorded at intervals not to exceed 4 hours. Readings of the indicating temperature device(s) and temperature recorder(s) must be made and recorded at the time the first container enters the retort and thereafter with sufficient frequency to ensure compliance with the process schedule. These observations should be made and recorded at intervals not exceeding 30 minutes of continuous retort operation. Functioning of the condensate bleeder(s) must be observed and recorded at the time the first container enters the retort and thereafter as specified in § 431.305(b)(3)(v).
(4) Hydrostatic retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent(s) closed, time process temperature reached, time first containers enter the retort, time last containers exit the retort, and, if specified in the process schedule, measurements of temperatures in the hydrostatic water legs. Readings of the temperature indicating device, which is located in the steam/water interface, and the temperature recording device must be observed and the temperatures recorded at the time the first containers enter the steam dome. Thereafter, these instruments must be read and the temperatures recorded with sufficient frequency to ensure compliance with the temperature specified in the process schedule and should be made at least every hour of continuous retort operation. Container conveyor speed, and for agitating hydrostatic retorts, the rotative chain speed, must be determined and recorded at intervals of sufficient frequency to ensure compliance with the process schedule and should be performed at least every 4 hours.
(b) Processing in water—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, the start of process timing, water level, water recirculation rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder must be read at the same time at least once during process timing and the observed temperatures recorded.
(2) Batch agitating retorts. In addition to recording the information required in paragraph (b)(1) of this section, record the retort or reel speed.
(c) Processing in steam/air mixtures. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, venting procedure, if applicable, the start of process timing, maintenance of circulation of the steam/air mixture, air flow rate or forced recirculation flow rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder must be read at the same time at least once during process timing and the observed temperatures recorded.
(d) Atmospheric cookers—(1) Batch-type systems. For each cooker batch, record the cooker number or other designation and the approximate number of containers. In addition, record all critical factors of the process schedule such as cooker temperature, initial temperature, the time the thermal process cycle begins and ends, hold time, and the final internal product temperature.
(2) Continuous-type systems. Record the cooker number or other designation, the time the first containers enter and the last containers exit a cooker, and the approximate total number of containers processed. In addition, record all critical factors of the process schedule such as the initial temperature, cooker speed, and final internal product temperature.
(a) Process records. Charts from temperature/time recording devices must be identified by production date, container code, processing vessel number or other designation, and other data as necessary to enable correlation with the records required in § 431.7. Each entry on a record must be made at the time the specific event occurs, and the recording individual must sign or initial each record form. No later than 1 working day after the actual process, the establishment must review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, must be signed or initialed and dated by the person conducting the review. All processing and production records required in this subpart must be made available to Program employees for review.
(b) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems must be designed and operated in a manner that will ensure compliance with the applicable requirements of § 431.7.
(c) Container closure records. Written records of all container closure examinations must specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records must be signed or initialed by the container closure technician and must be reviewed and signed by the establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart must be made available to Program employees for review.
(d) Distribution of product. Records must be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended use.
(e) Retention of records. Copies of all processing and production records required in § 431.7 must be retained for no less than 1 year at the establishment, and for an additional 2 years at the establishment or other location from which the records can be made available to Program employees within 3 working days.
(a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it must be considered a deviation in processing.
(b) Deviations in processing (or process deviations) must be handled according to:
(1) A HACCP plan for canned product that addresses hazards associated with microbial contamination; or,
(2) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or
(3) Paragraph (c) of this section.
(c) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.
(1) Deviations identified in-process. If a deviation is noted at any time before the completion of the intended process schedule, the establishment must:
(i) Immediately reprocess the product using the full process schedule; or
(ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 431.3(a) and (b) and is filed with the inspector in accordance with § 431.3(c); or
(iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment must provide the inspector the following:
(A) A complete description of the deviation along with all necessary supporting documentation;
(B) A copy of the evaluation report; and
(C) A description of any product disposition actions, either taken or proposed.
(iv) Product handled in accordance with paragraph (c)(1)(iii) of this section must not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product disposition actions.
(v) If an alternate process schedule is used that is not on file with the inspector or if an alternate process schedule is immediately calculated and used, the product must be set aside for further evaluation in accordance with paragraphs (c)(1)(iii) and (iv) of this section.
(vi) When a deviation occurs in a continuous rotary retort, the product must be handled in accordance with paragraphs (c)(1)(iii) and (iv) of this section or in accordance with the following procedures:
(A) Emergency stops. (1) When retort jams or breakdowns occur during the processing operations, all containers must be given an emergency still process (developed per § 431.3(b)) before the retort is cooled or the retort must be cooled promptly and all containers removed and either reprocessed, repacked and reprocessed, or destroyed. Regardless of the procedure used, containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or breakdown must be removed and either reprocessed, repacked and reprocessed and or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.
(2) The time the retort reel stopped and the time the retort is used for an emergency still retort process must be noted on the temperature/time recording device and entered on the other production records required in § 431.7.
(B) Temperature drops. When the retort temperature drops below the temperature specified in the process schedule, the reel must be stopped and the following actions must be taken:
(1) For temperature drops of less than 10 °F (or 5.5 °C) either:
(i) All containers in the retort must be given an emergency still process (developed per § 431.3(b)) before the reel is restarted;
(ii) Container entry to the retort must be prevented and an emergency agitating process (developed per § 431.3(b)) must be used before container entry to the retort is restarted; or
(iii) Container entry to the retort must be prevented and the reel restarted to empty the retort. The discharged containers must be reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.
(2) For temperature drops of 10 °F (or 5.5 °C) or more, all containers in the retort must be given an emergency still process (developed per § 431.3(b)). The time the reel was stopped and the time the retort was used for a still retort process must be marked on the temperature/time recording device by the establishment and entered on the other production records required in § 431.7. Alternatively, container entry to the retort must be prevented and the reel restarted to empty the retort. The discharged containers must be either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.
(2) Deviations identified through record review. Whenever a deviation is noted during review of the processing and production records required by § 431.8(a) and (b), the establishment must hold the product involved and the deviation must be handled in accordance with paragraphs (c)(1)(iii) and (iv) of this section.
(d) Process deviation file. The establishment must maintain full records regarding the handling of each deviation. Such records must include, at a minimum, the appropriate processing and production records, a full description of the corrective actions taken, the evaluation procedures and results, and the disposition of the affected product. Such records must be maintained in a separate file or in a log that contains the appropriate information. The file or log must be retained in accordance with § 431.8(e) and must be made available to Program employees upon request.
(a) Finished product inspections must be handled according to:
(1) An HACCP plan for canned product that addresses hazards associated with microbiological contamination;
(2) An FSIS-approved total quality control system;
(3) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or
(4) Paragraph (b) of this section.
(b) Procedures for handling finished product inspections where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.
(1) Incubation of shelf stable canned product—(i) Incubator. The establishment must provide incubation facilities which include an accurate temperature/time recording device, an indicating temperature device, a means for the circulation of the air inside the incubator to prevent temperature variations, and a means to prevent unauthorized entry into the facility. The Program is responsible for the security of the incubator.
(ii) Incubation temperature. The incubation temperature must be maintained at 95±5 °F (35±2.8 °C). If the incubation temperature falls below 90 °F (or 32 °C) or exceeds 100 °F (or 38 °C) but does not reach 103 °F (or 39.5 °C), the incubation temperature must be adjusted within the required range and the incubation time extended for the time the sample containers were held at the deviant temperature. If the incubation temperature is at or above 103 °F (or 39.5 °C) for more than 2 hours, the incubation test(s) must be terminated, the temperature lowered to within the required range, and new sample containers incubated for the required time.
(iii) Product requiring incubation. Shelf stable product requiring incubation includes:
(A) Low acid products as defined in § 431.1; and
(B) Acidified low acid products as defined in § 431.1.
(iv) Incubation samples. (A) From each load of product processed in a batch-type thermal processing system (still or agitation), the establishment must select at least one container for incubation.
(B) For continuous rotary retorts, hydrostatic retorts, or other continuous-type thermal processing systems, the establishment must select at least one container per 1,000 for incubation.
(C) Only normal-appearing containers must be selected for incubation.
(v) Incubation time. Canned product requiring incubation must be incubated for not less than 10 days (240 hours) under the conditions specified in paragraph (b)(1)(ii) of this section.
(vi) Incubation checks and record maintenance. Designated establishment employees must visually check all containers under incubation each working day and the inspector must be notified when abnormal containers are detected. All abnormal containers should be allowed to cool before a final decision on their condition is made. For each incubation test the establishment must record at least the product name, container size, container code, number of containers incubated, in and out dates, and incubation results. The establishment must retain such records, along with copies of the temperature/time recording charts, in accordance with § 431.8(d).
(vii) Abnormal containers. The finding of abnormal containers (as defined in § 431.1) among incubation samples is cause to officially retain at least the code lot involved.
(viii) Shipping. No product must be shipped from the establishment before the end of the required incubation period. An establishment wishing to ship product prior to the completion of the required incubation period must submit a written proposal to the District Office. Such a proposal must include provisions that will assure that shipped product will not reach the retail level of distribution before sample incubation is completed and that product can be returned promptly to the establishment should such action be deemed necessary by the incubation test results. Upon receipt of written approval from the District Office, product may be routinely shipped provided the establishment continues to comply with all requirements of this subpart.
(2) [Reserved]
(c) Container condition—(1) Normal containers. Only normal-appearing containers must be shipped from an establishment as determined by an appropriate sampling plan or other means acceptable to program employees.
(2) Abnormal containers. When abnormal containers are detected by any means other than incubation, the establishment must inform the inspector, and the affected code lot(s) must not be shipped until the Program has determined that the product is safe and stable. Such a determination will take into account the cause and level of abnormals in the affected lot(s) as well as any product disposition actions either taken or proposed by the establishment.
All operators of thermal processing systems specified in § 431.6 and container closure technicians must be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for properly training supervisors of canning operations.
Establishments must prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure must be made available to Program employees for review.
(a) Accredited Laboratory Program (ALP). The voluntary Food Safety and Inspection Service (FSIS) program in which non-Federal laboratories are accredited as capable of performing analyses with the level of quality that is necessary to maintain accreditation in the program, on samples of raw or processed meat, poultry, and egg products, and through which a proficiency testing sample program for quality assurance is conducted.
(b) Food chemistry. Analysis of raw or processed meat or poultry products for the components moisture, protein, fat, and salt.
(c) Initial accreditation proficiency testing sample. A sample provided by the FSIS ALP to a non-Federal laboratory to determine whether the laboratory's analytical capability meets the standards for acceptance into the program. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory.
(d) Inter-laboratory accreditation maintenance proficiency testing sample. A sample provided by the FSIS ALP to an accredited laboratory to assist in determining whether the laboratory is maintaining acceptable analytical performance for a given analyte or component. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory.
(e) International Organization for Standardization (ISO) 13528. ISO 13528:2015(E) Corrected version 2016, “Statistical methods for use in proficiency testing by interlaboratory comparison,” October 15, 2016, or updated versions.
(f) Probation. The period commencing with official notification to an accredited laboratory that it no longer satisfies the ALP performance requirements specified in this part and ending with official notification that accreditation is fully restored, is suspended, or is revoked.
(g) Refusal of accreditation. An action taken by FSIS when a laboratory that is applying for accreditation is denied the accreditation.
(h) Responsibly connected. Any individual, or entity, that is a partner, officer, director, manager, or owner of 10 percent or more of the voting stock of the applicant or recipient of accreditation or an employee in a managerial or executive capacity or any employee who conducts or supervises the analysis of FSIS samples.
(i) Revocation of accreditation. An action taken by FSIS against a laboratory thereby removing the laboratory's certification of accreditation and participation in inter-laboratory accreditation maintenance proficiency testing sample events.
(j) Suspension of accreditation. An action taken by FSIS against a laboratory thereby temporarily removing the laboratory's certification of accreditation and participation in the inter-laboratory accreditation maintenance proficiency testing sample events. Suspension of accreditation ends when accreditation either is fully restored or is revoked.
(k) z score. A statistically derived number representing a laboratory's performance for analyzing quantitative proficiency testing samples. The ALP calculates and interprets z scores consistent with the ISO 13528 standard.
(a) Participation in the ALP is voluntary. Application for accreditation must be made on designated paper or electronic forms provided by FSIS, or otherwise in writing, by the owner or manager of a non-Federal analytical laboratory. Application forms may be obtained by contacting the ALP at ALP@usda.gov. The forms must be sent to the ALP or may be submitted electronically. The application must specify the kinds of accreditation sought by the owner or manager of the laboratory. A laboratory whose accreditation has been refused or revoked for performance reasons may reapply for accreditation after 60 days from the effective date of that action and must provide written documentation specifying what corrections were made and illustrate to FSIS that the corrections are effective or would reasonably be expected to be effective.
(b) At the time that an application for accreditation is filed with the ALP, the laboratory must submit fees payable to the U.S. Department of Agriculture by check, bank draft, money order, or other form of payment accepted by the U.S. Department of Agriculture, in the amount specified by FSIS as directed in 9 CFR 391.5, along with the completed application for the accreditation(s).
(c) An application for accreditation will not be processed or allowed to advance, without further procedure, if the accreditation fee(s) is delinquent.
(d) FSIS will issue a bill annually in the amount specified by FSIS in 9 CFR 391.5 for each accreditation held and are due by the date required. Bills are payable to the U.S. Department of Agriculture by check, bank draft, money order, or other form of payment accepted by the U.S. Department of Agriculture.
(a) Analytical laboratories may be accredited for the analyses of foodborne indicator and pathogen analytes, or a specified chemical residue or a class of chemical residues, in raw or processed meat, poultry, and egg products. Analytical laboratories also may be accredited for the analyses of food chemistry components in raw or processed meat and poultry products.
(b) Accreditation will be granted only if the applying laboratory successfully satisfies FSIS requirements that are stated in this part.
(c) To obtain FSIS accreditation, an analytical laboratory must:
(1) Be supervised by a person holding, at a minimum, a bachelor's degree in biology, chemistry, microbiology, food science, food technology, or a related field.
(i) For food chemistry accreditation, the supervisor must also have one year of experience in food chemistry analysis, or equivalent qualifications.
(ii) For chemical residue accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years of experience determining analytes at or below part per million levels, or equivalent qualifications.
(iii) For indicator organisms or pathogen accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years of experience in foodborne pathogen analyses or equivalent qualifications.
(2) Demonstrate the capability to achieve quality assurance levels that are within acceptable limits as determined by evaluation that is consistent with ISO 13528 for the analysis of initial accreditation proficiency testing samples, in the analyte category for which accreditation is sought. FSIS and some Association of Official Analytical Collaboration (AOAC) International analytical test procedures are acceptable for use in this program. FSIS procedures may be found on the U.S. Department of Agriculture (USDA) FSIS website at www.fsis.usda.gov. AOAC procedures may be found on the AOAC website at www.aoac.org.
(3) Complete a second set of proficiency testing samples if the results of the first set of proficiency testing samples are unsuccessful.
(i) The second set of proficiency testing samples will be provided within 30 days following the date of receipt by FSIS of a request from the applying laboratory. The second set of proficiency testing samples will be analyzed only for the analyte(s) or analyte classes for which unacceptable initial results had been obtained by the laboratory.
(ii) If the results of the second set of proficiency testing samples are unsuccessful, the laboratory may request a third set of proficiency testing samples after a 60-day waiting period, commencing from the date of notification by FSIS of unsuccessful results. The third set of proficiency testing samples will be analyzed only for the analyte(s) or analyte classes for which unacceptable initial results had been obtained by the laboratory.
(iii) If the laboratory is unsuccessful for the third set and still wishes to pursue accreditation, the ALP will require a new application and an application fee if the initial accreditation process is not completed within eleven months. Documentation of corrective action(s) related to the previous unsuccessful accreditation attempt must be submitted to and accepted by the ALP.
(4) Allow inspection of the laboratory facility and pertinent documents by FSIS officials prior to the determination of granting accredited status.
(5) Pay the accreditation fee by the date required.
(a) Criteria. To maintain accreditation, an analytical laboratory must fulfill the requirements of this section.
(b) Records. To demonstrate traceable and appropriate application of equipment, standards, procedures, analysts, and approvals related to accreditation, an accredited laboratory must:
(1) Maintain laboratory quality control records for the most recent three years that samples have been analyzed.
(2) Maintain complete records of the receipt, analysis, and disposition of samples for the most recent three years that samples have been analyzed.
(3) Maintain in a secure electronic format or in a standards book, all records, readings, and calculations for prepared standards. Entries are to be dated and the analyst identified at the time of the entry, and manual calculations verified and documented by the supervisor, or by the supervisor's designee, before use of the standard. The standards records are to be retained for three years after the last recorded entry. The certificates of analysis are to be kept on file for purchased standards for at least the period of time that the materials are in use.
(4) Maintain records of instrument maintenance and calibration. The records are to be retained for three years after the last recorded entry.
(5) As provided in paragraph (e) of this section, records are to be made available for review by any duly authorized representative of the Secretary of Agriculture, including ALP personnel or their designees.
(c) Inter-laboratory accreditation maintenance proficiency testing sample. (1) An accredited laboratory must analyze inter-laboratory accreditation maintenance proficiency testing samples and return the results to the ALP by the due date, which is usually within approximately three weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS.
(2) Results must be those of the accredited laboratory. Analyses of proficiency testing samples must not be contracted out by the accredited laboratory.
(d) Corporate changes. The ALP must be informed within 30 days of any change of address or in the laboratory's ownership, officers, directors, supervisory personnel, or other responsibly connected individual or entity.
(e) On-site review. An accredited laboratory must permit any duly authorized representative of the Secretary to perform both announced and unannounced on-site laboratory reviews of facilities and records, both hard copy and electronic, during normal business hours, and to copy any records pertaining to the laboratory's participation in the ALP.
(f) Analytical test procedures. An accredited laboratory must use analytical test procedures designated by the FSIS ALP as being acceptable. FSIS and some AOAC analytical test procedures are acceptable.
(g) Quality assurance levels. An accredited laboratory must demonstrate the capability to maintain quality assurance levels that are within acceptable limits as evaluated by the ALP in the analysis of inter-laboratory accreditation maintenance proficiency testing samples for the analyte category for which accreditation was granted. An accredited laboratory will successfully demonstrate the maintenance of these capabilities if its results from inter-laboratory accreditation maintenance proficiency testing samples satisfy ALP evaluation criteria based on the ISO 13528 standard, to include performance evaluation by z score statistics.
(h) Fees. An accredited laboratory must pay the annual required accreditation fee when it is due.
(i) Probation. If placed on probation, an accredited laboratory must meet the ALP requirements as prescribed in this section in order to remove the probation status.
(1) The laboratory must successfully analyze a set of initial accreditation proficiency testing samples for the analyte(s) that triggered the probation and submit the analytical results to FSIS by the due date, which is typically within approximately three weeks of receipt of the samples.
(2) Similarly satisfy criteria for accreditation maintenance proficiency testing samples specified by the ALP in this part.
(3) Provide written corrective action documentation, related to the issue that triggered the probation, to the ALP by the date required.
(j) Suspension. If placed on suspension, an accredited laboratory must meet the ALP requirements as prescribed in this section in order to remove the suspension status. If the laboratory is unsuccessful in meeting the requirements to remove the suspension status, accreditation will be revoked.
(1) Laboratories that are suspended due to performance or response issues enter a waiting period of 60 days from the effective date of that action. After the 60-day period has passed, if the laboratory wishes to pursue reinstatement to the ALP, the laboratory must submit a written corrective action plan specifying what corrections were made and illustrate to FSIS that the corrections are effective or would reasonably be expected to be effective.
(i) After the corrective action plan has been accepted by the ALP, the laboratory must successfully analyze a set of initial accreditation proficiency testing samples for the analyte(s) that triggered the suspension and meet all other program requirements including payment of any annual fees that are due. The ALP may perform an on-site inspection at the laboratory's facility and/or require the laboratory to provide documentation to confirm that it meets the requirements of the program.
(ii) The suspended laboratory is allowed two attempts to successfully analyze the initial accreditation proficiency testing set(s) of samples.
(2) Laboratories that are suspended due to indictment or charges as described in § 439.52 may not seek removal of suspension status until being cleared of said indictment or charges.
Upon a determination by the FSIS Administrator (Administrator), a laboratory will be refused accreditation for the following reasons:
(a) A laboratory will be refused accreditation for failure to meet the requirements of the ALP as stated in this part.
(b) A laboratory will be refused accreditation if the laboratory or any individual or entity responsibly connected with the laboratory has been convicted of, or is under indictment for, or has charges on any information brought against them in a Federal or State court concerning any of the following violations of law:
(1) Any felony.
(2) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.
(3) Any misdemeanor based upon a false statement to any governmental agency.
(4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.
(5) Altering any official sample or analytical finding; or substituting any analytical result from any other laboratory and representing the result as its own.
Upon a determination by the Administrator, a laboratory will be placed on probation for the following reasons:
(a) If the laboratory fails to complete more than one inter-laboratory accreditation maintenance proficiency testing sample analysis within 12 consecutive months, unless written permission is granted by the Administrator.
(b) If the laboratory does not respond to ALP inquiries related to its participation in the program or fails to meet any of the requirements or criteria set in this part.
(c) If the laboratory does not successfully demonstrate the maintenance of quality assurance capabilities including its results from inter-laboratory accreditation maintenance proficiency testing samples. ALP evaluation criteria are based on the ISO 13528 standard, to include performance evaluation by z score statistics.
A laboratory will be suspended from the program if probation status is not rectified according to program requirements stated in this part. The accreditation of a laboratory will be immediately suspended if the laboratory or any individual or entity responsibly connected with the laboratory is indicted or has charges on information brought against them in a Federal or State court for any of the following violations of law. A laboratory must notify the ALP within 30 calendar days if any of these situations occur.
(a) Any felony.
(b) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.
(c) Any misdemeanor based upon a false statement to any governmental agency.
(d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.
(e) Altering any official sample or analytical finding; or substituting any analytical result from any other laboratory and representing the result as its own.
A laboratory will have its accreditation revoked from the program if suspension status is not rectified. The accreditation of a laboratory will also be revoked for the following reasons:
(a) An accredited laboratory will have its accreditation revoked if the Administrator determines that the laboratory or any responsibly connected individual or any agent or employee has:
(1) Altered any official sample or analytical finding; or
(2) Substituted any analytical result from any other laboratory and represented the result as its own.
(b) An accredited laboratory will have its accreditation revoked if the laboratory or any individual or entity responsibly connected with the laboratory is convicted in a Federal or State court of any of the following violations of law. A laboratory must notify the ALP within 30 calendar days if any of these situations occur.
(1) Any felony.
(2) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.
(3) Any misdemeanor based upon a false statement to any governmental agency.
(4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.
Accreditation of any laboratory will be refused, suspended, or revoked under the conditions previously described in this part. The owner or operator of the laboratory will be sent written notice of the refusal, suspension, or revocation of accreditation by the Administrator. In such cases, the laboratory owner or operator will be provided an opportunity to present, within 30 days of the date of the notification, a statement challenging the merits or validity of such action and to request an oral hearing with respect to the denial, suspension, or revocation decision. An oral hearing will be granted if there is any dispute of material fact joined in such responsive statement. The proceeding will be conducted thereafter in accordance with the applicable rules of practice, which will be adopted for the proceeding. Any such refusal, suspension, or revocation will be effective upon the receipt by the laboratory of the notification and will continue in effect until final determination of the matter by the Administrator.
(a) Raw livestock, poultry, and fish carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses or parts is an unavoidable consequence of the process used to meet applicable food safety requirements.
(b) Raw livestock, poultry, and fish carcasses and parts that retain water from post-evisceration processing and that are sold, transported, offered for sale or transportation, or received for transportation, in commerce, must bear a statement on the label in prominent letters and contiguous to the product name or elsewhere on the principal display panel of the label stating the maximum percentage of water that may be retained (e.g., “up to X% retained water,” “less than X% retained water,” “up to X% water added from processing”). The percent water statement need not accompany the product name on other parts of the label. Raw livestock and poultry carcasses and parts that retain no water may bear a statement that no water is retained.
(c)(1) An establishment subject to paragraph (a) of this section must maintain on file and available to FSIS its written data-collection protocol. The protocol must explain how data will be collected and used to demonstrate the amount of retained water in the product covered by the protocol that is an unavoidable consequence of the process used to meet specified food safety requirements.
(2) The establishment must notify FSIS as soon as it has a new or revised protocol available for review by the Agency. Within 30 days after receipt of this notification, FSIS may object to or require the establishment to make changes in the protocol.
(d) Expected elements of a protocol for gathering water retention data:
(1) Purpose statement. The primary purpose of the protocol should be to determine the amount or percentage of water absorption and retention that is unavoidable using a particular chilling system while achieving the regulatory pathogen reduction performance standard for Salmonella as set forth in the PR/HACCP regulations (9 CFR 310.25(b), 381.94(b)) and the time/temperature requirements set forth in 9 CFR 381.66. Additional purposes that could be included are determining chilling system efficiency and evaluating product quality.
(2) Type of washing and chilling system used by the establishment. Any post-evisceration washing or chilling processes that affect water retention levels in and microbial loads on raw products should be described. For poultry establishments, the main chiller types, identified by the mechanism used to transport the birds through the chiller or to agitate the water in the chiller, are the drag-through, the screw type, and the rocker-arm type.
(3) Configuration and any modifications of the chiller system components. A description of chiller-system configurations and modifications should be provided. The description should include the number and type of chillers in a series and arrangements of chilling system components, and the number of evisceration lines feeding into a chiller system. If there is a pre-chilling step in the process, its purpose and the type of equipment used should be accurately described. Any mechanical or design changes made to the chilling equipment should be described.
(4) Special features in the chilling process. Any special features in the chilling process, such as antimicrobial treatments, should be described. Also, the length and velocity of the dripping line should be described, as well as the total time allowed for dripping. Any special apparatus, such as a mechanism for squeezing excessive water from chilled birds, should be explained.
(5) Description of variable factors in the chilling system. The protocol should describe variable factors that affect water absorption and retention. In poultry processing, such factors are typically considered to be the time in chiller water, the water temperature, and agitation. The protocol should consider air agitation, where applicable. Additional factors that may affect water absorption and retention are scalding temperature and the pressure or amount of buffeting applied to birds by feather removal machinery, and the resultant loosening of the skin. Another factor that should be considered is the method used to open the bird for evisceration.
(6) Standards to be met by the chilling system. For example, the chilling system may be designed simply to achieve a reduction in temperature of ready-to-cook poultry to less than 40 °F within the time limit specified by the regulations, or in less time. As to the standard for pathogen minimization, the Salmonella pathogen reduction standards, as set forth in the PR/HACCP final rule, have been suggested. Although there is not yet an applicable Salmonella standard for turkeys, establishments are free to adopt practicable criteria for use in gathering data on turkeys under the protocols here suggested. Additional microbiological targets, such as E. coli or Campylobacter levels, or reductions in numbers of other microorganisms, may also be used.
(7) Testing methods to be employed. The protocol should detail the testing methods to be used both for measuring water absorption and retention and for sampling and testing product for pathogen reductions. The protocol should call for water retention and pathogen reduction tests at various chilling equipment settings and chilling time-and-temperature combinations. The method to be used in calculating water absorption and retention should be reproducible and statistically verifiable. With respect to the pathogen-reduction aspect of the testing, FSIS recommends the methods used for E. coli and Salmonella testing under the PR/HACCP regulations. The number of samples, the type of samples, the sampling time period, and the type of testing or measurement should be included in the protocol.
(8) Reporting of data and evaluation of results. The protocol should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.
(9) Conclusions. The protocol should provide for a statement of what the data obtained demonstrate and what conclusions were reached.
This part prescribes the procedures to be followed for determining net weight compliance and prescribes the reasonable variations allowed from the declared net weight on the labels of immediate containers of products in accordance with 9 CFR 317.2(c)(4), 317.2(h), and 381.121.
(a) For the purpose of § 442.1 of this part, the reasonable variations allowed, and the definitions and the procedures to be used, in determining net weight and net weight compliance are presented in the National Institute of Standards and Technology (NIST) Handbook 133, “Checking the Net Contents of Packaged Goods,” Fourth Edition, January 2005, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of NIST Handbook 133 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, 732 N. Capitol Street, NW., Washington, DC, 20401. You may contact the Government Printing Office Toll-Free at 1-866-512-1800 or go to: http://bookstore.gpo.gov. You may inspect a copy of NIST Handbook 133 at the FSIS Docket Room, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue, SW., Room 2534, Washington, DC 20250. You can contact the FSIS Docket room by calling 202-720-0344 or 202-720-3813. The NIST Handbook 133 is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The following NIST Handbook 133 requirements are not incorporated by reference.
2.3 Basic Test Procedure—Tare Procedures—Wet Tare
2.3 Basic Test Procedure—Moisture Allowances—What moisture allowance is used with wet tare when testing packages bearing a USDA seal of inspection?
2.4 Borax
3.5 Mayonnaise and Salad Dressing
3.7 Pressed and Blown Glass Tumblers and Stemware
3.8 Volumetric Test Procedures for Paint, Varnish, and Lacquers—Non Aerosol
3.9 Testing Viscous Materials—Such as Caulking Compounds and Pasters
3.10 Peat Moss
3.11 Mulch and Soils Labeled by Volume
3.12 Ice Cream Novelties
3.13 Fresh Oysters Labeled by Volume
3.14 Determining the Net Contents of Compressed Gas Cylinders
3.15 Volumetric Test Procedures for Packaged Firewood with a Labeled Volume of 133 L (4 Cu Ft) or Less
3.16 Boxed Firewood
3.17 Crosshatched Firewood
3.18 Bundles and Bags of Firewood
4.5 Paper Plates and Sanitary Paper Products
4.6 Special Test Requirements for Packages Labeled by Linear or Square Measure (Area)
4.7 Polyethylene sheeting
4.8 Packages Labeled by Linear or Square (Area) Measure
4.9 Bailer Twine—Test Procedure for Length
4.10 Procedure for Checking the Area Measurement of Chamois Appendix C Glossary—wet tare
(a) All scales used to determine the net weight of meat and poultry products sold or otherwise distributed in commerce in federally inspected meat and poultry establishments will be installed, maintained, and operated in a manner that ensures accurate weights. Such scales shall meet the applicable requirements contained in National Institute of Standards and Technology (NIST) Handbook 44, ”Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices,” 1999 Edition, November 1988, which is incorporated by reference. This incorporation was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (These materials are incorporated as they exist on the date of approval.) A notice of any change in the Handbook cited here will be published in the
(b) All scales used to determine the net weight of meat or poultry products sold or otherwise distributed in commerce or in States designated under section 301(c) of the Federal Meat Inspection Act and section 5(c) of the Poultry Products Inspection Act shall be of sufficient capacity to weigh the entire unit or package.
(c) No scale will be used at a federally inspected establishment to determine the net weight of meat or poultry products unless it has been found upon test and inspection, as specified in NIST Handbook 44 to provide accurate weight. If a scale is inspected or tested and found to be inaccurate, or if any repairs, adjustments, or replacements are made to a scale, it shall not be used until it has been reinspected and retested by a USDA official, or a State or local government weights and measures official, or a State registered or licensed scale repair firm or person, and it must meet all accuracy requirements as specified in NIST Handbook 44. If a USDA inspector has put a ”Retain” tag on a scale, the tag can only be removed by a USDA inspector. As long as the tag is on the scale, it shall not be used.
(a) The operator of each official establishment that weighs meat or poultry food products will cause such scales to be tested for accuracy in accordance with the technical requirements of NIST Handbook 44, at least once during the calendar year. In cases where the scales are found not to maintain accuracy between tests, more frequent tests may be required and verified by an authorized USDA program official.
(b) The operator of each official establishment shall display on or near each scale a valid certification of the scale's accuracy from a State or local government's weights and measures authority or from a State registered or licensed scale repair firm or person, or shall have alternative documented procedures showing that the scale has been tested for accuracy in accordance with the requirements of NIST Handbook 44.
Any lot of product that is found to be out of compliance with net weight requirements upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled as follows:
(a) A lot tested in an official establishment and found not to comply with net weight requirements may be reprocessed and must be reweighed and remarked to satisfy the net weight requirements of this section in accordance with the requirements of this part.
(b) A lot tested outside an official establishment and found not to comply with net weight requirements must be reweighed and remarked with a proper net weight statement, provided that such reweighing and remarking will not deface, cover, or destroy any other marking or labeling required under this subchapter, and the net quantity of contents is shown with the same prominence as the most conspicuous feature of a label.
(a) A “regulatory control action” is the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product.
(b) A “withholding action” is the refusal to allow the marks of inspection to be applied to products. A withholding action may affect all product in the establishment or product produced by a particular process.
(c) A “suspension” is an interruption in the assignment of program employees to all or part of an establishment; and (d) An establishment subject to Federal inspection or facility receiving voluntary inspection services under the regulations is “adversely affected” when that person has a legally cognizable interest, and the decision or action has caused or is substantially likely to cause injury to that interest.
(a) FSIS may take a regulatory control action because of:
(1) Insanitary conditions or practices;
(2) Product adulteration or misbranding;
(3) Conditions that preclude FSIS from determining that product is not adulterated or misbranded; or
(4) Inhumane handling or slaughtering of livestock.
(b) If a regulatory control action is taken, the program employee will immediately notify the establishment orally or in writing of the action and the basis for the action.
(c) An establishment may appeal a regulatory control action, as provided in §§ 306.5, 381.35, and 590.310 of this chapter.
(a) FSIS may take a withholding action or impose a suspension without providing the establishment prior notification because:
(1) The establishment produced and shipped adulterated or misbranded product as defined in 21 U.S.C. 453, 21 U.S.C. 602, or 21 U.S.C. 1033;
(2) The establishment does not have a HACCP plan as specified in § 417.2 of this chapter;
(3) The establishment does not have Sanitation Standard Operating Procedures as specified in §§ 416.11-416.12 of this chapter;
(4) Sanitary conditions are such that products in the establishment are or would be rendered adulterated;
(5) The establishment violated the terms of a regulatory control action;
(6) An establishment operator, officer, employee, or agent assaulted, threatened to assault, intimidated, or interfered with an FSIS employee; or
(7) The establishment did not destroy a condemned meat or poultry carcass, or part or product thereof, or egg product, that has been found to be adulterated and that has not been reprocessed, in accordance with part 314 or part 381, subpart L, or part 590 of this chapter within three days of notification.
(b) FSIS also may impose a suspension without providing the establishment prior notification because the establishment is handling or slaughtering animals inhumanely.
FSIS may take a withholding action or impose a suspension after an establishment is provided prior notification and the opportunity to demonstrate or achieve compliance because:
(a) The HACCP system is inadequate, as specified in § 417.6 of this chapter, due to multiple or recurring noncompliances;
(b) The Sanitation Standard Operating Procedures have not been properly implemented or maintained as specified in §§ 416.13 through 416.16 of this chapter;
(c) The establishment has not maintained sanitary conditions as prescribed in §§ 416.2-416.8 of this chapter due to multiple or recurring noncompliances;
(d) The establishment did not collect and analyze samples for Escherichia coli Biotype I and record results in accordance with § 310.25(a) or § 381.94(a) of this chapter;
(e) The establishment did not meet the Salmonella performance standard requirements prescribed in § 310.25(b) or § 381.94(b) of this chapter.
(a) If FSIS takes a withholding action or imposes a suspension, the establishment will be notified orally and, as promptly as circumstances permit, in writing. The written notification will:
(1) State the effective date of the action(s),
(2) Describe the reasons for the action(s),
(3) Identify the products or processes affected by the action(s),
(4) Provide the establishment an opportunity to present immediate and corrective action and further planned preventive action; and
(5) Advise the establishment that it may appeal the action as provided in §§ 306.5, 381.35, and 590.310 of this chapter.
(b) The prior notification provided for in § 500.4 of this part will:
(1) State the type of action that FSIS may take;
(2) Describe the reason for the proposed action;
(3) Identify the products or processes affected by the proposed action;
(4) Advise the establishment of its right to contact FSIS to contest the basis for the proposed action or to explain how compliance has been or will be achieved; and
(5) Advise the establishment that it will have three business days from receipt of the written notification to respond to FSIS unless the time period is extended by FSIS.
(c) An establishment may appeal the withholding action or suspension, as provided in §§ 306.5, 381.35, and 590.310 of this chapter.
(d) If FSIS suspends inspection and does not hold the suspension action in abeyance as provided in paragraph (e) of this section, the establishment may request a hearing pursuant to the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. Upon such request, the Administrator will file a complaint that will include a request for an expedited hearing.
(e) FSIS may hold a suspension in abeyance and allow the establishment to operate under the conditions agreed to by FSIS and the establishment.
(a)The FSIS Administrator may file a complaint to withdraw a grant of Federal inspection in accordance with the Uniform Rules of Practice, 7 CFR subtitle A, part 1, subpart H because:
(1) An establishment produced and shipped adulterated product;
(2) An establishment did not have or maintain a HACCP plan in accordance with part 417 of this chapter;
(3) An establishment did not have or maintain Sanitation Standard Operating Procedures in accordance with part 416 of this chapter;
(4) An establishment did not maintain sanitary conditions;
(5) An establishment did not collect and analyze samples for Escherichia coli Biotype I and record results as prescribed in § 310.25(a) or § 381.94(a) of this chapter;
(6) [Reserved]
(7) An establishment did not slaughter or handle livestock humanely;
(8) An establishment operator, officer, employee, or agent assaulted, threatened to assault, intimidated, or interfered with an FSIS program employee; or
(9) A recipient of inspection or anyone responsibly connected to the recipient is unfit to engage in any business requiring inspection as specified in section 401 of the FMIA, section 18(a) of the PPIA, or section 18 of the EPIA.
(b) [Reserved]
(a) The FSIS Administrator may refuse to grant Federal inspection because an applicant:
(1) Does not have a HACCP plan as required by part 417 of this chapter;
(2) Does not have Sanitation Standard Operating Procedures as required by part 416 of this chapter;
(3) Has not demonstrated that adequate sanitary conditions exist in the establishment as required by part 308, subpart H of part 381, part 416, or part 590 of this chapter;
(4) Has not demonstrated that livestock will be handled and slaughtered humanely; or
(5) Is unfit to engage in any business requiring inspection as specified in section 401 of the FMIA, section 18(a) of the PPIA, or section 18 of the EPIA.
(b) If the Administrator refuses to grant inspection, the applicant will be provided the opportunity for a hearing in accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H.
(a) FSIS may rescind or refuse approval of false or misleading marks, labels, or sizes or forms of any container for use with any meat, poultry, or egg product, under section 7 of the FMIA, under section 8 of the PPIA, or under sections 7 or 14 of the EPIA.
(b) FSIS will provide written notification that:
(1) Explains the reason for rescinding or refusing the approval;
(2) Provides an opportunity for the establishment to modify the marking, labeling, or container so that it will no longer be false or misleading; and
(3) Advises the establishment of its opportunity to submit a written statement to respond to the notification and to request a hearing.
(c) If FSIS rescinds or refuses approval of false or misleading marks, labels, or sizes or forms of any container for use with any meat, poultry, or egg product, an opportunity for a hearing will be provided in accordance with the Uniform Rules of Practice, 7 CFR subtitle A, part 1, subpart H.
(a) Any establishment subject to Federal inspection or facility under voluntary inspection and adversely affected by a decision or action of an inspector or other Agency employee related to an inspection activity mandated under the FMIA, PPIA, or EPIA or related to voluntary reimbursable inspection services allowed under the AMA may appeal the decision or action. Initial appeals of an applicable decision or action, as well as subsequent appeals of denied appeals through final Agency action, must be made within 30 calendar days after receipt of written notification of the contested decision or action. Appeals may be supported by any argument or evidence that the appellant may wish to offer as to why the contested decision or action should be reconsidered.
(b) Any initial appeal of a decision or action of an inspector or other Agency employee must be made to his/her immediate supervisor having jurisdiction over the subject matter of the appeal.
(a) The regulations in this subchapter provide for the inspection of Siluriformes fish and fish products. The inspection and regulations are intended to prevent the sale, transportation, offer for sale or transportation, or receipt for transportation, in commerce of any fish or fish product that is capable of use as human food and is adulterated or misbranded at the time of the sale, transportation, offer for sale or transportation, or receipt for transportation.
(b) Fish as defined in this subchapter are amenable to the Act, including, as the Administrator may determine, to provisions of the Act in which other amenable species are named, except where the Act specifically excludes the provisions from applicability to fish.
The Food Safety and Inspection Service, U.S. Department of Agriculture, administers an inspection program for fish and fish products. The organization of FSIS and the principal offices of FSIS and their functions are described, and organizational terms defined, in 9 CFR part 300, subchapter A of this chapter. Section 300.3 lists the FSIS district offices and the geographic areas of the districts.
The provisions of 9 CFR 300.6 apply to fish processing establishments and related industries as they do to other establishments subject to the FMIA.
As used in this subchapter, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:
Act. The Federal Meat Inspection Act, as amended, (34 Stat. 1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 106 Stat. 4499, 119 Stat. 2166, 122 Stat. 1369, 122 Stat. 2130, 21 U.S.C., sec. 601 et seq.).
Adulterated. This term applies to any carcass, part thereof, fish or fish food product under one or more of the following circumstances:
(1) If it bears or contains any such poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(2)(i) If it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is:
(A) A pesticide chemical in or on a raw agricultural commodity;
(B) A food additive; or
(C) A color additive which may, in the judgment of the Administrator, make such article unfit for human food;
(ii) If it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
(iii) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
(iv) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, That an article which is not deemed adulterated under paragraphs (2)(ii), (iii), or (iv) of this definition shall nevertheless be deemed adulterated if use of the pesticide chemical food additive, or color additive in or on such article is prohibited by the regulations in this subchapter in official establishments;
(3) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;
(4) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(5) If it is, in whole or in part, the product of an animal which has died otherwise than by slaughter;
(6) If its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;
(7) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act;
(8) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefore; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
Amenable species. A species that is, and whose products are, subject to the Act and regulations promulgated under the Act, except as the Act may provide.
Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from the carcass or parts or products of the carcass of any amenable species, except that the term animal food as used herein does not include:
(1) Processed dry animal food or
(2) Feeds for amenable species manufactured from processed by products of amenable species.
Applicant. Any person who requests inspection service, exemption, or other authorization under the regulations.
Biological residue. Any substance, including metabolites, remaining in fish at time of slaughter or in any of their tissues after slaughter as the result of treatment or exposure of the fish to a pesticide, organic or inorganic compound, hormone, hormone like substance, anthelmintic, or other therapeutic or prophylactic agent.
Capable of use as human food. This term applies to any carcass or part or product of a carcass of any fish unless it is denatured or otherwise identified as required by § 540.3 of this subchapter to deter its use as a human food, or it is naturally inedible by humans; e.g., barbels or fins in their natural state.
Carcass. All parts, including viscera, of any slaughtered livestock.
Commerce. Commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.
Consumer package. Any container in which a fish product is enclosed for the purpose of display and sale to household consumers.
Container. Any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover.
Dead fish. The body of a fish that has died otherwise than by slaughter.
Dying or diseased fish. Fish affected by any of the conditions for which the fish are required to be condemned under part 539 or other regulations in this subchapter.
Edible. Intended for use as human food.
Farm-raised. Grown under controlled conditions, within an enclosed space, as on a farm.
Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.
Firm. Any partnership, association, or other unincorporated business organization.
Fish. (1) For the purposes of this subchapter, any fish of the order Siluriformes, whether live or dead.
(2) The skeletal muscle tissue of fish. As applied to products of fish of the order Siluriformes, this term has a meaning comparable to that of “meat” in the meat inspection regulations (9 CFR 301.2).
Fish byproduct. Any fish part capable of use as human food, other than the skeletal muscle tissue, that has been derived from one or more fish.
Fish food product. Any article capable of use as human food that is made wholly or in part from any fish or part thereof; or any product that is made wholly or in part from any fish or part thereof, excepting those exempted from definition as a fish product by the Administrator in specific cases or by a regulation in this subchapter; upon a determination that they contain fish ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the fish food industry, and provided that they comply with any requirements that are imposed in such cases or regulations as conditions of such exemptions to ensure that the fish meat or other portions of such carcasses contained in such articles are not adulterated, and that such articles are not represented as fish food products.
Fish product. Any fish or fish part; or any product that is made wholly or in part from any fish or fish part, except for those exempted from definition as a fish product by the Administrator in a regulation in this subchapter. Except where the context requires otherwise (e.g., in part 540 of this subchapter), this term is limited to articles capable of use as human food.
Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments.
Immediate container. The receptacle or other covering in which any product is directly contained or wholly or partially enclosed.
Inedible. Adulterated, uninspected, or not intended for use as human food.
“Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof). This term means that the product so identified has been inspected and passed under the regulations in this subchapter, and at the time it was inspected, passed, and identified, it was found to be not adulterated.
Label. A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.
Labeling. All labels and other written, printed, or graphic matter:
(1) Upon any article or any of its containers or wrappers, or
(2) Accompanying such article.
Misbranded. This term applies to any carcass, part thereof, fish or fish food product under one or more of the following circumstances:
(1) If its labeling is false or misleading in any particular;
(2) If it is offered for sale under the name of another food;
(3) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated;
(4) If its container is so made, formed, or filled as to be misleading;
(5) If in a package or other container unless it bears a label showing:
(i) The name and place of business of the manufacturer, packer, or distributor; and
(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in part 317 of this subchapter with respect to the quantity of contents;
(6) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(7) If it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations in part 319 of this subchapter unless:
(i) It conforms to such definition and standard, and
(ii) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;
(8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;
(9) If it is not subject to the provisions of paragraph (7)(ii) of this definition unless its label bears:
(i) The common or usual name of the food, if any there be, and
(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except as otherwise provided in part 317 of this subchapter;
(10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as is required by the regulations in part 317 of this subchapter.
(11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided by the regulations in part 317 of this subchapter; or
(12) If it fails to bear, directly thereon or on its containers, when required by the regulations in part 316 or 317 of this subchapter, the inspection legend and, unrestricted by any of the foregoing, such other information as the Administrator may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.
Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of fish food and fish products excluding labeling and packaging materials as covered in part 541 of this subchapter.
Official certificate. Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act.
Official device. Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark.
Official establishment. Any slaughtering, cutting, boning, fish product canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter.
Official import inspection establishment. This term means any establishment, other than an official establishment as defined in this section, where inspections are authorized to be conducted as prescribed in part 557 of this subchapter.
Official inspection legend. Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act.
Official mark. The official inspection legend or any other symbol prescribed by the regulations in this subchapter to identify the status of any article, fish, or fish product under the Act.
Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for fish products.
Person. Any individual, firm, or corporation.
Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for purposes of the Act and the regulations in this subchapter as under the Federal, Drug, and Cosmetic Act.
Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.
Process authority. A person or organization with expert knowledge in fish production process control and relevant regulations. This definition does not apply to § 548.6 of this subchapter or to subpart G of part 318 of this chapter.
Process schedule. A written description of processing procedures, consisting of any number of specific, sequential operations directly under the control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. This definition does not apply to § 548.6 of this subchapter or to subpart G of part 318 of this chapter.
Producer. Any person engaged in the business of growing farm-raised fish.
Product. Any carcass, fish, fish product, or fish food product, capable of use as human food.
Program. The organizational unit within the Department having the responsibility for carrying out the provisions of the Act.
Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program.
Slaughter. With respect to fish, intentional killing under controlled conditions.
State. Any State of the United States or the Commonwealth of Puerto Rico.
Territory. Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States.
U.S. Condemned. This term means that the fish, part, or product of fish so identified was inspected and found to be adulterated and is condemned.
U.S. Detained. This term applies to fish, fish products, and other articles which are held in official custody in accordance with section 402 of the Act (21 U.S.C. 672), pending disposal as provided in the same section 402.
U.S. Retained. This term means that the fish, part, or product of fish so identified is held for further examination by an inspector at an official establishment to determine its disposal.
United States. The States, the District of Columbia, and the Territories of the United States.
(a) No establishment may process or prepare fish, fish parts, or fish products capable of use as human food, or sell, transport, or offer for sale or transportation in commerce any of these articles without inspection under these regulations, except as expressly exempted in § 532.3.
(b) Inspection under the regulations is required at:
(1) Every establishment, except as provided in the regulation on exemption of retail operations (§ 532.3), in which any fish or fish products are wholly or in part, processed for transportation or sale in commerce, as articles intended for use as human food.
(2) Every establishment, except as provided in the regulation on exemption of retail operations (§ 532.3), within any State or organized territory which is designated pursuant to section 301 of the Act (21 U.S.C. 661), at which any fish or fish products are processed for use as human food solely for distribution within that State or territory.
(3) Except as provided in the regulation on exemption of retail operations (§ 532.3), every establishment designated by the administrator under section 301 of the Act (21 U.S.C. 661) as one producing adulterated fish products which would clearly endanger the public health.
(4) Coverage of fish and fish products processed in official establishments. All fish and fish products prepared in an official establishment must be inspected, handled, processed, marked, and labeled as required by the regulations.
(5) Other inspection. Periodic inspections may be made of:
(i) The records of all persons engaged in the business of hatching, feeding, growing, or transporting fish between premises where fish are bred, hatcheries, and premises where fish are grown, and from these premises to processing establishments.
(ii) Exempted retail establishments to determine that those establishments are operating in accordance with these regulations.
(a) Application for inspection is as required by 9 CFR 304.1.
(b) Information to be furnished is as required by 9 CFR 304.2(a), (b), and (c)(1). Conditions for receiving inspection, including having written Sanitation SOPs, HACCP plans and written recall procedures, are as required by 9 CFR 304.3.
(c) Official numbers; inauguration of inspection; withdrawal of inspection; reports of violation. The requirements for assignment of official numbers, inauguration of inspection, withdrawal of inspection, and reports of violations at fish processing establishments are as required by part 305 of this chapter for meat establishments.
(d) Assignment and authorities of program employees. The requirements concerning the assignment and authorities of Program employees at fish processing establishments are as required by parts 306 and 307 of this chapter with respect to Program employees at meat establishments.
(a) The exemption in 9 CFR 303.1(d) for operations of types traditionally and usually conducted at retail stores and restaurants applies with respect to fish products as it does with respect to products of other amenable species under the FMIA.
(b) The exemption also applies to the slaughtering of fish conducted at and by the operator of a retail store or restaurant, with respect to live fish purchased by a consumer at the retail store or restaurant, in accordance with the consumer's instructions.
(c) A retail quantity of fish or fish products sold to a household consumer is a normal retail quantity if it does not exceed 75 pounds and the quantity of fish or fish product sold by a retail supplier to a non-household consumer is a normal retail quantity if it does not exceed 150 pounds in the aggregate.
(a) Requirements within the scope of the Act with respect to premises, facilities, and operations of any official establishment that are in addition to or different than those made under this subchapter may not be imposed by any State or local jurisdiction except that the State or local jurisdiction may impose recordkeeping and other requirements within the scope of § 550.1 of this subchapter, if consistent with those requirements, with respect to the establishment.
(b) Labeling, packaging, or ingredient requirements in addition to or different than those made under this subchapter, the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act may not be imposed by any State or local jurisdiction with respect to any fish or fish products processed at any official establishment in accordance with the requirements under this subchapter and those Acts.
The following articles contain fish ingredients only in a relatively small proportion or historically have not been considered by consumers to be products of the fish food products industry. Therefore, the articles are exempted from the definition of “fish product” and the requirements of the Act and the regulations that apply to fish products, if they comply with the conditions specified in this section.
(a) Any human food product if:
(1) It contains less than 3 percent raw or 2 percent cooked fish;
(2) The fish ingredients used in the product were prepared under Federal inspection or were inspected under a foreign inspection system approved under § 557.2 of this subchapter and imported in compliance with the Act and the regulations;
(3) The immediate container of the product bears a label which shows the name of the product in accordance with this section; and
(4) The product is not represented as a fish product. The percentage of cooked fish ingredients must be computed on the basis of the moist, deboned, cooked fish in the ready-to-serve product when prepared according to the serving directions on the consumer package.
(b) A product exempted under this section will be deemed to be represented as a fish product if the term “fish” or a term representing a fish species that is covered by the definition of “fish” in part 531 of this subchapter is used in the product name of the product without appropriate qualification.
(c) A product exempted under this section is subject to the requirements of the Federal Food, Drug, and Cosmetic Act.
Each official establishment shall be separate and distinct from any unofficial establishment and from any other official establishment, except an establishment preparing products under the FMIA, the PPIA, or the EPIA, or under State fish inspection requirements and authorities that are deemed to be at least equal to those provided under the FMIA. Further, doorways, or other openings, may be permitted between establishments at the discretion of the Administrator and under such conditions as he may prescribe. An official establishment that is not separate and distinct from another official or unofficial establishment must ensure that no sanitary hazards are created by the lack of separation.
Office space, including necessary furnishings, light, heat, and janitor service, must be provided by official establishments, rent free, for the exclusive use for official purposes of the inspector and other Program employees assigned thereto. The space set aside for this purpose shall meet with approval of the District Manager or the frontline supervisor and must be conveniently located, properly ventilated, and provided with lockers suitable for the protection and storage of Program supplies and with facilities suitable for Program employees to change clothing if such facilities are deemed necessary by the frontline supervisor. At the discretion of the Administrator, small establishments requiring the services of less than one full-time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Laundry service for inspectors' outer work clothing must be provided by each establishment.
When required by the District Manager or the frontline supervisor, each official establishment must provide the following facilities and conditions, and such others as may be found to be essential to efficient conduct of inspection and maintenance of sanitary conditions:
(a) Sufficient light to be adequate for the proper conduct of inspection;
(b) Tables, benches, and other equipment on which inspection is to be performed, of such design, material, and construction as to enable Program employees to conduct their inspection in a ready, efficient and clean manner;
(c) Receptacles for holding and handling diseased carcasses and parts, so constructed as to be readily cleaned and to be marked in a conspicuous manner with the phrase “U.S. Condemned” in letters not less than 2 inches high, and, when required by the frontline supervisor, to be equipped in a way that allows the receptacles to be locked or sealed;
(d) Adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, for sterilizing all implements used in handling diseased carcasses, for cleaning and sanitizing floors, and such other articles and places as may be contaminated by diseased carcasses or otherwise;
(e) Adequate facilities, including denaturing materials, for the proper disposal of condemned articles in accordance with the regulations in this subchapter;
(f) Docks and receiving rooms, to be designated by the operator of the official establishment, with the frontline supervisor, for the receipt and inspection of fish, fish products, or other products.
(g) Suitable lockers in which brands bearing the official inspection legend and other official devices (excluding labels) can be stored. Official certificates shall be kept when not in use in suitable file cabinets. All such lockers and file cabinets shall be equipped for sealing or locking with locks or seals to be supplied by the Department. The keys of such locks shall not leave the custody of Program employees.
The requirements governing the schedule of operations for fish processing establishments are as required by 9 CFR 307.4 for meat establishments.
The requirements governing overtime and holiday inspection service in 9 CFR 307.5 apply to fish processing establishments.
The requirements for billing and overtime and holiday inspection services are as required by 9 CFR 307.6.
Fish that are harvested for use as human food must have grown and lived under conditions that will not render the fish or their products unsound, unwholesome, unhealthful, or otherwise unfit for human food.
Farmers of fish should monitor the water in which the fish are raised for the presence of suspended solids, organic matter, nutrients, heavy metals, pesticides, fertilizers, and industrial chemicals that may contaminate fish. FSIS will collect samples of feed, fish, and water from producers, at intervals to be determined by the Administrator, for the purpose of verifying that fish are being raised under conditions that will yield safe, wholesome products.
New animal drugs that are the subject of an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) under section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b), or a conditional approval under section 571 of the Act (21 U.S.C. 360ccc), or an investigational exemption under section 512(j) of the Act (21 U.S.C. 360b(j)) may be used in the raising of fish. New animal drugs approved under section 512 of the Act may be used in an extra-label manner if such use complies with section 512(a)(4) of the Act and FDA regulations found at 21 CFR part 530.
A vehicle used to transport fish from a producer's premises to a processing establishment must be equipped with vats or other containers for holding the fish. The vats or other containers must be maintained in a sanitary condition. Sufficient water and sufficient oxygen must be provided to the vats that hold the fish to ensure that fish delivered to the processing establishment will not be adulterated. Any fish that are dead, dying, diseased, or contaminated with substances that may adulterate fish products are subject to condemnation at the official fish processing establishments.
(a)(1) Any official establishment that prepares or processes fish or fish products for human food must comply with the requirements contained in 9 CFR parts 416, Sanitation and 417, Hazard Analysis and Critical Control Point (HACCP) Systems, except as otherwise provided in this subchapter.
(2) For the purposes of 9 CFR part 416, Sanitation; 9 CFR part 417, Hazard Analysis and Critical Control Point (HACCP) Systems; and 9 CFR part 500, Rules of Practice, an “official establishment” or “establishment” includes a plant that prepares or processes fish or fish products.
(a) A fish establishment's hazard analysis shall take into account the food safety hazards that can occur before, during, and after harvest.
(b) The failure of an establishment to develop and implement a hazard analysis and a HACCP plan that comply with this part or to operate in accordance with the requirements of 9 CFR Chapter III, Subchapter E, will render the products produced under these conditions adulterated.
Each official establishment must promptly notify the local FSIS District Office within 24 hours of learning or determining that an adulterated or misbranded fish product received by or originating from the official establishment has entered commerce, in accordance with the requirements of 9 CFR part 418.
(a)(1) Carcasses or parts of fish affected by abscesses or lesions, zoonotic and non-zoonotic parasites such as cestodes, or such parasites as digenean trematodes, metacercaria (Bolbophorus spp.), yellow grubs (Clinostomum spp.), or white grubs (Hysteromorpha spp.) are subject to condemnation unless properly disposed of by the establishment to prevent their use as human food.
(2) Fish affected by Heterophyid intestinal flukes or Dictophymatidae nematodes are subject to condemnation unless properly disposed of by the establishment.
(b) Fish affected by diseases, including columnaris (infection by Flavobacterium columnare/Flexibacter columnaris) and enteric septicemia of fish (ESC), are subject to condemnation unless properly disposed of by the establishment to prevent their use as human food.
(c) Fish carcasses or parts or fish products that are found to be in a state of spoilage or decomposition are subject to condemnation unless properly disposed of by the establishment to prevent their use as human food.
(d) Fish with unusual gross deformities caused by disease or chemical contamination may not be used for human food.
(a) Fish and fish products that are contaminated with physical matter are subject to official retention and condemnation.
(b) Antibiotic or other drug residues in fish tissues must be within applicable tolerances in 21 CFR part 556 or within an applicable import tolerance established under 21 U.S.C. 360b(a)(6).
(c) Pesticide residues in fish tissues must be within applicable tolerances in 40 CFR part 180.
(d) Fish or fish products containing violative concentrations of drugs or other chemicals are subject to condemnation.
(a) With the exception of dead fish that have died en route to an official establishment that have been received with live fish at the official establishment, and that are subject to sorting and disposal at the official establishment, no fish or part of the carcass of fish that died otherwise than by slaughter may be brought onto the premises of an official establishment without advance permission from the FSIS frontline supervisor.
(b) The official establishment shall maintain physical separation between slaughtered fish and the edible parts or products of slaughtered fish and any fish or parts of fish that have died otherwise than by slaughter. Fish or any parts of fish that have died otherwise than by slaughter shall be excluded from any room or compartment in which edible product is prepared, handled, or stored.
The requirements of 9 CFR 314.9 apply to the handling and release of specimens of condemned or other inedible fish materials.
Condemned or other inedible fish and fish parts shall be separated from edible fish. If not disposed of on the premises of the establishment, the condemned and inedible fish parts shall be conveyed from the official establishment for disposition at a rendering plant, an animal feed manufacturing establishment, or at another establishment for other non-food use. If not decharacterized by use of approved denaturants or colorings, the inedible materials shall be enclosed in containers that are conspicuously marked to indicate that the contents are condemned or otherwise inedible. The materials may be shipped under company or official seal to a rendering facility or for other inedible processing.
The marks, devices, and certificates prescribed or referenced in this part are official marks, devices, and certificates for the purposes of the Act respecting fish and fish products. The marks, devices, and certificates shall be used only in accordance with the regulations in this part.
(a)(1) The official inspection legend required by this part must be shown on all labels for inspected and passed fish and fish products and must be in the following form prescribed in 9 CFR 312.2(b)(1) for inspected and passed products of cattle, sheep, swine, and goats, or in another form to be prescribed by the Administrator, except that it need not be of the size illustrated, if it is of a sufficient size and color to be conspicuously displayed, and readily legible, and in the same proportions of letter size and boldness are maintained as illustrated:
(2) The official inspection legend shall contain the words “U.S. Inspected and Passed” or an abbreviation of those words approved by the Administrator.
(b) This official mark must be applied by mechanical means and must not be applied by a hand stamp.
(c)(1) The official inspection legend, or the approved abbreviation of the legend, must be printed on consumer packages and other immediate containers of inspected and passed fish products or on labels to be securely affixed to the containers of the products and may be printed or stenciled on the containers but must not be applied by rubber stamping.
(2) The official inspection legend may also be used for the purposes of marking shipping containers, band labels, and other articles with the approval of the Administrator.
(d) Whole gutted fish carcasses that have been inspected and passed in an official establishment and are intended for sale as whole gutted fish must be marked with the official inspection legend or properly packaged in an immediate container labeled with the official inspection legend and all other required labeling features, that will ensure that the fish carcasses are identified as “Inspected and Passed” and will not become misbranded while in commerce. The official inspection legend used for this purpose must be in the form illustrated below or in another form determined by the Administrator:
The official mark for use in sealing railroad cars, cargo containers, or other means of conveyance as prescribed in part 555 of this subchapter must be the inscription and serial number shown in 9 CFR 312.5 or another official mark approved by the Administrator. Any seal approved by the Administrator for applying the official mark is an official device for the purposes of the Act. The seal must be attached to the means of conveyance only by a Program employee, who shall also affix a “Warning Tag” (Form MP-408-3 or similar official form).
(a) The official export inspection mark for fish required by part 552 of this subchapter must be in the same form as that specified in 9 CFR 312.8(a) or otherwise as prescribed by the Administrator.
(b) The official export certificate for fish and fish products required by part 552 must be in the same form as that prescribed for meat and meat food products in 9 CFR 312.8(b) or otherwise as prescribed by the Administrator.
The official mark for shipments of articles and fish detained under this subchapter is the designation “U.S. Detained,” and the official device for applying the mark is the official “U.S. Detained” tag (FSIS Form 8400-2) as prescribed in 9 CFR 329.2 or otherwise by the Administrator.
(a) General labeling requirements. The requirements in part 317, subpart A, of this chapter, governing labels and labeling, safe-handling labeling, abbreviations of official marks, the use of approved labels, the labeling of products for foreign commerce, prohibited practices, the reuse of official inspection marks, filling of containers, relabeling of products, the storage and distribution of labels, and the requirements for packaging materials, apply to fish and fish products.
(b) A country of origin statement on the label of any fish “covered commodity” as defined in 7 CFR part 60, subpart A, that is sold by a “retailer,” as defined in 7 CFR 60.124, must comply with the requirements of 7 CFR 60.200 and 60.300.
(c) The safe handling instructions required on labels of fish and fish products specified in paragraph (a) of this section shall replace statements that include the terms “meat” and “poultry” with the following:
(1) In the rationale statement, “This product was prepared from inspected and passed fish. Some food products may contain bacteria that could cause illness if the product is mishandled and cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements.
(2) In the labeling statements, “Keep raw fish separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw fish. (A graphic illustration of soapy hands under a faucet shall be displayed next to statement.)”
(d)(1) Labels and labeling of fish in the order Siluriformes and the products of those fish must bear the appropriate common or usual names of the fish. For example, among fish in the family Pangasiidae, the labels and labeling for fish of the species Pangasius bocourti must bear the term “basa”; for the species Pangasius hypophthalmus or Pangasionodon hypophthalmus, “swai,” “tra,” or “sutchi.”
(2) The labels and labeling only of fish and fish products within the family Icataluridae may bear the term “catfish.”
(e) The requirements in part 441 of this chapter, governing water retained from processing in raw meat and poultry, apply to retained water in fish. The requirements in part 442 of this chapter, governing quantity of contents labeling, the testing of scales, and the handling of product that is found to be out of compliance with net weight requirements, apply to fish and fish products.
(1) Packages of frozen or fresh-frozen fish carcasses or parts must be labeled to reflect 100-percent net weight after thawing. The de-glazed net weight must average 100 percent of the stated net weight of the frozen product when sampled and weighed according to the method prescribed in National Institute of Standards and Technology (NIST) Handbook 133 Chapter 2, Section 2.6.
(2) [Reserved]
(f) Nutrition labeling. The requirements for nutrition labeling of meat and meat food products in part 317, subpart B, of this chapter, also apply to the labeling of fish and fish food products.
(g) Label approval. The requirements for the label approval of meat and meat food products in part 412 of this chapter, also apply to the labeling of fish and fish products.
(a) No fish product may bear or contain any food ingredient that would render it adulterated or misbranded or that is not approved in part 424 of this chapter, or in this part or elsewhere in this subchapter, or by the Administrator in specific cases.
(b) [Reserved]
(a) All processes used in preparing any fish product in official establishments shall be subject to inspection by Program employees unless such preparation is conducted as or consists of operations that are exempted from inspection under 9 CFR 303.1. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.
(b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. To carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to ensure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter.
All ingredients and other articles used in the preparation of any fish product must be clean, sound, healthful, wholesome, and otherwise such as will not result in the product's being adulterated.
Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Program, for examination, as often as may be deemed necessary for the efficient conduct of the inspection.
Ready-to-eat fish products are subject to the requirements in part 430 of this chapter.
The requirements for canning and canned products in 9 CFR part 431 apply to fish products that are canned.
Edible tissues of fish with residues exceeding tolerance levels specified in 21 CFR part 556 or established in an import tolerance under 21 U.S.C. 360b(a)(6) are adulterated within the meaning of section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act because they bear or contain a new animal drug that is unsafe within the meaning of section 512 of the Federal Food, Drug, and Cosmetic Act.
In the event that there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of the products that have been rendered adulterated by the water must be condemned. After the polluted water has receded from the establishment, the establishment must follow the cleaning and sanitizing procedures in § 318.4 of this chapter.
A non-Federal analytical laboratory that has met the requirements for accreditation specified in 9 CFR part 439 and hence, at an establishment's discretion, may be used in lieu of an FSIS laboratory for analyzing official regulatory samples. Payment for the analysis of regulatory samples is to be made by the establishment using the accredited laboratory.
The requirements in 9 CFR 320.1 for records to be kept apply to persons that engage in businesses relating to fish and fish products as they do to persons that engage in businesses relating to the carcasses, parts, or products of other species amenable to the FMIA.
The requirements in 9 CFR 320.2 for the place where records are to be maintained apply in the keeping of records under this part.
The record retention requirements in 9 CFR 320.3 apply to records required to be kept under this part.
The provisions of 9 CFR 320.4 apply to businesses dealing in fish and fish products.
The registration requirements in 9 CFR 320.5 apply to persons engaging in businesses, in or for commerce, relating to fish and fish products as they do to persons engaging in businesses relating to the carcasses, parts, and products, or any livestock, of other animal species that are amenable to the FMIA.
The information and reporting requirements in 9 CFR 320.6 for operators of official establishments apply with respect to fish and fish products as they do with respect to other species amenable to the FMIA.
The requirements in 9 CFR 320.7 for reports by consignees of allegedly adulterated or misbranded products apply with respect to fish and fish products as they do with respect to products of other species amenable to the Act.
(a) The manner of affixing stamps and marking products for export is that prescribed in § 322.1(a) of this chapter.
(b) The requirements for the issuance of export certificates are as prescribed in § 322.2 of this chapter.
(c) The requirements for clearing vessels and other transportation vehicles are set out in § 322.4 of this chapter.
(a) No person may sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any fish or fish product that is capable of being used as human food and is adulterated or fails to bear an official inspection legend or is otherwise misbranded at the time of such sale, transportation, offer or receipt, except otherwise provided in this paragraph or in part 557 of this subchapter.
(b) No person, engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, fish products capable of use as human food, or importing such articles, shall transport, offer for transportation, or receive for transportation, in commerce or in any State designated under § 560.3 of this subchapter, any fish product which is capable of use as human food and is not wrapped, packaged, or otherwise enclosed to prevent adulteration by airborne contaminants, unless the railroad car, truck, or other means of conveyance in which the product is contained or transported is completely enclosed with tight fitting doors or other covers for all openings. In all cases, the means of conveyance shall be reasonably free of foreign matter (such as dust, dirt, rust, or other articles or residues), and free of chemical residues, so that product placed therein will not become adulterated.
(c) Any cleaning compound, lye, soda solution, or other chemical used in cleaning the means of conveyance must be thoroughly removed from the means of conveyance prior to its use. Such means of conveyance onto which product is loaded, being loaded, or intended to be loaded, shall be subject to inspection by an inspector at any official establishment.
(d) The decision whether or not to inspect a means of conveyance in a specific case, and the type and extent of such inspection shall be at the Agency's discretion and shall be adequate to determine if fish product in such conveyance is, or when moved could become, adulterated.
(e) Circumstances of transport that can be reasonably anticipated shall be considered in making said determination. These include, but are not limited to, weather conditions, duration and distance of trip, nature of product covering, and effect of restowage at stops en route. Any means of conveyance found upon such inspection to be in such condition that fish product placed therein could become adulterated shall not be used until such condition which could cause adulteration is corrected.
Fish product placed in any means of conveyance that is found by the inspector to be in such condition that the fish product may have become adulterated shall be removed from the means of conveyance and handled in accordance with part 539 or § 540.3 of this subchapter.
When any shipment of any fish product is offered to any carrier for transportation within the United States as a part of an export movement, the same certificate shall be required as if the shipment were destined to a point within the United States.
The requirements governing transportation of fish product that has been inspected and passed, but not so marked, from one official establishment to another official establishment are the same as those in § 325.5 of this chapter that apply to unmarked inspected meat products.
The provisions of § 325.10 of this chapter regarding the handling of products that may have become adulterated or misbranded apply to fish and fish products.
The provisions in § 325.11(e) of this chapter regarding the transportation of inedible livestock products apply to the transportation of inedible fish parts or products.
The provisions in § 325.14 of this chapter regarding the filing of original certificates of unmarked inspected meat products delivered to carriers applies with respect to fish and fish products.
The official seals required by this part are those prescribed in § 541.3 and § 312.5 of this chapter.
The requirements in 9 CFR 325.17 governing the unloading of any meat or meat food product from an officially sealed railroad car, truck, or other means of conveyance containing any unmarked product or loading any means of conveyance after the product leaves an official establishment are applicable to fish and fish products.
(a) Shipments of inspected and passed fish products that bear the inspection legend may be diverted from the original destination without a reinspection of the articles if the waybills, transfer bills, running slips, conductor's card, or other papers accompanying the shipments are marked, stamped, or have attached thereto signed statements in accordance with § 325.15 of this chapter.
(b) In case of a wreck or similar extraordinary emergency, the Department seals on a railroad car or other means of conveyance containing any inspected and passed product may be broken by the carrier, and if necessary, the articles may be reloaded into another means of conveyance, or the shipment may be diverted from the original destination, without another shipper's certificate; but in all such cases the carrier must immediately report the facts by telephone or telegraph to the District Manager in the area in which the emergency occurs. The report must include the following information:
(1) Nature of the emergency.
(2) Place where seals were broken.
(3) Original points of shipment and destination.
(4) Number and initial of the original car or truck.
(5) Number and initials of the car or truck into which the articles are reloaded.
(6) New destination of the shipment.
(7) Kind and amount of articles.
The provisions of this part do not apply:
(a) To specimens of product sent to or by the Department of Agriculture or divisions thereof in Washington, DC, or elsewhere, for laboratory examination, exhibition purposes, or other official use;
(b) To material released for educational, research, and other nonfood purposes, as prescribed in § 540.2 of this subchapter;
(c) To tissues for use in preparing pharmaceutical, organotherapeutic, or technical products and not used for human food, as described in § 540.2 of this subchapter;
(d) To material or specimens of product for laboratory examination, research, or other nonhuman food purposes, when authorized by the Administrator, and under conditions prescribed by him in specific cases; and
(e) To articles that are naturally inedible by humans.
No person engaged in the business of buying, selling, or transporting in commerce, or importing any dead, dying, or diseased fish or parts of fish that died otherwise than by slaughter shall:
(a) Sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any dead, dying, or diseased fish or parts of fish that died otherwise than by slaughter, unless the fish and parts are consigned and delivered, without avoidable delay, to establishments of animal food manufacturers, renderers, or collection stations that are registered as required by part 550 of this subchapter, or to official establishments that operate under Federal inspection, or to establishments that operate under a State or Territorial inspection system approved by FSIS as one that imposes requirements at least equal to the Federal requirements for purposes of section 301(c) of the Act;
(b) Buy in commerce or import any dead, dying, or diseased fish or parts of fish that died otherwise than by slaughter, unless he is an animal food manufacturer or renderer and is registered as required by part 550 of this subchapter, or is the operator of an establishment inspected as required by paragraph (a) of this section and such fish or parts of fish are to be delivered to establishments eligible to receive them under paragraph (a) of this section;
(c) Unload en route to any establishment eligible to receive them under paragraph (a) of this section, any dead, dying, or diseased fish or parts of fish that died otherwise than by slaughter, which are transported in commerce or imported by any such person: Provided, That any such dead, dying, or diseased fish, or parts of fish may be unloaded from a means of conveyance en route where necessary in case of a wreck or otherwise extraordinary emergency, and may be reloaded into another means of conveyance; but in all such cases, the carrier must immediately report the facts by telephone or other electrical or electronic means to the Office of Investigation, Enforcement and Audit, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(d) Load into any means of conveyance containing any dead, dying, or diseased fish, or parts of fish that died otherwise than by slaughter, while in the course of importation or other transportation in commerce any fish or parts of fish not within the foregoing description or any other products or other commodities.
All vehicles and other means of conveyance used by persons subject to § 555.11 for transporting in commerce or importing, any dead, dying, or diseased fish or parts of fish that died otherwise by slaughter must be leak proof and so constructed and equipped as to permit thorough cleaning and sanitizing. The means of conveyance used in conveying the fish or parts of fish must be cleaned and disinfected before being used in the transportation of any product intended for use as human food. The cleaning procedure must include the complete removal from the means of conveyance of any fluid, parts, or product of dead, dying, or diseased fish and the thorough application of a disinfectant approved by the Administrator to the interior surfaces of the cargo space.
(a) When used in this part, the following terms shall be construed to mean:
(1) Import. To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.
(2) Offer for entry. Presentation of the imported product by the importer to the Program for reinspection.
(3) Entry. The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection in accordance with § 557.26 of this subchapter.
(b) The provisions of this part shall apply to fish and fish products that are capable of use as human food. Compliance with the conditions for importation of products under this part does not excuse the need for compliance with applicable requirements under other laws, including the provisions in part 94 of chapter I of this title.
(a) The requirements in 9 CFR 327.2(a)(1), (a)(2)(i), (a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (a)(3), for determining the acceptability of foreign meat inspection systems for the importation of meat and meat food products into the United States, apply in determining the acceptability of foreign fish inspection systems for the importation of fish and fish products into the United States. In determining the acceptability of these systems, the Agency will evaluate the manner in which they take into account the conditions under which fish are raised and transported to a processing establishment.
(b) The countries eligible to export specific process categories of fish and fish products are listed at http://www.fsis.usda.gov/importlibrary. Such products must be covered by foreign inspection certificates of the country of origin as required by § 557.4. Products from such countries are eligible under the regulations in this subchapter for entry into the United States after inspection and marking as required by the applicable provisions of this part. .
No fish or fish product offered for importation from any foreign country shall be admitted into the United States if it is adulterated or misbranded or does not comply with all the requirements of this subchapter that would apply to it if it were a domestic product.
(a) Except as provided in § 557.16, each consignment containing any fish or fish products consigned to the United States from a foreign country must be accompanied by an electronic foreign inspection certificate or a paper foreign inspection certificate for fish and fish products. The certificate must have been issued by an official of the foreign government agency responsible for the inspection and certification.
(b) An official of the foreign government must certify that any fish or fish product described on any official certificate was produced in accordance with the regulatory requirements in § 557.2.
(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment, and be available to import inspection personnel.
(d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue inspection certificates for products imported to the United States.
(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign establishment number;
(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;
(4) The product's description, including the process category, the product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or identification;
(8) The net weight of each lot;
(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.
(a) Applicants must submit an import inspection application, to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be submitted, electronically or on paper, to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 557.16 and 557.17.
(a)(1) Except as provided in §§ 557.16 and 557.17, all fish and fish products offered for entry from any foreign country shall be reinspected by a Program inspector before they shall be allowed entry into the United States.
(2) Every lot of product shall routinely be given visual inspection by a Program import inspector for appearance and condition, and checked for certification and label compliance.
(3) The electronic inspection system will be consulted for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.
(4) When the inspector deems it necessary, the inspector may sample and inspect lots not designated by the electronic system.
(b) Fish and fish products required by this part to be inspected must be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section.
(c) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application must be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, and must include all information called for by that form.
(d) Approval for Federal import inspection must be in accordance with §§ 304.1 and 304.2 of this chapter. Also, before approval is granted, the establishment must have developed written Sanitation Standard Operating Procedures in accordance with part 416 of this chapter.
(e) Owners or operators of establishments at which import inspections of product are to be made shall furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 307.1, 307.2(b), (d), (f), (h), (k), and (l) and 416.1 through 416.6 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments.
(f) The Administrator is authorized to approve any establishment as an official import inspection establishment, provided that an application has been filed in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(g) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may be withdrawn in accordance with section 401 of the Act and applicable rules of practice.
(h) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment.
(i) A product examination must be made, as provided in paragraph (a) of this section, of a foreign fish or fish product, including defrosting if necessary to determine its condition. Inspection standards for foreign chilled fresh or frozen fresh fish shall be the same as those used for domestic fish or fish products. Samples may be collected at no cost to FSIS and submitted to an FSIS laboratory for analysis (See § 557.18).
(j) Imported canned products are required to be sound, healthful, properly labeled, wholesome, and otherwise not adulterated at the time the products are offered for importation into the United States. Provided other requirements of this part are met, the determination of the acceptability of the product and the condition of the containers shall be based on the results of an examination of a statistical sample drawn from the consignment as provided in paragraph (a) of this section. If the inspector determines, on the basis of the sample examination, that the product does not meet the requirements of the Act and regulations thereunder, the consignment shall be refused entry. However, a consignment rejected for container defects but otherwise acceptable may be reoffered for inspection under the following conditions:
(1) If the defective containers are not indicative of an unsafe and unstable product as determined by the Administrator;
(2) If the number and kinds of container defects found in the original sample do not exceed the limits specified for this purpose in FSIS guidelines; and
(3) If the defective containers in the consignment have been sorted out and exported or destroyed under the supervision of an inspector.
(k) Program inspectors or Customs officers at border or seaboard ports shall report the sealing of cars, trucks, or other means of conveyance, and the sealing or identification of containers of foreign product to Program personnel at points where such product is to be inspected.
(l) Representative samples of canned product designated by the Administrator in instructions to inspectors shall be incubated under supervision of such inspectors in accordance with § 318.309(d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of this chapter. The importer or his/her agent shall provide the necessary incubation facilities in accordance with § 318.309(d)(1)(i) of this chapter.
(m) Sampling plans and acceptance levels as prescribed in paragraphs (j) and (l) of this section may be obtained, upon request, from the Office of Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
The requirements in 9 CFR 327.7 respecting the movement or conveyance from any port, or delivery to the consignee, of any product required to be inspected under part 327, apply to fish and fish products.
Compartments of ocean vessels, railroad cars, and other means of conveyance transporting any fish or fish product to the United States, and all trucks, chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any fish or fish product offered for importation into the United States, shall be maintained in a sanitary condition.
The provisions in 9 CFR 327.10 governing the taking of samples, the inspection of consignments, the refusal of entry, and the controlled pre-stamping of shipments of meat and meat food products apply with respect to fish and fish products.
FSIS will issue to importers official receipts for samples of foreign products collected for laboratory analysis, as provided in § 327.11 of this chapter.
Foreign canned or packaged fish and fish products bearing on their immediate containers trade labels that have or have not been approved in accordance with the regulations in § 541.7 of this subchapter are to be sampled and inspected in the same manner as provided by § 327.12 of this chapter for foreign canned meat food products.
Program inspectors are to report their findings as to any fish or fish products that have been inspected in accordance with this part in the same manner as that provided by § 327.13 of this chapter for meat products. Fish and fish products that are refused entry are to be handled in the same manner as provided by § 327.13 of this chapter for meat products that are refused entry. Import personnel will identify to the Port Director of U.S. Customs and Border Protection and the Importer of record any products refused entry into the United States.
The regulations in 9 CFR 327.14 governing the marking of meat and meat food products and the labeling of immediate containers of those products for importation apply with respect to fish and fish products.
The requirements in 9 CFR 327.15 governing the marking and labeling of outside containers of meat and meat food products apply also with respect to fish and fish products.
The exemption in 9 CFR 327.16 for small importations of meat or meat food products for the importer's own consumption applies with respect to fish or fish products.
U.S. inspected and passed and so marked fish products exported to and returned from foreign countries will be admitted into the United States without compliance with this part upon notification of and approval by the Assistant Administrator, Office of Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, in specific cases.
The regulations in 9 CFR 327.18 governing the offer for entry into the United States of meat and meat food products apply with respect to fish and fish products. Products that fail to meet these regulatory requirements are subject to penalties as administered by the U.S. Port Director of Customs and Border Protection. Likewise, the products may be subject to detention and to being proceeded against as determined by the Administrator.
Importation of fish or fish product samples for trade show exhibition, laboratory examination, research, evaluative testing, trade show exhibition, or other scientific purposes are subject to the same conditions as imported meat or meat product specimens under § 327.19 of this chapter.
An appeal from a decision of any Program employee is to be made as provided by 9 CFR 327.24.
Disposition procedures for condemned fish or fish products ordered destroyed under import inspection are as those for carcasses, parts, meat, and meat food products under 9 CFR 327.25.
The official inspection legend and other marks to be applied to imported fish and fish products are as required by 9 CFR 327.26 for meat food products prepared from cattle, sheep, swine, and goats.
The provisions of 9 CFR 329.1 through 329.5 governing the administrative detention of carcasses, parts, meat, and meat food products of livestock apply also with respect to the carcasses, parts, and products of fish.
The provisions of 9 CFR 329.6 through 329.8 governing the judicial seizure and condemnation of carcasses, parts, meat, and meat food products of livestock apply also with respect to the carcasses, parts, and products of fish.
The criminal provisions of the Act apply with respect to the inspection of fish and fish products as they do with respect to the inspection of other food products subject to the Act.
The provisions in § 321.1 of this chapter authorizing the Administrator to cooperate with any State (including Puerto Rico) or any organized Territory in developing and administering a meat inspection program for the State or Territory apply with respect to fish and fish products inspection.
Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize employees and facilities of any State in carrying out Federal functions under the FMIA, including functions relating to the inspection of fish and fish products. A cooperative program for this purpose is called a Federal-State program.
The provisions in § 321.3 authorizing the Administrator to coordinate with States that have meat inspection programs as provided in § 321.1 of this chapter to select certain establishments operating under these programs to participate in a cooperative program to ship products in interstate commerce apply with respect to fish and fish products inspection.
The following requirements apply with respect to fish and fish products inspection:
(a) The requirements in 9 CFR 331.3 governing the designation of States for Federal inspection under section 301(c) of the Act (21 U.S.C. 661(c));
(b) The requirements in 9 CFR 331.5 governing the designation under section 301(c) of the Act of establishments whose operations would clearly endanger the public health; and
(c) The requirements governing the designation of States under section 205 of the Act.
The rules of practice in part 500 of this chapter, governing inspection actions taken by FSIS with respect to establishments and products, apply to actions taken with respect to fish slaughter, fish processing, fish, and fish products regulated under this subchapter.
The procedures that the Agency must follow before reporting a violation of the Federal Meat Inspection Act for prosecution by the Department of Justice are given in part 335 of this chapter.
Under these regulations, words in the singular shall be deemed to mean the plural and vice versa, as the case may demand.
For the purpose of these regulations, unless the context otherwise requires, the following terms shall be construed, respectively, as follows:
Acceptable means suitable for the purpose intended and acceptable to the Administrator.
Act means the applicable provisions of the Egg Products Inspection Act (Pub. L. 91-597, 84 Stat. 1620 et seq.).
Administrator means the Administrator of the Food Safety and Inspection Service or any officer or employee of the Department of Agriculture to whom authority has been delegated or may be delegated to act in his or her stead.
Adulterated means any egg or egg product under one or more of the following circumstances:
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(b)(1) If it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may in the judgment of the Secretary, make such article unfit for human food;
(2) If it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
(3) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
(4) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, that an article which is not otherwise deemed adulterated under paragraph (b)(2), (3), or (4) of this definition shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive, in or on such article, is prohibited by regulations of the Secretary in official plants;
(c) If it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human food;
(d) If it has been prepared, packaged, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(e) If it is an egg which has been subjected to incubation or the product of any egg which has been subjected to incubation;
(f) If its container is composed, in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health;
(g) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act; or
(h) If any valuable constituent has been, in whole or in part, omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
Ambient temperature means the air temperature maintained in an egg storage facility or transport vehicle.
Applicant means any person who requests any inspection service as authorized under the Act or the regulations of this part.
Capable of use as human food means any egg or egg product, unless it is denatured, or otherwise identified, as required by these regulations to deter its use as human food.
Class means any subdivision of a product based on essential physical characteristics that differentiate between major groups of the same kind, type, or method of processing.
Commerce means interstate, foreign, or intrastate commerce.
Condition means any condition (including, but not being limited to, the state of preservation, cleanliness, soundness, wholesomeness, or fitness for human food) of any product which affects its merchantability; or any condition, including but not being limited to, the processing, handling, or packaging which affects such product.
Container or Package includes for egg products, any box, can, tin, plastic, or other receptacle, wrapper, or cover and for shell eggs, any carton, basket, case, cart, pallet, or other receptacle.
(a) Immediate container means any package or other container in which egg products or shell eggs are packed for household or other ultimate consumers.
(b) Shipping container means any container used in packing an immediate container.
Department means the U.S. Department of Agriculture.
Egg means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea. Some of the terms applicable to shell eggs are as follows:
(a) Check means an egg that has a broken shell or crack in the shell but has its shell membranes intact and contents not leaking.
(b) Clean and sound shell egg means any egg whose shell is free of adhering dirt or foreign material and is not cracked or broken.
(c) Dirty egg or Dirt means an egg that has a shell that is unbroken and has adhering dirt or foreign material.
(d) Incubator reject means an egg that has been subjected to incubation and has been removed from incubation during the hatching operations as infertile or otherwise unhatchable.
(e) Inedible means eggs of the following descriptions: Black rots, yellow rots, white rots, mixed rots, sour eggs, eggs with green whites, eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs containing embryo chicks (at or beyond the blood ring stage).
(f) Leaker means an egg that has a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell.
(g) Loss means an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains a bloody white, large meat spots, a large quantity of blood, or other foreign material.
(h) Restricted egg means any check, dirty egg, incubator reject, inedible, leaker, or loss.
Egg handler means any person, excluding the ultimate consumer, who engages in any business in commerce that involves buying or selling any eggs (as a poultry producer or otherwise), or processing any egg products, or otherwise using any eggs in the preparation of human food.
Egg product means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in a relatively small proportion or historically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as the Secretary may prescribe to assure that the egg ingredients are not adulterated and such products are not represented as egg products. For the purposes of this part, the following products, among others, are exempted as not being egg products: Cooked egg products, imitation egg products, dietary foods, dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, and sandwiches containing eggs or egg products, provided such products are prepared from inspected egg products or eggs containing no more restricted eggs than are allowed in the official standards for U.S. Consumer Grade B shell eggs. Balut and other similar ethnic delicacies are also exempted from inspection under this part.
Eggs of current production means shell eggs which have moved through the usual marketing channels since the time they were laid and are not in excess of 60 days old.
Fair Packaging and Labeling Act means the Act so entitled, approved November 3, 1966 (80 Stat. 1296), and Acts amendatory thereof or supplementary thereto.
Federal Food, Drug, and Cosmetic Act means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.
Inspection means the application of such inspection methods and techniques as are deemed necessary by the responsible Secretary to carry out the provisions of the Egg Products Inspection Act and the regulations under this part.
Inspection program personnel means any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program.
Inspection service means the official service within the Department having the responsibility for carrying out the provisions of the Egg Products Inspection Act. Inspection service also means the activities performed, including official reporting by such official service.
Interested party means any person financially interested in a transaction involving any inspection or appeal inspection of any product, or the decision of an inspector.
Label means a display of any printed, graphic, or other method of identification upon the shipping container, if any, or upon the immediate container, including but not limited to, an individual consumer package of eggs and egg products, or accompanying such product.
Misbranded means any egg products which are not labeled and packaged in accordance with the requirements prescribed by regulations of the Administrator under this part.
Nest-run eggs means eggs which are packed as they come from the production facilities without having been washed, sized and/or candled for quality, with the exception that some checks, dirties, or other obvious undergrades may have been removed.
Official certificate means any certificate prescribed by regulations of the Administrator for issuance by an inspector or other person performing official functions under this part.
Official device means any device prescribed or authorized by the Secretary for use in applying any official mark.
Official identification means the official inspection mark or any other symbol prescribed by regulations of this part to identify the status of any article.
Official inspection mark means any symbol prescribed by the regulations of the Administrator showing that egg products were inspected in accordance with this part.
Official plant means any plant in which the plant facilities, methods of operation, and sanitary procedures have been found suitable and adequate by the Administrator for the inspection of egg products pursuant to the regulations in this part and in which inspection service is carried on.
Official standards means the standards of quality, grades, and weight classes for eggs.
Office of inspection means the office of any inspector.
Pasteurize means the subjecting of each particle of egg products to heat or other treatments to destroy harmful viable microorganisms.
Person means any individual, partnership, corporation, association, or other business unit.
Pesticide chemical, Food additive, Color additive, and Raw agricultural commodity shall have the same meaning for purposes of this part as under the Federal Food, Drug, and Cosmetic Act.
Potable water means water that has been approved by a State health authority or other agency or laboratory acceptable to the Administrator as safe for drinking and suitable for food processing.
Processing means manufacturing of egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, freezing or drying, or packaging or repackaging egg products at official plants.
Producer-packer means any producer who sorts eggs only from his own production and packs them into their various qualities.
Quality means the inherent properties of any product which determine its relative degree of excellence.
Regulations means the provisions in this part.
Regulatory inspector means any employee of the U.S. Government, or State or local jurisdiction, who is authorized by the Secretary to make such inspections as required in § 590.28 of these regulations.
Sampling means the act of taking samples of any product for inspection or analyses.
Secretary means the Secretary of Agriculture or his delegate.
Shell egg packer means any person engaged in the sorting of shell eggs from sources other than or in addition to the person's own production into their various qualities, either mechanically or by other means.
Shipped for retail sale means eggs that are forwarded from the processing facility for distribution to the ultimate consumer.
Stabilization means the subjection of any egg product to a desugaring process.
State means any State of the United States, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and the District of Columbia.
Ultimate consumer means any household consumer, restaurant, institution, or any other party who has purchased or received shell eggs or egg products for consumption.
United States means the States.
Washed ungraded eggs means eggs which have been washed but not sized or segregated for quality.
White or albumen means, for the purpose of this part, the product obtained from the egg as broken from the shell and separated from the yolk.
The Administrator shall perform, for and under the supervision of the Secretary, such duties as the Secretary may require in the enforcement or administration of the provisions of the Act, and this part. The Administrator may waive for a limited period any particular provisions of the regulations to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements and at the same time to maintain full compliance with the spirit and intent of the regulations. The Food Safety and Inspection Service and its officers and employees will not be liable in damages through acts of commission or omission in the administration of this part.
The Secretary shall, whenever he determines that it would effectuate the purposes of the Act, authorize the Administrator to cooperate with appropriate State and other governmental agencies in carrying out any provisions of the Egg Products Inspection Act and these regulations. In carrying out the provisions of the Act and the regulations, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any such agency commissioned by him for such purpose. The Secretary shall reimburse the States and other agencies for the services rendered by them in such cooperative programs as agreed to in the cooperative agreements as signed by the Administrator and the duly authorized agent of the State or other agency.
(a) Purpose. This section collects and displays the control numbers assigned to information collection requirements by the Office of Management and Budget contained in 7 CFR 590 pursuant to the Paperwork Reduction Act of 1980, Pub. L. 96-511.
(b) Display.
| 7 CFR section where identified and described | Current OMB control number |
|---|---|
| § 590.10 | 0581-0113 |
| § 590.13 | 0581-0113 |
| § 590.22 | 0581-0113 |
| § 590.28(a)(1) | 0581-0113 |
| § 590.40 | 0581-0113 |
| § 590.45(c)(1) | 0581-0113 |
| § 590.45(c)(3) | 0581-0113 |
| § 590.45(d) | 0581-0113 |
| § 590.110(a) | 0581-0113 |
| § 590.112 | 0581-0113 |
| § 590.122 | 0581-0113 |
| § 590.124 | 0581-0113 |
| § 590.126 | 0581-0113 |
| § 590.128(a) | 0581-0113 |
| § 590.140 | 0581-0113 |
| § 590.144 | 0581-0113 |
| § 590.146(b) | 0581-0113 |
| § 590.146(d) | 0581-0113 |
| § 590.155 | 0581-0113 |
| § 590.160(c) | 0581-0113 |
| § 590.160(d) | 0581-0113 |
| § 590.160(f)(3) | 0581-0113 |
| § 590.160(f)(4) | 0581-0113 |
| § 590.200(a) | 0581-0113 |
| § 590.200(b) | 0581-0113 |
| § 590.220 | 0581-0113 |
| § 590.240 | 0581-0113 |
| § 590.320 | 0581-0113 |
| § 590.402(a) | 0581-0113 |
| § 590.411(a) | 0581-0113 |
| § 590.411(b) | 0581-0113 |
| § 590.411(e) | 0581-0113 |
| § 590.411(f) | 0581-0113 |
| § 590.418(c) | 0581-0113 |
| § 590.430(b) | 0581-0113 |
| § 590.435(b) | 0581-0113 |
| § 590.435(c) | 0581-0113 |
| § 590.440(c) | 0581-0113 |
| § 590.500(h) | 0581-0113 |
| § 590.504(c) | 0581-0113 |
| § 590.504(d) | 0581-0113 |
| § 590.504(h) | 0581-0113 |
| § 590.504(k) | 0581-0113 |
| § 590.504(o)(1) | 0581-0113 |
| § 590.504(o)(2) | 0581-0113 |
| § 590.504(o)(3)(i) | 0581-0113 |
| § 590.504(o)(3)(iii) | 0581-0113 |
| § 590.504(o)(3)(iv) | 0581-0113 |
| § 590.504(o)(3)(v) | 0581-0113 |
| § 590.515(a)(8) | 0581-0113 |
| § 590.520(h) | 0581-0113 |
| § 590.522(f) | 0581-0113 |
| § 590.522(x) | 0581-0113 |
| § 590.522(aa)(2) | 0581-0113 |
| § 590.530(d) | 0581-0113 |
| § 590.534(a) | 0581-0113 |
| § 590.544(b) | 0581-0113 |
| § 590.544(c) | 0581-0113 |
| § 590.544(d) | 0581-0113 |
| § 590.552(a)(3) | 0581-0113 |
| § 590.552(b)(1)(i) | 0581-0113 |
| § 590.552(b)(2) | 0581-0113 |
| § 590.570(c) | 0581-0113 |
| § 590.575(b)(3) | 0581-0113 |
| § 590.575(d) | 0581-0113 |
| § 590.580(c) | 0581-0113 |
| § 590.600 | 0581-0113 |
| § 590.610(a) | 0581-0113 |
| § 590.620 | 0581-0113 |
| § 590.640(b)(1) | 0581-0113 |
| § 590.680(a) | 0581-0113 |
| § 590.800 | 0581-0113 |
| § 590.840 | 0581-0113 |
| § 590.905(a) | 0581-0113 |
| § 590.915(a) | 0581-0113 |
| § 590.915(b) | 0581-0113 |
| § 590.920 | 0581-0113 |
| § 590.930(f) | 0581-0113 |
| § 590.950(a) | 0581-0113 |
| § 590.960 | 0581-0113 |
| § 590.965 | 0581-0113 |
Inspection of eggs and egg products shall be rendered pursuant to these regulations and under such conditions and in accordance with such methods as may be prescribed or approved by the Administrator.
No plant in which egg products processing operations are conducted shall process egg products without continuous inspection under these regulations, except as expressly exempted in § 590.100.
Eggs and egg products processed in an official plant shall be inspected, processed, marked, and labeled as required by these regulations. Egg products entering an official plant shall have been inspected, processed, marked, and labeled as required by these regulations.
Inspection program personnel will make periodic inspections of business premises, facilities, inventories, operations, transport vehicles, and records of egg handlers, and the records of all persons engaged in the business of transporting, shipping, or receiving any eggs or egg products.
(a) Requirements within the scope of the Act with respect to premises, facilities, and operations of any official plant which are in addition to or different than those made under this part may not be imposed by any State or local jurisdiction except that any such jurisdiction may impose recordkeeping and other requirements within the scope of § 590.200, if consistent therewith, with respect to any such plant.
(b) Labeling, packaging, or ingredient requirements in addition to or different than those made under this part, the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act may not be imposed by any State or local jurisdiction with respect to egg products processed at any official plant in accordance with the requirements under this part and such Acts.
Any State or local jurisdiction may exercise jurisdiction with respect to eggs and egg products for the purpose of preventing the distribution for human food purposes of any such articles which are outside of the official plant and are in violation of this part or any of said Federal Acts or any State or local law consistent therewith.
Periodic inspections will be made at any plant processing egg products which are not intended for use as human food of its operations and records to ensure compliance with the Act and the regulations in this part. Egg products not intended for use as human food shall be denatured or decharacterized prior to being offered for sale or transportation and identified as prescribed by the regulations in this part to prevent their use as human food.
(a) No person shall buy, sell, or transport or offer to buy or sell, or offer or receive for transportation in commerce, any eggs or egg products which are not intended for use as human food, unless they are denatured or decharacterized, unless shipped under seal as authorized in paragraphs (c) and (d) of this section or in §§ 590.504(c) and 590.720(a) and identified as required by the regulations in this part.
(b) No person shall import or export shell eggs classified as loss, inedible, or incubator rejects or any egg products which are unwholesome, adulterated, or are otherwise unfit for human food purposes, except as provided in paragraphs (c) and (d) of this section, unless they are denatured or decharacterized and identified as required by the regulations in this part.
(c) Egg products which are unwholesome, adulterated, or are otherwise unfit for human food purposes that are not denatured or decharacterized may be exported to foreign countries for industrial use or animal food under the following provisions:
(1) Authorized government official of the foreign country shall approve the importation of such products into that country.
(2) The egg products shall be shipped under U.S. Government seal and identified as required in § 590.840.
(3) Provisions for the control of such inedible product in the foreign country to preclude its use as human food must be established and approved by the Administrator. Such control may consist of, but not be limited to, receipt and inspection by an appropriate U.S. Government official, an official of an approved meat, poultry, or egg products inspection system of the foreign government, or, when acceptable to the Administrator, a foreign government official including other foreign health authorities.
(d) Foreign governments may petition the Administrator for approval to import into this country egg products which are unwholesome, adulterated, or otherwise unfit for human food purposes that are not denatured or decharacterized for industrial use or animal food requirements. Such products shall be subject to the provisions of this part and other applicable laws and regulations for importation into the United States.
(a) All shell eggs packed into containers destined for the ultimate consumer must be stored and transported under refrigeration at an ambient temperature of no greater than 45 °F (7.2 °C) and must bear safe handling instructions in accordance with 21 CFR 101.17(h).
(b) Any producer-packer with an annual egg production from a flock of 3,000 or fewer layers is exempt from the temperature and labeling requirements of this section. Such producer-packer is still required to comply with the labeling requirements in 21 CFR 101.17(h).
(a) [Reserved]
(b) The following are exempt, to the extent prescribed, from the inspection of egg products processing operations in section 5(a) of the Act (21 U.S.C. 1034(a)), provided the conditions for exemption and the provisions of these regulations are met:
(1) The processing and sale of egg products by any poultry producer from eggs of his own flock's production when sold directly to a household consumer exclusively for use by the consumer and members of the household and its nonpaying guests and employees.
(2) The processing in non-official plants, including but not limited to bakeries, restaurants, and other food processors, of certain categories of food products which contain eggs or egg products as an ingredient, as well as the sale and possession of such products. Such products must be manufactured from inspected egg products processed in accordance with the regulations in this part and 9 CFR part 591 or from eggs containing no more restricted eggs than are allowed in the official standards for U.S. Consumer Grade B shell eggs.
(a) Any person who is a Federal or State employee, or the employee of a local jurisdiction possessing proper qualifications as determined by an examination for competency and who is to perform services pursuant to this part, may be licensed by the Secretary as an inspector.
(b) Licenses issued by the Secretary are to be countersigned by the Administrator or by any other designated official of the Service.
(c) No person may be licensed to inspect any product in which he is financially interested.
Inspection program personnel will be furnished with a numbered official badge that will be carried in a proper manner at all times while on duty. This badge will be sufficient identification to entitle inspection program personnel entry at all regular entrances and to all parts of the official plant and premises to which inspection program personnel are assigned.
(a) Inspection program personnel will not inspect any product in which he or she has a financial interest; or that is produced by a plant at which the employee, the employee's spouse, minor child, partner, organization in which the employee is serving as officer, director, trustee, partner, or employee; or that is produced by any other person with whom inspection program personnel are negotiating or have any arrangements concerning prospective employment.
(b) All inspection program personnel are subject to statutory restrictions with respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
(c) Violation of the provisions of paragraph (a) of this section or the provisions of applicable statutes referenced in paragraph (b) of this section will constitute grounds for dismissal.
(d) Inspection program personnel are subject to all applicable provisions of law and regulations and instructions of the Department and the Food Safety and Inspection Service concerning employee responsibilities and conduct. The setting forth of certain prohibitions in this part in no way limits the applicability of such general or other regulations or instructions.
The inspector who is to perform the inspection in an official plant shall be given reasonable advance notice by plant management of the hours when such inspection will be required.
Operating schedules for an official plant shall be subject to approval of the Administrator. The normal operating schedule shall consist of a continuous 8-hour period per day and shall include the time for FSIS inspection program personnel to put on required gear and to walk to a work station, and the time for FSIS inspection program personnel to return from a work station and remove required gear (excluding not to exceed 1 hour for lunch), 5 consecutive days per week, within the administrative workweek, Sunday through Saturday, for each full shift required. Clock hours of daily operations need not be specified in a schedule, although as a condition of continuance of approval of a schedule, the hours of operation must be reasonably uniform from day to day.
When operations in an official plant require the services of inspection personnel beyond their regularly assigned tour of duty on any day or on a day outside the established schedule, such services are considered as overtime work. The official plant must give reasonable advance notice to the inspector of any overtime service necessary and must pay for such overtime. For each calendar year, FSIS will calculate the overtime rate for inspection service, per hour per program employee, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, multiplied by 1.5, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate. FSIS calculates the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt rate using the formulas set forth in § 592.510(b) and the cost of living increases and percentage of inflation factors set forth in § 592.510(c) of this chapter.
(a) When an official plant requires inspection service on a holiday or a day designated in lieu of a holiday, such service is considered holiday work. The official plant must, in advance of such holiday work, request the inspector in charge to furnish inspection service during such period and must pay the Agency for such holiday work at the hourly rate. For each calendar year, FSIS calculates the holiday rate for inspection service, per hour per program employee, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, multiplied by 2, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate. FSIS will calculate the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt rate using the formulas set forth in § 592.510(b), and the cost of living increases and percentage of inflation factors set forth in § 592.510(c) of this chapter.
(b) The term “holiday” shall mean the legal public holidays specified by the Congress in paragraph (a) of section 6103, title 5 of the United States Code. Information on legal holidays may be obtained from the supervisor.
Overtime and/or holiday services shall be billed to the official plant on the basis of each 15 minutes of overtime and/or holiday service performed by each inspector providing such service to the plant, except that when an official plant requires the services of an inspector after he has completed his day's assignment and left the plant or when he is called back to duty on a day outside the established normal operating schedule or on a holiday, the official plant shall pay for a minimum of 2 hours service at the applicable established rate. Extra travel expense incurred while rendering overtime or holiday service shall be billed to the official plant. Bills are payable upon receipt and become delinquent 30 days from date of billing. Overtime or holiday inspection service will not be performed at any plant that is delinquent, and processing operations shall be confined to the regular operating schedule of the plant. In addition, fees will be charged and collected for certifications requested by and provided for the official plant that are not within the scope of these regulations.
Access shall not be refused to any representative of the Secretary to any plant, place of business, or transport vehicle subject to inspection under the provisions of this part upon presentation of proper credentials.
(a) Each product for which inspection service is required shall be so placed as to disclose fully its class, quality, quantity, and condition as the circumstances may warrant.
(b) The perimeter of each cooler room used to store eggs must be made accessible in order for the Secretary's representatives to determine the ambient temperature under which shell eggs packed into containers destined for the ultimate consumer are stored.
(a) Inspection program personnel office. Office space, including, but not limited to, furnishings, light, heat, and janitor service, will be provided without cost in the official plant for the use of inspection program personnel for official purposes. The room or space set apart for this purpose must meet the approval of the Food Safety and Inspection Service and be conveniently located, properly ventilated, and provided with lockers or file cabinets suitable for the protection and storage of supplies and with accommodations suitable for inspection program personnel to change clothing. At the discretion of the Administrator, small official plants requiring the services of less than one full-time inspector need not furnish accommodations for inspection program personnel as prescribed in this section where adequate accommodations exist in a nearby convenient location.
(b) Accommodations and equipment. Such accommodations and equipment must include, but not be limited to, a room or area suitable for sampling product and a stationary or adequately secured storage box or cage (capable of being locked only by inspection program personnel) for holding official samples.
The proprietor or operator of each official plant and official import inspection establishment must make application to the Administrator for inspection service unless exempted by § 590.100. The application must be made in writing on forms furnished by the inspection service. In cases of change of name or ownership or change of location, a new application must be made.
An application for inspection service will be regarded as filed only when it has been:
(a) Filled in completely;
(b) Signed by the applicant; and
(c) Received in the appropriate District Office.
Proof of authority of any person applying for inspection service may be required at the discretion of the Administrator.
(a) Before inspection is granted, FSIS will survey the official plant to determine if the construction and facilities of the plant are in accordance with the regulations in this part. FSIS will grant inspection, subject to § 500.7 of this chapter, when these requirements are met and the requirements contained in § 590.149 are met.
(b) FSIS will give notice in writing to each applicant granted inspection and will specify in the notice the official plant, including the limits of the plant's premises, to which the grant pertains.
(a) Before receiving Federal inspection, a plant must have developed written sanitation Standard Operating Procedures, in accordance with part 416 and § 591.1(a) of this chapter.
(b) Before receiving Federal inspection, a plant must conduct a hazard analysis, and develop and implement a HACCP plan, in accordance with part 417 and § 591.1(a) of this chapter. A conditional grant of inspection may be provided for a period not to exceed 90 days, during which period the facility must validate its HACCP plan.
(c) Before producing new product for distribution in commerce, a plant must conduct a hazard analysis and develop a HACCP plan applicable to that product, in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the plant must validate its HACCP plan, in accordance with § 417.4 of this chapter.
An official plant number shall be assigned to each plant granted inspection service. Such plant number shall be used to identify all containers of inspected products prepared in the plant which are capable of use as human food. A plant shall not have more than one plant number.
Prior to the inauguration of service, the proprietor or operator of the plant shall be knowledgeable of the requirements of these regulations.
(a) Any applicant for inspection at a plant where the operations thereof may result in any discharge into the navigable waters in the United States is required by subsection 401(a)(1) (33 U.S.C. 1341) of the Clean Water Act as amended (86 Stat. 816, 91 Stat. 1566, 33 U.S.C. 1251 et seq.), to provide the Administrator with a certification, as prescribed in said subsection, that any such discharge will comply with the applicable provisions of sections 301, 302, 303, 306, and 307 of the Act (33 U.S.C. 1311, 1312, 1313, 1316, and 1317). No grant of inspection can be issued unless such certification has been obtained, or is waived, because failure of refusal of the State, interstate agency, or the Administrator of the Environmental Protection Agency to act on a request for certification within a reasonable period (which should not exceed 1 year after receipt of such a request). Further, upon receipt of an application for inspection and a certification as required by section 401(a)(1) of the Clean Water Act, the Administrator (as defined in § 590.5) is required by subparagraph (2) of said subsection to notify the Administrator of the Environmental Protection Agency for proceedings in accordance with that subsection. No grant of inspection can be made until the requirements of section 401(a)(1) and (2) have been met.
(b) Inspection may be suspended or revoked and plant approval terminated as provided in section 401(a)(4) and (5) of the Clean Water Act, as amended (33 U.S.C. 1341(a)(4) and (5)).
When inspection service is not performed at any plant for a period of at least 90 days, plant approval shall terminate upon notice by the Administrator without further proceedings; provided, however, that this section shall not apply to any plant where the Administrator determines that such a plant operates on a seasonal basis and the inspection service has not been used as a result of such seasonal operation, or where operations have ceased due to extraordinary circumstances determined by the Administrator as not warranting termination of plant approval.
(a) Persons engaged in the transporting, shipping, or receiving of any eggs or egg products in commerce, or holding such articles so received, and all egg handlers, except producer-packers with an annual egg production from a flock of 3,000 layers or fewer, must maintain records documenting, for a period of 2 years, the following, to the extent applicable:
(1) The date of lay, date and time of refrigeration, date of receipt, quantity and quality of eggs purchased or received, and from whom (including a complete address, unless a master list is maintained). Process records documenting that the temperature and labeling requirements in § 590.50(a) have been met must also be kept;
(2) The date of packaging, ambient air temperature surrounding product stored after processing, quantity and quality of eggs delivered or sold, and to whom (including a complete address, unless a master list is maintained);
(3) If a consecutive lot numbering system is not employed to identify individual eggs, containers of eggs, or egg products, record the alternative code system used, in accordance with § 590.411(c)(3);
(4) The date of disposal and quantity of restricted eggs, including inedible egg product or incubator reject product, sold or given away for animal food or other uses or otherwise disposed of, and to whom (including a complete address, unless a master list is maintained);
(5) The individual or composite (running tally) record of restricted egg sales to household consumers. Records should show number of dozens sold on a daily basis. The name and address of the consumer is not required;
(6) The date of production and quantity of egg products delivered or sold, and to whom (including a complete address, unless a master list is maintained);
(7) The date of receipt and quantity of egg products purchased or received, and from whom (including a complete address, unless a master list is maintained);
(8) The production records by categories of eggs such as graded eggs, nest-run eggs, dirties, checks, etc.; bills of sale, inventories, receipts, shipments, shippers, receivers, dates of shipment and receipt, carrier names, etc.
(b) All records required to be maintained by this section must be made available to an authorized representative of the Secretary for official review and copying.
(c) Records of all labeling, along with the product formulation and processing procedures as prescribed in §§ 590.410 through 590.412, must be kept by every person processing, except processors exempted under § 590.100.
When inspection service is performed at any plant, the plant operator shall furnish the inspector such information and assistance as may be required for the performance of inspection functions, preparing certificates, reports, and for other official duties.
Whenever any eggs or egg products subject to the Act are found by any authorized representative of the Secretary upon any premises, and there is reason to believe that they are or have been processed, bought, sold, possessed, used, transported, or offered or received for sale or transportation in violation of the Act or the regulations in this part, or that they are in any other way in violation of the Act, such articles may be detained by such representative for a period not to exceed 20 days, as more fully provided in section 19 of the Act. A detention tag or other similar device shall be used to identify detained product, and the custodian or owner shall be given a written notice of such detention. Only authorized representatives of the Secretary shall affix or remove detention identification. The provisions of this section shall in no way derogate from authority for condemnation or seizure conferred by other provisions of the Act, the regulations in this part, or other laws.
Any person receiving inspection service may, if dissatisfied with any decision or action of an inspector or other Agency employee relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.
Any appeal from the inspection decision by inspection program personnel must be made to the immediate supervisor having jurisdiction over the subject matter of the appeal in accordance with 9 CFR 500.9.
The request for an appeal inspection or review of inspection program personnel's decision may be made orally or in writing. If made orally, written confirmation may be required. The applicant must clearly identify the product involved, the decision being appealed, and the reasons for requesting the appeal.
When it appears to the official with whom an appeal request is filed that the reasons given in the request are frivolous or not substantial, or that the condition of the product has undergone a material change since the original inspection, or that the original lot has changed in some manner, or the Act or the regulations in this part have not been complied with, the applicant's request for the appeal inspection may be refused. In such case, the applicant shall be promptly notified of the reason(s) for such refusal.
An appeal inspection or review of inspection program personnel's decisions, as requested in § 590.310, must be performed by inspection program personnel of FSIS other than the one who made the initial decision.
A condition appeal sample will consist of product taken from the original sample containers plus an equal number of containers selected at random. A condition appeal cannot be made unless all originally sampled containers are available.
All certificates shall be issued on forms approved by the Administrator.
(a) Upon request of the applicant or the Service, any inspector is authorized to issue an egg products inspection certificate with respect to any lot of egg products inspected by him. In addition, an inspector is authorized to issue an inspection certificate covering product inspected in whole or in part by another inspector when the inspector has knowledge that the product is eligible for certification based on personal examination of the product or official inspection records.
(b) Each egg products inspection certificate shall show the name and address of the processor, the class and quantity of the egg products covered by such certificate, such shipping marks as are necessary to identify such products, all pertinent information concerning the wholesomeness thereof, and such other information as the Administrator may prescribe or approve.
Erasures or alterations shall be initialed by the issuing inspector on the original certificate and any copy thereof. All certificates made useless through clerical error or otherwise and all certificates canceled for whatever cause shall be voided and initialed and the original and all other copies shall be forwarded as prescribed by the Administrator.
The original and up to two copies of each official certificate shall be issued to the applicant or person designated by him. Other copies shall be filed and retained in accordance with the disposition schedule for inspection program records.
(a) Exporters must apply for export certification of inspected and passed products shipped to any foreign country. Exporters may apply for an export certificate using a paper or electronic application. FSIS will assess exporters that submit an electronic application the charge in § 592.500(d) of this chapter.
(b) FSIS will issue only one certificate for each consignment, except in the case of error in the certificate or loss of the certificate originally issued. A request for a replacement certificate, except in the case of a lost certificate, must be accompanied by the original certificate. The new certificate will carry the following statement: “Issued in replacement of ______”, with the numbers of the certificates that have been superseded.
(c) FSIS will deliver a copy of the export certificate to the person who requested such certificate or his agent. Such persons may duplicate the certificate as required in connection with the exportation of the product.
(d) FSIS will retain a copy of the certificate.
(e)(1) When authorized by inspection personnel, establishments must mark the outside container of any inspected and passed egg products destined for export, the securely enclosed pallet within the consignment, or closed means of conveyance transporting the consignment, with a mark that contains a unique identifier that links the consignment to the export certificate or an official mark with the following form:
(2) Ship stores, small quantities exclusively for the personal use of the consignee and not for sale or distribution, and shipments by and for the U.S. Armed Forces, are exempt from the requirements of this section.
(f) Exporters may request inspection personnel to issue certificates for export consignments of product of official establishments not under their supervision, provided the consignments are first identified as having been “U.S. inspected and passed,” are found to be neither adulterated nor misbranded, and are marked as required by paragraph (e) of this section.
(a)(1) Packaged egg products that require special handling to maintain their wholesome condition must have the statement “Keep Refrigerated,” “Keep Frozen,” “Perishable Keep Under Refrigeration,” or such similar statement prominently displayed on the principal display panel.
(2) Egg products that are distributed frozen and thawed prior to or during display for sale at retail must bear the statement “Keep Frozen” on the shipping container. Consumer-sized containers for such egg products must bear the statement “Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated.”
(3) The labels of packages of egg products produced from shell eggs that have been treated with ionizing radiation must reflect that treatment in the ingredient statement on the finished product labeling.
(b) Containers, portable tanks, and bulk shipments of edible egg products produced in official plants must be labeled in accordance with §§ 590.411 through 590.415 and must bear the official identification shown in Figure 1 of § 590.413.
(c) Bulk shipments of unpasteurized egg products and microbial pathogen-positive egg products produced in official plants must bear a label containing the words “date of loading,” followed by a suitable space in which the date the container, tanker truck, or portable tank is loaded must be inserted. The label must be conspicuously located and printed and affixed on material that cannot be detached or effaced due to exposure to weather. Before the truck or tank is removed from the place where it is unloaded, the carrier must remove or obliterate the label. Such shipments must also bear the official identification shown in Figure 2 of § 590.415.
(a) All official plants, including official plants certified under a foreign inspection system in accordance with § 590.910, must comply with the requirements contained in § 412.1 of this chapter, except as otherwise provided in this part.
(b) For the purposes of § 412.1 of this chapter, an official establishment or establishment certified under a foreign inspection system includes an official plant.
(c) Labels, containers, or packaging materials of egg products must show the following information, as applicable, on the principal display panel (except as otherwise permitted in this part), in accordance with the requirements of this part, or if applicable, 21 CFR 101.17(h):
(1) A statement showing by the common or usual names, if any, of the kinds of ingredients comprising the product. Formulas are to be expressed in terms of a liquid product except for product that is dry-blended. Also, for product to be dried, the label may show the ingredients in order of descending proportions by weight in the dried form. However, the formula submitted must include the percentage of ingredients in both liquid and dried form. If the product is comprised of two or more ingredients, such ingredients must be listed in the order of descending proportions by weight in the form in which the product is to be marketed (sold), except that ingredients in dried product (other than dry blended) may be listed in either liquid or dried form. When water (excluding that used to reconstitute dehydrated ingredients back to their normal composition) is added to a liquid or frozen egg product or to an ingredient of such products (in excess of the normal water content of that ingredient), the total amount of water added, including the water content of any cellulose or vegetable gums used, must be expressed as a percentage of the total product weight in the ingredient statement on the label;
(2) The name, address and zip code of the distributor; qualified by such terms as “distributed by,” or “distributors”;
(3) The lot number or an alternative code indicating the date of production, in accordance with § 590.200(a);
(4) The net contents;
(5) An official inspection symbol and the number of the official plant in which the product was processed under inspection as set forth in § 590.413;
(6) Egg products processed from edible eggs of turkeys, ducks, geese, or guineas must be clearly and distinctly labeled with the common or usual name of the product and indicating the type of eggs or egg products used in the product, e.g., “Frozen whole turkey eggs,” “Frozen whole chicken and turkey eggs.” Egg products labeled without qualifying words as to the type of egg used in the product must be produced only from the edible egg of the domesticated chicken.
(7) Egg products which are produced in an official plant from edible shell eggs of other than current production or from other egg products of shell eggs of other than current product must be clearly and distinctly labeled in close proximity to the common or usual name of the product, e.g., Manufactured from eggs of other than current production.”
(d) Liquid or frozen egg products identified as whole eggs and processed in other than natural proportions as broken from the shell must have a total egg solids content of 24.20 percent or greater.
(e) Nutrition information may be included on labels used to identify egg products, providing such labeling complies with the provisions of 21 CFR part 101, promulgated under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Since these regulations have different requirements for consumer-packaged products than for bulk packaged egg products not for sale or distribution to household consumers, label submission must be accompanied with information indicating whether the label covers consumer packaged or bulk packaged products. Nutrition labeling is required when nutrients, such as proteins, vitamins, and minerals are added to the product, or when a nutritional claim or information is presented on the labeling, except for the following, which are exempt from nutrition labeling requirements:
(1) Egg products shipped in bulk form for use solely in the manufacture of other food and not for distribution to household consumers in such bulk form or containers.
(2) Products containing an added vitamin, mineral, or protein, or for which a nutritional claim is made on the label, or in advertising, which is supplied for institutional food use only, provided that the manufacturer or distributor provides the required nutrition information directly to those institutions.
(3) Any nutrients included in the product solely for technological purposes may be declared solely in the ingredients statement, without complying with nutrition labeling, if the nutrient(s) is otherwise not referred to in labeling or in advertising. All labels showing nutrition information or claims are subject to review by the Food and Drug Administration prior to approval by the Department.
(f)(1) No label, container, or packaging material may contain any statement that is false or misleading. If the Administrator has reason to believe that a statement or formulation shows that an egg product is adulterated or misbranded, or that any labeling, including the size or form of any container in use or proposed for use, with respect to eggs or egg products, is false or misleading in any way, the Administrator may direct that such use be withdrawn unless the labeling or container is modified in such a manner as the Administrator may prescribe so that it will not be false or misleading, or the formulation of the product is altered in such a manner as the Administrator may prescribe so that it is not adulterated or would not cause misbranding.
(2) If the Administrator directs that the use of any label, container, or packaging material be withdrawn because it contains any statement that is false or misleading, an opportunity for a hearing will be provided in accordance with § 500.8(c) of this chapter.
(a) All official plants, including official plants certified under a foreign inspection system in accordance with § 590.910, may comply with the requirements in § 412.2 of this chapter.
(b) For the purposes of § 412.2 of this chapter, an official establishment or establishment certified under a foreign inspection system includes an official plant.
The shield set forth in Figure 1 of this section containing the letters “USDA” must be the official identification symbol used in connection with egg products to denote that the official plant receives official inspection service. The inspection mark used on containers of edible egg products is set forth in Figure 1 of this section, except that the plant number may be preceded by the letter “G” in lieu of the word plant. The plant number may also be omitted from the official mark if applied on the container's principal display panel or other prominent location and preceded by the letter “G.”
Egg products which are permitted to bear the inspection mark shall be processed in an official plant from edible shell eggs or other edible egg products and may contain other edible ingredients. The official mark shall be printed or lithographed and applied as a part of the principal display panel of the container but shall not be applied to a detachable cover.
All unpasteurized or microbial pathogen-positive egg products shipped from an official plant must be marked with the identification set forth in Figure 1 of this section. Such product must meet all requirements for egg products that are permitted to bear the official inspection mark shown in § 590.413, except for pasteurization, heat treatment, or other method of treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety. Such product must not be released into consumer channels until it has been subjected to pasteurization, heat treatment, or other method of treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety. After pasteurization or treatment, the product may bear the official inspection mark as shown in § 590.413.
(a) Containers or labels which bear official identification approved for use pursuant to § 590.411 shall be used only for the purpose for which approved. Any unauthorized use or disposition of approved containers or labels which bear any official identification may result in cancellation of the approval and denial of the use of containers or labels bearing official identification and may subject such violator to the penalties and denial of the benefits of the Act;
(b) The use of simulations or imitations of any official identification by any person is prohibited;
(c) Upon termination of inspection service in an official plant pursuant to these regulations, all labels or packaging materials indicating product packed by the plant which bear official identification shall either be destroyed under the supervision of the Service or, if used in another location, modified in a manner acceptable to the Service before use.
Affixing of official identification. No official identification shall be, or caused to be affixed to or placed on any product or container except by an inspector or under the supervision of an inspector or other person authorized by the Administrator. All such products shall have been inspected in accordance with these regulations. The inspector shall have supervision over the use and handling of all material bearing any official identification.
The reuse, by any person, of containers bearing official identification is prohibited unless such identification is applicable in all respects to product being packed therein. In such instances, the container and label may be used provided the packaging is accomplished under the supervision of an inspector and the container is in compliance with § 590.504(k).
(a) Inspection shall be made, pursuant to the regulations in this part, of the processing of egg products in each official plant processing egg products for commerce, unless exempted under § 590.100. Inspections, certifications, or specification-type gradings, and other inspections which may be requested by the official plant and are in addition to the normal inspection requirements and functions for the processing, production, or certification for a wholesome egg product under this part, shall be made pursuant to the voluntary egg products inspection regulations (part 592 of this chapter).
(b) Any food manufacturing establishment or institution which uses any eggs that do not meet the requirements of 21 U.S.C. 1044(a)(1) in the preparation of any articles for human food shall be deemed to be a plant processing egg products requiring inspection under the regulations in this part.
(c) Any product which is prepared under inspection in an official plant shall be inspected in such plant as often as the inspector deems necessary in order to ascertain if the product is unadulterated, wholesome, properly labeled, and fit for human food at the time it leaves the plant. Upon any such inspection, if any product or portion thereof is found to be adulterated, unwholesome, or otherwise unfit for human food, such product or portion thereof shall be condemned and shall receive such treatment as provided in § 590.422.
Eggs and egg products found to be adulterated at official plants shall be condemned and, if no appeal be taken from such determination of condemnation, such articles shall be destroyed for human food purposes under the supervision of an inspector: Provided, That articles which may by reprocessing be made not adulterated need not be condemned and destroyed if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated. If an appeal is requested, the eggs or egg products shall be appropriately marked and segregated pending completion of an appeal inspection.
(a) No egg product may be brought into an official plant except as provided in § 590.430(b) unless it has been prepared and handled in accordance with these regulations, and the container of such product is marked so as to identify the article as so inspected in accordance with this part.
(b) All egg products brought into any official plant shall be identified by the operator of the official plant at the time of receipt at the official plant and shall be subject to reinspection by inspection program personnel at the official plant in such manner and at such times as may be deemed necessary to ensure compliance with the regulations in this part. Upon reinspection, if any such product or portion of it is found to be unsound, unwholesome, adulterated, or otherwise unfit for human food, such product or portion shall be condemned and shall receive such treatment as provided in § 590.422, and shall, in the case of other products, be disposed of according to applicable law.
Retention tags or other devices and methods as may be approved by the Administrator shall be used for the identification and control of products which are not in compliance with the regulations or are held for further examination, and any equipment, utensils, rooms or compartments which are found to be unclean or otherwise in violation of the regulations. No product, equipment, utensil, room, or compartment shall be released for use until it has been made acceptable. Such identification shall not be removed by anyone other than an inspector.
(a) The Administrator shall limit the entry of eggs and egg products and other materials into official plants under such conditions as he may prescribe to assure that allowing the entry of such articles will be consistent with the purposes of the Act and these regulations.
(b) Inedible egg products may be brought into an official plant for storage, processing, and reshipment provided they are handled in such a manner that adequate segregation and inventory controls are maintained at all times. The processing of inedible egg products must be done under conditions that will not affect the processing of edible products, such as processing in separate areas or at times when no edible products are being processed. If the same equipment or areas are used to process both inedible and edible eggs, then the equipment and processing areas used to process inedible eggs must be thoroughly cleaned and sanitized prior to processing any edible egg products.
(a)(1) No substance which is a “food additive” as defined under 21 U.S.C. 321(s), including sources of radiation, may be used in the processing of egg products unless this use is authorized under the Federal Food, Drug, and Cosmetic Act.
(2) No substance which is intended to impart color in any egg product may be used unless such use is authorized under the Federal Food, Drug, and Cosmetic Act.
(3) Substances and ingredients used in the processing of egg products capable of use as human food must be clean, wholesome, and unadulterated.
(b) Substances permitted for use in egg products in subsection(a) will be permitted for such use under this chapter, subject to declaration requirements in § 424.22(c) of this chapter and § 590.411, unless precluded from such use or further restricted in this chapter. Such substances must be safe and effective under conditions of use and not result in the adulteration of product. The Administrator may require, in addition to listing the ingredients, a declaration of the additive and the purpose of its use.
(c) Substances to be used in the processing of egg products must be safe under the conditions of their intended use and in amounts sufficient to accomplish their intended purpose. Such substances may not promote deception or cause the product to be otherwise adulterated or unwholesome. Scientific data showing the additive meets the above specified criteria must be maintained and made available to FSIS inspection program personnel.
(a) Ova from slaughtered poultry may be brought into the official plant for processing: Provided, That the ova is from wholesome poultry inspected in a plant operating under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and such product is harvested in a sanitary manner, properly handled, cooled, packaged and labeled: And provided further, That such product is wholesome and the containers of such product bear official identification which assures the provisions of this paragraph have been met.
(b) The ova and products containing ova shall be processed, cooled, and pasteurized in the official plant in the same manner as liquid, frozen, or dried yolk products.
(c) All products containing ova must be labeled in accordance with § 590.411.
(a) Operations involving the processing, storing, and handling of eggs, ingredients, and egg products must be done in a sanitary manner.
(b)(1) Eggs and egg products are subject to inspection in each official plant processing egg products for commerce.
(2) Any eggs and egg products not processed in accordance with the regulations in this part or part 591 or that are not otherwise fit for human food must be removed and segregated.
(c)(1) All loss and inedible eggs or inedible egg products must be placed in a container clearly labeled “inedible” and containing a sufficient amount of denaturant or decharacterant, such as an FDA-approved color additive, suspended in the product. Eggs must be crushed and the substance dispersed through the product in amounts sufficient to give the product a distinctive appearance or odor. Inedible product may be held in containers clearly labeled “inedible” which do not contain a denaturant as long as such inedible product is properly packaged, labeled and segregated, and inventory controls are maintained. Such inedible product must be denatured or decharacterized before being shipped from a facility.
(2) Undenatured egg products or inedible egg products that are not decharacterized may be shipped from an official plant for industrial use or animal food, provided that it is properly packaged, labeled, and segregated, and inventory controls are maintained.
(d)(1) Egg products must be processed to meet the standard set out in § 590.570.
(2) Unpasteurized or microbial pathogen-positive egg products may be shipped from an official plant to another official plant only when they are to be pasteurized, heat treated, or treated using other methods of treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety in the second official plant. Official plants must maintain control of shipments of unpasteurized or microbial pathogen-positive egg products shipped from one official plant to another official plant for pasteurization or treatment. Shipping plants must seal such shipments in cars or trucks and label them in accordance with § 590.410(c). Containers of unpasteurized or microbial pathogen-positive egg product must be marked with the identification mark shown in Figure 2 of § 590.415.
(e) Inspection program personnel may allow an official plant to move egg products that have been sampled and analyzed for Salmonella, or for any other reason, before receiving the test results, if they do not suspect noncompliance by the plant with any provisions of this part. The official plant must maintain control of the products represented by the sample pending the results.
Eggs must be handled in a manner that minimizes sweating prior to breaking or processing.
(a) The eggs must be sorted and classified into the following categories:
(1) Eggs listed in paragraph (d) of this section.
(2) Dirty.
(3) Leakers as described in paragraph (c)(2) of this section.
(4) Eggs from other than chicken; duck, turkey, guinea, and goose eggs.
(5) Other eggs—satisfactory for use as breaking stock.
(b) Shell eggs having strong odors or eggs received in cases having strong odors shall be candled and broken separately to determine their acceptability.
(c) Shell eggs, when presented for breaking, shall be of edible interior quality and the shell shall be sound and free of adhering dirt and foreign material, except that:
(1) When presented for breaking, eggs must have an edible interior quality and the shell must be sound and free of adhering dirt and foreign material. However, checks and eggs with a portion of the shell missing may be used when the shell is free of adhering dirt and foreign material and the shell membranes are not ruptured.
(2) Eggs with clean shells which are damaged in candling and/or transfer and have a portion of the shell and shell membranes missing may be used only when the yolk is unbroken and the contents of the egg are not exuding over the outside shell. Such eggs shall be placed in leaker trays and be broken promptly.
(3) Eggs with meat or blood spots may be used if the spots are removed.
(d) All loss or inedible eggs must be placed in a designated container and handled as required in § 590.504(c). Eggs extensively damaged during breaking, whether not completely cracked open mechanically or in the movement of trays of eligible eggs for hand breaking, must be broken promptly. For the purpose of this section and § 590.522, inedible and loss eggs include crusted yolks, filthy and decomposed eggs, and the following:
(1) Any egg with visible foreign matter other than removable blood and meat spots in the egg meat.
(2) Any egg with a portion of the shell and shell membranes missing and with egg meat adhering to or in contact with the outside of the shell.
(3) Any egg with dirt or foreign material adhering to the shell and with cracks in the shell and shell membranes.
(4) Liquid egg recovered from shell egg containers and leaker trays.
(5) Open leakers made in the washing operation.
(6) Any egg which shows evidence that the contents are or have been exuding prior to transfer from the case.
(e) Incubator reject eggs shall not be brought into the official plant.
(a) All eggs, except as provided in § 590.801, must be clean prior to packaging, breaking, or pasteurizing. If a sanitizer is used, it must be used in accordance with FDA requirements for the intended use.
(b) Shell eggs shall be sufficiently dry at time of breaking to prevent contamination or adulteration of the liquid egg product from free moisture on the shell.
Each egg used in processed egg products must be broken in a sanitary manner and examined to ensure that the contents are acceptable for human consumption.
Freezing rooms, either on or off the premises, must be capable of solidly freezing, or reducing to a temperature of 10 °F or lower, all liquid egg products.
Pasteurized egg products must be produced to be edible without additional preparation to achieve food safety and may receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. Pasteurized egg products are not required to bear a safe-handling instruction or other labeling that directs that the product must be cooked or otherwise treated for safety.
(a) Official plants must test to determine that the production of egg products is in compliance with the Act and the egg products inspection regulations.
(b) To ensure adequate pasteurization:
(1) Pasteurized liquid, frozen, and dried egg products, and heat treated dried egg whites must be sampled and analyzed for the presence of Salmonella spp. Such testing by the official plant must be performed in a manner sufficient such that it is possible for the official plant to verify that the system is capable of eliminating Salmonella spp. at the time that the annual reassessment occurs, and as regularly as necessary between annual reassessments, to show that the system, when tested, is working.
(2) Samples must be analyzed for the presence of Salmonella spp. with such frequency and using such laboratory methods as is sufficient to ensure that product is not adulterated. For each category of product, sampling should be conducted on a rotating basis.
(3) Samples must be drawn from the final packaged form.
(c) Results of all partial and completed analyses performed under paragraph (b) of this section must be provided to inspection program personnel promptly upon receipt by the official plant. Positive test results must be provided to inspection program personnel immediately upon receipt by the official plant.
Irradiated shell eggs used to produce pasteurized egg products must be used in conjunction with heat or another lethality treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety. Unless otherwise approved by FDA, the irradiation treatment of the shell eggs must precede the heat or other lethality treatment applied to the egg products.
(a) No person may buy, sell, or transport, or offer to buy or sell, or offer or receive for transportation in any business in commerce any restricted eggs capable of use as human food, except as authorized in §§ 590.100 or 590.720.
(b) No egg handler may possess with the intent to use, or use, any restricted eggs in the preparation of human food, except as provided in §§ 590.100 or 590.720.
(a) Except as exempted in § 590.100, eggs classified as checks, dirts, incubator rejects, inedibles, leakers, or loss must be disposed of by one of the following methods at the point and time of segregation:
(1) Checks and dirts must be labeled in accordance with § 590.800 and shipped to an official plant for segregation and processing. Inedible and loss eggs must not be intermingled in the same container with checks and dirts.
(2) By destruction in a manner that clearly identifies the products as being inedible and not for human consumption, such as crushing and denaturing or decharacterizing in accordance with § 590.504(c)(1). The products must also be identified as “Inedible Egg Product-Not To Be Used As Human Food.”
(3) Processing for industrial use or for animal food. Such products must be handled in accordance with § 590.504(c) and identified as provided in §§ 590.840 and 590.860, or properly handled in a manner that clearly identifies the products as being inedible and not for human consumption and does not adulterate egg product intended for human consumption.
(4) By coloring the shells of loss and inedible eggs with a sufficient amount of an FDA-approved color additive to give a distinct appearance or applying a substance that will penetrate the shell and decharacterize the contents of the egg. However, lots of eggs containing significant percentages of eggs having small to medium blood spots or meat spots, but no other types of loss or inedible eggs, may be shipped directly to official plants, provided they are conspicuously labeled with the name and address of the shipper and the wording “Spots—For Processing Only In Official Egg Products Plants.”
(5) Incubator rejects must be broken or crushed and denatured or decharacterized in accordance with § 590.504(c)(1) and labeled as required in §§ 590.840 and 590.860.
(b) Eggs that are packed for the ultimate consumer and have been found to exceed the tolerance for restricted eggs permitted in the official standards for U.S. Consumer Grade B but have not been shipped for retail sale must be identified as required in §§ 590.800 and 590.860 and must be shipped directly or indirectly:
(1) To an official plant for proper segregation and processing; or
(2) Be re-graded so that they comply with the official standards; or
(3) Used as other than human food.
(c) Records must be maintained as provided in § 590.200 to ensure proper disposition.
The shipping container of restricted eggs shall be determined to be satisfactorily identified if such container bears the packer's name and address, the quality of the eggs in the container (e.g., dirties, checks, inedibles, or loss), or the statement “Restricted Eggs—For Processing Only In An Official USDA Egg Products Plant,” for checks or dirties, or “Restricted Eggs—Not To Be Used As Human Food,” for inedibles, loss, and incubator rejects, or “Restricted Eggs—To Be Regraded” for graded eggs which contain more restricted eggs than are allowed in the official standards for U.S. Consumer Grade B shell eggs. The size of the letters of the identification wording shall be as required in § 590.860.
Nest-run or washed ungraded eggs are exempt from the labeling provisions in § 590.800. However, when such eggs are sold to consumers, they may not exceed the tolerance for restricted eggs for U.S. Consumer Grade B shell eggs.
All inedible, unwholesome, or adulterated egg products shall be identified with the name and address of the processor, the words “Inedible Egg Products—Not To Be Used as Human Food.”
The letters of the identification wording shall be legible and conspicuous.
(a) When used in this subpart, the following terms will be construed to mean:
(1) Import (Imported). To bring within the territorial limits of the United States, whether that arrival is accomplished by land, air, or water.
(2) Offer(ed) for entry. The point at which the importer presents the imported product for reinspection.
(3) Entry (entered) means the point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 590.940.
(4) Official Import Inspection Establishment. This term means any establishment, other than an official establishment as defined in § 301.2 of this chapter, where inspections are authorized to be conducted as prescribed in § 590.925.
(b) No egg products may be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, unadulterated, or unfit for human food. Such products must also comply with the regulations prescribed in this subpart to ensure that they adhere to the standards provided for in the Act. The provisions of this subpart will apply to these products only if they are capable for use as human food.
(c) Approval for Federal import inspection must be in accordance with §§ 590.140 through 590.149.
(d) Egg products may be imported only if they are processed solely in the countries listed in § 590.910(b).
(a) All egg products, after entry into the United States in compliance with this subpart, will be deemed and treated and, except as provided in §§ 590.935 and 590.960, will be handled and transported as domestic product, and will be subject to the applicable provisions of this part and to the provisions of the Egg Products Inspection Act and the Federal Food, Drug, and Cosmetic Act.
(b) Imported egg products entered in accordance with this subpart may, subject to the provisions of the regulations, be taken into official plants and be mixed with or added to egg products that are inspected and passed or exempted from inspection in such plants.
(c) Imported egg products that have been inspected and passed under this subpart may be transported in commerce only upon compliance with the applicable regulations.
(a) No containers of restricted eggs other than checks or dirties will be imported into the United States. The shipping containers of such eggs shall be identified with the name, address, and country of origin of the exporter, and the date of pack and the quality of the eggs (e.g., checks or dirties) preceded by the word “Imported” or the statement “Imported Restricted Eggs—For Processing Only In An Official USDA Plant,” or “Restricted Eggs—Not To Be Used As Human Food.” Such identification shall be legible and conspicuous.
(b) For properly sealed and certified shipments of shell eggs for breaking at an official egg products plant, the containers need not be labeled, provided that the shipment is segregated and controlled upon arrival at the destination breaking plant.
(a) Whenever it is determined by the Administrator that the system of egg products inspection maintained by any foreign country is such that the egg products produced in such country are processed, labeled, and packaged in accordance with, and otherwise comply with, the standards of the Act and these regulations including, but not limited to the same sanitary, processing, facility requirements, and Government inspection as required in §§ 590.500 through 590.580 applicable to inspected articles produced within the United States, notice of that fact will be given according to paragraph (b) of this section. Thereafter, egg products from such countries shall be eligible for importation into the United States subject to the provisions of this part and other applicable laws and regulations. Such product must meet, to the extent applicable, the same standards and requirements that apply to comparable domestic product as set forth in these regulations. Egg products from foreign countries not deemed eligible in accordance with paragraph (b) of this section are not eligible for importation into the United States, except as provided by § 590.960. In determining if the inspection system of a foreign country is the equivalent of the system maintained in the United States, the Administrator shall review the inspection regulations of the foreign country and make a survey to determine the manner in which the inspection systems are administered within the foreign country. After approval of the inspection system of a foreign country, the Administrator may, as often and to the extent deemed necessary, authorize representatives of the Department to review the system to determine that it is maintained in such a manner as to be the equivalent of the system maintained by the United States.
(b) A list of countries eligible to export egg products to the United States is maintained at http://www.fsis.usda.gov/importlibrary.
(a) Except as provided in §§ 590.960 and 590.965, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.
(b) An official of the foreign government agency must certify that any product described on any official certificate was produced in accordance with the regulatory requirements of § 590.910.
(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment and be available to inspection program personnel.
(d) The paper foreign inspection certificate must accompany each consignment; be submitted to inspection program personnel at the official import inspection establishment; be in English; and bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue the inspection certificates for products imported into the United States.
(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign establishment number;
(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;
(4) The product's description including the process category, the product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or identification mark on the units;
(8) The net weight of each lot; and
(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.
(a) Applicants must submit an import inspection application to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 590.960 and 590.965.
(a)(1) Except as provided in §§ 590.960 and 590.965 and paragraph (b) of this section, egg products offered for entry from any foreign country must be reinspected at an official import inspection establishment or official plant by inspection program personnel before they may be allowed entry into the United States.
(2) Every lot of product must routinely be given visual reinspection by inspection program personnel for appearance and condition and be checked for certification and label compliance as provided in §§ 590.915, 590.950, and 590.955.
(3) Inspection program personnel must consult the electronic inspection system for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.
(b) Inspection program personnel may take, without cost to the United States, from each consignment of egg product offered for entry, such samples of the products as are deemed necessary to determine the eligibility of the products for entry into commerce of the United States.
(a) No egg products required by this subpart to be inspected will be released from customs custody prior to required inspections, but such product may be delivered to the importer, or his agent, prior to inspection, if the importer furnishes a bond, in a form prescribed by the Secretary of the Treasury, on the condition that the product must be returned, if demanded, to the collector of the port where the product was offered for clearance through customs.
(b) Notwithstanding paragraph (a) of this section, no product required by this subpart to be inspected will be moved prior to inspection from the port of arrival where first unloaded, and if arriving by water from the wharf where first unloaded at such port, to any place other than the place designated in accordance with this part as the place where the product must be inspected; and no product will be conveyed in any manner other than in compliance with this subpart.
(c) The importer, or his agent, must furnish such equipment and must provide such assistance for handling and inspecting, where applicable, egg products offered for entry as the program inspector may require.
(d) Official import inspection establishments must provide buildings and equipment that meet the sanitation requirements contained in part 416 of this chapter.
(a) Compartments of means of conveyance transporting any egg products to the United States, and all chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any egg products offered for entry into the United States, must be maintained in accordance with part 416.4 of this chapter.
(b) All conveyances containing imported liquid egg products must be sealed by inspection authorities in the exporting country. Seals may be broken at U.S. port-of-entry for purposes of inspection by program inspectors or customs officers.
(a) Except for products offered for entry from Canada, egg products that upon reinspection are found to be acceptable for entry into the United States must be identified as “U.S. Inspected and Passed” product. The official inspection legend shown in paragraph (b) of this section will identify product only after completion of official import inspection and product acceptance.
(b) The official mark for identifying egg products offered for entry as “U.S. Inspected and Passed” must be in the following form, and any device approved by the Administrator for applying such mark must be an official device.
(c) Owners or operators of plants, other than official plants, who want to have import inspections made at their plants, must apply to the Administrator for approval of their establishments for such purpose. Application must be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and must include all information called for by that form.
(d) No brand manufacturer or other person will cast or otherwise make, without an official certificate issued by inspection program personnel, a brand or other marking device containing an official inspection legend, or simulation thereof, as shown in § 590.940(b).
(e) The inspection legend may be placed on containers of product before completion of the official import inspection if the containers are being inspected by inspection program personnel who report directly to a program supervisor, the product is not required to be held at the official import inspection establishment pending receipt of laboratory test results, and a written procedure for the controlled stamping, submitted by the official import inspection establishment and approved by the Food Safety and Inspection Service, is on file at the import inspection location where the inspection is to be performed.
(f)(1) The written procedure for the controlled release and identification of product should be in the form of a letter and must include the following:
(i) That stamping under this subpart is limited to those lots of product that can be inspected on the day that certificates for the product are examined;
(ii) That all products that have been pre-stamped will be stored in the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and
(iv) That the establishment will maintain a daily stamping log containing the following information for each lot of product: The date of inspection, the country of origin, the foreign establishment number, the product name, the number of units, the shipping container marks and foreign inspection certificate number covering the product to be inspected. The daily log must be retained by the establishment in accordance with § 590.200.
(2) An establishment's controlled program privilege may be cancelled orally or in writing by the inspector who is supervising its enforcement whenever the inspector finds that the establishment has failed to comply with the provisions of this subpart or any conditions imposed pursuant thereto. If the cancellation is oral, the decision and the reasons for it must be confirmed in writing, as promptly as circumstances allow. Any person whose controlled pre-stamping program privilege has been cancelled may appeal the decision to the Administrator, in writing, within ten (10) days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the controlled program was wrongfully cancelled. The Administrator will grant or deny the appeal, in writing, stating the reasons for such decision, as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing must be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administrator. The cancellation of the controlled pre-stamping privilege will be in effect until there is a final determination of the preceding.
(a)(1) Inspection program personnel must report their findings as to any product that has been inspected in accordance with this subpart to the Director of Customs at the original port of entry where the same is offered for clearance through Customs inspection.
(2) When product is refused entry into the United States, the official mark to be applied to the product refused entry must be in the following form:
(3) When product has been identified as “U.S. Refused Entry,” inspection program personnel must request the Director of Customs to refuse admission of such product and to direct that it be exported by the owner or importer within the time specified in this section, unless the owner or importer, within the specified time, causes it to be destroyed by disposing of it under the supervision of program inspectors so that the product can no longer be used as human food, or by converting it to animal food uses, if permitted by the Food and Drug Administration. The owner or importer of the refused entry product must not transfer legal title to such product, except to a foreign importer for direct and immediate exportation, or to an end user, e.g., an animal food manufacturer or a renderer, for destruction for human food purposes. “Refused entry” product must be delivered to and used by the manufacturer or renderer within the 45-day time limit provided in paragraph (a)(4) of this section. Even if such title is illegally transferred, the subsequent purchaser will still be required to export the product or have it destroyed under paragraph (a)(4) of this section.
(4) The owner or importer will have 45 days after notice is given by FSIS to the Director of Customs at the original port of entry to take the action required in paragraph (a)(3) of this section for “refused entry” product. An extension beyond the 45-day period may be granted by the Administrator when extreme circumstances warrant it, e.g., a dock workers' strike or an unforeseeable vessel delay.
(5) If the owner or importer fails to take the required action within the time specified under paragraph (a)(4) of this section, the Department will take such actions as may be necessary to effectuate its order to have the product destroyed for human food purposes. The Department will seek court costs and fees, storage, and proper expenses in the appropriate forum.
(6) No egg product that has been refused entry and exported to another country pursuant to paragraph (a)(3) of this section may be returned to the United States under any circumstances. Any such product so returned to the United States will be subject to administrative detention in accordance with section 1048 of the Act and seizure and condemnation in accordance with section 1049 of the Act.
(7) Egg products that have been refused entry solely because of misbranding may be brought into compliance with the requirements of this chapter under the supervision of an authorized representative of the Administrator.
(b) Upon the request of the Director of Customs at the port where an egg product is offered for clearance through the customs, the importer of the product must, at the importer's own expense, immediately return to the Director any product that has been delivered to the importer under this subpart and subsequently designated “U.S. Refused Entry” or found in any request not to comply with the requirements in this part.
(c) Except as provided in § 590.930(a) or (b), no person will remove or cause to be removed from any place designated as the place of inspection of egg products that the regulations in this part require to be identified in any way, unless the same has been clearly and legibly identified in compliance with this part.
(d) Any person receiving inspection services may, if dissatisfied with any decision of a program inspector relating to any inspection, file an appeal from such decision. Any such appeal from a decision of a program inspector must be made to the inspector's immediate supervisor having jurisdiction over the subject matter of the appeal, and such supervisor must determine whether the inspector's decision was correct. Review of such an appeal determination, when requested, must be made by the immediate supervisor of the Department employee making the appeal determination. The egg products involved in any appeal must be identified by U.S. retained tags and segregated in a manner approved by the inspector pending completion of an appeal inspection.
(e) All loss or inedible eggs, or inedible egg products must be disposed of in accordance with § 590.504(c)(1).
(a) Immediate containers of product offered for entry into the United States must bear a label, printed in English, showing:
(1) The name of the product;
(2) The name of the country of origin of the product, and for consumer packaged products, preceded by the words “Product of,” which statement must appear immediately under the name of the product;
(3) [Reserved];
(4) The word “Ingredients” followed by a list of the ingredients in order of descending proportions by weight, if applicable,;
(5) The name and place of business of the manufacturer, packer, or distributor, qualified by a phrase which reveals the connection that such person has with the product;
(6) An accurate statement of the quantity;
(7) The inspection mark of the country of origin;
(8) The date of production and the plant number of the plant at which the egg products were processed or packed.
(b) For properly sealed and certified shipments of shell eggs for breaking at an official plant, the immediate containers need not be labeled, provided that the shipment is segregated and controlled upon arrival at the destination breaking plant.
(c) The labels must not be false or misleading in any respect.
Shipping containers of imported egg products are required to bear in a prominent and legible manner the name of the product, the name of the country of origin, the foreign inspection system plant number of the plant in which the product was processed, shipping or identification marks, production codes, and the inspection mark of the country or origin. Labeling on shipping containers must be examined at the time of inspection in the United States and if found to be false or misleading, the product must be refused entry.
(a) Egg products eligible for importation may be relabeled with an approved label under the supervision of an inspector at an official plant or official import inspection establishment. The new label for such product must indicate the country of origin, except for egg products that are processed (repasteurized or, in the case of dried product, dry blended with product produced in the United States) in an official plant.
(b) The label for relabeled products must state the name, address, and zip code of the distributor, qualified by an appropriate term such as “packed for”, “distributed by”, or “distributors”.
Egg products (other than those that are forbidden entry by other Federal law or regulation) from any country, that are exclusively for the importer's personal use, display, or laboratory analysis, and not for sale or distribution; that are sound, healthful, wholesome, and fit for human food; and that are not adulterated and do not contain any substance not permitted by the Act or regulations, may be admitted into the United States without a foreign inspection certificate. Such products are not required to be inspected upon arrival in the United States and may be shipped to the importer without further restriction under this part, except as provided in 9 CFR 590.925(b), provided that the Department may, with respect to any specific importation, require that the importer certify that such product is exclusively for said importer's personal use, display, or laboratory analysis and not for sale or distribution. The amount of liquid, frozen, or dried egg products imported must not exceed 50 pounds.
U.S. inspected and passed and so marked egg products exported to and returned from foreign countries will be admitted into the United States without compliance with this part upon notification to and approval of the Food Safety and Inspection Service, in specific cases.
(a) All official plants must comply with the sanitation requirements contained in part 416 of this chapter, Sanitation, except as otherwise provided in this chapter.
(b) All official plants must comply with the Hazard Analysis and Critical Control Point (HACCP) Systems requirements contained in part 417 of this chapter, except as otherwise provided in this chapter.
(c) For the purposes of this chapter, parts 416, Sanitation, 417, Hazard Analysis and Critical Control Point (HACCP) Systems, and 500, Rules of Practice, an official establishment or establishment includes an official plant.
(a) Pursuant to 21 U.S.C. 1035 and 1043, the failure of an official plant to develop and implement a HACCP plan that complies with part 417 of this chapter may render the products produced under those conditions adulterated.
(b) Pursuant to 21 U.S.C. 1035 and 1043, the failure of an official plant to operate in accordance with the requirements in part 416 of this chapter, Sanitation, may render the products produced under those conditions adulterated.
(c) Pursuant to 21 U.S.C. 1035 and 1043, the failure of an official plant to operate in accordance with the Hazard Analysis and Critical Control Point (HACCP) Systems requirements in part 417 of this chapter, may render the product produced under those conditions adulterated.
(d) Pursuant to 21 U.S.C. 1035 and 1043, the failure of an official plant to operate in accordance with the requirements in part 500 of this chapter, Rules of Practice, and part 590 of this chapter, Inspection of Eggs and Egg Products (Egg Products Inspection Act) may render the products produced under those conditions adulterated.
Under the regulations in this part words in the singular shall be deemed to import the plural and vice versa, as the case may demand.
For the purpose of the regulations in this part, unless the context otherwise requires, the following terms shall be construed, respectively:
Act means the applicable provisions of the Agricultural Marketing Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.), or any other Act of Congress conferring like authority.
Administrator means the Administrator of the Food Safety and Inspection Service (FSIS) of the Department or any other officer or employee of the Department to whom there has been delegated, or to whom there may be delegated the authority to act in the Administrator's stead.
Applicant means any interested party who requests any inspection service, or appeal inspection, with respect to any product.
Class means any subdivision of a product based on essential physical characteristics that differentiate between major groups of the same kind, species, or method of processing.
Condition means any condition (including, but not being limited to, the state of preservation, cleanliness, soundness, wholesomeness, or fitness for human food) of any product which affects its merchantability; or any condition, including, but not being limited to, the processing, or packaging which affects such product.
Department means the United States Department of Agriculture.
District Manager means the manager in charge of a district, which is a designated geographical area.
Eggs of Current Production means shell eggs that have moved through the usual marketing channels since the date of lay and are not in excess of 60 days old.
Holiday or Legal holiday means the legal public holidays specified by the Congress in paragraph (a) of section 6103, Title 5, of the United States Code.
Inspection means the act by inspection program personnel of:
(1) Determining, according to these regulations, the class, quality, quantity, or condition of any product by examining each unit thereof or a representative sample drawn by inspection program personnel;
(2) Issuing a certificate; or
(3) Identifying, when requested by the applicant, any product by means of official identification pursuant to the Act and this part.
Inspection certificate or certificate means a statement, either written or printed, issued by inspection program personnel pursuant to the Act and this part, relative to the class, quality, quantity, and condition of products.
Inspection program personnel (employee) means employees of the Department authorized by the Secretary to investigate and certify, in accordance with the Act and this part, to shippers of products and other interested parties the class, quality, quantity, and condition of such products.
Interested party means any person financially interested in a transaction involving any inspection or appeal inspection of any product.
Official plant means any plant in which the facilities and methods of operation therein have been found by the Administrator to be suitable and adequate for inspection in accordance with this part and in which such service is carried on.
Person means any individual, partnership, association, business trust, corporation, or any organized group of persons, whether incorporated or not.
Product or products means eggs (whether liquid, frozen, or dried), egg products, and any food product that is prepared or manufactured and contains eggs as an ingredient.
Program employee means any person employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the program.
Quality means the inherent properties of any product that determine its relative degree of excellence.
Regulations mean the provisions in this part.
Sampling means the act of taking samples of any product for inspection.
Secretary means the Secretary of the Department or any other officer or employee of the Department to whom there has heretofore been delegated, or to whom there may hereafter be delegated, the authority to act in the Secretary's stead.
Service means: (1) Any inspection, in accordance with the Agriculture Marketing Act and the regulations in this part, of any product,
(2) Supervision, in any official plant, of the processing, packaging and identification, or
(3) Any appeal inspection of any previously inspected product.
Shell eggs mean the shell eggs of the domesticated chicken, turkey, duck, goose, and guinea.
Subsection 203(h) of the Agricultural Marketing Act of 1946, as amended by Public Law 272, 84th Congress, provides criminal penalties for various specified offenses relating to official certificates, memoranda, marks or other identifications, and devices for making such marks or identifications, issued or authorized under section 203 of said Act, and certain misrepresentations concerning the inspection of agricultural products under said section. For the purposes of said subsection and the provisions in this part, the terms listed below shall have the respective meanings specified:
(a) Official certificate means any form of certification, either written or printed, used under this part to certify with respect to the sampling, inspection, class, quality, quantity, or condition of products (including the compliance of products with applicable specifications).
(b) Official memorandum means any initial record of findings made by an authorized person in the process of inspecting, or sampling pursuant to this part, any processing or plant-operation report made by an authorized person in connection with inspecting, or sampling under this part and any report made by an authorized person of services performed pursuant to this part.
(c) Official mark means the inspection mark, and any other mark or symbol formulated pursuant to the regulations in this part, stating that the product was inspected, or for the purpose of maintaining the identity of the product.
(d) Official identification means any United States (U.S.) standard designation of class, quality, quantity, or condition specified in this part or any symbol, stamp, label, or seal indicating that the product has been officially inspected or indicating the class, quality, quantity, or condition of the product approved by the Administrator and authorized to be affixed to any product, or affixed to or printed on the packaging material of any product.
(e) Official device means a printed label, or other method as approved by the Secretary for the purpose of applying any official mark or other identification to any product of the packaging material thereof.
The Administrator shall perform, for and under the supervision of the Secretary, such duties as the Secretary may require in the enforcement or administration of the provisions of the Act and this part. The Administrator is authorized to waive for a limited period any particular provisions of the regulations in this part to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements and at the same time to determine full compliance with the spirit and intent of the regulations in this part. The Food Safety Inspection Service and its officers and employees shall not be liable in damages through acts of commission or omission in the administration of this part.
The regulations in this part provide for the following kinds of services:
(a) Inspection of the processing in official plants of products containing eggs;
(b) Sampling of products; and
(c) Quantity and condition inspection of products.
(d) Export certification. Upon application, by any person intending to export any egg product, inspectors may make certifications regarding products for human food purposes, to be exported, as meeting conditions or standards that are not imposed or are in addition to those imposed by the regulations in the part and the laws under which such regulations were issued.
Any product may be inspected wherever inspection program personnel are available and the facilities and the conditions are satisfactory for the conduct of the service.
(a) Products shall be inspected in accordance with such standards, methods, and instructions as may be issued or approved by the Administrator. All service shall be subject to supervision at all times by the applicable FSIS designated supervisor. Whenever the supervisor of an inspection program person has evidence that such inspection program employee incorrectly inspected a product, such supervisor shall take such action as is necessary to correct the inspection and to cause any improper official identification that appears on the product or containers thereof to be corrected prior to shipment of the product from the place of the initial inspection.
(b) Whenever service is performed on a sample basis, such sample shall be drawn in accordance with the instructions as issued by the Administrator.
All inspection program personnel and supervisors shall have in their possession at all times while on duty and present upon request the means of identification furnished by the Department to such person.
All inspection program personnel are forbidden during the period of their respective appointments, to take an active part in political management or in political campaigns. Political activity in city, county, State, or national elections, whether primary or regular, or in behalf of any party or candidate is prohibited, except as authorized by law or regulation of the Department. This applies to all appointees, including, but not being limited to, temporary and cooperative employees and employees on leave of absence with or without pay. Willful violation of this section will constitute grounds for dismissal.
(a) Inspection program personnel are authorized:
(1) To make such observations and inspections as they deem necessary to enable them to certify that products have been prepared, processed, stored, and otherwise handled in conformity with the regulations in this part;
(2) To supervise the marking of packages containing products that are eligible to be identified with official identification;
(3) To retain in their custody, or under their supervision, labels with official identification, marking devices, samples, certificates, seals, and reports of inspection program personnel;
(4) To deface or remove, or cause to be defaced or removed under their personal supervision, any official identification from any package containing products whenever the program employee determines that such products were not processed in accordance with the regulations in this part or are not fit for human food;
(5) To issue a certificate upon request on any product processed in the official plant; and
(6) To use retention tags or other devices and methods as may be approved by the Administrator for the identification and control of products that are not in compliance with the regulations in this part or are held for further examination, and any equipment, utensils, rooms or compartments that are found to be unclean or otherwise in violation of any of the regulations in this part. No product, equipment, utensil, room, or compartment shall be released for use until it has been made acceptable. Such identification shall not be removed by anyone other than inspection program personnel.
(b) Inspection program personnel shall prepare such reports and records as may be prescribed by the Administrator.
(a) Facilities and equipment for proper sampling, weighing, examination of products, and monitoring processing procedures shall be furnished by the official plant for use by inspection program personnel. Such facilities and equipment shall include but not be limited to a room or area suitable for sampling product and stationary or adequately secured storage box or cage (capable of being locked only by inspection program personnel) for holding official samples.
(b) Acceptable furnished office space and equipment, including but not being limited to, a desk, lockers or cabinets (equipped with a satisfactory locking device) suitable for the protection and storage of supplies, and with facilities for inspection program personnel to change clothing.
Inspection operating schedules for services performed pursuant to this part shall be requested in writing and approved by the appropriate District Office. Normal operating schedules for a full-week consist of a continuous 8-hour period per day (excluding but not to exceed 1 hour for lunch), 5 consecutive days per week, within the administrative workweek, Sunday through Saturday, for each shift required. Less than 8-hour schedules may be requested and will be approved if inspection program personnel are available. Clock hours of daily operations need not be specified in the request, although as a condition of continued approval, the hours of operation shall consist of a continuous 10-hour period per day (excluding but not to exceed 1 hour for lunch), 4 consecutive days per week, within the administrative workweek, Sunday through Saturday for each full shift required. Inspection program personnel are to be given reasonable advance notice by management of any change in the hours the inspection service is requested.
(a) An application for service may be made by any interested person, including, but not being limited to, the United States, any State, county, municipality, or common carrier, and any authorized agent of the foregoing.
(b) Where service is offered: Any product may be inspected, wherever an inspection program employee is available and the facilities and the conditions are satisfactory for the conduct of the service.
(c) The applicant must have a tax identification number for billing purposes.
Proof of the authority of any person applying for any service may be required at the discretion of the Administrator.
(a) On a fee basis. An application for service may be made with any inspection program personnel at or nearest the place where the service is desired. Such application for service may be made orally (in person or by telephone), in writing or by transmission. If an application for inspection service is made orally, the inspection program personnel with whom such application is made, or the Administrator, may require that the application be confirmed in writing.
(b) Form of application. Each application for inspection of a specified lot of any product shall include such information as may be required by the Administrator in regard to the product and the premises where such product is to be inspected.
Any person desiring to process products under inspection service must receive approval of such plant and facilities as an official plant prior to the installation of such service. The initial survey, drawings, and specifications to be submitted, changes and revisions in the official plant, and final survey and procedure for plant approval shall be in accordance with and conform to the applicable provisions of Part 590 of this chapter.
(a) Any application for service may be rejected by the Administrator:
(1) Whenever the applicant fails to meet the requirements of the regulations in this part prescribing the conditions under which the service is made available;
(2) Whenever the product is owned by or located on the premises of a person currently denied the benefits of the Act;
(3) Where any individual holding office or a responsible position with or having a substantial financial interest or share in the applicant is currently denied the benefits of the Act or was responsible in whole or in part for the current denial of the benefits of the Act to any person;
(4) Where the Administrator determines that the application is an attempt on the part of a person currently denied the benefits of the Act to obtain service;
(5) Whenever the applicant, after an initial survey has been made in accordance with Part 590, fails to bring the plant, facilities, and operating procedures into compliance with the regulations in this part within a reasonable period of time;
(6) Notwithstanding any prior approval whenever, before inauguration of service, the applicant fails to fulfill commitments concerning the inauguration of the service;
(7) When it appears that to perform the services specified in this part would not be to the best interests of the public welfare or of the Government; or
(8) When it appears to the Administrator that prior commitments of the Department necessitate rejection of the application.
(b) Each such applicant shall be promptly notified by registered mail of the reasons for the rejection. A written petition for reconsideration of such rejection may be filed by the applicant with the Administrator if postmarked or delivered within 10 days after receipt of notice of the rejection. Such petition shall state specifically the errors alleged to have been made by the Administrator in rejecting the application. Within 20 days following the receipt of such a petition for reconsideration, the Administrator shall approve the application or notify the applicant by registered mail of the reasons for the rejection thereof.
An application for service may be withdrawn by the applicant at any time before the service is performed upon payment, by the applicant, of all expenses incurred by the Agency in connection with such application.
Service shall be performed, insofar as practicable, in the order in which applications therefor are made except that precedence may be given to any application for an appeal.
(a) Any plant approval pursuant to the regulations in this part may be suspended for:
(1) Failure to maintain plant and equipment in a satisfactory state of repairs;
(2) The use of operating procedures that are not in accordance with the regulations in this part; or
(3) Alterations of buildings, facilities, or equipment that cannot be approved in accordance with the regulations in this part.
(b) During such period of suspension, inspection service shall not be rendered. However, the other provisions of the regulations in this part pertaining to providing service will remain in effect unless service is terminated in accordance with the terms thereof. If the plant facilities or methods of operation are not brought into compliance within a reasonable period of time to be specified by the Administrator, the application and service shall be terminated. Upon termination of service in an official plant pursuant to the regulations in this part, the plant approval shall also become terminated, and all labels, seals, tags, or packaging material bearing official identification shall, under the supervision of a person designated by the Administrator, either be destroyed, or if to be used at another location, modified in a manner acceptable to the Agency.
(a) The following acts or practices or the causing thereof may be deemed sufficient cause for the debarment by the Administrator of any person, including any agents, officers, subsidiaries, or affiliates of such person, from any or all benefits of the Act for a specified period.
(1) Misrepresentation, or deceptive or fraudulent act or practice. Any willful misrepresentation or any deceptive or fraudulent act or practice found to be made or committed by any person in connection with:
(i) The making or filing of an application for any service or appeal;
(ii) The making of the product accessible for sampling or inspection;
(iii) The making, issuing, or using, or attempting to issue or use, any certificate, symbol, stamp, label, seal, or identification authorized pursuant to the regulations in this part;
(iv) The use of the terms “United States,” “U.S.,” “U.S. Inspected,” “Government Inspected,” or terms of similar import in the labeling or advertising of any product;
(v) The use of any official stamp, symbol, label, seal, or identification in the labeling or advertising of any product.
(2) Use of facsimile forms. Using or attempting to use a form that simulates in whole or in part any certificate, symbol, stamp, label, seal, or identification authorized to be issued or used under the regulations in this part.
(3) Willful violation of the regulations. Any willful violation of the regulations in this part or of the Act.
(4) Interfering with inspection program personnel or program employee of the Agency. Any interference with or obstruction or any attempted interference or obstruction of or assault upon any inspection program personnel or program employee of the Agency in the performance of their duties. The giving or offering, directly or indirectly, of any money, loan, gift, or anything of value to a program employee of the Agency, or the making or offering of any contribution to or in any way supplementing the salary, compensation or expenses of a program employee of the Agency, or the offering or entering into a private contract or agreement with a program employee of the Agency for any services to be rendered while employed by the Agency.
(5) Miscellaneous. The existence of any of the conditions set forth in § 592.150 constituting the basis for the rejection of an application for inspection service.
Compliance with the regulations in this part shall not excuse failure to comply with any other Federal or any State or municipal applicable laws or regulations.
Each inspection program employee shall report, in the manner prescribed by the Administrator, all violations and noncompliance under the Act and this part of which such inspection program employee has knowledge.
The reuse, by any person, of containers bearing official identification is prohibited unless such identification is applicable in all respects to product being packed therein. In such instances, the container and label may be used provided the packaging is accomplished under the supervision of inspection program personnel or program employee, and the container is in clean, sound condition and lined with a suitable inner liner.
Labeling procedures, required information on labels, and method of label approval, shall be in accordance with and conform to the applicable provisions of part 590 of this chapter.
(a) The shield set forth in Figure 1, containing the letters “USDA,” shall be the official identification symbol for the purposes of this part and when used, imitated, or simulated in any manner in connection with a product shall be deemed to constitute a representation that the product has been officially inspected for the purpose of § 592.5.
(b) The inspection marks that are permitted to be used on products shall be contained within the outline of a shield and with the wording and design set forth in Figure 2 of this section, except the plant number may be followed by the letter “G” in lieu of the word “plant.” Alternatively, it may be omitted from the official shield if applied on the container's principal display panel or other prominent location and preceded by the word “Plant” or followed by the letter “G.”
Products that are permitted to bear the inspection mark shall be processed in an official plant from edible shell eggs or other edible egg products eligible to bear the inspection mark and may contain other edible ingredients. The official mark, when used, shall be printed or lithographed and applied as a part of the principal display panel of the container, but shall not be applied to a detachable cover.
(a) Containers or labels that bear official identification approved for use pursuant to § 592.300 shall be used only for the purpose for which approved. Any unauthorized use or disposition of approved containers or labels that bear any official identification may result in cancellation of the approval and denial of the use of containers or labels bearing official identification or denial of the benefits of the Act pursuant to the provisions of § 592.200;
(b) The use of simulations or imitations of any official identification by any person is prohibited;
(c) Upon termination of inspection service in an official plant pursuant to the regulations in this part, all labels or packaging material bearing official identification to be used to identify product packed by the plant shall either be destroyed, or have the official identification completely obliterated under the supervision of a USDA representative, or, if to be used at another location, modified in a manner acceptable to the Agency.
(a) Evidence of label approval. Inspection program personnel shall authorize the use of official identification on any inspected product when they have evidence that such official identification or packaging material bearing such official identification has been approved in accordance with the provisions of § 592.300.
(b) Affixing of official identification. No official identification may be affixed to or placed on or caused to be affixed to or placed on any product or container thereof except by an inspection program employee or under the supervision of an inspection program employee or other person authorized by the Administrator. All such products shall have been inspected in accordance with the regulations in this part. Inspection program personnel shall have supervision over the use and handling of all material bearing any official identification.
(c) Labels for products sold under Government contract. Inspectors-in-charge may approve labels for containers of product sold under a contract specification to governmental agencies when such product is not offered for resale to the general public: Provided, that the contract specifications include complete specific requirements with respect to labeling, and are made available to inspection program personnel.
Each product for which service is requested shall be so placed as to disclose fully its class, quality, quantity, and condition as the circumstances may warrant.
Certificates (including appeal certificates) shall be issued on forms approved by the Administrator.
When performing inspection service at locations other than an official establishment, inspection program personnel shall issue a certificate covering each product inspected. An applicant may request issuance of a certificate for each production lot inspected.
The original and a copy of each certificate issued pursuant to § 592.370, and not to exceed two additional copies thereof if requested by the applicant prior to issuance, shall, immediately upon issuance, be delivered or mailed to the applicant or designee. Other copies shall be filed and retained in accordance with the disposition schedule for inspection program records.
Upon request of an applicant, all or part of the contents of any certificate issued to such applicant may be telephoned or transmitted to the applicant or designee, at the applicant's expense.
Any person receiving inspection service may, if dissatisfied with any decision or action of an inspector or other Agency employee relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.
(a) Prohibition on movement of product. Products shall not have been moved from the place where the inspection being appealed was performed and must have been maintained under adequate refrigeration, when applicable.
(b) Laboratory analyses. The appeal sample shall consist of product taken from the original sample containers plus an equal number of containers selected at random. When the original sample containers cannot be located, the appeal sample shall consist of product taken at random from double the number of original sample containers.
(c) Condition inspection. The appeal sample shall consist of product taken from the original sample containers plus an equal number of containers selected at random. A condition appeal cannot be made unless all originally sampled containers are available.
Immediately after an appeal inspection is completed, an appeal certificate shall be issued to show that the original inspection was sustained or was not sustained. Such certificate shall supersede any previously issued certificate for the product involved and shall clearly identify the number and date of the superseded certificate. The issuance of the appeal certificate may be withheld until any previously issued certificate and all copies have been returned when such action is deemed necessary to protect the interest of the Government. When the appeal inspection program employee assigns a different class to the lot or determines that a net weight shortage exists, the lot shall be retained pending correction of the labeling or approval of the product disposition by the District Office.
(a) Fees and charges for voluntary base time rate, overtime inspection service, holiday inspection service, and electronic export applications shall be paid by the interested party making the application for such service, in accordance with the applicable provisions of this section and § 592.510 through § 592.530, both inclusive. If so required by the inspection personnel, such fees and charges shall be paid in advance.
(b) Fees and charges for any service shall, unless otherwise required pursuant to paragraph (c) of this section, be paid by check, draft, or money order payable to the Food Safety Inspection Service and remitted promptly to FSIS.
(c) Fees and charges for any service under a cooperative agreement with any State or person shall be paid in accordance with the terms of such cooperative agreement.
(d) Exporters that submit electronic export certificate applications will be charged a fee per application submitted.
(e) For each calendar year, FSIS will calculate the electronic export certificate application fee, using the following formula: Labor Costs (Technical Support Cost + Export Library Maintenance Cost) + Information Technology Costs (On-going operations Cost + Maintenance Cost + eAuthentication Cost), divided by the number of export applications.
(f) FSIS will publish notice of the electronic export certificate application fee annually in the
(a) For each calendar year, FSIS will calculate the basetime rate for inspection services, per hour per program employee, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by the previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate.
(b) FSIS will calculate the benefits, travel and operating, overhead, and allowance for bad debt rate components of the basetime rate, using the following formulas:
(1) Benefits rate. The quotient of dividing the previous fiscal year's direct benefits costs by the previous fiscal year's total hours (regular, overtime, and holiday), plus the quotient multiplied by the calendar year's percentage cost of living increase. Some examples of direct benefits are health insurance, retirement, life insurance, and Thrift Savings Plan basic and matching contributions.
(2) Travel and operating rate. The quotient of dividing the previous fiscal year's total direct travel and operating costs by the previous fiscal year's total hours (regular, overtime, and holiday), plus the quotient multiplied by the calendar year's percentage of inflation.
(3) Overhead rate. The quotient of dividing the previous fiscal year's indirect costs plus the previous fiscal year's information technology (IT) costs in the Public Health Data Communication Infrastructure System Fund plus the previous fiscal year's Office of Management Program cost in the Reimbursable and Voluntary Funds plus the provision for the operating balance less any Greenbook costs (i.e., costs of USDA support services prorated to the service component for which fees are charged) that are not related to food inspection, by the previous fiscal year's total hours (regular, overtime, and holiday) worked across all funds, plus the quotient multiplied by the calendar year's percentage of inflation.
(4) Allowance for bad debt rate. Previous fiscal year's allowance for bad debt (for example, debt owed that is not paid in full by plants and establishments that declare bankruptcy) divided by the previous fiscal year's total hours (regular, overtime, and holiday) worked.
(c) The calendar year's cost of living increases and percentage of inflation factors used in the formulas in this section are based on the Office of Management and Budget's Presidential Economic Assumptions.
When operations in an official plant require the services of inspection personnel beyond their regularly assigned tour of duty on any day or on a day outside the established schedule, such services are considered as overtime work. The official plant must give reasonable advance notice to the inspector of any overtime service necessary. For each calendar year, FSIS will calculate the overtime rate for inspection service, per hour per program employee, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase multiplied by 1.5, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate. FSIS calculates the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt using the formulas set forth in § 592.510(b), and the cost of living increases and percentage of inflation factors set forth in § 592.510(c).
When an official plant requires inspection service on a holiday or a day designated in lieu of a holiday, such service is considered holiday work. The official plant must, in advance of such holiday work, request that the inspector in charge furnish inspection services during such period and must pay the Agency for such holiday work at the hourly rate. For each calendar year, FSIS will calculate the holiday rate for inspection service, per hour per program employee, using the following formula: The quotient of dividing the Office of Field Operations plus Office of International Affairs inspection program personnel's previous fiscal year's regular direct pay by previous fiscal year's regular hours, plus the quotient multiplied by the calendar year's percentage of cost of living increase, multiplied by 2, plus the benefits rate, plus the travel and operating rate, plus the overhead rate, plus the allowance for bad debt rate. FSIS calculates the benefits rate, the travel and operating rate, the overhead rate, and the allowance for bad debt using the formulas set forth in § 592.510(b), and the cost of living increases and percentage of inflation factors set forth in § 592.510(c).
Except as otherwise approved by the Administrator, the sanitary, processing, and facility requirements, as applicable, shall be the same for the product processed under this part as for egg products processed under part 590 of this chapter.
Examinations of the ingredients, processing, and the product shall be made to ensure the production of a wholesome, unadulterated, and properly labeled product. Such examinations include, but are not being limited to:
(a) Sanitation checks of plant premises, facilities, equipment, and processing operations.
(b) Checks on ingredients and additives used in products to ensure that they are not adulterated, are fit for use as human food, and are stored, handled, and used in a sanitary manner.
(c) Examination of the eggs or egg products used in the products to ensure they are wholesome, not adulterated, and comply with the temperature, pasteurization, or other applicable requirements.
(d) Inspection during the processing and production of the product to determine compliance with any applicable standard or specification for such product.
(e) Examination during processing of the product to ensure compliance with approved formulas and labeling.
(f) Test weighing and organoleptic examinations of finished product.